AM AMRITA SCHOOL OF PHARMACY Program Pharm D ARITA A

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AM

AMRITA SCHOOL OF PHARMACY

Program

Pharm DARITA A

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Table of Contents

Contents Pg. No.

PROGRAMME OUTCOMES 3

PROGRAMME SPECIFIC OUTCOMES 4

CURRICULUM STRUCTURE 16-21

COURSE OBJECTIVES 28-96

COURSE OUTCOMES 6-15

EVALUATION SCHEME AND GRADING SYSTEM 22-27

SYLLABUS 28-96

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PROGRAMME OUTCOMES

1. Pharmacy Knowledge: Possess knowledge and comprehension of the core and

Basic knowledge associated with the profession of pharmacy, including biomedical

sciences; pharmaceutical sciences; behavioral, social, and administrative pharmacy

sciences; and manufacturingpractices.

2. Planning Abilities: Demonstrate effective planning abilities including time

management, resource management, delegation skills and organizational skills.

Develop and implement plans and organize work to meetdeadlines.

3. Problem analysis: Utilize the principles of scientific enquiry, thinking analytically,

clearly and critically, while solving problems and making decisions during daily

practice. Find, analyze, evaluate and apply information systematically and shall make defensibledecisions.

4. Modern tool usage: Learn, select, and apply appropriate methods and procedures,

resources, and modern pharmacy-related computing tools with an understanding of

thelimitations.

5. Leadership skills: Understand and consider the human reaction to change,

motivation issues, leadership and team-building when planning changes required for

fulfillment of practice, professional and societal responsibilities. Assume participatory

roles as responsible citizens or leadership roles when appropriate to facilitate

improvement in health andwellbeing.

6. Professional Identity: Understand, analyze and communicate the value of their

professional roles in society (e.g. health care professionals, promoters of health,

educators, managers, employers,employees).

7. Pharmaceutical Ethics: Honour personal values and apply ethical principles in

professional and social contexts. Demonstrate behavior that recognizes cultural and

personal variability in values, communication and lifestyles. Use ethical frameworks;

apply ethical principles while making decisions and take responsibility for the

outcomes associated with thedecisions.

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8. Communication: Communicate effectively with the pharmacy community and with

society at large, such as, being able to comprehend and write effective reports, make

effective presentations and documentation, and give and receive clearinstructions.

9. The Pharmacist and society: Apply reasoning informed by the contextual

knowledge to assess societal, health, safety and legal issues and the consequent

responsibilities relevant to the professional pharmacypractice.

10. Environment and sustainability: Understand the impact of the professional

pharmacy solutions in societal and environmental contexts, and demonstrate the

knowledge of, and need for sustainabledevelopment.

11. Life-long learning: Recognize the need for, and have the preparation and ability to engage in

independent and life-long learning in the broadest context of

technological change. Self assess and use feedback effectively from others to

identify learning needs and to satisfy these needs on an ongoingbasis

Programme SpecificOutcome

1. Todevelopcompetentpharmacygraduatesbystructured teachinglearningprocessthroughdedicatedand devoted faculty.

2. Todevelopin-depthknowledgeofmedicationsthatisintegratedwithafoundationalunderstandingof thebiomedical, pharmaceutical,socio-behavioral and clinical sciences.

3. Todevelopresponsibleclinicalpharmacyprofessionalstopracticeincollaborationwithotherhealth carepractitionersfor the purpose of improving patientcare.

4. Topromoteprofessionalism,teamspirit,socialandethicalcommitmenttoboostleadershiproleassistingimprovement in healthcare sector.

5. Toemphasize socialresponsibilityindelegatingsafe, accurate, rationalandcost-effectiveuseofmedications.

6. Todevelopskillsinidentifyingrational,reasonableandpracticalsolutionstodrugrelatedproblemsforthe wellbeing of the patients.

7. Toinspirethegraduatesforhighereducation,researchorentrepreneurshipandlife¬longlearningin thecontext of technological advancem

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AMRITA VISHWA VIDYAPEETHAM is a multi-campus, multi-disciplinary research academia that isaccredited ‘A’ by NAAC and is ranked as one of the best research institutions in India. Amrita is spreadacross five campuses in three states of India - Kerala, Tamil Nadu and Karnataka, with the headquarters atEttimadai, Coimbatore, Tamil Nadu. The institution is managed by the Mata AmritanandamayiMath.

AMRITASCHOOLOFPHARMACYisaconstituentUnitofAMRITAVISHWAVIDYAPEETHAMDeemedUniversity established under Section 3 of UGC Act l956. It is located in the Health Sciences Cam- pus ofthe University at Kochi, Kerala, India. Amrita School of Pharmacy offers training for one ofthemostsoughtafterprofessions.TheSchool’scommitmenttoexcellenceinhealthcareisinline with the overallobjective of the Kochi - based Health Sciences campus of theUniversity.

AmritaSchoolofPharmacyisrecognizedbyPharmacyCouncilofIndia(PCI)andAllIndiaCouncil for TechnicalEducation (AICTE). The School and the Institution are accredited by The National Assessment andAccreditation Council (NAAC) with ‘A’Grade.

TheSchoolofPharmacystrivesnotonlytoprovidequalityeducationinpharmaceuticalsciencesbutalsotoestablishitselfinresearchandservesasanidealplatformfortheoveralldevelopmentofhighlycompetentpharmacyprofessionals.TheSchoolmaintainsanexemplaryclinicalpracticeandconductscommunityoutreachprogrammesthataddresstheneedsofthesocietyatlarge.

VISION

TodevelopasacenterofexcellenceinPharmacyeducationandresearchandbecomeoneamongthedistinguishedpharmainstitutionsinthecountry.Itenvisionstoestablisheffectivecollabora- tions withPharma industries and international pharmacy institutions for mutualbenefits.

MISSION

To provide high quality value-based education with high emphasis on research and mould com- petentand socially committed pharmacy professionals capable of practicing and managing the future ofpharmacy profession in the country and abroad.

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Programmes Offered:

• B.Pharm (4 years – 8semesters)

• M.Pharm (2 years – 4semesters)

o PharmacyPractice

o Pharmaceutics

o PharmaceuticalChemistry

o Pharmacology

• Pharm. D Regular (5 years plus 1 yearInternship)

• Pharm. D Post Baccalaureate (2 years plus 1 yearInternship)

• Ph.D in PharmaceuticalSciences

Doctor of Pharmacy (Pharm. D)

Amrita School of Pharmacy started offering the six year integrated Pharm. D. (Regular) and three yearPharm. D. Post Baccalaureate programmes from 2010, taking full advantage of its in house hospital andtheassociatedhealthcareservices.ThetwoprogrammeswerethefirstoftheirkindinthestateofKerala, where as itwas introduced in the country in2008.

Pharm. D regulations 2008 framed by Pharmacy Council of India under section 10 of the Pharmacy Act,1948 (8 of 1948) has been adopted by Amrita School of Pharmacy from 2010 onwards.

REGULATIONS (Pharm D)

Course Outcomes (COs)

Course Name CourseCode

Course Outcomes

First yearHUMAN ANATOMY ANDPHYSIOLOGY

1.1 The student should be able to

CO 1. Describe the structure (gross and histology) and functions ofvarious organs of the human body.

CO 2.Describe the various homeostatic mechanisms and theirimbalances of various systems.

CO 3. Identify the various tissues and organs of the different systemsof the human body.

CO 4. Perform the hematological tests and also record blood pressure,heart rate, pulse and respiratory volumes.

CO 5. Appreciate coordinated working pattern of different organs ofeach system.

CO 6. Appreciate the interlinked mechanisms in the maintenance of

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normal functioning (homeostasis) of human body.

PHARMACEUTICS 1.2 The student should be able to

CO 1. Know the formulation aspects of different dosage forms.

CO 2. Do different pharmaceutical calculation involved informulation.

CO 3. Formulate different types of dosage forms.

CO 4. Appreciate the importance of good formulation foreffectiveness.

MEDICINALBIOCHEMISTRY


CO 1. Understand the catalytic activity of enzymes and importance ofisoenzymes in diagnosis of diseases.

CO 2. Know the metabolic process of biomolecules in health andillness (metabolic disorders).

CO 3. Understand the genetic organization of mammalian genome;protein synthesis; replication; mutation and repair mechanism.

CO 4. Know the biochemical principles of organ function tests ofkidney, liver and endocrine gland.

CO 5. Do the qualitative analysis and determination of biomoleculesin the body fluids.

PHARMACEUTICALORGANIC CHEMISTRY


CO 1. Know the IUPAC/Common system of nomenclature ofsimple organic compounds belonging to different classes oforganic compounds.

CO 2. Understand some important physical properties of organiccompounds..CO 3. Know free radical/ nucleophyllic [alkyl/ acyl/aryl]/electrophyllic substitution, free radical/nucleophyllic/electrophyllic addition, elimination, oxidation andreduction reactions with mechanism, orientation of the reaction,order of reactivity, stability of compounds.

CO 4. Understand some named organic reactions withmechanisms.

CO 5. Know the methods of preparation, test for purity,principle involved in the assay, important medicinal uses of

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some important organic compounds.

PHARMACEUTICALINORGANIC CHEMISTRY


CO 1. Understand the principles and procedures of analysis of drugsand also regarding the application of inorganic pharmaceuticals.

CO 2. Know the analysis of the inorganic pharmaceuticals and theirapplications.

CO 3. Appreciate the importance of inorganic pharmaceuticals inpreventing and curing the disease.

REMEDIALMATHEMATICS/BIOLOGY


CO 1.Know Trignometry, Analytical geometry, Matrices,Determinant, Integration, Differential equation, Laplace transform andtheir applications.

CO 2. Solve the problems of different types by applying theory.

CO 3. Appreciate the important applications of mathematics inpharmacy.

Second yearPATHOPHYSIOLOGY 2.1 The student should be able to

CO 1. Describe the etiology and pathogenesis of the selected diseasestates.

CO 2. Name the signs and symptoms of the diseases.

CO 3. Mention the complications of the diseases.

PHARMACEUTICALMICROBIOLOGY


CO 1. Know the anatomy, identification, growth factors andsterilization of microorganisms.

CO 2. Know the mode of transmission of disease causingmicroorganism, symptoms of disease, and treatment aspect.

CO 3. Do estimation of RNA and DNA and there by identifying thesource.

CO 4. Do cultivation and identification of the microorganisms in thelaboratory.

CO 5. Do identification of diseases by performing the diagnostic tests.

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CO 6. Appreciate the behavior of motility and behavioralcharacteristics of microorganisms.

PHARMACOGNOSY &PHYTOPHARMACEUTICALS


CO 1. Understand the basic principles of cultivation, collection andstorage of crude drugs.

CO 2. Know the source, active constituents and uses of crude drugs.

CO 3. Appreciate the applications of primary and secondarymetabolites of the plant.

PHARMACOLOGY – I 2.4 The student should be able to

CO 1. Understand the pharmacological aspects of drugs.

CO 2. Handle and carry out the animal experiments.

CO 3. Appreciate the importance of pharmacology subject as a basisof therapeutics.

CO 4. Correlate and apply the knowledge therapeutically.

COMMUNITYPHARMACY


CO 1. Know pharmaceutical care services.

CO 2. Know the business and professional practice management skillsin community pharmacies.

CO 3. Do patient counseling & provide health screening services topublic in community pharmacy.

CO 4. Respond to minor ailments and provide appropriate medication.

CO 5. Show empathy and sympathy to patients.

CO 6. Appreciate the concept of Rational drug therapy.

PHARMACOTHERAPEUTICS-I

2.6 The student should be able to understand

CO 1. The pathophysiology of selected disease states and the rationalefor drug therapy.

CO 2. The therapeutic approach to management of these diseases.

CO 3. The controversies in drug therapy.

CO 4. The importance of preparation of individualized therapeutic

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plans based on diagnosis.

CO 5. Needs to identify the patient-specific parameters relevant ininitiating drug therapy, and monitoring therapy (including alternatives,time-course of clinical and laboratory indices of therapeutic responseand adverse effects).

CO 6. Describe the pathophysiology of selected disease states andexplain the rationale for drug therapy.

CO 7. Summarize the therapeutic approach to management of thesediseases including reference to the latest available evidence.

CO 8. Discuss the controversies in drug therapy.

CO 9. Discuss the preparation of individualized therapeutic plansbased on diagnosis.

CO 10. Identify the patient-specific parameters relevant in initiatingdrug therapy, and monitoring therapy (including alternatives, time-course of clinical and laboratory indices of therapeutic response andadverse effects).

Third YearPHARMACOLOGY – II 3.1 The student should be able to

CO 1. Understand the pharmacological aspects of drugs.

CO 2. Carry out the animal experiments confidently.

CO 3. Appreciate the importance of pharmacology subject as a basisof therapeutics.

CO. 4 Correlate and apply the knowledge therapeutically.

PHARMACEUTICALANALYSIS


CO 1. Understand the principles of volumetric and electro chemicalanalysis

CO 2. Carry out various volumetric and electrochemical titrations

CO3. Develop analytical skills

CO 4. Understand the interaction of matter with electromagneticradiations and its applications in druganalysis

CO 5. Understand the chromatographic separation and analysis ofdrugs.

CO 6. Perform quantitative & qualitative analysis of drugs using

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various analytical instruments

PHARMACOTHERAPEUTICS – II


CO 1. Know the pathophysiology of selected disease states and therationale for drug therapy.

CO 2. Know the therapeutic approach to management of thesediseases.

CO 3. Know the controversies in drug therapy.

CO 4.Knowtheimportanceofpreparationofindividualisedtherapeuticplansbasedondiagnosis.

CO 5. Appreciatetheneedtoidentifythepatientspecificparametersrelevant ininitiatingdrugtherapy, andmonitoringtherapy (includingalternatives,timecourseofclinicalandlaboratoryindicesoftherapeuticresponseandadverse effects).

PHARMACEUTICALJURISPRUDENCE


CO 1. Practice the Professional ethics.

CO 2. Understand the various concepts of the pharmaceuticallegislation in India.

CO 3. Know the various parameters in the Drug and Cosmetic Actand rules.

CO 4. Know the Drug policy, DPCO, Patent and design act.

CO 5. Understand the labeling requirements and packaging guidelinesfor drugs and cosmetics.

CO 6. Understand the concepts of Dangerous Drugs Act, PharmacyAct and Excise duties Act.

CO 7. Other laws as prescribed by the Pharmacy Council of Indiafrom time to time including International Laws.

MEDICINALCHEMISTRY


CO 1. Understand different classes of drugs including SAR,mechanism of action, synthesis of important compounds, chemicalnomenclature, brand names of important marketed products and theirside effects.

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PHARMACEUTICALFORMULATIONS


CO 1.Understand the principle involved in formulation of variouspharmaceutical dosage forms.

CO 2. Prepare various pharmaceutical formulation.

CO 3. Perform evaluation of pharmaceutical dosage forms.

CO 4. Understand and appreciate the concept of bioavailability andbioequivalence, their role in clinical situations.

Fourth Year

PHARMACOTHERAPEUTICS – III


CO 1. Understand the pathophysiology of selected disease states andthe rationale for drug therapy.

CO 2. Know the therapeutic approach to management of thesediseases.

CO 3. Understand the controversies in drug therapy.

CO 4. Importance of preparation of individualized therapeutic plansbased on diagnosis.

CO 5. Identify the patient-specific parameters relevant in initiatingdrug therapy, and monitoring therapy (including alternatives, time-course of clinical and laboratory indices of therapeutic response andadverse effects).

HOSPITAL PHARMACY 4.2 The student should be able to

CO 1. Know various drug distribution methods.

CO 2. Know the professional practice management skills inhospital pharmacies.

CO 3. Provide unbiased drug information to the doctors.

CO 4. Know the manufacturing practices of variousformulations in hospital set up.

CO 5. Appreciate the practice based research methods.

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CO 6. Appreciate the stores management and inventory control.

CLINICAL PHARMACY 4.3 The student should be able to

CO 1.Monitor drug therapy of patient through medication chart reviewand clinical review.

CO 2. Obtain medication history interview and counsel the patients.

CO 3. Identify and resolve drug related problems.

CO 4. Detect, assess and monitor adverse drug reaction.

CO 5. Interpret selected laboratory results (as monitoring parametersin therapeutics) of specific disease states;

CO 6. Retrieve, analyze, interpret and formulate drug or medicineinformation.

BIOSTATISTICS ANDRESEARCHMETHODOLOGY


CO 1. Know the operation of M.S. Excel, SPSS, R and MINITAB®,DoE (Design of Experiment)

CO 2. Know the various statistical techniques to solve statisticalproblems

CO 3. Appreciate statistical techniques in solving the problems.

BIOPHARMACEUTICSANDPHARMACOKINETICS


CO 1. Understand the basic concepts in biopharmaceutics andpharmacokinetics and their significance.

CO 2. Use of plasma drug concentration-time data to calculate thepharmacokinetic parameters to describethe kinetics of drug absorption, distribution, metabolism, excretion,elimination.

CO 3. To understand the concepts of bioavailability andbioequivalence of drug products and their significance.

CO 4. Understand various pharmacokinetic parameters, theirsignificance & applications

CLINICAL TOXICOLOGY 4.6 The student should be able to

CO 1. Explain the various types of toxicity studies.

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CO 2. Appreciate the importance of ethical and regulatoryrequirements for toxicity studies.

CO 3. Demonstrate the practical skills required to conduct thepreclinical toxicity studies.

Fifth year

CLINICAL RESEARCH 5.1 The student should be able to

CO 1. Understand the scope of clinical research

CO 2. Define the main terminologies pertaining to clinical research

CO 3. Understand the ethical issues in the design, conduct andreporting of clinical trials

CO 4. Explain the different phases and types of clinical trials

CO 5. Describe the different documents in clinical trial

CO 6. Understand the concepts of ICH E6, ICH E3, CDSCOguidelines and Schedule Y requirements for clinical trials

CO 7. Understand the different concepts of clinical trial management

PHARMACOEPIDEMIOLOGY ANDPHARMACOECONOMICS


CO 1. Understand the various epidemiological methods and theirapplications.

CO 2. Understand the fundamental principles of pharmacoeconomics.

CO 3. Identify and determine relevant cost and consequencesassociated with pharmacy products and services.

CO 4. Perform the key pharmacoeconomics analysis methods.

CO 5. Understand the pharmacoeconomic decision analysis methodsand its applications.

CO 6. Describe current pharmacoeconomic methods and issues.

CO 7.Understand the applications of pharmacoecono - mics tovarious pharmacy settings.

CLINICALPHARMACOKINETICSANDPHARMACOTHERAPEUTIC DRUG MONITORING


CO 1. Design the drug dosage regimen for individual patients.

CO 2. Interpret and correlate the plasma drug concentrations with

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patients’ therapeutic outcomes.

CO 3. Recommend dosage adjustment for patients with renal/ hepaticimpairment.

CO 4. Recommend dosage adjustment for paediatrics and geriatrics.

CO 5. Manage pharmacokinetic drug interactions.

CO 6. Apply pharmacokinetic parameters in clinical settings.

CO 7. Interpret the impact of genetic polymorphisms of individuals onpharmacokinetics and or pharmaco dynamics of drug.

CO 8. Do pharmacokinetic modeling for the given data using theprinciples of pharmacometrics

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[PUBLISHED IN THE GAZETTE OF INDIA, No.19, PART III,SECTION 4]

Ministry of Health and Family Welfare(Pharmacy Council of India)

New Delhi, 10th May,2008.

Pharm.D. Regulations 2008

Regulations framed under section 10 of the Pharmacy Act, 1948 (8 of 1948).

(As approved by the Government of India, Ministry of Health vide, letter No.V.13013/1/2007-PMS, datedthe 13th March, 2008 and notified by the Pharmacy Council of India).

No.14-126/2007-PCI.― In exercise of the powers conferred by section 10 of the Pharmacy Act, 1948 (8 of 1948), the Pharmacy Council of India, with the approval of the Central Government, hereby makes

the following regulations, namely:-

CHAPTER-I

1. Shorttitleandcommencement.–(1)TheseregulationsmaybecalledthePharm.D.Regulations2008.

(2) They shall come into force from the date of their publication in the official Gazette.

2. Pharm.D.shallconsistofacertificate,havingpassedthecourseofstudyandexaminationasprescribed in theseregulations, for the purpose of registration as a pharmacist to practice the profession under thePharmacy Act, 1948.

3. Duration of the course.–

CHAPTER-II

a) Pharm.D: The duration of the course shall be six academic years (five years of study and one year ofinternship or residency) full time with each academic year spread over a period of not less than twohundred working days. The period of six years duration is divided into two phases–

Phase I – consisting of First, Second, Third, Fourth and Fifth academic year.

PhaseII–consistingofinternshiporresidencytrainingduringsixthyearinvolvingpostinginspecialityunits.Itisaphaseoftrainingwhereinastudentisexposedtoactualpharmacypracticeorclinicalphar- macyservices and acquires skill under supervision so that he or she may become capable of function-ingindependently.

b) Pharm.D.(PostBaccalaureate):Thedurationofthecourseshallbeforthreeacademicyears(twoyears of studyand one year internship or residency) full time with each academic year spread over a period of notless than two hundred working days. The period of three years duration is divided into two phases–

Phase I – consisting of First and Second academic year.

PhaseII–consistingofInternshiporresidencytrainingduringthirdyearinvolvingpostinginspecialityunits.Itisaphaseoftrainingwhereinastudentisexposedtoactualpharmacypracticeorclinicalphar-macyservices,andacquiresskillundersupervisionsothatheorshemaybecomecapableoffunction-ingindependently.

Minimum qualification for admission to.–

a) Pharm.D. Part-I Course – A pass in any of the following examinations-

(1) 10+2 examination with Physics and Chemistry as compulsory subjects along with one of the following

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Mathematics or Biology.

(2) ApassinD.PharmcoursefromaninstitutionapprovedbythePharmacyCouncilofIndiaundersection 12 ofthe PharmacyAct.

(3) Any other qualification approved by the Pharmacy Council of India as equivalent to any of the aboveexaminations.

Provided that a student should complete the age of 17 years on or before 31st December of the year ofadmission to the course.

Provided that there shall be reservation of seats for the students belonging to the Scheduled Castes,ScheduledTribesandotherBackwardClassesinaccordancewiththeinstructionsissuedbytheCentralGovernment/StateGovernment/UnionTerritoryAdministrationasthecasemaybefromtimetotime.

b) Pharm.D. (Post Baccalaureate) Course-

A pass in B.Pharm from an institution approved by the Pharmacy Council of India under section 12 ofthe Pharmacy Act:

Provided that there shall be reservation of seats for the students belonging to the Scheduled Castes,ScheduledTribesandotherBackwardClassesinaccordancewiththeinstructionsissuedbytheCentralGovernment/StateGovernment/UnionTerritoryAdministrationasthecasemaybefromtimetotime.

4. Number of admissions in the above said programmes shall be as prescribed by the Pharmacy Councilof India from time to time and presently be restricted as below–

i) Pharm.D. Programme – 30students.

ii) Pharm.D. (Post Baccalaureate) Programme – 10students.

5. InstitutionsrunningB.Pharmprogrammeapprovedundersection12ofthePharmacyAct,willonlybepermitted to run Pharm.D. programme. Pharm.D. (Post Baccalaureate) programme will be permittedonly in those institutions which are permitted to run Pharm.D.programme.

6. Course of study. – The course of study for Pharm.D. shall include the subjects as given in the Tablesbelow.Thenumberofhoursinaweek,devotedtoeachsubjectforitsteachingintheory,practicaland tutorialshall not be less than that noted against it in columns (3), (4) and (5)below.

First Year:

* F

Sec

Th

S.No. Name of Subject No. of hours

of Theory

No. of hours

of Practical

No. of hours

of Tutorial

(1) (2) (3) (4) (5)

1.1 Human Anatomy and Physiology 3 3 1

1.2 Pharmaceutics 2 3 1

1.3 Medicinal Biochemistry 3 3 1

1.4 Pharmaceutical Organic Chemistry 3 3 1

1.5 Pharmaceutical Inorganic Chemistry 2 3 1

1.6 Remedial Mathematics/ Biology 3 3* 1

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orBiology

ond Year :

S.No. Name of Subject No. of

hours of

Theory

No. of

hours of

Practical

No. of hours

of Tutorial

(1) (2) (3) (4) (5)

2.1 Pathophysiology 3 - 1

2.2 Pharmaceutical Microbiology 3 3 1

2.3 Pharmacognosy & Phytopharmaceuticals 3 3 1

2.4 Pharmacology-I 3 - 1

2.5 Community Pharmacy 2 - 1

2.6 Pharmacotherapeutics-I 3 3 1

Total hours 17 9 6 = 32

ird Year :

Total hours 16 18 6 = (40)

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hours of

Theory

No. of

hours of

Practical

No. of

hours of

Tutorial(1) (2) (3) (4) (5)

3.1 Pharmacology-II 3 3 1

3.2 Pharmaceutical Analysis 3 3 1

3.3 Pharmacotherapeutics-II 3 3 1

3.4 Pharmaceutical Jurisprudence 2 - -

3.5 Medicinal Chemistry 3 3 1

3.6 Pharmaceutical Formulations 2 3 1


Fourth Year :


hours ofTheory

No. of hours of

Practical/Hospita

l Posting

No. of

hours ofTutorial

(1) (2) (3) (4) (5)

4.1 Pharmacotherapeutics-III 3 3 1

4.2 Hospital Pharmacy 2 3 1

4.3 Clinical Pharmacy 3 3 1

4.4 Biostatistics & Research Methodology 2 - 1

4.5 Biopharmaceutics & Pharmacokinetics 3 3 1

4.6 Clinical Toxicology 2 - 1


20

Fifth Year :


hours of

Theory

No. of hours of

Hospital

posting*

No. of

hours of

Seminar(1) (2) (3) (4) (5)

5.1 Clinical Research 3 - 1

5.2 Pharmacoepidemiology andPharmacoeconomics

3 - 1

5.3 Clinical Pharmacokinetics &Pharmacotherapeutic Drug Monitoring

2 - 1

5.4 Clerkship * - - 1

5.5 Project work (Six Months) - 20 -

Total hours 8 20 4 = 32* Attending ward rounds on daily basis.

Sixth Year:

Internship or residency training including postings in speciality units. Student should independently pro-vide the clinical pharmacy services to the allotted wards.

(i) Six months in General Medicine department,and

(ii) Two months each in three other specialitydepartments

7. Syllabus.–ThesyllabusforeachsubjectofstudyinthesaidTablesshallbeasspecifiedinAppendix-A totheseregulations.

8. Approval of the authority conducting the course of study. – (1) No person, institution, society or uni-versityshallstartandconductPharm.DorPharm.D.(PostBaccalaureate)programmewithoutthepriorapproval of the Pharmacy Council ofIndia.

(2) Anypersonorpharmacycollegeforthepurposeofobtainingpermissionundersub-section(1)ofsec- tion 12 ofthe Pharmacy Act, shall submit a scheme as prescribed by the Pharmacy Council ofIndia.

(3) Theschemereferredtoinsub-regulation(2)above,shallbeinsuchformandcontainsuchparticulars and bepreferred in such manner and be accompanied with such fee as may beprescribed:

Provided that the Pharmacy Council of India shall not approve any institution under these regulationsunless it provides adequate arrangements for teaching in regard to building, accommodation, labs.,equipments, teaching staff, non-teaching staff, etc., as specified in Appendix-B to these regulations.

9. Examination. – (1) Every year there shall be an examination to examine thestudents.

(2) Each examination may be held twice every year. The first examination in a year shall be the annualexamination and the second examination shall be supplementaryexamination.

(3) Theexaminationsshallbeofwrittenandpractical(includingoralnature)carryingmaximummarksfor eachpart of a subject as indicated in Tables below:

First Yearexamination :

T A B L E S

S.No. Name of Subject Maximum marks forTheory

Maximum marks forPracticals

Examination

Sessional Total

Examination

Sessional Total

1.1 Human Anatomy and

Physiology 70 30 100 70 30 100

1.2 Pharmaceutics 70 30 100 70 30 1001.3 Medicinal Biochemistry 70 30 100 70 30 100

1.4 Pharmaceutical Organic

Chemistry70 30 100 70 30 100

1.5 Pharmaceutical Inor-ganic Chemistry

70 30 100 70 30 100

1.6 Remedial Mathematics/

Biology70 30 100 70* 30* 100*

600 600=1200* for Biology

Second Year examination:

T

T A B L E S

S

2

2

2

2

2

2

.No. Name of Subject Maximum marks for Theory Maximum marks for Practicals

Examination Sessional Total Examination Sessional Total

.1 Pathophysiology 70 30 100 - - -

.2 Pharmaceutical

Microbiology70 30 100 70 30 100

.3 Pharmacognosy &

Phytopharmaceuticals70 30 100 70 30 100

.4 Pharmacology-I 70 30 100 - - -

.5 Community Pharmacy 70 30 100 - - -

.6 Pharmacotherapeutics-I 70 30 100 70 30 100

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hird Year examination :



Examination

Sessional Total

Examination

Sessional Total

3.1 Pharmacology-II 70 30 100 70 30 1003.2 Pharmaceutical

Analysis70 30 100 70 30 100

3.3 Pharmacotherapeutics-II 70 30 100 70 30 100

600 300 = 900

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3.4 Pharmaceutical

Jurisprudence

70 30 100 - - -

3.5 Medicinal Chemistry 70 30 100 70 30 100

3.6 Pharmaceutical

Formulations70 30 100 70 30 100

600 500=1100

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Fourth Year examination :



Examination

Sessional Total

Examination

Sessional Total

4.1 Pharmacotherapeutics-III 70 30 100 70 30 100

4.2 Hospital Pharmacy 70 30 100 70 30 100

4.3 Clinical Pharmacy 70 30 100 70 30 100

4.4 Biostatistics & Research

Methodology70 30 100 - - -

4.5 Biopharmaceutics &

Pharmacokinetics70 30 100 70 30 100

4.6 Clinical Toxicology 70 30 100 - - -

600 400=1000

Fifth Year examination :



Examination

Sessional Total Examination

Sessional Total

5.1 Clinical Research 70 30 100 - - -

5.2Pharmacoepidemiologyand Pharmacoeconomics

70 30 100 - - -

5.3

ClinicalPharmacokinetics &PharmacotherapeuticDrug Monitoring

70 30 100 - - -

Clerkship * - - - 70 30 100

5.4

5.5

Project work (Six

Months)- - - 100** - 100

300 200=500* Attending ward rounds on dailybasis.** 30 marks – viva-voce (oral)

70 marks – Thesis work

10. Eligibility for appearing Examination.― Only such students who produce certificate from the Head of the Institution in which he or she has undergone the Pharm.D. or as the case may be, the Pharm.D.(Post Baccalaureate) course, in proof of his or her having regularly and satisfactorily undergone thecourse of study by attending not less than 80% of the classes held both in theory and in practical sep-arately in each subject shall be eligible for appearing atexamination.

11. Mode of examinations.― (1) Theory examination shall be of three hours and practical examination shall be of four hoursduration.

(2) A Student who fails in theory or practical examination of a subject shall re-appear both in theory andpractical of the samesubject.

(3) Practical examination shall also consist of a viva –voce (Oral)examination.

25

(4) Clerkshipexamination–Oralexaminationshallbeconductedafterthecompletionofclerkshipofstu- dents.An external and an internal examiner will evaluate the student. Students may be asked to present theallotted medical cases followed by discussion. Students’ capabilities in deliveringclinical

pharmacy services, pharmaceutical care planning and knowledge of therapeutics shall be assessed.

12.Awardofsessionalmarksandmaintenanceofrecords.―(1)Aregularrecordofboththeoryandprac- ticalclassworkandexaminationsconductedinaninstitutionimpartingtrainingforPharm.D.orasthecasemaybe,Pharm.D.(PostBaccalaureate)course,shallbemaintainedforeachstudentintheinstitu-tionand30marksforeachtheoryand30marksforeachpracticalsubjectshallbeallottedassessional.

(2) Thereshallbeatleasttwoperiodicsessionalexaminationsduringeachacademicyearandthehighest aggregateof any two performances shall form the basis of calculating sessionalmarks.

(3) The sessional marks in practicals shall be allotted on the followingbasis:-

(i) Actual performance in thesessionalexamination (20marks);

(ii) Day to day assessment in the practical classwork,promptness, viva-voce recordmaintenance,etc.(10marks).

13. Minimum marks for passing examination.― A student shall not be declared to have passed examination unless he or she secures at least 50% marks in each of the subjects separately in the theoryexaminations, including sessional marks and at least 50% marks in each of the practical examinationsincluding sessional marks. The students securing 60% marks or above in aggregate in all subjects in asingleattemptatthePharm.D.orasthecasemaybe,Pharm.D.(PostBaccalaureate)courseexamina-tionshallbedeclaredtohavepassedinfirstclass.Studentssecuring75%marksoraboveinanysubject orsubjects shall be declared to have passed with distinction in the subject or those subjects provided heor she passes in all the subjects in a singleattempt.

14. Eligibilityforpromotiontonextyear.―Allstudentswhohaveappearedforallthesubjectsandpassed the first year annual examination are eligible for promotion to the second year and, so on. However,failureinmorethantwosubjectsshalldebarhimorherfrompromotiontothenextyearclasses.

15. Internship.― (1) Internship is a phase of training wherein a student is expected to conduct actual practice of pharmacy and health care and acquires skills under the supervision so that he or she maybecome capable of functioningindependently.

(2) Every student has to undergo one year internship as per Appendix-C to these regulations.

16. Approval of examinations.― Examinations mentioned in regulations 10 to12 and 14 shall be held by theexaminingauthorityhereinafterreferredtoastheuniversity,whichshallbeapprovedbythePhar- macyCouncil of India under sub-section (2) of section 12 of the Pharmacy Act, 1948. Such approvalshallbegrantedonlyiftheexaminingauthorityconcernedfulfillstheconditionsasspecifiedinAppen- dix–Dto theseregulations.

17. Certificateofpassingexamination.―EverystudentwhohaspassedtheexaminationsforthePharm.D. (DoctorofPharmacy)orPharm.D.(PostBaccalaureate)(DoctorofPharmacy)asthecasemaybe,shall begranted a certificate by the examiningauthority.

CHAPTER-III

Practicaltraining

18. Hospital posting.― Every student shall be posted in constituent hospital for a period of not less than fifty hours to be covered in not less than 200 working days in each of second, third & fourth yearcourse.EachstudentshallsubmitreportdulycertifiedbythepreceptoranddulyattestedbytheHeadoftheDepartmentorInstitutionasprescribed.Inthefifthyear,everystudentshallspendhalfadayinthemorninghoursattendingwardroundsondailybasisasapartofclerkship.Theoryteachingmaybe scheduledin theafternoon.

26

19. Project work.― (1) To allow the student to develop data collection and reporting skills in the area of community, hospital and clinical pharmacy, a project work shall be carried out under the supervision ofa teacher. The project topic must be approved by the Head of the Department or Head of the In-stitution. The same shall be announced to students within one month of commencement of the fifthyearclasses.Projectworkshallbepresentedinawrittenreportandasaseminarattheendoftheyear. Externaland the internal examiners shall do the assessment of the projectwork.

(2) Project work shall comprise of objectives of the work, methodology, results, discussions and conclu-sions.

20. Objectives of project work.― The main objectives of the project work isto―

(i) show the evidence of having made accurate description of published work of others and of havingrecorded the findings in an impartial manner;and

(ii) develop the students in data collection, analysis and reporting and interpretationskills.

21. Methodology.― To complete the project work following methodology shall be adopted,namely:―

(i) studentsshallworkingroupsofnotlessthantwoandnotmorethanfourunderanauthorisedteacher;

(ii) project topic shall be approved by the Head of the Department or Head of theInstitution;

(iii) project work chosen shall be related to the pharmacy practice in community, hospital and clinical set-up. It shall be patient and treatment (Medicine) oriented, like drug utilisation reviews, pharmacoepi-demiology, pharmacovigilance orpharmacoeconomics;

(iv) project work shall be approved by the institutional ethicscommittee;

(v) student shall present at least three seminars, one in the beginning, one at middle and one at the end ofthe project work;and

(vi) two-page write-up of the project indicating title, objectives, methodology anticipated benefits andreferences shall be submitted to the Head of the Department or Head of theInstitution.

22. Reporting.―(1)StudentworkingontheprojectshallsubmitjointlytotheHeadoftheDepartmentor HeadoftheInstitutionaprojectreportofabout40-50pages.Projectreportshouldincludeacertificate issued bythe authorised teacher, Head of the Department as well as by the Head of theInstitution

(2) ProjectreportshallbecomputertypedindoublespaceusingTimesRomanfontonA4 paper.Thetitle shall be inbold with font size 18, sub-tiles in bold with font size 14 and the text with font size 12. The cover pageof the project report shall contain details about the name of the student and the name of the authorisedteacher with font size14.

(3) Submission of the project report shall be done at least one month prior to the commencement of an-nual or supplementaryexamination.

23. Evaluation.― The following methodology shall be adopted for evaluating the projectwork―

(i) Project work shall be evaluated by internal and externalexaminers.

(ii) Students shall be evaluated in groups for four hours (i.e., about half an hour for a group of four stu-dents).

(iii) Three seminars presented by students shall be evaluated for twenty marks each and the average ofbest two shall be forwarded to the university with marks of othersubjects.

27

(iv) Evaluation shall be done on the following items: Marks

a) Write up of the seminar (7.5)

b) Presentation of work (7.5)

c) Communication skills (7.5)

d) Question and answer skills (7.5)

Total (30 marks)

(v) Final evaluation of project work shall be done on the following items: Marks

a) Write up of the seminar (17.5)

b) Presentation of work (17.5)

c) Communication skills (17.5)

d) Question and answer skills (17.5)

Total (70 marks)

Explanation.―Forthepurposesofdifferentiationintheevaluationincaseoftopicbeingthesameforthe groupofstudents,thesameshallbedonebasedonitemnumbersb,canddmentionedabove.

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APPENDIX-A(See regulation 8)

PHARM.D. SYLLABUS

First Year1.1 HUMAN ANATOMY & PHYSIOLOGY (THEORY)

Theory : 3 Hrs. /Week

1. Scope and Objectives: This course is designed to impart a fundamental knowledge on the structureand functions of the human body. It also helps in understanding both homeostasis mechanisms andhomeostaticimbalancesofvariousbodysystems.Sinceamedicament,whichisproducedbypharma- cist, isused to correct the deviations in human body, it enhances the understanding of how the drugs act onthe various body systems in correcting the disease state of theorgans.

2. Upon completion of the course the student shall be ableto:

a. describethestructure(grossandhistology)andfunctionsofvariousorgansofthehumanbody;

b. describe the various homeostatic mechanisms and their imbalances of varioussystems;

c. identify the various tissues and organs of the different systems of the humanbody;

d. performthehematologicaltestsandalsorecordbloodpressure,heartrate,pulseandRespiratory volumes;

e. appreciate coordinated working pattern of different organs of each system;and

f. appreciatetheinterlinkedmechanismsinthemaintenanceofnormalfunctioning(homeostasis)ofhumanbody

3. Coursematerials:

Text books

a. TortoraGerardJ.andNicholas,P.PrinciplesofanatomyandphysiologyPublisherHarpercollinscollege NewYork.

b. Wilson, K.J.W. Ross and Wilson’s foundations of anatomy and physiology. Publisher: ChurchillLiving- stone,Edinburg.

Reference books

a. Guyton arthur, C. Physiology of human body. Publisher:Holtsaunders.

b. Chatterjee,C.C. Human physiology. Volume 1&11. Publisher: medical allied agency,Calcutta.

c. Peter L. Williams, Roger Warwick, Mary Dyson and Lawrence,H.

d. Gray’s anatomy. Publisher:Churchill Livingstone,London.

4. Lecture wise program:

Topics

1 Scope of anatomy and physiology, basic terminologies used in this subject (Description of the body assuch planes andterminologies)

29

2 Structure of cell – its components and theirfunctions.

3 Elementarytissuesofthehumanbody:epithelial,connective,Muscularandnervoustissues-theirsub- typesandcharacteristics

4 a) Osseous system - structure, composition and functions of the Skeleton.(done in practical classes -6hrs)

b) Classification of joints, Types of movements of joints and disorders of joints (Definitions only)

5 HaemopoeticSystem

a) Composition and functions ofblood

b) Haemopoesis and disorders of blood components (definition ofdisorder)

c) Bloodgroups

d) Clotting factors andmechanism

e) Platelets and disorders ofcoagulation

6 Lymph

a) Lymph and lymphatic system, composition, formation andcirculation.

b) Spleen: structure and functions,Disorders

c) Disorders of lymphatic system (definitiononly)

7 Cardiovascularsystem

a) Anatomy and functions ofheart

b) Blood vessels and circulation (Pulmonary, coronary and systemiccirculation)

c) Electrocardiogram(ECG)

d) Cardiac cycle and heartsounds

e) Blood pressure – its maintenance andregulation

f) Definition of the followingdisorders

Hypertension, Hypotension, Arteriosclerosis, Atherosclerosis, Angina, Myocardial infarction, Conges-tive heart failure, Cardiac arrhythmias

8 Respiratorysystem

a) Anatomy of respiratory organs andfunctions

b) Mechanism / physiology of respiration and regulation ofrespiration

c) Transport of respiratory gases

d) Respiratoryvolumesandcapacities,andDefinitionof:Hypoxia,Asphyxia,

Dybarism, Oxygen therapy andresuscitation.

9 Digestivesystem

a) Anatomy and physiology ofGIT

30

b) Anatomy and functions of accessory glands ofGIT

c) Digestion andabsorption

d) Disorders of GIT

(definitionsonly) 10 Nervoussystem

a) Definition and classification of nervoussystem

b) Anatomy, physiology and functional areas ofcerebrum

c) Anatomy and physiology ofcerebellum

d) Anatomy and physiology of midbrain

e) Thalamus, hypothalamus and BasalGanglia

f) Spinal card: Structure &reflexes –mono-poly-planter

g) Cranial nerves – names andfunctions

h) ANS–Anatomy&functionsofsympathetic&parasympatheticN.S. 11

Urinarysystem

a) Anatomy and physiology of urinarysystem

b) Formation ofurine

c) Renin Angiotensin system – Juxtaglomerular apparatus - acid baseBalance

d) Clearance tests andmicturition

12 Endocrinesystem

a) Pituitarygland

b) Adrenalgland

c) Thyroid and Parathyroidglands

d) Pancreas andgonads

13 Reproductivesystem

a) Male and female reproductivesystem

b) Their hormones – Physiology ofmenstruation

c) Spermatogenesis &Oogenesis

d) Sex determination (geneticbasis)

e) Pregnancy and maintenance andparturition

f) Contraceptivedevices

14 Senseorgans

a) Eye

b) Ear

31

c) Skin

d) Tongue &

Nose 15

Skeletalmuscles

a) Histology

b) Physiology of Musclecontraction

c) Physiologicalpropertiesofskeletalmuscleandtheirdisorders(definitions) 16

Sportsphysiology

a) Muscles in exercise, Effect of athletic training on muscles and muscleperformance,

b) Respirationinexercise,CVSinexercise,Bodyheatinexercise,Bodyfluidsandsaltsinexercise,

c) Drugs andathletics

HUMAN ANATOMY & PHYSIOLOGY (PRACTICAL) Practical :

3Hrs./Week

General Requirements: Dissection box, Laboratory Napkin, muslin cloth, record, Observation book(100pages), Stationary items, Blood lancet.

Course materials:

Text books

Goyal, R. K, Natvar M.P, and Shah S.A, Practical anatomy, physiology and biochemistry, latest edition,Pub- lisher: B.S Shah Prakashan, Ahmedabad.

Reference books

Ranade VG, Text book of practical physiology, Latest edition, Publisher: PVG, Pune AndersonExperimental Physiology, Latest edition, Publisher: NA

List of Experiments:

1. Study of tissues of humanbody

(a) Epithelialtissue.

(b) Musculartissue.

2. Study of tissues of humanbody

(a) Connectivetissue.

(b) Nervoustissue.

3. Study of appliances used in hematologicalexperiments.

4. Determination of W.B.C. count ofblood.

5. Determination of R.B.C. count ofblood.

6. Determination of differential count ofblood.

7. Determination of (a) Erythrocyte SedimentationRate.

32

(b) Hemoglobin content ofBlood.

(c) Bleeding time & Clottingtime.

8. Determinationof

(a) BloodPressure.

(b) Bloodgroup.

9. Study of various systems with the help of charts, models &specimens

(a) Skeleton system part I-axialskeleton.

(b) Skeleton system part II- appendicularskeleton.

(c) Cardiovascularsystem.

(d) Respiratorysystem.

(e) Digestivesystem.

(f) Urinarysystem.

(g) Nervoussystem.

(h) Specialsenses.

(i) Reproductivesystem.

10. Study of different family planningappliances.

11. To perform pregnancy diagnosistest.

12. Study of appliances used in experimentalphysiology.

13. To record simple muscle curve using gastroenemius sciatic nervepreparation.

14. To record simple summation curve using gastroenemius sciatic nervepreparation.

15. To record simple effect of temperature using gastroenemius sciatic nervepreparation.

16. To record simple effect of load & after load using gastroenemius sciatic nervepreparation.

17. To record simple fatigue curve using gastroenemius sciatic nervepreparation.

Scheme of Practical Examination :

Sessionals Annual

Identification 04 10

Synopsis 04 10Major Experiment 07 20Minor Experiment 03 15Viva 02 15Max Marks 20 70Duration 03 hrs 04 hrs

Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity, promptness,viva-voce and record maintenance).

33

PHARMACEUTICS(THEORY)


1. Scope and objectives: This course is designed to impart a fundamental knowledge on the art and sci-enceofformulatingdifferentdosageforms.Itpreparesthestudentsformostbasicsoftheappliedfieldofpharmacy.

2. Upon the completion of the course the student should be ableto:

a. know the formulation aspects of different dosageforms;

b. do different pharmaceutical caluculation involved informulation;

c. formulate different types of dosage forms;and

d. appreciate the importance of good formulation foreffectiveness.

3. Coursematerials:

Text books

a. Cooper and Gunns Dispensing for pharmacystudents.

b. A text book Professional Pharmacy by N.K.Jain andS.N.Sharma.

Reference books

a. Introduction to Pharmaceutical dosage forms by Howard C.Ansel.

b. Remington’s Pharmaceutical Sciences.

c. Register of General Pharmacy by Cooper andGunn.

d. General Pharmacy byM.L.Schroff.

4. Lecture wiseprogramme:

Topics

1 a. Introduction to dosage forms - classification anddefinitions

b. Prescription: definition, parts andhandling

c. Posology:Definition,Factorsaffectingdoseselection.Calculationofchildrenandinfantdoses.

2 Historical back ground and development of profession of pharmacy and pharmaceutical industry inbrief.

3 Development of Indian Pharmacopoeia and introduction to other Pharmacopoeias such as BP, USP,European Pharmacopoeia, Extra pharmacopoeia and Indian nationalformulary.

4 Weights and measures, Calculations involving percentage solutions, allegation, proof spirit, isotonicsolutionsetc.

5 PowdersandGranules:Classificationadvantagesanddisadvantages,Preparationofsimple,compoundpowders,Insufflations,Dustingpowders,EutecticandExplosivepowders,Toothpowderandefferves- centpowders andgranules.

6 Monophasic Dosage forms: Theoretical aspects of formulation including adjuvant like stabilizers, col-orants,flavourswithexamples.StudyofMonophasicliquids likegargles,mouthwashes,Throatpaint,

34

Ear drops, Nasal drops, Liniments and lotions, Enemas and collodions.

7 Biphasicdosageforms:Suspensionsandemulsions,Definition,advantagesanddisadvantages,classifi-cation, test for the type of emulsion, formulation, stability andevaluation.

8 Suppositories and pessaries: Definition, advantages and disadvantages, types of base, method ofpreparation, Displacement value andevaluation.

9 Galenicals: Definition, equipment for different extraction processes like infusion, Decoction, Macera-tion and Percolation, methods of preparation of spirits, tinctures andextracts.

10 Pharmaceuticalcalculations.

11 Surgical aids: Surgical dressings, absorbable gelatin sponge, sutures, ligatures and medicatedbandages.

12 Incompatibilities: Introduction, classification and methods to overcome theincompatibilities.

PHARMACEUTICS(PRACTICAL)

Practical : 3 Hrs./Week


1. Syrups

a. Simple SyrupI.P

b. Syrup of Ephedrine HclNF

c. Syrup VasakaIP

d. Syrup of ferrous PhosphateIP

e. OrangeSyrup

2. Elixir

a. Piperizine citrate elixirBP

b. Cascara elixirBPC

c. Paracetamol elixirBPC

3. Linctus

a. Simple LinctusBPC

b. Pediatric simple LinctusBPC

4. Solutions

a. Solution of cresol with soapIP

b. Strong solution of ferric chlorideBPC

c. Aqueous Iodine SolutionIP

d. Strong solution of IodineIP

e. Strong solution of ammonium acetateIP

35

5. Liniments

a. Liniment of turpentineIP*

b. Liniment of camphorIP

6. Suspensions*

a. Calaminelotion

b. Magnesium Hydroxide mixtureBP

7. Emulsions*

a. Cod liver oilemulsion

b. Liquid paraffinemulsion

8. Powders

a. Eutecticpowder

b. Explosivepowder

c. Dustingpowder

d. Insufflations

9. Suppositories

a. Boric acidsuppositories

b. Chloralsuppositories

10. Incompatibilities

a. Mixtures withPhysical

b. Chemical & Therapeuticincompatibilities

* colourless bottles required for dispensing Paper envelope (white), butter paper and white paper required fordispensing.


Sessionals Annual

Synopsis 05 15

Major Experiment 10 25Minor Experiment 03 15Viva 02 15Max Marks 20 70Duration 03 hrs 04 hrs


36

MEDICINAL BIOCHEMISTRY(THEORY)


1. ScopeoftheSubject:Appliedbiochemistrydealswithcompleteunderstandingofthemolecularlevel of thechemical process associated with living cells.Clinical chemistry deals with the study of chemicalaspectsofhumanlifeinhealthandillnessandtheapplicationofchemicallaboratorymethodstodiag- nosis,control of treatment, and prevention ofdiseases.

2. Objectives of the Subject (Know, do, appreciate):

The objective of the present course is providing biochemical facts and the principles to the students ofpharmacy. Upon completion of the subject student shall be able to –

a. understandthecatalyticactivityofenzymesandimportanceofisoenzymesindiagnosisofdiseases;

b. know the metabolic process of biomolecules in health and illness (metabolicdisorders);

c. understand the genetic organization of mammalian genome; protein synthesis; replication; mutationand repairmechanism;

d. know the biochemical principles of organ function tests of kidney, liver and endocrine gland;and

e. do the qualitative analysis and determination of biomolecules in the bodyfluids.

Text books (Theory)

a. Harpers review of biochemistry -Martin

b. Text book of biochemistry –D.Satyanarayana

c. Text book of clinical chemistry- Alex kaplan &LaverveL.Szabo

Reference books (Theory)

a. Principles of biochemistry --Lehninger

b. Text book of biochemistry --Ramarao

c. Practical Biochemistry-DavidT.Plummer.

d. PracticalBiochemistry-Pattabhiraman.


Topics

1 Introduction to biochemistry: Cell and its biochemical organization, transport process across the cellmembranes. Energy rich compounds; ATP, Cyclic AMP and their biologicalsignificance.

2 Enzymes: Definition; Nomenclature; IUB classification; Factor affecting enzyme activity; Enzymeac- tion;enzymeinhibition.Isoenzymesandtheirtherapeuticanddiagnosticapplications;Coenzymesandtheir biochemical role and deficiencydiseases.

3 Carbohydrate metabolism: Glycolysis, Citric acid cycle (TCA cycle), HMP shunt, Glycogenolysis,gluco- neogenesis,glycogenesis.Metabolicdisordersofcarbohydratemetabolism(diabetesmellitusandgly-cogenstoragediseases);Glucose,Galactosetolerancetestandtheirsignificance;hormonalregulation ofcarbohydratemetabolism.

4 Lipidmetabolism:Oxidationofsaturated(ß-oxidation);Ketogenesisandketolysis;biosynthesisoffatty

37

acids, lipids; metabolism of cholesterol; Hormonal regulation of lipid metabolism. Defective metabo-lism of lipids (Atheroslerosis, fatty liver, hypercholesterolmiea).

5 Biological oxidation: Coenzyme system involved in Biological oxidation. Electron transport chain (itsmechanism in energy capture; regulation and inhibition); Uncouplers of ETC; Oxidative phosphoryla-tion

6 Protein and amino acid metabolism: protein turn over; nitrogen balance; Catabolism of Amino acids(Transamination, deamination & decarboxylation). Urea cycle and its metabolic disorders; productionof bile pigments; hyperbilirubinemia, porphoria, jaundice. Metabolic disorder of Aminoacids.

7 Nucleicacidmetabolism:Metabolismofpurineandpyrimidinenucleotides;Proteinsynthesis;Geneticcode;inhibitionofproteinsynthesis;mutationandrepairmechanism;DNAreplication(semiconserva- tive/onion peel models) and DNA repairmechanism.

8 Introductiontoclinicalchemistry:Cell;composition;malfunction;Rolloftheclinicalchemistrylabora-tory.

9 The kidney function tests: Role of kidney; Laboratory tests for normal functionincludes-

a) Urineanalysis(macroscopicandphysicalexamination,quantitativeandsemiquantitativetests.)

b) Test for NPN constituents. (Creatinine /urea clearance, determination of blood and urine creatinine,urea and uricacid)

c) Urine concentrationtest

d) Urinary tract calculi.(stones)

10 Liver function tests: Physiological role of liver, metabolic, storage, excretory, protective, circulatoryfunctions and function in bloodcoagulation.

a) Test for hepatic dysfunction-Bile pigments metabolism.

b) Test for hepatic function test- Serum bilirubin, urine bilirubin, and urineurobilinogen.

c) Dye tests of excretoryfunction.

d) Tests based upon abnormalities of serum proteins.

Selected enzymetests.

11 Lipid profile tests: Lipoproteins, composition, functions. Determination of serum lipids, total choles-terol, HDL cholesterol, LDL cholesterol andtriglycerides.

12 Immunochemical techniques for determination of hormone levels and protein levels in serum forendocrine diseases and infectious diseases. Radio immuno assay (RIA) and Enzyme Linked ImmunoSorbent Assay(ELISA)

13 Electrolytes: Body water, compartments, water balance, and electrolyte distrubution. Determination ofsodium, calcium potassium, chlorides, bicarbonates in the bodyfluids.

38

Title of theExperiment:

MEDICINAL BIOCHEMISTRY(PRACTICAL)


1 Qualitative analysis of normal constituents ofurine.*

2 Qualitative analysis of abnormal constituents ofurine.*

3 Quantitative estimation of urine sugar by Benedict’s reagentmethod.**

4 Quantitative estimation of urine chlorides by Volhard’smethod.**

5 Quantitative estimation of urine creatinine by Jaffe’smethod.**

6 Quantitative estimation of urine calcium by precipitationmethod.**

7 Quantitative estimation of serum cholesterol by Libermann Burchard’smethod.**

8 Preparation of Folin Wu filtrate fromblood.*

9 Quantitative estimation of bloodcreatinine.**

10 QuantitativeestimationofbloodsugarFolin-Wutubemethod.** 11

Estimation of SGOT inserum.**

12 Estimation of SGPT in serum.**

13 Estimation of Urea inSerum.**

14 Estimation of Proteins in Serum.**

15 Determination of serum bilirubin**

16 Determination of Glucose by means of Glucoseoxidase.**

17 Enzymatic hydrolysis of Glycogen/Starch by Amylases.**

18 Study of factors affecting Enzyme activity. (pH &

Temp.)**

19 Preparation of standard buffer solutions and its pH measurements (any two)* 20

Experiment on lipid profile tests**

21 Determination of sodium,calcium and potassium in serum.**

** indicate major experiments & * indicate minor experiments

Assignments:

Format of the assignment

1. Minimum & Maximum number ofpages.

2. It shall be computer draftcopy.

3. Reference(s) shall be included at theend.

4. Name and signature of thestudent.

39

5. Assignment can be a combined presentation at the end of the academicyear.

6. Time allocated for presentation may be 8+2Min.


Sessionals Annual

Synopsis 05 15



PHARMACEUTICAL ORGANIC CHEMISTRY(THEORY)


1. Scope and objectives: This course is designed to impart a very good knowledgeabout

a. IUPAC/Common system of nomenclature of simple organic compounds belonging to differentclasses of organiccompounds;

b. Some important physical properties of organiccompounds;

c. Free radical/ nucleophyllic [alkyl/ acyl/ aryl] /electrophyllic substitution, free radical/ nucleop-hyllic/electrophyllicaddition,elimination,oxidationandreductionreactionswithmechanism,orientation of the reaction, order of reactivity, stability ofcompounds;

d. Some named organic reactions with mechanisms;and

e. Methodsofpreparation,testforpurity,principleinvolvedinthe assay,importantmedicinaluses of someimportant organiccompounds.

2. Coursematerials:

Text books

a. T.R.Morrison and R. Boyd - Organicchemistry,

b. Bentley and Driver-Text book of Pharmaceuticalchemistry

c. I.L.Finer- Organic chemistry, the fundamentals ofchemistry

Reference books

a. Organic chemistry – J.M.Cram andD.J.Cram

b. Organic chemistry-Brown

c. Advanced organic chemistry- Jerry March,Wiley

d. Organic chemistry- Cram and Hammered, PineHendrickson

40

3. Lecture wise programme:

Topics

1 Structures and Physicalproperties:

a. Polarity of bonds, polarity of molecules, M.P, Inter molecular forces, B.P, Solubility, nonionic solutes and ionic solutes, protic and aprotic Solvents, ionpairs,

b. Acids and bases, Lowry bronsted and Lewistheories

c. Isomerism

2 Nomenclature of organic compound belonging to the following classes Alkanes, Alkenes, Dienes,Alkynes,Alcohols,Aldehydes,Ketones,Amides,Amines,Phenols,AlkylHalides,CarboxylicAcid,Esters,Acid Chlorides AndCycloalkanes.

3 Free radicals chain reactions of alkane : Mechanism, relative reactivity andstability

4 Alicyclic compounds : Preparations of cyclo alkanes, Bayer strain theory and orbital picture of anglestrain.

5 Nucleophilicaliphaticsubstitutionmechanism:Nucleophilesandleavinggroups,kineticsofsecondand firstorder reaction, mechanism and kinetics of SN2 reactions. Stereochemistry and steric hindrance, role ofsolvents, phase transfer catalysis, mechanism and kinetics of SN1 reactions, stereochemistry,carbocation and their stability, rearrangement of carbocation, role of solvents in SN1 reaction, Ion di-pole bonds, SN2 versus SN1 solvolyses, nucleophilic assistance by thesolvents.

6 Dehydro halogenation of alkyl halides: 1,2 elimination, kinetics, E2 and E1 mechanism, eliminationvia carbocation,evidenceforE2mechanism,absenceofrearrangementisotopeeffect,absencehydrogenexchange,theelementeffect,orientationandreactivity,E2versusE1,eliminationversussubstitution,dehydration of alcohol, ease of dehydration, acid catalysis, reversibility,orientation.

7 Electrophillicandfreeradicalsaddition:Reactionsatcarbon-carbon,doublebond,electrophile,hydro-genation,heatofhydrogenationandstabilityofalkenes,markownikoffrule,additionofhydrogenha- lides,addition of hydrogen bromides, peroxide effect, electrophillic addition, mechanism, rearrangement,absence of hydrogen exchange, orientation and reactivity, addition of halogen, mechanism, halohydinformation, mechanism of free radicals additon, mechanism of peroxide initiated additionofhydrogenbromide,orientationoffreeaddition,additionsofcarbenetoalkene,cycloadditionreac- tions.

8 Carbon-carbon double bond as substituents: Free radical halogenations of alkenes, comparision offreeradicalsubstitutionwithfreeradicaladdition,freeradicalsubstitutioninalkenes,orientationandreactivity, allylicrearrangements.

9 Theory of resonance: Allyl radical as a resonance hybrid, stability, orbital picture, resonance stabilisa-tion of allyl radicals, hyper conjugation, allyl cation as a resonance hybrid, nucleophyllic substitutionin allylic substrate, SN1 reactivity, allylic rearrangement, resonance stabilisation of allyl cation, hyperconjugation, nucleophilic substitution in allylic substrate, SN2 nucleophilic substituion in vinylic sub-strate, vinylic cation, stability of conjugated dienes, resonance in alkenes, hyper conjugation, ease offormationofconjugateddienes,orientationofelimination,electrophilicadditiontoconjugateddienes, 1,4-addition,1,2-versus1,4-addition,rateversusequilibrium,orientationandreactivityoffreeradical addition toconjugateddienes.

10 Elecrophilicaromaticsubstitution:Effectofsubstituentgroups,determinationoforientation,determi-nationofrelativereactivity,classificationofsubstituentgroup,mechanismofnitration,sulphonation,

41

halogenation, friedel craft alkylation, friedel craft acylation, reactivity and orientation, activating anddeactivating O,P,M directing groups, electron release via resonance, effect of halogen on electrophilicaromatic substitution in alkyl benzene, side chain halogination of alkyl benzene, resonance stabiliza-tion of benzyl radical.

11 Nucleophilic addition reaction: Mechanism, ionisation of carboxylic acids, acidity constants, acidityof acids, structure of carboxylate ions, effect of substituent on acidity, nucleophilic acyl substitutionreaction,conversionofacidtoacidchloride,esters,amideandanhydride.Roleofcaboxylgroup,com- parisonof alkyl nucleophilic substitution with acyl nucleophilicsubstitution.

12 Mechanism of aldol condensation, claisen condensation, cannizzaro reaction, crossed aldol conden-sation, crossed cannizzaro reaction, benzoin condensation, perkin condensation. Knoevenagel, Refor-matsky reaction, Wittig reaction, Michaeladdition.

13 Hoffman rearrangement: Migration to electron deficient nitrogen, Sandmeyer’s reaction, basicity ofamines, diazotisation and coupling, acidity of phenols, Williamson synthesis, Fries rearrangement,Kolbe reaction, Reimer tieman’s reactions.

14 Nucleophilicaromaticsubstitution:Bimoleculardisplacementmechanisms,orientation,comparisonofaliphatic nucleophilic substitution with that ofaromatic.

15 Oxidation reductionreaction.

16 Study of the following official compounds- preparation, test for purity, assay and medicinal uses ofChlorbutol, Dimercaprol, Glyceryl trinitrate, Urea, Ethylene diamine dihyrate, Vanillin, Paraldehyde,Ethylene chloride, Lactic acid, Tartaric acid, citric acid, salicylic acid, aspirin, methyl salicylate, ethylbenzoate,benzylbenzoate,dimethylpthalate,sodiumlaurylsulphate,saccharinsodium,mephensin.

PHARMACEUTICAL ORGANIC CHEMISTRY(PRACTICAL)


I. Introductiontothevariouslaboratorytechniquesthroughdemonstrationinvolvingsynthesisofthefollowing compounds (at least 8 compounds to besynthesised):

1. Acetanilde / aspirin(Acetylation)

2. Benzanilide / Phenyl benzoate(Benzoylation)

3. P-bromo acetanilide / 2,4,6 – tribromo aniline(Bromination)

4. Dibenzylidene acetone(Condensation)

5. 1-Phenylazo-2-napthol (Diazotisation andcoupling)

6. Benzoic acid / salicylic acid (Hydrolysis ofester)

7. M-dinitro benzene(Nitration)

8. 9,10–Antharaquinone(Oxidationofanthracene)/preparationofbenzoicacidfromtolueneorbenz- aldehyde

9. M-phenylene diamine (Reduction of M-dinitrobenzene) / Aniline fromnitrobenzene

10. Benzophenoneoxime

11. Nitration of salicylicacid

12. Preparation of picricacid

42

13. Preparation of O-chlorobenzoic acid fromO-chlorotolune

14. Preparation of cyclohexanone fromcyclohexanol

II. Identification of organic compounds belonging to the following classes by:

Systematic qualitative organic analysis including preparation of derivatives Phenols, amides, carbo-hydrates, amines, carboxylic acids, aldehyde and ketones, Alcohols, esters, hydrocarbons, anilides,nitrocompounds.

III. Introduction to the use of stereomodels:

Methane, Ethane, Ethylene, Acetylene, Cis alkene, Trans alkene, inversion of configuration.


Sessionals Annual

Synopsis 05 15



PHARMACEUTICAL INORGANIC CHEMISTRY(THEORY)


1. Scopeandobjectives:ThiscoursemainlydealswithfundamentalsofAnalyticalchemistryandalsothe studyof inorganic pharmaceuticals regarding their monographs and also the course deals with basicknowledge of analysis of variouspharmaceuticals.

2. Upon completion of the course student shall be ableto:

a. understandtheprinciplesandproceduresofanalysisofdrugsandalsoregardingtheapplication ofinorganicpharmaceuticals;

b. know the analysis of the inorganic pharmaceuticals their applications;and

c. appreciatetheimportanceofinorganicpharmaceuticalsinpreventingandcuringthedisease.

3. Coursematerials:

Text books

a. A text book Inorganic medicinal chemistry by Surendra N.Pandeya

b. A. H. Beckett and J. B. Stanlake’s Practical Pharmaceutical chemistry Vol-I &Vol-II

c. Inorganic Pharmaceutical Chemistry III-Edition P.Gundu Rao

Reference books

a. Inorganic Pharmaceutical Chemistry by Anand &Chetwal

43

b. Pharmaceutical Inorganic chemistry by Dr.B.G.Nagavi

c. Analytical chemistry principles by John H.Kennedy

d. I.P.1985 and 1996, Govt. of India, Ministry ofhealth

4. Lecture

wiseprogramme: Topics

1 Errors

2 Volumetricanalysis

3 Acid-basetitrations

4 Redoxtitrations

5 Non aqueoustitrations

6 Precipitationtitrations

7 Complexometrictitrations

8 Theory ofindicators

9 Gravimetry

10 Limittests

11 Medicinalgases

12 Acidifiers

13 Antacids

14 Cathartics

15 Electrolyte replenishers

16 Essential Trace elements

17Antimicrobials

18 Pharmaceuticalaids

19 DentalProducts

20 Miscellaneouscompounds

21 RadioPharmaceuticals

44

PHARMACEUTICAL INORGANIC CHEMISTRY(PRACTICAL)


1. Limit test (6 exercises)

a. Limit test forchlorides

b. Limit test forsulphates

c. Limit test foriron

d. Limit test for heavymetals

e. Limit test forarsenic

f. Modified limit tests for chlorides andsulphates

2. Assays (10 exercises)

a. Ammonium chloride- Acid-basetitration

b. Ferrous sulphate-Cerimetry

c. Copper sulpahte-Iodometry

d. Calcilugluconate-Complexometry

e. Hydrogen peroxide –Permanganometry

f. Sodium benzoate – Nonaqueoustitration

g. Sodium chloride – Modified volhard’smethod

h. Assay of KI – KIO3titration

i. Gravimetric estimation of barium as bariumsulphate

j. Sodium antimony gluconate or antimony potassiumtartarate

3. Estimation of mixture (Any two exercises)

a. Sodium hydroxide and sodiumcarbonate

b. Boric acid andBorax

c. Oxalic acid and sodiumoxalate

4. Test for identity (Any threeexercises)

a. Sodiumbicorbonate

b. Bariumsulphate

c. Ferroussulphate

d. Potassiumchloride

5. Test for purity (Any twoexercises)

a. Swelling power inBentonite

45

b. Acid neutralising capacity in aluminium hydroxidegel

c. Ammonium salts in potashalum

d. Adsorption power heavyKaolin

e. Presence of Iodates inKI

6. Preparations (Any twoexercises)

a. Boric acids

b. Potashalum

c. Calciumlactate

d. Magnesiumsuphate


Sessionals Annual

Synopsis 05 15



REMEDIAL MATHEMATICS/BIOLOGY(THEORY)


REMEDIAL MATHEMATICS :

1. Scope and objectives: This is an introductory course in mathematics. This subjects deals with the in-troductiontomatrices,determinants,trigonometry,analyticalgeometry,differentialcalculus,integralcalculus, differential equations, laplacetransform.

2. Upon completion of the course the student shall be able to :–

a. Know Trignometry, Analytical geometry, Matrices, Determinant, Integration, Differential equation,La- place transform and theirapplications;

b. solve the problems of different types by applying theory;and

c. appreciate the important applications of mathematics inpharmacy.

3. Coursematerials:

Text books

a. Differential calculus ByShantinarayan

b. Text book of Mathematics for second year pre-university byProf.B.M.Sreenivas

46

Reference books

a. Integral calculus ByShanthinarayan

b. Engineering mathematics ByB.S.Grewal

c. Trigonometry Part-I By S.L.Loney


Topics

1 Algebra : Determinants,Matrices

2 Trigonometry: Sides and angles of a triangle, solution oftriangles

3 Analytical Geometry: Points, Straight line, circle,parabola

4 Differential calculus: Limit of a function, Differential calculus, Differentiation of a sum, Product,Quo-tientComposite,Parametric,exponential,trigonometricandLogarithmicfunction.Successivedifferen-tiation, Leibnitz’s theorem, Partial differentiation, Euler’s theorem on homogeneous functions of twovariables

5 Integral Calculus: Definite integrals, integration by substitution and by parts, Properties of definiteintegrals.

6 Differential equations: Definition, order, degree, variable separable, homogeneous, Linear, heteroge-neous, linear, differential equation with constant coefficient, simultaneous linear equation of secondorder.

7 Laplace transform: Definition, Laplace transform of elementary functions, Properties of linearity andshifting.

BIOLOGY :

1. Scope and objectives: This is an introductory course in Biology, which gives detailed study of naturalsources such as plant and animal origin. This subject has been introduces to the pharmacy course inorder to make the student aware of various naturally occurring drugs and its history, sources, classifi-cation,distributionandthecharactersoftheplantsandanimals.ThissubjectgivesbasicfoundationtoPharmacognosy.

2. Coursematerials:

Text books

a. Text book of Biology byS.B.Gokhale

b. A Text book of Biology by Dr.Thulajappa and Dr.Seetaram.

Reference books

a. A Text book of Biology by B.V.SreenivasaNaidu

b. A Text book of Biology by Naidu andMurthy

c. Botany for Degree students ByA.C.Dutta.

d. Outlines of Zoology by M.Ekambaranatha ayyer andT.N.Ananthakrishnan.

e. A manual for pharmaceutical biology practical by S.B.Gokhale andC.K.Kokate.

47


Topic

PART –

A

01 Introduction

02 Generalorganizationofplantsanditsinclusions 03

Planttissues

04 Plant kingdom and its classification

05 Morphology of plants

06 Root, Stem, Leaf and Its modifications

07 Inflorescence and Pollination of flowers

08 Morphology of fruits and seeds

09 Plant physiology

10 Taxonomy of Leguminosae, umbelliferae, Solanaceae, Lilliaceae, Zinziberaceae, Rubiaceae

11 Study of Fungi, Yeast, Penicillin and Bacteria

PART-B

01 Study of Animal cell

02 Study animal tissues

03 Detailed study of frog

04 Study of Pisces, Reptiles,Aves

05 General organization ofmammals

06 Study of poisonousanimals

48

Title:

1.6 BIOLOGY (PRACTICAL)


1. Introduction of biologyexperiments

2. Study of cell wall constituents and cellinclusions

3. Study of Stemmodifications

4. Study of Rootmodifications

5. Study of Leafmodifications

6. Identification of Fruits andseeds

7. Preparation of Permanentslides

8. T.S. of Senna, Cassia, Ephedra,Podophyllum.

9. Simple plant physiologicalexperiments

10. Identification ofanimals

11. Detailed study ofFrog

12. Computer basedtutorials


Sessionals Annual

Synopsis 05 15



49

Second yearPATHOPHYSIOLOGY(THEORY)


1. Scope of the Subject: This course is designed to impart a thorough knowledge of the relevantaspectsofpathologyofvariousconditionswithreferencetoitspharmacologicalapplications,andunderstand-ingofbasicPathophysiologicalmechanisms.Henceitwillnotonlyhelptostudythesyllabusofpathol- ogy, butalso to get baseline knowledge of its application in other subject ofpharmacy.

2. Objectives of the Subject: Upon completion of the subject student shall be able to–

a. describe the etiology and pathogenesis of the selected diseasestates;

b. name the signs and symptoms of the diseases;and

c. mention the complications of thediseases.

Text books (Theory)

a. Pathologic basis of disease by- Cotran, Kumar,Robbins

b. Text book of Pathology- Harsh Mohan

c. Text book of Pathology- Y.M.Bhinde

Reference books(Theory)

a. Clinical Pharmacy and Therapeutics; Second edition; Roger Walker; Churchill

Livingstonepublication

3. Detailed syllabus and lecture wise schedule:

1 Basic principles of cell injuryandAdaptation

Chapter

a) Causes, Pathogenesis and morphology of cellinjury

b) Abnormalitiesinlipoproteinaemia,glycogeninfiltrationandglycogeninfiltrationandglycogeninfiltration and glycogen storagediseases

2 Inflammation

a) Pathogenesisofacuteinflammation,Chemicalmediatorsininflammation,Typesofchronicinflammation

b) Repairs of wounds in the skin, factors influencing healing ofwounds

3 Diseases ofImmunity

a) Introduction to Tand Bcells

b) MHC proteins or transplantationantigens

c) Immunetolerance

- Hypersensitivity

50

Hypersensitivity type I, II, III, IV, Biological significance, Allergy due to food, chemicals and drugs

- Autoimmunity

Criteriaforautoimmunity,Classificationsofautoimmunediseasesinman,mechanismofautoimmuni- ty,Transplantation and immunologic tolerance, allograft rejections,transplantation antigens, mecha- nismof rejection ofallograft.

- Acquired immune deficiency syndrome(AIDS)

- Amylodosis

4 Cancer: differences between benign and malignant tumors, Histological diagnosis of malignancy, in-vasions and metastasis, patterns of spread, disturbances of growth of cells, classification of tumors,general biology of tumors, spread of malignant tumors, etiology and pathogenesis ofcancer.

5 Types of shock, mechanisms, stages andmanagement

6 Biological effects ofradiation

7 Environmental and nutritionaldiseases

i) Air pollution and smoking- SO2,NO, NO2, andCO

ii) Protein calorie malnutrition, vitamins, obesity, pathogenesis ofstarvation.

8 Pathophysiology of commondiseases

a. Parkinsonism

b. Schizophrenia

c. Depression andmania

d. Hypertension,

e. Stroke (ischaemic and hemorrhage)

f. Angina, CCF, Atherosclerosis, Myocardialinfarction

g. DiabetesMellitus

h. Peptic ulcer and inflammatory boweldiseases

i. Cirrhosis and Alcoholic liverdiseases

j. Acute and chronic renalfailure

k. Asthma and chronic obstructive airwaydiseases

9 Infectious diseases:

Sexually transmitted diseases (HIV,Syphilis,Gonorrhea), Urinary tract infections, Pneumonia, Typhoid, Tu-berculosis, Leprosy, Malaria Dysentery (bacterial and amoebic ), Hepatitis- infective hepatitis.

4. Assignments:

Title of the Experiment

1 Chemical Mediators ofinflammation

51

2 DrugHypersensitivity

3 Cigarette smoking & its illeffects

4 Biological Effects ofRadiation

5 Etiology and hazards ofobesity

6 Complications ofdiabetes

7 Diagnosis ofcancer

8 Disorders ofvitamins

9 MethodsinPathology-Laboratoryvaluesofclinicalsignificance

10 Pathophysiology of Dengue Hemorrhagic Fever(DHF)


1 Minimum & Maximum number of pages.


3. Assignment can be a combined presentation at the end of the academicyear


5. Name and signature of thestudent


PHARMACEUTICAL MICROBIOLOGY(THEORY)


1. ScopeoftheSubject:Microbiologyhasalwaysbeenanessentialcomponentofpharmacycurriculum. This isbecause of the relevance of microbiology to pharmaceutical sciences and more specifically topharmaceutical industry. Pharmaceutical biotechnology is the logical extension of pharmaceutical mi-crobiology, which is expected to change the complete drug product scenario in thefuture.

Thiscoursedealswiththevariousaspectsofmicroorganisms,itsclassification,morphology,laboratorycultivationidentificationandmaintenance.Itsalsodiscusseswithsterilizationofpharmaceuticalprod-ucts,equipment,mediaetc.Thecoursefurtherdiscussestheimmunologicalpreparations,diseasesitstransmission, diagnosis, control and immunologicaltests.

2. Objectives of the Subject:

Upon completion of the subject student shall be able to –

a. know the anatomy, identification, growth factors and sterilization ofmicroorganisms;

b. know the mode of transmission of disease causing microorganism, symptoms of disease, and treat-mentaspect;

c. do estimation of RNA and DNA and there by identifying thesource;

d. do cultivation and identification of the microorganisms in thelaboratory;

52

e. do identification of diseases by performing the diagnostic tests;and

f. appreciate the behavior of motility and behavioral characteristics ofmicroorganisms.

Text books (Theory)

a. Vanitha Kale and Kishor Bhusari “ Applied Microbiology ” Himalaya Publishing houseMumbai.

b. Mary Louis Turgeon “ Immunology and Serology in Laboratory Medicines”

2nd edition, 1996 Mosby- Year book inc St. Louis Missouri63146.

c. Harsh Mohan, “ Text book of Pathology” 3rd edition, 1998, B-3 Ansari road Darya ganj N.Delhi.


a. PrescotL.M.,JarleyG.PKleinD.A“Microbiology”2nd-editionMcGrawHillCompanyInc

b. Rawlins E.A.”Bentley’s Text Book of Pharmaceutics” B ailliere Tindals 24-28 London1988

c. Forbisher “ Fundamentals of Microbiology” Philidelphia W.B.Saunders.

d. Prescott L.M. Jarley G.P., Klein.D.A. “ Microbiology.”2nd edition WMC Brown Publishers,Oxford.1993

e. War Roitt, Jonathan Brostoff, David male, “ Immunology”3rd edition 1996, Mosby-year book EuropeLtd,London.

f. Pharmacopoeia of India, Govt of India,1996.


Title of thetopic

1 Introductiontothescienceofmicrobiology.MajordivisionsofmicrobialworldandRelationshipamong them.

2 Different methods of classification of microbes and study of Bacteria, Fungi, virus, Rickettsiae, Spiro-chetes.

3 Nutritional requirements, growth and cultivation of bacteria and virus. Study of different importantmediarequiredforthegrowthofaerobicandanaerobicbacteria&fungi.Differentialmedia,enriched mediaand selective media, maintenance of labcultures.

4 Different methods used in isolation and identification of bacteria with emphasis to different stainingtechniques and biochemical reactions. Counting of bacteria -Total and Viable countingtechniques.

5 Detailed study of different methods of sterilization including their merits and demerits. Sterilizationmethodsforallpharmaceuticalproducts.Detailedstudyofsterilitytestingofdifferentpharmaceuticalpreparations . Brief information onValidation.

6 Disinfectants-Studyofdisinfectants,antiseptics,fungicidalandvirucidalagentsfactorsaffectingtheiractivationandmechanismofaction.Evaluationofbactericidal,bacteristatic,,virucidalactivities,eval- uationof preservatives in pharmaceuticalpreparations.

7 Immunology- Immunity, Definition, Classification, General principles of natural immunity, Phagocy-tosis, acquired immunity( active and passive ) . Antigens, chemical nature of antigens structure andformation of Antibodies, Antigen-Antibody reactions. Bacterial exotoxins and endotoxins.Significance of toxoids in active immunity, Immunization programme, and importance of boosterdose.

8 Diagnostictests:Schick’sTest,Elisatest,WesternBlottest,SouthernBlotPCRWidal,QBC,Mantaux

53

Peripheral smear. Study of malarial parasite.

9 Microbial culture sensitivity Testing: Interpretation of results Principles and methods of different mi-crobiological assays, microbiological assay of Penicillin, Streptomycin and vitamin B2 and B12. Stan-dardisation of vaccines andsera.

10 Study of infectious diseases: Typhoid, Tuberculosis, Malaria, Cholera, Hepatitis, Meningitis, Syphilis& Gonorrhea andHIV.

PHARMACEUTICAL MICROBIOLOGY(PRACTICAL)


Title of the Experiment:

1 Study of apparatus used in experimentalmicrobiology*.

2 Sterilisation of glass ware’s. Preparation of media andsterilisation.*

3 Staining techniques – Simple staining ; Gram’s staining ; Negativestaining**

4 Study of motilitycharacters*.

5 Enumeration of micro-organisms (Total andViable)*

6 Study of the methods of isolation of pureculture.*

7 Bio chemical testing for the identification ofmicroorganisms.*

8 Cultural sensitivity testing for somemicro-organisms.*

9 Sterility testing for powders andliquids.*

10 Determination of minimum inhibitoryconcentration.*

11 Microbiological assay of antibiotics by cup platemethod.*

12 Microbiological assay of vitamins by Turbidometric method**

13 Determination ofRWC.**

14 Diagnostic tests for some common diseases, Widal, malarial parasite.**

* Indicate minor experiment & ** indicate major experiment

Assignments:

1 Visit to some pathological laboratories & study the activities and equipment/instruments used andreporting the same.

2. Visit to milk dairies (Pasteurization) and microbial laboratories (other sterilization methods) & studythe activities and equipment/instruments used and reporting thesame.

3. Libraryassignments

a. Reportofrecentmicrobialtechniquesdevelopedindiagnosingsomecommondiseases.

b. Latestadvancementdevelopedinidentifying,cultivating&handlingofmicroorganisms.

54

Format of the assignment:








Sessionals Annual

Synopsis 05 15



PHARMACOGNOSY&PHYTOPHARMACEUTICALS(THEORY)


1. Scopeandobjectives:Thissubjecthasbeenintroducedforthepharmacycourseinordertomakethe studentaware of medicinal uses of various naturally occurring drugs its history, sources, distribution,methodofcultivation,activeconstituents,medicinaluses,identificationtests,preservationmethods,substitutes andadulterants.

2. Upon completion of the course student shall be ableto:

a. under stand the basic principles of cultivation, collection and storage of crudedrugs;

b. know the source, active constituents and uses of crude drugs;and

c. appreciate the applications of primary and secondary metabolites of theplant.

3. Coursematerials:

Text books

a. Pharmacognosy by G.E. Trease &W.C.Evans.

b. Pharmacognosy by C.K.Kokate,Gokhale &A.C.Purohit.

Reference books

a. Pharmacognosy by Brady&Tyler.E.

b. Pharmacognosy byT.E.Wallis.

55

c. Pharmacognosy by C.S. Shah &Qadery.

d. Pharmacognosy by M.A.Iyengar.


Topics

1 Introduction.

2 Definition, history and scope ofPharmacognosy.

3 Classification of crudedrugs.

4 Cultivation, collection, processing and storage of crudedrugs.

5 Detailed method of cultivation of crudedrugs.

6 Study of cell wall constituents and cellinclusions.

7 Microscopical and powder Microscopical study of crudedrugs.

8 Study of naturalpesticides.

9 Detailed study of various cellconstituents.

10 Carbohydrates and relatedproducts.

11 Detailed study carbohydrates containing drugs.(11drugs)

12 Definition sources, method extraction, chemistry andmethod

of analysis oflipids.

13 Detailed study ofoils.

14 Definition,classification,chemistryandmethodofanalysisofprotein. 15

Study of plants fibers used in surgical dressings and related products. 16

Different methods of adulteration of crudedrugs.

PHARMACOGNOSY & PHYTOPHARMACEUTICALS(PRACTICAL)


GeneralRequirements:LaboratoryNapkin,ObservationBook150pagesZerobrush,Needle,Blade,Matchbox.

List of experiments:

1 Introduction of Pharmacognosy laboratory andexperiments.

2 Studyofcellwallconstituentsandcellinclusions.

3 Macro,powderandmicroscopicstudyofDatura.

4 Macro, powder and microscopic study ofSenna.

5 Macro, powder and microscopic study ofCassia.cinnamon.

56

6 Macro, powder and microscopic study ofCinchona.

7 Macro,powderandmicroscopicstudyofEphedra.

8 Macro, powder and microscopic study ofQuassia.

9 Macro, powder and microscopic study of Clove

10 Macro, powder and microscopic study ofFennel.

11 Macro, powder and microscopic study of Coriander.

12 Macro, powder and microscopic study of Isapgol.

13 Macro, powder and microscopic study of Nux vomica.

14 Macro, powder and microscopic study of Rauwolfia.

15 Macro, powder and microscopic study of Liquorice.

16 Macro, powder and microscopic study ofGinger.

17 Macro,powderandmicroscopicstudyofPodophyllum. 18

Determination of Iodinevalue.

19 Determination of Saponification value and unsaponifiable matter. 20

Determination of ester value.

21 Determination of Acid value.

22 Chemical tests for Acacia.

23 Chemical tests for Tragacanth.

24 Chemical tests for Agar.

25 Chemical tests forStarch.

26 ChemicaltestsforLipids.(castoroil,sesameoil,sharkliveroil,beeswax) 27

Chemical tests forGelatin.


Sessionals Annual

Identification 04 10

Synopsis 04 10Major Experiment 07 20Minor Experiment 03 15Viva 02 15Max Marks 20 70Duration 03 hrs 04 hrs

Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity, promptness,viva-voce and record maintenance.

57

PHARMACOLOGY – I(THEORY)


1. Scope of the Subject: This subject will provide an opportunity for the student to learn about the drugwith regard to classification, pharmacodynamic and pharmacokinetic aspects, adverse effects, uses,dose, route of administration, precautions, contraindications and interaction with other drugs. In thissubject, apart from general pharmacology, drugs acting on autonomic nervous system, cardiovascularsystem, central nervous system, blood and blood forming agents and renal system will be taught. Inaddition to theoretical knowledge, the basic practical knowledge relevant to therapeutics will be im-parted.

2. Objectives of the Subject : Upon completion of the subject student shall be able to (Know, do, appre-ciate)–

a. understandthepharmacologicalaspectsofdrugsfallingundertheabovementionedchapters;

b. handle and carry out the animalexperiments;

c. appreciate the importance of pharmacology subject as a basis of therapeutics;and

d. correlate and apply the knowledgetherapeutically.

Text books (Theory) (Author, Title, Edition, Publication Place, Publisher, Year of Publication)

a. Tripathi, K. D. Essentials of medical pharmacology. 4th Ed, 1999. Publisher: Jaypee,Delhi.

b. Satoskar, R.S. and Bhadarkar, S.D. Pharmacology and pharmacotherapeutics. 16th edition (singlevolume), 1999. Publisher: Popular,Dubai.

c. Rang, H.P. & Dale, M.M. Pharmacology. 4th edition, 1999. Publisher: Churchill Livingstone.

Reference books (Theory) (Author, Title, Edition, Publication Place, Publisher, Publication Year)

a. Goodman Gilman, A., Rall, T.W., Nies, A.I.S. and Taylor, P.Goodman and Gilman’s Thepharmaco- logical Basis of therapeutics. 9th Ed, 1996. Publisher Mc Graw Hill, Pergamonpress.

b. Craig, C.R.&Stitzel, R.E. Modern Pharmacology. Latest edition. Publisher: LittleBrown.Co

c. Katzung, B.G. Basic and clinical pharmacology. Latest edition. Publisher: Prentice Hall,Int.

d. ShargelandLeon.AppliedBiopharmaceuticsandpharmacokinetics.Latestedition.Publisher:Prentice Hall,London.

Text books (Practical) :

Kulkarni, S. K. and Dandia, P. C. Hand book of experimental pharmacology. Latest edition, Publisher:Vallab, Delhi.

Reference books (Practical)

a. Macleod,L.J.Pharmacologicalexperimentsonintactpreparations.Latestedition,Publisher:Chur-chilllivingstone.

b. Macleod,L.J.Pharmacologicalexperimentsonisolatedpreparations.Latestedition,Publisher:Churchilllivingstone.

c. Ghosh, M.N. Fundamentals of experimental pharmacology. Latest edition, Publisher: Scientificbook agency,Kolkata.

58

d. Ian Kitchen. Textbook of in vitro practical pharmacology. Latest edition, Publisher: Black wellSci- entific.


Title of the topic

1. GeneralPharmacology

a) Introduction, definitions and scope ofpharmacology

b) Routes of administration ofdrugs

c) Pharmacokinetics (absorption, distribution, metabolism andexcretion)

d) Pharmacodynamics

e) Factors modifying drugeffects

f) Drug toxicity - Acute, sub- acute and chronictoxicity.

g) Pre-clinicalevaluations

h) Druginteractions

Note : The term Pharmacology used here refers to the classification, mechanism of action, pharmacokinetics,pharmacodynamics,adverseeffects,contraindications,Therapeuticuses,interactionsand doseand route ofadministration.

2. Pharmacology of drugs acting onANS

a) Adrenergic and antiadrenergicdrugs

b) Cholinergic and anticholinergicdrugs

c) Neuromuscularblockers

d) Mydriactics andmiotics

e) Drugs used in myastheniagravis

f) Drugs used inParkinsonism

3. Pharmacology of drugs acting on cardiovascularsystem

a) Antihypertensives

b) Anti-anginaldrugs

c) Anti-arrhythmicdrugs

d) Drugs used for therapy of Congestive HeartFailure

e) Drugs used forhyperlipidaemias

4. Pharmacology of drugs acting on Central NervousSystem

a) Generalanesthetics

b) Sedatives andhypnotics

c) Anticonvulsants

59

d) Analgesic and anti-inflammatoryagents

e) Psychotropicdrugs

f) Alcohol and methylalcohol

g) CNS stimulants and cognitionenhancers

h) Pharmacology of localanaesthetics

5. Pharmacology of Drugs acting on Respiratorytract

a) Bronchodilators

b) Mucolytics

c) Expectorants

d) Antitussives

e) NasalDecongestants

6. Pharmacology of Hormones and Hormoneantagonists

a) Thyroid and Antithyroiddrugs

b) Insulin, Insulin analogues and oral hypoglycemicagents

c) Sex hormones and oralcontraceptives

d) Oxytocin and other stimulants andrelaxants

7. Pharmacology of autocoids and theirantagonists

a) Histamines andAntihistaminics

b) 5-Hydroxytryptamine and itsantagonists

c) Lipid derived autocoids and platelet activatingfactor

COMMUNITY PHARMACY(THEORY)


1. Scope: In the changing scenario of pharmacy practice in India, Community Pharmacists are expectedto offer various pharmaceutical care services. In order to meet this demand, students will be learningvariousskillssuchasdispensingofdrugs,respondingtominorailmentsbyprovidingsuitablesafemed- ication,patient counselling, health screening services for improved patient care in the community set up.

2. Objectives: Upon completion of the course, the student shall be able to–

a. know pharmaceutical careservices;

b. know the business and professional practice management skills in communitypharmacies;

c. dopatientcounselling&providehealthscreeningservicestopublicincommunitypharmacy;

d. respond to minor ailments and provide appropriatemedication;

60

e. show empathy and sympathy to patients;and

f. appreciate the concept of Rational drugtherapy.

Text Books:

a. Health Education and Community Pharmacy byN.S.Parmar.

b. WHO consultative groupreport.

c. Drug store & Business management by Mohammed Ali &Jyoti.

Reference books:

a. Handbookofpharmacy–healthcare.Edt.RobinJHarman.ThePharmaceuticalpress.

b. Comprehensive Pharmacy Review – Edt. Leon Shargel. Lippincott Williams &Wilkins.

Special requirements:

1. Either the college is having model community pharmacy (meeting the schedule N requirement) or signMoU with at least 4-5 community pharmacies nearby to the college for training the students ondispensing and counsellingactivities.

2. Special equipments like B.P apparatus, Glucometer, Peak flow meter, and apparatus for cholesterolestimation.

3. Scheme of evaluation (80Marks)

1. Synopsis 10

2. MajorExperiment 30

(Counselling of patients with specific diseases – emphasis should be givenonCounselling introduc-tion, content, process andconclusion)

3. Minor Experiment(Ability to measure B.P/ CBG /Lungfunction) 15

4. Prescription Analysis (Analyzing the prescriptions for probable drug interaction and ability to tell themanagement) 15

5. Viva–Voce 10

4. Lecture wise programme :

Topics

1 Definition, scope, of communitypharmacy

Roles and responsibilities of Community pharmacist

2 Community PharmacyManagement

a) Selection of site, Space layout, anddesign

b) Staff, Materials- coding,stocking

c) Legalrequirements

d) Maintenance of variousregisters

61

e) Use of Computers: Business and health care softwares

3 Prescriptions – parts of prescription, legality & identification of medication related problemslike druginteractions.

4 Inventory control in community pharmacy

Definition,variousmethodsofInventoryControl

ABC, VED, EOQ, Lead time, safetystock

5 Pharmaceuticalcare

Definition and Principles of Pharmaceutical care.

6 Patientcounselling

Definition, outcomes, various stages, barriers, Strategies to overcome barriers

Patient information leaflets- content, design, & layouts, advisory labels

7 Patient medicationadherence

Definition, Factors affecting medication adherence, role of pharmacist in

improving the adherence.

8 Health screeningservices

Definition, importance, methods for screening

Blood pressure/ blood sugar/ lung function and

Cholesterol testing

9 OTC Medication- Definition, OTC medication list &Counselling

10 HealthEducation

WHODefinitionofhealth,andhealthpromotion,careforchildren,pregnant&breastfeedingwomen,and geriatricpatients. Commonly occurring Communicable Diseases, causativeagents,

Clinicalpresentationsandpreventionofcommunicablediseases–Tuberculosis,Hepatitis,Typhoid,Amoe-biasis, Malaria,Leprosy,

Syphilis, Gonorrhea and AIDS

Balance diet, and treatment & prevention of deficiency disorders Family planning – role of pharmacist 11

Responding to symptoms of minor ailments

Relevant pathophysiology, common drug therapy to, Pain, GI disturbances (Nausea, Vomiting, Dyspepsia,diarrhea, constipation), Pyrexia, Opthalmic symptoms, worms infestations.

12 Essential Drugs concept and Rational DrugTherapy

Role of community pharmacist

13 Code of ethics for communitypharmacists

62

PHARMACOTHERAPEUTICS - I(THEORY)


1. ScopeoftheSubject:Thiscourseisdesignedtoimpartknowledgeandskillsnecessaryforcontribution toquality use of medicines. Chapters dealt cover briefly pathophysiology and mostly therapeutics ofvariousdiseases.Thiswillenablethestudenttounderstandthepathophysiologyofcommondiseases andtheirmanagement.

2. Objectives:Atcompletionofthissubjectitisexpectedthatstudentswillbeabletounderstand–

a. the pathophysiology of selected disease states and the rationale for drugtherapy;

b. the therapeutic approach to management of thesediseases;

c. the controversies in drugtherapy;

d. the importance of preparation of individualised therapeutic plans based ondiagnosis;

e. needstoidentifythepatient-specificparametersrelevantininitiatingdrugtherapy,andmonitoringtherapy (including alternatives, time-course of clinical and laboratory indices of therapeuticresponse and adverseeffects);

f. describethepathophysiologyofselecteddiseasestatesandexplaintherationalefordrugthera- py;

g. summarisethetherapeuticapproachtomanagementofthesediseasesincludingreferencetothe latestavailableevidence;

h. discuss the controversies in drugtherapy;

i. discuss the preparation of individualised therapeutic plans based on diagnosis;and

j. identifythepatient-specificparametersrelevantininitiatingdrugtherapy,andmonitoringtherapy(including alternatives, time-course of clinical and laboratory indices of therapeutic response andadverseeffects).

Text Books

a. Clinical Pharmacy and Therapeutics - Roger and Walker, Churchill Livingstonepublication.

b. Pharmacotherapy: A Pathophysiologic approach - Joseph T. Dipiro et al. Appleton &Lange.

Reference Books

a. Pathologic basis of disease - Robins SL, W.B.Saunderspublication.

b. PathologyandtherapeuticsforPharmacists:ABasisforClinicalPharmacyPractice-GreenandHarris, Chapman and Hallpublication.

c. Clinical Pharmacy and Therapeutics - Eric T. Herfindal, Williams and WilkinsPublication.

d. Applied Therapeutics:The clinical Use of Drugs. Lloyd Young and Koda-KimbleMA

e. Avery’s Drug Treatment, 4th Edn, 1997, Adis InternationalLimited.

f. Relevant review articles from recent medical and pharmaceuticalliterature.

63


Etiopathogenesis and pharmacotherapy of diseases associated with following systems/ diseases

Title of the topic

1 Cardiovascular system: Hypertension, Congestive cardiac failure, Angina Pectoris, Myocardialinfarc- tion, , Hyperlipidaemias, Electrophysiology of heart andArrhythmias

2 Respiratorysystem:IntroductiontoPulmonaryfunctiontest,Asthma,Chronicobstructiveairwaysdis-ease,DruginducedpulmonarydiseasesEndocrinesystem:Diabetes,Thyroiddiseases,Oralcontracep- tives,Hormone replacement therapy, Osteoporosis

3 General prescribing guidelinesfor

a. Paediatricpatients

b. Geriatricpatients

c. Pregnancy and breastfeeding

4 Ophthalmology: Glaucoma, Conjunctivitis- viral &bacterial

5 Introduction to rational druguse

Definition, Role of pharmacist Essential drug concept Rational drug formulations

2.6 PHARMACOTHERAPEUTICS - I (PRACTICAL)


Practicals :

Hospital postings in various departments designed to complement the lectures by providing practicalclinical discussion; attending ward rounds; follow up the progress and changes made in drug therapy inallotted patients; case presentation upon discharge. Students are required to maintain a record of casespresented and the same should be submitted at the end of the course for evaluation. A minimum of 20cases should be presented and recorded covering most common diseases.

Assignments :

Students are required to submit written assignments on the topics given to them. Topics allotted shouldcover recent developments in drug therapy of various diseases. A minimum of THREE assignments [1500– 2000 words] should be submitted for evaluation.



2. Reference (s) shall be included at theend.





64


Sessionals Annual

Synopsis 05 15


Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity, promptness,viva-voce and record maintenance.

Third Year3.1 PHARMACOLOGY – II (THEORY)


1. Scope of the Subject: This subject will provide an opportunity for the student to learn about the drugwith regard to classification, pharmacodynamic and pharmacokinetic aspects, adverse effects, uses,dose, route of administration, precautions, contraindications and interaction with other drugs. In thissubject, drugs acting on autacoids, respiratory system, GIT, immune system and hormones, and phar-macologyofautocoidsandhormoneswillbeconcentrated.Inaddition,pharmacologyofchemothera-peuticagents,vitamines,essentialmineralsandprinciplesoftoxicologyarealsotaught.Inadditiontotheoretical knowledge, the basic practical knowledge relevant to therapeutics will beimparted.

2. Objectives of the Subject Upon completion of the subject student shall be ableto:

a. understandthepharmacologicalaspectsofdrugsfallingundertheabovementionedchapters,

b. carry out the animal experiments confidently,

c. appreciate the importance of pharmacology subject as a basis of therapeutics,and

d. correlate and apply the knowledgetherapeutically.

Text books (Theory)

a. Tripathi, K. D. Essentials of medical pharmacology. 4th edition, 1999. Publisher: Jaypee,Delhi.

b. Satoskar, R.S. and Bhadarkar, S.D. Pharmacology and pharmacotherapeutics. 16th edition (singlevolume), 1999. Publisher: Popular,Dubai.

c. Rang, H.P. and Dale, M.M. Pharmacology. 4th edition, 1999. Publisher: Churchill Livingstone.


a. Goodman Gilman, A., Rall, T.W., Nies, A.I.S. and Taylor, P.Goodman and Gilman’s Thepharmaco- logical Basis of therapeutics. 9th edition, 1996. Publisher: Mc Graw Hill,Pergamonpress.

b. Craig,C.R.andStitzel,R.E.ModernPharmacology.Latestedition.Publisher:LittleBrownandcompany.

c. Katzung,B.G.Basicandclinicalpharmacology.Latestedition.Publisher:PrenticeHall,Internation- al.

65

d. Gupta, P.K. and Salunkhe, D.K. Modern Toxicology. Volume I, II and III. Latest edition.Publisher:B.V. Gupta, Metropolitan Book Co. (p) Ltd, New Delhi.

Text books (Practical)

Kulkarni,S.K.andDandia,P.C.Handbookofexperimentalpharmacology.Latestedition,Publisher:Vallab,Delhi.

Reference books (Practical) :

a. Macleod,L.J.Pharmacologicalexperimentsonintactpreparations.Latestedition,Publisher:Chur-chilllivingstone.

b. Macleod,L.J.Pharmacologicalexperimentsonisolatedpreparations.Latestedition,Publisher:Churchilllivingstone.

c. Ghosh, M.N. Fundamentals of experimental pharmacology. Latest edition, Publisher: Scientificbook agency,Kolkata.

d. Ian Kitchen. Textbook of in vitro practical pharmacology. Latest edition, Publisher: Black wellSci- entific.

3. Detailed syllabus and lecture wiseschedule:

Title of the topic

1. Pharmacology of Drugs acting on Blood and blood formingagents

a) Anticoagulants

b) Thrombolytics and antiplateletagents

c) Haemopoietics and plasmaexpanders

2. Pharmacology of drugs acting on RenalSystem

a) Diuretics

b) Antidiuretics

3. Chemotherapy

a) Introduction

b) Sulfonamides andco-trimoxazole

c) Penicillins andCephalosporins

d) Tetracyclins andChloramphenicol

e) Macrolides, Aminoglycosides, Polyene & Polypeptideantibiotics

f) Quinolines andFluroquinolines

g) Antifungalantibiotics

h) Antiviralagents

i) Chemotherapy of tuberculosis andleprosy

j) Chemotherapy ofMalaria

66

k) Chemotherapy of protozoal infections (amoebiasis,Giardiasis)

l) Pharmacology of Anthelminticdrugs

m) Chemotherapy of cancer(Neoplasms)

4 Immunopharmacology

Pharmacology of immunosuppressants and stimulants

5. Principles of Animaltoxicology

Acute, sub acute and chronictoxicity

6. The dynamic cell: The structures and functions of the components of thecell

a) Cellandmacromolecules:Cellularclassification,subcellularorganelles,macromolecules,largemacromolecularassemblies

b) Chromosomestructure:Proandeukaryoticchromosomestructures,chromatinstructure,ge- nomecomplexity, the flow of geneticinformation.

c) DNAreplication:General,bacterialandeukaryoticDNAreplication.

d) Thecellcycle:Restrictionpoint,cellcycleregulatorsandmodifiers.

e) Cellsignaling:Communicationbetweencellsandtheirenvironment,ion-channels,signaltrans-duction pathways (MAP kinase, P38 kinase, JNK, Ras and PI3-kinase pathways,biosensors.

The Gene: Genome structure and function:

a) Gene structure: Organization and elucidation of geneticcode.

b) Geneexpression:Expressionsystems(proandeukaryotic),geneticelementsthatcontrolgeneexpression (nucleosomes, histones, acetylation, HDACS, DNA binding proteinfamilies.

c) TranscriptionandTranscriptionfactors:Basicprinciplesoftranscriptioninproandeukaryotes.Transcription factors that regulate transcription in pro andeukaryotes.

RNA processing: rRNA, tRNA and mRNA processing.

Protein synthesis: Mechanisms of protein synthesis, initiation in eukaryotes, translation control and post-translation events

Alteredgenefunctions:Mutations,deletions,amplifications,LOH,traslocations,trinucleotiderepeatsand othergenetic abnormalities. Oncogenes and tumor suppressorgenes.

The gene sequencing, mapping and cloning of human disease genes.

Introduction to gene therapy and targeting.

Recombinant DNA technology: principles. Processes (gene transfer technology) and applications

Books:

1 Molecular Biology of the Cell by Alberts B., Bray, D., Lewis, J., Raff M., Roberts, K and Watson, JD,3rd edition.

2 Molecular Cell Biology By Lodish, H., Baltimore, D., Berk, A et al., 5thedition.

3 Molecular Biology by Turner, PC., McLennan, AG., Bates, AD and White MRH 2ndedition.

67

4 Genes VIII by Lewin, B.,(2004)

5 Pharmaceutical Biotechnology, by Crommelin, DJA and Sindelar RD(1997)

6 Recombinant DNA by Watson, JD., Gilman, M., et al.,(1996)

7 Biopharmaceutical: Biochemistry and Biotechnology by Walsh, G.,(1998)

PHARMACOLOGY – II(PRACTICAL)



1. Studyoflaboratoryanimalsandtheirhandling(a.Frogs,b.Mice,c.Rats,d.Guineapigs,e.Rabbits).

2. Study of physiological salt solutions used in experimentalpharmacology.

3. Study of laboratory appliances used in experimentalpharmacology.

4. Study of use of anesthetics in laboratoryanimals.

5. TorecordthedoseresponsecurveofAchusingisolatedileum/rectusabdominismusclepreparation.

6. To carry out bioassay of Ach using isolated ileum/rectus abdominis muscle preparation by interpola-tionmethod.

7. To carry out bioassay of Ach using isolated ileum/rectus abdominis muscle preparation by three pointmethod.

8. To record the dose response curve of Histamine using isolated guinea-pig ileumpreparation.

9. Studyofagonisticandantagonisticeffectsofdrugsusingisolatedguinea-pigileumpreparation.

10. To carry out bioassay of Histamine using isolated guinea-pig ileum preparation by interpolation meth-od.

11. To carry out bioassay of Histamine using guinea-pig ileum preparation by three pointmethod.

12. To study the routes of administration of drugs in animals (Rats, Mice,Rabbits).

13. Study of theory, principle, procedure involved and interpretation of given results for the following ex-periments:

a) Analgesic property of drug usinganalgesiometer.

b) Antiinflammatory effect of drugs using rat-paw edemamethod.

c) Anticonvulsantactivityofdrugsusingmaximalelectroshockandpentylenetetrazolemethods.

d) Antidepressantactivityofdrugsusingpoleclimbingapparatusandpentobarbitoneinducedsleeping timemethods.

e) Locomotor activity evaluation of drugs using actophotometer androtorod.

f) Cardiotonic activity of drugs using isolated frog heart and mammalian heartpreparations.

68


Sessionals Annual

Identification 02 10Synopsis 04 10

Major Experiment (Bioassay) 08 30Minor Experiment (Interpretation of givenGraph or simulated experiment)

04 10

Viva 02 10

Max Marks 20 70Duration 3hrs 4hrs


PHARMACEUTICAL ANALYSIS(THEORY)


1. QualityAssurance:

a. Introduction, sources of quality variation, control of qualityvariation.

b. Concept of statistical qualitycontrol.

c. Validationmethods-qualityofequipment,validationofequipmentandvalidationofanalyticalinstruments andcalibration.

d. GLP, ISO9000.

e. Total quality management, quality review anddocumentation.

f. ICH- international conference forharmonization-guidelines.

g. Regulatorycontrol.

2. Chromatography:

Introduction, history, classification, separation techniques, choice of methods. The following tech-niquesbediscussedwithrelevantexamplesofpharmaceuticalproductsinvolvingprinciplesandtech- niquesof separation of drugs fromexcipients.

a. Column Chromatography: Adsorption column chromatography, Operational technique, frontalanalysisandelutionanalysis.Factorsaffectingcolumnefficiency,applicationsandpartitionchro-matography.

b. TLC: Introduction, principle, techniques, Rf value andapplications.

c. PC:Introduction,principle,typesofpaperchromatography,preparationtechniques,developmenttechniques,applications.

d. Ion-exchangechromatography:Introduction,principles,typesofionexchangesyntheticresins,physical properties, factors affecting ion exchange, methodology andapplications.

e. HPLC: Introduction, theory, instrumentation, andapplications.

f. HPTLC: Introduction, theory, instrumentation, andapplications.

69

g. Gas Chromatography: Introduction, theory, instrumentation-carrier gases, types of columns,stationaryphasesinGLC&GSC.Detectors-Flameionizationdetectors,electroncapturedetec- tor,thermal conductivity detector. Typical gas chromatogram, derivatisation techniques, pro-grammed temperature gas chromatography,applications.

h. Electrophoresis: Principles of separation, equipment for paper and gel electrophoresis, and ap-plication.

i. Gel filtration and affinity chromatography: Introduction, technique,applications.

3. ElectrometricMethods:

Theoretical aspects, instrumentation, interpretation of data/spectra and analytical applications be dis-cussed on the following topics.

a. Potentiometry: Electrical potential, electrochemical cell, reference electrodes, indicator elec-trodes,measurementofpotentialandpH,constructionandworkingofelectrodes,Potentiomet- rictitrations, methods of detecting end point, Karl Fischertitration.

b. Conductometry: Introduction, conductivity cell, conductometric titrations andapplications.

c. Polarography:Instrumentation,DME,residualcurrent,diffusioncurrentandlimitingcurrent,polarographicwave,Ilkovic’sequation,Effectofoxygenonpolarographicwave,Polarographicmaxima and suppressors andapplications.

d. Amperometric Titrations: Introduction, types of electrodes used, reference and indicator elec-trode,instrumentation,titrationprocedure,advantagesanddisadvantagesofAmperometryoverpotentiometry. Pharmaapplications.

4. Spectroscopy:

Theoretical aspects, instrumentation, elements of interpretation of data/spectra and application ofanalytical techniques be discussed on:

a. AbsorptionSpectroscopy:

- Theory of electronic, atomic and molecular spectra. Fundamental laws of photometry, Beer-Lam-bert’sLaw,applicationanditsdeviation,limitationofBeerlaw,applicationofthelawtosingleandmultiple component analysis, measurement of equilibrium constant and rate constant by spec-troscopy. Spectra of isolated chromophores, auxochromes, batho-chromic shift, hypsochromicshift, hyperchromic and hypochromic effect, effect of solvent on absorption spectra, molecularstructure and infraredspectra.

Instrumentation – Photometer, U.V.-Visible spectrophotometer – sources of U.V.-Visible radia-tions, collimating systems, monochromators, samples cells and following detectors-Photocell,Barrier layer cell, Phototube, Diode array, applications of U.V.-Visible spectroscopy in pharmacyand spectrophotometric titrations.

- Infrared Spectroscopy: Vibrational transitions, frequency – structure correlations, Infrared ab-sorption bands, Instrumentation–IR spectro-meter – sources of IR, Collimating systems, mono-chromators, sample cells, sample handling in IR spectroscopy and detectors–Thermocouple, Go-lay Cells, Thermistor, Bolometer, Pyroelectric detector, Applications of IR in pharmacy.

- Fluorimetric Analysis: Theory, luminescence, factors affecting fluorescence, quenching. Instru-mentation,Applications,fluorescentindicators,studyofpharmaceuticallyimportantcompoundsestimated byfluorimetry.

70

b. FlamePhotometry:Theory,nebulisation,flameandflametemperature,interferences,flamespectrometric techniques and instrumentation and pharmaceuticalapplications.

c. Atomic Absorption Spectrometry: Introduction, Theory, types of electrodes, instrumentationandapplications.

d. AtomicEmissionSpectroscopy:Spectroscopicsources,atomicemissionspectrometers,photo-graphic and photoelectricdetection.

e. NMR & ESR (introduction only): Introduction, theoretical aspects andapplications.

f. MassSpectroscopy:(Introductiononly)–Fragmentation,typesofionsproducedmassspectrumandapplications.

g. Polarimetry:(Introductiononly)–Introductiontoopticalrotatorydispersion,circulardichroism,polarimeter.

h. X-RAYDiffraction:(Introductiononly)–Theory,reciprocallatticeconcept,diffractionpatternsandapplications.

i. Thermal Analysis: Introduction, instrumentation, applications, and DSC and DTA.

List ofExperiments:

PHARMACEUTICAL ANALYSIS(PRACTICAL)


1. Separation and identification of Amino Acids by PaperChromatography.

2. Separation and identification of Sulpha drugs by TLCtechnique.

3. Effect of pH and solvent on the UV spectrum of givencompound.

4. Comparison of the UV spectrum of a compound with that of itsderivatives.

5. Determination of dissociation constant of indicators using UV-Visiblespectroscopy.

6. Conductometric titration of mixture of acids with a strongbase.

7. Potentiometric titration of a acid with a strongbase.

8. Estimation of drugs by Fluorimetrictechnique.

9. Study of quenching effect influorimetry.

10. Colourimetric estimation of Supha drugs using BMRreagent.

11. Simultaneous estimation of two drugs present in givenformulation.

12. Assay of Salicylic Acid bycolourimetry.

13. Determination of Chlorides and Sulphates in Calcium gluconate by NepheloturbidimetricMethod.

14. Determination of Na/K by FlamePhotometry.

15. Determination of pKa using pHmeter.

16. Determination of specificrotation.

71

17. Comparison of the IR spectrum of a compound with that of itsderivatives.

18. Demonstration ofHPLC.

19. Demonstration ofHPTLC.

20. Demonstration ofGC-MS.

21. Demonstration ofDSC.

22. Interpretation of NMR spectra of any onecompound.

Reference Books:

1. Text Book of Pharm. Analysis by Higuchi. T and Hasen. E. B., New York Inter SciencePublishers.

2. Quantitative Pharma. Analysis by Jenkins, The Blakiston division, NewYork.

3. Quantitative Drug Analysis, by Garrot. D, Chapman & Hall Ltd.,London.

4. Undergraduate Instrumental Analysis by James. E., CBSPublishers.

5. Instrumental Analysis by Willard and Merritt, EWP, East West Press Ltd.,Delhi/Madras.

6. Pharm Analysis by Skoog and West, Sounders Manipal CollegePublishing.

7. Text Book of Chemical Analysis, by A.I.Vogel, ELBS with Macmillan press, Hampshire.

8. Textbook of Pharm. Analysis by K.A.Connors, John Wiley & Sons, New York, Brisbane,Singapore.

9. Textbook of Pharm. Analysis (Practical) by Beckett & Stenlake, CBS Publishers,Delhi.

10. Textbook of Drug Analysis by P.D. Sethi., CBS Publishers,Delhi.

11. Spectroscopy by Silverstein, John & Wiley & Sons. Inc., Canada &Singapore.

12. HowtopractiseGMP-APlanfortotalqualitycontrolbyP.P.Sharma,VandanaPublications,Agra.

13. The Science & Practice of Pharmacy by Remington Vol-I & II, Mack Publishing Co.Pennsylvania.

14. TLC by Stahl, SpringVerlay.

15. Text Book of Pharm. Chemistry by Chatten, CBS Publications.

16. Spectroscopy by William Kemp, ELBS with Macmillan Press,Hampshire.

17. I.P.-1996, The Controller of Publications, NewDelhi.

18. BPC- Dept. of Health, U.K. forHMSO.

19. USP - Mack Publishing Co., Easton,PA.

20. The Extra Pharmacopoeia – The Pharm. Press,London.

72

PHARMACOTHERAPEUTICS – II(THEORY)


1. ScopeoftheSubject:Thiscourseisdesignedtoimpartknowledgeandskillsnecessaryforcontribution toquality use of medicines. Chapters dealt cover briefly pathophysiology and mostly therapeutics ofvariousdiseases.Thiswillenablethestudenttounderstandthepathophysiologyofcommondiseases andtheirmanagement.

2. Objectives of the Subject Upon completion of the subject student shall be able to–

a. know the pathophysiology of selected disease states and the rationale for drugtherapy

b. know the therapeutic approach to management of thesediseases;

c. know the controversies in drugtherapy;

d. knowtheimportanceofpreparationofindividualisedtherapeuticplansbasedondiagnosis;and

e. appreciatetheneedstoidentifythepatient-specificparametersrelevantininitiatingdrugtherapy,andmonitoringtherapy(includingalternatives,time-courseofclinicalandlaboratoryindicesoftherapeu- ticresponse and adverseeffects).

Text books (Theory)

Clinical Pharmacy and Therapeutics - Roger and Walker, Churchill Livingstone publication


a. Pharmacotherapy: A Pathophysiologic approach - Joseph T. Dipiro et al. Appleton &Lange

b. Clinical Pharmacy and Therapeutics - Eric T. Herfindal, Williams and WilkinsPublication

c. Applied Therapeutics: The clinical Use of Drugs. Lloyd Young and Koda-KimbleMA]


Etiopathogenesisandpharmacotherapyofdiseasesassociatedwithfollowingsystems/diseases– Title

of thetopic

1. Infectious disease: Guidelines for the rational use of antibiotics and surgical Prophylaxis,Tuberculosis, Meningitis, Respiratory tract infections, Gastroenteritis, Endocarditis, Septicemia,Urinary tract infections, Protozoal infection- Malaria, HIV & Opportunistic infections, Fungalinfections, Viral infections, Gonarrhoea and Syphillis

2 Musculoskeletaldisorders

Rheumatoid arthritis, Osteoarthritis, Gout, Spondylitis,Systemiclupus erythematosus.

3 Renalsystem

Acute Renal Failure, Chronic Renal Failure, Renal Dialysis, Drug induced renal disorders

4 Oncology:BasicprinciplesofCancertherapy,Generalintroductiontocancerchemotherapeuticagents,Chemotherapy of breast cancer, leukemia. Management of chemotherapy nausea andemesis

5 Dermatology: Psoriasis, Scabies, Eczema,Impetigo

73

Practicals :

PHARMACOTHERAPEUTICS – II(PRACTICAL)


Hospital postings in various departments designed to complement the lectures by providing practicalclinical discussion; attending ward rounds; follow up the progress and changes made in drug therapy inallotted patients; case presentation upon discharge. Students are required to maintain a record of casespresented and the same should be submitted at the end of the course for evaluation.

Thestudentshallbetrainedtounderstandtheprincipleandpracticeinvolvedinselectionofdrugtherapy includingclinicaldiscussion.

A minimum of 20 cases should be presented and recorded covering most common diseases.

Assignments :


Format of the assignment :








Sessionals Annual

Synopsis 05 15



74

PHARMACEUTICAL JURISPRUDENCE(THEORY)


1. Scope of the Subject: (4-6 lines): This course exposes the student to several important legislations re-latedtotheprofessionofpharmacyinIndia.TheDrugsandCosmeticsAct,alongwithitsamendmentsarethecoreofthiscourse.Otheracts,whicharecovered,includethePharmacyAct,dangerousdrugs, medicinaland toilet preparation Act etc. Besides this the new drug policy, professional ethics, DPCO, patent anddesign Act will bediscussed.

2. Objectives of the Subject: Upon completion of the subject student shall be able to (Know, do, andappreciate)–

a. practice the Professionalethics;

b. understand the various concepts of the pharmaceutical legislation inIndia;

c. know the various parameters in the Drug and Cosmetic Act andrules;

d. know the Drug policy, DPCO, Patent and designact;

e. understand the labeling requirements and packaging guidelines for drugs andcosmetics;

f. beabletounderstandtheconceptsofDangerousDrugsAct,PharmacyActandExcisedutiesAct; and

g. otherlawsasprescribedbythePharmacyCouncilofIndiafromtimetotimeincludingInterna-tionalLaws.

Text books (Theory)

Mithal, B M. Textbook of Forensic Pharmacy. Calcutta : National; 1988.

Reference books(Theory)

a. Singh, KK, editor. Beotra’s the Laws of Drugs, Medicines & cosmetics. Allahabad: Law BookHouse; 1984.

b. Jain, NK. A Textbook of forensic pharmacy. Delhi: Vallabh prakashan ;1995.

c. Reports of the Pharmaceutical enquiryCommittee

d. I.D.M.A., Mumbai. DPCO1995

e. Various reports ofAmendments.

f. Deshapande, S.W. The drugs and magic remedies act 1954 and rules 1955. Mumbai: Susmit Publi-cations;1998.

g. EasternBookCompany.Thenarcoticandpsychotropicsubstancesact1985,Lucknow:Eastern; 1987.


Title of the topic

1. Pharmaceutical Legislations – A briefreview.

2. Principle and Significance of professional ethics. Critical study of the code of pharmaceutical ethicsdrafted byPCI.

75

3. Drugs and Cosmetics Act, 1940,and its rules1945.

Objectives, Legal definition, Study of Schedule’s with reference to Schedule B, C&C1, D, E1, F&F1,F2, F3, FF, G, H, J, K, M, N, P, R, V, W, X, Y.

Sales, Import, labeling and packaging of Drugs And Cosmetics Provisions Relating to Indigenous Sys-tems. Constitution and Functions of DTAB,DCC,CDL.

Qualification and duties –Govt. analyst and Drugs Inspector.

4. Pharmacy Act–1948.

ObjectivesLegalDefinitions,GeneralStudy,ConstitutionandFunctionsofState&CentralCouncil,Reg-istration & Procedure,ER.

5. Medicinal and Toilet Preparation Act –1955.

Objectives, Legal Definitions, Licensing, Bonded and Non Bonded Laboratory, Ware Housing,Manufac- ture of Ayurvedic, Homeopathic, Patent & Proprietory Preparations.

6. NarcoticDrugsandPsychotropicsubstancesAct-1985andRules.Objectives,LegalDefinitions,Gener-alStudy,ConstitutionandFunctionsofnarcotic&PsychotropicConsultativeCommittee,NationalFund forControlling the Drug Abuse, Prohibition, Control and regulations, Schedules to theAct.

7. Study of Salient Features of Drugs and magic remedies Act and itsrules.

8. Study of essential Commodities Act Relevant to drugs price controlOrder.

9. Drug Price control Order & National Drug Policy(Current).

10. Prevention Of Cruelty to animalsAct-1960.

11. Patents & designAct-1970.

12. Brief study of prescription and Non-prescriptionProducts.

4. Assignments:


1. Minimum & Maximum number ofpages

2. It shall be a computer draftcopy




6. Time allocated for presentation may be 8+2Min

Case studies relating to

1. Drugs and Cosmetics Act and rules along with its amendments, Dangerous Drugs Act, Medicinal andToilet preparation Act, New Drug Policy, Professional Ethics, Drugs (Price control) Order, Patent andDesignAct.

2. Various prescription and non-prescriptionproducts.

3. Medical and surgicalaccessories.

4. Diagnostic aids and appliances available in themarket.

76

MEDICINAL CHEMISTRY(THEORY)


1. Modern concept of rational drug design: A brief introduction to Quantitative Structure Activity Re-lationaship (QSAR), prodrug, combinatorial chemistry and computer aided drug design (CADD) andconcept of antisensemolecules.

AstudyofthedevelopmentofthefollowingclassesofdrugsincludingSAR,mechanismofaction,syn- thesisof important compounds, chemical nomenclature, brand names of important marketed products andtheir sideeffects.

2. Anti-infectiveagents

a) Local anti-infectiveagents

b) Preservatives

c) Antifungalagents

d) Urinary tractanti-infectives

e) Antitubercularagents

f) Antiviral agents and Anti AIDSagents

g) Antiprotozoalagents

h) Anthelmentics

i) Antiscabies and Antipedicularagents

3. Sulphonamides and sulphones

4. Antimalarials

5. Antibiotics

6. Antineoplasticagents

7. Cardiovascularagents

a) Antihypertensiveagents

b) Antianginal agents andvasodilators

c) Antiarrhythmicagents

d) Antihyperlipidemicagents

e) Coagulants andAnticoagulants

f) Endocrine

8. Hypoglycemicagents

9. Thyroid and Antithyroidagents

10. Diureties

11. Diagnosticagents

12. Steroidal Hormones andAdrenocorticoids

77

MEDICINAL CHEMISTRY(PRACTICAL)


1. Assays of important drugs from the coursecontent.

2. Preparationofmedicinallyimportantcompoundsorintermediatesrequiredforsynthesisofdrugs.

3. Monograph analysis of importantdrugs.

4. Determinationofpartitioncoefficients,dissociationconstantsandmolarrefractivityofcompoundsforQSARanalysis.

Reference Books:

a. Wilson and Gisvold’s Text book of Organic, Medicinal and Pharmaceutical Chemistry,Lippin- cott-Raven Publishers-New York,Philadelphia.

b. William.O.Foye, Principles of Medicinal Chemistry, B.I. Waverly Pvt. Ltd., NewDelhi.

c. Burgers, Medicinal Chemistry, M.E.,Welly Med.Chemistry M.E. Walffed Johnwilley andSons,Wi- ley-interscience Publication, New York, Toranto.

d. ATextBookofMedicinalChemistryVol.IandIIbySurendraN.Pandeya,S.G.Publisher,6,DildayalNagar, Varanasi-10.

e. Indian Pharmacopoeia 1985 and 1996. The Controller of Publications, Civil Lines, Delhi -54.

f. CurrentIndexofMedicalSpecialities(CIMS)andMIMSIndia,MIMS,A.E.MorganPublications(I)Pvt. Ltd, NewDelhi-19.

g. Organic Drug Synthesis-Ledniser Mitzsher Vol. I andII.

h. Pharmaceutical Chemistry drug Synthesis Vol. I and II by H. J. Roth and A.Kleemann.

i. The Science and Practice of Pharmacy Vol. 1 and 2, Remington, MACK Publishing Company,Easton, Pennsylvania.

PHARMACEUTICAL FORMULATIONS(THEORY)


1. ScopeoftheSubject:Scopeandobjectivesofthecourse:Subjectdealswiththeformulationandeval- uation ofvarious pharmaceutical dosageforms.

2. ObjectivesoftheSubject:Uponcompletionofthesubjectstudentshallbeableto(Know,do,appreciate)–

a. understand the principle involved in formulation of various pharmaceutical dosageforms;

b. prepare various pharmaceuticalformulation;

c. perform evaluation of pharmaceutical dosage forms;and

d. understandandappreciatetheconceptofbioavailabilityandbioequivalence,theirroleinclinicalsituations.

78

Text books (Theory)

a. Pharmaceutical dosage forms, Vol, I,II and III bylachman

b. Rowlings Text book ofPharmaceutics

c. Tutorial Pharmacy – Cooper

&Gun Reference books(Theory)

a. Remington’s Pharmaceutical Sciences

b. USP/BP/IP


Title of the topic

1. Pharmaceutical dosage form- concept andclassification

2. Tablets:Formulationofdifferenttypesoftablets,tabletexcipients,granulationtechniquesqualitycon-trolandevaluationoftablets. Tablet coating,Typeofcoating,qualitycontroltestsforcoatedtablet.

3. Capsules; Production and filling of hard gelatin capsules, Raw material for shell, finishing, qualitycon- troltestsforcapsules.Productionandfillingofsoftgelatincapsules,qualitycontroltestsforsoftgelatincapsules.

4. Liquid orals: Formulation and evaluation of suspensions, emulsions and solutions. Stability of thesepreparations

5. Parenterals:IntroductionContainersusedforParenterals(includingofficialtests)Formulationoflarge andsmall volume ParenteralsSterilization

6. Ophthalmic preparations (Semi – Solids): Introduction and classification Factors affectingabsorption and anatomy of skin Packaging storage and labeling, Ointments Types of Ointment BasePreparation of ointment, Jellies Types of jellies Formulation of jellies Suppositories, Method ofpreparation, Types Packaging

7. Definition and concept of Controlled and novel Drug delivery systems with available examples, viz.parentral, trans dermal, buccal, rectal, nasal, implants,ocular

3.6 PHARMACEUTICAL FORMULATIONS (PRACTICAL)


List of Experiments :

1. Manufacture ofTablets

a. Ordinary compressed tablet-wetgranulation

b. Tablets prepared by directcompression.

c. Solubletablet.

d. Chewabletablet.

2. Formulation and filling of hard gelatincapsules

3. Manufacture ofparenterals

a. Ascorbic acidinjection

b. Calcium gluconateinjection

c. Sodium chlorideinfusion.

d. Dextrose and Sodium chloride injection/infusion.

4. Evaluation of Pharmaceutical formulations (QCtests)

a. Tablets

b. Capsules

c. Injections

5. Formulation of two liquid oral preparations and evaluation byassay

a. Solution: ParacetamolSyrup

b. Antacid suspensions- Aluminum hydroxidegel

6. Formulation of semisolids and evaluation byassay

a. Salicyclic acid and benzoic acidointment

b. Gel formulation Diclofenacgel

7. Cosmeticpreparations

a. Lipsticks

b. Cold cream and vanishingcream

c. Clear liquidshampoo

d. Tooth paste and toothpowders.

8. Tablet coating

(demonstration) Scheme of

P

N

ractical Examination:Sessionals Annual

Synopsis 05 15

Major Experiment 10 25Minor Experiment 03 15Viva 02 15Max Marks 20 70

79

ote : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity, promptness,viva-voce and record maintenance).

Duration 03 hrs 04 hrs

80

Fourth Year4.1 PHARMACOTHERAPEUTICS – III (THEORY)


1. Scope : This course is designed to impart knowledge and skills necessary for contribution to qualityuseofmedicines.Chaptersdealtcoverbrieflypathophysiologyandmostlytherapeuticsofvariousdis- eases.This will enable the student to understand the pathophysiology of common diseases and theirmanagement.

2. Objectives:Atcompletionofthissubjectitisexpectedthatstudentswillbeabletounderstand–

a. the pathophysiology of selected disease states and the rationale for drugtherapy;

b. the therapeutic approach to management of thesediseases;

c. the controversies in drugtherapy;

d. the importance of preparation of individualised therapeutic plans based ondiagnosis;

e. needstoidentifythepatient-specificparametersrelevantininitiatingdrugtherapy,andmonitoringtherapy (including alternatives, time-course of clinical and laboratory indices of therapeuticresponse and adverseeffects);

f. describethepathophysiologyofselecteddiseasestatesandexplaintherationalefordrugthera- py;

g. tosummarizethetherapeuticapproachtomanagementofthesediseasesincludingreferenceto the latestavailableevidence;

h. to discuss the controversies in drugtherapy;

i. to discuss the preparation of individualised therapeutic plans based on diagnosis;and

j. identifythepatient-specificparametersrelevantininitiatingdrugtherapy,andmonitoringtherapy(including alternatives, time-course of clinical and laboratory indices of therapeutic response andadverseeffects).

Text Books

a. Clinical Pharmacy and Therapeutics - Roger and Walker, Churchill Livingstonepublication

b. Pharmacotherapy: A Pathophysiologic approach - Joseph T. Dipiro et al. Appleton &Lange

Reference Books

a. Pathologic basis of disease - Robins SL, W.B.Saunderspublication

b. PathologyandtherapeuticsforPharmacists:ABasisforClinicalPharmacyPractice-GreenandHarris, Chapman and Hallpublication

c. Clinical Pharmacy and Therapeutics - Eric T. Herfindal, Williams and WilkinsPublication

d. Applied Therapeutics: The clinical Use of Drugs. Lloyd Young and Koda-KimbleMA

e. Avery’s Drug Treatment, 4th Edn, 1997, Adis InternationalLimited.

f. Relevant review articles from recent medical and pharmaceuticalliterature.

81

Etiopathogenesisandpharmacotherapyofdiseasesassociatedwithfollowingsystems/diseases:

Title of thetopic

1 Gastrointestinalsystem:Pepticulcerdisease,GastroEsophagealRefluxDisease,Inflammatoryboweldisease, Liver disorders - Alcoholic liver disease, Viral hepatitis including jaundice, and Drug inducedliverdisorders.

2 Haematological system: Anaemias, Venous thromboembolism,Drug

induced blood disorders.

3 Nervous system: Epilepsy, Parkinsonism, Stroke, Alzheimer’sdisease,

4 Psychiatrydisorders:Schizophrenia,Affectivedisorders,Anxietydisorders,Sleepdisorders,ObsessiveCompulsivedisorders

5 Pain management including Pain pathways, neuralgias,headaches.

6 Evidence BasedMedicine

PHARMACOTHERAPEUTICS – III(PRACTICAL)


Practicals:

Hospital postings for a period of at least 50 hours is required to understand the principles and practiceinvolved in ward round participation and clinical discussion on selection of drug therapy. Students are re-quiredtomaintainarecordof15casesobservedinthewardandthesameshouldbesubmittedattheend of the coursefor evaluation. Each student should present at least two medical cases they have observed and followed inthewards.

Assignments:



1. Minimum & Maximum number ofpages


3. Assignment can be a combined presentation at the end of the academicyear

4. It shall be computer draftcopy




Sessionals Annual

Synopsis 05 15



82

HOSPITAL PHARMACY(THEORY)


1. Scope:InthechangingscenarioofpharmacypracticeinIndia,forsuccessfulpracticeofHospitalPhar-macy,thestudentsarerequiredtolearnvariousskillslikedrugdistribution,drugdispensing,manufac- turingof parenteral preparations, drug information, patient counselling, and therapeutic drug monitoring forimproved patientcare.

2. Objectives: Upon completion of the course, the student shall be able to–

a. know various drug distributionmethods;

b. know the professional practice management skills in hospitalpharmacies;

c. provide unbiased drug information to thedoctors;

d. know the manufacturing practices of various formulations in hospital setup;

e. appreciate the practice based research methods;and

f. appreciate the stores management and inventorycontrol.

Text books: (latest editions)

a. Hospital pharmacy by William .E.Hassan

b. AtextbookofHospitalPharmacybyS.H.Merchant&Dr.J.S.Qadry.RevisedbyR.K.Goyal&R.K.Parikh

References:

a. WHO consultative groupreport.

b. R.P.S. Vol.2. Part –B; Pharmacy Practicesection.

c. Handbook of pharmacy – health care. Edt. Robin J Harman. The Pharmaceuticalpress.


Topics

1 Hospital - its Organisation andfunctions

2 Hospital pharmacy-Organisation andmanagement

a) Organizational structure-Staff, Infrastructure & work loadstatistics

b) Management of materials andfinance

c) Roles & responsibilities of hospitalpharmacist

3 The Budget – Preparation andimplementation

4 Hospital drugpolicy

a) Pharmacy and Therapeutic committee(PTC)

b) Hospitalformulary

c) Hospitalcommittees

83

- Infectioncommittee

- Research and ethicalcommittee

d) developing therapeuticguidelines

e) Hospital pharmacy communication -Newsletter

5 Hospital pharmacyservices

a) Procurement & warehousing of drugs andPharmaceuticals

b) Inventorycontrol

Definition, various methods of Inventory Control

ABC, VED, EOQ, Lead time, safety stock

c) Drug distribution in thehospital

i) Individual prescriptionmethod

ii) Floor stockmethod

iii) Unit dose drug distributionmethod

d) Distribution of Narcotic and other controlledsubstances

e) Central sterile supply services – Role ofpharmacist

6 Manufacture of Pharmaceuticalpreparations

a) Sterile formulations – large and small volumeparenterals

b) Manufacture of Ointments, Liquids, andcreams

c) Manufacturing of Tablets, granules, capsules, andpowders

d) Total parenteralnutrition

7 Continuingprofessionaldevelopmentprograms

Education andtraining

8 Radio Pharmaceuticals – Handling andpackaging

9 Professional Relations and practices of hospitalpharmacist

84

HOSPITAL PHARMACY(PRACTICAL)


1. Assessment of drug interactions in the givenprescriptions

2. Manufacture of parenteral formulations,powders.

3. Drug informationqueries.

4. Inventorycontrol

List of Assignments:

1. Design and Management of Hospital pharmacy department for a 300 beddedhospital.

2. Pharmacy and Therapeutics committee – Organization, functions, andlimitations.

3. Development of a hospital formulary for 300 bedded teachinghospital

4. Preparation of ABC analysis of drugs sold in one month from thepharmacy.

5. Different phases of clinical trials with elements to beevaluated.

6. Varioussourcesofdruginformationandsystematicapproachtoprovideunbiaseddruginformation.

7. Evaluation of prescriptions generated in hospital for drug interactions and find out the suitable man-agement.

Special requirements:

1. Each college should sign MoU with nearby local hospital having minimum 150 beds for providingnec- essary training to the students’ on hospital pharmacyactivities.

2. Well equipped with various resources of druginformation.


Sessionals Annual

Synopsis 05 15



85

CLINICAL PHARMACY(THEORY)


1. Objectives of the Subject:

Upon completion of the subject student shall be able to (Know, do, appreciate) –

a. monitor drug therapy of patient through medication chart review and clinicalreview;

b. obtain medication history interview and counsel thepatients;

c. identify and resolve drug relatedproblems;

d. detect, assess and monitor adverse drugreaction;

e. interpretselectedlaboratoryresults(asmonitoringparametersintherapeutics)ofspecificdis- easestates;and

f. retrieve, analyse, interpret and formulate drug or medicineinformation.

Text books (Theory)

a. Practice Standards and Definitions - The Society of Hospital Pharmacists ofAustralia.

b. Basic skills in interpreting laboratory data - Scott LT, American Society of Health SystemPharma- cistsInc.

c. Biopharmaceutics and Applied Pharmacokinetics - Leon Shargel, Prentice Hallpublication.

d. A text book of Clinical Pharmacy Practice; Essential concepts and skills, Dr.G.Parthasarathietal, Orient Orient Langram Pvt.Ltd.ISSBN8125026

References

a. Australiandruginformation-Proceduremanual.TheSocietyofHospitalPharmacistsofAustralia.

b. Clinical Pharmacokinetics - Rowland and Tozer, Williams and WilkinsPublication.

c. Pharmaceutical statistics. Practical and clinical applications. Sanford Bolton,Marcel Dekker, Inc.


Title of the topic

1. Definitions, development and scope of clinicalpharmacy

2. Introduction to daily activities of a clinicalpharmacist

a. Drug therapy monitoring (medication chart review, clinical review, pharmacistinterventions)

b. Ward round participation

c. Adverse drug reactionmanagement

d. Drug information and poisonsinformation

e. Medicationhistory

f. Patientcounseling

86

g. Drug utilisation evaluation (DUE) and review(DUR)

h. Quality assurance of clinical pharmacyservices

3. Patient dataanalysis

The patient’s case history, its structure and use in evaluation of drug therapy & Understanding commonmedical abbreviations and terminologies used in clinical practices.

4. Clinicallaboratorytestsusedintheevaluationofdiseasestates,andinterpretationoftestresults

a. Haematological, Liver function, Renal function, thyroid functiontests

b. Tests associated with cardiacdisorders

c. Fluid and electrolytebalance

d. Microbiological culture sensitivitytests

e. Pulmonary FunctionTests

5. Drug & Poisoninformation

a. Introduction to drug information resourcesavailable

b. Systematic approach in answering DIqueries

c. Critical evaluation of drug information andliterature

d. Preparation of written and verbalreports

e. Establishing a Drug InformationCentre

f. Poisons information- organization & informationresources

6. Pharmacovigilance

a. Scope, definition and aims ofpharmacovigilance

b. Adversedrugreactions-Classification,mechanism,predisposingfactors,causalityassessment[different scalesused]

c. Reporting, evaluation, monitoring, preventing & management ofADRs

d. Role of pharmacist in management ofADR.

7. Communication skills, including patient counselling techniques, medication history interview,presentation ofcases.

8. Pharmaceutical careconcepts

9. Critical evaluation of biomedicalliterature

10. Medicationerrors

87

CLINICAL PHARMACY(PRACTICAL)


Students are expected to perform 15 practicals in the following areas covering the topics dealt in theoryclass.

a. Answering drug information questions (4Nos)

b. Patient medication counselling (4Nos)

c. Case studies related to laboratory investigations (4Nos)

d. Patient medication history interview (3Nos)

Assignment:

Students are expected to submit THREE written assignments (1500 – 2000 words) on the topics given tothem covering the following areas dealt in theory class.

Drug information, Patient medication history interview, Patient medication counselling, Critical appraisalof recently published articles in the biomedical literature which deals with a drug or therapeutic issue.









Sessionals Annual

Synopsis 05 15



88

BIOSTATISTICS AND RESEARCH METHODOLOGY (THEORY)


1. Detailed syllabus and lecture wise schedule

1 ResearchMethodology

a) Types of clinical studydesigns:

Case studies, observational studies, interventional studies,

b) Designing themethodology

c) Sample size determination and Power of astudy

Determination of sample size for simple comparative experiments, determination of sample size toobtain a confidence interval of specified width, power of a study

d) Report writing and presentation ofdata

2 Biostatistics

a)Introduction

b) Types of datadistribution

c) Measures describing the central tendency distributions- average, median,mode

d) Measurementofthespreadofdata-range,variationofmean,standarddeviation,variance,coefficient ofvariation, standard error ofmean.

Datagraphics

Construction and labeling of graphs, histogram, piecharts, scatter plots, semilogarthimic plots

Basics of testinghypothesis

a) Nullhypothesis,levelofsignificance,poweroftest,Pvalue,statisticalestimationofconfidenceintervals.

b) Levelofsignificance(Parametricdata)-studentsttest(pairedandunpaired),chiSquaretest,Analysis of Variance (one-way andtwo-way)

c) Levelofsignificance(Non-parametricdata)-Signtest,Wilcoxan’ssignedranktest,Wilcoxanrank sumtest, Mann Whitney U test, Kruskal-Wall is test (one wayANOVA)

d) Linear regression and correlation- Introduction, Pearsonn’s and Spearmann’s correlation and cor-relationco-efficient.

e) Introduction to statistical software: SPSS, Epi Info,SAS.

Statistical methods inepidemiology

Incidence and prevalence, relative risk, attributable risk

3. Computer applications inpharmacy

Computer System in Hospital Pharmacy: Patterns of Computer use in Hospital Pharmacy – Patient recorddatabase management, Medication order entry – Drug labels and list – Intravenous solution and admix-ture, patient medication profiles, Inventory control, Management report & Statistics.

89

Computer In Community Pharmacy

Computerizing the Prescription Dispensing process

UseofComputersforPharmaceuticalCareincommunitypharmacy

Accounting and General ledgersystem

DrugInformationRetrieval&Storage:

Introduction – Advantages of Computerized Literature Retrieval

Use of Computerized Retrieval

Reference books:

a. Pharmaceuticalstatistics-practicalandclinicalapplications,SanfordBolton3rdedition,publisherMarcel Dekker Inc.NewYork.

b. DrugInformation-AGuideforPharmacists,PatrickMMalone,KarenL Kier, JohnEStanovich,3rdedition, McGraw Hill Publications2006

4.5 BIOPHARMACEUTICS AND PHARMACOKINETICS(THEORY)


1. Biopharmaceutics

1. Introduction toBiopharmaceutics

a. Absorption of drugs from gastrointestinaltract.

b. DrugDistribution.

c. DrugElimination.

2. Pharmacokinetics

2. Introduction toPharmacokinetics.

a. Mathematicalmodel

b. Drug levels inblood.

c. Pharmacokineticmodel

d. Compartmentmodels

e. Pharmacokineticstudy.

3. One compartment openmodel.

a. Intravenous Injection(Bolus)

b. Intravenousinfusion.

4. Multicompartmentmodels.

a. Two compartment openmodel.

90

b. IV bolus, IV infusion and oraladministration

5. Multiple – DosageRegimens.

a. Repititive Intravenous injections – One Compartment OpenModel

b. Repititive Extravascular dosing – One Compartment Openmodel

c. Multiple Dose Regimen – Two Compartment OpenModel

6. NonlinearPharmacokinetics.

a. Introduction

b. Factors causingNon-linearity.

c. Michaelis-menton method of estimatingparameters.

7. NoncompartmentalPharmacokinetics.

a. Statistical MomentTheory.

b. MRT for various compartmentmodels.

c. Physiological Pharmacokineticmodel.

8. Bioavailability andBioequivalence.

a. Introduction.

b. Bioavailability studyprotocol.

c. Methods of Assessment ofBioavailability

BIOPHARMACEUTICS AND PHARMACOKINETICS(PRACTICAL)


1. Improvement of dissolution characteristics of slightly soluble drugs by somemethods.

2. Comparison of dissolution studies of two different marketed products of samedrug.

3. Influence of polymorphism on solubility anddissolution.

4. Protein binding studies of a highly protein bound drug and poorly protein bounddrug.

5. Extentofplasma-proteinbindingstudiesonthesamedrug(i.e.highlyandpoorly

proteinbounddrug)atdifferentconcentrationsinrespectofconstanttime.

6. Bioavailability studies of some commonly used drugs on animal/humanmodel.

7. Calculation of Ka, Ke, t1/2, Cmax, AUC, AUMC, MRT etc. from blood profiledata.

8. Calculation of bioavailability from urinary excretion data for twodrugs.

9. Calculation of AUC and bioequivalence from the given data for twodrugs.

10. In vitro absorptionstudies.

91

11. Bioequivalency studies on the different drugs marketed. (eg) Tetracycline, Sulphamethoxzole,Trimethoprim, Aspirin etc., on animals and humanvolunteers.

12. Absorption studies in animal inverted intestine using variousdrugs.

13. Effect on contact time on the plasma protein binding ofdrugs.

14. Studying metabolic pathways for different drugs based on elimination kineticsdata.

15. Calculationofeliminationhalf-lifefordifferentdrugsbyusingurinaryeliminationdataandbloodlevel data.

16. Determination of renalclearance.

References:

a. Biopharmaceutics and Clinical Pharmacokinetics by, MiloGibaldi

b. Remington’s Pharmaceutical Sciences, By Mack Publishing Company,Pennsylvnia.

c. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel DekkerInc.

d. HandBookofClinicalPharmacokinetics,ByMiloGibaldiandLauriePrescottbyADISHealthSci-encePress.

e. Biopharmaceutics and Pharmacokinetics; By Robert FNotari

f. Biopharmaceutics; BySwarbrick

g. BiopharmaceuticsandPharmacokinetics-ATreatise,ByD.M.BrahmankarandSunil

B.Jaiswal, Vallabh Prakashan Pitampura,Delhi

h. CilincalPharmacokinetics,ConceptsandApplications:ByMalcolmRowlandand

Thomas, N. Tozen, Lea and Febrger, Philadelphia,1995.

i. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M,

Mack,Publishing Company, Pennsylvania1989.

j. BiopharmaceuticsandClinicalPharmacokinetics-Anintroduction4theditionRevised

and expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel,1987.

k. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James,

C. Roylan, Marcel Dekker Inc, New York1996.

CLINICAL TOXICOLOGY(THEORY)


1. General principles involved in the management ofpoisoning

2. Antidotes and the clinicalapplications.

3. Supportive care in clinicalToxicology.

4. GutDecontamination.

92

5. EliminationEnhancement.

6. Toxicokinetics.

7. Clinical symptoms and management of acute poisoning with the following agents–

a) Pesticidepoisoning:organophosphorouscompounds,carbamates,organochlorines,pyrethroids.

b) Opiatesoverdose.

c) Antidepressants

d) Barbiturates andbenzodiazepines.

e) Alcohol: ethanol,methanol.

f) Paracetamol andsalicylates.

g) Non-steroidal anti-inflammatorydrugs.

h) Hydrocarbons: Petroleum products andPEG.

i) Caustics: inorganic acids andalkali.

j) Radiationpoisoning

8. Clinical symptoms and management of chronic poisoning with the following agents–

Heavy metals: Arsenic, lead, mercury, iron, copper

9. Venomous snake bites: Families of venomous snakes, clinical effects of venoms, generalmanagementas first aid, early manifestations, complications and snake biteinjuries.

10. Plants poisoning. Mushrooms,Mycotoxins.

11. Foodpoisonings

12. Envenomations – Arthropod bites andstings.

Substance abuse:

Signs and symptoms of substance abuse and treatment of dependence

a) CNS stimulants:amphetamine

b) Opioids

c) CNSdepressants

d) Hallucinogens:LSD

e) Cannabisgroup

f) Tobacco

References:

a. MatthewJEllenhorn.ELLENHORNSMEDICALTOXICOLOGY–DIAGNOSISANDTREATMENTOFPOISON-ING. Second edition. Williams and Willkins publication, London

b. V V Pillay. HANDBOOK OF FORENSIC MEDICINE AND TOXICOLOGY. Thirteenth edition 2003Paras Pub- lication,Hyderabad

93

1. Drug development process:

Introduction

Fifth yearCLINICAL RESEARCH(THEORY)

Theory : 3 Hrs./Week

Various Approaches to drug discovery

1. Pharmacological

2. Toxicological

3. INDApplication

4. Drugcharacterization

5. Dosageform

2. Clinical development of drug:

1. Introduction to Clinicaltrials

2. Various phases of clinicaltrial.

3. Methods of post marketingsurveillance

4. Abbreviated New Drug Applicationsubmission.

5. Good Clinical Practice – ICH, GCP, Central drug standard control organisation (CDSCO)guidelines

6. Challenges in the implementation ofguidelines

7. Ethical guidelines in ClinicalResearch

8. Composition, responsibilities, procedures of IRB /IEC

9. Overview of regulatory environment in USA, Europe andIndia.

10. Role and responsibilities of clinical trial personnel as per ICHGCP

a. Sponsor

b. Investigators

c. Clinical researchassociate

d. Auditors

e. Contract researchcoordinators

f. Regulatoryauthority

11. Designing of clinical study documents (protocol, CRF, ICF, PIC withassignment)

12. Informed consentProcess

13. Data management and itscomponents

14. Safety monitoring in clinicaltrials.

94

References :

a. CentralDrugsStandardControlOrganization.GoodClinicalPractices-GuidelinesforClinicalTrials onPharmaceutical Products in India. New Delhi: Ministry of Health;2001.

b. InternationalConferenceonHarmonisationofTechnicalrequirementsforregistrationofPharma-ceuticals for human use. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Prac-tice.E6; May1996.

c. EthicalGuidelinesforBiomedicalResearchonHumanSubjects2000.IndianCouncilofMedicalResearch, NewDelhi.

d. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green,March2005, John Wiley andSons.

e. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna andHaynes.

f. ClinicalDataManagementeditedbyRKRondels,SAVarley,CFWebbs.SecondEdition,Jan2000,WileyPublications.

g. Goodman & Gilman: JG Hardman, LE Limbard, 10th Edn. McGraw Hill Publications,2001.

PHARMACOEPIDEMIOLOGY ANDPHARMACOECONOMICS(THEORY)


1. Pharmacoepidemiology:

Definition and scope:

Origin and evaluation of pharmacoepidemiology need for pharmacoepidemiology, aims and applications.

Measurement of outcomes in pharmacoepidemiology

Outcome measure and drug use measures

Prevalence, incidence and incidence rate. Monetary units, number of prescriptions, units of drugs dis-pensed, defined daily doses and prescribed daily doses, medication adherence measurement

Concept of risk in pharmacoepidemiology

Measurement of risk, attributable risk and relative risk, time-risk relationship and odds ratio

Pharmacoepidemiological methods

Includes theoretical aspects of various methods and practical study of various methods with the help ofcase studies for individual methods

Drug utilization review, case reports, case series, surveys of drug use, cross – sectional studies, cohortstudies, case control studies, case –cohort studies, meta – analysis studies, spontaneous reporting, pre-scription event monitoring and record linkage system.

Sources of data for pharmacoepidemiological studies

Ad Hoc data sources and automated data systems.

95

Selected special applications of pharmacoepidemiology

Studies of vaccine safety, hospital pharmacoepidemiology, pharmacoepidemiology and risk management,drug induced birth defects.

2. Phrmacoeconomics:

Definition, history, needs of pharmacoeconomic evaluations

Role in formulary management decisions

Pharmacoeconomic evaluation

Outcome assessment and types of evaluation

Includes theoretical aspects of various methods and practical study of various methods with the help ofcase studies for individual methods:

Cost – minimization, cost- benefit, cost – effectiveness, cost utility

3. Applications ofPharmacoeconomics

Software and case studies

CLINICAL PHARMACOKINETICS ANDPHARMACOTHERAPEUTIC

DRUG MONITORING (THEORY)


1. Introduction to Clinicalpharmacokinetics.

2. Design of dosageregimens:

Nomograms and Tabulations in designing dosage regimen, Conversion from intravenous to oral dosing,Determination of dose and dosing intervals, Drug dosing in the elderly and pediatrics and obese patients.

3. Pharmacokinetics of DrugInteraction:

a. Pharmacokinetic druginteractions

b. Inhibition and Induction of Drugmetabolism

c. Inhibition of BiliaryExcretion.

4. Therapeutic Drugmonitoring:

a. Introduction

b. Individualizationofdrugdosageregimen(Variability–Genetic,AgeandWeight,disease,Inter-actingdrugs).

c. Indications for TDM. Protocol forTDM.

d. Pharmacokinetic/Pharmacodynamic Correlation in drugtherapy.

e. TDMofdrugsusedinthefollowingdiseaseconditions:cardiovasculardisease,Seizuredisorders,Psychiatric conditions, and Organtransplantations.

96

5. Dosage adjustment in Renal and hepaticDisease.

a. Renalimpairment

b. Pharmacokineticconsiderations

c. General approach for dosage adjustment in Renaldisease.

d. Measurement of Glomerular Filtration rate and creatinineclearance.

e. Dosage adjustment for uremicpatients.

f. Extracorporeal removal ofdrugs.

g. Effect of Hepatic disease onpharmacokinetics.

6. PopulationPharmacokinetics.

a. Introduction to Bayesian Theory.

b. Adaptive method or Dosing with feedback.

c. Analysis of Population pharmacokineticData.

7. Pharmacogenetics

a. Genetic polymorphism in Drug metabolism: Cytochrome P-450Isoenzymes.

b. Genetic Polymorphism in Drug Transport and DrugTargets.

c. Pharmacogenetics and Pharmacokinetics/Pharmacodynamicconsiderations

97

1) SPECIFICOBJECTIVES:

APPENDIX-C(See regulation 16)

INTERNSHIP

i) to provide patient care in cooperation with patients, prescribers, and other members of an interpro-fessional health care team based upon sound therapeutic principles and evidence-based data, takinginto account relevant legal, ethical, social cultural, economic, and professional issues, emerging tech-nologies, and evolving biomedical, pharmaceutical, social or behavioral or administrative, and clinicalsciences that may impact therapeuticoutcomes.

ii) tomanageanduseresourcesofthehealthcaresystem,incooperationwithpatients,prescribers,oth-erhealthcareproviders,andadministrativeandsupportivepersonnel,topromotehealth;toprovide,assess,andcoordinatesafe,accurate,andtime-sensitivemedicationdistribution;andtoimprovether- apeuticoutcomes of medicationuse.

iii) topromotehealthimprovement,wellness,anddiseasepreventioninco-operationwithpatients,com-munities,at-riskpopulation,andothermembersofaninterprofessionalteamofhealthcareproviders.

iv) todemonstrateskillsinmonitoringoftheNationalHealthProgrammesandschemes,orientedtopro- videpreventive and promotive health care services to thecommunity.

v) to develop leadership qualities to function effectively as a member of the health care team organisedtodeliverthehealthandfamilywelfareservicesinexistingsocio-economic,politicalandculturalenvi-ronment.

vi) to communicate effectively with patients and thecommunity.

2) OTHER DETAILS:

i) All parts of the internship shall be done, as far as possible, in institutions in India. In case of any diffi-culties,themattermaybereferredtothePharmacyCouncilofIndiatobeconsideredonmerits.

ii) Where an intern is posted to district hospital for training, there shall be a committee consisting ofrepresentativesofthecollegeoruniversity,andthedistricthospitaladministration,whoshallregulatethetrainingofsuchtrainee.ForsuchtraineeacertificateofsatisfactorycompletionoftrainingshallbeobtainedfromtherelevantadministrativeauthoritieswhichshallbecountersignedbythePrincipalor DeanofCollege.

iii) Every candidate shall be required, after passing the final Pharm.D. or Pharm.D. (Post Baccalaureate)examinationasthecasemaybetoundergocompulsoryrotationalinternshiptothesatisfactionoftheCollegeauthoritiesandUniversityconcernedforaperiodoftwelvemonthssoastobeeligibleforthe award ofthe degree of Pharm.D. or Pharm.D. (Post Baccalaureate) as the case maybe.

3. ASSESSMENT OF INTERNSHIP :

i) Theinternshallmaintainarecordofworkwhichistobeverifiedandcertifiedbythepreceptor(teach-erpractioner)underwhomheworks.Apartfromscrutinyoftherecordofwork,assessmentandevalu-ationoftrainingshallbeundertakenbyanobjectiveapproachusingsituationtestsinknowledge,skillsandattitudeduringandattheendofthetraining.Basedontherecordofworkanddateofevaluation, the Dean orPrincipal shall issue certificate of satisfactory completion of training, following which the universityshall award the degree or declare him eligible forit.

ii) Satisfactory completion of internship shall be determined on the basis of thefollowing:-

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(1) Proficiency of knowledge required for eachcasemanagement SCORE0-5

(2) ThecompetencyinskillsexpectedforprovidingClinicalPharmacyServices SCORE0-5

(3) Responsibility,punctuality,workupofcase,involvementinpatientcare SCORE0-5

(4) Ability to work in a team (Behavior with other healthcare professionalsincludingmedical doctors, nursing staffandcolleagues). SCORE0-5

(5) Initiative, participation in discussions,researchaptitude. SCORE0-5

Poor Fair BelowAverage

Average Above Average Excellent

0 1 2 3 4 5

A Score of less than 3 in any of above items will represent unsatisfactory completion of internship.

Note: APPENDIX-B (Conditions to be fulfilled by the Academic training institution) &APPENDIX-B (Conditions to be fulfilled by the Examining authority) are not included in thissyllabus book

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ADDITIONAL GUIDELINES FOR PHARM D

The Pharm D programme of Amrita Vishwa Vidyapeetham follows the syllabus and regulations framedunder section 10 of Pharmacy Act 1948, as approved by Govt. of India and notified by Pharmacy CouncilofIndia(PCI)asPharmDregulations2008.ThefollowingshallserveasadditionalguidelinesforPharmD, ofAmrita VishwaVidyapeetham.

1. RemedialCourse

Allthestudentsshalltakeoneremedialcoursework;RemedialMaths/Biology.Thosewhohavenotstud- iedbiology in plus two shall study Remedial biology and those who have not studied Maths in plus twoshallstudyRemedialMathsandthosewhohavestudiedbothMathsandBiologyinplustwocanopteither of theremedial courses. The remedial courses shall be evaluated by school levelexam.

2. Maximum allowable carryover

As per PCI regulations the eligibility for promotion to next year is “All students who have appeared for allthe subjects and passed the first year annual examination are eligible for promotion to the second yearand,soon.However,failureinmorethantwosubjectsshalldebarhimorherfrompromotiontothenext yearclasses”.

Anyway the maximum allowable carry over at any time during 1st - 5th year shall be two subjects from anyprevious year and a student shall pass all the subjects of 1st year in order to be promoted to 4th year andshall pass all the subjects of 1st & 2nd year for promotion to 5th year. However a student shall become eligi-ble for internship only if he/she passes all the subjects of 1st - 5th year of Pharm D.

3. Hospital/Community pharmacytraining

Pharm D students shall undergo a training in a hospital or community pharmacy for not less than 150 hrsspread over 4 weeks during the vacation of either 2nd or 3rd year (can be done in one stretch or partlyduringthetwovacations)andshallsubmitthereportandcertificate.Studentsshallsuccessfullycomplete theevaluation of the same in order to be eligible for promotion to 4th year Pharm D and the evaluation can bedone by the faculty of the Dept. of PharmacyPractice.

4. Internship

Thestudentsshallpassallsubjectsof1st-5thyrforstartingtheinternship.Theyshallfollowtheguidelines andpolicies of the institution for internship and shall submit an undertaking towards this. The internshipshallbeevaluatedbasedonthewrittenfeedbackcollectedfromtheclinicalpreceptoraswellasthefacul-typreceptorandbythepresentationbythestudentaftereachposting.Thescorecardofinternshipbased on theseevaluations shall be issued after the completion of internship. The students are encouraged todointernshipinAMRITAonly.Onlyinspecialcases,andwithpriorpermissionstudentscanapplytootherhospitals/industry for internship preferably during the lastposting.

5. Question paper pattern for sessional & Universityexam.

Thepatternforquestionpaperisasfollows.Thereshallbenochoiceofquestionsintheuniversityaswell assessionalexam

University exam: There are two sections.

Section A

Essay questions (3 questions) = 3x10 = 30 marks

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Section B

Short answer questions (4 questions) = 4 x 5 marks = 20 marks

Very short answer questions (10 questions) = 10 x 2 = 20marks-------------------------

Sessional exam:

Total = 70 marks

Essay question (1 question) = 1 x 10 = 10 marks

Short answer questions (2 questions) = 2 x 5 = 10 marks

Very short answer questions (5 questions) = 5 x 2 = 10marks-------------------------

Total = 30marks

6. Eligibility of examiners & Question Paper setters (Q. P.Setter)

i) InternalExaminers:

Teachers of Amrita School of Pharmacy who are handling the respective courses and are having min-imum 3 years of teaching experience are eligible to be appointed as internal examiners for theory &practical exams for Pharm D 1st to 3rd year and teachers with not less than 5 years of teaching experi-ence are eligible to be appointed as internal examiners for theory & practical exams of Pharm D 4th &5th year.

ii) ExternalExaminers:

Teachers having a minimum of 5 years relevant teaching experience in PCI/AICTE approvedPharmacy institutions are eligible to be appointed as external examiners for 1st to 3rd year theory andpractical examinations. Teachers having not less than 10 years of relevant experience in concernedcourses in PCI/AICTE approved Pharmacy institutions are eligible to be appointed as externalexaminers for 4th and 5th year of Pharm D.

iii) Q.P.Setter

Faculty who are eligible to be internal & external examiners as per the above criteria are eligible to beQ.P setters too.

7. Project

AsperPCIregulations,thereshallbeagroupprojectinthe5thyearofPharmDinordertodevelopdata collection& reporting skills in the area of community, hospital & clinical pharmacy, under the supervision of afaculty and the topic must be approved by HOD or Head of the Institution. Project involving patientdata collection, patient interaction or intervention must get approval from Institutional EthicsCommittee (IEC). Each group shall do a project protocol presentation before the research committee ofthe school. The presentation shall cover the aim & objectives of the study, research question &hy-pothesis,relevanceofthestudyetc.,Theresearchcommitteeshallforwardtheprojectprotocolalong with itsrecommendations to IEC. The students will have to present before the IEC for approval. Theprojectreportintheformofthesisshallbesubmittedasperguidelinesandthefinalevaluationofthe project shallbe done by a committee including internal & external examiner, HOD & Principal. The evaluationshall be done as per the criteria mentioned in the regulations ofPCI.

8. Improvement of Internalmarks

A student who fails in university exam in the 1st attempt can apply for improvement sessional exam bysubmitting the duly filled application form when notified by the Principal.

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9. Condonation under exceptionalcases:

In case the attendance of student falls short of 80% in any course due to continuous absence caused byunforeseen circumstances, such case may be considered by the Principal for condonation of absencebased on the request of the student supported by recommendation of the respective class coordinator.However in such cases, the student must have duly applied for leave in time. The overallattendanceofastudentinsuchacaseshallnotfallbelow70%.Condonationwillbeconsideredonlyinthecaseofthosestudentswhohaveprovedthemselvestobeotherwise regular,byattendingatleast 80% of theclasses during the semester, excluding the period of long leave. At least 70% physical presence ismandatory in every course even in such exceptional cases and this provision can be exercisedbyastudent,onlyonceintheprogramme.However,thestudentmayapplyforasecondcondonation in the 5th

year provided he or she does not have anyarrears.

Condonation cannot be claimed as a matter of right. It shall be granted at the discretion of the au-thorities, based on the genuineness and validity of the reasons cited for the absence. A student is noteligible for condonation, if he had any unauthorized absence during the year.

10. Revaluation

A failed student shall have the right to apply for revaluation of the theory paper by filling the applica-tion form along with the required fees within the stipulated time after the publication of the result.

11. Additional courses for Pharm D PostBaccalaureate

Therapeutics I and Therapeutics II courses taught in 2nd and 3rd year respectively of Pharm. D regularprogramme are included in the 1st year of Pharm. D (PB) which is considered as equivalent to 4th yearPharm. D regular, by PCI as these subjects are not taught at the B. Pharm level (as per the revisedB. Pharm semester syllabus of PCI). Except for these two subjects all other classes will be handledtogether for Pharm D regular 4th year and Pharm D PB 1st year.

12. Publication ofpaper

The requirement of one publication in a Scopus indexed journal for eligibility for award of degree asmandatedbyAmritaVishwaVidyapeetham,shallbeapplicabletoPharmDconsideringthefactthatit is anapproved PGprogramme

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AM AMRITA SCHOOL OF PHARMACY Program Pharm D ARITA A

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