M. Pharm (Industrial Pharmacy)

ACADEMIC REGULATIONS, COURSE STRUCTURE

AND DETAILED SYLLABUS

FOR

MASTER PHARMACY TWO YEAR POST GRADUATE COURSE

(Applicable for the batches admitted from 2012-2013)

ANURAG GROUP OF INSTITUTIONS

(AUTONOMOUS)

SCHOOL OF PHARMACY

Venkatapur, Ghatkesar, Hyderabad – 500088

M. Pharm (Industrial Pharmacy)

2012-2013

2

Academic Regulations for M. Pharm (Regular) Degree Course (Effective for the students admitted into I year from the Academic Year 2012-2013 onwards)

The M.Pharm Degree of Jawaharlal Nehru Technological University

Hyderabad shall be conferred on candidates who are admitted to the

program and fulfill all the requirements for the award of the degree.

1.0 ELIGIBILITY FOR ADMISSIONS:

Admission to the above program shall be made subject to the eligibility,

qualifications and specialization prescribed by the university from time

to time.

Admissions shall be made on the basis of merit rank obtained by the

qualifying candidate at an Entrance Test conducted by the University or

on the basis of any other order of merit approved by the University,

subject to reservations prescribed by the university from time to time.

2.0 AWARD OF M.PHARM DEGREE:

2.1 A student shall be declared eligible for the award of the M.Pharm

degree, if he pursues a course of study and completes it successfully for

not less than two academic years and not more than four academic

years.

2.2 A Student, who fails to fulfil all the academic requirements for the

award of the degree within four academic years from the year of his

admission, shall forfeit his seat in M.Pharm course.

2.3 The minimum instruction period for each semester is 90 clear

instruction days.

3.0 COURSE OF STUDY The following specializations are offered at present for the M.Pharm

Course of study.

1. Hospital and Clinical Pharmacy

2. Pharmaceutics

3. Industrial Pharmacy

4. Pharmacology

5. Pharmaceutical Analysis and Quality Assurance

4.0 ATTENDANCE:

The programs are offered on a unit basis with each subject being

considered as an unit.

4.1 A candidate shall be deemed to have eligibility to write end semester

examinations in a subject if he has put in at least 75% of attendance in

the subject.

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4.2 Shortage of attendance up to 10% in any subject (i.e. 65% and above

and below 75%) may be condoned by the college Academic council on

genuine and valid reasons on representation by the candidate with

supporting evidence.

4.3 A candidate shall get minimum required attendance at least in three (3)

theory subjects in the present semester to get promoted to the next

semester. In order to qualify for the award of the M.Pharm Degree, The

candidate shall complete all the academic requirements of the subjects,

as per the course structure.

4.4 Shortage of attendance below 65% shall in no case be condoned

4.5 A stipulated fee shall be payable towards condonation of shortage of

attendance.

5.0 EVALUATION:

The performance of the candidate in each semester shall be evaluated

subject-wise, with a maximum of 100 marks for theory and 100 marks for

practical’s, on the basis of internal evaluation and End semester

Examination.

For the theory subjects 60 marks shall be awarded based on the performance

in the End semester Examination, 30 marks shall be awarded based on the

internal evaluation and 10 marks for assignment.

5.1 For theory subjects, during the semester there shall be 2 midterm

examinations. Each midterm examination consists of one subjective paper

and one assignment. The subjective paper is for 30 marks with duration

of 2 hours. Subjective paper of each semester shall contain 2 parts

Section-A & Section-B. Section-A comprises of five (5) short answer

type of questions. The student has to answer all the questions from

section-A. Each question carries two marks. A total of ten marks are

allocated to section-A. Section-B consists of five (5) essay type of

questions from which the student has to answer three questions. Each

question carry not more than seven (7) marks. A total of 20 marks are

allocated for section-B. The questions in the first midterm examination

includes the topics of first 2.5 units while the questions in the second

midterm examination includes the topics of remaining 2.5 units. The

assignments should be submitted before the conduct of respective

midterm examinations.

The total marks secured by the student are out of 40 marks (30marks

from midterm examination and 10 marks from assignment) in an internal

examination for a subject. The average of marks secured in two midterm

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examinations shall be taken as final marks. If he/she is absent for any test

/ assignment, he/she are awarded zero marks for that test / assignment.

5.2 For practical subjects, 60 marks shall be awarded based on the

performance in the End Semester Examinations, 40 marks shall be

awarded based on the day-to-day performance as internal marks.

5.3 There shall be two seminar presentations during I year I semester and II

Semester. For seminar, a student under the supervision of a faculty

member, shall collect the literature on a topic and critically review the

literature and submit it to the department in a report from and shall make

an oral presentation before the departmental committee. The departmental

committee consists of Head of the department, supervisor and two other

senior faculty members of the department. For each seminar there will be

only internal evaluation of 50 marks. A candidate has to secure a

minimum of 50% to be declared successful.

5.4 There shall be a Comprehensive Viva-Voce in II year I Semester. The

comprehensive Viva-Voce will be conducted by a committee consisting

of Head of the Department and two Senior Faculty members of the

Department. The comprehensive Viva-Voce is aimed to assess the

students’ understanding in various subjects he/she studies during the

M.Pharm course of study. The Comprehensive viva-voce valued for 100

marks by the Committee. There are no internal marks for the

Comprehensive viva-Voce

5.5 A candidate shall be deemed to have secured the minimum academic

requirement in a subject if he secures a minimum of 40% of marks in the

End Examination and a minimum aggregate of 50% of the total marks in

the End Semester Examination and Internal Evaluation taken together.

5.6 In case the candidate does not secure the minimum academic requirement

in any subject (as specified in 4.3) he has to reappear for the End

Examination in that subject. A candidate shall be given one chance to re-

register for each subject provided the internal marks secured by a

candidate are less than 50% and he has failed in the end examination. In

such case candidate must re-register subject(s) and secure required

minimum attendance. Attendance in the re-registered subject(s) has to be

calculated separately to become eligible to write the end examination in

the re-registered subject(s). The attendance of re-registered subject(s)

shall be calculated separately to decide upon the eligibility for writing the

end examination in those subject(s). In the event of taking another

chance, the internal marks and end examination marks obtained in the

previous attempt are nullified.

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5.7 In case the candidate secures less than the required attendance in any

subject(s), he shall not be permitted to appear for the End Examination in

that subject(s). He shall re-register the subject when next offered.

5.8 Laboratory examination for M.Pharm courses must be conducted with

two Examiners, one of them being Laboratory Class Teacher and second

examiner shall be other Laboratory Teacher.

6.0 EVALUATION OF PROJECT /DISSERTATION WORK:

Every candidate shall be required to submit thesis or dissertation after

taking up a topic approved by the project review committee.

6.1 A Project Review Committee (PRC) shall be constituted with Principal

as chair person, Heads of all the departments which are offering the

M.Pharm programs and two other senior faculty members.

6.2 Registration of Project work: A candidate is permitted to register for the

project work after satisfying the attendance requirement of all the

subjects (theory and practical subjects).

6.3 After satisfying 6.2, a candidate has to submit, in consultation with his

project supervisor, the title, objective and plan of action of his project

work to the Departmental Committee for its approval. Only after

obtaining the approval of Departmental Committee the student can

initiate the Project work.

6.4 If a candidate wishes to change his supervisor or topic of the project he

can do so with the approval of Departmental Committee. However, the

Departmental Committee shall examine whether the change of

topic/supervisor leads to a major change of his initial plans of project

proposal. If so, his date of registration for the project work starts from

the date of change of Supervisor or topic as the case may be.

6.5 A candidate shall submit status report (in a bound-form) in two stages at

least with a gap of 3 months between them.

6.6 The work on the project shall be initiated in the beginning of the second

year and the duration of the project is for two semesters. A candidate is

permitted to submit project thesis only after successful completion of

theory and practical course with the approval of PRC not earlier than 40

weeks from the date of registration of the project work. For the approval

of PRC the candidate shall submit the draft copy of thesis to the

Principal (through Head of the Department) and shall make an oral

presentation before the PRC.

6.7 Three copies of the Project Thesis certified by the supervisor shall be

submitted to the College/School/Institute.

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6.8 The thesis shall be adjudicated by one examiner selected by the

Institution. For this, Chairmen, BOS of the respective departments shall

submit a panel of 5 examiners, who are eminent in that field with the

help of the concerned guide and senior faculty of the department.

6.9 If the report of the examiner is not favourable, the candidate shall revise

and resubmit the thesis, in the time frame as prescribed by PRC. If the

report of the examiner is unfavourable again the thesis shall be

summarily rejected.

6.10 If the report of the examiner is favourable, viva-voce examination

shall be conducted by a board consisting of the supervisor, Head of the

Department and the examiner who adjudicated the Thesis.

The Board shall jointly report candidates work as:

A. EXCELLENT’

B. GOOD

C. SATISFACTORY

D. UNSATISFACTORY

Head of the Department shall coordinate and make arrangements for the

conduct of viva-voce examination. If the report of the viva-voce is

unsatisfactory, the candidate will retake the viva-voce examination after

three months. If he fails to get a satisfactory report at the second viva-voce

examination, he will not be eligible for the award of the degree.

7.0 AWARD OF DEGREE AND CLASS

After a student has satisfied the requirement prescribed for the

completion of the program and is eligible for the award of M.Pharm

Degree he shall be placed in one of the following three classes.

Class Awarded % of marks to be secured

First Class with Distinction 70% and above

First Class Below 70% but not less than 60%

Second Class Below 60% but not less than 50%

8.0 WITH – HOLDING OF RESULTS:

If the candidate has not paid any dues to the university or if any case

of in – discipline is pending against him, the result of the candidate

will be withheld and he will not be allowed into the next higher

semester. The issue of the degree is liable to be withheld in such

cases.

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9.0 TRANSITORY REGULATIONS:

Candidate who have discontinued or have been detained for want of

attendance or who have failed after having undergoing the course are

eligible for admission to the same or equivalent subjects as and when

subjects are offered, subject to 5.5 and 2.0.

10.0 GENERAL:

10.1 The academic regulations should be read as a whole for purpose of

any interpretation.

10.2 In case of any doubt or ambiguity in the interpretation of the above

rules, the decision of the Vice – Chancellor is final.

10.3 The University may change or amend the academic regulations and

syllabus at any time and the changes and amendments made shall be

applicable to all the students with effects from the date notified by the

University.

10.4 Whenever the word he, him or his occur, it will also include she, her

and hers.There shall be no transfer within the constituent colleges of

Jawaharlal Nehru Technological University.

2012-2013

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MALPRACTICES RULES

DISCIPLINARY ACTION FOR IMPROPER CONDUCT IN

EXAMINATIONS

Nature of Malpractices/Improper

conduct

Punishment

If the candidate:

1. (a) Possesses or keeps accessible in

examination hall, any paper, note

book, programmable calculators,

cell phones, pager, palm,

computers or any other form of

material concerned with or related

to the subject of the examination

(theory or practical) in which he is

appearing but has not made use of

(material shall include any marks

on the body of the candidate which

can be used as an aid in the subject

of the examination)

Expulsion from the examination hall and

cancellation of the performance in that

subject only

(b) Gives assistance or guidance or

receives it from any other

candidate orally or by any other

body language methods or

communicates through cell phones

with any candidate or persons in or

outside the exam hall in respect of

any matter.



subject only of all the candidates involved.

In case of an outsider, he will be handed

over to the police and a case is registered

against him.

2. Has copied in the examination hall

from any paper, book,

programmable calculators, palm

computers or any other form of

material relevant to the subject of

the examination (theory or

practical) in which the candidate is

appearing.



subject and all other subjects the candidates

has already appeared including practical

examinations and project work and shall

not be permitted to appear for the

remaining examinations of the subjects of

that semester/year. The hall ticket of the

candidate is to be cancelled and sent to the

controller of examinations, AGI.

3. Impersonates any other candidate

in connection with the

examination.

The candidate who has impersonated shall

be expelled from examination hall. The

candidate is also debarred and forfeits the

seat. The performance of the original

candidate who has been impersonated,

shall be cancelled in all the subjects of the

examination(including practical’s and

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project work) already appeared and shall

not be allowed to appear for examinations

of the remaining subjects of that

semester/year. The candidate is also

debarred for two consecutive semesters

from class work and all semester

examinations. The continuation of the

course by the candidate is subject to the

academic regulations in connection with

forfeiture of seat. If the imposter is an

outsider, he will be handed over to the

police and a case is registered against him.

4. Smuggles in the Answer book or

additional sheet or takes out or

arranges to send out the question

paper during the examination or

answer book or additional sheet,

during or after the examination.



subject and all other subjects the candidates

has already appeared including practical


not be permitted for the remaining

examinations of the subjects of that






academic regulations in connection with

forfeiture of seat.

5. Uses objectionable, abusive or

offensive language in the answer

paper or in letters to the examiners

or writes to the examiner

requesting him to award pass

marks.

Cancellation of the performance in that

subject.

6. Refuses to obey the orders of the

Chief Superintendent/Assistant-

Superintendent/ any officer on duty

or misbehaves or creates

disturbance of any kind in and

around the examination hall or

organizes a walk out or instigates

others to walk out, or threatens the

officer-in-charge or any person on

duty in or outside the examination

hall of any injury to his person or

to any office relations whether by

words, either spoken or written or

In case of students of the college, they shall

be expelled from examination halls and

cancellation of their performance in that

subjects and all other subjects the

candidate(s) has (have) already appeared

and shall not be permitted to appear for the

remaining examinations of the subjects of

that semester/year. The candidates also are

debarred and forfeit their seats. In case of

outsiders. They will be handed over to the

police and a police case is registered

against them.

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by signs or by visible

representation, assaults the officer-

in-charge, or any person on duty in

or outside the examination hall or

any of his relations, or indulges in

any other act of misconduct or

mischief which result in damage to

or destruction of property in the

examination hall or any part of the

college campus or engages in any

other act which in the opinion of

the officer on duty amounts to use

of unfair means or misconduct or

has the tendency to disrupt the

orderly conduct of the examination.

7. Leaves the exam hall taking away

answer script or intentionally tears

of the script or any part thereof

inside or outside the examination

hall.


cancellation of performance in that subject

and all the other subjects the candidates has

already appeared including practical









academic regulation in connection with

forfeiture of seat.

8. Posses any lethal weapon or

firearm in the examination hall.









debarred and forfeits the seat.

9. If student of the college, who is

not a candidate for the particular

examination or any person not

connected with college indulges in

any malpractice or improper

conduct mentioned in clause 6 to 8

Student of the college’s expulsion from the

examination hall and cancellation of

performance in that subject and all the

other subjects the candidates has already

appeared including practical examinations

and project work and shall not be permitted

for the remaining examinations of the

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subjects of that semester/year. The

candidate is also debarred and forfeiture the

seat.

Person(s) who do not belong to the

College will be handed over to police and,

a police case will be registered against

them.

10. Comes in a drunken condition to

the examination hall.








semester/year.

11. Copying detected on the basis of

internal evidence, such as, during

valuation or during special

scrutiny.

Cancellation of the performance in that

subject and all other subjects the candidate

has appeared including practical

examinations and project work of the

semester/year examinations.

12. If any malpractice is detected

which is not covered in the above

clauses 1 to 11 shall be reported to

the Malpractices committee, AGI

for further action to award suitable

punishment.

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M. PHARM. (Industrial Pharmacy)

COURSE STRUCTURE AND SYLLABUS

I YEAR I SEMESTER

Subject

Code

Group Subject L P Credits

A41001 IPT Modern Pharmaceutical Analytical

Techniques

3 0 3

A41002 IPT Advanced biostatistics and research

methods

3 0 3

A41006 IPT Biopharmaceutics and

Pharmacokinetics

3 0 3

A41007 IPT Advanced Physical Pharmaceutics 3 0 3

A41015 IPT Industrial Pharmaceutics 3 0 3

A41213 Lab Modern Pharmaceutical Analytical

Techniques Lab

0 3 2

A41214 Lab Advanced Physical pharmaceutics Lab 0 3 2

A41215 Seminar - - 2

Total Credits (5 Theory + 2 Labs + Seminar) 21

II SEMESTER

Subject

Code

Group Subject L P Credits

A42001 IPT Intellectual Property Rights and Drug

Regulatory Affairs

3 0 3

A42002 IPT Screening methods and clinical

research

3 0 3

A42006 IPT Advances in Drug Delivery Systems 3 0 3

A42015 IPT Industrial Pharmacy Management 3 0 3

A42008 IPT Advanced Pharmaceutical

Technology- II

3 0 3

A42213 Lab Advances in Drug Delivery Systems

Lab

0 3 2

A42214 Lab Advanced Pharmaceutical Technology

II Lab

0 3 2

A42215 Seminar - - 2

Total Credits (5 Theory + 2 Labs + Seminar) 21

2012-2013

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II YEAR I SEMESTER

Subject

Code

Group Subject Name L P Credits

A43213 Comprehensive Viva - - 2

A43214 Project Seminar - I - - 2

A43215 Project Work - - 18

Total Credits 22

II YEAR II SEMESTER

Subject

Code

Group Subject Name L P Credits

A44209 Project Work 0 0 20

A44210 Project Seminar - II 0 0 2

Total Credits 22

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14

I Year – I Sem. M.Pharmacy (INDUSTRIAL PHARMACY)

(A41001) MODERN PHARMACEUTICAL ANALYTICAL

TECHNIQUES

Unit I

a. Column Chromatography: Adsorption and partition, theory,

preparation, procedure and methods of detection

b. Thin Layer Chromatography: Theory, preparation, procedures,

detection of compounds

c. Paper Chromatography: Theory, different techniques employed, filter

papers used, qualitative and quantitative detection

d. Counter – current extraction, solid phase extraction techniques, gel

filtration

Unit II

a. Gas chromatography: Introduction, fundamentals, instrumentation,

columns: preparation and operation, detection, dramatization.

b. HPLC: Principles and instrumentation, solvents and columns used,

detection and applications

Unit III

a. UV-Visible spectroscopy: Introduction, electromagnetic spectrum,

absorbance laws and limitations, instrumentation-design and working

principle, chromophore concept, auxochromes, Wood-Fisher rules for

calculating absorption maximum, applications of UV-Visible

spectroscopy

b. IR spectroscopy: Basic principles-Molecular vibrations, vibrational

frequency, factors influencing vibrational frequencies, sampling

techniques, instrumentation, interpretation of spectra, FT-IR, theory

and applications

Unit IV

Mass spectroscopy: Theory, ionization techniques: electron impact

ionization, chemical ionization, field ionization, fast atom

bombardment, plasma desorption, fragmentation process: types of

fission, resolution, GC/MS, interpretation of spectra and applications

for identification and structure determination

2012-2013

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Unit V

NMR: Theory, instrumentation, chemical shift, shielding and

deshielding effects, splitting of signals, spin-spin coupling, proton

exchange reactions, coupling constant(J), nuclear overhauser

effect(NOE), 13

C NMR spectra and its applications, 2D-NMR, COSY

and applications in pharmacy

Text Books:

1. Sharma.B.K.(2007) Instrumental Methods of Chemical Analysis. 26th

Edition .

Goel Publishing House,

2. Sharma .Y.R.(2011) Organic spectroscopy.S.Chand & Co.

3. Connors K.A (2010) A Text book of Pharmaceutical Analysis 3rd

Edition Wiley India.

4. Vogel A.I (2009) Text book of Quantitative Chemical Analysis. 6th

edition.London: Pearson.

5. Beckeet A.H ,Stenlake J.B (2002) Practical Pharmaceutical

Chemistry. 4th

edition. New Delhi: C.B.S. Publication.

6. Finar I.L ( 2009) Organic Chemistry. 6th

edition. London: Pearson.

7. Kemp W (2005) Organic spectroscopy , 3rd

edition. Plagrave.

8. Grrett D.C (2007) Quantitative Analysis of Drugs. New Delhi: C.B.S

Publishers.

9. Sethi P.D (2010) Quantitative Analysis of Drugs in Pharmaceutical

Formulations. 3 rd edition. New Delhi: C.B.S Publishers.

10. Silverstein (2010) Spectrophotometric identification of Organic

Compounds. 6th

edition. John Wiley.

11. Seth P.D. HPTLC

12. Indian Pharmacopoeia( 2007)

2012-2013

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(A41002) ADVANCED BIOSTATISTICS AND RESEARCH

METHODS

Unit-I :

Developing a research question, Resources for research question,

Literature Review: Traditional Qualitative Review

Meta-Analysis—A Quantitative Review

Preparation of Research Proposal

Variables—Definition of Variable, Types of variables—Dependent and

Independent variables, Confounded variables, Measurement of variables,

Types of measurement scales and their comparison. Reliability and Validity

of Measurements.

Unit-II : Validity, Types of validity—Internal validity, Construct validity, External

validity, Threats to validity.

Control: Subject as own control (Within Subject control), Statistical control.

Unit-III:

Non-experimental Research:

Part 1—Observational, Archival and Case-Study Research: The

Hermeneutic Approach.

Observational Research: Naturalistic Observation, Participant-Observer

Research.

Archival Research: Archival Data Collection and Compilation.

Case Studies: Characteristic of Case Studies.

Non-experimental Research: Survey Research—Designing of

Questionnaire, Methods of Administration, Response Rates. Types of

Samples—Haphazard Samples, Purposive Samples, Convenience Samples

and Probability Samples.

Unit-IV :

True Experiments: Single-Factor Designs, Factors, Levels, Conditions, and

Treatments. Within-Subject Designs.

True Experiments Part-2—Factorial Designs—Main Effects, Interactions, A

Mixed Factorial Design.

Unit V :

Single-Subject Experiments: Advantages and Disadvantages.

Quasi Experiments: The differences between Quasi and True Experiments.

Design without Control Groups—Interrupted Time Series Designs and

Repeated Treatment Designs.

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Text Books

1. Donald H. McBurney -Theresa L. White (2009). 8th Ed. ―Research

Methods‖ :

Cengage learning India Pvt. Ltd

2. Hooda-R.P- MC .(2000). 3rd edition, Statistics for business and

economics : Millan

Business books 2012-2013.

3. Tiwar N.K.,Rao G.N (2008). First edition, Biostatistics & Computer

applications.

4. Lippincot Williams, (2006) Remingtons pharmaceutical Sciences, 21 st

edition.

5. Lachman (1991) .Theory & Practice of Industrial Pharmacy ,3rd edition :

Verghese

Publishing House.

2012-2013

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(A41006) BIOPHARMACEUTICS AND PHARMACOKINETICS

Unit-I

1. Bioavailability and bioequivalence studies: Designing of

bioavailability and bioequivalence studies and interpretation of

results.

2. Physicochemical properties affecting bioavailability, pH-partition

theory, dissolution, surface area adsorption, complexation,

polymorphism and techniques of enhancing dissolution rate.

3. Formulation factors affecting bioavailability of drugs in dosage forms

of tablets, capsules, parenterals, liquid orals and topical dosage forms.

Unit-II

4. Drug Distribution: Distribution in blood and other fluids, BBB

barriers, placental transfer of drugs and blood flow, volume of

distribution, Drug distribution and drug effects, Drug binding in

tissue, Plasma Protein binding and its role in clinical.

5. Drug metabolism: Site of metabolism, factors affecting drug

metabolism (genetic, species and environmental).

Unit-III

6. Basic concepts of pharmacokinetics: compartment models: One,

two and non-compartmental approaches to pharmacokinetics. Recent

trends, merits and limitations of these approaches. Application of

these models to determine the various pharmacokinetic parameters

pertaining to oral and parenteral.

a. Absorption: (wherever applicable) absorption rate constant,

absorption half-life, lag time and extent of absorption, AUC.

b. Distribution: Apparent volume of distribution and its

determination.

c. Metabolism: Metabolic rate constant

d. Elimination: Over all apparent elimination rate constant, and

half life.

e. Noninvasive methods of estimating pharmacokinetics

parameters with emphasis on salivary and urinary

compartments

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f. Concept of clearance: organ, total clearance, hepatic clearance,

lung clearance and renal clearance.

Unit-IV

7. Non-linear pharmacokinetics: Concepts of linear and non-liner

pharmacokinetics, Michaelis-Menton Kinetics characteristics. Basic

Kinetic parameters, possible causes of non-induction, non-linear

binding, and non-linearity of pharmacological responses.

8. Clinical Pharmacokinetics: Altered kinetics in pregnancy, infants

and geriatrics. Kinetics in liver and renal disease states.

Unit-V

9. Drug Interactions: Kinetics of drug interaction, study of drug-drug

interaction mediated through absorption, distribution, metabolism and

elimination, mechanisms of interaction and consequence. Influence of

alcohol, smoking, food and beverages on drug action.

10. Time dependent pharmacokinetics: Introduction, classification,

physiologically induced time dependency: Chronopharmacokinetics,

chemically induced dependency.

Text Books

1. Milo Gibaldi (1991). Biopharmaceutics and Clinical Pharmacokinetics.

4th Edition. The University of Michigan: Lea & Febiger.

2. Robert E. Notari (1975). Biopharmaceutics and Clinical pharmacy. 2nd

Edition. The University of Michigan: M. Dekker.

3. Robert E. Notari (1980). Biopharmaceutics and Clinical

Pharmacokinetics - An

Introduction. 3rd Edition. The University of Michigan: M. Dekker.

4. Leon Shargel .et. al (2010). Applied Biopharmacokinetics and

Pharmacokinetics. 5th Edition. Columbus: The McGraw-Hill Companies.

5. Brahmankar D.M..et.al. (2009). Bio-Pharmaceutics and

Pharmacokinetics. 1st Edition. Delhi: Vallabh Prakashan.

6. Venkateshwarlu .V (2008). Bio-Pharmaceutics and Pharmacokinetics by.

2nd

Edition. Hyderabad: PharmaMed Press.

7. Shobharani R. H. (2002).Text Book of Biopharmaceutics. 1st Edition.

Bangalore: Prism Publication.

2012-2013

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(A41007) ADVANCED PHYSICAL PHARMACEUTICS

Unit-I

1. Particle science and powder technology: Crystal structure,

amorphous state polymorphism, particle size distribution, particle size

analysis methods, solid dispersions/ solid solutions.

2. Physics of tablet compression: Compression and consolidation,

strength of granules, compression and consolidation under high loads,

effect of friction, distribution of forces in compaction, force volume

relationships, Heckel plots, compaction profiles, energy involved in

compaction, strength of tablet, crushing strength, friability, lamination,

instrumentation of tablet machines.

Unit-II

3. Kinetics and drug stability: Stability calculations, rate equation,

complex order kinetics, kinetics of some decompositions, strategy of

stability testing, method of stabilization, method of accelerated

stability testing in dosage forms, Freeze Thaw methods, centrifugal

methods, temperature and humidity control, physical stability testing

of pharmaceutical products. Determination of shelf life by accelerated

stability testing, overages and ICH guidelines

Unit-III

4. Theories on stability of disperse systems: Adsorption, wetting,

crystal growth mechanisms, physical stability of suspensions and

emulsions, stability testing of emulsions and suspensions and release

of drugs from suspension and emulsion formulations.

Biopharmaceutical aspects of disperse systems.

5. Rheology: Theoretical consideration, instrumentation, rheological

properties of disperse systems and semisolids.

Unit-IV

6. Dissolution and solubility: BCAS classification, Dissolution theories

and their mechanisms, Solubility and solubilization by the use of

surfactants, cosolvents, complexation, drug derivatisation and solid

state manipulation, dissolution rates of solids in liquids, measurement

of dissolution rates.

2012-2013

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Unit-V

7. Polymer science: Properties of polymers, Biodegradable and Non

degradable polymers and their mechanisms, phase separation,

polymers in solid state and application of polymers in pharmaceutical

formulations.

Text Books

1. Alfred Martin ( 2011) Physical Pharmacy . sixth edition. Lippincott

Williams&Wilki

2. Howard C. Ansel( 2005) Pharmaceutical Dosage forms . Ninth edition.

Lippincott Williams & Wilki.

3. Gaud and Gupta ( 2009) Practical Physical Pharmacy ,Vol-I and Vol-II.

CBS Publishers.

4. S.J Carter (2005) Cooper and Gunn`s Tutorial Pharmacy . 6th edition.

CBS Publishers.

5. S.J. Carter (2008) Cooper and Gunn`s Dispensing for Pharmaceutical

Students. 12th edition., CBS Publishers.

2012-2013

22


(A41015) INDUSTRIAL PHARMACEUTICS

Unit-1

1. Preformulation studies

Goals of preformulation, preformulation parameters, methodology, solid

state properties, solubility and partition coefficient, drug-excipient

compatibility.

Unit-II

Formulation development of solid and powder dosage forms

Improved production techniques for tablets, new materials, processes,

equipment improvements, high shear mixers, compression machines,

coating machines, coating techniques in tablet technology for product

development and computerization for in process quality control of

tablets. Formulation development and manufacture of powder dosage

form for internal and external use including inhalation dosage forms.

Unit-III

Formulation development of soft and hard gelatin capsules

Introduction, production and methods of manufacture, filling equipment and

filling operations, formulations, finishing, special techniques, the nature of

the capsule shell and capsule, advances in capsule manufacture, processing

and control including pharmaceutical aspects, physical stability and

packaging.

Unit-IV

Formulation development of liquid dosage forms

Recent advances in formulation aspects and manufacturing of

monophasic dosage forms as well as suspensions.

Unit-V

Optimization techniques in pharmaceutical formulation and

processing

Introduction, concept of optimization, optimization parameters, classical

optimization, statistical design, applied optimization methods and their

applications in pharmaceutical industry.

Text Books

1. Aulton, ME (2011) Pharmaceutics - The Science of Dosage form

design.3rd

edition. Churchill Livingstone.

2. Lieberman, Lachman and Schwartz (2005) Pharmaceutical Dosage forms

– Tablets, Vol I, II and III. 2nd edition. New York: Marcel Dekker

2012-2013

23

3. Avis, Lieberman and Lachman (1998) Pharmaceutical Dosage forms –

Disperse

systems , Vol I, II and III .second edition. New York: Marcel Dekker.

4. Gilbert S. Banker and Christopher T. Rhodes.(2005) Modern

Pharmaceutics., fourth

edition. New York: Marcel Dekker

5. Leon Lachman, Herbert A. Lieberman (2009) The Theory and Practice

of industrial Pharmacy .Special Indian edition. New Delhi: CBS Publishers

and Distributors.

6. A. Gennaro (2009) Remington’s Science and Practice of Pharmacy .21st

edition. Wolters Kluwer: Lippincott Williams & Wilkins.

7. Loyd V. Allen, Jr. Nicholas G. Popovich, Howard C. Ansel (2005)

Ansel’s

Pharmaceutical Dosage form and Drug delivery system. 9th edition. Wolters

Kluwer: Lippincott Williams & Wilkins.

9. Leon Shargel and Isadore Kanfer (2008) Generic Drug Product

Development. Informa Health Care.

10. SJ Carter (2008) Dispensing for Pharmaceutical Students. 12th edition.

Delhi: CBS Publishers.

2012-2013

24


(A41213) MODERN PHARMACEUTICAL ANALYTICAL

TECHNIQUES LAB

1. Use of spectrophotometer for analysis of Pharmacopoeial compounds

and their formulations

2. Simultaneous determination of combination formulations (Minimum

of 04 experiments)

3. Effect of pH and solvent on UV spectrum of certain drugs

4. Experiments of Chromatography

a. Thin layer chromatography

b. Paper chromatography: Ascending, Descending, circular and

two-dimensional techniques

5. Experiments based on HPLC and GC

6. IR, NMR and mass spectra: Interpretation for the structural

elucidation of organic compounds

7. Any other relevant experiments.

2012-2013

25


(A41214) ADVANCED PHYSICAL PHARMACEUTICS LAB

1. Determination of derived and flow properties of given API

2. Determination of partition coefficient of given API

3. Determination pH and pKa of given API

4. Determination of saturation solubility of given API

5. Verification of stroke’s law

6. Determination of effect of concentration on viscosity

7. Determination of first order constant

8. Determination of second order constant

9. Experiment on Adsorption studies

10. Determination of Loss on drying of a given API

11. Study of compression property by Heckles analysis

2012-2013

26

I Year – II Sem. M.Pharmacy (INDUSTRIAL PHARMACY)

(A42001) INTELLECTUAL PROPERTY RIGHTS AND DRUG

REGULATORY AFFAIRS

Intellectual Property Management:

Unit I : Types of IP, definition, scope, objectives Patents, types, contents of

patent, claims and types of claims, key terminology used in patents

(Application, examiner, prior art, priority, specifications,

provisional and non-provisional applications, claims, applicant,

assignee, inventor, anticipation, obviousness, infringement and

invalidation).

Unit II : Filing process, provisional and non-provisional applications, PCT

filing process, Advantages, Patentability requirement: (Novelty,

Utility, non-obviousness, enablement and best mode),

Understanding on infringement, invalidation and litigations

Unit III : Indian patent act and post 1995 amendments US and European

patent act Trademarks, copyrights, designs International

conventions, GATT, TRIPS, Paris convention, Patent cooperation

treaty.

Regulatory Affairs:

Unit IV: National drug regulatory requirements, national drug policy, Drugs

and Cosmetics Act and its amendments, over view of schedules,

details of schedule M, Schedule Y. US FDA, orange book, FDA

guidelines on IND, new drug approvals (NDA), ANDA approvals,

SUPAC changes and understanding on 505 (b) (2) applications.

Unit V : Office of generic drugs, recommendations on dissolution and bio-

equivalence requirements, types of ANDA filing (P I, II, III and

IV) PIV ANDA filing and process involved till the approval

Exclusivities (NCE, NS, NP, NDF, PED, ODE, PC exclusivity)

European regulatory agency, types of filing process (Centralized,

de-centralized, RMS countries), SPCs, SPC exclusivities, data

exclusivities, WHO, WIPO, ICH objectives and guidelines.

2012-2013

27

Text Books:

1. Guarino.,( 2002) New drug approval process, by 3rd

edition.

2. Commercial Manual on Drugs and Cosmetics (2004) 2nd

edition.

3. Vijay Malik (2006) Drugs and Cosmetics act., Publications Eastern

Book.

4. S.H. Wiling (2003) Vol. 78, Good Manufacturing Practices for

Pharmaceuticals, 2nd

edition Marcel Decker.

5. P.Das and Gokul Das., Protection of Industrial Property rights.

6. S.N. Katju (2009) Law and Drugs., Law Publications.

7. Original Laws Published by Govt. of India

8. Hussain Laws of drugs in India,

9. R.A.Guarino,, Vol 100 (2009) New Drug Approval Process, NY,

fourth edition, Marcel Decker.

10. fda.org,wipo.int,patentlawlinks.com, hc-sc.gc.ca,ich.org,cder.org

2012-2013

28


(A42002) PHARMACOLOGICAL SCREENING METHODS AND

CLINICAL RESEARCH

Unit I

Care Handling and breeding techniques of laboratory animals, Regulations

for laboratory animals, CPCSEA guidelines, alternatives to animal studies,

Good laboratory Practices.

Unit II

Bioassays: Basic principles of Biological standardization: Methods used in

the bio-assay of Rabbis Vaccine , Oxytocin , Tetanus Antitoxin and

Diphtheria Vaccine . Test for pyrogens.

Unit III

Toxicity tests: OECD guidelines, determination of LD50, acute, subacute

and chronic toxicity studies.

Unit IV

Organization of screening for the Pharmacological activity of new

substances with emphasis on the evaluation cardiac,

psychopharmacological, anti-inflammatory, analgesic and anti diabetic.

Unit V

Clinical evaluation of new drugs, Phases of clinical trial, protocol design,

Ethics in human research.

Pharmacovigilance: Definition, collection of data, reporting, assessment of

Post marketing surveillance, periodic safety update reports, Risk-benefit

assessment

Text Books:

1. Robert .A. Turner and Peter Hebborn (1979) Screening methods in

Pharmacology, Vol.-1&2.

2. H.G.Vogel and W.H.Vogel (2010) Heideleberg, 3rd

edition, Drug

discovery and evaluation, Springerverlag, Berlin.

3. S.K. Kulkarni (2012) 4th

edition, Handbook of experimental

pharmacology, Vallabh Prakashan, Delhi.

4. David Machin, Simon Day and Sylvan green (2007) 2nd

edition, Textbook

of clinical trials.

5. Giovanna di ignazio, Di Giovanna and Haynes (2001) 1st

edition,

Principles of clinical research.

6. ICH of technical requirements for registration of pharmaceuticals for

human use, ICH harmonized Tripartite guidelines - Guidelines for good

clinical practice, E6, May 1996.

7. Good clinical practice (2001) - Guidelines for Clinical trails on

pharmaceutical products in India, Central drug standard control

organization, New Delhi, Minister of Health.

2012-2013

29


(A42006) ADVANCES IN DRUG DELIVERY SYSTEMS

Unit-1

1. Fundamentals of controlled drug delivery systems, use of polymers

in controlled drug delivery, pharmacokinetic and pharmacodynamic

basis of controlled drug delivery. Design, fabrication, evaluation and

applications of the following controlled releasing systems

(a) Controlled release oral drug delivery systems

(b) Parenteral controlled release drug delivery systems

(c) Implantable therapeutic systems

Unit-2

(a) Transdermal delivery systems: Physical and chemical

methods of enhancing penetration, microneedle penetration

iontophoresis, sonophoresis.

(b) Intrauterine delivery systems

(c) Bioadhesive drug delivery systems

(d) Proteins and peptide drug delivery

Unit-3

Biochemical and molecular biology approaches to controlled drug

delivery of

1. Micro particulate drug carriers: Liposomes, Niosomes,

Microspheres, Nanoparticle and magnetic microspheres.

2. Monoclonal antibodies

Unit-4

Drug targeting to particular organs:

(a) Drug delivery to respiratory systems

(b) Problems of drug delivery to the brain and targeting to brain

(c) Drug delivery to eye

(d) Drug targeting in neoplastic diseases

(e) Drug delivery to colon

Unit-5

Drug carrier systems targeted to widely dispersed cells

a) Delivery to Macrophages

b) Delivery to lymphoid cells of immune network

c) Delivery to lysosomal storage diseases

2012-2013

30

Text Books

1. Yie W. Chien (2009) Novel Drug Delivery System, second

edition.Published by Informa Health care.

2. Joseph R. Robinson and Vincent H. L. Lee (2009) Controlled Drug

Delivery, second edition. Marcel Dekker, Inc.,New York.

3. N. K. Jain (2011) Controlled and Novel drug delivery systems. 4th

edition. CBS Publishers and distributers

4. S. P. Vyas and Khar (2002) Targeted and Controlled Drug

Delivery (Novel carrier systems), first edition. CBS Publishers and

distributors.

5. Gilbert S. Banker and Christopher T. Rhodes (2005) Modern Pharmaceutics,

fourth edition. Marcel Dekker, Inc., New York.

2012-2013

31


(A42015) INDUSTRIAL PHARMACY MANAGEMENT

Unit-I

Human Resource management: Human resource planning, job

analysis and design, recruitment, Personnel selection, orientation and

placement, training and development, supervision, performance

appraisal, remuneration and salaries, compensation and incentives,

industrial relations, motivation.

Unit-II

Entrepreneurship and Project Management-Quality Assurance

Management: Total quality management, Organization and

personnel, responsibilities, traning, hygience Premises: Location,

design,layout,construction, maintenance and sanitation,

environmental control, sterile areas, control contamination,

equipments: Selection, purchase specifications, maintenance, clean in

place, sterilize in place.

Unit-III

Production management: Production organization, objectives and

policies of good manufacturing practices, layout of buildings,

services, equipments and their maintenance, materials management,

handling and transportation, inventory management and control,

production and planning control, Sales forecasting, budget and cost

control, industrial and personal relationship.

Unit-IV

Process validation: Regulatory basis, validation of solid dosage

forms, sterile products, liquid dosage forms, raw materials, validation

of analytical methods, equipment and process.

Unit-V

Industrial Hazards and Pollution Mananagement:

Chemical hazards, gas hazards, fire and explosion hazards, safety

management. Water pollution, water Pollution abatement and effluent

treatment, Air pollution, air pollution control Devices, solid waste,

Solid waste waste management, Noise Pollution, Noise Abatement,

Effluent Analysis and Treatment Methods, Effluent Treatment in

Formulation Plants, Effluent Treatment in Synthetic Drugs Industry,

Effluent Treatment in Fermentation Industry.

2012-2013

32

Text Books 1. Warren L. McCabe, Julian C. Smith, Peter Harriott (2001) Unit

operations of Chemical Engineering by sixth edition. McGraw-Hill,

Inc, New Delhi.

2. Leon Lachman, Herbert A. Lieberman, special edition (2011) The

Theory and Practice of industrial Pharmacy. 3rd edition, Varghese

publishing house, Bombay.

3. Sidney H. Willig (2007) fourth edition, Good Manufacturing Practice

for Pharmaceuticals, Informa Healthcare.

4. Robert A. Nash, Alfred H. Wachter (2003) Pharmaceutical Process

validation third edition. Marcel Dekker.

5. Gilbert S. Banker and Christopher T. Rhodes (2005) Modern

Pharmaceutics fourth edition. Marcel Dekker.

6. CGMP, H.P.P. Sharma

7. C.V.S. Subrahmanyam (2011) Pharmaceutical production

management, Vallabh Prakash.

8. A. Gennaro (2009) Remington’s Science and Practice of Pharmacy.,

21st edition, Lippincott: Williams & Wilkins.

9. WL Badger and Julius T. Banchero (2010) Introduction to Chemical

Engineering, 25th

reprint,. McGraw-Hill, New York.

10. EA Rawlins (2010) Bentley’s Text book of Pharmaceutics by, 8th

edition. University Printing House, Oxford.

2012-2013

33


(A42008) ADVANCED PHARMACEUTICAL TECHNOLOGY-II

Unit-I

Pilot plant scale-up techniques used in pharmaceutical manufacturing

General considerations, preparation of master manufacturing procedures,

product considerations of solid dosage forms, liquid dosage forms,

semisolid products, suppositories, contract manufacture.

Unit-II

Formulation development of parenteral dosage forms

Advances in materials and production techniques, manufacturing of

small volume and large volume parenterals, large filling machines,

sterilizers, aseptic processing.

Unit-III

Pharmaceutical Aerosols

Advances in propellants, metered dose inhaler designs, dry powder

inhalers, selection of containers and formulation aspects in aerosols

formulation, manufacture and quality control.

Unit-IV

Formulation development of semi-solid dosage forms

Industrial processing, preparation of oil and aqueous phases, low energy

emulsification, and storage of semisolids.

Unit-V

Aseptic processing operation

Introduction, contamination control, microbial environmental

monitoring, microbiological testing of water, microbiological air testing,

characterization of aseptic process, media and incubation condition,

theoretical evaluation of aseptic operations.

Text Books

1. ME Aulton (2010) Pharmaceutics - The Science of Dosage form design, third

edition.

Chruchhill Livingstone.

2. Leon Lachman, Herbert A. Lieberman (2011).The Theory and Practice of

industrial Pharmacy, Informa. Healthcare, New York.

3. A. Gennaro (2009) Remington’s Science and Practice of Pharmacy, 21st

edition, Lippincott: Williams & Wilkins.

2012-2013

34

4. Loyd V. Allen, Jr. Nicholas G. Popovich, Howard C. Ansel (2005)

Ansel’s Pharmaceutical Dosage form and Drug delivery system by, 9th

edition. Lippincott Williams & Wilkins.

5. Avis, Lieberman and Lachman (1986) Pharmaceutical Dosage forms -

Parenterals (Vol I, II and III) by, second edition. Marcel Dekker N.Y.

6. EA Rawlins (2010). Bentley`s Text Book of Pharmaceutics by, eigth

edition. University Printing House, Oxford.

7. Leon Shargel, (2008) Generic Drug Product Development. Informa

Healthcare.

8. SJ Carter (2008) Dispensing for Pharmaceutical Students by 12th edition.

CBS Publishers and Distributors, Delhi,

9. Gilbert S. Banker and Christopher T. Rhodes (2005) Modern Pharmaceutics,

4th

edition, Wiley-Liss, Inc.

2012-2013

35


(A42213) ADVANCES IN DRUG DELIVERY SYSTEMS LAB

1. Formulation and evaluation of novel tablets (3 Expts)

2. Topical novel formulation (2 Expts)

3. Experiments on solubility enhancement techniques (2 Expts)

4. Semi solid dosage forms (2 Expts)

5. Formulation and evaluation of Oral delivery systems (2 Expts)

6. Formulation and evaluation of Dispersion system. (2 Expts)

2012-2013

36


(A42214) ADVANCED PHARMACEUTICAL TECHNOLOGY LAB

1. Formulation and evaluation of oral disintegrating tablets (1 Expts)

2. Formulation and evaluation of topical gels (2 Expts)

3. Formulation and evaluation of injections (2 Expts)

4. Formulation and evaluation of emulsion (2 Expts)

5. Formulation and evaluation of suspension. (2 Expts)

6. Formulation and evaluation of rectal suppositories. (1 Expts)

7. Formulation and evaluation of enteric coating tablets. (1 Expts)

8. Comparision of dissolution release profile of two marketed products(2 Expts)

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