Research & Reviews:

A Journal of Drug Formulation,

Development & Production

RRJoDFDP

May - August 2014

STM JOURNALSScientific Technical Medical

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Dr. Abhay Dharamsi Professor and Head Department of Pharmaceutics, Maliba Pharmacy

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Dr. Atul GoelPrincipal Scientist, Medicinal and Process

Chemistry Division CSIR-CDRI, Lucknow, India.

Dr. Bhavin P. MaroliaAssistant Professor, Dept. of Quality

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Malaysia.

Dr. Bharat Bhusan SubudhiAssociate Professor, School of

Pharmaceutical Sciences, Siksha O Anusandhan University,

Bhubaneswar, India.

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Analysis & QA Shri Vishnu College of Pharmacy , A.P., India.

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University, India.

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Hospital, Greece.

Dr. Jayarajakumar KalaimaniFaculty of Pharmacy, AIMST University,

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CDRI, Lucknow, India.

Dr. Kashmira GohilProfessor and HOD, Shree Dhanvantari

Pharmacy College (SDPC), Surat, Gujarat, India.

Dr. Koteshwara K.BProfessor, Department of Pharmaceutics,

Manipal College of Pharmaceutical Sciences, Manipal University,India.

Editorial Board

Dr. Mahalaxmi RathnanandAssociate Professor ,Dept of

Pharmaceutics Manipal College of Pharmaceutical

Sciences, Manipal, India.

Dr. Mohamed SalamaProfessor,Faculty of Pharmacy,

UiTM , Malaysia.

Dr. Poonam SinghScientist CSIR-Central Drug Research

Institute, Lucknow.

Dr. Pranav ShahAssociate Professor, Maliba Pharmacy College,

Maliba Campus, Surat, Gujarat, India.

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Malysia, Malaysia.

Dr. Mohd Shihabuddin B. A. Noorden Senior Lecturer Faculty of Pharmacy, Universiti Teknologi MARA, 42300 Puncak Alam, Selangor, Malaysia.

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Research Institute, Lucknow, India.

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CSIR-Central Drug Rsearch Institute Medicinal and process chemistry Division

CSIR Lucknow India.

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Bioinformatics, School of Bioengineering, Kattankulathur

Campus, SRM University, India.

Dr. Sanghapal D. SawantCSIR-Indian Institute of Integrative

Medicine,Jammu, India.

Prof. Dr. Sapna ShrikumarPrincipal, Moulana College of Pharmacy,

Angadtppuram (P.O), Perinthalmanna, Malappuram, Kerala,

India.

Editorial Board

Dr. Shashank K SinghSenior Scientist,CSIR-Indian institute of

Integrative Medicine ,Canal Road Jammu, India.

Mr. Soh Yee ChangFaculty of Pharmacy

UiTM Puncak Alam CampusMalaysia.

Dr. V. RavichandranFaculty of Pharmacy,AIMST University,

Semeling - 08100,Kedah, Malaysia.

Mr. Viral Dineshchandra JagiwalaAssistant Professor, Shree Dhanvantary Pharmacy College, Surat, Gujarat, India.

Dr. Suneel .I.MajagiAssociate Professor Department of Pharmacology J.N.Medical College

Belgaum-590010.Karnataka.

Dr. Sridevi Chigurupati Senior Lecturer Faculty of Pharmacy,

AIMST University, Malaysia.

Dr. Vivek BhosaleScientist, Division of Clinical and

Experimental Medicine CSIR-Central Drug Research Institute, Lucknow, India.

Dr. Waseem RizviAssociate Professor

Department of Pharmacology, J. N. MedicalCollege, A. M. U, Aligarh, India.

J.N. Medical CollegeA.M.U, Aligarh, India.

Dr. Santanu ChakrabortyAssistant Professor, Department:

Pharmaceutics, Dr. B. C. Roy Engineering College, Kolkata, India.

Dr. Yahaya Bin HassanHead, Faculty of Pharmacy, Universiti Teknologi MARA(UiTM) , Selangor ,

Malaysia.

Dr. Sandip Prabhakar ZineAssistant Professor, Department of

Pharmaceutical Chemistry, Vivekanand Education Society's College of

Pharmacy, Mumbai, India.

I take the privilege to present the print version for the Volume 1 Issue (2) of Journal of Drug Formulation, Development and Production. The intension of RRJoDFDP is to create an atmosphere that stimulates creativeness, research and growth in the area of Drug Formulation, Development and Production.

The development and growth of the mankind is the consequence of brilliant Research done by eminent Scientists and Engineers in every field. RRJoDFDP provides an outlet for Research findings and reviews in areas of Drug Formulation, Development and Production found to be relevant for National and International recent developments & research initiative.

The aim and scope of the Journal is to provide an academic medium and an important reference for the advancement and dissemination of Research results that support high level learning, teaching and research in the domain of Drug Formulation, Development and Production .

Finally, I express my sincere gratitude and thanks to our Editorial/ Reviewer board and Authors for their continued support and invaluable contributions and suggestions in the form of authoring write ups/ reviewing and providing constructive comments for the advancement of the journals. With regards to their due continuous support and co-operation, we have been able to publish quality Research/Reviews findings for our customers base.

I hope you will enjoy reading this issue and we welcome your feedback on any aspect of the Journal.

Dr. Archana Mehrotra

Director

STM Journals

Research & Reviews: A

Director's Desk

STM JOURNALS

1. Variation in Extract Yield in Different Parts of Albizia lebbeck Jenifer S., Priya S. 1

2. Pharmaceutical Product Registration Requirements in ASEAN & CIS Countries Rao MS, Dixit M, Charyulu RN, Shetty A, Bengre P, Thomas S 6

3. In Vitro Efficacy of Some Medicinal Plant Extracts against Aspergillus Niger: A Disease Causing Plant FungusJenifer S., John Bastin T. M. M., Kezia Laveena D., Singh S. J. S., Priya S. 11

4. Review on Different Approaches of Drug Development ProcessShailja Chauhan 18

5. Characterization of Tabletting Properties of Mango GumDixit M., Selvam P. R., Kulkarni P. K., Charyulu R. N. 22

ContentsResearch & Reviews: A Journal of Drug Formulation, Development and Production

RRJoDFDP (2014) STM Journals 2014. All Rights Reserved

Research & Reviews: A Journal of Drug Formulation, Development and Production

Volume 1, Issue 2

www.stmjournals.com

Variation in Extract Yield in Different Parts

of Albizia lebbeck

Jenifer S.1, Priya S.

2* 1Department of Biotechnology, Bon Secours College for Womens, Thanjavur, Tamil Nadu, India

2Department of Biotechnology, S.T.E.T. Womens College, Mannargudi, Tamil Nadu, India

Abstract Phytochemical screening is an important step which leads to the isolation of new and

novel compound. Solvent extract of the plant material with the help of different solvent

such as n-hexane, chloroform, alcohol and aqueous revealed that in alcohol and aqueous solvent maximum extract yield obtained in all studied parts. Phytochemical screening

analysis of the extract revealed presence of tannins, phenolics, flavonoids, alkaloids, terpenes and steroids in most parts. In qualitative analysis, leaf showed presence of all

tested phytochemical followed by the stem and aerial root of Albizia lebbeck.

Keywords: extractive yield, phytochemical, qualitative analysis, Albizia lebbeck

RRJoDFDP (2014) STM Journals 2014. All Rights Reserved

Research & Reviews: A Journal of Drug Formulation, Development and Production

Volume 1, Issue 2

www.stmjournals.com

Pharmaceutical Product Registration Requirements in

ASEAN & CIS Countries

Rao MS*, Dixit M, Charyulu RN, Shetty A, Bengre P, Thomas S Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte

University, Mangalore-575018, Karnataka, India

Abstract The Association of Southeast Asian Nations (ASEAN) and the Commonwealth of

Independent States (CIS) nations are two of the emerging pharmaceutical markets. There is a rise in income levels of middle class, rise in health consciousness and growing

burden of disease among the aged groups which has led to an increased demand for

general and lifesaving medicines in the emerging pharmaceutical markets. This paper approaches the pharmaceutical product registration requirements in ASEAN and CIS

countries. Diversity of regulatory requirements is noticed among the two regions; hence it is difficult to obtain marketing approval for pharmaceuticals at the same time in these

nations because of unnecessary duplication of work, waste of valuable resources etc.

Further attempts needs to be carried out globally to harmonise regulations so that the drug approval process becomes easy and duplication of work and waste of valuable

resources is avoided.

Keywords: ASEAN, CIS, CTD, ACTD, harmonisation

RRJoDFDP (2014) STM Journals 2014. All Rights Reserved

Research & Reviews: A Journal of Drug Formulation, Development and Production

Volume 1, Issue 2

www.stmjournals.com

In Vitro Efficacy of Some Medicinal Plant Extracts

against Aspergillus Niger: A Disease Causing

Plant Fungus

Jenifer S.1*, John Bastin T. M. M.2, Kezia Laveena D.1, Singh S. J. S.3, Priya S.4

1Department of Biotechnology, Bon Secours College for Womens, Thanjavur, Tamil Nadu, India

2Department of Agricultural Sciences and Technology, (SJCAST), Songea, Tanzania

3Bishop Heber College Trichy, Tamil Nadu, India

4Department of Biotechnology, S.T.E.T. Womens College, Mannargudi, Tamilnadu Nadu, India

Abstract Medicinal plants have been used in the prevention, treatment, and cure disorders and

diseases in ancient times and they provide abundant resources of antimicrobial

compounds, has been used for centuries to inhibit the microbial growth. Diseases of

medicinal plants were caused by the pathogenic microbes: especially fungi are common

throughout the world. Microbial diseases of plants cause malfunctions such as disturb normal functions by degrading enzymes, toxin, and growth substances, reduce the yield,

survival capacity, and resulting to death. In recent times, the medicinal plants were affected by exogenous, endogenous, and microbial infections. The medicinal plant

Argemone mexicana L. (Mexican poppy) is an annual exotic weed flora used for medicine

in several countries throughout the world and chosen for this study. This plant was frequently affected by many fungal pathogens. The present investigation focuses the

isolation of frequent disease causing fungal pathogen (Aspergillus niger) from infected

leaves and their control measures by using herbal extracts (Andrographis paniculata and Phyla nodiflora, Acalypha indica) via. In vitro approach.

Keywords: Argemone mexicana, exotic weed, exogenous, endogenous, pathogen,

toxin

RRJoDFDP (2014) STM Journals 2014. All Rights Reserved

Research & Reviews: A Journal of Drug Formulation, Development and Production

Volume 1, Issue 2

www.stmjournals.com

Review on Different Approaches of Drug

Development Process

Shailja Chauhan* Department of Biotechnology, Bhimtal Campus, Kumaun University, India

Abstract This paper is all about the process of bringing a new compound into the market. Different

approaches to drug development are mentioned. Function of drug development to assess

all parameters prior to human clinical trials and satisfying the regulatory requirements of drug licensing authorities, generally a number of tests are designed to determine the

major toxicities of a novel compound prior to first use in man are the objectives of drug

development, which are presented in this paper along with the few drug development tools.

Keywords: Drug development, clinical phase, preclinical phase, NME

RRJoDFDP (2014) STM Journals 2014. All Rights Reserved

Research & Reviews: A Journal of Drug Formulation, Development and Production

Volume 1, Issue 2

www.stmjournals.com

Characterization of Tabletting Properties of Mango Gum

Dixit M.1*, Selvam P. R.

2, Kulkarni P. K.

2, Charyulu R. N.

1

1Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences,

Nitte University, Mangalore, Karnataka, India 2Department of Pharmaceutics, J.S.S College of Pharmacy, J.S.S University,

Mysore, Karnataka, India

Abstract The aim of the study is to elucidate the physical, thermal, sorption, and functional

properties of a mango gum obtained from the stem of Mangifera indica were characterized viz. elemental analysis, Fourier transmittance infrared, particle size

analysis, thermogravimetric analysis, differential scanning colorimetry, scanning

electron microscopy, and X-ray powder diffraction. Mango gum had a glass transition

temperature (Tg) and melting peak of 90 and 318.795C, respectively. This material

showed a 14.59% loss in weight at 200C. The sample had peaks at approximately 21, 29, and 39 2 degrees of 2-theta () in the X-ray powder diffraction pattern. Elemental analysis showed that mango gum contains 35.62, 6.12, 56.57, and 1.67% of carbon,

hydrogen, oxygen, and nitrogen, respectively. The results obtained in this study establish

the fundamental characteristics of mango gum. The in vitro drug release was found to be 95.07% at 30 min ketoprofen tablets with 2.5% w/w binder concentration showed

optimum results than standard binder, thus conclusion was drawn that mango gum was found to be useful for the preparation of uncoated tablet dosage form.

Keywords: Mangifera indica, mango gum, tablet binder, excipients, ketoprofen

Research & Reviews A Journal of Drug Formulation(1-5) Variation in Extract Yield(6-10) Pharmaceutical Product Registration Requirements_ed(11-17) INVITRO EFFICACY OF SOME MEDICINAL(18-21) Review_on_Different_Approaches_of_Drug_Development_Process_Chauhan(22-30) Characterization of Tabletting Properties