Research & reviews a journal of drug formulation, development (vol1, issue2) by STM Journals Publication

Research & Reviews:

A Journal of Drug Formulation, Development & Production May - August 2014 RRJoDFDP

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Dr. Nahlah Elkudsiah Ismail Faculty of Pharmacy, Universiti Teknologi MARA (UiTM) Puncak Alam Campus, Bandar Puncak Alam, Selangor, Malaysia.

Dr. Mudit Dixit Head-Department of Drug Regulatory Affairs & Assistant Professor (Pharmaceutics) (Senior Grade), NGSM Institute of Pharmaceutical Sciences, Mangalore, India.

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Dr. Abhay Dharamsi Professor and Head Department of Pharmaceutics, Maliba Pharmacy College, Surat, Gujarat, India.

Dr. Atla Srinivasa Rao Professor & HOD Dept. of Pharmaceutical Analysis & QA Shri Vishnu College of Pharmacy , A.P., India.

Dr. Atul Goel Principal Scientist, Medicinal and Process Chemistry Division CSIR-CDRI, Lucknow, India.

Dr. Bharat Bhusan Subudhi Associate Professor, School of Pharmaceutical Sciences, Siksha O Anusandhan University, Bhubaneswar, India.

Dr. Bhavin P. Marolia Assistant Professor, Dept. of Quality Assurance & Pharmaceutical Analysis, Maliba Pharmacy College UKA Tarsadia University, Tarsadi.

Dr. Chiau Long Lecturer, Faculty of Pharmacy, Universiti T eknologi MARA, Puncak Alam, Selangor, Malaysia.

Mrs. Divya Suares Assistant professor, NMIMS University, India.

Dr. George D Geromichalos Head, Molecular Modeling & Drug Design, Symeonidion Research Center Theagenion Cancer Hospital, Greece.

Dr. Jayarajakumar Kalaimani Faculty of Pharmacy, AIMST University, Bedong,Malaysia.

Dr. K.R. Arya Principal Scientist, Botany Division, CDRI, Lucknow, India.

Dr. Kashmira Gohil Professor and HOD, Shree Dhanvantari Pharmacy College (SDPC), Surat, Gujarat, India.

Dr. Koteshwara K.B Professor, Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University,India.

Editorial Board

Dr. Mahalaxmi Rathnanand Associate Professor ,Dept of Pharmaceutics Manipal College of Pharmaceutical Sciences, Manipal, India.

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

Dr. Mohamed Salama Professor,Faculty of Pharmacy, UiTM , Malaysia.

Dr. Neeraj Kumar Fuloria Faculty of Pharmacy, AIMST University, Malysia, Malaysia.

Dr. Poonam Singh Scientist CSIR-Central Drug Research Institute, Lucknow.

Dr. Pranav Shah Associate Professor, Maliba Pharmacy College, Maliba Campus, Surat, Gujarat, India.

Dr. R.K Singh Senior Principal Scientist, CDRI, Lucknow, India.

Dr. Rabi Bhatta Scientist Lab no: PCN-108 Pharmacokinetic and Metabolism Division CSIR-Central Drug Research Institute, Lucknow, India.

Dr. Rama Pati Tripathi Professor AcSIR, Cheif Scientist CSIR-Central Drug Rsearch Institute Medicinal and process chemistry Division CSIR Lucknow India.

Dr. S. K. M. Habeeb Assistant Professor, Department of Bioinformatics, School of Bioengineering, Kattankulathur Campus, SRM University, India.

Dr. Sanghapal D. Sawant CSIR-Indian Institute of Integrative Medicine, Jammu, India.

Prof. Dr. Sapna Shrikumar Principal, Moulana College of Pharmacy, Angadtppuram (P.O), Perinthalmanna, Malappuram, Kerala, India.

Editorial Board

Dr. Shashank K Singh Senior Scientist,CSIR-Indian institute of Integrative Medicine ,Canal Road Jammu, India.

Dr. Sridevi Chigurupati Senior Lecturer Faculty of Pharmacy, AIMST University, Malaysia.

Mr. Soh Yee Chang Faculty of Pharmacy UiTM Puncak Alam Campus Malaysia.

Dr. Suneel .I.Majagi Associate Professor Department of Pharmacology J.N.Medical College Belgaum-590010. Karnataka.

Dr. V. Ravichandran Faculty of Pharmacy,AIMST University, Semeling - 08100,Kedah, Malaysia.

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

Dr. Vivek Bhosale Scientist, Division of Clinical and Experimental Medicine CSIR-Central Drug Research Institute, Lucknow, India.

Dr. Waseem Rizvi Associate Professor Department of Pharmacology, J. N. Medical College, A. M. U, Aligarh, India.

J.N. Medical College A.M.U, Aligarh, India.

Dr. Yahaya Bin Hassan Head, Faculty of Pharmacy, Universiti Teknologi MARA(UiTM) , Selangor , Malaysia.

Dr. Santanu Chakraborty Assistant Professor, Department: Pharmaceutics, Dr. B. C. Roy Engineering College, Kolkata, India.

Dr. Sandip Prabhakar Zine Assistant Professor, Department of Pharmaceutical Chemistry, Vivekanand Education Society's College of Pharmacy, Mumbai, India.

Director's Desk

STM JOURNALS

I take the privilege to present the print version for the Volume 1 Issue (2) of Research & Reviews: A 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 Journal of Drug Formulation, Development and Production

Contents

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

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

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

4. Review on Different Approaches of Drug Development Process Shailja Chauhan

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

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* 1

Department of Biotechnology, Bon Secours College for Women’s, Thanjavur, Tamil Nadu, India 2 Department of Biotechnology, S.T.E.T. Women’s 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

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

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 Department of Biotechnology, Bon Secours College for Women’s, Thanjavur, Tamil Nadu, India 2 Department of Agricultural Sciences and Technology, (SJCAST), Songea, Tanzania 3 Bishop Heber College Trichy, Tamil Nadu, India 4 Department of Biotechnology, S.T.E.T. Women’s 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

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

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 1

Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India 2 Department 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 318.795°C, respectively. This material showed a 14.59% loss in weight at 200C. The sample had peaks at approximately 21, 29, and 39 2θ degrees of 2-theta (θ) 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