August 9, 2012

PRODUCT DEVELOPMENT AND FORMULATION (MPY- 104) SYLLABUS



Theory
1. Preformulation studies: Study of physical, chemical and
pharmaceutical factors influencing formulation of drugs.

2. Formulation additives: Study of formulation additives, Drug – Excipient, Excipient - Excipient interactions and Incompatibilities.

3. Solubilization: Theory of solubilization, methods of solubility enhancement and factor influencing solubility. Solids dispersion.

4. Dissolution Technology: Design of dissolution apparatus, dissolution media, dissolution testing of different types of dosage formulations, data interpretation, in-vitro and in-vivo correlation.

5. Tablets: Recent advances in tablet technology and automation in manufacturing process, formulation and evaluation of dispersible, effervescent, floating and multilayers tablets.

6. Formulation consideration and evaluation: Parenterals and Ophthalmics.

7. Polymers: Classification, General method of synthesis, Properties, Characterization, Evaluation and Application in pharmacy. A detail account of biodegradable polymers.

8. Nutraceuticals: Introduction, formulations, uses, recent developments and law governing nutraceuticals.

9. Pharmaceutical packaging: Packaging materials, type and tests of containers and closures, Pilot plant scale up technique.

10. Drug stability: Stability study programmes for formulations. Determination of Expiry date (shelf life) and Overage calculations. Stability indicating assays and ICH guidelines for stability.

11. OptimizationTechniques: Computers in pharmacy, Optimization techniques, Computer aided drug formulations.


Books and References Recommended:
1. Swarbrick, J. and Boyran, J. C., Encyclopedia of Pharmaceutical Technology” Vol.1-3, Marcel Dekkar, Inc., New York.
2. Gennaro, A.R., Remington’s “The Science and practice of
Pharmacy”, Lippincot, Wiliams & Wilkins, Philadelphia.
3. Aulton, M.E., “Pharmaceutics- The science of doses form design”, Churchill Livingstone, London.
4. Carstersen, J.T., “Drug stability: Principal & practice”, Marcel Dekker, Inc., NY
5. Banker and Rhodes, Modern Pharmaceutics. Marcel Dekker Inc. NY.
6. Liium, L. and Davis, S.S., “Polymers in controlled drug delivery”, Wright Bristol.
7. Kibbe, “ Hand book of Pharmaceutical Excipients., Pharmaceutical Press, London.
8. Lachmen, L. & Lieberman, H.A., “ Theory and Practice of Industrial Pharmacy”, Verghese publishing house, Bombay.
9. Martin, Physical Pharmacy.
10. Lieberman, H.A. & Lachmen, L., “ Pharmaceutical Dosage forms – Dispersed Systems’’ Vol.1-3 ,Marcel Dekker, Inc., NY.
11. Avise, K. E. & Lachmen, L., “ Pharmaceutical Dosage forms – “Parenteral Medications’’ Vol.1-3 ,Marcel Dekker, Inc., NY.
12. Lieberman, H.A. & Lachmen, L., “ Pharmaceutical Dosage forms – Tablets’’ Vol.1-3 ,Marcel Dekker, Inc., NY.
13. Yalkowsky,S.H.” Techniques of Solubilization of drugs”, Marcel Dekker, Inc., NY.

3 comments:

shalinikumar said...

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Marine Engineering

Unknown said...

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ATSTAT 10 (SS) 10X10
Indian Pharma Industry
Pharmaceutical Company India

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