Pharmaceutical Microbiology

SEMESTER – V

DSE – 3A

APMB 354 PHARMACEUTICAL MICROBIOLOGY (4 credits)

Unit - I

Introduction – Overview of products, classification of pharmacologic agents based on chemistry and source. Phytopharmaceuticals: screening tests for phytoconstituents – alkaloids and terpenoids. Three examples of commercial natural products from marine and terrestrial organisms.

Unit - II

Drug development: Biology guided fractionation methods: in vitro assay systems based on enzymes, tissue, and organ or growth inhibition. Animal models: transgenic animals, cell lines. Antimicrobial activity studies (antibacterial, antiviral, antifungal and antiparasitic activities).

Unit - III

Gene therapy: general introduction, ex vivo and in vivo gene therapy, potential targets for gene therapy, inherited disorders. Vaccine design and production, classification, genetically recombinant vaccines, advantages and disadvantages – examples – hepatitis B vaccines, cholera vaccines, edible vaccines, DNA vaccines – principles and mechanism.

Unit - IV

Immunologicals: Antisera – hyper immune gamma globulin – monoclonal antibodies – uses. Recombinant proteins: strategies and genetic manipulations for overproduction of biomolecules – insulin production, production of interferons.

Unit - V

Other biomolecules: probiotics and neutraceuticals – economic and legal considerations in pharmaceutical biotechnology: FDA guidelines – preclinical trials, acute, sub-acute, chronic and teratogenic studies. Clinical trials – Phases I, II, III and IV. ICMR guidelines for design and conduct of clinical trials, licensing and drug control.

Text Books

1. Denyer S.P., Hodges N.A. and Gorman S.P. (2004) Hugo and Russell’s Pharmaceutical Microbiology, 7^th Edn. Blackwell Publishers.

2. Mehra P.S. (2011) A text book of Pharmaceutical Microbiology, IK International Publishing House.

Reference Books

1. Baird R.M., Hodges N.A. and Denyer S.P. (2005) Handbook of Microbiological Quality control in Pharmaceutical and Medical Devices, Taylor and Francis Inc.

2. Saghee M.R., Sandle T. and Tidswell E.C. (2011) Microbiology and Sterility Assurance in Pharmaceuticals and Medical devices, Business Horizons publishers.

3. Hanlon G. and Sandle T. (2015) Industrial Pharmaceutical Microbiology: Standards and Controls, Euromed Communications.