BT8009 - BIOPHARMACEUTICAL TECHNOLOGY (Syllabus) 2017-regulation Anna University

BT8009 - BIOPHARMACEUTICAL TECHNOLOGY (Syllabus) 2017-regulation Anna University

BT8009

BIOPHARMACEUTICAL TECHNOLOGY

 LPTC
3003

OBJECTIVES:
The aim of the course is to give strong foundation and advanced information on biopharmaceutical aspects in relation to drug development. This course provides core responsibilities for the development and monitoring of the drug and the preparation of medicines according to the norms. • To gain knowledge in physicochemical properties, pharmacology and the formulation of commonly used biopharmaceuticals.

UNIT I

INTRODUCTION

9
Pharmaceutical industry & development of drugs ; types of therapeutic agents and their uses; economics and regulatory aspects .

UNIT II

DRUG ACTION, METABOLISM AND PHARMACOKINETICS

9
Mechanism of drug action; physico-chemical principles of drug metabolism; radioactivity; pharmacokinetics.


UNIT III

MANUFACTURE OF DRUGS, PROCESS AND APPLICATIONS

9
Types of reaction process and special requirements for bulk drug manufacture.

UNIT IV

PRINCIPLES OF DRUG MANUFACTURE

9
Compressed tablets; dry and wet granulation; slugging or direct compression; tablet presses; coating of tablets; capsule preparation; oval liquids – vegetable drugs – topical applications; preservation of drugs; analytical methods and other tests used in drug manufacture; packing techniques; quality management; GMP.

UNIT V

BIOPHARMACEUTICALS

9
Various categories of therapeutics like vitamins, laxatives, analgesics, contraceptives, antibiotics, hormones and biologicals.

TOTAL : 45 PERIODS

OUTCOMES: The course would facilitate the students to
• The knowledge gained in this course would be used to understand and evaluate different pharmaceutical parameters for the current and future biotechnology related products on the market.
• This course paves a ways to the students to acquire knowledge on novel biotechnological and pharmaceutical products, current medicines and their applications in therapeutic and diagnostic fields.
• Demonstrate knowledge and understanding of current topical and newly emerging aspects of pharmaceutical biotechnology.
• Understand the legal steps involved in progressing a new drug to market. Grasping the current regulatory acts and safety norms of the modern pharmaceutical industries.

TEXT BOOK:
1. Finkel, Richard, etal., “Lippincott’s Illustrated Reviews Pharmacology” IVth Edition. Wolters Kluwer / Lippincott Williams & Wilkins, 2009.

REFERENCES:
1. Gareth Thomas. Medicinal Chemistry. An introduction. John Wiley. 2000.
2. Katzung B.G. Basic and Clinical Pharmacology, Prentice Hall of Intl. 1995.
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