Course

Unit I (07 Hours)

Introduction to pharmaceutical product development, objectives, regulations related to preformulation, formulation development, stability assessment, manufacturing and quality control testing of different types of dosage forms

Unit II (10 Hours)

An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a special reference to the following categories

1. Tablet and capsule excipients
2. Directly compressible vehicles
3. Coat materials
4. Excipients in parenteral and aerosols products
5. Excipients for formulation of NDDS

Selection and application of excipients in pharmaceutical formulations with specific industrial applications

Unit III (10 Hours)

1. Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its constitution and func- tions, Education Regulations, State and Joint state pharmacy councils; constitution and functions, Registration of Pharmacists, Offences and Penalties
2. Medicinal and Toilet Preparation Act –1955: Objectives, Definitions, Licensing, Manufacture In bond and Outside bond, Export of alcoholic preparations, Manufacture of Ayurvedic, Homeopathic, Patent & Proprietary Preparations. Offences and Penalties.
3. Narcotic Drugs and Psychotropic substances Act-1985 and Rules: Objectives, Definitions, Au- thorities and Officers, Constitution and Functions of narcotic & Psychotropic Consultative Com- mittee, National Fund for Controlling the Drug Abuse, Prohibition, Control and Regulation, opium poppy cultivation and production of poppy straw, manufacture, sale and export of opium, Offences and Penalties

Unit IV (10 Hours)

Optimization techniques in pharmaceutical product development.A study of various optimization techniques for pharmaceutical product development with specific examples.Optimization by factorial designs and their applications.A study of QbD and its application in pharmaceutical product development.

Unit V (07 Hours)

Selection and quality control testing of packaging materials for pharmaceutical product development- regulatory considerations.

‘Pharmaceutical Product Development’ is a course offered as elective of B. Pharm program at School of Pharmacy, Health Sciences campus, Amrita Vishwa Vidyapeetham.

Recommended Books (Latest Editions)

1. Pharmaceutical Statistics Practical and Clinical Applications by Stanford Bolton, CharlesBon; Marcel Dekker Inc.
2. Encyclopedia of Pharmaceutical Technology, edited by James swarbrick, Third Edition,Informa Healthcare publishers.
3. Pharmaceutical Dosage Forms, Tablets, Volume II, edited by Herbert A. Lieberman andLeon Lach- man; Marcel Dekker, Inc.
4. The Theory and Practice of Industrial Pharmacy, Fourth Edition, edited by Roop kKhar, S P Vyas, Farhan J Ahmad, Gaurav K Jain; CBS Publishers and Distributors Pvt.Ltd. 2013.
5. Martin’s Physical Pharmacy and Pharmaceutical Sciences, Fifth Edition, edited by Patrick J. Sinko, BI Publications Pvt. Ltd.
6. Targeted and Controlled Drug Delivery, Novel Carrier Systems by S. P. Vyas and R. K.Khar, CBS Pub- lishers and Distributors Pvt. Ltd, First Edition 2012.
7. Pharmaceutical Dosage Forms and Drug Delivery Systems, Loyd V. Allen Jr., Nicholas B.Popovich, Howard C. Ansel, 9th Ed. 40
8. Aulton’s Pharmaceutics – The Design and Manufacture of Medicines, Michael E. Aulton,3rd Ed.
9. Bare Acts of the said laws published by Government. Reference books (Theory)
10. Remington – The Science and Practice of Pharmacy, 20th Ed.
11. Pharmaceutical Dosage Forms – Tablets Vol 1 to 3, A. Liberman, Leon Lachman andJoseph B. Schwartz
12. Pharmaceutical Dosage Forms – Disperse Systems Vol 1 to 3, H.A. Liberman, Martin, M.R and Gil- bert S. Banker.
13. Pharmaceutical Dosage Forms – Parenteral Medication Vol 1 & 2, Kenneth E. Avis andH.A. Liber- mann.
14. Advanced Review Articles related to the topics.