B.Pharm Pharmaceutical Product Development Notes

PHARMACEUTICAL PRODUCT DEVELOPMENT UNIT-WISE NOTES

Unit – 1

• 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 – 2

• An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a special reference to the following categories
• i. Solvents and solubilizers
• ii. Cyclodextrins and their applications
• iii. Non – ionic surfactants and their applications
• iv. Polyethylene glycols and sorbitols
• v. Suspending and emulsifying agents
• vi. Semi solid excipients

Unit – 3

• An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a special reference to the following categories
• i. Tablet and capsule excipients
• ii. Directly compressible vehicles
• iii. Coat materials
• iv. Excipients in parenteral and aerosols products
• v. Excipients for formulation of NDDS
• Selection and application of excipients in pharmaceutical formulations with specific industrial applications

Unit – 4

• 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 – 5

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