Pharmaceutical Product Development

Unit-I 

Introduction to pharmaceutical product development, objectives, regulations related topre-formulation, formulation development, stability assessment, manufacturing andquality control testing of different types of dosage forms

Unit-II

An advanced study of Pharmaceutical Excipients in pharmaceutical product developmentwith 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 sorbitol.

v. Suspending and emulsifying agents.

vi. Semi solid excipients

Unit-III 

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-IV 

Optimization techniques in pharmaceutical product development. A study of variousoptimization techniques for pharmaceutical product development with specificexamples. Optimization by factorial designs and their applications. A study of QbD and itsapplication in pharmaceutical product development. 

Unit-V 

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