PUBLIC HEALTH PHARMACY

PHARMACEUTICAL PRODUCT DEVELOPMENT BP813ET

UNIT -01

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

UNIT -02

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

UNIT -03

 

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

UNIT -04

  • 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 -05

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