Pharmaceutical Product Development Book B.Pharm 8th Semester

Syllabus

                        Pharmaceutical Product Development

(Course Code: BP813ET)

Module 01                                                                                        10 Hours

·         Introduction to pharmaceutical product development, objectives, regulations related to preformulation, formulation development, stability assessment, manufacturinga n d quality control testing of different types of dosage forms.

Module 02                                                                                        10 Hours

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

a)                   Solvents and solubilizers

b)                   Cyclodextrins and their applications

c)                   Non - ionic surfactants and their applications

d)                   Polyethylene glycols and sorbitols

e)                   Suspending and emulsifying agents

f)                    Semi solid excipients

Module 03                                                                                        10 Hours

·         An advanced study of Pharmaceutical Excipients in pharmaceutical productdevelopment with a special       reference to the following categories:

             a)  Tablet and capsule excipients

b)                   Directly compressible vehicles

c)                   Coat materials

d)                   Excipients in parenteral and aerosols products

e)                   Excipients for formulation of NDDS

·         Selection and application of excipients in pharmaceutical ormulations with specific industrial applications.

Module 04                                                                                        08 Hours

·         Optimization techniques in pharmaceutical product development.

·         A study of various optimization techniques for pharmaceutical roduct development with specific examples.

·         Optimization by factorial designs and their applications.

·         A study of QbD and its application in pharmaceutical product development.

Module 05                                                                                        07 Hours

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