Pharmaceutical development of suspension dosage form

Abstract

This chapter begins with a definition of the Target Product Profile which defines the goal for the drug product and guides formulation research and development activities. Formulation research begins with the generation of the preformulation information (physicochemical properties) and leads to the selection of a prototype suspension formulation. This chapter also outlines the formulation optimization and development activities required to iteractively refine the formulation composition and process as the project proceeds to the point of filing an NDA.