Dissolution Profile Consideration in Pharmaceutical Product Development

Abstract

Dissolution testing has been evolved as an approach based on risk and science, to control the quality of pharmaceutical dosage forms, as well as to assist pharmaceutical product development, approval, and postapproval dossier submissions. It reduces regulatory burden, resource requirements, and thus development times and cost in the long, arduous, and expensive process of formulation development. It is considered as an important tool used in formulation development and optimization; estimation of drug release under physiological conditions; assurance of batch-to-batch consistency; stability monitoring; bioequivalence determination between pharmaceutical formulations. This chapter highlights the significance of the dissolution and the related concepts throughout the pharmaceutical drug development continuum. The initial part of the chapter outlines the development of a relevant dissolution test; taking into consideration all the parameters that influence its performance and results. The later part highlights the concepts of dissolution profile comparison, IVIVC and BCS (integrating with QbD), and their roles from nonclinical to the postmarketing stage of drug development to ensure a high-quality biopharmaceutical product of desirable attributes. © 2018 Elsevier Inc. All rights reserved.