Chapter 16 - Application of QbD Elements for the Development of Conventional to Lipid Vesicular for Topical Drug Delivery System

Abstract

The quality and the stability of the topical dosage form are the most important aspects. Quality by testing (QbT) is used to ensure the quality of topical products. But the specifications set by QbT are not based on the critical quality attributes (CQAs) of the materials. Another development that has emerged is quality by design (QbD). It is a modern approach to ensure the quality of pharmaceutical products. It can identify the critical attributes of the materials and the process parameters involved in the development of the formulations via scientific understanding and established design space. In the development of topical products, implementations of QbD tools such as design of experiment, risk assessment, and process analytical technology to control strategy of products are employed. Moreover, the present chapter also addresses the development of novel lipid vesicular topical formulation by the applications of QbD, which results in improved quality of the topical formulations.