Quality by Design approach for systematic development of nanoformulations

Abstract The development of pharmaceutical drug products using the conventional batch manufacturing processes is a complex process that involves multiple steps and unit operations. However, this approach of manufacturing always experiences challenges with respect to poor product and process performance, and robustness. In this regard, almost a decade back, the Quality by Design (QbD) approach was adopted as a revolutionary solution for addressing the manufacturing challenges and regulatory hiccups. It has wider applicability for the development of new products as well as generic products, and beyond. The application of QbD for nanopharmaceutical products has also gained significant momentum, as development of such formulations involves a high degree of variability and at times creates the situation for product recalls and rejects. So far the application of the QbD approach to pharmaceuticals is mandatory for generic products, and its utility in nanopharmaceutical development has yielded great benefits. This chapter provides an in-depth review of the methodology, advantages, disadvantages, and applications of QbD methodology with special emphasis on nanopharmaceutical product development.