Chapter 6 - Application of Quality by Design Paradigms for Development of Solid Dosage Forms

Abstract

Quality by design (QbD) has prevailed in its innovative perspectives to be conducive for the development, design, and manufacture of quality drug products. The vital applications of QbD in health-care product development are now driving force for the regulatory authorities and medicine industry. The leading principles and versatile applications of QbD in overall health-care fraternity for effective product development are reported by the ICH and USFDA. The prime components of QbD including quality target product profile (QTPP), critical quality attributes (CQAs), critical material attributes (CMAs), critical processing parameters (CPPs), design space, and control strategy have been presented in the chapter in order to understand the product performance in the light of solid-dosage form development. This chapter also reviews the intent of QbD paradigm along with vital tools like risk assessment, design of experiments (DOEs), and process analytical technology (PAT) toward solid-dosage form manufacturing including tablets, capsules, pellets, etc. and highlights the current and future challenges by adopting the QbD paradigm in the modern scenario.