ABSTRACT
This chapter focuses on technologies and suggests paradigms to broadly accomplish the development of robust solid dosage formulations and process understanding for future generations of new water-insoluble drug products. The goal in the early phase of drug development is to minimize resource commitment and simplify the assessment of new chemical entities in the clinic. The drug development of the concept Quality by Design (QbD) has significantly transformed pharmaceutical quality regulation from an empirical process to a more scientific and risk-based approach. The elements of QbD consists some parameters: quality target product profile, critical quality attributes, critical material attributes, and critical process parameters. Formulation and process scientists generally take a balanced approach to achieve the overall quality objective. The formulation development objectives include preformulation work that entails understanding of solid state of active pharmaceutical ingredient, preliminary bioperformance, and drug–excipient compatibility studies.
