ABSTRACT
INTRODUCTION A detailed understanding of the properties of the drug substance is essential to minimize formulation problems in later stages of drug development, reduce drug development costs, and decrease the product’s time to market (i.e., from drug substance to drug product). The goals of preformulation studies are to choose the correct form of the drug substance, evaluate its physical properties, and generate a thorough understanding of the material’s stability under the conditions that will lead to development of an optimal drug delivery system. This chapter examines the continuously evolving scope of preformulation studies. These changes are driven by three forces: the regulatory requirements, the market requirements, and the technological development. However, prior to reviewing the various requirements that determine the scope of preformulation studies, it is important to review how the drug discovery models are rapidly changing and why there is a need for not just one, but several levels of preformulation studies.
