Developing Optimal Formulations Using Biorelevant Predictive Tools And Advanced Bioavailability Enhancement Technologies

By Jennifer Dressman, Professor, University of Frankfurt and Fraunhofer Institute of Translational Medicine and Pharmacology, and Stephen Tindal, Director, Science and Technology, Catalent

It is widely known that for every small molecule that reaches the market, a large number of compounds are evaluated for their potential to be an effective treatment. Since the oral route of administration is often preferred, it makes sense that tools designed to guide development of oral formulations have been developed. One such tool used for this purpose is the refined Developability Classification System (rDCS), proposed and published by Rosenberger, Butler and Dressman in 2018 (1). The rDCS helps formulators, at the preclinical stage, identify the formulation strategies most likely to achieve good oral bioavailability in humans. However, extensive formulation development work at early stages is limited by the relatively small quantities of drug substance that are usually available. To address this challenge, Catalent utilizes in-vitro screening tools to recommend optimal formulation strategies using minimal quantities of drug substance.