Issue link: https://www.e-digitaleditions.com/i/1218534
24 March 2020 Tablets & Capsules A Neha Shah Recro Gainesville Formulating drug products with complex APIs formulation This article provides guidance to help formulators develop solid oral drug products using complex active pharmaceutical ingredients (APIs). bout 90 percent of API molecules in the discovery pipeline are water insoluble, contributing to bioavailabil- ity challenges [1]. Pharmaceutical developers use special methodologies—such as spray drying and microniza- tion—to improve the solubility and bioavailability of such poorly soluble APIs. However, successfully formu- lating a final dosage form and designing an appropriate manufacturing process with APIs prepared using such complex methods can be challenging.