Application of Predictive Modeling in the Development of Amorphous Solid Dispersions

Formulators challenged by promising investigational drug candidates with high bioactivity but limited solubility increasingly find amorphous solid dispersions (ASDs) an attractive solution for enhancing bioavailability. The FDA approved nearly 50 drug products formulated as ASDs between 2012 and 2023.¹ However, identifying the optimum method of ASD preparation (e.g., spray-drying [SD] or hot-melt extrusion [HME]), and choosing the polymeric carrier, surfactant, and drug loading level can be challenging.