CAPS: A Novel Co-Processing Approach to Enhance ASD Properties

Increasing number of new chemical entities (NCEs) in drug development pipelines are BCS class II or IV which pose significant challenges for developability of a bioavailable drug. Amorphous solid dispersions (ASDs) prepared via hot-melt extrusion (HME) and spray drying are among the most commonly used strategies to enhance the solubility and bioavailability of poorly water-soluble compounds. However the material properties of ASDs can present formulation and processing challenges in drug product manufacturing. In this work, we introduce a novel Controlled API-Polymer Solidification (CAPS) technology for a cost-effective preparation of ASDs with superior physical properties, including improved density, flowability, and particle size distribution. These enhanced properties facilitate streamlined drug product manufacturing, enabling direct compression into tablets without additional processing steps. In-vitro dissolution-permeation system used to predict ASDs performances, as well as in-vivo pharmacokinetic (PK) evaluations, demonstrated that CAPS-prepared ASDs exhibit bioequivalence to spray-dried formulations. This study highlights the advantages of CAPS as an alternative ASD manufacturing approach, offering enhanced physical properties and simplified downstream processing compared to conventional ASD processes.