Amorphous Solid Dispersion: Improving Dissolution Rate of Poorly Water-Soluble Drug Substance

Research studies show that the majority of API candidates in the development pipeline have a BCS Class II rating, which means those APIs need a solubilization strategy to promote the bioavailability to improve their chance of clinical success.

One commercially validated technique to improve the solubility of poorly-soluble APIs is to prepare them as amorphous solid dispersions (ASD). J-star Research Inc. has spray drying (SD), hot melt extrusion (HME) and co-processing in house to establish ASD technique. This case study is focused on the preparation and evaluation of one model ASD produced at J-STAR using Spry Drying.