Pharmaceutical amorphous solid dispersion: A review of manufacturing strategies
Sonal V. Bhujbal, Biplob Mitra, Uday K. Jain, Yuchuan Gong, Anjali Agrawal, Shyam Karki, Lynne S. Taylor, Sumit Kumar, Qi Zhou
Abstract
Amorphous solid dispersions (ASDs) are popular for enhancing the solubility and bioavailability of poorly water-soluble drugs. Various approaches have been employed to produce ASDs and novel techniques are emerging. This review provides an updated overview of manufacturing techniques for preparing ASDs. As physical stability is a critical quality attribute for ASD, the impact of formulation, equipment, and process variables, together with the downstream processing on physical stability of ASDs have been discussed. Selection strategies are proposed to identify suitable manufacturing methods, which may aid in the development of ASDs with satisfactory physical stability.