Amorphous solid dispersion to facilitate the delivery of poorly water-soluble drugs: recent advances on novel preparation processes and technology coupling.

Introduction: Amorphous solid dispersion (ASD) technique has recently been used as an effective formulation strategy to significantly improve the bioavailability of insoluble drugs. The main industrialized preparation methods for ASDs are mainly hot melt extrusion and spray drying techniques; however, they face the limitations of being unsuitable for heat-sensitive materials and organic reagent residues, respectively, and therefore novel preparation processes and technology coupling for developing ASDs have received increasing attention.

Areas covered: This paper reviews recent advances in ASD and provides an overview of novel preparation methods, mechanisms for improving drug bioavailability, and especially technology coupling.

Expert covered: As a mature pharmaceutical technology, ASD has broad application prospects and values. During the period from 2012 to 2024, the FDA has approved 49 formulation products containing ASDs. However, with the diversification of drug types and clinical needs, the traditional formulation technology of ASDs is gradually no longer sufficient to meet the needs of clinical medication. Therefore, this review summarizes the studies on both novel preparation processes and technology combinations; and provides a comprehensive overview of the mechanisms of ASD to improve drug bioavailability, in order to better select appropriate preparation methods for the development of ASD formulations.