Recent Progress on Crystal Nucleation of Amorphous Solid Dispersion

Amorphous solid dispersion (ASD) is a highly effective formulation strategy for enhancing the water solubility and oral bioavailability of drugs that are poorly soluble in water. Despite its benefits, maintaining the physical stability of the amorphous state is a significant challenge in ASD development. Crystallization plays a pivotal role in determining the physical stability of the ASD. In recent years, nucleation, as a key step in the crystallization process of ASDs, has attracted increasing attention. In this review, we have examined the existing theories related to nucleation within the ASDs. Additionally, we provide a summary of the latest research on the impact of additives and various influencing factors on the nucleation process. The goal of this review is to deepen the understanding of the nucleation mechanisms in ASDs and to explore strategies for controlling crystallization during the development of ASD formulations.