New Strategies for Improving the Development and Performance of Amorphous Solid Dispersions

Abstract

The understanding of amorphous solid dispersions has grown significantly in the past decade. This is evident from the number of approved commercial amorphous solid dispersion products. While amorphous formulation is considered an enabling technology, it has become the norm for formulating poorly soluble compounds. Despite this success, improvements can still be made that enable early development formulation decisions, to develop a rationale for selecting a manufacturing process, to overcome degradation and phase separation during processing, to help achieve physical stability during storage, and to optimize dissolution behavior. The purpose of this literature review is to present recently reported strategies for improving the development and performance of ASDs. The benefits and limitations of each strategy as well as recent relevant case studies will be presented in this review. The strategies are presented from three different aspects: (a) prediction techniques that enable formulation decisions, (b) manufacturing considerations that help produce physically and chemically stable ASDs, and

Keywords: amorphous solid dispersion; chemical stability; dissolution behavior; physical stability; process impact.