Excipients for Amorphous Solid Dispersions

Pharmaceutical excipients play a significant role in stabilization of amorphous solid dispersions, as these systems are thermodynamically unstable. This chapter illustrates the challenges associated with amorphous solid dispersion stability and the role that excipients play in stabilization of amorphous solid dispersions by influencing the physicochemical properties of the drug molecule of interest. The classification of various excipients is categorized in detail, covering polymers, solubilizers, plasticizers, antioxidants, and other suitable fillers. The impact of excipients on various amorphous solid dispersion technologies is also discussed in detail. Discovery of newer polymers and greater understanding of excipients’ role in the stabilization of amorphous solid dispersion are the primary reasons for successful launch of several marketed drug products. In addition, safety and regulatory aspects of these excipients also need to be considered for the development of successful products. In summary, excipients play a significant role in stabilizing amorphous solid dispersions, maximizing bioavailability, and overcoming absorption issues associated with poorly soluble drugs.