The functionality and stability of HPMCAS when used in hot-melt extrusion

The majority of today’s new chemi- cal entities are poorly water-soluble. One widely used means of overcom- ing that problem is to develop solid dispersions by mixing at the molecular level the drug candidate into a polymer matrix [1]. Spray drying and hot-melt extrusion (HME) are the most common technologies used to manufacture these amorphous solid dispersions. With spray drying, an organic solvent dissolves the API and polymer, followed by rapid removal of the solvent. With HME, an API-poly- mer blend is extruded at high tempera- ture and high shear to create a solid dispersion. HME is preferred because it can operate continuously and offers economic advantages.