Physical, Chemical, and Performance Assessment of Amorphous Solid Dispersions of Ritonavir Prepared by Hot Melt Extrusion

Abstract

The purpose of this study was to compare the chemical and physical stability of amorphous solid dispersions of Ritonavir formulated with either AFFINISOL™ HPMC HME 15LV or copovidone at 3 drug loads when placed on accelerated stability testing for a period of 6 months. Additionally, dissolution performance of the resulting amorphous solid dispersions before and after stability testing was analyzed to investigate the impact of storage and drug load on performance maintenance with each polymer.