Ask an Expert - Drug solubility in polymer: Kinetic and thermodynamic phase behavior of amorphous solid dispersions

About The Event

Amorphous solid dispersions (ASDs) offer a promising approach to enhancing the bioavailability of poorly soluble active pharmaceutical ingredients (APIs). In this webinar, we will explore the long-term physical stability (LTPS) of polyvinyl alcohol (PVA)-based solid dispersions produced via hot-melt extrusion (HME) and compare them to API–PVA temperature–composition (T–C) phase diagrams. Using two APIs with contrasting glass-forming abilities (GFA)—indomethacin (IND) with good GFA and naproxen (NAP) with poor GFA—the study evaluates the stability of the extrudates over time. Results show that despite low solubility predictions, IND remained fully amorphous after 24 months, while NAP experienced significant recrystallization after 12 months. The webinar will discuss the role of GFA, the limitations of phase diagrams, and the influence of water uptake and HME processing on extrudate stability. This session will provide valuable insights for researchers working on API solubility and the development of ASDs in semi-crystalline polymers.