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.
Palestrante
- Natalia Dadivanyan - Segment Marketing Manager, Malvern Panalytical
- Alex Mathers - Postdoctoral Researcher, University of Chemistry and Technology, Prague (UCT Prague)
Mais informações
Who should attend?
- Scientists and researchers interested in enhancing the bioavailability of poorly water-soluble drugs;
- Anyone interested in the challenges associated with effectively screening drug–polymer compatibility.
What will you learn?
- Learn how to efficiently measure the solubility of a drug in a polymer at elevated temperatures using the step-wise dissolution method;
- Discover how X-ray diffraction can be used to identify the absence/presence of a crystalline phase in a drug–polymer sample;
- Understand why it is challenging to determine the solubility of a drug in a polymer at a typical storage temperature (e.g., T = 25 °C).