Hot Melt Extrusion
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Hot-Melt Extrusion (HME) is an innovative technology used in the preparation of amorphous solid dispersions (ASDs), which enhance the bioavailability of poorly soluble compounds. It is recognized for its flexibility, scalability, consistent high quality, and process efficiency. HME technology is applied in various areas, including the development of ASDs, sustained-release formulations, targeted drug delivery systems, and oral films.
WuXi STA has a specialized team of formulators and analytical scientists dedicated to the HME platform. We manage the scope of HME formulation – from exploratory research and development at the gram level, through process optimization at the kilogram level, to commercial production at the hundred-kilogram scale. Our offerings are designed to support customers from early- to late-stage development studies, as well as preclinical toxicological batch production, clinical supply, and all the way to commercial supply production.
Our service range includes:
- Amorphous Solid Dispersion (ASD) formulation screening & pre-formulation study
- Formulation development and process development
- Clinical Trial Material (CTM) manufacturing
- Commercial supply production