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Hot-Melt Extrusion: Enhancing Drug Efficacy and Bioavailability
Solid oral drugs must dissolve in gastrointestinal fluid to enable absorption. Yet 90% of new chemical entities and 40% of top solid oral drugs in the U.S. and Europe are poorly water soluble.¹
Hot-melt extrusion (HME) enhances API bioavailability and enables tailored release profiles. In HME, drug particles or molecules are dispersed in a polymer matrix under controlled thermal and mechanical conditions. The final dispersion depends on process and material properties.
In this 28-page compendium, we cover HME fundamentals, material behavior during heating, solvent-free process design, and downstream dosage form development.
Highlights include:
- Pharmaceutical HME overview
- Physical and thermal characterization
- Process design and development
- Downstream processing and dosage forms
- HME case examples
¹ M. Richter et al., “Dry Amorphization of Itraconazole Using Mesoporous Silica and Twin-Screw Technology,” Pharmaceutics, 2024, 16, 1368.