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Characterization of Different Copovidone Grades as Carrier Materials in Hot Melt Extrusion of Amorphous Solid
Marvin Daalmann1, Vincent Kimmel1,2, Christian Muehlenfeld3
1Laboratory of Solids Process Engineering, Department of Biochemical and Chemical Engineering, TU Dortmund University, Emil-Figge-Str. 68, 44227 Dortmund, Germany.
Abstract:
Background/Objectives: Copovidone (polyvinylpyrrolidone-vinyl acetate copolymer, PVP/VA) is a widely used pharmaceutical excipient with various applications in drug formulation. In hot melt extrusion (HME), PVP/VA is an approved carrier material for the production of amorphous solid dispersions (ASDs) by embedding drugs on a molecular level. This study investigates the properties and processability of two copovidone grades-Plasdone™ S-630 (PS-630) and the novel Plasdone™ S-630 Ultra (PS-630U)-to assess their suitability as ASD carrier materials. Methods: The thermal and physicochemical characteristics of both polymers were evaluated, focusing on glass transition temperature and polymer melt rheology. The process performance in HME was investigated on small-scale as well as in production-scale extrusion. The two model drugs itraconazole and griseofulvin were used to examine drug dissolution and degradation during HME via in-line UV-vis spectroscopy. Results: When comparing both polymers, PS-630U offers various advantages due to the improved powder feeding behavior and reduced yellowing of extruded products while maintaining similar melt properties and drug compatibility compared to PS-630. Conclusions: These findings support the use of PS-630U as an optimized copovidone grade for ASD manufacturing, facilitating improved processing characteristics and best product qualities without the requirement of significant formulation adjustments.
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