Characterization of different copovidone grades as carrier materials in hot melt extrusion of amorphous solid dispersions
| dc.contributor.author | Daalmann, Marvin | |
| dc.contributor.author | Kimmel, Vincent | |
| dc.contributor.author | Muehlenfeld, Christian | |
| dc.contributor.author | Thommes, Markus | |
| dc.contributor.author | Winck, Judith | |
| dc.date.accessioned | 2025-09-26T10:19:05Z | |
| dc.date.available | 2025-09-26T10:19:05Z | |
| dc.date.issued | 2025-08-30 | |
| dc.description.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. | en |
| dc.identifier.uri | http://hdl.handle.net/2003/44007 | |
| dc.language.iso | en | |
| dc.relation.ispartofseries | Pharmaceutics; 17(9) | |
| dc.rights.uri | https://creativecommons.org/licenses/by/4.0/ | |
| dc.subject | Copovidone | en |
| dc.subject | Extrusion | en |
| dc.subject | Solid dispersion | en |
| dc.subject | Solubility | en |
| dc.subject | Degradation | en |
| dc.subject.ddc | 660 | |
| dc.title | Characterization of different copovidone grades as carrier materials in hot melt extrusion of amorphous solid dispersions | en |
| dc.type | Text | |
| dc.type.publicationtype | Article | |
| dcterms.accessRights | open access | |
| eldorado.dnb.deposit | true | |
| eldorado.doi.register | false | |
| eldorado.secondarypublication | true | |
| eldorado.secondarypublication.primarycitation | Daalmann, M., Kimmel, V., Muehlenfeld, C., Thommes, M., & Winck, J. (2025). Characterization of different copovidone grades as carrier materials in hot melt extrusion of amorphous solid dispersions. Pharmaceutics, 17(9), Article 1138. https://doi.org/10.3390/pharmaceutics17091138 | |
| eldorado.secondarypublication.primaryidentifier | https://doi.org/10.3390/pharmaceutics17091138 |