Investigation of the Influence of Copovidone Properties and Hot-Melt Extrusion Process on Level of Impurities, In Vitro Release, and Stability of an Amorphous Solid Dispersion Product-Reference-Cited by-同舟云学术

Investigation of the Influence of Copovidone Properties and Hot-Melt Extrusion Process on Level of Impurities, In Vitro Release, and Stability of an Amorphous Solid Dispersion Product

Published:2024-09-12 Issue: Volume: Page:
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Saraf Isha¹,Jakasanovski Ognen²³,Stanić Tijana³,Kralj Eva³,Petek Boštjan³,Williams Jason D.⁴⁵,Dmytro Neshchadin⁶^ORCID,Georg Gescheidt⁶,Bernd Werner⁷,Klaus Zangger⁷^ORCID,Perhavec Petra³,German Ilić Ilija²^ORCID,Paudel Amrit¹⁸^ORCID,Kushwah Varun¹^ORCID

Affiliation:

1. Research Center Pharmaceutical Engineering (RCPE) GmbH, Inffeldgasse 13, 8010 Graz, Austria

2. Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, 1000 Ljubljana, Slovenia

3. Product Development, Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia

4. Institute of Chemistry, University of Graz, NAWI Graz, Heinrichstrasse 28, 8010 Graz, Austria

5. Center for Continuous Flow Synthesis and Processing (CCFLOW), Research Center Pharmaceutical Engineering GmbH (RCPE), Inffeldgasse 13, 8010 Graz, Austria

6. Institute of Physical and Theoretical Chemistry, Graz University of Technology, Stremayrgasse 9, 8010 Graz, Austria

7. Institute of Chemistry, University of Graz, Heinrichstr. 28, 8010 Graz, Austria

8. Institute of Process and Particle Engineering, Graz University of Technology, 8010 Graz, Austria

Funder

Lek Pharmaceuticals, Sandoz

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.4c00707

Reference33 articles.

1. Drug-like properties and the causes of poor solubility and poor permeability

2. Drug Solubility: Importance and Enhancement Techniques

3. An investigation of the inter-molecular interaction, solid-state properties and dissolution properties of mixed copovidone hot-melt extruded solid dispersions

4. Theoretical evaluation of supersaturation of amorphous solid dispersion formulations with different drug/polymer combinations using mathematical modeling

5. A systematic and robust assessment of hot-melt extrusion-based amorphous solid dispersions: Theoretical prediction to practical implementation