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Pharmaceutics
Volume 16
Issue 8
10.3390/pharmaceutics16081071
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Article

Impact of Hot-Melt Extrusion on Glibenclamide’s Physical and Chemical States and Dissolution Behavior: Case Studies with Three Polymer Blend Matrices

by
Nina Zupan
1,2,
Ines Yous
1,
Florence Danede
2,
Jeremy Verin
1,
Mostafa Kouach
3,
Catherine Foulon
3,
Emeline Dudognon
2 and
Susanne Florin Muschert
1,*
1
Univ. Lille, Inserm, CHU Lille, U1008, F-59000 Lille, France
2
Univ. Lille, CNRS, INRAE, Centrale Lille, UMR 8207-UMET, F-59000 Lille, France
3
Univ. Lille, CHU Lille, ULR 7365-GRITA, F-59000 Lille, France
*
Author to whom correspondence should be addressed.
Pharmaceutics 2024, 16(8), 1071; https://doi.org/10.3390/pharmaceutics16081071
Submission received: 16 July 2024 / Revised: 3 August 2024 / Accepted: 13 August 2024 / Published: 15 August 2024
(This article belongs to the Section Pharmaceutical Technology, Manufacturing and Devices)
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Abstract

This research work dives into the complexity of hot-melt extrusion (HME) and its influence on drug stability, focusing on solid dispersions containing 30% of glibenclamide and three 50:50 polymer blends. The polymers used in the study are Ethocel Standard 10 Premium, Kollidon SR and Affinisol HPMC HME 4M. Glibenclamide solid dispersions are characterized using thermal analyses (thermogravimetric analysis (TGA) and differential scanning calorimetry), X-ray diffraction and scanning electron microscopy. This study reveals the transformation of glibenclamide into impurity A during the HME process using mass spectrometry and TGA. Thus, it enables the quantification of the extent of degradation. Furthermore, this work shows how polymer–polymer blend matrices exert an impact on process parameters, the active pharmaceutical ingredient’s physical state, and drug release behavior. In vitro dissolution studies show that the polymeric matrices investigated provide extended drug release (over 24 h), mainly dictated by the polymer’s chemical nature. This paper highlights how glibenclamide is degraded during HME and how polymer selection crucially affects the sustained release dynamics.
Keywords: hot-melt extrusion; solid dispersion; ternary blends; degradation; glibenclamide; sustained drug release hot-melt extrusion; solid dispersion; ternary blends; degradation; glibenclamide; sustained drug release

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MDPI and ACS Style

Zupan, N.; Yous, I.; Danede, F.; Verin, J.; Kouach, M.; Foulon, C.; Dudognon, E.; Florin Muschert, S. Impact of Hot-Melt Extrusion on Glibenclamide’s Physical and Chemical States and Dissolution Behavior: Case Studies with Three Polymer Blend Matrices. Pharmaceutics 2024, 16, 1071. https://doi.org/10.3390/pharmaceutics16081071

AMA Style

Zupan N, Yous I, Danede F, Verin J, Kouach M, Foulon C, Dudognon E, Florin Muschert S. Impact of Hot-Melt Extrusion on Glibenclamide’s Physical and Chemical States and Dissolution Behavior: Case Studies with Three Polymer Blend Matrices. Pharmaceutics. 2024; 16(8):1071. https://doi.org/10.3390/pharmaceutics16081071

Chicago/Turabian Style

Zupan, Nina, Ines Yous, Florence Danede, Jeremy Verin, Mostafa Kouach, Catherine Foulon, Emeline Dudognon, and Susanne Florin Muschert. 2024. "Impact of Hot-Melt Extrusion on Glibenclamide’s Physical and Chemical States and Dissolution Behavior: Case Studies with Three Polymer Blend Matrices" Pharmaceutics 16, no. 8: 1071. https://doi.org/10.3390/pharmaceutics16081071

APA Style

Zupan, N., Yous, I., Danede, F., Verin, J., Kouach, M., Foulon, C., Dudognon, E., & Florin Muschert, S. (2024). Impact of Hot-Melt Extrusion on Glibenclamide’s Physical and Chemical States and Dissolution Behavior: Case Studies with Three Polymer Blend Matrices. Pharmaceutics, 16(8), 1071. https://doi.org/10.3390/pharmaceutics16081071

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