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Pharmaceuticals 2019, 12(1), 40; https://doi.org/10.3390/ph12010040

Physical Stability and Viscoelastic Properties of Co-Amorphous Ezetimibe/Simvastatin System

1
Institute of Physics, University of Silesia, SMCEBI, 75 Pułku Piechoty 1a, 41-500 Chorzów, Poland
2
Univ Lille, CNRS, UMR 8207, UMET, Unité Matériaux et Transformations, F59000 Villeneuve d’Ascq, France
3
Department of Physical Chemistry, Medical University of Gdansk, 84-416 Gdansk, Poland
*
Author to whom correspondence should be addressed.
Received: 5 March 2019 / Revised: 14 March 2019 / Accepted: 16 March 2019 / Published: 19 March 2019
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Abstract

The purpose of this paper is to examine the physical stability as well as viscoelastic properties of the binary amorphous ezetimibe–simvastatin system. According to our knowledge, this is the first time that such an amorphous composition is prepared and investigated. The tendency toward re-crystallization of the amorphous ezetimibe–simvastatin system, at both standard storage and elevated temperature conditions, have been studied by means of X-ray diffraction (XRD). Our investigations have revealed that simvastatin remarkably improves the physical stability of ezetimibe, despite the fact that it works as a plasticizer. Pure amorphous ezetimibe, when stored at room temperature, begins to re-crystallize after 14 days after amorphization. On the other hand, the ezetimibe-simvastatin binary mixture (at the same storage conditions) is physically stable for at least 1 year. However, the devitrification of the binary amorphous composition was observed at elevated temperature conditions (T = 373 K). Therefore, we used a third compound to hinder the re-crystallization. Finally, both the physical stability as well as viscoelastic properties of the ternary systems containing different concentrations of the latter component have been thoroughly investigated. View Full-Text
Keywords: ezetimibe; simvastatin; co-amorphous; melt viscosity; solubility enhancement ezetimibe; simvastatin; co-amorphous; melt viscosity; solubility enhancement
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).
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Knapik-Kowalczuk, J.; Chmiel, K.; Jurkiewicz, K.; Correia, N.T.; Sawicki, W.; Paluch, M. Physical Stability and Viscoelastic Properties of Co-Amorphous Ezetimibe/Simvastatin System. Pharmaceuticals 2019, 12, 40.

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