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Importance of Mesoporous Silica Particle Size in the Stabilization of Amorphous Pharmaceuticals-The Case of Simvastatin
Authors: Knapik-Kowalczuk Justyna | Kramarczyk Daniel | Chmiel Krzysztof | Romanová Jana | Kawakami Kohsaku | Paluch Marian
Year: 2020
Type of publication: článek v odborném periodiku
Name of source: Pharmaceutics
Publisher name: MDPI
Place: BASEL
Page from-to: "384-1"-"384-21"
Titles:
Language Name Abstract Keywords
cze Důležitost velikosti částic mezoporézní siliky pro stabilizaci amorfních léčiv - Případ Simvastatin Práce studuje roli mezoporézní siliky pro stabilizaci amorfního léčiva Simvastatin. Inhibice rekrystalizace je sledována metodami DSC a BDS. simvastatin; amorfní léčiva; mezoporézní silika; stabilizace; rekrystalizace
eng Importance of Mesoporous Silica Particle Size in the Stabilization of Amorphous Pharmaceuticals-The Case of Simvastatin In this paper, the role of mesoporous silica (MS) particle size in the stabilization of amorphous simvastatin (SVT) is revealed. For inhibiting recrystallization of the supercooled drug, the two MS materials (Syloid((R)) XDP 3050 and Syloid((R)) 244 FP) were employed. The crystallization tendency of SVT alone and in mixture with the MS materials was investigated by Differential Scanning Calorimetry (DSC) and Broadband Dielectric Spectroscopy (BDS). Neither confinement of the SVT molecules inside the MS pores nor molecular interactions between functional groups of the SVT molecules and the surface of the stabilizing excipient could explain the observed stabilization effect. The stabilization effect might be correlated with diffusion length of the SVT molecules in the MS materials that depended on the particle size. Moreover, MS materials possessing different particle sizes could offer free spaces with different sizes, which might influence crystal growth of SVT. All of these factors must be considered when mesoporous materials are used for stabilizing pharmaceutical glasses. simvastatin; amorphous pharmaceuticals; mesoporous silica; stabilization; recrystallization

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