Characterization and performance assessment of solid dispersions prepared by hot melt extrusion and spray drying process
Characterization and performance assessment of solid dispersions prepared by hot melt extrusion and spray drying process
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DOI：
10.1016/j.ijpharm.2013.08.081
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发表时间：
2013-11-30
影响因子：
5.8
通讯作者：
Raikes, Michelle S.
中科院分区：
文献类型：
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作者：
Agrawal, Anjali M.;Dudhedia, Mayur S.;Raikes, Michelle S.
本研究考察了热熔挤出（HME）和喷雾干燥（SD）等生产方法对固体分散体的理化性质、可生产性、物理稳定性和产品性能的影响。当通过SD和HME方法制备时，化合物X和PVP VA 64（1：2）的固体分散体通过偏光显微镜、粉末X射线衍射法和具有单一玻璃化转变温度的调制差示扫描量热法分析是无定形的。傅里叶变换红外（FT-IR）和拉曼光谱分析揭示了化合物X和PVP VA 64之间类似的分子水平相互作用，如通过SD和HME固体分散体中的重叠FT-IR和FT拉曼光谱所证明的。通过两种加工技术制备的固体分散体的可压实性、可压片性、崩解和溶出性能相似。在SD和HME固体分散体之间观察到材料性质如表面积、形态结构、粉末密度和流动特性的差异。在加速稳定性条件下，SD固体分散体的物理稳定性低于HME固体分散体。本研究的结果表明，如果通过两种不同技术加工的固体分散体的分子性质相似，则可以获得相似的产品性能。然而，材料性质的差异可能影响固体分散体的物理稳定性。由爱思唯尔公司出版
The present study investigated effect of manufacturing methods such as hot melt extrusion (HME) and spray drying (SD) on physicochemical properties, manufacturability, physical stability and product performance of solid dispersion. Solid dispersions of compound X and PVP VA64 (1:2) when prepared by SD and HME process were amorphous by polarized light microscopy, powder X-ray diffractometry, and modulated differential scanning calorimetry analyses with a single glass transition temperature. Fourier transform infrared (FT-IR) and Raman spectroscopic analyses revealed similar molecular level interactions between compound X and PVP VA64 as evident by overlapping FT-IR and FT Raman spectra in SD and HME solid dispersions. The compactibility, tabletability, disintegration and dissolution performance were similar for solid dispersions prepared by both processing techniques. Differences in material properties such as surface area, morphological structure, powder densities, and flow characteristics were observed between SD and HME solid dispersion. The SD solid dispersion was physically less stable compared to HME solid dispersion under accelerated stability conditions. Findings from this study suggest that similar product performance could be obtained if the molecular properties of the solid dispersion processed by two different techniques are similar. However differences in material properties might affect the physical stability of the solid dispersions. Published by Elsevier B.V.