On the mechanism of colloidal silica action to improve flow properties of pharmaceutical excipients

On the mechanism of colloidal silica action to improve flow properties of pharmaceutical excipients
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DOI:
10.1016/j.ijpharm.2018.11.066
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发表时间:
2019-02-10
影响因子:
5.8
通讯作者:
Zamostny, Petr
Zamostny, Petr
中科院分区:
医学2区
文献类型:
--
作者:
Diem Trang Tran;Majerova, Diana;Zamostny, Petr

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已知胶态二氧化硅改善药物粉末流动性能的作用机理是基于粘附于颗粒表面的二氧化硅颗粒的颗粒间力破坏。在本文中,动力学方面的这种行动进行了调查,侧重于非球形颗粒的不同尺寸。使用粉末流变仪检查包含微晶纤维素或磷酸氢钙二水合物和胶态二氧化硅的共混物。配制共混物以代表粒度、表面纹理、胶态二氧化硅负载和混合时间的影响。使用预处理、剪切试验、压缩性和流动能量测量来监测流动特性。组分和共混物进行了分析,使用粒度分析和扫描电子显微镜(SEM),使用能量色散谱(EDS)和背散射电子(BSE)检测,以确定表面颗粒排列。所有研究的参数被发现有实质性的影响粉末共混物的流动性能。这些影响的解释,通过确定关键步骤的胶态二氧化硅的行动,这被发现在实质上不同的速度进行,导致流动性能随时间的变化取决于共混物配方和组件的性能。
The mechanism of colloidal silica action to improve flow properties of pharmaceutical powders is known to be based on inter-particle force disruption by silica particles adhered to the particle surface. In the present article, the kinetic aspects of this action are investigated, focusing on non-spherical particles of different size. Blends comprising microcrystalline cellulose or calcium hydrogen phosphate dihydrate and colloidal silica were examined using powder rheometer. The blends were formulated to represent effects of particle size, surface texture, colloidal silica loading, and mixing time. Pre-conditioning, shear testing, compressibility, and flow energy measurements were used to monitor flow properties. Components and blends were analyzed using particle size analysis and scanning electron microscopy (SEM), using energy dispersive spectroscopy (EDS) and back-scattered electron (BSE) detection to determine surface particle arrangement. All studied parameters were found to have substantial effects on flow properties of powder blends. Those effects were explained by identifying key steps of colloidal silica action, which were found to proceed at substantially different rates, causing the flow properties change over time being dependent on the blend formulation and the component properties.