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Effect of Impeller Design on Homogeneity, Size and Strength of Pharmaceutical Granules produced by High Shear Wet Granulation

机译:叶轮设计对高剪切湿法制粒药物颗粒均质性,尺寸和强度的影响

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摘要

Small mixer impeller design is not tailored for granulation because impellers are intended for a wide range of processes. The aim of this research was to evaluate the performances of several impellers to provide guidance on the selection and design for the purposes of granulation. Lactose granules were produced using wet granulation with water as a binder. A Kenwood KM070 mixer was used as a standard apparatus and five impeller designs with different shapes and surface areas were used. The efficacy of granulate formation was measured by adding an optically sensitive tracer to determine variations in active ingredient content across random samples of granules from the same size classes. It was found that impeller design influenced the homogeneity of the granules and therefore can affect final product performance. The variation in active ingredient content across granules of differing size was also investigated. The results show that small granules were more potent than larger granules.
机译:小型搅拌机叶轮设计不适用于造粒,因为叶轮适用于多种工艺。这项研究的目的是评估几种叶轮的性能,以为造粒目的选择和设计提供指导。使用以水为粘合剂的湿法制粒生产乳糖颗粒。使用Kenwood KM070混合机作为标准设备,并使用了五个具有不同形状和表面积的叶轮设计。通过添加光敏示踪剂来测定颗粒形成的功效,以确定来自相同尺寸类别的随机颗粒样品中活性成分含量的变化。发现叶轮设计影响了颗粒的均质性,因此可以影响最终产品的性能。还研究了不同大小颗粒之间活性成分含量的变化。结果表明,小颗粒比大颗粒更有效。

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