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首页> 外文期刊>International Journal of Pharmaceutics >Statistical analysis and comparison of a continuous high shear granulator with a twin screw granulator: Effect of process parameters on critical granule attributes and granulation mechanisms
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Statistical analysis and comparison of a continuous high shear granulator with a twin screw granulator: Effect of process parameters on critical granule attributes and granulation mechanisms

机译：用双螺杆造粒机连续高剪切造粒机的统计分析及比较：工艺参数对临界颗粒属性和造粒机制的影响

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摘要

This study is concerned with identifying the design space of two different continuous granulators and their respective granulation mechanisms. Performance of a continuous high shear granulator and a twin screw granulator with paracetamol formulations were examined by face-centered cubic design, which focused on investigating key performance metrics, namely, granule size, porosity, flowability and particle morphology of granules as a function of essential input process parameters (liquid content, throughput and rotation speed). Liquid and residence time distribution tests were also performed to gain insights into the liquid-powder mixing and flow behavior. The results indicated that continuous high shear granulation was more sensitive to process variation and produced spherical granules with monomodal size distribution and distinct internal structure and strength variation. Twin screw granulation with such a particular screw configuration showed narrower design space and granules were featured with multimodal size distribution, irregular shape, less detectible porosity difference and tighter range of strength. Granulation mechanisms explored on the basis of nucleation and growth regime maps revealed that for most cases liquid binder was uniformly distributed with fast droplet penetration into the powder bed and that granule consolidation and coalescence mainly took place in the nucleation, steady growth and rapid growth regimes. (C) 2016 Elsevier B. V. All rights reserved.
机译：本研究涉及识别两种不同连续造粒机的设计空间及其各自的造粒机制。通过面向中心的立方体设计检查连续高剪切造粒机和双螺杆造粒机的性能，其集中于研究关键性能度量，即颗粒尺寸，颗粒尺寸，孔隙率，流动性和颗粒形貌，作为颗粒的函数输入过程参数（液体内容，吞吐量和旋转速度）。还进行液体和停留时间分布试验以获得液体粉末混合和流动性的见解。结果表明，连续的高剪切造粒对工艺变化更敏感，并产生具有单兆尺寸分布和不同的内部结构和强度变化的球形颗粒。具有这种特定螺杆配置的双螺杆颗粒显示出较窄的设计空间和颗粒，具有多模式尺寸分布，不规则的形状，可检测的孔隙率差和更严格的强度。基于成核和生长制度图探索的造粒机制显示，对于大多数情况而言，对于大多数情况，液体粘合剂均匀地分布在粉末床中，颗粒固结和聚结主要发生在成核，稳定的生长和快速增长中。 （c）2016年Elsevier B. V.保留所有权利。

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