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Model-based analysis of a twin-screw wet granulation system for continuous solid dosage manufacturing

机译:基于模型的双螺杆湿法制粒系统的连续固体制剂制造分析

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摘要

Implementation of twin-screw granulation in a continuous from-powder-to-tablet manufacturing line requires process knowledge development. This is often pursued by application of mechanistic models incorporating the underlying mechanisms. In this study, granulation mechanisms considered to be dominant in the kneading element regions of the granulator i.e., aggregation and breakage, were included in a one-dimensional population balance model. The model was calibrated using the experimentally determined inflow granule size distribution, and the mean residence time was used as additional input to predict the outflow granule size distribution. After wetting, the first kneading block caused an increase in the aggregation rate which was reduced afterwards. The opposite was observed in case of the breakage rate. The successive kneading blocks lead to a granulation regime separation inside the granulator under certain process conditions. Such a physical separation between the granulation regimes is promising for future design and advanced control of the continuous granulation process. (C) 2016 Elsevier Ltd. All rights reserved.
机译:在从粉末到片剂的连续生产线上实施双螺杆制粒需要过程知识的发展。这通常是通过应用包含潜在机制的机械模型来追求的。在本研究中,一维种群平衡模型包括被认为在制粒机的揉合元素区域占主导地位的制粒机制,即聚集和破碎。使用实验确定的流入颗粒尺寸分布对模型进行校准,并将平均停留时间用作预测流出颗粒尺寸分布的额外输入。润湿后,第一个捏合块导致聚集速率增加,随后降低。在破损率的情况下观察到相反的情况。在某些工艺条件下,连续的捏合块导致造粒机内部的造粒区域分离。制粒方案之间的这种物理分离有望用于未来设计和对连续制粒工艺的高级控制。 (C)2016 Elsevier Ltd.保留所有权利。

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