Using Computational Fluid Dynamics to Compare Shear Rate and Turbulence in the TIM-Automated Gastric Compartment With USP Apparatus II
Using Computational Fluid Dynamics to Compare Shear Rate and Turbulence in the TIM-Automated Gastric Compartment With USP Apparatus II
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DOI：
10.1016/j.xphs.2018.03.019
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发表时间：
2018-07-01
影响因子：
3.8
通讯作者：
Barker, Richard
中科院分区：
文献类型：
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作者：
Hopgood, Matthew;Reynolds, Gavin;Barker, Richard
我们使用计算流体力学来比较一个先进的体外胃模型(TIMagc)在模拟空腹状态移行运动复合体I和II时的切变率和湍流，并与美国药典Paddle溶出仪II(USPII)进行比较。一个具体的重点放在这些装置中的剪切率如何影响以侵蚀为基础的固体口腔制剂。研究发现，TIMAGC的片剂表面剪切率与时间有很强的相关性，在0.001-360%S(-1)之间波动。在USPII中，在给定的划桨速度下，片剂的表面切变率几乎是恒定的，并且随着划桨速度从25rpm增加到100rpm，片剂表面切变率从9 S(-1)线性增加到36 S(-1)。在USPII中，片剂表面剪切速率与片剂侵蚀速率之间存在很强的线性关系，而TIMagc则表现出高度可变的行为。利用雷诺数分析，将每个装置中存在的流型与活体预测进行了比较。TIMagc中流动的雷诺数主要在体内预测的范围内(0.01-30)，而USPII中流动的雷诺数在桨速度低至25rpm时高于预测的上限(33)。(C)2018年美国药剂师协会(R)。爱思唯尔公司出版，版权所有。
We use computational fluid dynamics to compare the shear rate and turbulence in an advanced in vitro gastric model (TIMagc) during its simulation of fasted state Migrating Motor Complex phases I and II, with the United States Pharmacopeia paddle dissolution apparatus II (USPII). A specific focus is placed on how shear rate in these apparatus affects erosion-based solid oral dosage forms. The study finds that tablet surface shear rates in TIMagc are strongly time dependant and fluctuate between 0.001 and 360 s(-1). In USPII, tablet surface shear rates are approximately constant for a given paddle speed and increase linearly from 9 s(-1) to 36 s(-1) as the paddle speed is increased from 25 to 100 rpm. A strong linear relationship is observed between tablet surface shear rate and tablet erosion rate in USPII, whereas TIMagc shows highly variable behavior. The flow regimes present in each apparatus are compared to in vivo predictions using Reynolds number analysis. Reynolds numbers for flow in TIMagc lie predominantly within the predicted in vivo bounds (0.01-30), whereas Reynolds numbers for flow in USPII lie above the predicted upper bound when operating with paddle speeds as low as 25 rpm (33). (C) 2018 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.