Otto H. York Department of Chemical, Biological and Pharmaceutical Engineering, New Jersey Institute of Technology, Newark, NJ 07102, USA.
Int J Pharm. 2011 Jan 17;403(1-2):1-14. doi: 10.1016/j.ijpharm.2010.09.022. Epub 2010 Sep 29.
The fluid velocity profiles at different locations inside a standard USP Dissolution Testing Apparatus 2 were experimentally obtained via Laser Doppler Velocimetry (LDV) at three impeller agitations speeds, namely 50rpm, 75rpm and 100rpm. The experimental results were compared with the predictions obtained with Computational Fluid Dynamics (CFD) where the κ-ω model with low Reynolds number correction was used to account for turbulence effects. In general, good agreement was found between the experimental LDV velocity measurements and the CFD simulation predictions. The non-dimensional tangential, axial and radial velocity profiles (scaled with the impeller tip speed) and the flow pattern were found to be nearly independent of the agitation speed in most regions of the vessel, implying that increasing the agitation speed generally produced a corresponding increase in the local values of the velocity. However, the velocity profiles and flow pattern in the inner core region just below the impeller, where the dissolving tablet is usually located, were found to be much less sensitive to agitation speed. In this region, the axial and radial velocities were especially low and were not significantly affected by agitation increases. This inner core region at the center of the vessel bottom persisted irrespective of agitation intensity. The CFD predictions also indicated that increasing the agitation speed resulted in a higher shear strain rate distribution along the vessel bottom, although the strain rate was always very low at the center of the vessel bottom, even when the agitation speed was increased.
通过在三个搅拌速度(即 50rpm、75rpm 和 100rpm)下使用激光多普勒测速仪(LDV),在标准 USP 溶解测试设备 2 内部的不同位置获得了流体速度分布。将实验结果与使用计算流体动力学(CFD)获得的预测结果进行了比较,其中κ-ω模型与低雷诺数修正一起用于考虑湍流效应。通常,实验 LDV 速度测量值与 CFD 模拟预测值之间存在良好的一致性。在容器的大多数区域,无量纲切向、轴向和径向速度分布(以叶轮尖端速度为单位)和流动模式几乎与搅拌速度无关,这意味着增加搅拌速度通常会导致局部速度值相应增加。然而,在叶轮下方的溶解片剂通常所在的内芯区域的速度分布和流动模式对搅拌速度的敏感性要低得多。在该区域,轴向和径向速度特别低,并且不受搅拌增加的显著影响。无论搅拌强度如何,容器底部中心的这个内芯区域都持续存在。CFD 预测还表明,增加搅拌速度会导致沿容器底部的剪切应变速率分布更高,尽管即使增加搅拌速度,容器底部中心的应变速率也始终非常低。