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桨法溶出度试验装置中不对称放置片剂的流体动力学模拟(计算流体动力学):对溶出速率和变异性的影响

Hydrodynamic simulation (computational fluid dynamics) of asymmetrically positioned tablets in the paddle dissolution apparatus: impact on dissolution rate and variability.

作者信息

D'Arcy D M, Corrigan O I, Healy A M

机构信息

School of Pharmacy, University of Dublin, Trinity College, Dublin 2, Ireland.

出版信息

J Pharm Pharmacol. 2005 Oct;57(10):1243-50. doi: 10.1211/jpp.57.10.0002.

Abstract

The aim of this work was to investigate the dissolution rate from both the curved and planar surfaces of cylindrical compacts of benzoic acid, which were placed centrally and non-centrally at the base of the vessel of the paddle dissolution apparatus. The effect of fixing the compacts to a particular position on the variability of dissolution results was also examined. In addition, computational fluid dynamics (CFD) was used to simulate fluid flow around compacts in the different positions in the vessel, and the relationship between the local hydrodynamics in the region of the compacts and the dissolution rate determined. The dissolution rate was found to increase from the centre position to the off-centre positions for each surface examined. There was a corresponding increase in maximum fluid velocities calculated from the CFD fluid flow simulations at a fixed distance from the compact. There was less variability in dissolution from compacts fixed to any of the positions compared with those that were not fixed. Fluid flow around compacts in different positions could be successfully modelled, and hydrodynamic variability examined, using CFD. The effect of asymmetric fluid flow was evident visually from the change in shape of the eroded compacts.

摘要

本研究的目的是研究苯甲酸圆柱形压片的曲面和平面的溶出速率,这些压片分别放置在桨法溶出仪容器底部的中心和非中心位置。还考察了将压片固定在特定位置对溶出结果变异性的影响。此外,使用计算流体动力学(CFD)模拟容器中不同位置压片周围的流体流动,并确定压片区域的局部流体动力学与溶出速率之间的关系。在所考察的每个表面上,溶出速率从中心位置到偏心位置均增加。在距压片固定距离处,根据CFD流体流动模拟计算出的最大流体速度相应增加。与未固定的压片相比,固定在任何位置的压片溶出变异性较小。使用CFD可以成功模拟不同位置压片周围的流体流动,并考察流体动力学变异性。从侵蚀压片形状的变化可以直观地看出不对称流体流动的影响。

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