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选择几何和操作参数对溶解仪器 2（桨叶仪器）中的流体动力学的影响：基于计算流体动力学模拟的实验设计分析。

Impact of Select Geometric and Operational Parameters on Hydrodynamics in Dissolution Apparatus 2 (Paddle Apparatus): A Design of Experiments Analysis Based on Computational Fluid Dynamics Simulations.

机构信息

US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852-1790, USA.

European Directorate for the Quality of Medicines and Healthcare, 7 Allee Kastner, 67000, Strasbourg, France.

出版信息

Pharm Res. 2022 May;39(5):919-934. doi: 10.1007/s11095-022-03272-4. Epub 2022 May 16.

DOI:10.1007/s11095-022-03272-4
PMID:35578063
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9160126/
Abstract

PURPOSE

A Design of Experiments (DOE) analysis driven by Computational Fluid Dynamics (CFD) simulations was used to evaluate individual and two-factor interaction effects of varying select geometric and operational parameters on the hydrodynamics in dissolution apparatus 2 (paddle apparatus).

METHODS

Simulations were run with meshing controls and solution strategies retained from a mesh-independent validated baseline model. Distance between vessel and impeller bottom surfaces, impeller offset, vessel radius and impeller rotation speed were considered as input parameters. The velocity magnitudes at four locations near the vessel bottom surface were considered as output parameters. Response surfaces and Pareto charts were generated to understand individual and two-factor interaction effects of input parameters on the output parameters.

RESULTS

Impeller offset has a dominating influence of a linear and quadratic nature on the output parameters and affects overall hydrodynamics. Changes to other input parameters have limited influence on velocity magnitudes at locations closest to the vessel axis and on overall hydrodynamics. However, these parameters have important influences of varying degrees on velocity magnitudes at locations away from the vessel axis.

CONCLUSIONS

The hydrodynamics in Apparatus 2 is influenced differently by different parameters and their combinations. Impeller offset has a stronger influence when compared to parameters that do not alter apparatus symmetry.

摘要

目的

通过计算流体动力学（CFD）模拟进行实验设计（DOE）分析，评估在溶解设备 2（桨叶设备）中改变选择的几何和操作参数对流体动力学的个体和双因素相互作用效应。

方法

模拟采用从网格无关验证基准模型保留的网格控制和解决方案策略运行。容器和叶轮底部表面之间的距离、叶轮偏置、容器半径和叶轮转速被视为输入参数。容器底部表面附近四个位置的速度大小被视为输出参数。生成响应曲面和 Pareto 图，以了解输入参数对输出参数的个体和双因素相互作用效应。

结果

叶轮偏置对输出参数具有线性和二次的主导影响，并影响整体流体动力学。其他输入参数的变化对最接近容器轴的位置处的速度大小和整体流体动力学影响有限。然而，这些参数对远离容器轴的位置处的速度大小具有不同程度的重要影响。

结论

设备 2 中的流体动力学受到不同参数及其组合的不同影响。与不改变设备对称性的参数相比，叶轮偏置的影响更大。

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