Shear-induced variability in the United States Pharmacopeia apparatus 2: Modifications to the existing system
Shear-induced variability in the United States Pharmacopeia apparatus 2: Modifications to the existing system
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DOI：
10.1208/aapsj070483
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发表时间：
2005-01-01
期刊：
影响因子：
4.5
通讯作者：
Muzzio, FJ
中科院分区：
文献类型：
--
作者：
Baxter, JL;Kukura, J;Muzzio, FJ
美国药典装置2中的流体动力学已被证明是高度不均匀的，可能会在溶出速率测量中产生显著的变化。通过使用现成的工程工具，在本研究中评价了器械的几种几何改良。具体而言，我们研究了叶轮间隙、搅拌器类型（径向和轴向）和容器几何形状（PEAK容器）对流体流动特性的影响及其与测得溶出速率的关系。观察到增加叶轮间隙会加剧剪切不均匀性，并可能导致溶出度测量值的变异性更大。改变叶轮类型会导致流体动力学行为发生变化;然而，试验的总体性能和问题保持不变。观察到使用PEAK容器可降低检测期间片剂最有可能进入的区域的剪切异质性;然而，较高的剪切速率可能导致无法区分溶出速率的真实差异。
The hydrodynamics within the United States Pharmacopeia Apparatus 2 have been shown to be highly non-uniform with a potential to yield substantial variability in dissolution rate measurements. Through the use of readily available engineering tools, several geometric modifications to the device were evaluated in this study. Specifically, we examined the influence of impeller clearance, agitator type ( radial and axial), and vessel geometry ( PEAK vessel) on the fluid flow properties and their relation to measured dissolution rates. Increasing the impeller clearance was observed to exacerbate the heterogeneity in shear and would likely result in greater variability in dissolution measurements. Altering the impeller type was shown to yield changes in the hydrodynamic behavior; however, the overall properties and problems with the test remain the same. Use of the PEAK vessel was observed to reduce shear heterogeneity in the regions where tablets are most likely to visit during testing; however, higher shear rates may result in the inability to discriminate between true differences in dissolution rates.