Hydrodynamics-induced variability in the USP apparatus II dissolution test
Hydrodynamics-induced variability in the USP apparatus II dissolution test
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DOI：
10.1016/j.ijpharm.2004.08.003
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发表时间：
2005-03-23
影响因子：
5.8
通讯作者：
Muzzio, FJ
中科院分区：
文献类型：
--
作者：
Baxter, JL;Kukura, J;Muzzio, FJ
USP片剂溶出度试验是一种分析工具，用于在制药行业内验证药物释放过程和处方选择。考虑到这次测试的强大影响，运行条件和测试设备的选择都是凭经验进行的，这令人惊讶。事实上，USP测试中的流动现象在过去很少受到关注。对USP装置II中的流体动力学的检查表明，该装置极易受到混合问题的影响，这些问题可能会影响测试性能和一致性。实验和计算技术表明，装置内的流场并不均匀，溶出结果可能会随着药片在容器中的位置而变化很大。具体地说，计算预测沿容器底部的剪切力急剧变化，那里是药片最有可能下沉的地方。仔细控制片剂位置的实验表明，测试装置内剪切的变化会影响测量的溶出度。(C)2004年，爱思唯尔出版。
The USP tablet dissolution test is an analytical tool used for the verification of drug release processes and formulation selection within the pharmaceutical industry. Given the strong impact of this test, it is surprising that operating conditions and testing devices have been selected empirically. In fact, the flow phenomena in the USP test have received little attention in the past. An examination of the hydrodynamics in the USP apparatus II shows that the device is highly vulnerable to mixing problems that can affect testing performance and consistency. Experimental and computational techniques reveal that the flow field within the device is not uniform, and dissolution results can vary dramatically with the position of the tablet within the vessel. Specifically, computations predict sharp variations in the shear along the bottom of the vessel where the tablet is most likely to settle. Experiments in which the tablet location was carefully controlled reveal that the variation of shear within the testing device can affect the measured dissolution rate. (c) 2004 Published by Elsevier B.V.