Lou Hao, Hageman Michael J
Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS, 66047, USA.
Biopharmaceutical Innovation and Optimization Center, University of Kansas, Lawrence, KS, 66047, USA.
AAPS PharmSciTech. 2021 Mar 11;22(3):99. doi: 10.1208/s12249-021-01979-y.
The objective of this work was to investigate the influence of tablet location along the bottom of a USP apparatus II vessel on polymer erosion and drug release of surface-erodible sustained-release tablets using computational simulation methods. Computational fluid dynamics (CFD) methods were performed to simulate the velocity distribution. A mathematical model was developed to describe polymer erosion and tablet deformation according to the mass transfer coefficient. Numerical analysis was used to simulate drug release controlled by drug diffusion and polymer erosion. The results indicated that tablets located at the off-center position deformed faster than the tablets located at the center position. However, tablet location had no profound impact on drug release rate since all drug release profiles were "similar" according to the f similarity values which were above 50. Hence, our simulation supported that the USP apparatus II was a reliable and robust device for the dissolution testing of surface-erodible sustained-release tablets.
本研究的目的是使用计算模拟方法，研究美国药典（USP）装置II容器底部片剂位置对表面可蚀性缓释片聚合物侵蚀和药物释放的影响。采用计算流体动力学（CFD）方法模拟速度分布。建立了一个数学模型，根据传质系数描述聚合物侵蚀和片剂变形。采用数值分析方法模拟药物扩散和聚合物侵蚀控制的药物释放。结果表明，位于偏心位置的片剂比位于中心位置的片剂变形更快。然而，片剂位置对药物释放速率没有显著影响，因为根据f相似性值（均高于50），所有药物释放曲线“相似”。因此，我们的模拟结果支持USP装置II是一种用于表面可蚀性缓释片溶出度测试的可靠且稳健的装置。
