4.4 Article

Investigating the Influence of Tablet Location Inside Dissolution Test Apparatus on Polymer Erosion and Drug Release of a Surface-Erodible Sustained-Release Tablet Using Computational Simulation Methods

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AAPS PHARMSCITECH
卷 22, 期 3, 页码 -

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SPRINGER
DOI: 10.1208/s12249-021-01979-y

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tablet dissolution testing; surface erosion; sustained release; computational fluid dynamics; USP apparatus II; computational simulation

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Computational fluid dynamics methods were used to investigate the influence of tablet location on polymer erosion and drug release of surface-erodible sustained-release tablets. The results showed that tablet deformation was faster at off-center positions, but had minimal impact on drug release rate, indicating the reliability of the USP apparatus II for dissolution testing of such tablets.
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(2) 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.

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