| Shearing of the tablet surface and mixing of tablet fragments show great variability in the USP II, and fluctuations in the flow within the USP II vessel leave the test vulnerable to high hydrodynamics variability within the small geometry. Using FLUENT (a computational fluid dynamics program) and experimental methods, mixing of the fluid, surface shear on the tablet, and drug release were studied in the TIM-1 system (an in vitro GI tract model used for tablet dissolution that closely simulates the physiological processes in the stomach and small intestines). Comparing fluid (from computational models) and drug release profiles from the TIM-1 system and the USP II, a correlation between TIM-1 (nearly in vivo) and USP II hydrodynamic behavior and drug release can be achieved. In verifying/nullifying a correlation between the profiles, properties and problems with the USP II testing method are evaluated. |