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In this article, three well-established engineering tools are used to examine hydrodynamics in dissolution testing apparatuses. The application of these tools would provide detailed information about the flow, shear, and homogeneity in dissolution tests. Particle image velocimetry successfully measures two-dimensional cross-sections of the velocity field in an experimental device under both laminar and turbulent conditions. The velocity field is also calculated with computational fluid dynamics (CFD), which can rapidly provide data that is difficult or impossible to obtain experimentally. The occurrence of segregated regions within a USP Apparatus II under mild agitation conditions is revealed by CFD simulations and confirmed by laser-induced fluorescence experiments. The results clearly demonstrate that under current operation settings, the USP Apparatus II operates in a regime where the flow is in incipient turbulence, which is a highly time-dependent condition that might explain possible inconsistencies in dissolution results. It is further demonstrated that proposed changes advocating lower speeds or smaller vessels displace the system toward laminar flow conditions characterized by segregation, compromising the robustness of the test and making it vulnerable to variability with respect to sample location.

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.