Engineering tools for understanding the hydrodynamics of dissolution tests.

Abstract

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.