Experimental and computational determination of the hydrodynamics of mini vessel dissolution testing systems.

Mini vessel dissolution testing systems consist of a small-scale 100-mL vessel with a small paddle impeller, similar to the USP Apparatus 2, and are typically utilized when only small amounts of drug product are available during drug development. Despite their common industrial use, mini vessels have received little attention in the literature. Here, Computational Fluid Dynamics (CFD) was used to predict velocity profiles, flow patterns, and strain rate distribution in a mini vessel at different agitation speeds. These results were compared with experimental velocity measurements obtained with Particle Image Velocimetry (PIV). Substantial agreement was observed between CFD results and PIV data. The flow is strongly dominated by the tangential velocity component. Secondary flows consist of vertical upper and lower recirculation loops above and below the impeller. A low recirculation zone was observed in the lower part of the vessel. The radial and axial velocities in the region just below the impeller are very small especially in the innermost core zone below the paddle, where tablet dissolution occurs. Increasing agitation speed reduces the radius of this zone, which is always present at any speed, and only modestly increases the tangential flow intensity, with significant implication for dissolution testing in mini vessels.