Hydrodynamics-induced variability in the USP apparatus II dissolution test

摘要: The USP tablet dissolution test is an analytical tool used for the verification of drug release processes and formulation selection within pharmaceutical industry. Given strong impact this test, it surprising that operating conditions testing devices have been selected empirically. In fact, flow phenomena in received little attention past. An examination hydrodynamics apparatus II shows device highly vulnerable to mixing problems can affect performance consistency. Experimental computational techniques reveal field not uniform, results vary dramatically with position vessel. Specifically, computations predict sharp variations shear along bottom vessel where most likely settle. Experiments which location was carefully controlled variation measured rate.