Systematic Error Associated with Apparatus 2 of the USP Dissolution Test I: Effects of Physical Alignment of the Dissolution Apparatus

Velocity Distribution and Shear Rate Variability Resulting from Changes in the Impeller Location in the USP Dissolution Testing Apparatus II

“…Even when USP calibrator tablets are used, errors and inconsistencies have been reported (4,6,9,14,15). Many of these same studies indicate that the system hydrodynamics could play a key role in the variability and the poor reproducibility of the testing results.…”

“…Although this apparatus has been in use since the USP first officially introduced it some 30 years ago (2) and despite the fact that it still is the most widely used dissolution testing apparatus in the pharmaceutical industry today, concerns remains about the apparatus susceptibility to significant error and test failures, as indicated by many literature reports (3)(4)(5)(6)(7)(8)(9)(10).…”

Hydrodynamic Investigation of USP Dissolution Test Apparatus II

“…A review of the literature shows that there have been numerous reports describing high variability of test results, [4][5][6][7][8][9][10][11] even when the so called ''calibrator tablets'' (i.e., tablets manufactured for the sole purpose of testing the proper operation of the dissolution test equipment) are used. 5,7,10,12,13 Failures linked to dissolution testing resulted in 47 product recalls during the period 2000-2002, representing 16% of non-manufacturing recalls for oral solid dosage forms. [14][15][16] Irrespective of the underlying causes (such as incorrect use of the equipment or deviation of dissolution profile from the standard caused by incorrect tablet formulation) failed dissolution tests can result in product recalls, costly investigations, potential production delays, which, in turn, can have a significantly negative financial impact.…”

Hydrodynamic, mass transfer, and dissolution effects induced by tablet location during dissolution testing

“…Although the USP Apparatus II was officially introduced more than 30 years ago 2 and it is still commonly used today, a review of the literature shows that a number of test errors and failures associated with the use of this equipment have been reported. [3][4][5][6][7][8][9][10] Such issues appear to arise even when the USP dissolution calibrator tablets are used, 4,6,9,11,12 thus raising questions on the ability of the calibrating testing process and the use of calibrator tablets to capture the complexities of the dissolution process. Pharmaceutical companies are directly affected by such failures because of the high costs associated with them.…”