Intrinsic Dissolution Performance Testing of the USP Dissolution Apparatus 2 (Rotating Paddle) Using Modified Salicylic Acid Calibrator Tablets: Proof of Principle

Hydrodynamic and Species Transfer Simulations in the USP 4 Dissolution Apparatus: Considerations for Dissolution in a Low Velocity Pulsing Flow

“…The flow visualisation studies were performed using a modified version of the method used by Mauger et al (28), using a tripod-mounted Canon MV890 digital video camcorder. It should be noted that, as this was a qualitative observational flow visualisation study, no optical distortion reduction methods were used.…”

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.…”

Hydrodynamic Investigation of USP Dissolution Test Apparatus II

“…3 Nevertheless, and despite its widespread use in the industry, dissolution testing remains susceptible to significant error and test failures. 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.…”