Abstract
This report summarizes some trends observed in drug dissolution testing, based upon the United States Pharmacopeia (USP) dissolution Apparatus Suitability Test results and the preliminary data obtained from an international collaborative study to assess the pharmaceutical quality of furosemide products in different countries. Based on the USP calibrator data submitted by the participants, representing four lots each of nondisintegrating (Salicylic Acid) and disintegrating (Prednisone) tablets, overall variability can be high and failures to meet the specification in a dissolution run can be frequent. This high level of variability and failure seems to be dependent on the combination of calibrator and apparatus type. Although deaeration of dissolution media tends to reduce the frequency of failure, its effect on reducing the variability appears to be minimal. It appears that calibrator-apparatus combinations of Prednisone tablets/Basket Method and Salicylic Acid tablets/Paddle Method show some sort of interaction, therefore, use of these combinations to test suitability of dissolution apparatus needs to be evaluated. Prednisone Tablets with the Paddle Method and Salicylic Acid Tablets with the Basket Method, however, appear to provide sufficient information for dissolution apparatus calibration and their use should be continued.
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