Vibration effects on dissolution tests with USP apparatuses 1 and 2.
Dissolution testing is of primary importance for drug formulation and quality control. Many sources of variability are accounted for in the apparatus' mechanical calibration process; the effect of vibration on dissolution tests is not well understood in that the test's tolerance for environmental vibration with respect to magnitude or frequency is largely unknown. In this study, USP Apparatuses 1 and 2 were used. Dissolution profiles were obtained for both disintegrating and nondisintegrating tablets. In separate experiments, a lab vacuum pump or a lab mixer, both commonly used in laboratories, was used to generate vibration during dissolution runs with vibration parameters being recorded at a location close to the dissolution vessels. Disintegrating tablets were found to be sensitive to induced vibrations with both the paddle and basket methods. Average dissolution results for nondisintegrating tablets were not sensitive to the studied vibrations; however, variability of the results increased in some cases. The dissolution profiles suggest that the vibration effects on paddle and basket method occur through different mechanisms. The importance of vibration to dissolution test results depends on the vibration source, product being tested and the apparatus type.
Gao
Zongming
Z
Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St. Louis, Missouri 63101, USA. zongming.gao@fda.hhs.gov
Moore
Terry W
TW
Doub
William H
WH
D004864:Equipment and Supplies; D004364:Pharmaceutical Preparations; D012995:Solubility; D013607:Tablets; D014732:Vibration
D004364:Pharmaceutical Preparations; D013607:Tablets