Collaborative study on the development of a standard for evaluation of vibration levels for dissolution apparatus

This collaborative study in which seven laboratories participated was carried out in order to develop a dissolution standard for evaluating vibration levels for dissolution apparatus using enteric-coated granules of cefalexin (EG). Vibration levels for the dissolution apparatus were not dependent on whether the rotating basket (50 rpm) or paddle (50 rpm) methods were used. However, dissolution rates of cefalexin from EG were significantly increased by dissolution apparatus at high levels of vibration in the rotating basket method, while they were not affected by the variation in vibration levels in the paddle method. Dissolution apparatus could be divided into two groups according to their vibration levels and the dissolution test results by the rotating basket method at 50 rpm. The critical value of acceleration was about 0.05 m/s². The upper limit of normal dissolution rates of EG was calculated from the results of the rotating basket method at 50 rpm obtained from low vibration apparatus. All high vibration apparatus used in this study were distinguished by the confidence limit of the EG dissolution rate determined from low vibration apparatus. These results suggest that EG would be useful as a calibrator for detection of apparatus at high vibration levels. Copyright (C) 1998 Elsevier Science B.V.