Vibration measurements on dissolution systems and effects on dissolution of prednisone tablets RS

Abstract

Efforts are being made by various groups (1,2) to focus more on mechanical calibration as a potential replacement for Prednisone tablets RS (calibrator tablets). Although some mechanical calibration is currently performed (e.g.,wobble,centering), the PhRMA committee’s original proposal was to replace the Prednisone tablets RS through use of enhanced mechanical calibration. A collaborative study (3) executed by PhRMA members to determine the feasibility of this idea demonstrated that the results obtained from the Prednisone tablets are operationally sensitive to several critical bath parameters. In addition,it was found that insufficient information exists to establish a meaningful tolerance for vibration (4). The present study was performed to collect vibration information using two commercially available vibration meters, VanKel QAII station and Balmac 200.Vibration measurements were taken under normal conditions and in the presence of perturbations (slight and forced) generated artificially using a vortexer and a Vorti-Siv mixer. The main objective of the study was to determine if the apparatus could meet the proposed 0.1-mil displacement tolerance limit at the centerline of the vessel plate,and to observe what level of vibration is associated with 0.2-mil displacement. In addition, the effect of vibration on the release of Prednisone from Prednisone tablets RS was also evaluated on three representative bath models:Varian VK-7000,Varian VK-7025,and Distek 2100B.