Dose Dumping Study for Gliclazide Sustained-Release Tablets
OBJECTIVE To evaluate the effects of drug release for gliclazide sustained-release tablets in ethanolic media and conduct the risk assessment for the dose dumping.METHODS Release profiles of gliclazide sustained-release tablets from 3 manu-factures in different ethanolic media were determined by HPLC.Release mechanisms were analyzed and the risk of dose dumping was e-valuated by the similar factors(f2)of the release data.RESULTS Release profiles of formulations in the presence of 5％,20％and 40％ethanol of pH 7.4 phosphate buffer media at 100 r·min-1 were similar.The erosion rate was the key factor that affected the re-lease profiles of gliclazide sustained-release tablets.CONCLUSION The commercial formulations are considered to be robust against alcohol effects and the risk of alcohol-induced dose dumping is relatively little.
万方数据
维普
