The Study On The Design And Evaluation Of Gliclazide Sustained Release Tablets

Gliclazide is sulfonylurea hypoglycemic which is commonly used in clinical forthe treatment of type2diabetes can not be controlled by diet alone. Gliclazide canlower blood sugar by stimulating pancreatic β cells to release insulin. In this paper, weused hypromellose (HPMC) as matrix materials to prepare gliclazide MR.We established a UV spectrophotometry to determinate the release in vitro ofgliclazide sustained-release tablets and the HPLC detection for the determination ofthe content.The method is accurate, sensitive and convenient, which is good to meetthe requirements of the analysis indicators in this experiment.In the preformulation studies, we measured the solubility of gliclazide, selectingpH7.4phosphate buffer as release medium. We made a preliminary stability test forgliclazide APIs. The results show that there were no significant differences with thecontent and character of Gliclazide API at high temperatures, high humidity, lightingconditions.We found the influence of each formulation factors, technical factors andconditions on the release by the evaluation criteria which is make for the release ofsustained-release tablets in vitro in0to12hours. We optimized the prescription,screened the optimal prescription, and then we made the sustained-release tablets oncedaily.In the study of the release mechanism, we used Peppas model to fit curve,indicating that the release mechanism for sustained-release tablets is the synergyresults of drug diffusion and matrix erosion. Gliclazide MR preliminary stability testsshow that it was stable to light, heat, air, water, etc., the content and release were nosignificant change also.Through laboratory re-evaluation of the quality of homemade tablet, we textedthe release profile of the sample and the original development agents in the dissolution medium, showing that the sample and the original development agentshave relatively similar dissolution profiles, and we also improve the relevance of thesample in vivo. Three types of samples were measured in four dissolution dissolutionprofiles are up more than80percent, and the sample in pH6.8phosphate buffer wasthe slowest release one. So we propose to change the existing quality standards, usingpH6.8phosphate buffer in stead of pH7.4phosphate buffer.