بررسی تأثیر نوع و میزان پلیمر بر پایداری فیزیکی حالت جامد و انحلال قرص‌های آهسته رهش دیلتیازم

Abstract Background and purpose: The dissolution of a drug has an important role in its bioavailability. Any change in the physico-chemical properties can result in changes in the drug release, and furthermore in its bioavailability. In order to overcome such changes, it is necessary to determine the storage conditions required for obtaining a desired drug release. Materials and methods: Diltiazem tablets were obtained by the Direct Compression method and using Ethylcellulose and HPMC K4M. After conducting some initial tests, these tablets were subjected in different temperatures and humilities for six months. From different formulations the Diltiazam release was analyzed and then data were fitted to Kinetic model. Differential Scanning Calorimetry (DSC) was used to determine the physical stability of tablets and possible adverse interactions between drugs with polymers or other materials. Results: The results of drug release from different formulations showed no significant difference among various times (zero, three and six months). Also by studying the Dsc thermogram of different formulations the peak Diltiazem was seen in approximately 210°C, and the thermogram does not show any change. Conclusion: Overall, the statistical results on dissolution showed that keeping Diltiazem tablets for three and six months in different conditions does not cause significant changes in the drug release. Moreover, no change was observed in the physical stability of tablets.