聚合物对格列美脲基质片释放动力学影响的比较研究

S. Chowdhury, M. Babu, K. Ankitha, B. Shirisha, Madhurika Sirigadi, E. Kavya
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引用次数: 0

摘要

目的:研究合成聚合物和天然聚合物对格列美脲基质片释放性能的影响。格列美脲是治疗II型糖尿病的第一个第三代磺胺脲类药物。以Methocel K15M、Olibanum Gum为缓释改性高分子。方法:采用不同浓度的天然聚合物和合成聚合物制备9种制剂,对其进行预压缩研究。采用直接压缩法制备片剂;所有制剂均进行了理化研究、体外药物释放、动力学研究和稳定性研究。理化结果在限定范围内。结果:FTIR研究未发现药物与赋形剂相互作用,优化处方F-7的释药时间延长12小时。F-7的释放动力学表明,其释放符合零级模型。对优化后的配方进行了稳定性研究,结果表明其药物含量、理化参数和释放模式均无明显变化。结论:本研究结果表明,上述聚合物适于制备格列美脲缓释制剂,可有效治疗2型糖尿病。
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A comparative study on effect of polymers on release kinetics glimepiride matrix tablet
Objective: The Present investigation was performed to find out the effect of synthetic and natural polymers on the release properties of glimepiride matrix tablet. Glimepiride is a first third generation sulphonyl urea agent for the treatment of type- II diabetes mellitus. Methocel K15M, Olibanum Gum were used as key release modifying polymers. Methods: Nine formulations were prepared taking different concentration of natural and synthetic polymers, The drug excipient mixtures were subjected to pre-compression studies. The tablets were prepared by direct compression method; all formulations were subjected to physicochemical studies, in- vitro drug release, kinetic studies and stability studies. The physicochemical results were found within the limits. Results: FTIR study interpretation did not show any drug–excipient interaction The drug release from the optimized formulation F-7 was extended for a period of 12 hours. The release kinetics of F-7 formulation showed that the release of drug follows zero order models. The optimized formulations were subjected to stability studies and shown there were no significant changes in drug content, physicochemical parameters and release pattern. Conclusions: Results of the present study indicated the suitability of the above mentioned polymers in the preparation of sustained release formulation of Glimepiride for the management of type-II diabetes mellitus effectively.
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