格列本脲控释基质片的处方研制与评价

Biji Palatty, Praveena Raj, Daiay Pa, Boby JOHNS .G
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引用次数: 0

摘要

以三种不同的聚合物为缓释剂,以格列本脲为模型药物制备基质片。格列本脲是第二代口服降糖药,其控释基质片的研制与评价是本研究的目的。本研究选择了三种不同药高比的聚合物HPMC k15、HPMC k100和EC。用FTIR光谱法对该药物进行了鉴定。所有配方的预压缩和后压缩参数均在可接受范围内。采用美国药典i型溶出度测定仪(筐法)研究了格列本脲在基质片中的释放度。含EC 50mg的配方F6在24 h内的最大释放量为99.28%,表明EC具有较好的缓释效果,因此选择F6为最佳配方。优化制剂的体外释放数据可拟合到多个动力学模型中,不同模型中体外释放数据最适合于零级动力学模型。最符合Higuchi模型的处方表明,所制备的基质片通过扩散过程释放药物。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Formulation development and evaluation of controlled release matrix tablets of glibenclamide
Matrix tablets were prepared by three different polymers as sustained-release agents, using Glibenclamide as a model drug. The aim of the present study was to formulate and evaluate the controlled release matrix tablets of Glibenclamide which is an antidiabetic drug which belongs to the second generation oral hypoglycemics. Three polymers were selected for this study- HPMC K 15, HPMC K 100 and EC in different drug: polymer ratio. The drug was identified by FTIR spectroscopic method. The pre compression and post compression parameters of all formulations were found to be within acceptable limit. The release rate of Glibenclamide from matrix tablets was studied using USP Dissolution Testing Apparatus type-I (Basket method). The formulation F6 which contained EC 50mg showed a maximum release of 99.28% in 24 hrs and revealed that EC was more effective in sustaining the drug release and therefore the formulation F6 selected as the optimized formulation. The in-vitro release data of optimized formulation was fit into various kinetic models, among the different models data of in-vitro release of best fit into Zero order kinetic model. The formulation best fit to Higuchi model showed that drug release from the prepared matrix tablets occurs via diffusion process.
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