Development of controlled-release matrix tablets of anti-diabetic agent using natural and synthetic polymers

C. Prudhvi , S. Sivaneswari , N. Preethi , B. Mounika , B. Naveen Kumar , S. Vasudeva Murthy , E. Karthikeyan
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Abstract

The aim of this study was to develop and produce natural polymer-based controlled-release matrix tablets of metformin hydrochloride. The formulations were manufactured from a mixture of natural and synthetic polymers, including gum copal, gum damar, gum olibanum, xanthum gum, and hydroxypropyl methylcellulose (HPMC) K15M. The granules were characterized by Fourier transform infrared spectroscopy (FTIR). The kinetics of drug release from the formulations was determined by zero-order kinetic analysis. The formulas were found to be in the following ranges: 4.20.054 to 5.10.58 ​kg/cm2, 844.86.84 to 852.64.13 ​mg, 0.230.002 to 0.670.048 percent, and 99.450.15 to 101.930.16 percent, respectively. For all formulations, it was found that Carr's index, Hausner's ratio, bulk density, tapped density, and angle of repose were less than 15% and 1.18, respectively, indicating that the generated tablets had acceptable flow properties. Formulations F3, F4, and F5, which contained varying amounts of gum copal, showed respective drug release rates of 91.21 percent, 85.69 percent, or 99.87 percent after 12 ​h. For formulations F11, F12, and F13, which included varying quantities of olibazine gum, after 10, 10, and 9.5 ​h, it generated 100% drug release after 10, 10.5, and 10 ​h. Formulation F5 which included gum copal, and the HPMC showed sufficient release to exert the necessary therapeutic effect in under 12 ​h, whereas the other formulations showed anomalous or non-Fickian diffusion. This study suggests that matrix tablets for continuous controlled release can be made.

利用天然和合成聚合物制备抗糖尿病药物控释基质片
本研究的目的是开发和生产基于天然聚合物的盐酸二甲双胍控释基质片。该配方由天然和合成聚合物的混合物制成,包括科帕尔胶、大马士革胶、olibanum胶、黄原胶和羟丙基甲基纤维素(HPMC)K15M。用傅立叶变换红外光谱(FTIR)对颗粒进行了表征。通过零级动力学分析确定药物从制剂中释放的动力学。发现配方在以下范围内:4.20.054至5.10.58​kg/cm2,844.86.84至852.64.13​mg,分别为0.230.002至0.670.048%和99.450.15至101.930.16%。对于所有配方,发现Carr指数、Hausner比、堆积密度、振实密度和休止角分别小于15%和1.18,表明所产生的片剂具有可接受的流动特性。配方F3、F4和F5含有不同量的树胶,在12天后分别显示出91.21%、85.69%或99.87%的药物释放率​h.对于配方F11、F12和F13,其包括不同量的奥列巴津胶,在10、10和9.5之后​h、 它在10、10.5和10后产生100%的药物释放​h.包括复方胶和HPMC的制剂F5显示出足够的释放,以在12岁以下儿童中发挥必要的治疗作用​h、 而其它制剂显示异常或非菲克扩散。本研究表明,可以制备连续控释基质片。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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