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The effect of tablet formulation and hardness on in vitro release of cephalexin from Eudragit L100 based extended release tablets.

机译:片剂的配方和硬度对头孢氨苄从Eudragit L100缓释片剂中体外释放的影响。

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摘要

Eighteen batches of cephalexin extended release tablet were prepared by wet granulation method by using Eudragit L100. The effect of the concentration of Eudragit L100, microcrystalline cellulose and tablet hardness on cephalexin release was studied. The formulated tablets were also characterized for physical and chemical parameters. The dissolution results showed that a higher amount of Eudragit in tablet composition and higher tablet hardness resulted in reduced drug release. An increased amount of microcrystalline cellulose in tablet composition resulted in enhanced drug release. Tablet composition of 13.3% w/w Eudragit L100 and 6.6 to 8% w/w microcrystalline cellulose with hardness of 7-11 kg/cm2 gave predicted release for 6 h. The in vitro release was compared with a marketed tablet. Physical and chemical parameters of all formulated tablets were within acceptable limits. The effect of storage on in vitro release and physicochemical parameters of tablets was evaluated and two batches among formulated eighteen batches found to be in acceptable limits.
机译:采用Eudragit L100通过湿法制粒制备了十八批头孢氨苄缓释片。研究了Eudragit L100的浓度,微晶纤维素和片剂硬度对头孢氨苄释放的影响。还对配制的片剂的物理和化学参数进行了表征。溶出度结果表明,片剂组合物中的Eudragit含量较高,片剂硬度较高,导致药物释放减少。片剂组合物中微晶纤维素的量增加导致药物释放增强。片剂组成为13.3%w / w的Eudragit L100和6.6至8%w / w的微晶纤维素,硬度为7-11 kg / cm2,可预测释放6小时。将体外释放与市售片剂进行比较。所有配制片剂的物理和化学参数均在可接受的范围内。评估了贮藏对片剂的体外释放和理化参数的影响,发现配制的18批次中有2批次在可接受的范围内。

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