盐酸伊伐布雷定口腔分散片的研制与评价

D. Patel, K. Patel, P. Bharadia
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引用次数: 1

摘要

目的:研究盐酸伊伐布雷定口腔分散片的处方,并对其进行不同评价参数的评价。方法:采用直接加压法制备。在压缩前对片剂的流动特性进行表征,在压缩后对不同参数的光分散片剂配方进行评价。结果:研制的盐酸伊伐布雷定口腔分散片与市售制剂相比,释放度明显提高;研制并研究了九种配方。药物释放值的差异分别为100.88±0.10。采用不同的药典方法,在HPLC、pH、感官性质等试验的基础上,对该药物进行了表征。评价参数在规定范围内,并显示出良好的自由流动性能。以崩解时间为21±3.0,溶出度为99.29%的F6批为优化配方。这是比较传统的市场配方,发现优越。F6批次也进行了两个月的稳定性研究,每月检测其硬度、润湿时间、崩解时间、药物含量和溶出行为。结论:合理选择辅料,可研制盐酸伊伐布雷定分散片。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Formulation and evaluation of orodispersible tablet of ivabradine hydrochloride
Objective: The objective of present research work was to develop formulation of orodispersible tablets of Ivabradine HCl and evaluate it for different evaluation parameters. Methods: The tablets were prepared by direct compression method. The formulation of the tablets were evaluated before compression for characterization of flow properties and after compression for different parameters of orodispersible tablet formulation. Results: Ivabradine hydrochloride orodispersible tablets were developed with considerable increase in drug release as compared to marketed formulations; nine formulations were developed and studied. The difference in drug release values was found to be 100.88 ± 0.10 respectively. The drug was characterized according to different compendial methods, on the basis of identification by HPLC, pH, organoleptic properties and other tests. Parameters evaluated were within prescribed limits and indicated good free flowing properties. The F6 batch with disintegration time 21 ± 3.0 and dissolution 99.29% was selected as optimized formulation. This was compared with conventional marketed formulation and was found superior. Batch F6 was also subjected to stability studies for two months and was tested for its hardness, wetting time, disintegration time, drug contents and dissolution behaviour monthly. Conclusions: By appropriate selection of excipients, it was possible to develop orodispersible tablets of Ivabradine HCl.
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