二甲双胍和维格列汀片仿制药质量评价

Bhavana Habib, Jyoti Mittha
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引用次数: 1

摘要

本研究的目的是评价和比较在印度市场上可买到的四种不同的二甲双胍和维格列汀片。对这些片剂进行了各种药典质量控制试验。评价指标包括重量变化、硬度、脆度、药物含量、崩解时间等。所有选定产品的结果均在可接受范围内(三个仿制药和一个创新产品)。这些结果表明,测试的仿制产品在生物制药方面与创新配方相似。因此,消费者可以选择这些等效产品中的任何一种作为创新者产品的替代品,以防成本问题或不可用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Quality Evaluation of Generic Products of Metformin and Vildagliptin Tablets
The aim of the present study was the evaluation and comparison between four different Metformin and Vildagliptin tablets which are commercially available in Indian market. These tablets were assessed for various pharmacopoeial quality control tests. Parameters including weight variation, hardness, friability, drug content, and disintegration time were evaluated. Results were within acceptable limits for all selected products (three generic and an innovator). These results show that the tested generic products were biopharmaceutically similar to the innovator formulation. Therefore, the consumer can select any one of these equivalent products as a substitute for innovator product in case of cost concern or unavailability.
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