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首页> 外文期刊>Pharmaceutical Chemistry Journal >EQUIVALENCE OF RANITIDINE GENERIC TABLETS STUDIED USING THE IN VITRO DISSOLUTION TEST
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EQUIVALENCE OF RANITIDINE GENERIC TABLETS STUDIED USING THE IN VITRO DISSOLUTION TEST

机译：使用体外溶出度试验研究制得的雷尼定一般片剂的等效性

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摘要

The pharmaceutical equivalence of Zantac (reference drug) and 10 domestic and foreign generics of ranitidine hydrochloride as 150-mg coated tablets has been studied using the pharmacopoeic (USP 29) dissolution test. Analyses showed insignificant differences in the excipients entering into the compositions of ranitidine generic tablets registered in Russia. It is established that Zantac and generics of two manufacturers are rapidly soluble (according to the WHO classification). Analysis of the similarity coefficients determined for the dissolution profiles measured in media with different pH values showed the biological nonequivalence of some generics and the reference drug. It is demonstrated that the in vitro dissolution test recommended by WHO can be used for determining the bioequivalence of ranitidine generics.
机译：使用药典（USP 29）溶出度试验研究了Zantac（参考药物）与10种国内外盐酸雷尼替丁的仿制药作为150毫克包衣片剂的等效性。分析表明，赋形剂进入俄罗斯注册的雷尼替丁非专利片剂的成分中差异不明显。已确定两家生产商的Zantac和仿制药可快速溶解（根据WHO分类）。对在不同pH值的介质中测得的溶出度曲线确定的相似系数的分析表明，某些仿制药与参考药物在生物学上不相等。事实证明，世卫组织推荐的体外溶出度试验可用于确定雷尼替丁仿制药的生物等效性。

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