著者

鳴戸 郁江 岡本 佳菜美 西方 真弓 松山 賢治

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.32, no.6, pp.523-530, 2006-06-10 (Released:2007-11-09)

参考文献数

9

被引用文献数

6 6

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In order to evaluate generic versions of famotidine, 11 kinds of famotidine tablets and 7 kinds of famotidine injection (both tablets and injection included the branded product, respectively) were subjected to dissolution testing and HPLC analysis.In the case of tablets, both the branded drug (Gaster®) and the 10 generics satisfied the standard dissolution test requirement that more than 70% of tablets should dissolve within 60 min, though there were significant differences in the time taken to achieve more than 70% dissolution. In this respect, some of the generics were quite different from the branded drug.As for the famotidine injection-formulations, both the branded drug, (Gaster® injection) and the 6 generics satisfied the standard for the content test in JP XIV. However, HPLC analysis showed that generic formulations contained a variety of impurities while the branded injection (Gaster® for injection 20 mg) contained very few impurities. In three of the generic injection-formulations-Famostagine® for injection 20 mg, Progogue® for injection 20 mg and Gasport® for injection 20 mg —the contents of impurities were significantly different from that of Gaster® for injection 20 mg.The present study showed that there were appreciable quality differences between the branded and generic versions of famotidine irrespective of formulation.