ファモチジン錠およびファモチジン注射剤の後発医薬品に関する品質評価

概要

論文の詳細を見る
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.
日本医療薬学会の論文