総合的な同等性評価が問われる後発医薬品 : 塩酸ベニジピン錠の剤形変更時の特性および情報提供の比較

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In Japan, prescription costs account for more than 20% of the national health care budget. In order to curtail such expenditure as much as possible, the government recommends switching from branded products to generics. However, the information available regarding the equivalence of branded products and generics is often insufficient. With this in mind, we evaluated the equivalence of the branded benidipine hydrochloride tablets and generics of it, by comparing such aspects as their passage through a nasogastric tube, and the characteristics of divided tablets. Further, since drug information (DI) is a vital factor for evaluating generics, we conducted an objective evaluation of the adequacy of DI supplied for them. Among sixteen generic products, the passage through a nasogastric tube was significantly delayed for 2 products and for 1 of these products, there was a large variation in the weight of the halves of divided tablets. Further, the amount of information supplied by the manufacturers of the generics was less than that supplied by the manufacturer of the original product and for most of the former, it took longer to obtain. In the clinical setting, tablets are often divided or made into suspensions and our results suggest that the generics are not necessarily equivalent to the branded product when used in these ways. We therefore conclude that generics should be evaluated not just from the aspect of bioequivalence with no change in dosage form but from a wider overall perspective.
日本医療薬学会の論文
2008-04-10

総合的な同等性評価が問われる後発医薬品 : 塩酸ベニジピン錠の剤形変更時の特性および情報提供の比較

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