塩酸アロチノロール製剤の品質評価 : 先発医薬品と後発医薬品の比較

概要

論文の詳細を見る
We evaluated the quality of the branded product (two presentations: 5 and 10mg) and generic versions (nine products: one of them 5mg and the other eight 10mg) of arotinoiol hydrochloride through dissolution, purity, content, and content uniformity tests. The results of an estimation of dissolution characteristics based on the quality reevaluation procedure showed that the dissolution characteristics of six products differed from those at the time of the quality reevaluation. Furthermore, differences in dissolution characteristics between production lots were observed for two products, suggesting that there may be products showing variation in quality on the market. However, our results showed that none of the products had quality-related problems as regards content and content uniformity for individual tablets or entire lots. They further indicated that the purity of seven generic products was equal to or higher than that of the branded product. Based on a comprehensive evaluation of the quality parameters we selected, the quality of one generic product was equal to or higher than that of the branded product.
日本医療薬学会の論文
2006-09-10