経口後発医薬品の溶出試験と簡易懸濁法の適否に関する検討

概要

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By means of dissolution tests, we compared the quality of generic oral products (amantadine, ticlopidine, loxoprofen, diclofenac, brotizolam and clarithromycin) that had already undergone the official post-approval reevaluation of quality with the innovator products. The generic versions of ticlopidine, loxoprofen, diclofenac and brotizolam all met the official dissolution test standards but generic amantadine did not. Conducting the dissolution testing of generic clarithromycin under acidic conditions (pH 3.0) in observance of the revised guidelines which will come into force in November 2007 produced a significantly lower dissolution rate than that for the innovator product suggesting that a change in the test conditions should be considered. On investigating the propriety of the simple suspension method for the testing of oral products, in the case of loxoprofen we found that there was quite a variation in the results among products. Our findings show that more accurate information is needed for generic products.
2007-11-10