後発医薬品評価における病院薬剤師と薬科大学との連携 ロキソプロフェンナトリウム錠の溶出試験を例にして

Abstract

We selected eight generic drugs of sodium loxoprofen, a nonsteroidal anti-inflammatory drug (NSAID), and examined the dissolution ability of these drugs using the paddle method described in JP XIII.When performing the dissolution test performed on the 1st solution (disintengration test solution, pH 1.2) under the condition of 100 rpm and 37°C, the pioneer drug (Tablet A) was found to completely dissolve within 15 min. Some generic drugs showed almost the same dissolution profiles as the pioneer drug, whereas only one generic drug (Tablet F) showed a slower dissolution profile, a 63.8% release within 15 min.Furthermore, for Tablet A and Tablet F, the dissolution test using the 1st solution was performed at 50 rpm and 37°C. As a result, tablet F did not meet the minimum requirement established by the Ministry of Health and Welfare.The above dissolution tests were performed by the authors at the pharmaceutical laboratory of the School of Pharmaceutical Sciences, Mukogawa Women's University. Such collaboration by pharmacists in hospitals with pharmaceutical college in order to evaluate generic drugs should be more strongly encouraged in the future.