フロセミド錠の先発医薬品および後発医薬品の溶出性比較試験

Comparative dissolution study of original and generic furosemide tablets

Furosemide is one of the most used loop diuretics. While several generic versions of furosemide tablets are available in clinical situation, similarities in dissolution property of these tablets have not been reported. Hence, we compared the differences of dissolution property of furosemide 40 mg tablets between the original and generic A in dissolution and disintegration tests.
Simple suspension of the generic A tablets showed a greater particle dispersion than that of the original product. The furosemide dissolution rate of generic A in the dissolution test showed a significant small compared to the original product during from 2 to 4 minutes after the beginning, but it became higher, in turn, at 30 minutes after. In the disintegration test, the generic A tablet had a longer disintegration time of 1-2 minutes than the original product. The generic A tablet contained specific additives of coating agents such as titanium dioxide, Hypromellose, and PEG6000. The presence of insoluble titanium dioxide causes white cloudiness in simple suspension of the generic A tablet. Both Hypromellose and PEG6000 were supposed to increases the dispersibility of furosemide, which could lead to the increased dissolution rate of the generic A tablet. These findings of this study on furosemide tablet are considered to provide helpful information for an alternative use with generic agents.

Creators TSURUDOME Yuya

Creators FUNAKI Tomoharu

Creators HORIGUCHI Michiko

Creators USHIJIMA Kentaro