DULOXETINE PREPARATION AND METHOD OF STABILIZING THE SAME

To provide a method of stabilizing an enteric preparation containing duloxetine or a pharmaceutically acceptable salt thereof.SOLUTION: The present invention provides a method of stabilizing an enteric preparation containing a medicinal core that contains duloxetine or a pharmaceutically acceptable...

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Bibliographische Detailangaben
Hauptverfasser: MATSUDA KIZUKU, OKAMOTO YASUNOBU, OKAZAWA NAOTO, KABASHIMA HIROKO
Format: Patent
Sprache:eng ; jpn
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Zusammenfassung:To provide a method of stabilizing an enteric preparation containing duloxetine or a pharmaceutically acceptable salt thereof.SOLUTION: The present invention provides a method of stabilizing an enteric preparation containing a medicinal core that contains duloxetine or a pharmaceutically acceptable salt thereof, an intermediate layer, and an enteric layer that contains hypromellose acetate succinate. The stabilizing method does not cause the intermediate layer to include sugar and/or sugar alcohol having a solubility higher than 50 mg/mL.SELECTED DRAWING: Figure 1 【課題】デュロキセチンまたはその薬学的に許容される塩を含む腸溶性製剤の安定化方法を提供する。【解決手段】デュロキセチンまたはその薬学的に許容される塩を含む薬物コアと、中間層と、ヒプロメロース酢酸エステルコハク酸エステルを含む腸溶層と、を含む、腸溶性製剤の安定化方法であって、前記中間層に50mg/mLよりも高い溶解度を有する糖および/または糖アルコールを含ませないことを特徴とする、安定化方法。【選択図】図1