GALENIC FORMULA WITH EXTENDED RELEASE OF MILNACIPRAN
    7.
    发明申请
    GALENIC FORMULA WITH EXTENDED RELEASE OF MILNACIPRAN 审中-公开
    加利福尼亚州扩大释放的GALENIC公式

    公开(公告)号:WO1998008495A1

    公开(公告)日:1998-03-05

    申请号:PCT/FR1997001525

    申请日:1997-08-26

    IPC分类号: A61K31/13

    摘要: The invention concerns a galenic formula with prolonged release, for oral administration of a single daily dose of 60 to 140 mg of Milnacipran, having a multi-particulate form containing a plurality of microgranules each comprising an active microsphere containing a saccharose and/or starch nucleus of a size grade between 200 and 2000 mu m and containing 150 to 1000 mu m of Milnacipran and a binding agent, each microgranule being coated with a film, with a base of at least one polymer insoluble in water but permeable to physiological liquids, of a thickness between 20 and 100 mu m, the said galenic formula enabling an in vitro release corresponding to the following pattern: between 10 and 55 % of the dose released in 2 hours, between 40 and 75 % of the dose released in 4 hours, between 70 and 90 % of the dose released in 8 hours, between 80 and 100 % of the dose released in 12 hours.

    摘要翻译: 本发明涉及具有延长释放的盖仑配方,用于口服单次日剂量60至140mg米那普兰,具有多颗粒形式,其包含多个微粒,每个微粒包含含有蔗糖和/或淀粉核的活性微球 尺寸等级在200和2000微米之间,并且含有150到1000微米的米那普兰和粘合剂,每个微粒被涂覆有至少一种不溶于水但可渗透生理液体的聚合物的基底, 厚度在20和100微米之间,所述盖仑配方使得能够相应于以下模式的体外释放:2小时内释放的剂量的10至55%,4小时内释放的剂量的40至75% 在8小时内释放的剂量的70至90%之间,在12小时内释放的剂量的80至100%之间。