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Galenic form for prolonged release of milnacipran

机译:盖仑形式延长米那普仑的释放

摘要

The invention concerns a pharmaceutical composition 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 between 200 and 2000 mum and containing 150 to 1000 mum of Milnacipran and a binding agent, each microgranule being coated with a film having a base of at least one polymer insoluble in water but permeable to physiological liquids, of a thickness between 20 and 100 mum, the said pharmaceutical composition 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.
机译:本发明涉及用于口服给药的单日剂量为60至140mg的Milnacipran的具有延长释放的药物组合物,其具有包含多个微粒的多颗粒形式,每个微粒包含含有蔗糖和/或淀粉核的活性微球。颗粒的大小在200至2000微米之间,并包含150至1000微米的Milnacipran和一种粘合剂,每个微颗粒都被涂有一层薄膜,该薄膜具有至少一种不溶于水但对生理性液体可渗透的聚合物的底以及100μm,所述药物组合物能够实现与以下模式相对应的体外释放:2小时内释放的剂量的10%至5​​5%,4小时内释放的剂量的40%至75%,70%至90%。 8小时内释放的剂量的12%,即12小时内释放的剂量的80%至100%。

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