Pharmaceutical composition with extended release of Milnacipran

The subject of the present invention relates to the development of a multiparticulate form of the controlled-release minigranule type for the oral route, allowing the administration, in a single daily dose, of a particular antidepressant, namely: Milnacipran. The invention concerns a pharmaceutical...

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Hauptverfasser: Paillard, Bruno, Goutay, Eric, Avan, Jean-Louis, Bougaret, Joël
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung:The subject of the present invention relates to the development of a multiparticulate form of the controlled-release minigranule type for the oral route, allowing the administration, in a single daily dose, of a particular antidepressant, namely: Milnacipran. 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 m and containing 150 to 1000 m 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 m, 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.