Galenic formula with extended release of milnacipran

Details Galenic formula with extended release of milnacipran Galenic formula with extended release of milnacipran

A - Human Necessities

61

K

A61K 31/165 (2006.01) A61K 9/16 (2006.01) A61K 9/50 (2006.01) A61P 25/24 (2006.01)

Patent

CA 2264238

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.

L'objet de la présente invention concerne une forme galénique à libération prolongée, destinée à l'administration par voie orale en une prise journalière unique de 60 à 140 mg de Milnacipran, se présentant sous une forme multiparticulaire réunissant une pluralité de minigranules comportant chacune une minisphère active comprenant un noyau de saccharose et/ou d'amidon de granulométrie comprise entre 200 et 2000 µm et renfermant de 150 à 1000 µg de Milnacipran ainsi qu'un agent liant, chaque minigranule étant enrobée par un film, à base d'au moins un polymère non hydrosoluble mais perméable aux liquides physiologiques, d'épaisseur comprise entre 20 et 100 µm, ladite forme galénique permettant une libération in vitro correspondant au profil suivant: entre 10 et 55 % de la dose libérée en 2 heures; entre 40 et 75 % de la dose libérée en 4 heures; entre 70 et 90 % de la dose libérée en 8 heures; entre 80 et 100 % de la dose libérée en 12 heures.

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