Extended release pharmaceutical formulation of metoprolol...

A - Human Necessities – 61 – K

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A61K 9/50 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 31/135 (2006.01) A61K 31/137 (2006.01) A61K 31/554 (2006.01) A61P 9/12 (2006.01)

Patent

CA 2657202

The invention provides an extended release coated granule comprising a granule having a particle size ranging from 0.2 to 2 mm, a friability lower than or equal to 1% and comprising metoprolol succinate as active ingredient in an amount ranging from 10 to 75% by weight of the granule and at least one binder selected from microcrystalline cellulose and methylcellulose, coated with a film-former coating agent. It also provides a process for the preparation of said extended release coated granules, as well as pharmaceutical formulations containing them.

L'invention concerne un granule enrobé à libération prolongée comprenant un granule présentant un diamètre compris entre 0,2 et 2 mm et une friabilité inférieure ou égale à 1%, et renfermant du succinate de métoprolol comme ingrédient actif en proportion comprise entre 10 et 75% en poids du granule, et au moins un liant choisi parmi la cellulose microcristalline et la méthylcellulose, ledit granule étant enrobé d'un agent d'enrobage filmogène. L'invention concerne également un procédé de préparation de ces granules enrobés à libération prolongée ainsi que des préparations pharmaceutiques les contenant.

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