A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/20 (2006.01) A61K 31/34 (2006.01) A61K 31/343 (2006.01)
Patent
CA 2286904
An orally administered tablet comprising a therapeutic amount of a pharmaceutically acceptable salt of amiodarone (e.g., an acid salt of amiodarone such as amiodarone hydrochloride) is described. Other ingredients include a disaccharide which is preferably a reducing disaccharide, pregelatinized starch, and an alkali metal starch glycolate. The tablet preferably also comprises at least one of the following: a) 2 to 6 % by weight stearic acid, b) less than 1 % by weight magnesium stearate, c) 2 to 25 % by weight of wet binder, and d) less than 0.1 % by weight of silica gel.
La présente invention concerne un comprimé d'administration orale comprenant une quantité thérapeutique d'un sel pharmaceutiquement admis d'amiodarone, notamment un sel acide d'amiodarone tel qu'un hydrochlorure d'amiodarone. Parmi les autres ingrédients du comprimé, on compte notamment un disaccharide qui est de préférence un disaccharide réducteur, de l'amidon préalablement rectifié en gélatine, et un glycolate d'amidon de métal alcalin. Le comprimé comprend également de préférence l'un au moins des constituants suivants: a) 2 % à 6 % en masse d'acide stéarique, b) moins de 1 % en masse de stéarate de magnésium, c) de 2 % à 25 % en masse d'un liant humide, et d) moins de 0,1 % en masse de silice colloïdale.
Daisy Samuel Jr.
Tourek William J.
Bereskin & Parr
Upsher-Smith Laboratories Inc.
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