Pharmaceutical composition with controlled active ingredient...

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/28 (2006.01) A61K 9/00 (2006.01)

Patent

CA 2661561

The invention relates to a pharmaceutical preparation comprising a) a core with an active ingredient and with an organic acid and/or with the salt of an organic acid; b) a coating which surrounds the core and which comprises content of polymer composed of (meth)acrylate copolymers having no more than 15% by weight of cationic or anionic groups, and which comprises at least 60% by weight of a (meth)acrylate copolymer which is composed of free-radical-polymerized units of from 93 to 98% by weight of C1-C4-alkyl esters of acrylic or methacrylic acid and from 7 to 2% by weight of (meth)acrylate monomers having a quaternary ammonium group in the alkyl radical, characterized in that the water-solubility of the active ingredient is at least 10 g/l at 20°C and the coating comprises silicon dioxide particles whose average particle size is in the range from 1 to 50 mm.

L'invention concerne une composition pharmaceutique comprenant a) un noyau contenant une substance active et un acide organique et/ou le sel d'un acide organique ; b) un revêtement entourant le noyau, ledit revêtement comprenant une partie polymère en copolymères de (méth)acrylate qui présentent une quantité de groupements cationiques ou anioniques inférieure ou égale à 15 % en poids et comprenant une quantité de copolymère de (méth)acrylate supérieure ou égale à 60 % en poids, ledit copolymère étant constitué d'unités polymérisées radicalairement de 93 à 98 % en poids d'ester alkylique en C1 à C4 de l'acide acrylique ou méthacrylique et de 7 à 2 % en poids de monomère (méth)acrylate avec un groupement ammonium quaternaire dans le radical alkyle, caractérisée en ce que la substance active présente une solubilité dans l'eau supérieure ou égale à 10 g/l à 20 °C et en ce que le revêtement contient des particules de dioxyde de silicium ayant une taille de particule moyenne de 1 à 50 µm.

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