Coating and binding agent for pharmaceutical formulations...

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/28 (2006.01) A61K 47/10 (2006.01) A61K 47/12 (2006.01) A61K 47/20 (2006.01) A61K 47/32 (2006.01)

Patent

CA 2403831

The invention relates to a process for the preparation of a coating and binding agent for oral or dermal pharmaceutical forms, essentially consisting of (a) a copolymer consisting of free-radical-polymerized C1 to C4 esters of acrylic or methacrylic acid and further (meth)acrylate monomers which contain functional tertiary ammonium groups, the coplymer being present in powdered form having an average particle size of 1 - 40 µm, (b) 3 to 15% by weight, based on (a), of an emulsifier having an HLB of at least 14 and (c) 5 to 50% by weight, based on (a), of a C12- to C18-monocarboxylic acid or a C12- to C18-hydroxyl compound, the components (a), (b) and (c) being blended or mixed with one another with or without addition of water and if appropriate with addition of a pharmaceutical active compound and further customary additives and the coating and binding agent being produced from the mixture by melting, casting, spreading or spraying. The invention further relates to the coating and binding agent itself.

Procédé de production d'un agent d'enrobage et liant pour des formes galéniques orales ou dermiques. Ledit agent est constitué pour l'essentiel (a) d'un copolymère constitué d'esters C1 à C4 polymérisés de manière radicalaire de l'acide acrylique ou méthacrylique et d'autres monomères de (méth)acrylate possédant des groupes ammonium tertiaires fonctionnels, le copolymère se présentant sous forme de poudre à taille moyenne des particules allant de 1 à 40 mu m, (b) de 3 à 15 % en poids, par rapport à (a), d'un émulsifiant ayant une valeur HLB d'au moins 14 et (c) de 5 à 50 % en poids, par rapport à (a), d'un acide monocarboxylique C12 à C18 ou d'un composé hydroxyle C12 à C18. Les constituants (a), (b) et (c) sont mêlés ou mélangés ensemble avec ou sans ajout d'eau et éventuellement avec ajout d'un principe pharmaceutique actif et d'autres additifs courants. L'argent d'enrobage et liant est obtenu à partir dudit mélange par fusion, coulage, étalement ou pulvérisation. La présente invention concerne en outre l'agent d'enrobage et liant lui-même.

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