Granules or powder for the production of coating agents and...

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/28 (2006.01) A61K 9/16 (2006.01) A61K 9/50 (2006.01)

Patent

CA 2464502

The invention relates to a process for the production of granules or powders, suitable as coating agents and binders for oral or dermal pharmaceutical forms, for cosmetics or food supplements, consisting essentially 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 amino groups, (b) 3 to 25% by weight, based on (a), of an emulsifier having an HLB of at least 14, (c) 5 to 50% by weight, based on (a), of a C12- to C18-monocarboxylic acid or of a C12- to C18-hydroxyl compound, where the components (a), (b) and (c) are simultaneously or successively blended or mixed with one another, optionally with addition of a pharmaceutical active compound and/or further customary additives, fused in a heatable mixer, mixed, the melt is cooled and comminuted to give granules or powders.

L'invention concerne un procédé pour fabriquer des granules ou une poudre servant de couverture ou de liant à des formes médicamenteuses d'administration orale ou cutanée, pour des compléments cosmétiques ou alimentaires, lesdites granules ou ladite poudre étant composées des éléments suivants : (a) un copolymère, constitué d'esters C1 à C4 à polymérisation radicalaire des acides acrylique ou méthacrylique ainsi que d'autres monomères (méth)acrylate contenant des groupes amine tertiaire fonctionnels, (b) 3 à 25 % en poids, relativement à (a), d'un émulsifiant dont la balance hydrophile/lipophile est d'au moins 14, (c) 5 à 50 % en poids, relativement à (a), d'un acide monocarbonique C12 à C18 ou d'un composé hydroxylé C12 à C18. Les éléments (a), (b) et (c) sont mélangés simultanément ou successivement, éventuellement avec addition d'un agent pharmaceutique actif et/ou d'autres additifs usuels, puis ils sont fondus et malaxés dans un mélangeur chauffant, la masse fondue ainsi obtenue étant alors refroidie et réduite en granules ou en poudre.

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