Coating and binding agent for oral or dermal pharmaceutical...

C - Chemistry – Metallurgy – 08 – L

Patent

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Details

C08L 33/08 (2006.01) A61K 9/28 (2006.01) A61K 9/70 (2006.01) A61K 47/32 (2006.01) C08L 33/10 (2006.01)

Patent

CA 2338750

The invention relates to a method for the production of a coating and excipient agent for oral or dermal dosage forms, consisting of (a) 35-98 % by weight of a copolymer consisting of radically polymerized C1- C4 esters of acrylic or methacrylic acid and additional (meth)acrylate monomers having functional tertiary ammonium groups and (b) 1- 50 % by weight of a softener and 1-15 % by weight of an emulgator with an HLB value of less than 14, wherein constituents (a), (b) and (c) are mixed with or without adding water and optionally adding a pharmaceutical active substance and other conventional additives and the coating and excipient agent is produced by melting, casting, spreading or spraying. The invention is characterized in that the copolymer (a) is applied in powder form with a mean particle size of 1-40 µm.

L'invention concerne un procédé pour la fabrication d'un agent servant d'enrobant et d'excipient pour des formes médicamenteuses orales ou cutanées, comportant (a) 35-98 % en poids d'un copolymère constitué d'esters C1-C4, polymérisés par voie radicalaire, de l'acide acrylique ou méthacrylique, et d'autres monomères de (méth)acrylate possédant des groupes ammonium tertiaires fonctionnels, (b) 1-50 % en poids d'un plastifiant, ainsi qu' 1-15 % en poids d'un émulsifiant avec une valeur HLB d'au moins 14. Les constituants (a), (b) et (c) sont mélangés avec ou sans addition d'eau et éventuellement avec apport d'un principe actif pharmaceutique et d'autres additifs usuels, et l'agent servant d'enrobant et d'excipient est appliqué par fusion, coulée, enrobage ou pulvérisation. Le procédé est caractérisé en ce que le copolymère (a) est incorporé sous forme pulvérulente avec une taille particulaire moyenne de 1-40 mu m.

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