Percutaneously absorbable preparation

Details Percutaneously absorbable preparation Percutaneously absorbable preparation

A - Human Necessities

61

M

A61M 37/00 (2006.01) A61K 9/70 (2006.01) A61K 31/565 (2006.01) A61K 31/57 (2006.01) A61K 47/10 (2006.01) A61K 47/12 (2006.01) A61K 47/14 (2006.01) A61K 47/18 (2006.01)

Patent

CA 2195748

A percutaneously absorbable preparation which contains norethisterone, estradiol or ester thereof, each of which is highly absorbable percutaneously, can readily be stuck to the skin, and is lowly skin irritating. It is prepared by applying a pressure-sentitive adhesive layer comprising a drug and a pressure-sensitive adhesive to one side of a support. The drug comprises at least one member selected from among norethisterone, estradiol and pharmacologically acceptable esters thereof, while the adhesive comprises a copolymer composed of 20-55 mol.% of vinylpyrrolidone and 80-45 mol.% of alkyl (C4-C18) (meth)acrylate. The adhesive layer further contains a sorbifacient comprising 0.1-10 wt.% of at least one member selected from among dicarboxylic acids, hydroxy carboxylic acids, plyoxyethylene alkyl ethers and amide compounds and 5-40 wt.%, both based on the adhesive layer, of a higher fatty acid ester prepared from a C10-C18 fatty acid and a C1-C20 alcohol and also contains a cohesive force improver.

L'invention concerne une préparation peu irritante et se collant facilement sur la peau, contenant de la noréthistérone, de l'oestradiol ou un ester de ceux-ci et permettant une forte absorption percutanée de ces composés. Elle est réalisée en appliquant une couche auto-adhésive contenant un médicament et une couche auto-adhésive sur un côté d'un support. Le médicament contient au moins un composé choisi parmi la noréthistérone, l'oestradiol et les esters de ceux-ci acceptables sur le plan pharmacologique, alors que l'adhésif contient un polymère composé de 20-55 % en moles de vinylpyrrolidone et 80-45 % en moles d'un alkyl(C4-C18)méthacrylate. La couche adhésive contient en outre 0,1-10 % en poids d'un agent facilitant l'absorption choisi parmi les acides dicarboxyliques, les composés hydroxycarboxyliques, les polyoxyéthylène alkyle éthers et les composés amides, 5-40 % en poids d'un ester d'un acide gras supérieur préparé à partir d'acides gras en C10-C18 et d'alcools en C1-C20, ainsi qu'un agent pour améliorer la cohésion.

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