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1. EP0773028 - PERCUTANEOUSLY ABSORBABLE PREPARATION

Office European Patent Office
Application Number 95925997
Application Date 20.07.1995
Publication Number 0773028
Publication Date 14.05.1997
Publication Kind A4
IPC
A61K 9/70
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
70Web, sheet or filament bases
A61K 31/565
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopentahydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
A61K 47/10
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen
10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols ; Poloxamers; PEG/POE alkyl ethers
A61K 47/12
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen
12Carboxylic acids; Salts or anhydrides thereof
A61K 47/14
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen
14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
A61K 47/18
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
16containing nitrogen
18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
CPC
A61K 9/7053
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
70Web, sheet or filament bases ; ; Films; Fibres of the matrix type containing drug;
7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
703characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
7046the adhesive comprising macromolecular compounds
7053obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
A61K 9/7061
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
70Web, sheet or filament bases ; ; Films; Fibres of the matrix type containing drug;
7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
703characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
7046the adhesive comprising macromolecular compounds
7053obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
7061Polyacrylates
A61K 31/565
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
A61K 31/566
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
566having an oxo group in position 17, e.g. estrone
A61K 31/569
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
568substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
569substituted in position 17 alpha, e.g. ethisterone
A61K 31/575
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
575substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
Applicants SEIKISUI CHEMICAL CO LTD
Inventors HASHIMOTO MASAKI
MANO MITSUHITO
AMANO MUTSUKI
WAKIYA TAKESHI
Designated States
Priority Data 1994170945 22.07.1994 JP
9501442 20.07.1995 JP
Title
(DE) PERKUTAN ABSORBIERBARES PRÄPARAT
(EN) PERCUTANEOUSLY ABSORBABLE PREPARATION
(FR) PREPARATION SE PRETANT A UNE ABSORPTION PERCUTANEE
Abstract
(EN)
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.

(FR)
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.