DK2305195T3 - Sammensætninger til lægemiddelindgivelse til forbedret stabilitet af steroider - Google Patents

Sammensætninger til lægemiddelindgivelse til forbedret stabilitet af steroider Download PDF

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Publication number
DK2305195T3
DK2305195T3 DK10180180.1T DK10180180T DK2305195T3 DK 2305195 T3 DK2305195 T3 DK 2305195T3 DK 10180180 T DK10180180 T DK 10180180T DK 2305195 T3 DK2305195 T3 DK 2305195T3
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DK
Denmark
Prior art keywords
drug
patch device
group
matrix patch
stabilized matrix
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Application number
DK10180180.1T
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English (en)
Inventor
Charles Ebert
Uday Jain
Srinivasan Venkateshwaran
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Theratech Inc
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Publication of DK2305195T3 publication Critical patent/DK2305195T3/da

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • A61K9/7061—Polyacrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A61K31/569—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26—Androgens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (10)

1. Stabiliseret matrixplasterindretning til transdermal indgivelse af et steroid-lægemiddel indeholdende en 3-keto-4-en funktionel gruppe, hvor det steroide lægemiddel er stabilt ved forlænget opbevaring af indretningen, hvor den stabiliserede plasterindretning omfatter: a. en virkningsfuld mængde af det steroide lægemiddel valgt fra gruppen bestående af: (i) androgener valgt fra gruppen bestående af testosteron, methyltestosteron, fluoxymesteron, methandrostenolon, nandrolon, norethandrolon og estere og blandinger deraf, og (ii) korti kosteroider valgt fra gruppen bestående af hydroxykortison, kortison, de-soxykortikosteron, fludrokortison, betamethasom, dexamethason, prednisolon, prednison, methylprednisolon, paramethason, triamcinolon, flumethason, fluocinolon, fluocinonid, fluprednisolon, halcinonid, flurandrenolid, meprednison, medryson og estere og blandinger deraf; b. en penetrationsforstærker, hvor penetrationsforstærkeren ingen funktionelle syregrupper har og ikke danner nogen funktionelle syregrupper ved opbevaring; og c. et bærestof omfattende et biokompatibelt polymert klæbemiddel, hvor det biokompatible polymere klæbemiddel er fortrinsvis en blok-copolymer af N-vinyl-pyrrolidon og 2-ethyl-hexylacrylat, og hvor bærestoffet ingen funktionelle syregrupper har og ikke danner nogle funktionelle syregrupper ved opbevaring.
2. Stabiliseret matrixplasterindretning ifølge krav 1, hvor penetrationsforstærkeren er valgt fra gruppen bestående af isopropylmyristat, methyllaureat, oleylalkohol, glyce-rolmonooleat, glyceroldioleat, glyceroltrioleat, glycerolmonostearat, glycerolmonolaurat, propylenglycolmonolaurat og sorbitanestere og blandinger deraf.
3. Stabiliseret matrixplasterindretning ifølge krav 1 eller krav 2, yderligere omfattende et andet steroid-lægemiddel, som ikke indeholder en 3-keto-4-en funktionel gruppe valgt fra gruppen bestående af østrogener, progestiner, androgener og korti kosteroider.
4. Stabiliseret matrixplasterindretning ifølge krav 3, hvor det andet steroidlægemiddel er et østrogen, fortrinsvis østradiol.
5. Stabiliseret matrixplasterindretning ifølge krav 3, hvor progestinet er no-rethindron, norethindronacetat, estere og blandinger deraf.
6. Stabiliseret matrixplasterindretning ifølge et hvilket som helst af krav 1-5, hvor ikke mere end omkring 6% vægt/vægt af steroid-lægemidlet, som indeholder en 3-keto-4-en funktionel gruppe nedbrydes under opbevaring ved omkring 45°C i omkring 8,5 uger.
7. Stabiliseret matrixplasterindretning ifølge et hvilket som helst af krav 1-6, yderligere omfattende et solvent valgt fra gruppen bestående af vand, dioler, monoalkoholer, DMSO, dimethylformamid, N, N-dimethylacetamid, 2-pyrrolidon, azoner og blandinger deraf.
8. Stabiliseret matrixplasterindretning ifølge et hvilket som helst af krav 1-7, hvor penetrationsforstærkeren er en sorbitanester.
9. Stabiliseret matrixplasterindretning ifølge et hvilket som helst af krav 1-8, hvor penetrationsforstærkeren er sorbitanmonooleat.
10. Stabiliseret matrixplasterindretning ifølge et hvilket som helst af krav 1-9, hvor bærestoffet er en blok-copolymer af N-vinylpyrrolidon og 2-ethyl-hexylacrylat.
DK10180180.1T 1995-07-20 1996-06-21 Sammensætninger til lægemiddelindgivelse til forbedret stabilitet af steroider DK2305195T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/504,430 US5780050A (en) 1995-07-20 1995-07-20 Drug delivery compositions for improved stability of steroids
EP96921735.5A EP0876131B1 (en) 1995-07-20 1996-06-21 Drug delivery compositions for improved stability of androgens

Publications (1)

Publication Number Publication Date
DK2305195T3 true DK2305195T3 (da) 2015-06-29

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Family Applications (2)

Application Number Title Priority Date Filing Date
DK96921735.5T DK0876131T3 (da) 1995-07-20 1996-06-21 Sammensætninger til lægemiddelindgivelse til forbedret stabilitet af androgener
DK10180180.1T DK2305195T3 (da) 1995-07-20 1996-06-21 Sammensætninger til lægemiddelindgivelse til forbedret stabilitet af steroider

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Application Number Title Priority Date Filing Date
DK96921735.5T DK0876131T3 (da) 1995-07-20 1996-06-21 Sammensætninger til lægemiddelindgivelse til forbedret stabilitet af androgener

Country Status (13)

Country Link
US (1) US5780050A (da)
EP (2) EP2305195B1 (da)
JP (2) JP3422796B2 (da)
KR (1) KR100505171B1 (da)
CN (2) CN100446769C (da)
AU (1) AU710760B2 (da)
BR (1) BR9609738B1 (da)
CA (1) CA2226425C (da)
DK (2) DK0876131T3 (da)
HK (2) HK1017983A1 (da)
MX (1) MX9800545A (da)
WO (1) WO1997003629A1 (da)
ZA (1) ZA965607B (da)

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CA2226425A1 (en) 1997-02-06
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