WO2005058287A3 - Transdermal delivery system of hormones without penetration enhancers - Google Patents

Transdermal delivery system of hormones without penetration enhancers Download PDF

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Publication number
WO2005058287A3
WO2005058287A3 PCT/IB2004/052752 IB2004052752W WO2005058287A3 WO 2005058287 A3 WO2005058287 A3 WO 2005058287A3 IB 2004052752 W IB2004052752 W IB 2004052752W WO 2005058287 A3 WO2005058287 A3 WO 2005058287A3
Authority
WO
WIPO (PCT)
Prior art keywords
hormones
patch
penetration enhancers
delivery system
transdermal delivery
Prior art date
Application number
PCT/IB2004/052752
Other languages
French (fr)
Other versions
WO2005058287A2 (en
Inventor
Stefan Bracht
Michael Dittgen
Petra Huber
Thomas Langguth
Dirk Schenk
Original Assignee
Schering Ag
Stefan Bracht
Michael Dittgen
Petra Huber
Thomas Langguth
Dirk Schenk
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34702342&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2005058287(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to MXPA06006682A priority Critical patent/MXPA06006682A/en
Priority to BRPI0417530A priority patent/BRPI0417530B8/en
Priority to CN2004800413210A priority patent/CN1913878B/en
Priority to CA2549916A priority patent/CA2549916C/en
Priority to KR1020067013923A priority patent/KR101168449B1/en
Priority to NZ548091A priority patent/NZ548091A/en
Priority to JP2006543709A priority patent/JP4965263B2/en
Application filed by Schering Ag, Stefan Bracht, Michael Dittgen, Petra Huber, Thomas Langguth, Dirk Schenk filed Critical Schering Ag
Priority to EA200601089A priority patent/EA011160B1/en
Priority to AU2004298930A priority patent/AU2004298930B2/en
Publication of WO2005058287A2 publication Critical patent/WO2005058287A2/en
Publication of WO2005058287A3 publication Critical patent/WO2005058287A3/en
Priority to IL176112A priority patent/IL176112A/en
Priority to NO20062594A priority patent/NO341989B1/en
Priority to ZA2006/05713A priority patent/ZA200605713B/en
Priority to CU20100143A priority patent/CU23868B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • 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
    • 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
    • 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
    • A61K31/567—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 position 17 alpha, e.g. mestranol, norethandrolone
    • 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
    • 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
    • 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
    • A61K9/7076—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising ingredients of undetermined constitution or reaction products thereof, e.g. rosin or other plant resins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18—Feminine contraceptives

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Botany (AREA)
  • Gynecology & Obstetrics (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Reproductive Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)

Abstract

The present invention relates to a patch comprising a drug-containing layer with low content of hormones, such as gestodene, and optionally an estrogen (e.g. ethinyl estradiol). Upon administering the patch to a woman, plasma levels of at least 1.0 ng/ml of Gestodene is achieved at steady state conditions without the need of incorporating penetration enhancers or permeation enhancers in the drug-containing layer. Satisfactorily plasma levels of the hormones is also achieved throughout a period of at least 1 week, making the patch applicable for being used in female contraception with the concept of administering the patch ones weekly.
PCT/IB2004/052752 2003-12-12 2004-12-10 Transdermal delivery system of hormones without penetration enhancers WO2005058287A2 (en)

Priority Applications (13)

Application Number Priority Date Filing Date Title
AU2004298930A AU2004298930B2 (en) 2003-12-12 2004-12-10 Transdermal delivery system of hormones without penetration enhancers
JP2006543709A JP4965263B2 (en) 2003-12-12 2004-12-10 Transdermal delivery of hormones without the need for penetration enhancers
CN2004800413210A CN1913878B (en) 2003-12-12 2004-12-10 Transdermal delivery of hormones without the need of penetration enhancers
CA2549916A CA2549916C (en) 2003-12-12 2004-12-10 Transdermal delivery system of hormones without penetration enhancers
EA200601089A EA011160B1 (en) 2003-12-12 2004-12-10 A composition for transdermal delivery of hormones without penetration enhancers and its use
NZ548091A NZ548091A (en) 2003-12-12 2004-12-10 Transdermal delivery system of hormones without penetration enhancers
BRPI0417530A BRPI0417530B8 (en) 2003-12-12 2004-12-10 composition for transdermal hormone release without the need for penetration enhancers, transdermal therapeutic system, and kit
MXPA06006682A MXPA06006682A (en) 2003-12-12 2004-12-10 Transdermal delivery of hormones without the need of penetration enhancers.
KR1020067013923A KR101168449B1 (en) 2003-12-12 2004-12-10 Transdermal delivery system of hormones without penetration enhancers
IL176112A IL176112A (en) 2003-12-12 2006-06-05 Composition for transdermal delivery containing gestodene and a carrier, a transdermal therapeutic system comprising gestodene and a kit
NO20062594A NO341989B1 (en) 2003-12-12 2006-06-06 Transdermal administration of hormones without the need for penetration enhancers.
ZA2006/05713A ZA200605713B (en) 2003-12-12 2006-07-11 Transdermal delivery system of hormones without penetration enhancers
CU20100143A CU23868B1 (en) 2003-12-12 2010-07-05 TRANSDERMAL ADMINISTRATION HORMONES THAT DO NOT NEED PENETRATION POTENTIATORS

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US52871803P 2003-12-12 2003-12-12
US60/528,718 2003-12-12
EP03078881 2003-12-12
EP03078881.4 2003-12-12

Publications (2)

Publication Number Publication Date
WO2005058287A2 WO2005058287A2 (en) 2005-06-30
WO2005058287A3 true WO2005058287A3 (en) 2006-03-02

Family

ID=34702342

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2004/052752 WO2005058287A2 (en) 2003-12-12 2004-12-10 Transdermal delivery system of hormones without penetration enhancers

Country Status (15)

Country Link
JP (1) JP4965263B2 (en)
KR (1) KR101168449B1 (en)
CN (1) CN1913878B (en)
AU (1) AU2004298930B2 (en)
BR (1) BRPI0417530B8 (en)
CA (1) CA2549916C (en)
CU (1) CU23868B1 (en)
EA (1) EA011160B1 (en)
EC (1) ECSP066694A (en)
IL (1) IL176112A (en)
MX (1) MXPA06006682A (en)
NO (1) NO341989B1 (en)
NZ (1) NZ548091A (en)
WO (1) WO2005058287A2 (en)
ZA (1) ZA200605713B (en)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE333271T1 (en) 2003-02-21 2006-08-15 Schering Ag UV-STABLE TRANSDERMAL PLASTER
US8962013B2 (en) 2005-05-02 2015-02-24 Bayer Intellectual Property Gmbh Multi-layered transdermal system with triazine UV absorber
DE102005050729A1 (en) * 2005-10-19 2007-04-26 Schering Ag Method of preventive on-demand hormonal contraception
FR2900048B1 (en) * 2006-04-21 2012-11-16 Oreal COMPOSITIONS COMPRISING A DIPHENYL-METHANE HYDROXYLATED DERIVATIVE
DE102010040299A1 (en) 2010-09-06 2012-03-08 Bayer Schering Pharma Aktiengesellschaft Transdermal therapeutic systems with crystallization-inhibiting protective film (release liner)
DK2613772T3 (en) 2010-09-06 2017-03-06 Bayer Ip Gmbh TRANSDERMAL LOW DOSAGE PATTERNS WITH HIGH PHARMACEUTICAL RELEASE
AU2015203180B2 (en) * 2010-09-06 2016-06-30 Bayer Intellectual Property Gmbh Transdermal therapeutic systems with crystallization-inhibiting protective film (release liner)
EP2806862A2 (en) * 2012-01-27 2014-12-03 Agile Therapeutics, Inc. Transdermal hormone delivery
US20180125860A1 (en) * 2015-05-18 2018-05-10 Agile Therapeutics, Inc. Contraceptive Compositions and Methods for Improved Efficacy and Modulation of Side Effects

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992007590A1 (en) * 1990-10-29 1992-05-14 Alza Corporation Transdermal contraceptive formulations, methods and devices
EP0573133A1 (en) * 1988-10-27 1993-12-08 Schering Aktiengesellschaft Means for transdermal application of Gestoden
US5512292A (en) * 1990-10-29 1996-04-30 Alza Corporation Transdermal contraceptive formulations methods and devices
US5858394A (en) * 1993-08-26 1999-01-12 Schering Aktiengesellschaft Agent for transdermal administration that contains gestodene esters
US5904931A (en) * 1994-02-18 1999-05-18 Schering Aktiengesellschaft Transdermal therapeutic systems that contain sex steroids and dimethyl isosorbide
DE19906152A1 (en) * 1999-02-10 2000-08-17 Jenapharm Gmbh Active ingredient-containing laminates for transdermal systems
WO2002034200A2 (en) * 2000-10-27 2002-05-02 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic systems comprising photosensitive active substances
WO2002045701A2 (en) * 2000-12-05 2002-06-13 Noven Pharmaceuticals, Inc. Crystallization inhibition of drugs in transdermal drug delivery systems

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU692944B2 (en) * 1994-11-18 1998-06-18 Hisamitsu Pharmaceutical Co., Inc. Percutaneously absorbable patch
ES2190472T5 (en) * 1995-06-07 2012-03-09 Ortho-Mcneil Pharmaceutical, Inc. TRANSDERMAL PATCH FOR THE ADMINISTRATION OF 17-DEACETIL NORGESTIMATO, IN COMBINATION WITH A STROGEN.
JP4346696B2 (en) * 1996-05-28 2009-10-21 久光製薬株式会社 Transdermal therapeutic device
JP4167750B2 (en) * 1997-04-16 2008-10-22 久光製薬株式会社 Transdermal absorption base and percutaneous absorption preparation containing the base
JP4399044B2 (en) * 1998-10-14 2010-01-13 久光製薬株式会社 Absorption enhancer and transdermal absorption preparation comprising the absorption enhancer
KR20010112479A (en) * 1999-07-01 2001-12-20 나까도미 히로다카 Adhesive preparation for percutaneous absorption

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0573133A1 (en) * 1988-10-27 1993-12-08 Schering Aktiengesellschaft Means for transdermal application of Gestoden
WO1992007590A1 (en) * 1990-10-29 1992-05-14 Alza Corporation Transdermal contraceptive formulations, methods and devices
US5512292A (en) * 1990-10-29 1996-04-30 Alza Corporation Transdermal contraceptive formulations methods and devices
US5858394A (en) * 1993-08-26 1999-01-12 Schering Aktiengesellschaft Agent for transdermal administration that contains gestodene esters
US5904931A (en) * 1994-02-18 1999-05-18 Schering Aktiengesellschaft Transdermal therapeutic systems that contain sex steroids and dimethyl isosorbide
DE19906152A1 (en) * 1999-02-10 2000-08-17 Jenapharm Gmbh Active ingredient-containing laminates for transdermal systems
WO2002034200A2 (en) * 2000-10-27 2002-05-02 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic systems comprising photosensitive active substances
WO2002045701A2 (en) * 2000-12-05 2002-06-13 Noven Pharmaceuticals, Inc. Crystallization inhibition of drugs in transdermal drug delivery systems

Also Published As

Publication number Publication date
BRPI0417530B1 (en) 2018-01-23
NO341989B1 (en) 2018-03-12
CA2549916A1 (en) 2005-06-30
AU2004298930B2 (en) 2009-11-26
IL176112A0 (en) 2006-10-05
IL176112A (en) 2011-02-28
CU23868B1 (en) 2013-03-27
CU20100143A7 (en) 2011-10-31
CN1913878B (en) 2010-05-26
MXPA06006682A (en) 2006-08-11
CN1913878A (en) 2007-02-14
ECSP066694A (en) 2006-10-31
NO20062594L (en) 2006-07-10
JP4965263B2 (en) 2012-07-04
WO2005058287A2 (en) 2005-06-30
ZA200605713B (en) 2008-01-08
CA2549916C (en) 2013-09-17
AU2004298930A1 (en) 2005-06-30
EA200601089A1 (en) 2006-12-29
BRPI0417530A (en) 2007-03-13
KR20060128910A (en) 2006-12-14
JP2007513938A (en) 2007-05-31
NZ548091A (en) 2009-12-24
KR101168449B1 (en) 2012-07-25
BRPI0417530B8 (en) 2021-05-25
EA011160B1 (en) 2009-02-27

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