HRP20140077T1 - Transdermalni sustav za davanje hormona bez sredstava za pospješivanje prodiranja - Google Patents

Transdermalni sustav za davanje hormona bez sredstava za pospješivanje prodiranja Download PDF

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Publication number
HRP20140077T1
HRP20140077T1 HRP20140077TT HRP20140077T HRP20140077T1 HR P20140077 T1 HRP20140077 T1 HR P20140077T1 HR P20140077T T HRP20140077T T HR P20140077TT HR P20140077 T HRP20140077 T HR P20140077T HR P20140077 T1 HRP20140077 T1 HR P20140077T1
Authority
HR
Croatia
Prior art keywords
kit
drug
weeks
kit according
gestoden
Prior art date
Application number
HRP20140077TT
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English (en)
Inventor
Thomas Langguth
Michael Dittgen
Stefan Bracht
Petra Huber
Dirk Schenk
Original Assignee
Bayer Intellectual Property Gmbh
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.)
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Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34924031&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20140077(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bayer Intellectual Property Gmbh filed Critical Bayer Intellectual Property Gmbh
Publication of HRP20140077T1 publication Critical patent/HRP20140077T1/hr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds 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
    • A61K31/567Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal 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
    • A61K9/7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053Transdermal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal 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
    • A61K9/7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053Transdermal 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
    • A61K9/7061Polyacrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal 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
    • A61K9/7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7076Transdermal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18Feminine contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones

Landscapes

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

Claims (12)

1. Komplet koji sadrži 1 do 11 jediničnih doza namijenjen za razdoblje liječenja od 12 tjedana koji je formuliran u obliku za transdermalno davanje Gestodena, te navedena jedinica doziranja sadrži pripravak za transdermalno davanje koji sadrži sloj koji sadrži lijek koji uključuje Gestoden i nosač koji je odabran iz skupine koja sadrži poliizobutilene, polibutene, poliizoprene, polistirene, stiren izopren stiren blok polimere, stiren butadien stiren blok polimere i njihove smjese, naznačen time da sloj koji sadrži lijek ima topljivost za navedeni Gestoden od ne više od 3% težinski sloja koji sadrži lijek, te pri čemu je Gestoden prisutan u količini u rasponu između 0.5 i 3% težinski sloja koji sadrži lijek.
2. Komplet prema zahtjevu 1, naznačen time da je komplet namijenjen za razdoblje liječenja od 12 tjedana i komplet sadrži 1 do 9 jediničnih doza.
3. Komplet prema zahtjevu 1, naznačen time da je komplet namijenjen za razdoblje liječenja od 12 tjedana i komplet sadrži 11 jediničnih doza koje se daju neprekidno jednom tjedno tijekom razdoblja od 11 tjedana nakon čega slijedi tjedan dana bez davanja jedinica doziranja ili davanje placeba.
4. Komplet prema zahtjevu 1, naznačen time da je komplet namijenjen za razdoblje liječenja od 12 tjedana i komplet sadrži 9 jediničnih doza.
5. Komplet koji sadrži 1 do 3 jediničnih doza, naznačen time da je komplet namijenjen za razdoblje liječenja od 4 tjedna formuliran u obliku za transdermalno davanje Gestodena ili njegovog estera, te pri čemu navedena jedinica doziranja sadrži pripravak za transdermalno davanje koji uključuje sloj koji sadrži lijek koji sadrži Gestoden ili njegov ester i nosač koji je odabran iz skupine koja sadrži poliizobutilene, polibutene, poliizoprene, polistirene, stiren izopren stiren blok polimere, stiren butadien stiren blok polimere i njihove smjese, pri čemu sloj koji sadrži lijek ima topljivost za navedeni Gestoden od ne više od 3% težinski sloja koji sadrži lijek, te pri čemu je Gestoden ili njegov ester prisutan u količini u rasponu između 0.5 i 3% težinski sloja koji sadrži lijek.
6. Komplet prema zahtjevu 5, naznačen time da je komplet namijenjen za razdoblje liječenja od 4 tjedna i komplet sadrži 3 jedinične doze koje se daju tjedno tijekom perioda od 3 tjedna, nakon čega slijedi tjedan dana bez davanja jedinica doziranja ili davanje placeba.
7. Komplet prema bilo kojem prethodnom zahtjevu, naznačen time da svaka jedinica doziranja sadrži Gestoden u dozi od oko 0.5 do 5 mg, poželjno 1 do 3 mg, poželjnije 1.5 do 2.5 mg.
8. Komplet prema bilo kojem prethodnom zahtjevu, naznačen time da sloj koji sadrži lijek dodatno sadrži ljepljivo sredstvo odabrano iz skupine koja sadrži smole ugljikovodika, smole kalofonija i terpenske smole.
9. Komplet prema zahtjevu 8, naznačen time da je ljepljivo sredstvo ester kalofonija.
10. Komplet prema bilo kojem prethodnom zahtjevu, naznačen time da jedinica doziranja dodatno sadrži estrogen.
11. Komplet prema bilo kojem prethodnom zahtjevu, naznačen time da je nosač poliizobutilen u količini od barem 30% težinski.
12. Komplet prema bilo kojem prethodnom zahtjevu, naznačen time da nosač ne uključuje kopolimere izoprena.
HRP20140077TT 2003-12-12 2014-01-24 Transdermalni sustav za davanje hormona bez sredstava za pospješivanje prodiranja HRP20140077T1 (hr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP03078881 2003-12-12

Publications (1)

Publication Number Publication Date
HRP20140077T1 true HRP20140077T1 (hr) 2014-02-28

Family

ID=34924031

Family Applications (2)

Application Number Title Priority Date Filing Date
HR20100254T HRP20100254T1 (hr) 2003-12-12 2010-05-04 Transdermalni sustav za davanje gestodena
HRP20140077TT HRP20140077T1 (hr) 2003-12-12 2014-01-24 Transdermalni sustav za davanje hormona bez sredstava za pospješivanje prodiranja

Family Applications Before (1)

Application Number Title Priority Date Filing Date
HR20100254T HRP20100254T1 (hr) 2003-12-12 2010-05-04 Transdermalni sustav za davanje gestodena

Country Status (23)

Country Link
EP (2) EP2138169B1 (hr)
CN (1) CN101843603B (hr)
AR (1) AR046762A1 (hr)
AT (1) ATE457168T1 (hr)
CR (1) CR8465A (hr)
CY (2) CY1110637T1 (hr)
DE (1) DE602004025444D1 (hr)
DK (2) DK2138169T3 (hr)
ES (2) ES2340925T3 (hr)
GT (1) GT200400262A (hr)
HN (1) HN2004000526A (hr)
HR (2) HRP20100254T1 (hr)
JO (1) JO2606B1 (hr)
ME (1) ME01069B (hr)
MY (2) MY144053A (hr)
PE (1) PE20051035A1 (hr)
PL (2) PL1541137T3 (hr)
PT (2) PT1541137E (hr)
RS (2) RS51260B (hr)
SI (2) SI1541137T1 (hr)
SV (1) SV2006001970A (hr)
TW (1) TWI257299B (hr)
UA (1) UA89766C2 (hr)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI1594483T1 (sl) 2003-02-21 2006-12-31 Schering Ag UV-stabilni transdermalni terapevtski obliz
US8668925B2 (en) 2003-12-12 2014-03-11 Bayer Intellectual Property Gmbh Transdermal delivery of hormones without the need of penetration enhancers
US8962013B2 (en) 2005-05-02 2015-02-24 Bayer Intellectual Property Gmbh Multi-layered transdermal system with triazine UV absorber
DE102005050729A1 (de) * 2005-10-19 2007-04-26 Schering Ag Verfahren zur präventiven bedarfsweisen hormonalen Kontrazeption
CA2740002C (en) 2008-10-08 2016-11-01 Agile Therapeutics, Inc. Transdermal delivery
EP2343964A4 (en) 2008-10-08 2012-11-07 Agile Therapeutics Inc TRANSDERMAL ADMINISTRATION
CA2740005C (en) 2008-10-08 2016-11-01 Agile Therapeutics, Inc. Transdermal delivery
WO2010111488A1 (en) * 2009-03-27 2010-09-30 Agile Therapeutics, Inc. Transdermal delivery
ES2617334T3 (es) 2010-09-06 2017-06-16 Bayer Intellectual Property Gmbh Parches transdérmicos de dosificación baja con liberación elevada de fármaco
DE102010040299A1 (de) * 2010-09-06 2012-03-08 Bayer Schering Pharma Aktiengesellschaft Transdermale therapeutische Systeme mit kristallisationsinhibierender Schutzfolie (Release Liner)
AU2015203180B2 (en) * 2010-09-06 2016-06-30 Bayer Intellectual Property Gmbh Transdermal therapeutic systems with crystallization-inhibiting protective film (release liner)
HK1204287A1 (en) * 2012-01-27 2015-11-13 敏捷治疗公司 Transdermal hormone delivery

Family Cites Families (12)

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US4081537A (en) 1975-10-10 1978-03-28 Schering Aktiengesellschaft Δ15 -Steroids and pharmaceutical compositions thereof
EP0394429B1 (de) * 1988-10-27 1996-01-10 Schering Aktiengesellschaft Mittel zur transdermalen applikation enthaltend gestoden
US5512292A (en) 1990-10-29 1996-04-30 Alza Corporation Transdermal contraceptive formulations methods and devices
MX9101787A (es) 1990-10-29 1992-06-05 Alza Corp Formulaciones,metodos y dispositivos anticonceptivos transdermicos
DE4336557C2 (de) 1993-05-06 1997-07-17 Lohmann Therapie Syst Lts Estradiolhaltiges transdermales therapeutisches System, Verfahren zu seiner Herstellung und seine Verwendung
DE4329242A1 (de) * 1993-08-26 1995-03-02 Schering Ag Mittel zur transdermalen Applikation enthaltend Gestodenester
DE4405898A1 (de) * 1994-02-18 1995-08-24 Schering Ag Transdermale therapeutische Systeme enthaltend Sexualsteroide
US5762956A (en) 1996-04-24 1998-06-09 Rutgers, The State University Of New Jersey Transdermal contraceptive delivery system and process
DE19906152B4 (de) 1999-02-10 2005-02-10 Jenapharm Gmbh & Co. Kg Wirkstoffhaltige Laminate für Transdermalsysteme
JP4841781B2 (ja) 1999-11-24 2011-12-21 アジル・セラピューティクス・インコーポレイテッド 改良された経皮的避妊薬送達系および方法
DE10053375C1 (de) * 2000-10-27 2002-01-24 Lohmann Therapie Syst Lts Transdermale therapeutische Systeme mit lichtempfindlichen Wirkstoffen
TWI287455B (en) * 2000-12-05 2007-10-01 Noven Pharma Crystallization inhibition of drugs in transdermal drug delivery systems and methods of use

Also Published As

Publication number Publication date
MY152750A (en) 2014-11-28
JO2606B1 (en) 2011-11-01
SV2006001970A (es) 2006-02-16
HK1132682A1 (en) 2010-03-05
ES2340925T3 (es) 2010-06-11
EP1541137A3 (en) 2005-11-16
SI2138169T1 (sl) 2014-03-31
GT200400262A (es) 2005-10-31
PT2138169E (pt) 2014-02-17
CN101843603A (zh) 2010-09-29
RS53182B (sr) 2014-06-30
HRP20100254T1 (hr) 2010-06-30
ME01069B (me) 2012-10-20
PL2138169T3 (pl) 2014-04-30
CY1115064T1 (el) 2016-12-14
CY1110637T1 (el) 2015-04-29
EP2138169A2 (en) 2009-12-30
UA89766C2 (en) 2010-03-10
DE602004025444D1 (de) 2010-03-25
DK2138169T3 (da) 2013-11-18
HN2004000526A (es) 2010-02-01
RS51260B (sr) 2010-12-31
TW200528073A (en) 2005-09-01
CR8465A (es) 2007-06-06
EP2138169B1 (en) 2013-11-06
TWI257299B (en) 2006-07-01
PT1541137E (pt) 2010-05-17
CN101843603B (zh) 2012-06-27
DK1541137T3 (da) 2010-04-26
ES2445690T3 (es) 2014-03-04
AR046762A1 (es) 2005-12-21
MY144053A (en) 2011-08-15
SI1541137T1 (sl) 2010-06-30
PL1541137T3 (pl) 2010-07-30
EP2138169A3 (en) 2011-04-06
ATE457168T1 (de) 2010-02-15
EP1541137A2 (en) 2005-06-15
EP1541137B1 (en) 2010-02-10
PE20051035A1 (es) 2006-02-08
HK1074801A1 (en) 2005-11-25

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