DK2613772T3 - Transdermale lavdosisplastre med høj lægemiddelfrigivelse - Google Patents

Transdermale lavdosisplastre med høj lægemiddelfrigivelse Download PDF

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Publication number
DK2613772T3
DK2613772T3 DK11757811.2T DK11757811T DK2613772T3 DK 2613772 T3 DK2613772 T3 DK 2613772T3 DK 11757811 T DK11757811 T DK 11757811T DK 2613772 T3 DK2613772 T3 DK 2613772T3
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DK
Denmark
Prior art keywords
drug
gestodene
ethinylestradiol
layer
containing layer
Prior art date
Application number
DK11757811.2T
Other languages
English (en)
Inventor
Ildiko Terebesi
Christian Zurth
Hannes-Friedrich Ulbrich
Original Assignee
Bayer Ip 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.)
Filing date
Publication date
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Application filed by Bayer Ip Gmbh filed Critical Bayer Ip Gmbh
Application granted granted Critical
Publication of DK2613772T3 publication Critical patent/DK2613772T3/da

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Classifications

    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds 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
    • 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

Landscapes

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

Claims (11)

1. Transdermalt terapeutisk system, der i rækkefølge indeholder: a) et støttelag, b) mindst ét lægemiddelholdigt klæbelag, der omfatter de aktive bestanddele gestoden og ethinylestradiol i en polyisobutylenholdig matrix og eventuelt andre farmaceutisk acceptable bestanddele, og c) en aftagelig strimmel; hvor gestodenmængden er fra 0,4 til 1,95 vægt-% af det lægemiddelholdige lag, og ethinylestradiolmængden er ca. 0,5 vægt-% (vægt/vægt) af det lægemiddelholdige lag, og hvor gestodenmængden er 1,05 mg sammen med 0,55 mg ethinylestradiol eller 0,525 mg gestoden sammen med 0,55 mg ethinylestradiol ved en størrelse på 11 cm2.
2. Transdermalt terapeutisk system ifølge krav 1, hvilket det transdermale terapeutiske system indeholder et yderligere lag med en UV-absorber mellem støttelaget og det lægemiddelholdige klæbelag.
3. Transdermalt terapeutisk system ifølge krav 2, hvilket transdermale terapeutiske system indeholder et yderligere mellem- eller separationslag mellem det yderligere lag med en UV-absorber og det lægemiddelholdige klæbelag.
4. Transdermalt terapeutisk system ifølge krav 1, hvor gestodenmængden er fra 0,9 til 1,5 vægt-% af det lægemiddelholdige lag.
5. Transdermalt terapeutisk system ifølge krav 1, der i rækkefølge indeholder: a) et støttelag, b) et klæbelag, der omfatter en UV-absorber, c) et mellemlag, der er uigennemtrængeligt for UV-absorbere og/eller de aktive bestanddele gestoden og ethinylestradiol, d) mindst ét polyisobutylenholdigt klæbelag, der omfatter de aktive bestanddele gestoden og ethinylestradiol og farmaceutisk acceptable bestanddele, e) en aftagelig strimmel.
6. Transdermalt terapeutisk system ifølge krav 1, der indeholder mindre end 5 % penetreringsforstærkere.
7. Transdermalt terapeutisk system ifølge krav 1, der indeholder dimethylisosorbid i en mængde på mindre end 0,5 vægt-% (vægt/vægt) af det lægemiddelholdige lag.
8. Transdermalt terapeutisk system ifølge krav 1 som en doseringsenhed til kontinuert administration over 7 dage.
9. Kit, der omfatter 1-52 doseringsenheder ifølge krav 8.
10. Transdermalt terapeutisk system ifølge krav 8, hvor doseringsenheden har 0,525 eller 1,05 mg gestoden pr. doseringsenhed sammen med 0,55 mg ethinylestradiol i en polyisobutylenholdig matrix ved en størrelse på 11 cm2.
11. Transdermalt terapeutisk system ifølge krav 10, hvor doseringsenheden indeholder 1,05 mg gestoden.
DK11757811.2T 2010-09-06 2011-09-05 Transdermale lavdosisplastre med høj lægemiddelfrigivelse DK2613772T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP10175498 2010-09-06
EP11155469 2011-02-22
PCT/EP2011/065261 WO2012031999A2 (en) 2010-09-06 2011-09-05 Low-dose transdermal patches with high drug release

Publications (1)

Publication Number Publication Date
DK2613772T3 true DK2613772T3 (da) 2017-03-06

Family

ID=44653287

Family Applications (1)

Application Number Title Priority Date Filing Date
DK11757811.2T DK2613772T3 (da) 2010-09-06 2011-09-05 Transdermale lavdosisplastre med høj lægemiddelfrigivelse

Country Status (19)

Country Link
US (1) US8671945B2 (da)
EP (1) EP2613772B1 (da)
CN (1) CN103189064B (da)
AR (1) AR082906A1 (da)
CY (1) CY1118684T1 (da)
DK (1) DK2613772T3 (da)
ES (1) ES2617334T3 (da)
HK (1) HK1186968A1 (da)
HR (1) HRP20170292T1 (da)
HU (1) HUE031326T2 (da)
LT (1) LT2613772T (da)
ME (1) ME02618B (da)
PL (1) PL2613772T3 (da)
PT (1) PT2613772T (da)
RS (1) RS55681B1 (da)
SI (1) SI2613772T1 (da)
TW (1) TW201215393A (da)
UY (1) UY33593A (da)
WO (1) WO2012031999A2 (da)

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4081537A (en) 1975-10-10 1978-03-28 Schering Aktiengesellschaft Δ15 -Steroids and pharmaceutical compositions thereof
CH674618A5 (da) 1987-04-02 1990-06-29 Ciba Geigy Ag
WO1990004397A1 (de) 1988-10-27 1990-05-03 Schering Aktiengesellschaft Berlin Und Bergkamen Mittel zur transdermalen applikation enthaltend gestoden
US5512292A (en) 1990-10-29 1996-04-30 Alza Corporation Transdermal contraceptive formulations methods and devices
PT99338A (pt) 1990-10-29 1992-10-30 Alza Corp Processo para a preparacao de composicoes de farmacos anticoncepcionais administradas transdermicamente contendo uma mistura dum estrogeno e gestodeno e dispositivos para a sua administracao transdermica
DE4336557C2 (de) 1993-05-06 1997-07-17 Lohmann Therapie Syst Lts Estradiolhaltiges transdermales therapeutisches System, Verfahren zu seiner Herstellung und seine Verwendung
DE4405898A1 (de) 1994-02-18 1995-08-24 Schering Ag Transdermale therapeutische Systeme enthaltend Sexualsteroide
DE19527925C2 (de) * 1995-07-29 1997-07-03 Lohmann Therapie Syst Lts Transdermales therapeutisches System mit einer trennmittelbeschichteten Schutzschicht
DE19827732A1 (de) 1998-06-22 1999-12-23 Rottapharm Bv Transdermales System vom Matrix-Typ zur Abgabe von Wirkstoffen mit einer hohen Abgaberate von Steroid-Hormonen und die Verwendung eines derartigen Systems zur Hormonersatztherapie
DE19906152B4 (de) * 1999-02-10 2005-02-10 Jenapharm Gmbh & Co. Kg Wirkstoffhaltige Laminate für Transdermalsysteme
AU2002235155A1 (en) 2000-12-05 2002-06-18 Noven Pharmaceuticals, Inc. Crystallization inhibition of drugs in transdermal drug delivery systems
NZ530227A (en) * 2001-06-18 2006-09-29 Noven Pharma Enhanced drug delivery in transdermal systems
DE10261696A1 (de) 2002-12-30 2004-07-15 Schwarz Pharma Ag Vorrichtung zur transdermalen Verabreichung von Rotigotin-Base
EP1594483B1 (de) * 2003-02-21 2006-07-19 Schering AG Uv-stabiles transdermales pflaster
DE602004018156D1 (de) 2003-08-25 2009-01-15 Bfs Diversified Products Llc Verfahren und vorrichtung zur überwachung der druckfestigkeit von isolierplatten
EP1541136A1 (de) 2003-12-10 2005-06-15 Schering AG UV-Licht stabile halbfeste transdermale Systeme, die einen lichtempfindlichen Wirkstoff und einen UV-Absorber enthalten
EA011160B1 (ru) 2003-12-12 2009-02-27 Шеринг Акциенгезельшафт Композиция для трансдермальной доставки гормонов без необходимости использования агентов, усиливающих проникновение, и ее применения
UA89766C2 (en) * 2003-12-12 2010-03-10 Байер Шеринг Фарма Акциенгезельшафт Transdermal delivery system of gestodene
US8668925B2 (en) * 2003-12-12 2014-03-11 Bayer Intellectual Property Gmbh Transdermal delivery of hormones without the need of penetration enhancers
EP1719504A1 (de) * 2005-05-02 2006-11-08 Schering AG Festes transdermales therapeutisches System mit UV-Absorber
JP2012504609A (ja) 2008-10-06 2012-02-23 マイラン・テクノロジーズ,インコーポレイテッド アモルファスロチゴチン経皮システム

Also Published As

Publication number Publication date
PL2613772T3 (pl) 2017-06-30
ES2617334T3 (es) 2017-06-16
RS55681B1 (sr) 2017-07-31
EP2613772A2 (en) 2013-07-17
TW201215393A (en) 2012-04-16
HRP20170292T1 (hr) 2017-04-21
AR082906A1 (es) 2013-01-16
SI2613772T1 (sl) 2017-03-31
HK1186968A1 (en) 2014-03-28
WO2012031999A3 (en) 2012-08-02
US20120073578A1 (en) 2012-03-29
PT2613772T (pt) 2017-03-06
ME02618B (me) 2017-06-20
UY33593A (es) 2012-04-30
CN103189064A (zh) 2013-07-03
EP2613772B1 (en) 2016-12-14
US8671945B2 (en) 2014-03-18
LT2613772T (lt) 2017-03-27
CN103189064B (zh) 2015-08-12
WO2012031999A2 (en) 2012-03-15
CY1118684T1 (el) 2017-07-12
HUE031326T2 (hu) 2017-07-28

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