HRP20170292T1 - Transdermalni flasteri niske doze s visokim otpuštanjem lijeka - Google Patents
Transdermalni flasteri niske doze s visokim otpuštanjem lijeka Download PDFInfo
- Publication number
- HRP20170292T1 HRP20170292T1 HRP20170292TT HRP20170292T HRP20170292T1 HR P20170292 T1 HRP20170292 T1 HR P20170292T1 HR P20170292T T HRP20170292T T HR P20170292TT HR P20170292 T HRP20170292 T HR P20170292T HR P20170292 T1 HRP20170292 T1 HR P20170292T1
- Authority
- HR
- Croatia
- Prior art keywords
- therapeutic system
- transdermal therapeutic
- layer
- ethinylestradiol
- drug
- Prior art date
Links
- 239000003814 drug Substances 0.000 title claims 8
- 229940079593 drug Drugs 0.000 title claims 7
- 239000010410 layer Substances 0.000 claims 12
- 230000001225 therapeutic effect Effects 0.000 claims 12
- SIGSPDASOTUPFS-XUDSTZEESA-N gestodene Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](CC)([C@](C=C4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 SIGSPDASOTUPFS-XUDSTZEESA-N 0.000 claims 8
- BFPYWIDHMRZLRN-UHFFFAOYSA-N 17alpha-ethynyl estradiol Natural products OC1=CC=C2C3CCC(C)(C(CC4)(O)C#C)C4C3CCC2=C1 BFPYWIDHMRZLRN-UHFFFAOYSA-N 0.000 claims 7
- BFPYWIDHMRZLRN-SLHNCBLASA-N Ethinyl estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 BFPYWIDHMRZLRN-SLHNCBLASA-N 0.000 claims 7
- 229960002568 ethinylestradiol Drugs 0.000 claims 7
- 239000012790 adhesive layer Substances 0.000 claims 5
- 229960005352 gestodene Drugs 0.000 claims 5
- 239000006096 absorbing agent Substances 0.000 claims 4
- 229920002367 Polyisobutene Polymers 0.000 claims 3
- 239000004480 active ingredient Substances 0.000 claims 3
- 239000004615 ingredient Substances 0.000 claims 2
- 239000011159 matrix material Substances 0.000 claims 2
- 239000000758 substrate Substances 0.000 claims 2
- MEJYDZQQVZJMPP-ULAWRXDQSA-N (3s,3ar,6r,6ar)-3,6-dimethoxy-2,3,3a,5,6,6a-hexahydrofuro[3,2-b]furan Chemical compound CO[C@H]1CO[C@@H]2[C@H](OC)CO[C@@H]21 MEJYDZQQVZJMPP-ULAWRXDQSA-N 0.000 claims 1
- 239000003961 penetration enhancing agent Substances 0.000 claims 1
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
- 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
- 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
- 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)
- 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. Transdermalni terapijski sustav koji sadrži, redom:
a) sloj podloge,
b) barem jedan ljepljivi sloj koji sadrži lijek koji sadrži aktivne sastojke Gestoden i Etinilestradiol u matrici koja sadrži poliizobutilen i proizvoljno druge farmaceutski prihvatljive sastojke, te
c) traku za sprječavanje oslobađanja;
naznačen time da je količina Gestodena od 0.4 do 1.95 % težinski sloja koji sadrži lijek i količina Etinilestradiola je oko 0.5 % (w/w) težinski sloja koji sadrži lijek i,
naznačen time da je količina Gestodena 1.05 mg zajedno s 0.55 mg Etinilestradiola ili 0.525 mg Gestodena zajedno s 0.55 mg Etinilestradiola s veličinom od 11 cm2.
2. Transdermalni terapijski sustav prema zahtjevu 1, naznačen time da transdermalni terapijski sustav sadrži dodatni sloj s UV absorberom između sloja podloge i ljepljivog sloja koji sadrži lijek.
3. Transdermalni terapijski sustav prema zahtjevu 2, naznačen time da transdermalni terapijski sustav sadrži dodatni međusloj ili razdjelni sloj između dodatnog sloja s UV absorberom i ljepljivog sloja koji sadrži lijek.
4. Transdermalni terapijski sustav prema zahtjevu 1, naznačen time da je količina Gestodena od 0.9 do 1.5 % težinski sloja koji sadrži lijek.
5. Transdermalni terapijski sustav prema zahtjevu 1 naznačen time da sadrži, redom:
a) sloj podloge,
b) ljepljivi sloj koji sadrži UV absorber,
c) međusloj koji je nepropusan za UV absorbere i/ili za aktivne sastojke Gestoden i Etinilestradiol,
d) barem jedan ljepljivi sloj koji sadrži poliizobutilen koji sadrži aktivne sastojke Gestoden i Etinilestradiol i farmaceutski prihvatljive sastojke,
e) traka za sprječavanje oslobađanja.
6. Transdermalni terapijski sustav prema zahtjevu 1 naznačen time da sadrži manje od 5 % pojačivača penetracije.
7. Transdermalni terapijski sustav prema zahtjevu 1 naznačen time da sadrži dimetilizosorbid u količini od manje od 0.5 % (w/w) težinski sloja koji sadrži lijek.
8. Transdermalni terapijski sustav prema zahtjevu 1 naznačen time da je jedinica doziranja za kontinuiranu primjenu tijekom 7 dana.
9. Komplet naznačen time da sadrži 1-52 jedinice doziranja prema zahtjevu 8.
10. Transdermalni terapijski sustav prema zahtjevu 8 naznačen time da jedinica doziranja ima 0.525 ili 1.05 mg Gestodena po jedinici doziranja zajedno s 0.55 mg Etinilestradiola u matrici koja sadrži poliizobutilen s veličinom od 11 cm2.
11. Transdermalni terapijski sustav prema zahtjevu 10 naznačen time da jedinica doziranja sadrži 1.05 mg Gestodena.
Applications Claiming Priority (4)
| 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 |
| EP11757811.2A EP2613772B1 (en) | 2010-09-06 | 2011-09-05 | Low-dose transdermal patches with high drug release |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20170292T1 true HRP20170292T1 (hr) | 2017-04-21 |
Family
ID=44653287
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20170292TT HRP20170292T1 (hr) | 2010-09-06 | 2017-02-22 | Transdermalni flasteri niske doze s visokim otpuštanjem lijeka |
Country Status (19)
| Country | Link |
|---|---|
| US (1) | US8671945B2 (hr) |
| EP (1) | EP2613772B1 (hr) |
| CN (1) | CN103189064B (hr) |
| AR (1) | AR082906A1 (hr) |
| CY (1) | CY1118684T1 (hr) |
| DK (1) | DK2613772T3 (hr) |
| ES (1) | ES2617334T3 (hr) |
| HK (1) | HK1186968A1 (hr) |
| HR (1) | HRP20170292T1 (hr) |
| HU (1) | HUE031326T2 (hr) |
| LT (1) | LT2613772T (hr) |
| ME (1) | ME02618B (hr) |
| PL (1) | PL2613772T3 (hr) |
| PT (1) | PT2613772T (hr) |
| RS (1) | RS55681B1 (hr) |
| SI (1) | SI2613772T1 (hr) |
| TW (1) | TW201215393A (hr) |
| UY (1) | UY33593A (hr) |
| WO (1) | WO2012031999A2 (hr) |
Family Cites Families (21)
| 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 (hr) | 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 |
-
2011
- 2011-09-05 CN CN201180053091.XA patent/CN103189064B/zh not_active Expired - Fee Related
- 2011-09-05 HU HUE11757811A patent/HUE031326T2/hu unknown
- 2011-09-05 PT PT117578112T patent/PT2613772T/pt unknown
- 2011-09-05 EP EP11757811.2A patent/EP2613772B1/en not_active Revoked
- 2011-09-05 DK DK11757811.2T patent/DK2613772T3/en active
- 2011-09-05 WO PCT/EP2011/065261 patent/WO2012031999A2/en active Application Filing
- 2011-09-05 ES ES11757811.2T patent/ES2617334T3/es active Active
- 2011-09-05 SI SI201131114A patent/SI2613772T1/sl unknown
- 2011-09-05 LT LTEP11757811.2T patent/LT2613772T/lt unknown
- 2011-09-05 RS RS20170194A patent/RS55681B1/sr unknown
- 2011-09-05 ME MEP-2017-54A patent/ME02618B/me unknown
- 2011-09-05 PL PL11757811T patent/PL2613772T3/pl unknown
- 2011-09-06 AR ARP110103249A patent/AR082906A1/es unknown
- 2011-09-06 TW TW100132152A patent/TW201215393A/zh unknown
- 2011-09-06 UY UY0001033593A patent/UY33593A/es unknown
- 2011-09-06 US US13/225,829 patent/US8671945B2/en not_active Expired - Fee Related
-
2013
- 2013-12-31 HK HK13114426.0A patent/HK1186968A1/xx not_active IP Right Cessation
-
2017
- 2017-02-22 HR HRP20170292TT patent/HRP20170292T1/hr unknown
- 2017-03-01 CY CY20171100272T patent/CY1118684T1/el unknown
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 |
| AR082906A1 (es) | 2013-01-16 |
| DK2613772T3 (en) | 2017-03-06 |
| 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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