DK2376086T3 - Behandling af vaginal atrofi hos kvinder med risiko for kardiovaskulær patologi - Google Patents
Behandling af vaginal atrofi hos kvinder med risiko for kardiovaskulær patologi Download PDFInfo
- Publication number
- DK2376086T3 DK2376086T3 DK09781638.3T DK09781638T DK2376086T3 DK 2376086 T3 DK2376086 T3 DK 2376086T3 DK 09781638 T DK09781638 T DK 09781638T DK 2376086 T3 DK2376086 T3 DK 2376086T3
- Authority
- DK
- Denmark
- Prior art keywords
- estriol
- day
- use according
- pharmaceutical formulation
- women
- Prior art date
Links
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Classifications
-
- 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
- A61K31/566—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 having an oxo group in position 17, e.g. estrone
-
- 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
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- 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
-
- 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
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
-
- 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
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
Landscapes
- Health & Medical Sciences (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)
- Epidemiology (AREA)
- Reproductive Health (AREA)
- Gynecology & Obstetrics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Endocrinology (AREA)
- Urology & Nephrology (AREA)
- Inorganic Chemistry (AREA)
- Pregnancy & Childbirth (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Steroid Compounds (AREA)
Claims (14)
1. Anvendelse af østriol til fremstilling af en farmaceutisk formulering til vaginal administration med evne til selvbegrænsning af absorptionen af østriol til forebyggelse og/eller behandling af urogenital atrofi hos kvinder, der lider eller har lidt af en kardio-vaskulær patologi, valgt blandt kvinder, som lider af eller har lidt af en koronar sygdom, slagtilfælde, dyb venetrombose, lungeemboli, superficiel tromboflebitis, trombofili og/eller alvorlig migræne med aura; og hvor den farmaceutiske formulering tilvejebringer østriol i en dosis, der er mindre end 0,3 mg/dag.
2. Anvendelse ifølge krav 1, hvor den farmaceutiske formulering tilvejebringer østriol i en dosis, der er mindre end 0,1 mg/dag.
3. Anvendelse ifølge krav 2, hvor den farmaceutiske formulering tilvejebringer østriol i en dosis på mellem 0,002 og 0,07 mg/dag.
4. Anvendelse ifølge krav 3, hvor den farmaceutiske formulering tilvejebringer østriol i en dosis på mellem 0,01 og 0,05 mg/dag.
5. Anvendelse ifølge et hvilket som helst af de foregående krav, hvor den farmaceutiske formulering er en mucoadhæsiv gel, cremegel eller creme indeholdende mindst én bioadhæsiv polymer.
6. Anvendelse ifølge krav 5, hvor den bioadhæsive polymer er valgt fra gruppen bestående af cellulosepolymerer, naturlige gummier, natriumalginat, polyoxyethylener, acryl-polymerer og blandinger deraf.
7. Anvendelse ifølge krav 6, hvor den bioadhæsive polymer er valgt fra gruppen bestående af methylcellulose, carboxymethylcellulose-natrium (CMC), hydroxyethylcellulose (HEC), hydroxypropylcellulose (HPC) og hydroxypropylmethylcellulose (HPMC).
8. Anvendelse ifølge krav 6, hvor den bioadhæsive polymer er valgt fra gruppen bestående af polymerer af typen af acrylsyre tværbundet med divinylglycol og polymerer afledt af acrylsyre tværbundet med allylsaccharose eller allylpentaerythritol.
9. Anvendelse ifølge krav 5, 6 eller 8, hvor den farmaceutiske formulering indeholder mindst én polyacrylsyre tværbundet med divinylglycol og mindst én polymer af acryl-syre tværbundet med allylethere af pentaerythritol.
10. Anvendelse ifølge krav 9, hvor acrylsyren tværbundet med allylethere af penta-erythritol er de, der er polymeriseret i ethylacetat eller i en blanding af ethylacetat og cyclohexan, fortrinsvis med en viskositet på mellem 4.000 og 11.000 cP.
11. Anvendelse ifølge krav 8 til 10, hvor mængderne af den acrylpolymer, der er tværbundet med divinylglycol, og/eller de nævnte polymerer afledt af acrylsyre tværbundet med allylethere af saccharose eller allylethere af pentaerythritol, er individuelt omfattet mellem 0,05 og 5 vægtprocent af formuleringen, fortrinsvis mellem 0,1 og 2%, mere foretrukket mellem 0,25 og 1,5%.
12. Anvendelse ifølge krav 1, hvor den koronare sygdom er myokardieinfarkt, og hvor lungeembolien er lungetromboemboli.
13. Farmaceutisk formulering, som omfatter østriol til vaginal administration, med evne til selvbegrænsning af absorptionen af østriol til anvendelse til forebyggelse og/eller behandling af urogenital atrofi hos kvinder, hvor kvinderne lider eller har lidt af en koro-nar sygdom, slagtilfælde, dyb venetrombose, lungeemboli, superficiel tromboflebitis, trombofili og/eller alvorlig migræne med aura; og hvor den farmaceutiske formulering tilvejebringer østriol i en dosis, der er mindre end 0,3 mg/dag.
14. Farmaceutisk præparat ifølge krav 13, hvor den koronare sygdom er myokardieinfarkt, og hvor lungeembolien er lungetromboemboli.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES200803623A ES2344675B1 (es) | 2008-12-19 | 2008-12-19 | Uso de estriol en la preparacion de una formulacion farrmaceutica para el tratamiento de atrofia vaginal en mujeres con riesgo de patologiacardiovascular. |
| PCT/EP2009/060304 WO2010069621A1 (en) | 2008-12-19 | 2009-08-07 | Treatment of vaginal atrophy in women with cardiovascular pathology risk |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2376086T3 true DK2376086T3 (da) | 2018-12-10 |
Family
ID=41050933
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK09781638.3T DK2376086T3 (da) | 2008-12-19 | 2009-08-07 | Behandling af vaginal atrofi hos kvinder med risiko for kardiovaskulær patologi |
Country Status (23)
| Country | Link |
|---|---|
| US (1) | US8835414B2 (da) |
| EP (1) | EP2376086B1 (da) |
| JP (1) | JP2012512818A (da) |
| KR (1) | KR101734380B1 (da) |
| CN (1) | CN102325533A (da) |
| CA (1) | CA2747314C (da) |
| CL (1) | CL2011001493A1 (da) |
| CO (1) | CO6382128A2 (da) |
| CY (1) | CY1120971T1 (da) |
| DK (1) | DK2376086T3 (da) |
| EC (1) | ECSP11011211A (da) |
| ES (2) | ES2344675B1 (da) |
| HR (1) | HRP20182022T1 (da) |
| HU (1) | HUE040394T2 (da) |
| LT (1) | LT2376086T (da) |
| MA (1) | MA32984B1 (da) |
| MX (1) | MX2011006696A (da) |
| PE (1) | PE20120496A1 (da) |
| PL (1) | PL2376086T3 (da) |
| PT (1) | PT2376086T (da) |
| RU (1) | RU2555752C2 (da) |
| SI (1) | SI2376086T1 (da) |
| WO (1) | WO2010069621A1 (da) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11246934B2 (en) * | 2015-01-05 | 2022-02-15 | B.G. Negev Technologies & Applications Ltd. At Ben-Gurion University | Nanoparticles and methods for preparation thereof |
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| FR1866M (fr) | 1961-04-07 | 1963-06-17 | Vismara Francesco Spa | Nouveaux éthers des hormones oestrogenes. |
| ATE151286T1 (de) | 1983-11-14 | 1997-04-15 | Columbia Lab Inc | Bioadhäsive mittel |
| US5719197A (en) | 1988-03-04 | 1998-02-17 | Noven Pharmaceuticals, Inc. | Compositions and methods for topical administration of pharmaceutically active agents |
| EP0452334A4 (en) | 1989-10-31 | 1991-12-11 | Watson Laboratoires, Inc. | Mucoadhesive carrier for delivery of therapeutical agent |
| DE69014081T2 (de) | 1989-10-31 | 1995-03-30 | Columbia Laboratories, Inc., Miami, Fla. | Mittel zur Feuchthaltung vaginalen Gewebes. |
| US5340586A (en) * | 1991-04-12 | 1994-08-23 | University Of Southern California | Methods and formulations for use in treating oophorectomized women |
| US5543150A (en) | 1993-09-15 | 1996-08-06 | Columbia Laboratories, Inc. | Method of progesterone delivery and affect thereof |
| US5667492A (en) | 1994-10-07 | 1997-09-16 | Columbia Laboratories, Inc. | Use and composition of an anti-sexually transmitted diseases formulation |
| AT408067B (de) | 1995-03-17 | 2001-08-27 | Gebro Pharma Gmbh | Pharmazeutische zusammensetzung zur topischen applizierung und verfahren zu ihrer herstellung |
| US5741525A (en) | 1995-10-24 | 1998-04-21 | Marshall University Research Corporation | Vaginal pharmaceutical hydrogen peroxide composition |
| IT1275816B1 (it) | 1995-10-27 | 1997-10-17 | Montefarmaco Spa | Composizioni farmaceutiche solide per uso vaginale |
| AU714797B2 (en) | 1996-06-14 | 2000-01-13 | Mcneil-Ppc, Inc. | Moisture containing compositions that are spreadable onto and adherable to biomembranes, methods of making and use thereof |
| IT1284874B1 (it) | 1996-08-02 | 1998-05-22 | Farmigea Spa | Complessi bioadesivi di polycarbophil e farmaci antifungini o antiprotozoari azolici |
| US5942243A (en) | 1996-11-12 | 1999-08-24 | Polytherapeutics, Inc. | Mucoadhesive compositions for administration of biologically active agents to animal tissue |
| ATE442844T1 (de) | 1996-11-14 | 2009-10-15 | Lipomedica Ehf | Topische zusammensetzungen enthaltend als therapeutisch aktiven wirkstoff ein monoglycerid zur behandlung von schleimhautinfektionen |
| DE69819748T2 (de) | 1997-09-12 | 2004-09-30 | Columbia Laboratories (Bermuda) Ltd. | Arzneimittel zur behandlung von dysmenorrhöe und verfrühten wehen |
| US6159491A (en) | 1999-02-12 | 2000-12-12 | Biovector Technologies, Inc. | Prolonged release bioadhesive vaginal gel dosage form |
| ATE481108T1 (de) | 1999-02-26 | 2010-10-15 | Novartis Vaccines & Diagnostic | Verwendung von bioadhaesiven und adjuvantien für die mukosale anwendung von antigenen |
| UA74168C2 (uk) | 1999-10-05 | 2005-11-15 | Коламбіа Леборетеріс (Бермуда) Лімітед | Лікування ендометріозу або безпліддя, або покращення плідності та застосування бета-адренергічного агоніста для виробництва лікарського засобу |
| CA2386422A1 (en) | 1999-10-22 | 2001-04-26 | Lif-Hlaup Ehf. Bio-Gels Pharmaceuticals Inc. | Pharmaceutical composition for treatment of mucosal epithelial ulceration and/or erosion |
| CN101934078A (zh) * | 2000-01-18 | 2011-01-05 | 拜耳先灵医药股份有限公司 | 包含屈螺酮和雌激素的药物组合物及其应用 |
| ATE355854T1 (de) | 2000-08-03 | 2007-03-15 | Antares Pharma Ipl Ag | Neue zusammensetzung zur transdermalen und/oder transmukosalen wirkstoffanwendung mit geeignetem therapeutischen spiegel |
| US20040092494A9 (en) | 2000-08-30 | 2004-05-13 | Dudley Robert E. | Method of increasing testosterone and related steroid concentrations in women |
| JP3655846B2 (ja) | 2001-06-27 | 2005-06-02 | 埼玉日本電気株式会社 | Ｃｄｍａ移動通信システム、及びその呼切断防止方法 |
| ES2237298B1 (es) * | 2003-07-16 | 2006-11-01 | Italfarmaco, S.A. | Formulaciones mucoadhesivas semisolidas. |
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| EP1890704A1 (en) | 2005-12-16 | 2008-02-27 | Lyle Corporate Development, Inc. | Regeneration of vaginal tissue with non-systemic vaginal administration of estrogen |
| US20070264309A1 (en) * | 2006-01-20 | 2007-11-15 | Chollet Janet A | Method Of Treating Atrophic Vaginitis |
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| WO2008089405A1 (en) | 2007-01-19 | 2008-07-24 | Neurosci, Inc. | Composition of multiple hormones delivered vaginally in a single cream |
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-
2008
- 2008-12-19 ES ES200803623A patent/ES2344675B1/es active Active
-
2009
- 2009-08-07 PT PT09781638T patent/PT2376086T/pt unknown
- 2009-08-07 WO PCT/EP2009/060304 patent/WO2010069621A1/en active Application Filing
- 2009-08-07 SI SI200931909T patent/SI2376086T1/sl unknown
- 2009-08-07 DK DK09781638.3T patent/DK2376086T3/da active
- 2009-08-07 KR KR1020117016748A patent/KR101734380B1/ko active IP Right Grant
- 2009-08-07 MA MA34038A patent/MA32984B1/fr unknown
- 2009-08-07 EP EP09781638.3A patent/EP2376086B1/en active Active
- 2009-08-07 JP JP2011541240A patent/JP2012512818A/ja active Pending
- 2009-08-07 HU HUE09781638A patent/HUE040394T2/hu unknown
- 2009-08-07 LT LTEP09781638.3T patent/LT2376086T/lt unknown
- 2009-08-07 CA CA2747314A patent/CA2747314C/en active Active
- 2009-08-07 RU RU2011127702/15A patent/RU2555752C2/ru active
- 2009-08-07 US US13/140,602 patent/US8835414B2/en active Active
- 2009-08-07 CN CN2009801571799A patent/CN102325533A/zh active Pending
- 2009-08-07 ES ES09781638T patent/ES2707873T3/es active Active
- 2009-08-07 PL PL09781638T patent/PL2376086T3/pl unknown
- 2009-08-07 PE PE2011001250A patent/PE20120496A1/es not_active Application Discontinuation
- 2009-08-07 MX MX2011006696A patent/MX2011006696A/es active IP Right Grant
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2011
- 2011-06-17 CL CL2011001493A patent/CL2011001493A1/es unknown
- 2011-07-15 EC EC2011011211A patent/ECSP11011211A/es unknown
- 2011-07-19 CO CO11090537A patent/CO6382128A2/es not_active Application Discontinuation
-
2018
- 2018-11-30 HR HRP20182022TT patent/HRP20182022T1/hr unknown
- 2018-12-07 CY CY181101306T patent/CY1120971T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CL2011001493A1 (es) | 2012-01-13 |
| ECSP11011211A (es) | 2011-08-31 |
| CO6382128A2 (es) | 2012-02-15 |
| EP2376086B1 (en) | 2018-09-19 |
| KR20110108358A (ko) | 2011-10-05 |
| PE20120496A1 (es) | 2012-05-04 |
| KR101734380B1 (ko) | 2017-05-11 |
| WO2010069621A1 (en) | 2010-06-24 |
| MA32984B1 (fr) | 2012-01-02 |
| CN102325533A (zh) | 2012-01-18 |
| HRP20182022T1 (hr) | 2019-01-25 |
| CA2747314A1 (en) | 2010-06-24 |
| LT2376086T (lt) | 2019-01-10 |
| ES2707873T3 (es) | 2019-04-05 |
| US8835414B2 (en) | 2014-09-16 |
| PT2376086T (pt) | 2018-12-18 |
| US20110312929A1 (en) | 2011-12-22 |
| ES2344675B1 (es) | 2011-04-28 |
| RU2011127702A (ru) | 2013-01-27 |
| CY1120971T1 (el) | 2019-12-11 |
| MX2011006696A (es) | 2011-07-28 |
| PL2376086T3 (pl) | 2019-05-31 |
| ES2344675A1 (es) | 2010-09-02 |
| RU2555752C2 (ru) | 2015-07-10 |
| JP2012512818A (ja) | 2012-06-07 |
| CA2747314C (en) | 2017-04-18 |
| HUE040394T2 (hu) | 2019-03-28 |
| EP2376086A1 (en) | 2011-10-19 |
| WO2010069621A8 (en) | 2011-07-21 |
| SI2376086T1 (sl) | 2019-02-28 |
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