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 PDF

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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
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DK
Denmark
Prior art keywords
estriol
day
use according
pharmaceutical formulation
women
Prior art date
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DK09781638.3T
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English (en)
Inventor
Fernández Áivaro Acebrón
Lousame Dolores Blanco
Del Prado Jaime Moscoso
Magro Concepción Nieto
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Itf Res Pharma Slu
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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
    • A61K31/566Compounds 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
    • 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
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0034Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system

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  • 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.
DK09781638.3T 2008-12-19 2009-08-07 Behandling af vaginal atrofi hos kvinder med risiko for kardiovaskulær patologi DK2376086T3 (da)

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)

* Cited by examiner, † Cited by third party
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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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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