DK2523666T3 - Farmaceutisk sammensætning omfattende 3-beta-hydroxy-5-alfa-pregnan-20-on med forbedrede opbevarings- og opløselighedsegenskaber - Google Patents

Farmaceutisk sammensætning omfattende 3-beta-hydroxy-5-alfa-pregnan-20-on med forbedrede opbevarings- og opløselighedsegenskaber Download PDF

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DK2523666T3
DK2523666T3 DK11733156.1T DK11733156T DK2523666T3 DK 2523666 T3 DK2523666 T3 DK 2523666T3 DK 11733156 T DK11733156 T DK 11733156T DK 2523666 T3 DK2523666 T3 DK 2523666T3
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pharmaceutical composition
pregnan
beta
hydroxy
alpha
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DK11733156.1T
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Anders Carlsson
Torbjörn Bäckström
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Asarina Pharma Ab
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    • 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
    • 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
    • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61P15/18—Feminine contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
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    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
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    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32—Alcohol-abuse
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A—HUMAN NECESSITIES
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    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • A61K9/0043—Nose

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Psychiatry (AREA)
  • Endocrinology (AREA)
  • Addiction (AREA)
  • Pain & Pain Management (AREA)
  • Reproductive Health (AREA)
  • Anesthesiology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Hospice & Palliative Care (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (14)

1. Farmaceutisk sammensætning omfattende 3-beta-hydroxy-5-alfa-pregnan-20-on, kolesterol og en blanding af acylglyceroler med et indhold af fast fedtstof på under 25 % ved 25 °C og 0 % ved 37 C°.
2. Farmaceutisk sammensætning ifølge krav 1, hvor blandingen af acylglyceroler er en vegetabilsk olie.
3. Farmaceutisk sammensætning ifølge krav 2, hvor den vegetabilske olie er udvalgt fra gruppen bestående af sesamolie, jordnøddeolie, olivenolie og amerikansk olie.
4. Farmaceutisk sammensætning ifølge krav 1, hvor blandingen af acylglyceroler repræsenterer et samlet procentisk indhold af fedtsyrer med 8 carbonatomer og 10 carbona-tomer på mindst 95 %.
5. Farmaceutisk sammensætning ifølge krav 1, hvor blandingen af acylglyceroler repræsenterer en blanding af monoacylglyceroler, diacylglyceroler og triacylglyceroler.
6. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 5, hvor 3-beta-hydroxy-5-alfa-pregnan-20-on er opløst.
7. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 5, omfattende en opslæmning af 3-beta-hydroxy-5-alfa-pregnan-20-on.
8. Farmaceutisk sammensætning til parenteral indgift ifølge et hvilket som helst af kravene 1 til 7.
9. Farmaceutisk sammensætning til oral indgift ifølge et hvilket som helst af kravene 1 til 7.
10. Farmaceutisk sammensætning til vaginal indgift ifølge et hvilket som helst af kravene 1 til 7.
11. Farmaceutisk sammensætning til nasal indgift ifølge et hvilket som helst af kravene 1 til 7.
12. Fremgangsmåde til fremstilling af en farmaceutisk sammensætning ifølge krav 6, hvilken fremgangsmåde omfatter trinnene a) at opløse 3-beta-hydroxy-5-alfa-pregnan-20-on i ethanol, b) at tilsætte en blanding af acylglyceroler med et indhold af fast fedtstof på under 25 % ved 25 °C og 0 % ved 37 °C og en sterol eller ester deraf, c) at blande indtil en homogen væske opnås, og d) at afdampe ethanolen.
13. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 11 til anvendelse i behandling eller forebyggelse af tilstande i centralnervesystemet udvalgt fra gruppen bestående af epilepsi, menstruationscyklusafhæng epilepsi, depression, stressforbundet depression, migræne, træthed og navnlig stressforbundet træthed, præmenstruelt syndrom, præmenstruel dysfori, stressforbundne hukommelsesforandringer, Alzheimer-demens, stofmisbrug, bivirkninger ved orale svangerskabsforebyggende midler og postklimakteriel behandling eller kombinationer deraf.
14. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 11 til anvendelse i afslutning af steroidinduceret anæstesi.
DK11733156.1T 2010-01-14 2011-01-14 Farmaceutisk sammensætning omfattende 3-beta-hydroxy-5-alfa-pregnan-20-on med forbedrede opbevarings- og opløselighedsegenskaber DK2523666T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US29502710P 2010-01-14 2010-01-14
SE1050029 2010-01-14
PCT/SE2011/050036 WO2011087441A1 (en) 2010-01-14 2011-01-14 A pharmaceutical composition comprising 3-beta-hydroxy-5-alpha-pregnan-20-one with improved storage and solubility properties

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DK2523666T3 true DK2523666T3 (da) 2016-04-04

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US (4) US20120322781A1 (da)
EP (1) EP2523666B8 (da)
JP (1) JP5687287B2 (da)
CN (1) CN102753181B (da)
AU (1) AU2011205821B2 (da)
BR (1) BR112012017136B1 (da)
CA (1) CA2786330C (da)
DK (1) DK2523666T3 (da)
ES (1) ES2566765T3 (da)
HU (1) HUE027298T2 (da)
MX (1) MX2012008257A (da)
PL (1) PL2523666T3 (da)
RU (1) RU2012133627A (da)
WO (1) WO2011087441A1 (da)
ZA (1) ZA201204574B (da)

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JP5687287B2 (ja) 2015-03-18
RU2012133627A (ru) 2014-04-20
BR112012017136A2 (pt) 2018-06-12
EP2523666B1 (en) 2016-01-13
JP2013517269A (ja) 2013-05-16
EP2523666A4 (en) 2013-07-03
MX2012008257A (es) 2012-11-21
ES2566765T3 (es) 2016-04-15
BR112012017136B1 (pt) 2021-05-25
CN102753181B (zh) 2014-09-17
CA2786330A1 (en) 2011-07-21
HUE027298T2 (en) 2016-10-28
WO2011087441A1 (en) 2011-07-21
PL2523666T3 (pl) 2016-06-30
CA2786330C (en) 2013-11-19
ZA201204574B (en) 2013-08-28
US11534446B2 (en) 2022-12-27
US20230117905A1 (en) 2023-04-20
US20150164914A1 (en) 2015-06-18
CN102753181A (zh) 2012-10-24
AU2011205821A1 (en) 2012-07-12
EP2523666B8 (en) 2016-04-06
EP2523666A1 (en) 2012-11-21
US9687496B2 (en) 2017-06-27
US20170258809A1 (en) 2017-09-14
US20120322781A1 (en) 2012-12-20
AU2011205821B2 (en) 2013-07-25

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