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HK1118202A1 - Pharmaceutical compositions of a neuroactive steroid and uses thereof - Google Patents

Pharmaceutical compositions of a neuroactive steroid and uses thereof Download PDF

Info

Publication number
HK1118202A1
HK1118202A1 HK08109178.7A HK08109178A HK1118202A1 HK 1118202 A1 HK1118202 A1 HK 1118202A1 HK 08109178 A HK08109178 A HK 08109178A HK 1118202 A1 HK1118202 A1 HK 1118202A1
Authority
HK
Hong Kong
Prior art keywords
pregnan
hydroxy
methoxymethyl
imidazolyl
pharmaceutical composition
Prior art date
Application number
HK08109178.7A
Other languages
German (de)
English (en)
Chinese (zh)
Other versions
HK1118202B (en
Inventor
Richard M. Woodward
Original Assignee
Euro-Celtique S.A.
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
Application filed by Euro-Celtique S.A. filed Critical Euro-Celtique S.A.
Priority to HK10107380.1A priority Critical patent/HK1140947B/en
Publication of HK1118202A1 publication Critical patent/HK1118202A1/en
Publication of HK1118202B publication Critical patent/HK1118202B/en

Links

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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/22—Anxiolytics
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32—Alcohol-abuse
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Neurosurgery (AREA)
  • Psychiatry (AREA)
  • Addiction (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Pain & Pain Management (AREA)
  • Reproductive Health (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (6)

  1. Composition pharmaceutique pour une utilisation dans le traitement de la dépression, de l'addiction et/ou de la dépendance à l'alcool, la tension prémenstruelle, le syndrome prémenstruel ou un trouble dysphorique prémenstruel, comprenant de la 3α-hydroxy-3β-méthoxyméthyl-21-(1'-imidazolyl)-5α-prégnan-20-one, ou un sel ou un solvat pharmaceutiquement acceptable de celle-ci, et un ou plusieurs excipients pharmaceutiquement acceptables, dans laquelle la composition procure, à l'état stationnaire, des taux plasmatiques de 3α-hydroxy-3β-méthoxyméthyl-21-(1'-imidazolyl)-5α-prégnan-20-one, dans la plage de 5 ng/ml à 500 ng/ml pendant une durée de 12 h à 24 h après administration.
  2. Composition pharmaceutique pour une utilisation selon la revendication 1, dans laquelle la composition procure, à l'état stationnaire, des taux plasmatiques de 3α-hydroxy-3β-méthoxyméthyl-21-(1'-imidazolyl)-5α-prégnan-20-one, dans la plage de 50 ng/ml à 500 ng/ml, de 50 ng/ml à 400 ng/ml, de 50 ng/ml à 325 ng/ml, de 50 ng/ml à 100 ng/ml, ou de 100 ng/ml à 250 ng/ml.
  3. Composition pharmaceutique pour une utilisation selon la revendication 1, dans laquelle la composition procure, à l'état stationnaire, des taux plasmatiques de 3α-hydroxy-3β-méthoxyméthyl-21-(1'-imidazolyl)-5α-prégnan-20-one, dans la plage de 50 ng/ml à 250 ng/ml.
  4. Composition pharmaceutique pour une utilisation selon l'une quelconque des revendications 1 à 3, dans laquelle la composition pharmaceutique comprend de 20 mg à 40 mg, de préférence, 30 mg, de 3α-hydroxy-3β-méthoxyméthyl-21-(1'-imidazolyl)-5α-prégnan-20-one.
  5. Composition pharmaceutique pour une utilisation selon l'une quelconque des revendications 1 à 3, dans laquelle la composition pharmaceutique est adaptée à une administration orale.
  6. Composition pharmaceutique pour une utilisation selon la revendication 3, dans laquelle la composition pharmaceutique est sous la forme d'un comprimé à matrice hydrophile, un produit pulvérulent à particules extrudées à l'état fondu encapsulées, un comprimé à matrice hydrophobe, de granulés extrudés à l'état fondu ou de billes à libération contrôlée.
HK08109178.7A 2005-06-09 2006-06-09 Pharmaceutical compositions of a neuroactive steroid and uses thereof HK1118202B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
HK10107380.1A HK1140947B (en) 2005-06-09 2008-08-18 Pharmaceuticals compositions of a neuroactive steroid and uses thereof

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US68890505P 2005-06-09 2005-06-09
US60/688,905 2005-06-09
PCT/EP2006/005574 WO2006131392A1 (fr) 2005-06-09 2006-06-09 Compositions pharmaceutiques a base d'un steroide neuroactif et leurs utilisations

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
HK10107380.1A Division HK1140947B (en) 2005-06-09 2008-08-18 Pharmaceuticals compositions of a neuroactive steroid and uses thereof

Related Child Applications (1)

Application Number Title Priority Date Filing Date
HK10107380.1A Addition HK1140947B (en) 2005-06-09 2008-08-18 Pharmaceuticals compositions of a neuroactive steroid and uses thereof

Publications (2)

Publication Number Publication Date
HK1118202A1 true HK1118202A1 (en) 2009-02-06
HK1118202B HK1118202B (en) 2010-10-15

Family

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Also Published As

Publication number Publication date
NZ562979A (en) 2010-11-26
IL187813A0 (en) 2008-08-07
ATE464054T1 (de) 2010-04-15
KR20120028407A (ko) 2012-03-22
IL216194A (en) 2013-09-30
ZA200709188B (en) 2008-08-27
HK1140947A1 (en) 2010-10-29
KR20100095661A (ko) 2010-08-31
CA2611430C (fr) 2013-09-10
AU2006256851C1 (en) 2010-07-15
US20120276196A1 (en) 2012-11-01
ES2380060T3 (es) 2012-05-08
IL211114A (en) 2014-04-30
JP2008542419A (ja) 2008-11-27
DE602006013622D1 (de) 2010-05-27
DK1888080T3 (da) 2010-07-19
HRP20100372T1 (hr) 2010-08-31
CY1112499T1 (el) 2015-12-09
ES2344313T3 (es) 2010-08-24
BRPI0612921A2 (pt) 2010-12-07
EP2168585A1 (fr) 2010-03-31
HRP20120264T1 (hr) 2012-04-30
EA200800007A1 (ru) 2008-04-28
PL2168585T3 (pl) 2012-05-31
IL216194A0 (en) 2012-01-31
RS51304B (sr) 2010-12-31
EP2263675A3 (fr) 2011-05-18
ATE538797T1 (de) 2012-01-15
WO2006131392A8 (fr) 2007-02-15
RS52199B (sr) 2012-10-31
AU2006256851A1 (en) 2006-12-14
EP2263675A2 (fr) 2010-12-22
PT1888080E (pt) 2010-07-06
CN101193640A (zh) 2008-06-04
EP2168585B1 (fr) 2011-12-28
EP1888080B1 (fr) 2010-04-14
KR20080017091A (ko) 2008-02-25
CA2611430A1 (fr) 2006-12-14
IL187813A (en) 2011-12-29
PT2168585E (pt) 2012-03-05
UA94909C2 (ru) 2011-06-25
CY1110199T1 (el) 2015-01-14
SI2168585T1 (sl) 2012-04-30
EA013744B1 (ru) 2010-06-30
AU2006256851B2 (en) 2009-12-17
EP1888080A1 (fr) 2008-02-20
NO20076319L (no) 2007-12-07
DK2168585T3 (da) 2012-02-27
US20090131383A1 (en) 2009-05-21
JP2012229261A (ja) 2012-11-22
SI1888080T1 (sl) 2010-08-31
PL1888080T3 (pl) 2010-09-30
WO2006131392A1 (fr) 2006-12-14

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Legal Events

Date Code Title Description
PC Patent ceased (i.e. patent has lapsed due to the failure to pay the renewal fee)

Effective date: 20150609