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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

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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
English (en)
French (fr)
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

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/22Anxiolytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32Alcohol-abuse
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Molecular Biology (AREA)
  • Psychiatry (AREA)
  • Addiction (AREA)
  • Inorganic Chemistry (AREA)
  • Reproductive Health (AREA)
  • Endocrinology (AREA)
  • Pain & Pain Management (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. Eine pharmazeutische Zusammensetzung zur Verwendung in der Behandlung von Depression, Alkoholsucht und/oder -abhängigkeit, prämenstrueller Anspannung, prämenstruellem Syndrom oder prämenstrueller dysphorischer Störung, enthaltend 3α-Hydroxy-3β-methoxymethyl-21-(1'-imidazolyl)-5α-pregnan-20-on oder ein pharmazeutisch akzeptables Salz oder Solvat davon, und einen oder mehrere pharmazeutisch akzeptable Hilfsstoffe, wobei die Zusammensetzung steady-state-Plasmaspiegel des 3α-Hydroxy-3β-methoxymethyl-21-(1'-imidazolyl)-5α-pregnan-20-on in einem Bereich von 5 ng/ml bis 500 ng/ml für eine Zeitdauer von 12 Stunden bis 24 Stunden nach Verabreichung bewirkt.
  2. Die pharmazeutische Zusammensetzung zur Verwendung gemäß Anspruch 1, wobei die Zusammensetzung steady-state-Plasmaspiegel von 3α-Hydroxy-3β-methoxymethyl-21-(1'-imidazolyl)-5α-pregnan-20-on in einem Bereich von 50 ng/ml bis 500 ng/ml, von 50 ng/ml bis 400 ng/ml, von 50 ng/ml bis 325 ng/ml, von 50 ng/ml bis 100 ng/ml oder von 100 ng/ml bis 250 ng/ml bewirkt.
  3. Die pharmazeutische Zusammensetzung zur Verwendung gemäß Anspruch 1, wobei die Zusammensetzung steady-state-Plasmaspiegel von 3α-Hydroxy-3β-methoxymethyl-21-(1'-imidazolyl)-5α-pregnan-20-on in einem Bereich von 50 ng/ml bis 250 ng/ml bewirkt.
  4. Die pharmazeutische Zusammensetzung zur Verwendung gemäß irgendeinem der Ansprüche 1 bis 3, wobei die pharmazeutische Zusammensetzung von 20 mg bis 40 mg, vorzugsweise 30 mg, 3α-Hydroxy-3β-methoxymethyl-21-(1'-imidazolyl)-5α-pregnan-20-on enthält.
  5. Die pharmazeutische Zusammensetzung zur Verwendung gemäß irgendeinem der Ansprüche 1 bis 3, wobei die pharmazeutische Zusammensetzung zur oralen Gabe geeignet ist.
  6. Die pharmazeutische Zusammensetzung zur Verwendung gemäß Anspruch 3, wobei die pharmazeutische Zusammensetzung in Form einer hydrophilen Matrixtablette, eines verkapselten schmelzextrudierten Multipartikulats, einer hydrophoben Matrixtablette, eines schmelzextrudierten Granulats oder von Kügelchen zur kontrollierten Freigabe vorliegt.
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 (en) 2005-06-09 2006-06-09 Pharmaceutical compositions of a neuroactive steroid and uses thereof

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

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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