HRP20100372T1 - Farmaceutski sastavi neuroaktivnog steroida i njihova uporaba - Google Patents

Farmaceutski sastavi neuroaktivnog steroida i njihova uporaba Download PDF

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Publication number
HRP20100372T1
HRP20100372T1 HR20100372T HRP20100372T HRP20100372T1 HR P20100372 T1 HRP20100372 T1 HR P20100372T1 HR 20100372 T HR20100372 T HR 20100372T HR P20100372 T HRP20100372 T HR P20100372T HR P20100372 T1 HRP20100372 T1 HR P20100372T1
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HR
Croatia
Prior art keywords
pharmaceutical composition
pregnan
methoxymethyl
imidazolyl
hydroxy
Prior art date
Application number
HR20100372T
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English (en)
Inventor
M. Woodward Richard
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.)
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Application filed by Euro-Celtique S.A. filed Critical Euro-Celtique S.A.
Publication of HRP20100372T1 publication Critical patent/HRP20100372T1/hr

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    • 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

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  • 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)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Addiction (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (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)

Abstract

Farmaceutski sastav za uporabu u liječenju depresije, bolesne potrebe za alkoholom i/ili ovisnosti o alkoholu, predmenstrualne napetosti, predmenstrualnog sindroma ili predmenstrualnog disforičnog poremećaja, naznačen time, da sadrži 3α-hidroksi-3 -metoksimetil-21-(1'-imidazolil)-5α-pregnan-20-on ili njegovu farmaceutski prihvatljivu sol ili solvat i jedan ili više farmaceutski prihvatljivih ekscipijenata, kod čega sastav daje stacionarno stanje razine u plazmi 3α-hidroksi-3 -metoksimetil-21-(1'-imidazolil)-5α-pregnan-20-ona u području od 5ng/ml do 500 ng/ml u trajanju od 12 h do 24 h nakon davanja. Patent sadrži još 5 patentnih zahtjeva.

Claims (6)

1. Farmaceutski sastav za uporabu u liječenju depresije, bolesne potrebe za alkoholom i/ili ovisnosti o alkoholu, predmenstrualne napetosti, predmenstrualnog sindroma ili predmenstrualnog disforičnog poremećaja, naznačen time, da sadrži 3α-hidroksi-3β-metoksimetil-21-(1'-imidazolil)-5α-pregnan-20-on ili njegovu farmaceutski prihvatljivu sol ili solvat i jedan ili više farmaceutski prihvatljivih ekscipijenata, kod čega sastav daje stacionarno stanje razine u plazmi 3α-hidroksi-3β-metoksimetil-21-(1'-imidazolil)-5α-pregnan-20-ona u području od 5ng/ml do 500 ng/ml u trajanju od 12 h do 24 h nakon davanja.
2. Farmaceutski sastav za uporabu prema patentnom zahtjevu 1, naznačen time, da daje stacionarno stanje razine u plazmi 3α-hidroksi-3β-metoksimetil-21-(1'-imidazolil)-5α-pregnan-20-ona u području od 50 ng/ml do 500 ng/ml, od 50 ng/ml do 400 ng/ml, od 50 ng/ml do 325 ng/ml, od 50 ng/ml do 100 ng/ml ili od 100 ng/ml do 250 ng/ml.
3. Farmaceutski sastav za uporabu prema patentnom zahtjevu 1, naznačen time, da sastav daje stacionarno stanje razine u plazmi 3α-hidroksi-3β-metoksimetil-21-(1'-imidazolil)-5α-pregnan-20-ona u području od 50 ng/ml do 250 ng/ml.
4. Farmaceutski sastav za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da farmaceutski sastav sadrži od 20 mg do 40 mg, prvenstveno 30 mg 3α-hidroksi-3β-metoksimetil-21-(1'-imidazolil)-5α-pregnan-20-ona.
5. Farmaceutski sastav za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da je farmaceutski sastav prikladan za oralno davanje.
6. Farmaceutski sastav za uporabu prema patentnom zahtjevu 3, naznačen time, da je farmaceutski sastav u obliku hidrofilne matriks tablete, inkapsuliranog iz taline ekstrudiranog multipartikulata, hidrofobne matriks tablete, granulata ekstrudiranog iz taline ili zrnaca za kontrolirano oslobađanje.
HR20100372T 2005-06-09 2010-07-02 Farmaceutski sastavi neuroaktivnog steroida i njihova uporaba HRP20100372T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US68890505P 2005-06-09 2005-06-09
PCT/EP2006/005574 WO2006131392A1 (en) 2005-06-09 2006-06-09 Pharmaceutical compositions of a neuroactive steroid and uses thereof

Publications (1)

Publication Number Publication Date
HRP20100372T1 true HRP20100372T1 (hr) 2010-08-31

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ID=36790861

Family Applications (2)

Application Number Title Priority Date Filing Date
HR20100372T HRP20100372T1 (hr) 2005-06-09 2010-07-02 Farmaceutski sastavi neuroaktivnog steroida i njihova uporaba
HR20120264T HRP20120264T1 (hr) 2005-06-09 2012-03-23 Farmaceutski sastavi neuroaktivnog steroida i njihove uporabe

Family Applications After (1)

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HR20120264T HRP20120264T1 (hr) 2005-06-09 2012-03-23 Farmaceutski sastavi neuroaktivnog steroida i njihove uporabe

Country Status (26)

Country Link
US (2) US20090131383A1 (hr)
EP (3) EP1888080B1 (hr)
JP (2) JP2008542419A (hr)
KR (3) KR20080017091A (hr)
CN (1) CN101193640A (hr)
AT (2) ATE538797T1 (hr)
AU (1) AU2006256851C1 (hr)
BR (1) BRPI0612921A2 (hr)
CA (1) CA2611430C (hr)
CY (2) CY1110199T1 (hr)
DE (1) DE602006013622D1 (hr)
DK (2) DK1888080T3 (hr)
EA (1) EA013744B1 (hr)
ES (2) ES2344313T3 (hr)
HK (2) HK1118202A1 (hr)
HR (2) HRP20100372T1 (hr)
IL (3) IL187813A (hr)
NO (1) NO20076319L (hr)
NZ (1) NZ562979A (hr)
PL (2) PL2168585T3 (hr)
PT (2) PT2168585E (hr)
RS (2) RS52199B (hr)
SI (2) SI2168585T1 (hr)
UA (1) UA94909C2 (hr)
WO (1) WO2006131392A1 (hr)
ZA (1) ZA200709188B (hr)

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JP2024506942A (ja) 2021-02-18 2024-02-15 プラクシス プレシジョン メディシンズ, インコーポレイテッド Gaba-aポジティブアロステリック調節物質のヘミ-クエン酸塩およびその結晶形態
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Also Published As

Publication number Publication date
EP2263675A3 (en) 2011-05-18
PL2168585T3 (pl) 2012-05-31
DE602006013622D1 (de) 2010-05-27
HRP20120264T1 (hr) 2012-04-30
CA2611430C (en) 2013-09-10
KR20120028407A (ko) 2012-03-22
RS52199B (en) 2012-10-31
ZA200709188B (en) 2008-08-27
ES2380060T3 (es) 2012-05-08
PT2168585E (pt) 2012-03-05
RS51304B (sr) 2010-12-31
KR20100095661A (ko) 2010-08-31
CA2611430A1 (en) 2006-12-14
AU2006256851C1 (en) 2010-07-15
AU2006256851B2 (en) 2009-12-17
PL1888080T3 (pl) 2010-09-30
JP2012229261A (ja) 2012-11-22
WO2006131392A8 (en) 2007-02-15
HK1140947A1 (en) 2010-10-29
EP2168585B1 (en) 2011-12-28
SI2168585T1 (sl) 2012-04-30
WO2006131392A1 (en) 2006-12-14
IL216194A0 (en) 2012-01-31
PT1888080E (pt) 2010-07-06
US20120276196A1 (en) 2012-11-01
SI1888080T1 (sl) 2010-08-31
US20090131383A1 (en) 2009-05-21
JP2008542419A (ja) 2008-11-27
CN101193640A (zh) 2008-06-04
DK2168585T3 (da) 2012-02-27
UA94909C2 (ru) 2011-06-25
EP2263675A2 (en) 2010-12-22
DK1888080T3 (da) 2010-07-19
ES2344313T3 (es) 2010-08-24
EP1888080B1 (en) 2010-04-14
IL187813A (en) 2011-12-29
HK1118202A1 (en) 2009-02-06
NZ562979A (en) 2010-11-26
IL216194A (en) 2013-09-30
ATE464054T1 (de) 2010-04-15
CY1112499T1 (el) 2015-12-09
IL187813A0 (en) 2008-08-07
IL211114A (en) 2014-04-30
KR20080017091A (ko) 2008-02-25
BRPI0612921A2 (pt) 2010-12-07
AU2006256851A1 (en) 2006-12-14
EP2168585A1 (en) 2010-03-31
EA200800007A1 (ru) 2008-04-28
CY1110199T1 (el) 2015-01-14
NO20076319L (no) 2007-12-07
ATE538797T1 (de) 2012-01-15
EA013744B1 (ru) 2010-06-30
EP1888080A1 (en) 2008-02-20

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