DK2768821T3 - Faste former af (1,1-dioxo-4-thiomorpholinyl)-[6-[[3-(4-fluorphenyl)-5-methyl-4-isoxazolyl]methoxy]-3-pyridinyl]-methanon - Google Patents

Faste former af (1,1-dioxo-4-thiomorpholinyl)-[6-[[3-(4-fluorphenyl)-5-methyl-4-isoxazolyl]methoxy]-3-pyridinyl]-methanon Download PDF

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Publication number
DK2768821T3
DK2768821T3 DK12772789.9T DK12772789T DK2768821T3 DK 2768821 T3 DK2768821 T3 DK 2768821T3 DK 12772789 T DK12772789 T DK 12772789T DK 2768821 T3 DK2768821 T3 DK 2768821T3
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disorders
solid
xrpd
formula
solvent
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DK12772789.9T
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Pascal Dott
Olaf Grassmann
Michael Kammerer
Joachim Manns
Urs Schwitter
Andrew Thomas
Nicole Wyttenbach
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Hoffmann La Roche
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D401/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
    • C07D401/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
    • C07D401/12—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings linked by a chain containing hetero atoms as chain links
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D413/00—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms
    • C07D413/02—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms containing two hetero rings
    • C07D413/12—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms containing two hetero rings linked by a chain containing hetero atoms as chain links
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/541—Non-condensed thiazines containing further heterocyclic rings
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61P25/20—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
    • A61P25/22—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
    • A61P25/28—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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Neurosurgery (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Psychiatry (AREA)
  • Addiction (AREA)
  • Psychology (AREA)
  • Pain & Pain Management (AREA)
  • Hospice & Palliative Care (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Nitrogen And Oxygen As The Only Ring Hetero Atoms (AREA)
  • Medicinal Preparation (AREA)

Claims (10)

1. Fast form af en forbindelse med formel (I)
(i). kendetegnet ved et XRPD-mønster omfattende mindst én XRPD-top i området af diffraktionsvinkler 2Theta (CuKa) 10,3° til 13,3° hvor den faste form er krystallinsk (l,l-dioxo-lA6-thiomorpholin-4-yl)-{6-[3-(4-fluor-phenyl)-5-methyl-isoxazol-4-ylmethoxy]-pyridin-3-yl}-methanon i vandfri polymorf form C, kendetegnet ved et XRPD-diffraktionsmønster omfattende XRPD-toppe ved diffraktionsvinkler 2Theta (CuKa) 17,4°±0,2°, og 23,4°±0,2°.
2. Krystallinsk polymorf form C ifølge krav 1, kendetegnet ved et XRPD-diffraktionsmønster omfattende XRPD-toppe ved diffraktionsvinkler 2Theta (CuKa) på 11,7°±0,2°, 17,4°±0,2°, og 23,4°±0,2°.
3. Krystallinsk polymorf form C ifølge et hvilket som helst af kravene 1 eller 2, kendetegnet ved et XRPD-diffraktionsmønster omfattende XRPD-toppe ved diffraktionsvinkler 2Theta (CuKa) of 10,5°±0,2°, 11,7°±0,2°, 14,2°±0,2°, 16,3°±0,2°, 16,7°±0,2°, 17,4°±0,2°, 17,9°±0,2°, 19,3°±0,2°, 23,4°±0,2°, 24,7°±0,2°, 25,1°±0,2°, og 25,9°±0,2°.
4. Krystallinsk polymorf form C ifølge et hvilket som helst af kravene 1 til 3, kendetegnet ved et smeltepunkt med starttemperatur (DSC) i området på 146°C til 150°C.
5. Fast form afen forbindelse med formel (I) ifølge et hvilket som helst af kravene 1 to 4, hvor den faste form er er til stede i den specificerede faste form i en renhed på mindst 90% (vægt/vægt).
6. Destillationsopløsningsmiddelombytningsfremgangsmåde til fremstillingen afen fast form af forbindelsen med formel (I) ifølge et hvilket som helst af kravene 1 til 5 omfattende: a) opløsning af eduktfastformen i et opløsningsmiddel; b) destillation af opløsningsmidlet mens reaktorvæskeniveauet holdes konstant ved at erstatte destillatet med et antiopløsningsmiddel; c) fysisk separation af den ønskede faste form fra suspensionen.
7. Højforskydningsfremgangsmåde til fremstillingen af en fast form af forbindelsen med formel (I) ifølge et hvilket som helst af kravene 1 til 5 omfattende: d) indsprøjtning afen opløsning af edukt-fastformen i et opløsningsmiddel ind i en højforskydningsblander omfattende et antiopløsningsmiddel; e) omrøring af rotor-statorsystemet af højforskydningsblanderen; f) fysisk separation af den ønskede faste form fra suspensionen.
8. farmaceutiske sammensætninger omfattende en fast form af en forbindelse med formel (I) ifølge et hvilket som helst af kravene 1 til 5 og en farmaceutisk acceptabel excipiens.
9. Fast form afen forbindelse med formel (I) ifølge et hvilket som helst af kravene 1 til 5 til anvendelse som terapeutisk aktivstof.
10. Fast form af en forbindelse med formel (I) ifølge et hvilket som helst af kravene 1 til 5 til anvendelse i behandlingen eller forebyggelse af akut og/eller kronisk neurologiske forstyrrelser, kognitive forstyrrelser, Alzheimer's sygdom, mangelfuld hukommelse, skizofreni, positiv, negativ og/eller kognitive symptomer forbundet med skizofreni, bipolære lidelser, autisme, Down syndrom, neurofibromatose type I, søvnforstyrrelser, kredsløbsforstyrrelser, amyotrof lateral sclerose (ALS), demens forårsaget af AIDS, psykotiske forstyrrelser, stof inducerede psykotiske forstyrrelser, angstlidelser, generaliserede angstlidelser, paniklidelser, vrangforestillinger, obsessive/kompulsive lidelser, akutte stress-lidelser, stofafhængighed, bevægelsesforstyrrelser, Parkinson's sygdom, restless leg syndrom, erkendelses ufuldkommenhed-forstyrrelser, multi-infarkt demens, humørlidelser, depression, neuropsykiatriske tilstande, psykose, attention-underskud/hyperaktivitetslidelser, neuropatisk smerte, slagtilfælde, multipel sclerose (MS), akut meningitis, føtalt alkoholsyndrom, og opmærksomhedsforstyrrelser, til anvendelse i slagtilfældegenvindingsterapi, eller til anvendelse som kognitive forstærkere.
DK12772789.9T 2011-10-20 2012-10-17 Faste former af (1,1-dioxo-4-thiomorpholinyl)-[6-[[3-(4-fluorphenyl)-5-methyl-4-isoxazolyl]methoxy]-3-pyridinyl]-methanon DK2768821T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP11185993 2011-10-20
PCT/EP2012/070522 WO2013057124A1 (en) 2011-10-20 2012-10-17 Solid forms of 1,l-dioxo-4-thiomorpholinyl)-[6-[[3(4-fluorophenyl)-5-methyl-4-isoxazolyl]methoxy]-3-pyridinyl]-methanone

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DK2768821T3 true DK2768821T3 (da) 2017-01-23

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US (2) US8785435B2 (da)
EP (1) EP2768821B1 (da)
JP (1) JP5918856B2 (da)
KR (1) KR20140079503A (da)
CN (1) CN103889971B (da)
AR (1) AR088359A1 (da)
AU (1) AU2012318294B2 (da)
BR (1) BR112014009288A8 (da)
CA (1) CA2850441A1 (da)
DK (1) DK2768821T3 (da)
ES (1) ES2606547T3 (da)
HK (1) HK1193611A1 (da)
HU (1) HUE030298T2 (da)
IL (1) IL231532A0 (da)
MX (1) MX341492B (da)
PL (1) PL2768821T3 (da)
RU (1) RU2618524C2 (da)
SG (1) SG11201401591WA (da)
SI (1) SI2768821T1 (da)
WO (1) WO2013057124A1 (da)

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BR112014009288A8 (pt) 2020-04-22
NZ622215A (en) 2016-06-24
JP2014530832A (ja) 2014-11-20
ES2606547T3 (es) 2017-03-24
JP5918856B2 (ja) 2016-05-18
RU2618524C2 (ru) 2017-05-04
AU2012318294A1 (en) 2013-05-09
EP2768821B1 (en) 2016-11-16
HUE030298T2 (en) 2017-04-28
CA2850441A1 (en) 2013-04-25
CN103889971A (zh) 2014-06-25
US8785435B2 (en) 2014-07-22
US20130172329A1 (en) 2013-07-04
HK1193611A1 (zh) 2014-09-26
MX341492B (es) 2016-08-23
SI2768821T1 (sl) 2017-01-31
RU2014118968A (ru) 2015-11-27
PL2768821T3 (pl) 2017-05-31
KR20140079503A (ko) 2014-06-26
AR088359A1 (es) 2014-05-28
AU2012318294B2 (en) 2015-10-01
US20140329806A1 (en) 2014-11-06
MX2014004678A (es) 2014-05-28
BR112014009288A2 (pt) 2017-06-13
US8975397B2 (en) 2015-03-10
EP2768821A1 (en) 2014-08-27
WO2013057124A1 (en) 2013-04-25
CN103889971B (zh) 2016-08-31
IL231532A0 (en) 2014-04-30
SG11201401591WA (en) 2014-05-29

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