HUE030298T2 - (l,l-dioxo-4-tiomorfolinil)-[6-[[3-(4-fluorfenil)-5-metil- 4-izoxazolil]metoxi]-3-piridinil]-metanon szilárd formái - Google Patents

(l,l-dioxo-4-tiomorfolinil)-[6-[[3-(4-fluorfenil)-5-metil- 4-izoxazolil]metoxi]-3-piridinil]-metanon szilárd formái Download PDF

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Publication number
HUE030298T2
HUE030298T2 HUE12772789A HUE12772789A HUE030298T2 HU E030298 T2 HUE030298 T2 HU E030298T2 HU E12772789 A HUE12772789 A HU E12772789A HU E12772789 A HUE12772789 A HU E12772789A HU E030298 T2 HUE030298 T2 HU E030298T2
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Hungary
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solid
disorders
xrpd
methyl
diffraction
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HUE12772789A
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English (en)
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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
    • 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
    • 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
    • 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 (6)

  1. As EP 2 ?68 821 iajstrom&æàmù európai stábácfaiom igénypontjainak mágffir fordítási: 1, p) képletei végydfét:
    (!) szilárd íormája. amelym olyan por rőmgertdiffraktogram (XRPD partém; jellemző, amely tartalma/ legalább egy por rOntgenditfraklogram csúcsot a 2'í'eta tCuKoj diffrakciós szögek 10 T - 13.3" tartományában. ahol a szilárd forma kristályos {1.1 'dsoxo 1 λ3 tjurnorfoNfMal)-{8~[3~(4«fluor-feifiill metil izoxazoi-4-ilrnelo>n]-p*ndin-3~ül-metanon vízmentes C polimorf formában, amelyre olyarí por ronicendíffraktogram jellemző, amely tartalmaz por röntgendifíraktogram csúcsokat a 17.4-3:0,2° ós a 23,4"±0,2': 2Teta (CuKo) d Iff ra ke ló s szöge k nel.
  2. 2, Az 1. igénypont szerinti kristályos € polimorf forma, amelyre olyan por rentgendltfraktogram jellemző. amely tartalmaz, por rontgendiffraktogram csűcsokat a 11 ,7“±0,23 17,4'±0,2° és a 23/Γ±ϋ.2° 2Teta (CuKa) diffrakciós szögeknél.
  3. 3, Az 1. vagy .2. Igénypont szerinti kristályos C polimorf forma, amelyre olyan por rőnigendiffrakiogram jellemző: amely tartalmaz por röntgenorffrakcios csúcsokai. a 10,5-3-.0.23 11,7’±0,23 14,23(:0.23 16,3°t0,23 10,73:0,23 17.4“±0,23 17,931:0.23 19,33*0,23 23,4--10,23 24,72::0,23 25,r±0,2es a 25,9° ±0,2“ 2Teta iCuKaj d itIrakd és szög e k n è I.
  4. 4, Az 1-3. jgényponiok bármelyike szerinti kristályos C polimorf forma, amelyre jellemző egy olvadáspont (DSC) a 148 °C ~ 150 'G tartományban levő kezdeti hőmérséklettel.
  5. 5, Az (Ί) képletei vegyidet 1-4. Igénypontok bármelyiké szerinti szilárd formája, a hol a : szilárd forma a meghatározott szilárd formában legalább 90 tömeg/iőrneg% tisztaságban van jelen. Ci Oeszállációs okiószarmsems eljárás az (1) kèpleiü vegyúlet 1-¾ igénypernek bármelyike szerinti szilárd lomtájanak előállítására amely ácsán a) feloldjuk a kiindulási (educh szilárd fondât oldószerben; b) desztilláljuk az oldószert, miközben a reaklor folyadék-szintjét állandóan tártjuk é desztillálóin anti-oldószerret való helyettesítésével: e) fizikailag elkülönítjük a kívánt szlàrd formát a szuszpenziéból. ?. tdagy-nylrású eljárás az ih képlete vegyidet 1-5. igénypontok bármelyike szerinti szilárd formájának elöállitásam, amely során. dl injektáljuk a kiindulási szilárd fonna oldószerrel készült oldatát egy nagy-nyírásé kövembe, amely anteoidószert tartalmaz; e) mozgásba hozzuk a nagy-nylrású keverő rotor-sztator rendszerét; í) fizikailag elkülönítjük a kívánt szilárd terméket a szuszpenzlábói,
  6. 8. Gyógyszerkészítmények, amelyek az (h képlsiú vegyúlet 1-5. igényporífók bármelyike szerinti szilárd formáját tartalmazzák gyogyászatiiag elfogadható segédanyaggal együtt. 9, fl) kèpleiü vegyidet 1-5. igénypontok bármelyike szerinti szilárd formája terápiásán hatásos anyagként való alkalmazásra. 19, (I) képleté vegyúlet 1-5. igénypontok bármelyike szerinti szilárd formája az akdt és/vagy krónikus neurológiai rendellenességek, kognitiv rendeliermssègok, Aizheimer-beíegség, memóriahiányok, szkizoírénia, szkizoiYènlâval társuló pozitív, negatív és/vagy kognitív szimpláméig bipoláris rendellenességek, autIzmus. Down-üüíndröma, I típusú neurofibromatosis, alvási rondeííenosségok, cirkadián ritmusok rendellenességei: izomsorvadasos laterális szkierózis (ALS), AIDS által okozott fjemen ele, pszinhózisos rendellenességek, anyag által kiváltott pszicriózisos rendellenesség, szorongás-rendellenességek, általánossá vált szorongás-rendellenességek, pánik rendellenesség, hailueináoios ?eedelleeessóg, obszesszív/kompulzív rendeliermeségek, akut stressz rendellenesség, drogfüggőségek, rrmuges-rené o l l e n es sè g ok, Parkinson - betegség, nyy gtalan láb szindróma, észlelés-hiány rendellenességek, nsjileiníaégus démonán, hangulat-rendellenességek. depresszió, neuropezichâlrial állapotok, pszichózis, figyelem-kíhagyás/hiperaklivitás rendellenessog, neuropátlás fájdalom, szkok, sclerosis multiplex CMS), akut agyhártyagyulladás, magzati alkohol szindróma és ügyelem-íendélienességek kezelésében vagy megelőzésében való alkalmazásra, szlrókból vidé felépülési terápiában való alkalmazásra vagy kognitiv serkentő szerekként való itkitmâEâm
HUE12772789A 2011-10-20 2012-10-17 (l,l-dioxo-4-tiomorfolinil)-[6-[[3-(4-fluorfenil)-5-metil- 4-izoxazolil]metoxi]-3-piridinil]-metanon szilárd formái HUE030298T2 (hu)

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US (2) US8785435B2 (hu)
EP (1) EP2768821B1 (hu)
JP (1) JP5918856B2 (hu)
KR (1) KR20140079503A (hu)
CN (1) CN103889971B (hu)
AR (1) AR088359A1 (hu)
AU (1) AU2012318294B2 (hu)
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ES (1) ES2606547T3 (hu)
HK (1) HK1193611A1 (hu)
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IL (1) IL231532A0 (hu)
MX (1) MX341492B (hu)
PL (1) PL2768821T3 (hu)
RU (1) RU2618524C2 (hu)
SG (1) SG11201401591WA (hu)
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DK2768821T3 (en) 2017-01-23
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
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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