HUE035608T2 - Gyógyászati készítmények (R )-7-klór-N-(kinuklidin-3-il)-benzo(b)tiofén-2- karboxamid-hidroklorid-monohidrát kristályos formái tartalommal - Google Patents

Gyógyászati készítmények (R )-7-klór-N-(kinuklidin-3-il)-benzo(b)tiofén-2- karboxamid-hidroklorid-monohidrát kristályos formái tartalommal Download PDF

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Publication number
HUE035608T2
HUE035608T2 HUE15202184A HUE15202184A HUE035608T2 HU E035608 T2 HUE035608 T2 HU E035608T2 HU E15202184 A HUE15202184 A HU E15202184A HU E15202184 A HUE15202184 A HU E15202184A HU E035608 T2 HUE035608 T2 HU E035608T2
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Prior art keywords
pharmaceutical composition
crystalline form
chloro
thiophene
benzo
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HUE15202184A
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English (en)
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Patricia Oliver-Shaffer
Gideon Shapiro
Richard Chesworth
Muneki Kishida
Takayuki Ishige
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Forum Pharmaceuticals Inc
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D453/00—Heterocyclic compounds containing quinuclidine or iso-quinuclidine ring systems, e.g. quinine alkaloids
    • C07D453/02—Heterocyclic compounds containing quinuclidine or iso-quinuclidine ring systems, e.g. quinine alkaloids containing not further condensed quinuclidine ring systems
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/439—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom the ring forming part of a bridged ring system, e.g. quinuclidine
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4535—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
    • 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
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • 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
    • A61P25/14—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
    • A61P25/28—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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D409/00—Heterocyclic compounds containing two or more hetero rings, at least one ring having sulfur atoms as the only ring hetero atoms
    • C07D409/02—Heterocyclic compounds containing two or more hetero rings, at least one ring having sulfur atoms as the only ring hetero atoms containing two hetero rings
    • C07D409/12—Heterocyclic compounds containing two or more hetero rings, at least one ring having sulfur atoms as the only ring hetero atoms containing two hetero rings linked by a chain containing hetero atoms as chain links
    • C—CHEMISTRY; METALLURGY
    • C30—CRYSTAL GROWTH
    • C30B—SINGLE-CRYSTAL GROWTH; UNIDIRECTIONAL SOLIDIFICATION OF EUTECTIC MATERIAL OR UNIDIRECTIONAL DEMIXING OF EUTECTOID MATERIAL; REFINING BY ZONE-MELTING OF MATERIAL; PRODUCTION OF A HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; SINGLE CRYSTALS OR HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; AFTER-TREATMENT OF SINGLE CRYSTALS OR A HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; APPARATUS THEREFOR
    • C30B29/00—Single crystals or homogeneous polycrystalline material with defined structure characterised by the material or by their shape
    • C30B29/54—Organic compounds
    • C—CHEMISTRY; METALLURGY
    • C30—CRYSTAL GROWTH
    • C30B—SINGLE-CRYSTAL GROWTH; UNIDIRECTIONAL SOLIDIFICATION OF EUTECTIC MATERIAL OR UNIDIRECTIONAL DEMIXING OF EUTECTOID MATERIAL; REFINING BY ZONE-MELTING OF MATERIAL; PRODUCTION OF A HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; SINGLE CRYSTALS OR HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; AFTER-TREATMENT OF SINGLE CRYSTALS OR A HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; APPARATUS THEREFOR
    • C30B7/00—Single-crystal growth from solutions using solvents which are liquid at normal temperature, e.g. aqueous solutions
    • C30B7/08—Single-crystal growth from solutions using solvents which are liquid at normal temperature, e.g. aqueous solutions by cooling of the solution
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Materials Engineering (AREA)
  • Metallurgy (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Psychiatry (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Crystals, And After-Treatments Of Crystals (AREA)

Claims (12)

Szabadalmi igénypontok
1. Gyógyászati készítmény, amely (R )-7-klóf-N-fkínukíídm-3-il)-benzoíb]tiofén-2-km-box8mid-bidroklorid-monohidrát kristályos I formáját tartalmazza terápiásán hatásos mennyiségben, ahol a gyógyászati készítmény egy tabletta vagy kapszula, és az (R )-7-klór-N-(kim!klídín-3-ií.!-benzoíhJtiofén-2-karboxamid-hidrokiorid-monohidrá! í kr istályos formájára jellemző, hogy röntgensugár por-diffrakciós spektrumában 2 teíában kifejezve 17,48 és 20,58 plusz-mínusz 0,20 fok. értékek kiazül egynél vagy mindkettőnél csúcs van egy belső szilikon standarddal szemben mérve, továbbá jellemző, hogy röntgensugár por-diffrakciós spektrumában 2 Sétában kifejezve 4,50,9.04, 14,60, 15,14, 1 5,80,16,60, 18,16, 18,44, 19,48, 21,74 és 25,46 plusz-mínusz 0,20 fok értékeknél legalább négy csúcs, hat csúcs, nyolc csúcs vagy mindenhol csúcsok vannak egy belső szilikon standarddal szentben mérve.
2. Gyógyászati készittsiény, amely (R !-7-kÍót'N-<kíS!ukltdin-3-il!-benzoíbltiofén-2-karboxainíd-hidroklorid-monobidntt kristályos II formáját tartalmazza terápiásán hatásos mennyiségben, aboi a gyógyászati készítmény egy tabletta vagy kapszula, és az (R >?-klór’N-(kinuklidin-3-ll)-benzo[bltlofén-2-karboxamjd-bidroklorld-monohidrát ΪΙ kristályos formájára jellemző, hogy röntgensugár por-diffrakciós spektrumában 2 Sétában kifejezve 21, í 6 és 21,38 plusz-mínusz 0,20 fok értékek közül egynél vagy mindkettőnél csúcs van egv beísö szilikon standarddal szemben mérve, továbbá jellemző, hogy röntgensugár por-diffrakciós spektrumában 2 totóban kifejezve 4,48, 9,00, 13,58, 15,62, 16,48, 19,02, 19,44, 22,46 és 25,00 plusz-mínusz 0,20 fok értékeknél legalább négy csúcs, hat csúcs, nyolc csúcs vagy mindenhol csúcsok vannak egy belső szilikon standarddal szemben mérve,
3. Az 1. vagy 2. igénypont szerinti gyógyászati készítmény, ahol a gyógyászati készítmény tableítás készítmény.
4. Az 1. vagy 2. igénypont szerinti gyógyászati készítmény, ahol a gyógyászati készítmény kapszulás készítmény.
5. A 3. vagy 4. igénypont szerinti gyógyászati készítmény, ahol a gyógyászati készítmény ütemezett hatóanyag-leadású készítmény.
6. A 3. vagy 4. igényponl szerinti gyógyászati készítmény, aboi a gyógyászati készítmény késleltetett hatóanyag-leadású készítmény.
7. Az I * 6. igénypontok bármelyike szerinti gyógyászati készítmény ilyen kezelést igénylő egyénnél korral összefüggő tnomörtazavar kezelésére szolgáló módszernél való alkalmazásra.
8. Gyógyászati készítmény a 7, igénypont szerinti alkalmazásra, ahol az egyén 60 évnél idősebb.
9. Gyógyászati készítmény a 7. vagy 8, igénypont szerinti alkalmazásra, ahol az egyén Alzheítner-korban szenved.
10. Gyógyászati készítmény a 7, vagy 8. igénypont szerinti alkalmazásra. ahol az egyén skizofréniában szenved. 1 i.
Az i - 6. igénypontok bármelyike szerinti gyógyászati készítmény időskor előtti dernencia (enyhe kognitív károsodás) kezelésére szolgáló módszernél való alkalmazásra.
12. Az l - 6, igénypontok bármelyike szerinri gyógyászati készítmény Alzheimer-kór kezelésére szolgáló módszernél való alkalmazásra, ahol a módszer magába foglalja egy acetil-koiineszteráz inhibitor terápiásán hatásos mennyiségének egyidejű beadását.
HUE15202184A 2010-05-17 2011-05-17 Gyógyászati készítmények (R )-7-klór-N-(kinuklidin-3-il)-benzo(b)tiofén-2- karboxamid-hidroklorid-monohidrát kristályos formái tartalommal HUE035608T2 (hu)

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US34536310P 2010-05-17 2010-05-17
US35209210P 2010-06-07 2010-06-07

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HUE15202184A HUE035608T2 (hu) 2010-05-17 2011-05-17 Gyógyászati készítmények (R )-7-klór-N-(kinuklidin-3-il)-benzo(b)tiofén-2- karboxamid-hidroklorid-monohidrát kristályos formái tartalommal
HUE11721413A HUE027545T2 (hu) 2010-05-17 2011-05-17 Az (R)-7-klór-N-(kinuklidin-3-il)benzo[b]tiofén-2-karboxamid hidroklorid monohidrát kristályos formája

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