HRP20160208T4 - Polimorfi dasatiniba i postupak za njihovu pripremu - Google Patents

Polimorfi dasatiniba i postupak za njihovu pripremu Download PDF

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Publication number
HRP20160208T4
HRP20160208T4 HRP20160208TT HRP20160208T HRP20160208T4 HR P20160208 T4 HRP20160208 T4 HR P20160208T4 HR P20160208T T HRP20160208T T HR P20160208TT HR P20160208 T HRP20160208 T HR P20160208T HR P20160208 T4 HRP20160208 T4 HR P20160208T4
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Croatia
Prior art keywords
dasatinib
solution
water
precipitation
methanol
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HRP20160208TT
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English (en)
Inventor
Ondrej Simo
Roman Gabriel
Jiri Filipcik
Alexandr Martaus
Alexandr Jegorov
Ales Gavenda
Judith Aronhime
Pavel Vraspir
Tamas Koltai
Jiri Faustmann
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Teva Pharmaceutical Industries Ltd.
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40580164&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20160208(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Teva Pharmaceutical Industries Ltd. filed Critical Teva Pharmaceutical Industries Ltd.
Publication of HRP20160208T1 publication Critical patent/HRP20160208T1/hr
Publication of HRP20160208T4 publication Critical patent/HRP20160208T4/hr

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D417/00—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00
    • C07D417/14—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00 containing three or more hetero rings
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D417/00—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00
    • C07D417/02—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00 containing two hetero rings
    • C07D417/12—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • 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

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)

Claims (11)

1. Bezvodni oblik dasatiniba naznačen XRD uzorkom sukladno slici 2.
2. Bezvodni oblik dasatiniba iz patentnog zahtjeva 1, nadalje naznačen podacima odabranim iz skupine koja se sastoji od: sadržaja vode od oko 0,5 tež.% kako je izmjereno s KF.
3. Bezvodni oblik dasatiniba u skladu s bilo kojim od patentnih zahtjeva 1-2, naznačen time što ima manje od oko 15 tež. %, ili manje oko 10 mas.%, ili manje od oko 5% tež kristalnih oblika dasatiniba N-6 naznačen time što XRD uzorak s maksimumima na 6.9, 12.4, 13.2, 13.8, 16.8, 17.2, 21.1, 24.4, 24.9 i 27.8 + 0.2 stupnjeva 2-theta, i H1-7 naznačen time što praškasti XRD uzorak s maksimumima na 4.6, 9.2, 11.2, 13.8, 15.2, 17.9, 19.5, 23.1, 23.6, 25.9 i 28.0 + 0,2 stupnja 2-teta ili bilo koji drugi oblik.
4. Postupak za pripremu bezvodnog oblika dasatiniba prema zahtjevu 1, naznačen time, da sadrži kristaliziranje dasatiniba iz smjese koja sadrži spoj formule 1 slijedeće formule N- (2-hidroksietil) piperazin, N-etildiizopropilamin i smjesu DMSO, metanola i vode; poželjno, gdje kristalizacija obuhvaća reakciju spoja formule 1, N- (2-hidroksietil) piperazina i N-etildiizopropilamina u DMSO da se dobije otopina koja sadrži dasatinib, dodajući metanol i zatim vode do spomenute otopine da se dobije drugu otopinu, i taloženje spomenutog kristalnog oblika za dobivanje suspenzije.
5. Postupak prema patentnom zahtjevu 4, naznačen time što reakcija spoja formule 1, N- (2-hidroksietil) piperazin, i N-etildiizopropilamin u DMSO je izvedena na temperaturi od oko 40° C do oko 150° C, i / ili gdje se metanol i voda dodaju na temperaturi od oko 60° C do oko 65° C, i / ili, pri čemu se taloženje vrši hlađenjem otopine.
6. Postupak za pripremu bezvodnog oblika dasatiniba prema zahtjevu 1, naznačen time što sadrži kristalizirajući dasatinib iz smjese koja sadrži etanol i vodu, poželjno, gdje kristalizacija sadrži dobivanje otopine dasatiniba u smjesi etanola i vode i taloženje spomenutog kristalnog oblika za dobivanje suspenzije.
7. Postupak prema patentnom zahtjevu 6, naznačen time što je otopina osigurana kombiniranjem dasatiniba i smjese etanola i vode, te zagrijavanjem kombinacije, poželjno do temperature od oko 75° C do oko 80° C; i / ili gdje se taloženje vrši hlađenjem druge otopine na temperaturu od oko 5° C do oko 0° C.
8. Postupak za pripremu bezvodnog oblika dasatiniba prema zahtjevu 1, naznačen time, da sadrži opalescentnu otopinu dasatiniba u metanolu i taloženje spomenutog kristalnog oblika da se dobije suspenzija, poželjno, gdje je osigurana opalescentna otopina kombiniranjem dasatiniba i metanola, i zagrijavanjem kombinacije, poželjno do temperature od oko 65° C; i / ili pri čemu se taloženje provodi hlađenjem opalescenta otopine do temperature od oko 5° C do oko 0° C.
9. Postupak u skladu s bilo kojim od patentnih zahtjeva 4-8, naznačen time što dodatno sadrži ponovno dobivanje kristalnog oblika.
10. Formulacija ili farmaceutski pripravak koji sadrži dasatinib kao što je definirano u bilo kojem od patentnih zahtjeva 1-3 i najmanje jedan farmaceutski prihvatljiv ekscipijens.
11. Dasatinib kao što je definiran u bilo kojem od patentnih zahtjeva 1-3 za uporabu u liječenju kronične mijelogene leukemije (CML) i Philadelphia kromosom-pozitivna akutna limfoblastična leukemija.
HRP20160208TT 2007-10-23 2016-02-26 Polimorfi dasatiniba i postupak za njihovu pripremu HRP20160208T4 (hr)

Applications Claiming Priority (14)

Application Number Priority Date Filing Date Title
US99999807P 2007-10-23 2007-10-23
US869907P 2007-12-20 2007-12-20
US1910608P 2008-01-04 2008-01-04
US3901108P 2008-03-24 2008-03-24
US4138408P 2008-04-01 2008-04-01
US5251308P 2008-05-12 2008-05-12
US5530908P 2008-05-22 2008-05-22
US5687608P 2008-05-29 2008-05-29
US6105408P 2008-06-12 2008-06-12
US7362808P 2008-06-18 2008-06-18
US7954808P 2008-07-10 2008-07-10
US8038208P 2008-07-14 2008-07-14
US9160708P 2008-08-25 2008-08-25
EP11194987.1A EP2508523B2 (en) 2007-10-23 2008-10-23 Polymorphs of dasatinib and process for preparation thereof

Publications (2)

Publication Number Publication Date
HRP20160208T1 HRP20160208T1 (hr) 2016-03-25
HRP20160208T4 true HRP20160208T4 (hr) 2019-08-09

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Family Applications (1)

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HRP20160208TT HRP20160208T4 (hr) 2007-10-23 2016-02-26 Polimorfi dasatiniba i postupak za njihovu pripremu

Country Status (8)

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US (2) US8067423B2 (hr)
EP (3) EP2207777A2 (hr)
JP (2) JP2010539156A (hr)
KR (2) KR20120033357A (hr)
ES (1) ES2565521T5 (hr)
HR (1) HRP20160208T4 (hr)
PL (1) PL2508523T5 (hr)
WO (1) WO2009053854A2 (hr)

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US20070219370A1 (en) 2006-03-15 2007-09-20 Bristol-Myers Squibb Company Process for preparing n-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino] -5-thiazolecarboxamide and related metabolites thereof
EA036701B1 (ru) † 2015-12-16 2020-12-09 Синтон Б.В. Таблетированная фармацевтическая композиция, содержащая безводный дазатиниб

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HRP20160208T1 (hr) 2016-03-25
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KR20100058660A (ko) 2010-06-03
US8067423B2 (en) 2011-11-29
EP2537847A1 (en) 2012-12-26
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US7973045B2 (en) 2011-07-05
US20100256158A1 (en) 2010-10-07
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PL2508523T3 (pl) 2016-06-30
JP2010539156A (ja) 2010-12-16
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ES2565521T5 (es) 2019-12-10
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EP2508523A3 (en) 2013-02-27
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