CN102203084B - 盐酸尼洛替尼晶型 - Google Patents

盐酸尼洛替尼晶型 Download PDF

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Publication number
CN102203084B
CN102203084B CN200980144606.XA CN200980144606A CN102203084B CN 102203084 B CN102203084 B CN 102203084B CN 200980144606 A CN200980144606 A CN 200980144606A CN 102203084 B CN102203084 B CN 102203084B
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China
Prior art keywords
nilotinib
nilotinib hydrochloride
degrees
powder diffraction
ray powder
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Active
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CN200980144606.XA
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English (en)
Chinese (zh)
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CN102203084A (zh
Inventor
G·斯特里姆鲍姆
S·莱维
A·约里
T·科尔泰
V·尼达姆-希尔德舍伊姆
M·皮兰
S·阿西斯
H·埃森-内沃
D·M·克罗
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Teva Pharmaceutical Industries Ltd
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Teva Pharmaceutical Industries Ltd
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D403/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00
    • C07D403/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings
    • C07D403/04—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings directly linked by a ring-member-to-ring-member bond
    • 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
    • C07D401/14—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 three or more hetero rings
    • 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
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D233/00—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings
    • C07D233/02—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings having no double bonds between ring members or between ring members and non-ring members
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D403/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00
    • C07D403/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Exhaust Gas Treatment By Means Of Catalyst (AREA)
CN200980144606.XA 2008-11-05 2009-11-05 盐酸尼洛替尼晶型 Active CN102203084B (zh)

Applications Claiming Priority (17)

Application Number Priority Date Filing Date Title
US11156108P 2008-11-05 2008-11-05
US61/111561 2008-11-05
US15578909P 2009-02-26 2009-02-26
US61/155789 2009-02-26
US17745409P 2009-05-12 2009-05-12
US61/177454 2009-05-12
US22721009P 2009-07-21 2009-07-21
US61/227210 2009-07-21
US24070909P 2009-09-09 2009-09-09
US61/240709 2009-09-09
US24251409P 2009-09-15 2009-09-15
US61/242514 2009-09-15
US24679909P 2009-09-29 2009-09-29
US61/246799 2009-09-29
US24937609P 2009-10-07 2009-10-07
US61/249376 2009-10-07
PCT/US2009/063365 WO2010054056A2 (en) 2008-11-05 2009-11-05 Nilotinib hci crystalline forms

Publications (2)

Publication Number Publication Date
CN102203084A CN102203084A (zh) 2011-09-28
CN102203084B true CN102203084B (zh) 2014-10-29

Family

ID=41666779

Family Applications (1)

Application Number Title Priority Date Filing Date
CN200980144606.XA Active CN102203084B (zh) 2008-11-05 2009-11-05 盐酸尼洛替尼晶型

Country Status (12)

Country Link
US (2) US8227477B2 (enExample)
EP (2) EP2530081A3 (enExample)
JP (1) JP5486012B2 (enExample)
KR (2) KR20120111743A (enExample)
CN (1) CN102203084B (enExample)
CA (1) CA2740794A1 (enExample)
DK (1) DK2262793T3 (enExample)
ES (1) ES2394258T3 (enExample)
HR (1) HRP20120793T1 (enExample)
PL (1) PL2262793T3 (enExample)
TW (1) TW201022240A (enExample)
WO (1) WO2010054056A2 (enExample)

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011086541A1 (en) * 2010-01-15 2011-07-21 Generics [Uk] Limited Novel polymorph of nilotinib monohydrochloride monohydrate
WO2011133675A1 (en) * 2010-04-21 2011-10-27 Teva Pharmaceutical Industries Ltd. Gabapentin enacarbil compositions
CN103038227A (zh) * 2010-06-21 2013-04-10 特瓦制药工业有限公司 尼洛替尼盐及其晶形
KR20130042498A (ko) 2010-06-21 2013-04-26 테바 파마슈티컬 인더스트리즈 리미티드 닐로티닙 염 및 이의 결정형
CN102453024B (zh) * 2010-10-27 2014-09-03 浙江九洲药业股份有限公司 一种尼罗替尼盐酸盐晶型及其制备方法
US8703788B2 (en) * 2010-11-26 2014-04-22 Bandi Parthasaradhi Reddy Polymorph of nilotinib hydrochloride
IN2011CH01887A (enExample) * 2011-06-02 2012-12-14
AR086913A1 (es) * 2011-06-14 2014-01-29 Novartis Ag 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]-amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluoro-metil)-fenil]-benzamida amorfa, forma de dosificacion que la contiene y metodo para prepararlas
ES2564969T3 (es) * 2012-02-09 2016-03-30 Natco Pharma Limited Proceso para la preparación de clorhidrato de nilotinib
US9061028B2 (en) 2012-02-15 2015-06-23 Natco Pharma Limited Process for the preparation of Nilotinib
US9376419B2 (en) 2012-10-15 2016-06-28 Apotex Inc. Solid forms of nilotinib hydrochloride
KR20150068483A (ko) 2012-10-19 2015-06-19 바스프 에스이 닐로티닙 및 선택된 공-결정 형성제를 포함하는 다성분 결정질 시스템
WO2014174456A2 (en) * 2013-04-24 2014-10-30 Dr. Reddys Laboratories Limited Polymorphic forms of nilotinib hydrochloride
US9636340B2 (en) 2013-11-12 2017-05-02 Ayyappan K. Rajasekaran Kinase inhibitors
WO2015092624A1 (en) 2013-12-16 2015-06-25 Ranbaxy Laboratories Limited Nilotinib mono-oxalate and its crystalline form
US9926296B2 (en) 2014-08-08 2018-03-27 Dr. Reddy's Laboratories Limited Process for the preparation of polymorphic forms of nilotinib hydrochloride
WO2016058081A1 (en) 2014-10-16 2016-04-21 Apotex Inc. Solid forms of nilotinib hydrochloride
CN106478603B (zh) * 2015-08-25 2021-01-01 江苏豪森药业集团有限公司 尼洛替尼盐酸盐的新晶型及其制备方法和医药用途
EA036204B1 (ru) * 2015-10-16 2020-10-14 Нобел Илач Санайи Ве Тиджарет А.Ш. Фармацевтические композиции нилотиниба гидрохлорида
EP3408264B1 (en) 2016-01-26 2020-03-11 Farma GRS, d.o.o. Nilotinib dinitrate (v) and crystalline forms thereof
SMT202000563T1 (it) 2016-03-14 2020-11-10 Pliva Hrvatska D O O Forem allo stato solido di sali di nilotinib
EP3404025B1 (en) * 2017-05-16 2019-12-04 F.I.S.- Fabbrica Italiana Sintetici S.p.A. Process for the preparation of pure nilotinib and its salt
CZ2017821A3 (cs) 2017-12-20 2019-07-03 Zentiva, K.S. Léková forma obsahující krystalický nilotinib
EP3806858A4 (en) 2018-06-15 2022-03-09 Handa Pharmaceuticals, Inc. KINA INHIBITOR SALTS AND COMPOSITIONS THEREOF
WO2020095187A1 (en) * 2018-11-05 2020-05-14 Laurus Labs Limited Crystalline form of nilotinib hydrochloride, process for its preparation and pharmaceutical composition containing the same
US20240316044A1 (en) 2021-06-19 2024-09-26 Helm Ag Granulate composition comprising nilotinib
EP4122452A1 (en) 2021-07-23 2023-01-25 KRKA, d.d., Novo mesto Pharmaceutical composition comprising nilotinib and method of manufacturing the same

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101228150A (zh) * 2005-07-20 2008-07-23 诺瓦提斯公司 4-甲基-n-[3-（4-甲基-咪唑-1-基）-5-三氟甲基-苯基]-3-（4-吡啶-3-基-嘧啶-2-基氨基）-苯甲酰胺的晶形

Family Cites Families (9)

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Publication number Priority date Publication date Assignee Title
GB0215676D0 (en) 2002-07-05 2002-08-14 Novartis Ag Organic compounds
GB0325031D0 (en) 2003-10-27 2003-12-03 Novartis Ag Organic compounds
MY146795A (en) 2005-06-09 2012-09-28 Novartis Ag Process for the synthesis of organic compounds
SA06270147B1 (ar) 2005-06-09 2009-12-22 نوفارتيس ايه جي عملية لتخليق 5-(مثيل–1h–إيميدازول–1-يل )–3-(ثلاثي فلـورو مثيل)–بنزامـين
GT200600315A (es) 2005-07-20 2007-03-19 Formas cristalinas de 4-metilo-n-[3-(4-metilo-imidazol-1-ilo)-5-trifluorometilo-fenilo]-3-(4-pyridina-3-ilo-pirimidina-2-iloamino)-benzamida
GT200600316A (es) 2005-07-20 2007-04-02 Sales de 4-metilo-n-(3-(4-metilo-imidazol-1-ilo)-5-trifluorometilo-fenilo)-3-(4-piridina-3-ilo-pirimidina-2-iloamino)- benzamida.
KR100674813B1 (ko) 2005-08-05 2007-01-29 일양약품주식회사 Ｎ-페닐-2-피리미딘-아민 유도체 및 그의 제조방법
FR2889524B1 (fr) 2005-08-05 2008-08-29 Rhodia Chimie Sas Procede de formation d'une liaison carbone-azote
US20100016590A1 (en) * 2008-07-17 2010-01-21 Teva Pharmaceutical Industries Ltd. Nilotinib intermediates and preparation thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101228150A (zh) * 2005-07-20 2008-07-23 诺瓦提斯公司 4-甲基-n-[3-（4-甲基-咪唑-1-基）-5-三氟甲基-苯基]-3-（4-吡啶-3-基-嘧啶-2-基氨基）-苯甲酰胺的晶形

Also Published As

Publication number Publication date
US8227477B2 (en) 2012-07-24
KR20120111743A (ko) 2012-10-10
WO2010054056A3 (en) 2010-09-16
PL2262793T3 (pl) 2013-01-31
EP2530081A3 (en) 2013-04-10
US20100190812A1 (en) 2010-07-29
KR101251726B1 (ko) 2013-04-05
EP2530081A2 (en) 2012-12-05
ES2394258T3 (es) 2013-01-30
JP5486012B2 (ja) 2014-05-07
HRP20120793T1 (hr) 2012-12-31
CN102203084A (zh) 2011-09-28
CA2740794A1 (en) 2010-05-14
WO2010054056A2 (en) 2010-05-14
US8592442B2 (en) 2013-11-26
US20130096304A1 (en) 2013-04-18
EP2262793A2 (en) 2010-12-22
JP2012508178A (ja) 2012-04-05
TW201022240A (en) 2010-06-16
KR20100099257A (ko) 2010-09-10
EP2262793B1 (en) 2012-10-03
DK2262793T3 (da) 2012-10-15

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