JP5486012B2 - ニロチニブＨＣｌ結晶形 - Google Patents

ニロチニブＨＣｌ結晶形 Download PDF

Info

Publication number
JP5486012B2
JP5486012B2 JP2011534915A JP2011534915A JP5486012B2 JP 5486012 B2 JP5486012 B2 JP 5486012B2 JP 2011534915 A JP2011534915 A JP 2011534915A JP 2011534915 A JP2011534915 A JP 2011534915A JP 5486012 B2 JP5486012 B2 JP 5486012B2
Authority
JP
Japan
Prior art keywords
nilotinib hcl
nilotinib
degrees
powder
ray diffraction
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
JP2011534915A
Other languages
English (en)
Japanese (ja)
Other versions
JP2012508178A (ja
JP2012508178A5 (enExample
Inventor
ステリンバウム，グレタ
レビ，シガリット
イェオリ，アディ
コルタイ，タマス
ニッダム−ヒルデシェイム，バレリー
ピラン，マイタル
アシス，シャイ
エイセン−ネボ，ハギト
マルコルム クロウ，デイビッド
Original Assignee
テバ ファーマシューティカル インダストリーズ リミティド
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41666779&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP5486012(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by テバ ファーマシューティカル インダストリーズ リミティド filed Critical テバ ファーマシューティカル インダストリーズ リミティド
Publication of JP2012508178A publication Critical patent/JP2012508178A/ja
Publication of JP2012508178A5 publication Critical patent/JP2012508178A5/ja
Application granted granted Critical
Publication of JP5486012B2 publication Critical patent/JP5486012B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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

Landscapes

  • 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)
JP2011534915A 2008-11-05 2009-11-05 ニロチニブＨＣｌ結晶形 Active JP5486012B2 (ja)

Applications Claiming Priority (17)

Application Number Priority Date Filing Date Title
US11156108P 2008-11-05 2008-11-05
US61/111,561 2008-11-05
US15578909P 2009-02-26 2009-02-26
US61/155,789 2009-02-26
US17745409P 2009-05-12 2009-05-12
US61/177,454 2009-05-12
US22721009P 2009-07-21 2009-07-21
US61/227,210 2009-07-21
US24070909P 2009-09-09 2009-09-09
US61/240,709 2009-09-09
US24251409P 2009-09-15 2009-09-15
US61/242,514 2009-09-15
US24679909P 2009-09-29 2009-09-29
US61/246,799 2009-09-29
US24937609P 2009-10-07 2009-10-07
US61/249,376 2009-10-07
PCT/US2009/063365 WO2010054056A2 (en) 2008-11-05 2009-11-05 Nilotinib hci crystalline forms

Publications (3)

Publication Number Publication Date
JP2012508178A JP2012508178A (ja) 2012-04-05
JP2012508178A5 JP2012508178A5 (enExample) 2012-12-20
JP5486012B2 true JP5486012B2 (ja) 2014-05-07

Family

ID=41666779

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2011534915A Active JP5486012B2 (ja) 2008-11-05 2009-11-05 ニロチニブＨＣｌ結晶形

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

Family Cites Families (10)

* Cited by examiner, † Cited by third party
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
CN101228150B (zh) * 2005-07-20 2014-10-15 诺华股份有限公司 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
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

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
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
CN102203084B (zh) 2014-10-29

Similar Documents

Publication Publication Date Title
JP5486012B2 (ja) ニロチニブＨＣｌ結晶形
TWI849124B (zh) 新的結晶形狀
US20090298947A1 (en) Polymorphic and amorphous forms of lacosamide and amorphous compositions
WO2009049495A1 (en) Crystalline imidazol-5-carboxylic acid derivate
US8835635B2 (en) Amorphous form of vilazodone hydrochloride substantially free of crystalline forms
US20190300483A1 (en) POLYMORPHS OF BETRlXABAN & ITS MALEATE SALT
US20100087459A1 (en) Forms of lapatinib compounds and processes for the preparation thereof
US20160200716A1 (en) Cobicistat dichlohydrate salt
US20090306106A1 (en) Forms of crystalline lapatinib and processes for preparation thereof
JP2018521055A (ja) サクビトリルカルシウム塩
JP2011522829A (ja) 固体状のアリスキレン遊離塩基
WO2014016842A1 (en) Amorphous coprecipitates of rivaroxaban
JP2007527924A (ja) 非晶質バルサルタンの製造方法
US20240293420A1 (en) Pharmaceutical composition, preparation, and preparation method therefor and use thereof
JPWO2011152411A1 (ja) チエノピリミジン誘導体の結晶
WO2018042320A1 (en) Salts of betrixaban and processes for preparation thereof
WO2011085130A1 (en) Solid state forms of fosamprenavir calcium salt and process for preparation thereof
US20220389022A1 (en) Solid forms of ponatinib hydrochloride and process thereof
KR101423630B1 (ko) 비칼루타미드와 니코틴아미드의 공결정
WO2009007853A2 (en) Novel polymorphs of darifenacin free base and its hydrobromide salt
WO2011028919A2 (en) Solid forms of aliskiren hemifumarate and processes for preparation thereof
JP2008526780A (ja) ドルゾルアミド塩酸塩の非晶質および結晶質の形態およびそれらを製造する方法
CN101258156A (zh) 无定形和结晶形态的多佐胺盐酸盐以及它们的制备方法

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20120821

A871 Explanation of circumstances concerning accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A871

Effective date: 20120821

A975 Report on accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A971005

Effective date: 20120918

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20121031

A871 Explanation of circumstances concerning accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A871

Effective date: 20121031

A975 Report on accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A971005

Effective date: 20121113

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20121127

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20130227

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20130409

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20130708

RD03 Notification of appointment of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7423

Effective date: 20130805

RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20130805

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20130910

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20131209

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20140121

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20140220

R150 Certificate of patent or registration of utility model

Ref document number: 5486012

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250