BR112015000045A2 - forma i cristalina de inibidor de dimaleato de tirosina quinase e métodos de preparação desta - Google Patents

forma i cristalina de inibidor de dimaleato de tirosina quinase e métodos de preparação desta

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Publication number
BR112015000045A2
BR112015000045A2 BR112015000045A BR112015000045A BR112015000045A2 BR 112015000045 A2 BR112015000045 A2 BR 112015000045A2 BR 112015000045 A BR112015000045 A BR 112015000045A BR 112015000045 A BR112015000045 A BR 112015000045A BR 112015000045 A2 BR112015000045 A2 BR 112015000045A2
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BR
Brazil
Prior art keywords
dimaleate
tyrosine kinase
preparation
methods
crystalline form
Prior art date
Application number
BR112015000045A
Other languages
English (en)
Other versions
BR112015000045B1 (pt
Inventor
Yuan Bo
Wu Guaili
Sun Piaoyang
Chen Yongjiang
Original Assignee
Jiangsu Hengrui Medicine Co
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
Application filed by Jiangsu Hengrui Medicine Co filed Critical Jiangsu Hengrui Medicine Co
Publication of BR112015000045A2 publication Critical patent/BR112015000045A2/pt
Publication of BR112015000045B1 publication Critical patent/BR112015000045B1/pt

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Classifications

    • 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
    • A61K31/435—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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4709—Non-condensed quinolines 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C55/00—Saturated compounds having more than one carboxyl group bound to acyclic carbon atoms
    • C07C55/02—Dicarboxylic acids
    • C07C55/08—Malonic acid
    • 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
    • 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
    • C07D403/14—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 three or more hetero rings
    • 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

Landscapes

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

Abstract

resumo patente de invenção: "forma i cristalina de inibidor de dimaleato de tirosina quinase e métodos de preparação desta". a presente invenção refere-se à proporção de forma i cristalina de dimaleato de (r,e)-n-(4-(3-cloro-4-(piridin-2-il metóxi)-fenilamino)-3-ciano-7-etóxi-quinolin-6-il)-3-(1-metilpirrolidin-2-il) propenamida (denominado dimaleato de shr1258 para curta), métodos de preparação desta, e composição farmacêutica contendo a mesma. referida forma i cristalina de dimaleato de shr1258 tem boa estabilidade de cristal e estabilidade química, e pode ser usada na preparação de medicamentos para tratamento de doenças relevantes para receptor de tirosina quinase de egfr ou receptor de tirosina quinase de her-2.
BR112015000045-2A 2012-07-12 2013-06-04 Crista de forma i de inibidor de dimaleato de tirosina quinase, seu uso e seu método de preparação, e composição farmacêutica BR112015000045B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201210240697.0A CN103539783A (zh) 2012-07-12 2012-07-12 一种酪氨酸激酶抑制剂的二马来酸盐的i型结晶及制备方法
CN201210240697.0 2012-07-12
PCT/CN2013/076717 WO2014008794A1 (zh) 2012-07-12 2013-06-04 一种酪氨酸激酶抑制剂的二马来酸盐的i型结晶及制备方法

Publications (2)

Publication Number Publication Date
BR112015000045A2 true BR112015000045A2 (pt) 2017-06-27
BR112015000045B1 BR112015000045B1 (pt) 2021-10-26

Family

ID=49915377

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112015000045-2A BR112015000045B1 (pt) 2012-07-12 2013-06-04 Crista de forma i de inibidor de dimaleato de tirosina quinase, seu uso e seu método de preparação, e composição farmacêutica

Country Status (21)

Country Link
US (1) US9309226B2 (pt)
EP (1) EP2873664B1 (pt)
JP (1) JP6170146B2 (pt)
KR (1) KR102078077B1 (pt)
CN (2) CN103539783A (pt)
AU (1) AU2013289789B2 (pt)
BR (1) BR112015000045B1 (pt)
CA (1) CA2876884C (pt)
DK (1) DK2873664T3 (pt)
ES (1) ES2656623T3 (pt)
HK (1) HK1199027A1 (pt)
HU (1) HUE037946T2 (pt)
MX (1) MX349672B (pt)
NO (1) NO2873664T3 (pt)
PL (1) PL2873664T3 (pt)
PT (1) PT2873664T (pt)
RU (1) RU2631321C2 (pt)
TW (1) TWI597277B (pt)
UA (1) UA113658C2 (pt)
WO (1) WO2014008794A1 (pt)
ZA (1) ZA201500471B (pt)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105985408B (zh) * 2015-02-12 2020-06-26 正大天晴药业集团股份有限公司 一种卡非佐米的纯化方法
US10413519B2 (en) 2015-07-22 2019-09-17 Anavex Life Sciences Corp. Crystal forms of tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanmethanamine hydrochloride, processes of making such forms, and their pharmaceutical compositions
CN108354909B (zh) * 2016-01-27 2021-05-14 江苏恒瑞医药股份有限公司 一种含有喹啉衍生物或其盐的药物组合物
PT3378479T (pt) * 2016-01-27 2020-07-20 Jiangsu Hengrui Medicine Co Método para preparação de uma composição farmacêutica compreendendo um derivado de quinolina ou um seu sal
CN107708698A (zh) * 2016-01-28 2018-02-16 江苏恒瑞医药股份有限公司 一种egfr/her2受体酪氨酸激酶抑制剂在制备治疗her2突变癌症药物中的用途
JP7007287B2 (ja) * 2016-03-22 2022-01-24 ジエンス ハンセン ファーマセウティカル グループ カンパニー リミテッド Ｅｇｆｒ阻害薬フリー塩基または酸性塩の多結晶形、その製造方法、および応用
CN108778275A (zh) 2017-01-22 2018-11-09 江苏恒瑞医药股份有限公司 Egfr/her2抑制剂联合嘧啶类抗代谢药物的用途
WO2019029477A1 (zh) * 2017-08-07 2019-02-14 江苏恒瑞医药股份有限公司 一种酪氨酸激酶抑制剂的二马来酸盐的晶型及其制备方法
CN109516976B (zh) * 2017-09-19 2022-05-27 南京圣和药业股份有限公司 取代嘧啶类pi3k抑制剂甲磺酸盐的晶型及其制备方法
CA3079916A1 (en) 2017-10-24 2019-05-02 Jiangsu Hengrui Medicine Co., Ltd. Pharmaceutical composition containing quinoline derivative
CN110960529A (zh) * 2018-09-30 2020-04-07 江苏恒瑞医药股份有限公司 一种降低了毒性杂质含量的酪氨酸激酶抑制剂的原料药
TWI770934B (zh) 2018-10-22 2022-07-11 大陸商江蘇恒瑞醫藥股份有限公司 酪胺酸激酶抑制劑的一馬來酸鹽的晶型及其製備方法
CN111138414A (zh) * 2018-11-05 2020-05-12 江苏恒瑞医药股份有限公司 一种酪氨酸激酶抑制剂的晶型及其制备方法
TW202115027A (zh) * 2019-08-30 2021-04-16 大陸商江蘇恒瑞醫藥股份有限公司 低雜質含量的酪胺酸激酶抑制劑
CN114674937B (zh) * 2020-12-24 2024-07-05 沈阳药科大学 一种马来酸长链脂肪酰胺中长链脂肪胺的测定方法

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA73073C2 (uk) * 1997-04-03 2005-06-15 Уайт Холдінгз Корпорейшн Заміщені 3-ціанохіноліни, спосіб їх одержання та фармацевтична композиція
US20020048610A1 (en) * 2000-01-07 2002-04-25 Cima Michael J. High-throughput formation, identification, and analysis of diverse solid-forms
US8022216B2 (en) * 2007-10-17 2011-09-20 Wyeth Llc Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
CN101824029A (zh) 2009-03-05 2010-09-08 厦门艾德生物医药科技有限公司 酪氨酸激酶不可逆抑制剂、其药物组合物及其用途
CN102020639A (zh) * 2009-09-14 2011-04-20 上海恒瑞医药有限公司 6-氨基喹唑啉或3-氰基喹啉类衍生物、其制备方法及其在医药上的应用
CN102675287A (zh) * 2011-03-11 2012-09-19 江苏恒瑞医药股份有限公司 (e)-n-[4-[[3-氯-4-(2-吡啶基甲氧基)苯基]氨基]-3-氰基-7-乙氧基-6-喹啉基]-3-[(2r)-1-甲基吡咯烷-2-基]丙-2-烯酰胺的可药用的盐、其制备方法及其在医药上的应用

Also Published As

Publication number Publication date
RU2015103065A (ru) 2016-08-27
EP2873664B1 (en) 2017-11-01
HUE037946T2 (hu) 2018-09-28
HK1199027A1 (zh) 2015-06-19
JP2015522042A (ja) 2015-08-03
CN103974949B (zh) 2015-11-25
ZA201500471B (en) 2016-10-26
KR102078077B1 (ko) 2020-02-17
ES2656623T3 (es) 2018-02-27
CA2876884A1 (en) 2014-01-16
DK2873664T3 (en) 2018-01-08
MX2014015623A (es) 2015-06-23
EP2873664A4 (en) 2015-12-30
AU2013289789A1 (en) 2015-01-22
PT2873664T (pt) 2018-01-24
AU2013289789B2 (en) 2017-06-29
CN103539783A (zh) 2014-01-29
CN103974949A (zh) 2014-08-06
NO2873664T3 (pt) 2018-03-31
KR20150036336A (ko) 2015-04-07
US20150166511A1 (en) 2015-06-18
JP6170146B2 (ja) 2017-07-26
CA2876884C (en) 2019-12-10
TWI597277B (zh) 2017-09-01
BR112015000045B1 (pt) 2021-10-26
RU2631321C2 (ru) 2017-09-21
TW201402563A (zh) 2014-01-16
US9309226B2 (en) 2016-04-12
EP2873664A1 (en) 2015-05-20
WO2014008794A1 (zh) 2014-01-16
PL2873664T3 (pl) 2018-06-29
MX349672B (es) 2017-08-08
UA113658C2 (xx) 2017-02-27

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06I Publication of requirement cancelled [chapter 6.9 patent gazette]

Free format text: ANULADA A PUBLICACAO CODIGO 6.6.1 NA RPI NO 2462 DE 13/03/2018 POR TER SIDO INDEVIDA.

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B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B09X Republication of the decision to grant [chapter 9.1.3 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/06/2013, OBSERVADAS AS CONDICOES LEGAIS.