CN103694241A - Pci-32765的新晶型a及其制备方法 - Google Patents

Pci-32765的新晶型a及其制备方法 Download PDF

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Publication number
CN103694241A
CN103694241A CN201310616065.4A CN201310616065A CN103694241A CN 103694241 A CN103694241 A CN 103694241A CN 201310616065 A CN201310616065 A CN 201310616065A CN 103694241 A CN103694241 A CN 103694241A
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CN
China
Prior art keywords
crystal form
pci
preparation
virahol
normal heptane
Prior art date
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Pending
Application number
CN201310616065.4A
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English (en)
Chinese (zh)
Inventor
陈敏华
张炎锋
杨朝惠
张晓宇
王鹏
李丕旭
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SUZHOU PENGXU PHARMATECH Co Ltd
Crystal Pharmatech Co Ltd
Original Assignee
SUZHOU PENGXU PHARMATECH Co Ltd
Crystal Pharmatech Co Ltd
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 SUZHOU PENGXU PHARMATECH Co Ltd, Crystal Pharmatech Co Ltd filed Critical SUZHOU PENGXU PHARMATECH Co Ltd
Priority to CN201310616065.4A priority Critical patent/CN103694241A/zh
Publication of CN103694241A publication Critical patent/CN103694241A/zh
Priority to CN201410542609.1A priority patent/CN104327085B/zh
Priority to ES14866302.4T priority patent/ES2684094T3/es
Priority to CA2932059A priority patent/CA2932059C/en
Priority to JP2016535162A priority patent/JP6483126B2/ja
Priority to PT14866302T priority patent/PT3073999T/pt
Priority to MX2016006901A priority patent/MX363265B/es
Priority to AU2014354728A priority patent/AU2014354728B2/en
Priority to PCT/US2014/067586 priority patent/WO2015081180A1/en
Priority to EP14866302.4A priority patent/EP3073999B1/en
Priority to US15/100,247 priority patent/US9751889B2/en
Priority to HUE14866302A priority patent/HUE039718T2/hu
Priority to PL14866302T priority patent/PL3073999T3/pl
Priority to DK14866302.4T priority patent/DK3073999T3/en
Priority to IL245865A priority patent/IL245865B/en
Pending legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D487/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00
    • C07D487/02—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00 in which the condensed system contains two hetero rings
    • C07D487/04—Ortho-condensed 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
    • A61K31/495—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
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with 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
    • 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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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
CN201310616065.4A 2013-11-27 2013-11-27 Pci-32765的新晶型a及其制备方法 Pending CN103694241A (zh)

Priority Applications (15)

Application Number Priority Date Filing Date Title
CN201310616065.4A CN103694241A (zh) 2013-11-27 2013-11-27 Pci-32765的新晶型a及其制备方法
CN201410542609.1A CN104327085B (zh) 2013-11-27 2014-10-14 Pci-32765的晶型a及其制备方法
DK14866302.4T DK3073999T3 (en) 2013-11-27 2014-11-26 CRYSTALINE FORM I OF IBRUTINIB
MX2016006901A MX363265B (es) 2013-11-27 2014-11-26 Forma cristalina i de ibrutinib.
EP14866302.4A EP3073999B1 (en) 2013-11-27 2014-11-26 Crystalline form i of ibrutinib
JP2016535162A JP6483126B2 (ja) 2013-11-27 2014-11-26 イブルチニブの結晶形態ｉ
PT14866302T PT3073999T (pt) 2013-11-27 2014-11-26 Forma cristalina i de ibrutinib
ES14866302.4T ES2684094T3 (es) 2013-11-27 2014-11-26 Forma cristalina I del ibrutinib
AU2014354728A AU2014354728B2 (en) 2013-11-27 2014-11-26 Crystalline Form I of ibrutinib
PCT/US2014/067586 WO2015081180A1 (en) 2013-11-27 2014-11-26 Crystalline form i of ibrutinib
CA2932059A CA2932059C (en) 2013-11-27 2014-11-26 Crystalline form i of ibrutinib
US15/100,247 US9751889B2 (en) 2013-11-27 2014-11-26 Crystalline form I of ibrutinib
HUE14866302A HUE039718T2 (hu) 2013-11-27 2014-11-26 Ibrutinib I. kristályos formája
PL14866302T PL3073999T3 (pl) 2013-11-27 2014-11-26 Krystaliczna Postać I ibrutynibu
IL245865A IL245865B (en) 2013-11-27 2016-05-26 Form i of crystalline ibrutinib

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201310616065.4A CN103694241A (zh) 2013-11-27 2013-11-27 Pci-32765的新晶型a及其制备方法

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CN201410542609.1A Active CN104327085B (zh) 2013-11-27 2014-10-14 Pci-32765的晶型a及其制备方法

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US (1) US9751889B2 (enExample)
EP (1) EP3073999B1 (enExample)
JP (1) JP6483126B2 (enExample)
CN (2) CN103694241A (enExample)
AU (1) AU2014354728B2 (enExample)
CA (1) CA2932059C (enExample)
DK (1) DK3073999T3 (enExample)
ES (1) ES2684094T3 (enExample)
HU (1) HUE039718T2 (enExample)
IL (1) IL245865B (enExample)
MX (1) MX363265B (enExample)
PL (1) PL3073999T3 (enExample)
PT (1) PT3073999T (enExample)
WO (1) WO2015081180A1 (enExample)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105085529A (zh) * 2014-05-15 2015-11-25 广东东阳光药业有限公司 依鲁替尼新晶型及其制备方法
WO2016127960A1 (en) 2015-02-09 2016-08-18 Zentiva, K.S. Ibrutinib sulphate salt
CN106905320A (zh) * 2015-12-23 2017-06-30 杭州容立医药科技有限公司 一种适合药用的依鲁替尼及其制剂
CN106995445A (zh) * 2016-01-22 2017-08-01 山东新时代药业有限公司 一种布鲁顿酪氨酸激酶抑制剂晶型及其制备方法
WO2017174044A1 (en) 2016-04-06 2017-10-12 Zentiva, K.S. Solid forms of ibrutinib
EP3243824A1 (en) 2016-05-11 2017-11-15 Zentiva K.S. Solid forms of ibrutinib free base
US9884869B2 (en) 2014-03-27 2018-02-06 Perrigo Api Ltd. Ibrutinib solid forms and production process therefor
WO2019195827A1 (en) 2018-04-06 2019-10-10 Johnson Matthey Public Limited Company Novel form of ibrutinib
WO2019211870A1 (en) 2018-05-02 2019-11-07 Cipla Limited Polymorphic forms of ibrutinib
CN111138436A (zh) * 2018-11-04 2020-05-12 鲁南制药集团股份有限公司 伊布替尼晶型a单晶及其制备方法
WO2023242384A1 (en) 2022-06-17 2023-12-21 Krka, D.D., Novo Mesto Crystalline form of ibrutinib

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US9296753B2 (en) 2012-06-04 2016-03-29 Pharmacyclics Llc Crystalline forms of a Bruton's tyrosine kinase inhibitor
AU2015300798A1 (en) 2014-08-07 2017-02-02 Pharmacyclics Llc Novel formulations of a Bruton's tyrosine kinase inhibitor
WO2016025720A1 (en) * 2014-08-14 2016-02-18 Assia Chemical Industries Ltd. Solid state forms of ibrutinib
US10477780B2 (en) * 2015-02-13 2019-11-19 Hgci, Inc. Multiple cell tray with media plugs
IL315294A (en) 2015-03-03 2024-10-01 Pharmacyclics Llc Pharmaceutical formulations of bruton's tyrosine kinase inhibitor
WO2016150349A1 (zh) * 2015-03-20 2016-09-29 苏州晶云药物科技有限公司 一种pci-32765晶型a的制备方法
CN106153797B (zh) * 2015-04-20 2017-08-29 北京睿创康泰医药研究院有限公司 一种依鲁替尼及依鲁替尼制剂有关物质分析方法
CN106153798B (zh) * 2015-04-22 2017-08-29 北京睿创康泰医药研究院有限公司 一种用于分析依鲁替尼及依鲁替尼制剂有关物质的hplc方法以及这些杂质做参比标准的用途
KR20180040694A (ko) * 2015-08-19 2018-04-20 썬 파마슈티칼 인더스트리스 리미티드 이브루티닙의 결정형 및 그 제조 방법
ITUB20155616A1 (it) * 2015-11-16 2017-05-16 Laboratorio Chimico Int S P A Procedimento per la preparazione della forma amorfa dell?ibrutinib e nuova forma cristallina.
CN105294696A (zh) * 2015-11-19 2016-02-03 上海创诺医药集团有限公司 依鲁替尼新晶型及其制备方法
CN107286163A (zh) * 2016-03-30 2017-10-24 上海星泰医药科技有限公司 一种依鲁替尼的新晶型及其制备方法
CN106117214A (zh) * 2016-06-29 2016-11-16 上海创诺医药集团有限公司 依鲁替尼新晶型及其制备方法
CN106008529A (zh) * 2016-08-08 2016-10-12 上海工程技术大学 一种依鲁替尼溶剂化物及其制备方法
US10183024B2 (en) 2016-12-02 2019-01-22 Apotex Inc. Crystalline forms of ibrutinib
WO2019070698A1 (en) 2017-10-02 2019-04-11 Johnson Matthey Public Limited Company Novel forms of ibrutinib
CZ2017787A3 (cs) 2017-12-08 2019-06-19 Zentiva, K.S. Farmaceutické kompozice obsahující ibrutinib
BR112020022185A2 (pt) 2018-05-03 2021-02-02 Juno Therapeutics Inc terapia de combinação de uma terapia de células t do receptor de antígeno quimérico (car) e um inibidor de quinase
EP3575300A1 (en) 2018-05-31 2019-12-04 Apotex Inc. Novel crystalline forms of ibrutinib
KR20210022674A (ko) * 2018-06-19 2021-03-03 메르크 파텐트 게엠베하 1-(4-｛[6-아미노-5-(4-페녹시-페닐)-피리미딘-4-일아미노]-메틸｝-4-플루오로-피페리딘-1-일)-프로펜온의 신규한 결정 형태, 이의 염 형태, 및 이를 수득하는 방법
US10688050B1 (en) 2018-12-21 2020-06-23 Synthon B.V. Pharmaceutical composition comprising ibrutinib
EP3669867A1 (en) 2018-12-21 2020-06-24 Synthon B.V. Pharmaceutical composition comprising ibrutinib
CN113214261A (zh) * 2020-01-21 2021-08-06 尚科生物医药（上海）有限公司 一种依鲁替尼晶型a的纯化方法
US11433072B1 (en) * 2021-06-10 2022-09-06 Hikma Pharmaceuticals USA, Inc. Oral dosage forms of ibrutinib
WO2022260667A1 (en) 2021-06-10 2022-12-15 Hikma Pharmaceuticals Usa Inc. Oral dosage forms of ibrutinib
US20250302954A1 (en) 2022-05-11 2025-10-02 Celgene Corporation Methods to overcome drug resistance by re-sensitizing cancer cells to treatment with a prior therapy via treatment with a t cell therapy

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EP1998777A1 (en) 2006-03-20 2008-12-10 F. Hoffmann-La Roche AG Methods of inhibiting btk and syk protein kinases
EP2529621B1 (en) 2006-09-22 2016-10-05 Pharmacyclics LLC Inhibitors of bruton's tyrosine kinase
JP6068340B2 (ja) 2010-08-10 2017-01-25 セルジーン アヴィロミクス リサーチ， インコーポレイテッド Ｂｔｋ阻害剤のベシル酸塩
EP2836214B1 (en) * 2012-04-11 2018-06-27 Acerta Pharma B.V. Bruton's tyrosine kinase inhibitors for hematopoietic mobilization
WO2013157021A1 (en) 2012-04-20 2013-10-24 Advinus Therapeutics Limited Bicyclic compounds, compositions and medicinal applications thereof
US9296753B2 (en) * 2012-06-04 2016-03-29 Pharmacyclics Llc Crystalline forms of a Bruton's tyrosine kinase inhibitor
CN103121999A (zh) * 2012-08-29 2013-05-29 苏州迪飞医药科技有限公司 一种酪氨酸激酶抑制剂pci-32765的合成方法
CN103142601A (zh) * 2013-03-13 2013-06-12 杭州雷索药业有限公司 Pci-32765在制备抗血管生成类药物中的应用

Cited By (13)

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US9884869B2 (en) 2014-03-27 2018-02-06 Perrigo Api Ltd. Ibrutinib solid forms and production process therefor
US10280173B2 (en) 2014-03-27 2019-05-07 Wavelength Enterprises Ltd Ibrutinib solid forms and production process therefor
CN105085529A (zh) * 2014-05-15 2015-11-25 广东东阳光药业有限公司 依鲁替尼新晶型及其制备方法
WO2016127960A1 (en) 2015-02-09 2016-08-18 Zentiva, K.S. Ibrutinib sulphate salt
CN106905320A (zh) * 2015-12-23 2017-06-30 杭州容立医药科技有限公司 一种适合药用的依鲁替尼及其制剂
CN106995445A (zh) * 2016-01-22 2017-08-01 山东新时代药业有限公司 一种布鲁顿酪氨酸激酶抑制剂晶型及其制备方法
CN106995445B (zh) * 2016-01-22 2021-08-03 山东新时代药业有限公司 一种布鲁顿酪氨酸激酶抑制剂晶型及其制备方法
WO2017174044A1 (en) 2016-04-06 2017-10-12 Zentiva, K.S. Solid forms of ibrutinib
EP3243824A1 (en) 2016-05-11 2017-11-15 Zentiva K.S. Solid forms of ibrutinib free base
WO2019195827A1 (en) 2018-04-06 2019-10-10 Johnson Matthey Public Limited Company Novel form of ibrutinib
WO2019211870A1 (en) 2018-05-02 2019-11-07 Cipla Limited Polymorphic forms of ibrutinib
CN111138436A (zh) * 2018-11-04 2020-05-12 鲁南制药集团股份有限公司 伊布替尼晶型a单晶及其制备方法
WO2023242384A1 (en) 2022-06-17 2023-12-21 Krka, D.D., Novo Mesto Crystalline form of ibrutinib

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Publication number Publication date
IL245865A0 (en) 2016-07-31
CN104327085A (zh) 2015-02-04
CA2932059C (en) 2019-07-02
PL3073999T3 (pl) 2018-10-31
ES2684094T3 (es) 2018-10-01
JP2016538314A (ja) 2016-12-08
EP3073999A4 (en) 2017-03-22
US20170002009A1 (en) 2017-01-05
AU2014354728A1 (en) 2016-06-16
CN104327085B (zh) 2016-08-24
EP3073999A1 (en) 2016-10-05
AU2014354728B2 (en) 2019-02-28
DK3073999T3 (en) 2018-09-03
IL245865B (en) 2019-05-30
US9751889B2 (en) 2017-09-05
PT3073999T (pt) 2018-10-16
HUE039718T2 (hu) 2019-02-28
CA2932059A1 (en) 2015-06-04
MX363265B (es) 2019-03-19
WO2015081180A1 (en) 2015-06-04
JP6483126B2 (ja) 2019-03-13
MX2016006901A (es) 2016-10-28
EP3073999B1 (en) 2018-05-30

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Application publication date: 20140402