AU2014354728B2 - Crystalline Form I of ibrutinib - Google Patents

Crystalline Form I of ibrutinib Download PDF

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Publication number
AU2014354728B2
AU2014354728B2 AU2014354728A AU2014354728A AU2014354728B2 AU 2014354728 B2 AU2014354728 B2 AU 2014354728B2 AU 2014354728 A AU2014354728 A AU 2014354728A AU 2014354728 A AU2014354728 A AU 2014354728A AU 2014354728 B2 AU2014354728 B2 AU 2014354728B2
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AU
Australia
Prior art keywords
crystalline form
ibrutinib
ray powder
powder diffraction
diffraction pattern
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AU2014354728A
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AU2014354728A1 (en
Inventor
Minhua Chen
Heng GE
Pixu Li
Fei Lu
Peng Wang
Chaohui YANG
Xiaoyu Zhang
Yanfeng Zhang
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SUZHOU PENGXU PHARMATECH Co Ltd
Crystal Pharmatech Co Ltd
Original Assignee
SUZHOU PENGXU PHARMATECH CO Ltd
Crystal Pharmatech Co Ltd
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Publication of AU2014354728A1 publication Critical patent/AU2014354728A1/en
Assigned to CRYSTAL PHARMATECH CO., LTD., SUZHOU PENGXU PHARMATECH CO., LTD. reassignment CRYSTAL PHARMATECH CO., LTD. Request for Assignment Assignors: CRYSTAL PHARMATECH INC., SUZHOU PENGXU PHARMATECH CO., LTD.
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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)
  • 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)
  • Oncology (AREA)
  • Hematology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
AU2014354728A 2013-11-27 2014-11-26 Crystalline Form I of ibrutinib Active AU2014354728B2 (en)

Applications Claiming Priority (5)

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
CN201310616065.4 2013-11-27
CN201410542609.1 2014-10-14
CN201410542609.1A CN104327085B (zh) 2013-11-27 2014-10-14 Pci-32765的晶型a及其制备方法
PCT/US2014/067586 WO2015081180A1 (en) 2013-11-27 2014-11-26 Crystalline form i of ibrutinib

Publications (2)

Publication Number Publication Date
AU2014354728A1 AU2014354728A1 (en) 2016-06-16
AU2014354728B2 true AU2014354728B2 (en) 2019-02-28

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ID=50355928

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2014354728A Active AU2014354728B2 (en) 2013-11-27 2014-11-26 Crystalline Form I of ibrutinib

Country Status (14)

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

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SG11201700849XA (en) 2014-08-07 2017-03-30 Pharmacyclics Llc Novel formulations of a bruton's tyrosine kinase inhibitor
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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
AU2016236578B2 (en) * 2015-03-20 2019-04-04 Crystal Pharmatech Co., Ltd. Preparation method of crystalline form a of pci-32765
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
US11001585B2 (en) 2015-08-19 2021-05-11 Sun Pharmaceutical Industries Limited Crystalline forms of ibrutinib
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
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
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
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
CZ2016196A3 (cs) 2016-04-06 2017-10-18 Zentiva, K.S. Pevné formy Ibrutinibu
CZ2016276A3 (cs) 2016-05-11 2017-11-22 Zentiva, K.S. Pevné formy volné báze ibrutinibu
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
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
US20210121466A1 (en) 2018-05-03 2021-04-29 Juno Therapeutics, Inc. Combination therapy of a chimeric antigen receptor (car) t cell therapy and a kinase inhibitor
EP3575300A1 (en) 2018-05-31 2019-12-04 Apotex Inc. Novel crystalline forms of ibrutinib
CN112313214A (zh) 2018-06-19 2021-02-02 默克专利有限公司 1-(4-{[6-氨基-5-(4-苯氧基-苯基)-嘧啶-4-基氨基]-甲基}-4-氟代-哌啶-1-基)-丙烯酮及其盐形式的新晶体形式以及获得方法
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
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
MA63498A1 (fr) 2021-06-10 2024-07-31 Hikma Pharmaceuticals Usa Inc. Formes posologiques orales d'ibrutinib
US11433072B1 (en) * 2021-06-10 2022-09-06 Hikma Pharmaceuticals USA, Inc. Oral dosage forms of ibrutinib
WO2023220655A1 (en) 2022-05-11 2023-11-16 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
WO2023242384A1 (en) 2022-06-17 2023-12-21 Krka, D.D., Novo Mesto Crystalline form of ibrutinib

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BRPI0622054B8 (pt) * 2006-09-22 2021-05-25 Oxford Amherst Llc composto e composição farmacêutica
CN105566229A (zh) * 2010-08-10 2016-05-11 西建阿维拉米斯研究公司 Btk抑制剂的苯磺酸盐及其用途和制备方法
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WO2013157021A1 (en) 2012-04-20 2013-10-24 Advinus Therapeutics Limited Bicyclic compounds, compositions and medicinal applications thereof
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

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Also Published As

Publication number Publication date
CA2932059A1 (en) 2015-06-04
JP6483126B2 (ja) 2019-03-13
CN104327085B (zh) 2016-08-24
MX363265B (es) 2019-03-19
ES2684094T3 (es) 2018-10-01
DK3073999T3 (en) 2018-09-03
IL245865B (en) 2019-05-30
PL3073999T3 (pl) 2018-10-31
CA2932059C (en) 2019-07-02
MX2016006901A (es) 2016-10-28
EP3073999A1 (en) 2016-10-05
CN104327085A (zh) 2015-02-04
CN103694241A (zh) 2014-04-02
EP3073999B1 (en) 2018-05-30
IL245865A0 (en) 2016-07-31
PT3073999T (pt) 2018-10-16
JP2016538314A (ja) 2016-12-08
WO2015081180A1 (en) 2015-06-04
EP3073999A4 (en) 2017-03-22
US9751889B2 (en) 2017-09-05
AU2014354728A1 (en) 2016-06-16
HUE039718T2 (hu) 2019-02-28
US20170002009A1 (en) 2017-01-05

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Owner name: SUZHOU PENGXU PHARMATECH CO., LTD.

Free format text: FORMER APPLICANT(S): SUZHOU PENGXU PHARMATECH CO., LTD.; CRYSTAL PHARMATECH INC.

Owner name: CRYSTAL PHARMATECH CO., LTD.

Free format text: FORMER APPLICANT(S): SUZHOU PENGXU PHARMATECH CO., LTD.; CRYSTAL PHARMATECH INC.

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