AU2014354728B2 - Crystalline Form I of ibrutinib - Google Patents

Crystalline Form I of ibrutinib Download PDF

Info

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
Authority
AU
Australia
Prior art keywords
crystalline form
ibrutinib
ray powder
powder diffraction
diffraction pattern
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
AU2014354728A
Other languages
English (en)
Other versions
AU2014354728A1 (en
Inventor
Minhua Chen
Heng GE
Pixu Li
Fei Lu
Peng Wang
Chaohui YANG
Xiaoyu Zhang
Yanfeng Zhang
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.)
Crystal Pharmatech Co Ltd
Suzhou Pengxu Pharmatech Co Ltd
Original Assignee
Crystal Pharmatech Co Ltd
Suzhou Pengxu 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 Crystal Pharmatech Co Ltd, Suzhou Pengxu Pharmatech Co Ltd filed Critical Crystal Pharmatech Co Ltd
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.
Application granted granted Critical
Publication of AU2014354728B2 publication Critical patent/AU2014354728B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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

Landscapes

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

Family

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 (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)

Families Citing this family (39)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MA37711A1 (fr) 2012-06-04 2017-05-31 Pharmacyclics Inc Formes cristallines d'un inhibiteur de tyrosine kinase de bruton
EP3122753A4 (en) 2014-03-27 2017-11-29 Perrigo Api 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
US9545407B2 (en) 2014-08-07 2017-01-17 Pharmacyclics Llc Formulations of a bruton's tyrosine kinase inhibitor
CA2958139A1 (en) 2014-08-14 2016-02-18 Assia Chemical Industries Ltd. Solid state forms of ibrutinib
CZ201584A3 (cs) 2015-02-09 2016-08-17 Zentiva, K.S. Sůl Ibrutinib sulfátu
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 proton tyrosine kinase inhibitor
MX2017011990A (es) * 2015-03-20 2018-06-06 Crystal Pharmatech Co Ltd Metodo de preparacion de la forma a cristalina de 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
EP3337485B1 (en) 2015-08-19 2021-03-17 Sun Pharmaceutical Industries Ltd 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
IL293319B1 (en) 2016-08-16 2026-01-01 Beone Medicines Ltd Crystal structure of s)–7–(1–acryloylpiperidin–4–yl)–2–(4–)phenoxyphenyl)–4,5,6,7–tetra–hydropyrazolo(1,5–a)pyrimidine–3–carboxamide, methods of preparation and uses thereof
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
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
EP3810590A1 (en) * 2018-06-19 2021-04-28 Merck Patent GmbH Novel crystalline forms of 1-(4-{[6-amino-5-(4-phenoxy-phenyl)-pyrimidin-4-ylamino]-methyl}-4-fluoro-piperidin-1-yl)-propenone, salt forms thereof, and processes to obtain
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
TN2023000295A1 (en) 2021-06-10 2025-07-02 Hikma Pharmaceuticals Usa Inc Oral dosage forms of ibrutinib
US11433072B1 (en) * 2021-06-10 2022-09-06 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
WO2023242384A1 (en) 2022-06-17 2023-12-21 Krka, D.D., Novo Mesto Crystalline form of ibrutinib
CN117752664A (zh) * 2023-12-13 2024-03-26 苏州晶云星空制药有限公司 一种包含伊布替尼晶型a的药物组合物及用途

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013184572A1 (en) * 2012-06-04 2013-12-12 Pharmacyclics, Inc. Crystalline forms of a bruton's tyrosine kinase inhibitor

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007107469A1 (en) * 2006-03-20 2007-09-27 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
PH12013500246A1 (en) 2010-08-10 2019-10-11 Celgene Avilomics Res Inc Besylate salt of a btk inhibitor
HK1206624A1 (en) 2012-04-11 2016-01-15 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
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

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013184572A1 (en) * 2012-06-04 2013-12-12 Pharmacyclics, Inc. Crystalline forms of a bruton's tyrosine kinase inhibitor

Also Published As

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

Similar Documents

Publication Publication Date Title
CA2932059C (en) Crystalline form i of ibrutinib
WO2022237815A1 (en) Novel forms of Compound I and use thereof
CN113784971B (zh) 一种egfr抑制剂的晶型及其制备方法
JP2021191756A (ja) Ｎ−（４−｛［６，７−ビス（メチルオキシ）キノリン−４−イル］オキシ｝フェニル）−ｎ’−（４−フルオロフェニル）シクロプロパン−１，１−ジカルボキサミドのリンゴ酸塩およびその結晶質形態
JP2019513140A (ja) 新規共結晶
CN104961731A (zh) 一种表皮生长因子受体抑制剂的磷酸盐、其晶型及制备方法
US11168072B2 (en) Crystal form of morpholino quinazoline compound, preparation method therefor and use thereof
WO2020244348A1 (zh) 呋喃并咪唑并吡啶类化合物的合成方法、呋喃并咪唑并吡啶类化合物的晶型及其盐的晶型
TW202502767A (zh) 喹啉取代化合物之結晶
CN114026088A (zh) Jak2抑制剂的结晶形式
US12428369B2 (en) Crystal form of aromatic vinyl derivatives, and preparation method therefor and use thereof
CN116554177A (zh) 一种含氮杂环化合物的盐型、晶型及其应用
CN110981798A (zh) 一种抗肿瘤药物卡博替尼杂质、其制备方法及应用
KR102967883B1 (ko) Fgfr4 억제제 산성염 및 이의 제조 방법과 응용
AU2015247489B2 (en) Polymorphic forms and co-crystals of a c-Met inhibitor
US20240368157A1 (en) Forms and compositions of a jak2 inhibitor
TW202545933A (zh) 一種吡唑基-胺基-嘧啶基衍生物的苯甲醯胺的晶型、製備方法及應用
HK40058904B (en) Synthesis method of furoimidazopyridine compound, crystal form of furoimidazopyridine compound, and crystal form of salt thereof
TW202328138A (zh) 稠合二環類衍生物的可藥用鹽、晶型及其製備方法
WO2023185869A1 (zh) 一种吡咯并杂环类衍生物的富马酸盐的晶型及其制备方法
CN121969633A (zh) 一种喹唑啉衍生物的结晶形式及其制备方法
JP2012041331A (ja) ４−アミノ−５−クロロ−２−エトキシ−ｎ−［［４−（４−フルオロベンジル）−２−モルホリニル］メチル］ベンズアミド・クエン酸塩の結晶

Legal Events

Date Code Title Description
PC1 Assignment before grant (sect. 113)

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.

FGA Letters patent sealed or granted (standard patent)