JP2016538314A5 - - Google Patents
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- Publication number
- JP2016538314A5 JP2016538314A5 JP2016535162A JP2016535162A JP2016538314A5 JP 2016538314 A5 JP2016538314 A5 JP 2016538314A5 JP 2016535162 A JP2016535162 A JP 2016535162A JP 2016535162 A JP2016535162 A JP 2016535162A JP 2016538314 A5 JP2016538314 A5 JP 2016538314A5
- Authority
- JP
- Japan
- Prior art keywords
- diffraction pattern
- ray powder
- powder diffraction
- crystalline form
- pharmaceutical composition
- 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.)
- Granted
Links
- 238000000634 powder X-ray diffraction Methods 0.000 claims 8
- IMNFDUFMRHMDMM-UHFFFAOYSA-N N-Heptane Chemical compound CCCCCCC IMNFDUFMRHMDMM-UHFFFAOYSA-N 0.000 claims 6
- 238000000034 method Methods 0.000 claims 6
- 239000008194 pharmaceutical composition Substances 0.000 claims 6
- 230000005855 radiation Effects 0.000 claims 6
- 150000001335 aliphatic alkanes Chemical class 0.000 claims 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 4
- XYFPWWZEPKGCCK-GOSISDBHSA-N ibrutinib Chemical compound C1=2C(N)=NC=NC=2N([C@H]2CN(CCC2)C(=O)C=C)N=C1C(C=C1)=CC=C1OC1=CC=CC=C1 XYFPWWZEPKGCCK-GOSISDBHSA-N 0.000 claims 4
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 3
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims 3
- 239000002177 L01XE27 - Ibrutinib Substances 0.000 claims 3
- 229960001507 ibrutinib Drugs 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 239000002904 solvent Substances 0.000 claims 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims 2
- 208000031671 Large B-Cell Diffuse Lymphoma Diseases 0.000 claims 2
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims 2
- 208000025205 Mantle-Cell Lymphoma Diseases 0.000 claims 2
- 239000013078 crystal Substances 0.000 claims 2
- 206010012818 diffuse large B-cell lymphoma Diseases 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 208000035475 disorder Diseases 0.000 claims 2
- 150000002576 ketones Chemical class 0.000 claims 2
- 208000034578 Multiple myelomas Diseases 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 1
- 102000004022 Protein-Tyrosine Kinases Human genes 0.000 claims 1
- 108090000412 Protein-Tyrosine Kinases Proteins 0.000 claims 1
- 210000003719 b-lymphocyte Anatomy 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 238000001816 cooling Methods 0.000 claims 1
- 238000002425 crystallisation Methods 0.000 claims 1
- 230000008025 crystallization Effects 0.000 claims 1
- 238000000113 differential scanning calorimetry Methods 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 230000036210 malignancy Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 230000008018 melting Effects 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310616065.4 | 2013-11-27 | ||
| CN201310616065.4A CN103694241A (zh) | 2013-11-27 | 2013-11-27 | Pci-32765的新晶型a及其制备方法 |
| 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 (3)
| Publication Number | Publication Date |
|---|---|
| JP2016538314A JP2016538314A (ja) | 2016-12-08 |
| JP2016538314A5 true JP2016538314A5 (enExample) | 2018-01-11 |
| JP6483126B2 JP6483126B2 (ja) | 2019-03-13 |
Family
ID=50355928
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016535162A Active JP6483126B2 (ja) | 2013-11-27 | 2014-11-26 | イブルチニブの結晶形態ｉ |
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 (37)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EA201492082A1 (ru) | 2012-06-04 | 2015-03-31 | Фармасайкликс, Инк. | Кристаллические формы ингибитора тирозинкиназы брутона |
| US9884869B2 (en) | 2014-03-27 | 2018-02-06 | 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 |
| EP3193877A4 (en) | 2014-08-07 | 2018-04-04 | Pharmacyclics LLC | Novel formulations of a bruton's tyrosine kinase inhibitor |
| EP3180343A1 (en) * | 2014-08-14 | 2017-06-21 | 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 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 |
| 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 |
| US20220009929A1 (en) | 2018-05-02 | 2022-01-13 | 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 |
| WO2019243223A1 (en) * | 2018-06-19 | 2019-12-26 | 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 |
| EP3669867A1 (en) | 2018-12-21 | 2020-06-24 | Synthon B.V. | Pharmaceutical composition comprising ibrutinib |
| US10688050B1 (en) | 2018-12-21 | 2020-06-23 | 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 |
| 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 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2645583A1 (en) * | 2006-03-20 | 2007-09-27 | F. Hoffman-La Roche Ag | Methods of inhibiting btk and syk protein kinases |
| EP2526934B1 (en) * | 2006-09-22 | 2015-12-09 | Pharmacyclics LLC | Inhibitors of bruton's tyrosine kinase |
| NZ607845A (en) | 2010-08-10 | 2015-03-27 | 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 |
| EA201492082A1 (ru) * | 2012-06-04 | 2015-03-31 | Фармасайкликс, Инк. | Кристаллические формы ингибитора тирозинкиназы брутона |
| 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 |
-
2013
- 2013-11-27 CN CN201310616065.4A patent/CN103694241A/zh active Pending
-
2014
- 2014-10-14 CN CN201410542609.1A patent/CN104327085B/zh active Active
- 2014-11-26 WO PCT/US2014/067586 patent/WO2015081180A1/en not_active Ceased
- 2014-11-26 DK DK14866302.4T patent/DK3073999T3/en active
- 2014-11-26 CA CA2932059A patent/CA2932059C/en active Active
- 2014-11-26 HU HUE14866302A patent/HUE039718T2/hu unknown
- 2014-11-26 JP JP2016535162A patent/JP6483126B2/ja active Active
- 2014-11-26 EP EP14866302.4A patent/EP3073999B1/en active Active
- 2014-11-26 AU AU2014354728A patent/AU2014354728B2/en active Active
- 2014-11-26 PT PT14866302T patent/PT3073999T/pt unknown
- 2014-11-26 MX MX2016006901A patent/MX363265B/es unknown
- 2014-11-26 US US15/100,247 patent/US9751889B2/en active Active
- 2014-11-26 ES ES14866302.4T patent/ES2684094T3/es active Active
- 2014-11-26 PL PL14866302T patent/PL3073999T3/pl unknown
-
2016
- 2016-05-26 IL IL245865A patent/IL245865B/en active IP Right Grant
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