JP2019506387A5 - - Google Patents
Download PDFInfo
- Publication number
- JP2019506387A5 JP2019506387A5 JP2018537505A JP2018537505A JP2019506387A5 JP 2019506387 A5 JP2019506387 A5 JP 2019506387A5 JP 2018537505 A JP2018537505 A JP 2018537505A JP 2018537505 A JP2018537505 A JP 2018537505A JP 2019506387 A5 JP2019506387 A5 JP 2019506387A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- lymphoma
- ibrutinib
- solid tablet
- filler
- 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
- 239000008194 pharmaceutical composition Substances 0.000 claims description 60
- 239000007787 solid Substances 0.000 claims description 35
- 238000002360 preparation method Methods 0.000 claims description 28
- 238000000034 method Methods 0.000 claims description 27
- 239000002177 L01XE27 - Ibrutinib Substances 0.000 claims description 24
- 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 description 24
- 229960001507 ibrutinib Drugs 0.000 claims description 24
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 23
- 239000007916 tablet composition Substances 0.000 claims description 19
- 239000000945 filler Substances 0.000 claims description 18
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 16
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 16
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 16
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 16
- 206010025323 Lymphomas Diseases 0.000 claims description 14
- 206010028980 Neoplasm Diseases 0.000 claims description 14
- 239000000203 mixture Substances 0.000 claims description 13
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 12
- 201000011510 cancer Diseases 0.000 claims description 12
- 229960000913 crospovidone Drugs 0.000 claims description 12
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 12
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 12
- 206010012818 diffuse large B-cell lymphoma Diseases 0.000 claims description 10
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical group O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 9
- 238000009472 formulation Methods 0.000 claims description 9
- 208000031671 Large B-Cell Diffuse Lymphoma Diseases 0.000 claims description 8
- 210000003719 b-lymphocyte Anatomy 0.000 claims description 8
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 7
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims description 6
- 208000025205 Mantle-Cell Lymphoma Diseases 0.000 claims description 6
- 239000000314 lubricant Substances 0.000 claims description 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 6
- 239000004094 surface-active agent Substances 0.000 claims description 6
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims description 5
- 208000032852 chronic lymphocytic leukemia Diseases 0.000 claims description 5
- 238000007908 dry granulation Methods 0.000 claims description 5
- 208000011691 Burkitt lymphomas Diseases 0.000 claims description 4
- 208000034578 Multiple myelomas Diseases 0.000 claims description 4
- 206010035226 Plasma cell myeloma Diseases 0.000 claims description 4
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 4
- 239000011230 binding agent Substances 0.000 claims description 4
- 201000010099 disease Diseases 0.000 claims description 4
- 201000003444 follicular lymphoma Diseases 0.000 claims description 4
- 208000032839 leukemia Diseases 0.000 claims description 4
- 206010025135 lupus erythematosus Diseases 0.000 claims description 4
- 210000004698 lymphocyte Anatomy 0.000 claims description 4
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 4
- 208000023275 Autoimmune disease Diseases 0.000 claims description 3
- 239000003795 chemical substances by application Substances 0.000 claims description 3
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims description 3
- 208000035475 disorder Diseases 0.000 claims description 3
- 208000026278 immune system disease Diseases 0.000 claims description 3
- 235000019359 magnesium stearate Nutrition 0.000 claims description 3
- 230000036210 malignancy Effects 0.000 claims description 3
- 239000000377 silicon dioxide Substances 0.000 claims description 3
- GUBGYTABKSRVRQ-UHFFFAOYSA-N 2-(hydroxymethyl)-6-[4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxane-3,4,5-triol Chemical compound OCC1OC(OC2C(O)C(O)C(O)OC2CO)C(O)C(O)C1O GUBGYTABKSRVRQ-UHFFFAOYSA-N 0.000 claims description 2
- 208000006386 Bone Resorption Diseases 0.000 claims description 2
- 208000023611 Burkitt leukaemia Diseases 0.000 claims description 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 2
- 201000003791 MALT lymphoma Diseases 0.000 claims description 2
- 229930195725 Mannitol Natural products 0.000 claims description 2
- 206010029461 Nodal marginal zone B-cell lymphomas Diseases 0.000 claims description 2
- 208000001132 Osteoporosis Diseases 0.000 claims description 2
- 208000007452 Plasmacytoma Diseases 0.000 claims description 2
- 208000016025 Waldenstroem macroglobulinemia Diseases 0.000 claims description 2
- 208000033559 Waldenström macroglobulinemia Diseases 0.000 claims description 2
- 230000024279 bone resorption Effects 0.000 claims description 2
- 230000001684 chronic effect Effects 0.000 claims description 2
- 229940125904 compound 1 Drugs 0.000 claims description 2
- 239000007884 disintegrant Substances 0.000 claims description 2
- 210000000416 exudates and transudate Anatomy 0.000 claims description 2
- 238000005469 granulation Methods 0.000 claims description 2
- 230000003179 granulation Effects 0.000 claims description 2
- 208000027866 inflammatory disease Diseases 0.000 claims description 2
- 208000026876 intravascular large B-cell lymphoma Diseases 0.000 claims description 2
- 239000000594 mannitol Substances 0.000 claims description 2
- 235000010355 mannitol Nutrition 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 208000008585 mastocytosis Diseases 0.000 claims description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 2
- 206010039073 rheumatoid arthritis Diseases 0.000 claims description 2
- 238000009490 roller compaction Methods 0.000 claims description 2
- 206010036711 Primary mediastinal large B-cell lymphomas Diseases 0.000 claims 1
- 210000004027 cell Anatomy 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- -1 glidants Substances 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 201000007924 marginal zone B-cell lymphoma Diseases 0.000 claims 1
- 208000021937 marginal zone lymphoma Diseases 0.000 claims 1
- 230000002062 proliferating effect Effects 0.000 claims 1
- 230000003393 splenic effect Effects 0.000 claims 1
- 208000035269 cancer or benign tumor Diseases 0.000 description 2
- 208000003950 B-cell lymphoma Diseases 0.000 description 1
- 208000032568 B-cell prolymphocytic leukaemia Diseases 0.000 description 1
- 208000033014 Plasma cell tumor Diseases 0.000 description 1
- 208000035416 Prolymphocytic B-Cell Leukemia Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000003211 malignant effect Effects 0.000 description 1
- 208000010626 plasma cell neoplasm Diseases 0.000 description 1
- 210000000952 spleen Anatomy 0.000 description 1
- 210000001541 thymus gland Anatomy 0.000 description 1
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2022063871A JP2022105009A (ja) | 2016-01-19 | 2022-04-07 | Ｂｔｋ阻害剤を含む製剤／組成物 |
| JP2023183050A JP2024023184A (ja) | 2016-01-19 | 2023-10-25 | Ｂｔｋ阻害剤を含む製剤／組成物 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN201621001986 | 2016-01-19 | ||
| IN201621001986 | 2016-01-19 | ||
| PCT/EP2017/050962 WO2017125423A1 (en) | 2016-01-19 | 2017-01-18 | Formulations/compositions comprising a btk inhibitor |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022063871A Division JP2022105009A (ja) | 2016-01-19 | 2022-04-07 | Ｂｔｋ阻害剤を含む製剤／組成物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2019506387A JP2019506387A (ja) | 2019-03-07 |
| JP2019506387A5 true JP2019506387A5 (enExample) | 2020-02-27 |
| JP7109365B2 JP7109365B2 (ja) | 2022-07-29 |
Family
ID=57851067
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018537505A Active JP7109365B2 (ja) | 2016-01-19 | 2017-01-18 | Ｂｔｋ阻害剤を含む製剤／組成物 |
| JP2022063871A Withdrawn JP2022105009A (ja) | 2016-01-19 | 2022-04-07 | Ｂｔｋ阻害剤を含む製剤／組成物 |
| JP2023183050A Pending JP2024023184A (ja) | 2016-01-19 | 2023-10-25 | Ｂｔｋ阻害剤を含む製剤／組成物 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022063871A Withdrawn JP2022105009A (ja) | 2016-01-19 | 2022-04-07 | Ｂｔｋ阻害剤を含む製剤／組成物 |
| JP2023183050A Pending JP2024023184A (ja) | 2016-01-19 | 2023-10-25 | Ｂｔｋ阻害剤を含む製剤／組成物 |
Country Status (15)
| Country | Link |
|---|---|
| US (2) | US20190282577A1 (enExample) |
| EP (1) | EP3405177A1 (enExample) |
| JP (3) | JP7109365B2 (enExample) |
| KR (1) | KR20180101521A (enExample) |
| CN (1) | CN108472259A (enExample) |
| AR (1) | AR107391A1 (enExample) |
| AU (2) | AU2017208472B2 (enExample) |
| BR (1) | BR112018014590A2 (enExample) |
| CA (1) | CA3008338A1 (enExample) |
| EA (1) | EA201891440A1 (enExample) |
| HK (2) | HK1259440A1 (enExample) |
| MA (1) | MA43649A (enExample) |
| MX (3) | MX2018008771A (enExample) |
| TW (1) | TWI803454B (enExample) |
| WO (1) | WO2017125423A1 (enExample) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20250151610A (ko) | 2012-06-04 | 2025-10-21 | 파마싸이클릭스 엘엘씨 | 브루톤 타이로신 키나아제 저해제의 결정 형태 |
| IL315294A (en) * | 2015-03-03 | 2024-10-01 | Pharmacyclics Llc | Pharmaceutical formulations of bruton's tyrosine kinase inhibitor |
| HRP20251152T1 (hr) * | 2016-01-19 | 2025-12-05 | Janssen Pharmaceutica Nv | Formulacije/pripravci koji sadrže inhibitor btk-a |
| TWI794171B (zh) | 2016-05-11 | 2023-03-01 | 美商滬亞生物國際有限公司 | Ｈｄａｃ抑制劑與ｐｄ-ｌ１抑制劑之組合治療 |
| TWI808055B (zh) | 2016-05-11 | 2023-07-11 | 美商滬亞生物國際有限公司 | Hdac 抑制劑與 pd-1 抑制劑之組合治療 |
| WO2018065504A1 (en) | 2016-10-06 | 2018-04-12 | Janssen Pharmaceutica Nv | Processes and intermediates for preparing a btk inhibitor |
| WO2018119142A1 (en) | 2016-12-21 | 2018-06-28 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| BR112020006039A2 (pt) | 2017-09-26 | 2020-10-06 | Tesaro, Inc. | formulações de niraparibe |
| US11576917B2 (en) | 2018-01-20 | 2023-02-14 | Natco Pharma Limited | Pharmaceutical compositions comprising Ibrutinib |
| EP3806824A1 (en) | 2018-06-15 | 2021-04-21 | Janssen Pharmaceutica NV | Formulations/compositions comprising ibrutinib |
| US10688050B1 (en) * | 2018-12-21 | 2020-06-23 | Synthon B.V. | Pharmaceutical composition comprising ibrutinib |
| CN117064862B (zh) * | 2023-04-10 | 2025-12-19 | 山东新时代药业有限公司 | 一种伊布替尼肠溶片及其制备方法 |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4327725A (en) | 1980-11-25 | 1982-05-04 | Alza Corporation | Osmotic device with hydrogel driving member |
| US4624848A (en) | 1984-05-10 | 1986-11-25 | Ciba-Geigy Corporation | Active agent containing hydrogel devices wherein the active agent concentration profile contains a sigmoidal concentration gradient for improved constant release, their manufacture and use |
| US4968509A (en) | 1987-07-27 | 1990-11-06 | Mcneilab, Inc. | Oral sustained release acetaminophen formulation and process |
| IL92966A (en) | 1989-01-12 | 1995-07-31 | Pfizer | Dispensing devices powered by hydrogel |
| DE69222847T3 (de) | 1991-04-16 | 2005-09-15 | Nippon Shinyaku Co., Ltd. | Verfahren zur herstellung einer festen dispersion |
| CA2122479C (en) | 1991-11-22 | 1998-08-25 | Richard John Dansereau | Risedronate delayed-release compositions |
| US5461140A (en) | 1992-04-30 | 1995-10-24 | Pharmaceutical Delivery Systems | Bioerodible polymers for solid controlled release pharmaceutical compositions |
| US5323907A (en) | 1992-06-23 | 1994-06-28 | Multi-Comp, Inc. | Child resistant package assembly for dispensing pharmaceutical medications |
| EP0665010B1 (en) | 1992-10-16 | 2002-09-11 | Nippon Shinyaku Company, Limited | Method of manufacturing wax matrices |
| US5686105A (en) | 1993-10-19 | 1997-11-11 | The Procter & Gamble Company | Pharmaceutical dosage form with multiple enteric polymer coatings for colonic delivery |
| US6326469B1 (en) | 1994-04-22 | 2001-12-04 | Sugen, Inc. | Megakaryocytic protein tyrosine kinases |
| CA2220451A1 (en) | 1995-05-17 | 1996-11-21 | Cedars-Sinai Medical Center | Methods and compositions for improving digestion and absorption in the small intestine |
| US6395300B1 (en) | 1999-05-27 | 2002-05-28 | Acusphere, Inc. | Porous drug matrices and methods of manufacture thereof |
| US6465014B1 (en) | 2001-03-21 | 2002-10-15 | Isp Investments Inc. | pH-dependent sustained release, drug-delivery composition |
| US7711492B2 (en) | 2003-09-03 | 2010-05-04 | The United States Of America As Represented By The Department Of Health And Human Services | Methods for diagnosing lymphoma types |
| DK2529622T3 (en) | 2006-09-22 | 2018-05-07 | Pharmacyclics Llc | INHIBITORS OF BRUTON-TYROSINKINASE |
| US7718662B1 (en) * | 2009-10-12 | 2010-05-18 | Pharmacyclics, Inc. | Pyrazolo-pyrimidine inhibitors of bruton's tyrosine kinase |
| KR20250151610A (ko) * | 2012-06-04 | 2025-10-21 | 파마싸이클릭스 엘엘씨 | 브루톤 타이로신 키나아제 저해제의 결정 형태 |
| US20150140085A1 (en) * | 2012-06-29 | 2015-05-21 | Principia Biopharma Inc. | Formulations comprising ibrutinib |
| WO2015071432A1 (en) * | 2013-11-14 | 2015-05-21 | Sandoz Ag | Pharmaceutical compositions of ibrutinib |
| EP2902016A1 (en) * | 2014-01-30 | 2015-08-05 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Febuxostat tablet |
| CA2955747A1 (en) * | 2014-08-07 | 2016-02-11 | Pharmacyclics Llc | Novel formulations of a bruton's tyrosine kinase inhibitor |
| CN104523695A (zh) * | 2014-11-12 | 2015-04-22 | 广东东阳光药业有限公司 | 一种治疗过度增生性疾病的药物组合物 |
| IL315294A (en) * | 2015-03-03 | 2024-10-01 | Pharmacyclics Llc | Pharmaceutical formulations of bruton's tyrosine kinase inhibitor |
-
2017
- 2017-01-18 MX MX2018008771A patent/MX2018008771A/es unknown
- 2017-01-18 AU AU2017208472A patent/AU2017208472B2/en active Active
- 2017-01-18 HK HK19101844.5A patent/HK1259440A1/zh unknown
- 2017-01-18 BR BR112018014590A patent/BR112018014590A2/pt not_active Application Discontinuation
- 2017-01-18 HK HK19101838.3A patent/HK1259434A1/zh unknown
- 2017-01-18 US US16/071,448 patent/US20190282577A1/en not_active Abandoned
- 2017-01-18 WO PCT/EP2017/050962 patent/WO2017125423A1/en not_active Ceased
- 2017-01-18 KR KR1020187023222A patent/KR20180101521A/ko active Pending
- 2017-01-18 CN CN201780006752.0A patent/CN108472259A/zh active Pending
- 2017-01-18 MA MA043649A patent/MA43649A/fr unknown
- 2017-01-18 JP JP2018537505A patent/JP7109365B2/ja active Active
- 2017-01-18 EA EA201891440A patent/EA201891440A1/ru unknown
- 2017-01-18 CA CA3008338A patent/CA3008338A1/en active Pending
- 2017-01-18 EP EP17700820.8A patent/EP3405177A1/en active Pending
- 2017-01-19 AR ARP170100141A patent/AR107391A1/es unknown
- 2017-01-19 TW TW106101783A patent/TWI803454B/zh not_active IP Right Cessation
-
2018
- 2018-07-17 MX MX2022006768A patent/MX2022006768A/es unknown
- 2018-07-17 MX MX2024009894A patent/MX2024009894A/es unknown
-
2022
- 2022-04-07 JP JP2022063871A patent/JP2022105009A/ja not_active Withdrawn
- 2022-05-04 US US17/736,305 patent/US20220339157A1/en active Pending
- 2022-11-25 AU AU2022275514A patent/AU2022275514A1/en not_active Abandoned
-
2023
- 2023-10-25 JP JP2023183050A patent/JP2024023184A/ja active Pending
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP2019506387A5 (enExample) | ||
| JP2019506450A5 (enExample) | ||
| TWI724993B (zh) | Ｃ-ｍｅｔ抑制劑的錠劑配方 | |
| FI3405178T3 (fi) | Btk:n estäjää käsittäviä formulaatioita/koostumuksia | |
| WO2012164578A1 (en) | Compositions and methods for preparing immediate release formulations of nilotinib | |
| WO2015189386A1 (en) | Composition with a high drug load of sofosbuvir | |
| WO2007059106A2 (en) | Administration of mntor inhibitor to treat patients with cancer | |
| JP2022514569A (ja) | 非晶質スパルセンタン組成物 | |
| WO2020242414A1 (en) | Tablet formulations of apremilast | |
| JPWO2020028258A5 (enExample) | ||
| JP2017502062A5 (enExample) | ||
| CN119868364A (zh) | 用于治疗异常细胞生长的组合物和方法 | |
| AU2016231883B2 (en) | Pharmaceutical compositions of dimethyl fumarate | |
| WO2019142207A1 (en) | Pharmaceutical compositions comprising ibrutinib | |
| EP2644197A1 (en) | Novel Pharmaceutical Compositions of Entecavir | |
| WO2019171394A1 (en) | Stable pharmaceutical compositions comprising trifluridine and tipiracil hydrochloride | |
| US20150224086A1 (en) | Pharmaceutical Formulations of Rufinamide | |
| US20200054659A1 (en) | Extended release capecitabine capsules | |
| JP2018184381A (ja) | エゼチミブ含有錠剤およびその製法 | |
| JP5525453B2 (ja) | 医薬組成物 | |
| EP2644196B1 (en) | Pharmaceutical compositions of Entecavir | |
| WO2022029798A1 (en) | Pharmaceutical compositions comprising ribociclib | |
| JP7115825B2 (ja) | エゼチミブ含有経口製剤及びその製造方法 | |
| EP2846778B1 (en) | Oral solid dosage formulation of 1,1-dimethylethyl [(1s)-1-{[(2s,4r)-4-(7-chloro-4methoxyisoquinolin-1-yloxy)-2-({(1r,2s)-1-[(cyclopropylsulfonyl)carbamoyl]-2-ethenylcyclopropyl}carbamoyl)pyrrolidin-1-yl]carbonyl}-2,2-dimethylpropyl]carbamate | |
| EP4153137A1 (en) | Pharmaceutical formulations and their preparations for treatment of cancer |