JP2017536398A5 - - Google Patents
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- Publication number
- JP2017536398A5 JP2017536398A5 JP2017529604A JP2017529604A JP2017536398A5 JP 2017536398 A5 JP2017536398 A5 JP 2017536398A5 JP 2017529604 A JP2017529604 A JP 2017529604A JP 2017529604 A JP2017529604 A JP 2017529604A JP 2017536398 A5 JP2017536398 A5 JP 2017536398A5
- Authority
- JP
- Japan
- Prior art keywords
- solid dispersion
- arn
- hpmcas
- formulation
- weight ratio
- 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
- 239000007962 solid dispersion Substances 0.000 claims description 35
- HJBWBFZLDZWPHF-UHFFFAOYSA-N apalutamide Chemical compound C1=C(F)C(C(=O)NC)=CC=C1N1C2(CCC2)C(=O)N(C=2C=C(C(C#N)=NC=2)C(F)(F)F)C1=S HJBWBFZLDZWPHF-UHFFFAOYSA-N 0.000 claims description 17
- 239000000203 mixture Substances 0.000 claims description 17
- ZUAAPNNKRHMPKG-UHFFFAOYSA-N acetic acid;butanedioic acid;methanol;propane-1,2-diol Chemical compound OC.CC(O)=O.CC(O)CO.OC(=O)CCC(O)=O ZUAAPNNKRHMPKG-UHFFFAOYSA-N 0.000 claims description 16
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims description 12
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 12
- 239000002245 particle Substances 0.000 claims description 6
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 6
- 239000006185 dispersion Substances 0.000 claims description 4
- 239000003814 drug Substances 0.000 claims description 4
- 239000003937 drug carrier Substances 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 4
- 238000002360 preparation method Methods 0.000 claims description 4
- 239000002904 solvent Substances 0.000 claims description 4
- 238000001694 spray drying Methods 0.000 claims description 4
- 206010060862 Prostate cancer Diseases 0.000 claims description 2
- 208000000236 Prostatic Neoplasms Diseases 0.000 claims description 2
- 238000001125 extrusion Methods 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 238000002156 mixing Methods 0.000 claims description 2
- 239000006104 solid solution Substances 0.000 claims description 2
- 238000009472 formulation Methods 0.000 claims 11
- 239000002246 antineoplastic agent Substances 0.000 claims 3
- 229960004103 abiraterone acetate Drugs 0.000 claims 1
- UVIQSJCZCSLXRZ-UBUQANBQSA-N abiraterone acetate Chemical group C([C@@H]1[C@]2(C)CC[C@@H]3[C@@]4(C)CC[C@@H](CC4=CC[C@H]31)OC(=O)C)C=C2C1=CC=CN=C1 UVIQSJCZCSLXRZ-UBUQANBQSA-N 0.000 claims 1
- 239000003098 androgen Substances 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 239000003112 inhibitor Substances 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- XOFYZVNMUHMLCC-ZPOLXVRWSA-N prednisone Chemical compound O=C1C=C[C@]2(C)[C@H]3C(=O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 XOFYZVNMUHMLCC-ZPOLXVRWSA-N 0.000 claims 1
- 229960004618 prednisone Drugs 0.000 claims 1
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 238000004364 calculation method Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000012088 reference solution Substances 0.000 description 1
- 238000010971 suitability test Methods 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14196594 | 2014-12-05 | ||
| EP14196594.7 | 2014-12-05 | ||
| PCT/US2015/063661 WO2016090098A1 (en) | 2014-12-05 | 2015-12-03 | Anticancer compositions |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020076516A Division JP7174006B2 (ja) | 2014-12-05 | 2020-04-23 | 抗癌性組成物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2017536398A JP2017536398A (ja) | 2017-12-07 |
| JP2017536398A5 true JP2017536398A5 (enExample) | 2019-01-24 |
| JP6937692B2 JP6937692B2 (ja) | 2021-09-22 |
Family
ID=52006906
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017529604A Active JP6937692B2 (ja) | 2014-12-05 | 2015-12-03 | 抗癌性組成物 |
| JP2020076516A Active JP7174006B2 (ja) | 2014-12-05 | 2020-04-23 | 抗癌性組成物 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020076516A Active JP7174006B2 (ja) | 2014-12-05 | 2020-04-23 | 抗癌性組成物 |
Country Status (29)
| Country | Link |
|---|---|
| US (3) | US20170360754A1 (enExample) |
| EP (2) | EP3226841B1 (enExample) |
| JP (2) | JP6937692B2 (enExample) |
| KR (2) | KR102348320B1 (enExample) |
| CN (2) | CN114886852A (enExample) |
| AR (1) | AR102926A1 (enExample) |
| AU (3) | AU2015358490B2 (enExample) |
| BR (1) | BR112017011788A2 (enExample) |
| CA (1) | CA2969656A1 (enExample) |
| CL (1) | CL2017001371A1 (enExample) |
| CO (1) | CO2017005572A2 (enExample) |
| CR (1) | CR20170216A (enExample) |
| EA (1) | EA201791222A1 (enExample) |
| ES (1) | ES2996833T3 (enExample) |
| HR (1) | HRP20241719T1 (enExample) |
| HU (1) | HUE069689T2 (enExample) |
| IL (2) | IL252323B (enExample) |
| MA (1) | MA41107B1 (enExample) |
| MD (1) | MD3226841T2 (enExample) |
| MX (2) | MX387933B (enExample) |
| NZ (1) | NZ770528A (enExample) |
| PH (1) | PH12017500964A1 (enExample) |
| PL (1) | PL3226841T3 (enExample) |
| RS (1) | RS66323B1 (enExample) |
| SG (1) | SG11201704267VA (enExample) |
| SM (1) | SMT202400518T1 (enExample) |
| TW (2) | TWI754258B (enExample) |
| UA (1) | UA120950C2 (enExample) |
| WO (1) | WO2016090098A1 (enExample) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014052237A1 (en) | 2012-09-26 | 2014-04-03 | Aragon Pharmaceuticals, Inc. | Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer |
| CN114886852A (zh) | 2014-12-05 | 2022-08-12 | 阿拉贡药品公司 | 抗癌组合物 |
| RS62421B1 (sr) | 2014-12-05 | 2021-10-29 | Aragon Pharmaceuticals Inc | Anti-kancerogeni sastavi |
| KR20240096623A (ko) | 2017-10-16 | 2024-06-26 | 아라곤 파마슈티컬스, 인코포레이티드 | 비-전이성 거세-저항성 전립선암의 치료를 위한 항-안드로겐 |
| WO2020144649A1 (en) | 2019-01-10 | 2020-07-16 | Aragon Pharmaceuticals, Inc. | Pharmaceutical composition comprising enzalutamide dispersed in apple sauce |
| KR20210122275A (ko) | 2019-01-30 | 2021-10-08 | 얀센 파마슈티카 엔.브이. | 분자 아형에 기초하여 전립선암을 치료하는 방법 |
| SG11202107712SA (en) | 2019-01-30 | 2021-08-30 | Aragon Pharmaceuticals Inc | Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer |
| WO2020239478A1 (en) | 2019-05-28 | 2020-12-03 | Pharma Mar, S.A. | Trabectedin for treating sarcomas based on genomic markers |
| EP3811932A1 (en) | 2019-10-22 | 2021-04-28 | Zentiva K.S. | Dosage form of apalutamide |
| DK4054572T3 (da) | 2019-11-04 | 2026-08-03 | Aragon Pharmaceuticals Inc | Apalutanid til behandling af ikke-metastatisk kastrationsresistent prostatacancer hos subjekter med svært nedsat leverfunktion |
| WO2021245285A1 (en) | 2020-06-05 | 2021-12-09 | Janssen Pharmaceutica Nv | Methods of treating prostate cancer based on molecular subtypes |
| WO2022049523A1 (en) | 2020-09-04 | 2022-03-10 | Aragon Pharmaceuticals, Inc. | Methods for treating prostate cancer |
| WO2022195407A1 (en) | 2021-03-19 | 2022-09-22 | Aragon Pharmaceuticals, Inc. | Methods for treating prostate cancer |
| WO2023122842A1 (es) * | 2021-12-31 | 2023-07-06 | Gador Limitada | Proceso para la preparación de apalutamida, intermediarios de sintesis y la dispersion solida amorfa que la contiene |
| WO2023152611A1 (en) | 2022-02-11 | 2023-08-17 | Aragon Pharmaceuticals, Inc. | Apalutamide and relugolix for the treatment of prostate cancer |
| WO2023209555A1 (en) | 2022-04-26 | 2023-11-02 | Aragon Pharmaceuticals, Inc. | Approved drug products and methods for treating prostate cancer |
| CN116183787A (zh) * | 2022-12-26 | 2023-05-30 | 郑州德迈药业有限公司 | 醋酸羟丙甲纤维素琥珀酸酯在阿帕他胺溶出检测中的应用以及检测方法 |
| JP2026515598A (ja) | 2023-03-16 | 2026-05-19 | バイエル・コンシューマー・ケア・アクチェンゲゼルシャフト | ホルモン感受性前立腺がんの生化学的再発を有する患者の処置のためのアンドロゲン受容体アンタゴニスト |
| AU2025209171A1 (en) * | 2024-01-18 | 2026-05-28 | Nanoform Finland Oyj | Composition comprising crystalline nanosized apalutamide |
| WO2025174375A1 (en) * | 2024-02-15 | 2025-08-21 | Aragon Pharmaceuticals, Inc. | Anticancer compositions |
| WO2026052846A1 (en) | 2024-09-09 | 2026-03-12 | Synthon B.V. | Pharmaceutical formulation comprising apalutamide |
Family Cites Families (39)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2138618T3 (es) | 1992-03-31 | 2000-01-16 | Btg Int Ltd | Esteroides 17-sustituidos utiles en el tratamiento del cancer. |
| PT901786E (pt) * | 1997-08-11 | 2007-08-07 | Pfizer Prod Inc | Disperções farmacêuticas sólidas com biodisponibilidade melhorada |
| AU2001232348A1 (en) | 2000-02-21 | 2001-08-27 | Takeda Chemical Industries Ltd. | Sustained release preparations of physiologically active compound hardly solublein water and production process and use of the same |
| CZ20032225A3 (cs) | 2001-02-27 | 2003-11-12 | Astrazeneca Ab | Farmaceutická formulace |
| CZ20032647A3 (cs) | 2001-04-02 | 2004-09-15 | Astrazeneca Ab | Pevná farmaceutická kompozice obsahující 4-kyanotrifluor-3-(4-fluorfenylsulfonyl)-2-hydroxy-2-methylpropiono-m-toluidin a PVP |
| CA2450762A1 (en) * | 2001-06-22 | 2003-01-03 | Pfizer Products Inc. | Pharmaceutical compositions comprising low-solubility and/or acid-sensitive drugs and neutralized acidic polymers |
| SE0103424D0 (sv) * | 2001-10-15 | 2001-10-15 | Astrazeneca Ab | Pharmaceutical formulation |
| EP1469830A2 (en) * | 2002-02-01 | 2004-10-27 | Pfizer Products Inc. | Method for making homogeneous spray-dried solid amorphous drug dispersions using pressure nozzles |
| JPWO2003077827A1 (ja) | 2002-03-19 | 2005-07-14 | 日本新薬株式会社 | 医薬固体分散体の製造方法 |
| JP2007518670A (ja) | 2003-12-15 | 2007-07-12 | カウンシル オブ サイエンティフィク アンド インダストリアル リサーチ | 苦味のある薬物、及びｐＨ感受性ポリマーを含む風味マスクされた医薬組成物 |
| GB0502790D0 (en) | 2005-02-10 | 2005-03-16 | Univ London Pharmacy | Solid dispersion of hydrophobic bioactive |
| NZ564223A (en) | 2005-05-13 | 2011-03-31 | Univ California | Diarylhydantoin compounds for treating hormone refractory prostate cancer |
| BRPI0709771B1 (pt) * | 2006-03-27 | 2022-01-25 | The Regents Of The University Of California | Composto e composição farmacêutica |
| CA2738573C (en) | 2009-04-03 | 2013-02-19 | F. Hoffmann-La Roche Ag | Compositions of propane-1 sulfonic acid {3-[5-(4-chloro-phenyl)-1h-pyrrolo[2,3-b]pyridine-3-carbonyl]-2,4-difluoro-phenyl}-amide and uses thereof |
| EP3124481B1 (en) | 2010-02-16 | 2018-03-28 | Aragon Pharmaceuticals, Inc. | Androgen receptor modulators and uses thereof |
| CN102525876B (zh) | 2010-12-15 | 2014-03-12 | 西安力邦医药科技有限责任公司 | 阿司匹林固体分散体、其制备方法、药物组合物和用途 |
| CA2839301C (en) | 2011-06-15 | 2021-02-16 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Nuclear receptor modulators and their use for the treatment and prevention of cancer |
| US20150037407A1 (en) | 2012-03-21 | 2015-02-05 | Emphascience, Inc. | Method to improve the safety of handling of high potency drugs in solid dosage forms without changing their efficacy |
| WO2013152342A1 (en) | 2012-04-06 | 2013-10-10 | OSI Pharmaceuticals, LLC | Anti-cancer mtor inhibitor and anti-androgen combination |
| UA123142C2 (uk) | 2012-06-07 | 2021-02-24 | Арагон Фармасьютікалз, Інк. | Кристалічні форми модулятора андрогенного рецептора |
| US10668156B2 (en) | 2012-06-22 | 2020-06-02 | Basf Se | Active-ingredient-containing solid dispersions based on diethylaminoethyl methacrylate copolymers |
| BR112015002055A2 (pt) * | 2012-08-24 | 2017-07-04 | Dow Global Technologies Llc | acetato succinato de hidroxialquil metil celulose, composição, dispersão sólida, processo para produzir uma dispersão sólida, forma de dosagem e cápsula de envoltório |
| US9977033B2 (en) | 2012-09-11 | 2018-05-22 | The Board Of Regents Of The University Of Texas System | Methods for assessing cancer recurrence |
| TWI673051B (zh) | 2012-09-11 | 2019-10-01 | 美商梅維森前列腺療法有限責任公司 | 恩雜魯它脈（ｅｎｚａｌｕｔａｍｉｄｅ）之調和物 |
| WO2014052237A1 (en) | 2012-09-26 | 2014-04-03 | Aragon Pharmaceuticals, Inc. | Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer |
| EP2945628B1 (en) | 2013-01-15 | 2020-04-15 | Aragon Pharmaceuticals, Inc. | Androgen receptor modulator in combination with abiraterone acetate and prednisone for treating prostate cancer |
| NZ708272A (en) | 2013-01-22 | 2020-07-31 | Hoffmann La Roche | Pharmaceutical composition with improved bioavailability |
| TWI686212B (zh) | 2013-03-15 | 2020-03-01 | 阿聯商太陽法瑪全球有限公司 | 醋酸阿比特龍配方 |
| WO2014167428A2 (en) | 2013-04-10 | 2014-10-16 | Shilpa Medicare Limited | Amorphous 4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl)-2-fluoro-n-methylbenzamide |
| KR20160058774A (ko) * | 2013-08-12 | 2016-05-25 | 토카이 파마슈티컬, 아이엔씨. | 안드로겐-표적 치료제를 이용하는 종양 질환 치료를 위한 바이오마커 |
| WO2015116696A1 (en) | 2014-01-28 | 2015-08-06 | Massachusetts Institute Of Technology | Combination therapies and methods of use thereof for treating cancer |
| CN106102716A (zh) | 2014-02-05 | 2016-11-09 | 斯洛文尼亚莱柯制药股份有限公司 | 雄激素受体拮抗剂的固体药物组合物 |
| TWI718102B (zh) | 2014-08-08 | 2021-02-11 | 日商中外製藥股份有限公司 | ４環性化合物的非晶質體 |
| RS62421B1 (sr) | 2014-12-05 | 2021-10-29 | Aragon Pharmaceuticals Inc | Anti-kancerogeni sastavi |
| CN114886852A (zh) * | 2014-12-05 | 2022-08-12 | 阿拉贡药品公司 | 抗癌组合物 |
| WO2016090101A1 (en) | 2014-12-05 | 2016-06-09 | Aragon Pharmaceuticals, Inc. | Anticancer compositions |
| EA201892828A1 (ru) | 2016-06-03 | 2019-05-31 | Арагон Фармасьютикалз, Инк. | Противораковые композиции |
| KR20210023987A (ko) | 2018-06-20 | 2021-03-04 | 크리스탈 파마슈티컬 (쑤저우) 씨오., 엘티디. | Arn-509의 결정형, 그 제조방법 및 그 용도 |
| EP3811932A1 (en) | 2019-10-22 | 2021-04-28 | Zentiva K.S. | Dosage form of apalutamide |
-
2015
- 2015-12-03 CN CN202210133724.8A patent/CN114886852A/zh active Pending
- 2015-12-03 EP EP15817641.2A patent/EP3226841B1/en active Active
- 2015-12-03 CA CA2969656A patent/CA2969656A1/en active Pending
- 2015-12-03 MX MX2017007203A patent/MX387933B/es unknown
- 2015-12-03 PL PL15817641.2T patent/PL3226841T3/pl unknown
- 2015-12-03 AU AU2015358490A patent/AU2015358490B2/en active Active
- 2015-12-03 SM SM20240518T patent/SMT202400518T1/it unknown
- 2015-12-03 MA MA41107A patent/MA41107B1/fr unknown
- 2015-12-03 EP EP24202355.4A patent/EP4494636A3/en active Pending
- 2015-12-03 UA UAA201707020A patent/UA120950C2/uk unknown
- 2015-12-03 BR BR112017011788A patent/BR112017011788A2/pt not_active Application Discontinuation
- 2015-12-03 CR CR20170216A patent/CR20170216A/es unknown
- 2015-12-03 NZ NZ770528A patent/NZ770528A/en unknown
- 2015-12-03 JP JP2017529604A patent/JP6937692B2/ja active Active
- 2015-12-03 HR HRP20241719TT patent/HRP20241719T1/hr unknown
- 2015-12-03 MD MDE20170152T patent/MD3226841T2/ro unknown
- 2015-12-03 ES ES15817641T patent/ES2996833T3/es active Active
- 2015-12-03 HU HUE15817641A patent/HUE069689T2/hu unknown
- 2015-12-03 WO PCT/US2015/063661 patent/WO2016090098A1/en not_active Ceased
- 2015-12-03 RS RS20241412A patent/RS66323B1/sr unknown
- 2015-12-03 US US15/533,188 patent/US20170360754A1/en not_active Abandoned
- 2015-12-03 EA EA201791222A patent/EA201791222A1/ru unknown
- 2015-12-03 KR KR1020177018239A patent/KR102348320B1/ko active Active
- 2015-12-03 SG SG11201704267VA patent/SG11201704267VA/en unknown
- 2015-12-03 KR KR1020207035390A patent/KR20200141533A/ko not_active Ceased
- 2015-12-03 CN CN201580066233.4A patent/CN106999431B/zh active Active
- 2015-12-04 TW TW109112959A patent/TWI754258B/zh active
- 2015-12-04 AR ARP150103982A patent/AR102926A1/es not_active Application Discontinuation
- 2015-12-04 TW TW104140822A patent/TWI702966B/zh active
-
2017
- 2017-05-16 IL IL252323A patent/IL252323B/en active IP Right Grant
- 2017-05-25 PH PH12017500964A patent/PH12017500964A1/en unknown
- 2017-05-29 CL CL2017001371A patent/CL2017001371A1/es unknown
- 2017-06-05 MX MX2021013965A patent/MX2021013965A/es unknown
- 2017-06-05 CO CONC2017/0005572A patent/CO2017005572A2/es unknown
-
2020
- 2020-04-23 JP JP2020076516A patent/JP7174006B2/ja active Active
- 2020-12-29 IL IL279833A patent/IL279833B/en unknown
-
2021
- 2021-03-30 AU AU2021201979A patent/AU2021201979B2/en active Active
-
2023
- 2023-03-29 US US18/192,244 patent/US20230233529A1/en not_active Abandoned
- 2023-05-02 AU AU2023202710A patent/AU2023202710A1/en not_active Abandoned
-
2024
- 2024-05-10 US US18/660,698 patent/US12303493B2/en active Active
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