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) | EP4494636A3 (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) | TWI702966B (enExample) |
| UA (1) | UA120950C2 (enExample) |
| WO (1) | WO2016090098A1 (enExample) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115737643A (zh) | 2012-09-26 | 2023-03-07 | 阿拉贡药品公司 | 用于治疗非转移性去势抵抗性前列腺癌的抗雄激素 |
| US10285948B2 (en) | 2014-12-05 | 2019-05-14 | Janssen Pharmaceutica Nv | Anticancer compositions |
| EA201791222A1 (ru) | 2014-12-05 | 2017-09-29 | Арагон Фармасьютикалз, Инк. | Противораковые композиции |
| MX2020003845A (es) | 2017-10-16 | 2020-11-06 | Aragon Pharmaceuticals Inc | Antiandrógenos para el tratamiento de cáncer de próstata no metastásico resistente a la castración. |
| WO2020144647A1 (en) | 2019-01-10 | 2020-07-16 | Aragon Pharmaceuticals, Inc. | Pharmaceutical composition comprising apalutamide dispersed in apple sauce |
| JP2022523094A (ja) | 2019-01-30 | 2022-04-21 | アラゴン ファーマシューティカルズ，インコーポレイテッド | 転移性去勢感受性前立腺癌の治療のための抗アンドロゲン剤 |
| CN113711316A (zh) | 2019-01-30 | 2021-11-26 | 詹森药业有限公司 | 基于分子亚型治疗前列腺癌的方法 |
| 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 |
| EP4054572A1 (en) | 2019-11-04 | 2022-09-14 | Aragon Pharmaceuticals, Inc. | Androgen receptor inhibitors for the treatment of non-metastatic castration-resistant prostate cancer in subjects with severe hepatic impairment |
| WO2021245285A1 (en) | 2020-06-05 | 2021-12-09 | Janssen Pharmaceutica Nv | Methods of treating prostate cancer based on molecular subtypes |
| TW202228794A (zh) | 2020-09-04 | 2022-08-01 | 美商艾瑞岡醫藥公司 | 用於治療前列腺癌之方法 |
| 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 |
| KR20250157532A (ko) | 2023-03-16 | 2025-11-04 | 바이엘 컨수머 케어 악티엔게젤샤프트 | 호르몬 감수성 전립선암의 생화학적 재발이 있는 환자의 치료를 위한 안드로겐 수용체 길항제 |
| WO2025153768A1 (en) * | 2024-01-18 | 2025-07-24 | 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 |
|---|---|---|---|---|
| GB2265624B (en) | 1992-03-31 | 1995-04-19 | British Tech Group | 17-substituted steroids useful in cancer treatment |
| DK0901786T3 (da) | 1997-08-11 | 2007-10-08 | Pfizer Prod Inc | Faste farmaceutiske dispersioner med foröget biotilgængelighed |
| US20030068374A1 (en) | 2000-02-21 | 2003-04-10 | Shigeru Kamei | Sustained release preparations of physiologically active compound hardly soluble in water and production process and use of the same |
| ATE307571T1 (de) | 2001-02-27 | 2005-11-15 | Pharmazeutische formulierung enthaltend bicalutamid | |
| CA2443040A1 (en) | 2001-04-02 | 2002-10-17 | Nicola Frances Bateman | Solid pharmaceutical composition comprising 4 -cyano-trifluoro-3-(4-fluorophenyl-sulphonyl) -2-hydroxy-2-methylpropiono- m toluidide and pvp |
| WO2003000292A1 (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 |
| JP2005523260A (ja) | 2002-02-01 | 2005-08-04 | ファイザー・プロダクツ・インク | 圧力ノズルを用いた均質噴霧乾燥固体非晶質薬剤分散体の製造方法 |
| WO2003077827A1 (en) | 2002-03-19 | 2003-09-25 | Nippon Shinyaku Co., Ltd. | Process for producing drug solid dispersion |
| AU2003292509B2 (en) | 2003-12-15 | 2007-08-02 | Council Of Scientific And Industrial Research | Taste masked pharmaceutical compositions comprising bitter drug and pH sensitive polymer |
| GB0502790D0 (en) | 2005-02-10 | 2005-03-16 | Univ London Pharmacy | Solid dispersion of hydrophobic bioactive |
| CA2608436C (en) | 2005-05-13 | 2015-03-24 | The Regents Of The University Of California | Diarylhydantoin compounds and their use in the treatment of hyperproliferative disorders |
| ES2689292T3 (es) * | 2006-03-27 | 2018-11-13 | The Regents Of The University Of California | Modulador del receptor de andrógenos para el tratamiento del cáncer de próstata y enfermedades asociadas con el receptor de andrógenos |
| HUE027598T2 (en) | 2009-04-03 | 2016-10-28 | Hoffmann La Roche | Propane-1-sulfonic acid {3- [5- (4-chlorophenyl) -1H-pyrrolo [2,3-B] pyridine-3-carbonyl] -2,4-difluorophenyl} amide compositions and their uses |
| SG10201907588XA (en) | 2010-02-16 | 2019-09-27 | 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 |
| WO2012174436A1 (en) | 2011-06-15 | 2012-12-20 | 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 |
| RS60617B1 (sr) | 2012-06-07 | 2020-09-30 | Aragon Pharmaceuticals Inc | Kristalni oblici modulatora receptora androgena |
| US10668156B2 (en) | 2012-06-22 | 2020-06-02 | Basf Se | Active-ingredient-containing solid dispersions based on diethylaminoethyl methacrylate copolymers |
| CN104981483B (zh) * | 2012-08-24 | 2017-10-24 | 陶氏环球技术有限责任公司 | 新的羟烷基甲基醋酸琥珀酸纤维素 |
| 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 |
| CN115737643A (zh) | 2012-09-26 | 2023-03-07 | 阿拉贡药品公司 | 用于治疗非转移性去势抵抗性前列腺癌的抗雄激素 |
| DK2945628T3 (da) | 2013-01-15 | 2020-05-04 | Aragon Pharmaceuticals Inc | Androgen receptormodulator i kombination med abirateronacetat og prednison til behandling af prostatacancer |
| SG11201504499VA (en) | 2013-01-22 | 2015-08-28 | Hoffmann La Roche | Pharmaceutical composition with improved bioavailability |
| EP2969227B1 (en) | 2013-03-15 | 2019-05-08 | Iceutica Inc. | Abiraterone acetate formulation |
| 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 |
| EP3033088A4 (en) * | 2013-08-12 | 2017-03-08 | Tokai Pharmaceuticals, Inc. | Biomarkers for treatment of neoplastic disorders using androgen-targeted therapies |
| US9566280B2 (en) | 2014-01-28 | 2017-02-14 | Massachusetts Institute Of Technology | Combination therapies and methods of use thereof for treating cancer |
| MX386859B (es) * | 2014-02-05 | 2025-03-19 | Lek Pharmaceuticals | Composiciones farmacéuticas sólidas de antagonistas de los receptores de andrógenos. |
| TWI831347B (zh) | 2014-08-08 | 2024-02-01 | 日商中外製藥股份有限公司 | 包含４環性化合物的非晶質體之固體分散體及製劑 |
| HUE051888T2 (hu) | 2014-12-05 | 2021-03-29 | Aragon Pharmaceuticals Inc | Rákellenes készítmények |
| US10285948B2 (en) | 2014-12-05 | 2019-05-14 | Janssen Pharmaceutica Nv | Anticancer compositions |
| EA201791222A1 (ru) * | 2014-12-05 | 2017-09-29 | Арагон Фармасьютикалз, Инк. | Противораковые композиции |
| JP2019517497A (ja) | 2016-06-03 | 2019-06-24 | アラゴン ファーマシューティカルズ，インコーポレイテッド | 抗癌性組成物 |
| WO2019242439A1 (zh) | 2018-06-20 | 2019-12-26 | 苏州科睿思制药有限公司 | Arn-509的晶型及其制备方法和用途 |
| EP3811932A1 (en) | 2019-10-22 | 2021-04-28 | Zentiva K.S. | Dosage form of apalutamide |
-
2015
- 2015-12-03 EA EA201791222A patent/EA201791222A1/ru unknown
- 2015-12-03 MA MA41107A patent/MA41107B1/fr unknown
- 2015-12-03 KR KR1020177018239A patent/KR102348320B1/ko active Active
- 2015-12-03 SM SM20240518T patent/SMT202400518T1/it unknown
- 2015-12-03 HU HUE15817641A patent/HUE069689T2/hu unknown
- 2015-12-03 NZ NZ770528A patent/NZ770528A/en unknown
- 2015-12-03 CN CN202210133724.8A patent/CN114886852A/zh active Pending
- 2015-12-03 CA CA2969656A patent/CA2969656A1/en active Pending
- 2015-12-03 JP JP2017529604A patent/JP6937692B2/ja active Active
- 2015-12-03 CR CR20170216A patent/CR20170216A/es unknown
- 2015-12-03 KR KR1020207035390A patent/KR20200141533A/ko not_active Ceased
- 2015-12-03 BR BR112017011788A patent/BR112017011788A2/pt not_active Application Discontinuation
- 2015-12-03 UA UAA201707020A patent/UA120950C2/uk unknown
- 2015-12-03 ES ES15817641T patent/ES2996833T3/es active Active
- 2015-12-03 PL PL15817641.2T patent/PL3226841T3/pl unknown
- 2015-12-03 MX MX2017007203A patent/MX387933B/es unknown
- 2015-12-03 US US15/533,188 patent/US20170360754A1/en not_active Abandoned
- 2015-12-03 WO PCT/US2015/063661 patent/WO2016090098A1/en not_active Ceased
- 2015-12-03 MD MDE20170152T patent/MD3226841T2/ro unknown
- 2015-12-03 SG SG11201704267VA patent/SG11201704267VA/en unknown
- 2015-12-03 EP EP24202355.4A patent/EP4494636A3/en active Pending
- 2015-12-03 HR HRP20241719TT patent/HRP20241719T1/hr unknown
- 2015-12-03 RS RS20241412A patent/RS66323B1/sr unknown
- 2015-12-03 CN CN201580066233.4A patent/CN106999431B/zh active Active
- 2015-12-03 AU AU2015358490A patent/AU2015358490B2/en active Active
- 2015-12-03 EP EP15817641.2A patent/EP3226841B1/en active Active
- 2015-12-04 AR ARP150103982A patent/AR102926A1/es not_active Application Discontinuation
- 2015-12-04 TW TW104140822A patent/TWI702966B/zh active
- 2015-12-04 TW TW109112959A patent/TWI754258B/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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