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 |
|---|---|---|---|
| EP14196594.7 | 2014-12-05 | ||
| EP14196594 | 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) | KR20200141533A (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 (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PT3305285T (pt) | 2012-09-26 | 2020-11-24 | Aragon Pharmaceuticals Inc | Antiandrogénios para o tratamento de cancro da próstata resistente à castração não metastático |
| CA2969675C (en) | 2014-12-05 | 2023-06-06 | Aragon Pharmaceuticals, Inc. | Anticancer compositions |
| BR112017011788A2 (pt) | 2014-12-05 | 2017-12-26 | Aragon Pharmaceuticals Inc | composições anticâncer |
| EP4438126A3 (en) | 2017-10-16 | 2025-01-01 | Aragon Pharmaceuticals, Inc. | Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer |
| WO2020144646A1 (en) | 2019-01-10 | 2020-07-16 | Aragon Pharmaceuticals, Inc. | Apalutamide dispersed in applesauce for treating prostate cancer |
| WO2020157699A1 (en) | 2019-01-30 | 2020-08-06 | Aragon Pharmaceuticals, Inc. | Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer |
| BR112021014657A2 (pt) | 2019-01-30 | 2021-09-21 | Janssen Pharmaceutica N.V. | Métodos para tratar câncer de próstata com base em subtipos moleculares |
| 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 |
| WO2024189186A1 (en) | 2023-03-16 | 2024-09-19 | Bayer Consumer Care Ag | Androgen receptor antagonists for the treatment of patients with biochemical recurrence of hormone sensitive prostate cancer |
| 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 |
Family Cites Families (39)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE69327096T2 (de) | 1992-03-31 | 2000-06-21 | Btg International Ltd., London | 17-substituierte steroide, verwendbar bei behandlung von krebs |
| ATE364374T1 (de) | 1997-08-11 | 2007-07-15 | Pfizer Prod Inc | Feste pharmazeutische dispersionen mit erhöhter bioverfügbarkeit |
| 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 |
| DE60206889T2 (de) | 2001-02-27 | 2006-07-27 | Astrazeneca Ab | Pharmazeutische formulierung enthaltend bicalutamid |
| KR20030087048A (ko) | 2001-04-02 | 2003-11-12 | 아스트라제네카 아베 | 4-시아노-트리플루오로-3-(4-플루오로페닐설포닐)-2-히드록시-2-메틸프로피오노-ｍ 톨루이다이드 및 ｐｖｐ를포함하는 고체 약학 조성물 |
| HUP0400264A2 (hu) | 2001-06-22 | 2004-08-30 | Pfizer Products Inc. | Alacsony oldékonyságú és/vagy savra érzékeny hatóanyagokat és semlegesített savas polimereket tartalmazó gyógyszerkészítmények és eljárás az előállításukra |
| 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 |
| WO2005055987A1 (en) | 2003-12-15 | 2005-06-23 | Council Of Scientific & 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 |
| RS52274B2 (sr) | 2005-05-13 | 2018-05-31 | Univ California | Jedinjenje diarilhidantoina |
| PL3412290T3 (pl) * | 2006-03-27 | 2021-09-06 | The Regents Of The University Of California | Modulator receptora androgenowego do leczenia raka gruczołu krokowego i chorób związanych z receptorem androgenowym |
| MX2011008303A (es) | 2009-04-03 | 2011-11-29 | Plexxikon Inc | Composiciones del acido propano-1-sulfonico {3-[5-(4-cloro-fenil)- 1h-pirrolo [2,3-b]-piridina-3-carbonil]-2,4-difluoro-fenil}-amida y el uso de las mismas. |
| EA028869B1 (ru) | 2010-02-16 | 2018-01-31 | Арагон Фармасьютикалс, Инк. | Модуляторы рецептора андрогенов и их применение |
| 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 |
| ES2809738T3 (es) * | 2012-06-07 | 2021-03-05 | Aragon Pharmaceuticals Inc | Formas cristalinas de un modulador de receptor de andrógenos |
| US10668156B2 (en) | 2012-06-22 | 2020-06-02 | Basf Se | Active-ingredient-containing solid dispersions based on diethylaminoethyl methacrylate copolymers |
| JP6215945B2 (ja) * | 2012-08-24 | 2017-10-18 | ダウ グローバル テクノロジーズ エルエルシー | 新規ヒドロキシアルキルメチルセルロースアセテートサクシネート |
| US9977033B2 (en) | 2012-09-11 | 2018-05-22 | The Board Of Regents Of The University Of Texas System | Methods for assessing cancer recurrence |
| WO2014043208A1 (en) | 2012-09-11 | 2014-03-20 | Medivation Prostate Therapeutics, Inc. | Formulations of enzalutamide |
| PT3305285T (pt) | 2012-09-26 | 2020-11-24 | Aragon Pharmaceuticals Inc | Antiandrogénios para o tratamento de cancro da próstata resistente à castração não metastático |
| JOP20200097A1 (ar) | 2013-01-15 | 2017-06-16 | Aragon Pharmaceuticals Inc | معدل مستقبل أندروجين واستخداماته |
| EA028009B1 (ru) | 2013-01-22 | 2017-09-29 | Ф.Хоффманн-Ля Рош Аг | Фармацевтическая композиция с улучшенной биодоступностью |
| CN105246598B (zh) | 2013-03-15 | 2019-09-13 | 太阳药业环球公司 | 乙酸阿比特龙酯制剂 |
| 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 |
| WO2015023710A1 (en) * | 2013-08-12 | 2015-02-19 | 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. |
| TWI803187B (zh) | 2014-08-08 | 2023-05-21 | 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 |
| CA2969675C (en) | 2014-12-05 | 2023-06-06 | Aragon Pharmaceuticals, Inc. | Anticancer compositions |
| BR112017011788A2 (pt) | 2014-12-05 | 2017-12-26 | Aragon Pharmaceuticals Inc | composições anticâncer |
| CR20170217A (es) | 2014-12-05 | 2017-08-30 | Aragon Pharmaceuticals Inc | Composiciones anticancerígenas |
| TW201808287A (zh) | 2016-06-03 | 2018-03-16 | 美商艾瑞岡醫藥公司 | 抗癌組成物 |
| 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 BR BR112017011788A patent/BR112017011788A2/pt not_active Application Discontinuation
- 2015-12-03 HR HRP20241719TT patent/HRP20241719T1/hr unknown
- 2015-12-03 EP EP24202355.4A patent/EP4494636A3/en active Pending
- 2015-12-03 NZ NZ770528A patent/NZ770528A/en unknown
- 2015-12-03 UA UAA201707020A patent/UA120950C2/uk 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 MD MDE20170152T patent/MD3226841T2/ro unknown
- 2015-12-03 SM SM20240518T patent/SMT202400518T1/it unknown
- 2015-12-03 JP JP2017529604A patent/JP6937692B2/ja active Active
- 2015-12-03 CN CN202210133724.8A patent/CN114886852A/zh active Pending
- 2015-12-03 KR KR1020207035390A patent/KR20200141533A/ko not_active Ceased
- 2015-12-03 SG SG11201704267VA patent/SG11201704267VA/en unknown
- 2015-12-03 WO PCT/US2015/063661 patent/WO2016090098A1/en not_active Ceased
- 2015-12-03 HU HUE15817641A patent/HUE069689T2/hu unknown
- 2015-12-03 AU AU2015358490A patent/AU2015358490B2/en active Active
- 2015-12-03 CN CN201580066233.4A patent/CN106999431B/zh active Active
- 2015-12-03 MX MX2017007203A patent/MX387933B/es unknown
- 2015-12-03 RS RS20241412A patent/RS66323B1/sr unknown
- 2015-12-03 PL PL15817641.2T patent/PL3226841T3/pl unknown
- 2015-12-03 CA CA2969656A patent/CA2969656A1/en active Pending
- 2015-12-03 CR CR20170216A patent/CR20170216A/es unknown
- 2015-12-03 KR KR1020177018239A patent/KR102348320B1/ko active Active
- 2015-12-03 MA MA41107A patent/MA41107B1/fr unknown
- 2015-12-03 ES ES15817641T patent/ES2996833T3/es active Active
- 2015-12-03 EP EP15817641.2A patent/EP3226841B1/en active Active
- 2015-12-04 TW TW104140822A patent/TWI702966B/zh active
- 2015-12-04 AR ARP150103982A patent/AR102926A1/es not_active Application Discontinuation
- 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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