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 (https=) | 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 (https=) |
| EP (2) | EP4494636A3 (https=) |
| JP (2) | JP6937692B2 (https=) |
| KR (2) | KR102348320B1 (https=) |
| CN (2) | CN114886852A (https=) |
| AR (1) | AR102926A1 (https=) |
| AU (3) | AU2015358490B2 (https=) |
| BR (1) | BR112017011788A2 (https=) |
| CA (1) | CA2969656A1 (https=) |
| CL (1) | CL2017001371A1 (https=) |
| CO (1) | CO2017005572A2 (https=) |
| CR (1) | CR20170216A (https=) |
| EA (1) | EA201791222A1 (https=) |
| ES (1) | ES2996833T3 (https=) |
| HR (1) | HRP20241719T1 (https=) |
| HU (1) | HUE069689T2 (https=) |
| IL (2) | IL252323B (https=) |
| MA (1) | MA41107B1 (https=) |
| MD (1) | MD3226841T2 (https=) |
| MX (2) | MX387933B (https=) |
| NZ (1) | NZ770528A (https=) |
| PH (1) | PH12017500964A1 (https=) |
| PL (1) | PL3226841T3 (https=) |
| RS (1) | RS66323B1 (https=) |
| SG (1) | SG11201704267VA (https=) |
| SM (1) | SMT202400518T1 (https=) |
| TW (2) | TWI754258B (https=) |
| UA (1) | UA120950C2 (https=) |
| WO (1) | WO2016090098A1 (https=) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SG11201501870RA (en) | 2012-09-26 | 2015-04-29 | Aragon Pharmaceuticals Inc | Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer |
| ES3019912T3 (en) | 2014-12-05 | 2025-05-21 | Aragon Pharmaceuticals Inc | Anticancer compositions |
| WO2016090098A1 (en) | 2014-12-05 | 2016-06-09 | Aragon Pharmaceuticals, Inc. | Anticancer compositions |
| AU2018351714A1 (en) | 2017-10-16 | 2020-04-30 | Aragon Pharmaceuticals, Inc. | Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer |
| WO2020144647A1 (en) | 2019-01-10 | 2020-07-16 | Aragon Pharmaceuticals, Inc. | Pharmaceutical composition comprising apalutamide dispersed in apple sauce |
| AU2020215177A1 (en) | 2019-01-30 | 2021-08-12 | Janssen Pharmaceutica Nv | Methods of treating prostate cancer based on molecular subtypes |
| TWI840496B (zh) | 2019-01-30 | 2024-05-01 | 美商艾瑞岡醫藥公司 | 用於治療轉移性去勢敏感性前列腺癌之抗雄性激素 |
| 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 |
| ATE364374T1 (de) | 1997-08-11 | 2007-07-15 | Pfizer Prod Inc | Feste pharmazeutische dispersionen mit erhöhter bioverfügbarkeit |
| EP1258254A4 (en) | 2000-02-21 | 2004-02-04 | Takeda Chemical Industries Ltd | COMPOSITIONS FOR DELAYED DELIVERY OF PHYSIOLOGICALLY ACTIVE COMPOUNDS THAT ARE LOW WATER-SOLUBLE, METHOD FOR THE PRODUCTION AND USE THEREOF |
| JP3548566B2 (ja) | 2001-02-27 | 2004-07-28 | アストラゼネカ アクチボラグ | 医薬製剤 |
| EP1381358B1 (en) | 2001-04-02 | 2006-05-03 | Astrazeneca AB | Solid pharmaceutical composition comprising 4'-cyano-trifluoro-3-(4-fluorophenylsulphonyl) -2-hydroxy-2-methylpropiono- m toluidide and pvp |
| KR20040011549A (ko) * | 2001-06-22 | 2004-02-05 | 화이자 프로덕츠 인크. | 저용해도 및(또는) 산-민감성 약물 및 중화된 산성중합체를 포함하는 제약 조성물 |
| SE0103424D0 (sv) * | 2001-10-15 | 2001-10-15 | Astrazeneca Ab | Pharmaceutical formulation |
| PL371593A1 (en) | 2002-02-01 | 2005-06-27 | Pfizer Products Inc. | Method for making homogeneous spray-dried solid amorphous drug dispersions using pressure nozzles |
| WO2003077827A1 (en) | 2002-03-19 | 2003-09-25 | Nippon Shinyaku Co., Ltd. | Process for producing drug solid dispersion |
| CA2549572A1 (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 |
| JP4644737B2 (ja) | 2005-05-13 | 2011-03-02 | ザ リージェンツ オブ ザ ユニバーシティ オブ カリフォルニア | ジアリールヒダントイン化合物 |
| LT2656842T (lt) | 2006-03-27 | 2016-09-26 | The Regents Of The University Of California | Androgeno receptoriaus moduliatorius, skirtas prostatos vėžio ir su androgeno receptoriumi susijusių ligų gydymui |
| KR101739994B1 (ko) | 2009-04-03 | 2017-05-25 | 에프. 호프만-라 로슈 아게 | 프로판-１-술폰산 ｛３-［５-（４-클로로-페닐）-１Ｈ-피롤로［２，３-ｂ］피리딘-３-카르보닐］-２，４-디플루오로-페닐｝-아미드 조성물 및 그의 용도 |
| WO2011103202A2 (en) | 2010-02-16 | 2011-08-25 | 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 |
| EP2721003B1 (en) | 2011-06-15 | 2018-01-03 | 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 |
| EA201992010A1 (ru) * | 2012-06-07 | 2020-01-24 | Арагон Фармасьютикалз, Инк. | Кристаллическая форма а 4-[7-(6-циано-5-трифторметилпиридин-3-ил)-8-оксо-6-тиоксо-5,7-диазаспиро[3.4]окт-5-ил]-2-фтор-n-метилбензамида для лечения заболевания или состояния, связанного с активностью андрогенных рецепторов, включая рак простаты |
| US10668156B2 (en) | 2012-06-22 | 2020-06-02 | Basf Se | Active-ingredient-containing solid dispersions based on diethylaminoethyl methacrylate copolymers |
| MX2015002430A (es) * | 2012-08-24 | 2015-06-22 | Dow Global Technologies Llc | Acetato-succinatos de hidroxialquilmetilcelulosa. |
| 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 |
| SG11201501870RA (en) | 2012-09-26 | 2015-04-29 | Aragon Pharmaceuticals Inc | Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer |
| SG10201907684PA (en) | 2013-01-15 | 2019-10-30 | Aragon Pharmaceuticals Inc | Androgen receptor modulator and uses thereof |
| CN112353762A (zh) | 2013-01-22 | 2021-02-12 | 霍夫曼-拉罗奇有限公司 | 具有改善的生物利用度的药物组合物 |
| MX2015013247A (es) | 2013-03-15 | 2016-11-25 | Iceutica Inc | Formulacion de acetato de abiraterona. |
| 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 |
| CA2920317A1 (en) | 2013-08-12 | 2015-02-19 | Tokai Pharmaceuticals, Inc. | Biomarkers for treatment of neoplastic disorders using androgen-targeted therapies |
| WO2015116696A1 (en) | 2014-01-28 | 2015-08-06 | Massachusetts Institute Of Technology | Combination therapies and methods of use thereof for treating cancer |
| CA2940984A1 (en) * | 2014-02-05 | 2015-08-13 | Lek Pharmaceuticals D.D. | Solid pharmaceutical compositions of androgen receptor antagonists |
| 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 |
| WO2016090098A1 (en) | 2014-12-05 | 2016-06-09 | Aragon Pharmaceuticals, Inc. | Anticancer compositions |
| ES2839128T3 (es) | 2014-12-05 | 2021-07-05 | Aragon Pharmaceuticals Inc | Composiciones anticancerosas |
| ES3019912T3 (en) | 2014-12-05 | 2025-05-21 | Aragon Pharmaceuticals Inc | Anticancer compositions |
| TN2018000366A1 (en) | 2016-06-03 | 2020-06-15 | Aragon Pharmaceuticals Inc | Anticancer compositions. |
| JP2021527680A (ja) | 2018-06-20 | 2021-10-14 | クリスタル ファーマシューティカル（スーチョウ）カンパニー，リミテッド | Ａｒｎ−５０９の結晶形、その製造方法及びその用途 |
| EP3811932A1 (en) | 2019-10-22 | 2021-04-28 | Zentiva K.S. | Dosage form of apalutamide |
-
2015
- 2015-12-03 WO PCT/US2015/063661 patent/WO2016090098A1/en not_active Ceased
- 2015-12-03 HR HRP20241719TT patent/HRP20241719T1/hr unknown
- 2015-12-03 MX MX2017007203A patent/MX387933B/es unknown
- 2015-12-03 KR KR1020177018239A patent/KR102348320B1/ko active Active
- 2015-12-03 SG SG11201704267VA patent/SG11201704267VA/en unknown
- 2015-12-03 EP EP24202355.4A patent/EP4494636A3/en active Pending
- 2015-12-03 ES ES15817641T patent/ES2996833T3/es active Active
- 2015-12-03 KR KR1020207035390A patent/KR20200141533A/ko not_active Ceased
- 2015-12-03 MD MDE20170152T patent/MD3226841T2/ro unknown
- 2015-12-03 CA CA2969656A patent/CA2969656A1/en active Pending
- 2015-12-03 JP JP2017529604A patent/JP6937692B2/ja active Active
- 2015-12-03 UA UAA201707020A patent/UA120950C2/uk unknown
- 2015-12-03 CN CN202210133724.8A patent/CN114886852A/zh active Pending
- 2015-12-03 CN CN201580066233.4A patent/CN106999431B/zh active Active
- 2015-12-03 SM SM20240518T patent/SMT202400518T1/it unknown
- 2015-12-03 US US15/533,188 patent/US20170360754A1/en not_active Abandoned
- 2015-12-03 MA MA41107A patent/MA41107B1/fr unknown
- 2015-12-03 HU HUE15817641A patent/HUE069689T2/hu unknown
- 2015-12-03 EP EP15817641.2A patent/EP3226841B1/en active Active
- 2015-12-03 RS RS20241412A patent/RS66323B1/sr unknown
- 2015-12-03 AU AU2015358490A patent/AU2015358490B2/en active Active
- 2015-12-03 PL PL15817641.2T patent/PL3226841T3/pl unknown
- 2015-12-03 CR CR20170216A patent/CR20170216A/es unknown
- 2015-12-03 BR BR112017011788A patent/BR112017011788A2/pt not_active Application Discontinuation
- 2015-12-03 NZ NZ770528A patent/NZ770528A/en unknown
- 2015-12-03 EA EA201791222A patent/EA201791222A1/ru unknown
- 2015-12-04 AR ARP150103982A patent/AR102926A1/es not_active Application Discontinuation
- 2015-12-04 TW TW109112959A patent/TWI754258B/zh active
- 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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