JP2016530238A5 - - Google Patents
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- Publication number
- JP2016530238A5 JP2016530238A5 JP2016525401A JP2016525401A JP2016530238A5 JP 2016530238 A5 JP2016530238 A5 JP 2016530238A5 JP 2016525401 A JP2016525401 A JP 2016525401A JP 2016525401 A JP2016525401 A JP 2016525401A JP 2016530238 A5 JP2016530238 A5 JP 2016530238A5
- Authority
- JP
- Japan
- Prior art keywords
- dosage form
- pharmaceutically acceptable
- atrasentan
- weight
- acceptable salt
- 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.)
- Pending
Links
- 239000002552 dosage form Substances 0.000 claims 78
- MOTJMGVDPWRKOC-QPVYNBJUSA-N atrasentan Chemical compound C1([C@H]2[C@@H]([C@H](CN2CC(=O)N(CCCC)CCCC)C=2C=C3OCOC3=CC=2)C(O)=O)=CC=C(OC)C=C1 MOTJMGVDPWRKOC-QPVYNBJUSA-N 0.000 claims 29
- 229950010993 atrasentan Drugs 0.000 claims 29
- 150000003839 salts Chemical class 0.000 claims 22
- 239000003963 antioxidant agent Substances 0.000 claims 18
- 230000003078 antioxidant effect Effects 0.000 claims 18
- 239000012458 free base Substances 0.000 claims 15
- XUJNEKJLAYXESH-REOHCLBHSA-N L-Cysteine Natural products SC[C@H](N)C(O)=O XUJNEKJLAYXESH-REOHCLBHSA-N 0.000 claims 11
- 239000011230 binding agent Substances 0.000 claims 11
- 239000004201 L-cysteine Substances 0.000 claims 7
- 235000013878 L-cysteine Nutrition 0.000 claims 7
- 239000007884 disintegrant Substances 0.000 claims 7
- 239000003085 diluting agent Substances 0.000 claims 6
- 238000000354 decomposition reaction Methods 0.000 claims 5
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 5
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 5
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 5
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical group OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 5
- 239000000314 lubricant Substances 0.000 claims 5
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 4
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical group O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 4
- 239000003814 drug Substances 0.000 claims 4
- 150000002148 esters Chemical class 0.000 claims 4
- 229920005596 polymer binder Polymers 0.000 claims 4
- 239000002491 polymer binding agent Substances 0.000 claims 4
- 239000007787 solid Substances 0.000 claims 4
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 3
- 125000000415 L-cysteinyl group Chemical group O=C([*])[C@@](N([H])[H])([H])C([H])([H])S[H] 0.000 claims 3
- 230000015556 catabolic process Effects 0.000 claims 3
- 238000006731 degradation reaction Methods 0.000 claims 3
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 3
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 3
- 239000008101 lactose Substances 0.000 claims 3
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical group CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical group C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 2
- 229960000913 crospovidone Drugs 0.000 claims 2
- 229940049654 glyceryl behenate Drugs 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 2
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 2
- 239000000377 silicon dioxide Substances 0.000 claims 2
- 235000012239 silicon dioxide Nutrition 0.000 claims 2
- 229940124597 therapeutic agent Drugs 0.000 claims 2
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 235000019739 Dicalciumphosphate Nutrition 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 1
- 239000001506 calcium phosphate Substances 0.000 claims 1
- 208000020832 chronic kidney disease Diseases 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 230000001186 cumulative effect Effects 0.000 claims 1
- NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 claims 1
- 229940038472 dicalcium phosphate Drugs 0.000 claims 1
- 229910000390 dicalcium phosphate Inorganic materials 0.000 claims 1
- 239000007888 film coating Substances 0.000 claims 1
- 238000009501 film coating Methods 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 239000000905 isomalt Substances 0.000 claims 1
- 235000010439 isomalt Nutrition 0.000 claims 1
- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 claims 1
- 208000017169 kidney disease Diseases 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361843799P | 2013-07-08 | 2013-07-08 | |
| US61/843,799 | 2013-07-08 | ||
| PCT/US2014/045581 WO2015006219A1 (en) | 2013-07-08 | 2014-07-07 | Stabilized pharmaceutical dosage forms comprising atrasentan |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2016530238A JP2016530238A (ja) | 2016-09-29 |
| JP2016530238A5 true JP2016530238A5 (https=) | 2017-08-17 |
Family
ID=51211921
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016525401A Pending JP2016530238A (ja) | 2013-07-08 | 2014-07-07 | アトラセンタンを含有する安定化医薬剤型 |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US9364458B2 (https=) |
| EP (1) | EP3019158A1 (https=) |
| JP (1) | JP2016530238A (https=) |
| KR (1) | KR20160029125A (https=) |
| CN (1) | CN105517541A (https=) |
| AU (1) | AU2014287496A1 (https=) |
| CA (1) | CA2916033C (https=) |
| CL (2) | CL2016000027A1 (https=) |
| CR (1) | CR20160037A (https=) |
| DO (1) | DOP2016000003A (https=) |
| EC (1) | ECSP16005195A (https=) |
| HK (1) | HK1223825A1 (https=) |
| IL (1) | IL243242B (https=) |
| MX (1) | MX2016000188A (https=) |
| PE (1) | PE20160221A1 (https=) |
| PH (1) | PH12016500042A1 (https=) |
| RU (1) | RU2016103764A (https=) |
| SG (2) | SG11201600107RA (https=) |
| WO (1) | WO2015006219A1 (https=) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9364458B2 (en) * | 2013-07-08 | 2016-06-14 | Abbvie Inc. | Stabilized pharmaceutical dosage forms comprising atrasentan |
| US10929741B2 (en) | 2018-06-18 | 2021-02-23 | University Of Florida Research Foundation, Incorporated | Cross-registration for unclonable chipless RFID tags |
| CA3161516A1 (en) | 2019-12-17 | 2021-06-24 | Philip Thomas FROHLICH | Methods of treating iga nephropathy with atrasentan |
| IL297208A (en) * | 2020-04-10 | 2022-12-01 | Chinook Therapeutics Inc | Treatment methods for diabetic kidney disease |
| WO2022009163A1 (en) | 2020-07-10 | 2022-01-13 | Astrazeneca Ab | Combination of zibotentan and dapagliflozin for the treatment of chronic kidney disease |
| US12156914B2 (en) * | 2022-06-30 | 2024-12-03 | Axsome Therapeutics, Inc. | Pharmaceutical compositions comprising bupropion and cysteine |
| AU2023366516A1 (en) | 2022-10-28 | 2025-05-15 | Aduro Biotech Holdings, Europe B.V. | Treatment of iga nephropathy using an endothelin receptor antagonist and an april binding antibody |
| US12565478B1 (en) | 2025-01-21 | 2026-03-03 | Axsome Therapeutics, Inc. | (S)-2-((S)-(2-ethoxyphenoxy)(phenyl)methyl)-4-nitrosomorpholine |
Family Cites Families (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5376645A (en) | 1990-01-23 | 1994-12-27 | University Of Kansas | Derivatives of cyclodextrins exhibiting enhanced aqueous solubility and the use thereof |
| KR0166088B1 (ko) | 1990-01-23 | 1999-01-15 | . | 수용해도가 증가된 시클로덱스트린 유도체 및 이의 용도 |
| US5767144A (en) | 1994-08-19 | 1998-06-16 | Abbott Laboratories | Endothelin antagonists |
| US7208517B1 (en) | 1994-08-19 | 2007-04-24 | Abbott Labortories | Endothelin antagonists |
| US6946481B1 (en) | 1994-08-19 | 2005-09-20 | Abbott Laboratories | Endothelin antagonists |
| US6162927A (en) | 1994-08-19 | 2000-12-19 | Abbott Laboratories | Endothelin antagonists |
| US7365093B2 (en) | 1994-08-19 | 2008-04-29 | Abbott Laboratories | Endothelin antagonists |
| US6124341A (en) | 1996-02-13 | 2000-09-26 | Abbott Laboratories | Endothelin antagonists |
| US5801250A (en) | 1996-12-13 | 1998-09-01 | Abbott Laboratories | Process for the stereoselective production of nitro-enamine compounds |
| GB9711643D0 (en) | 1997-06-05 | 1997-07-30 | Janssen Pharmaceutica Nv | Glass thermoplastic systems |
| CA2342217C (en) | 1998-09-14 | 2009-12-15 | Abbott Laboratories | Process for producing stereoselective nitro compounds |
| US20020055457A1 (en) | 2000-08-07 | 2002-05-09 | Janus Todd J. | Methods of treating cancer and the pain associated therewith using endothelin antagonists |
| US20030022811A1 (en) | 2001-04-11 | 2003-01-30 | Amitabh Singh | Favorable modulation of health-related quality of life and health-related quality-adjusted time-to-progression of disease in patients with prostate cancer |
| US20030092757A1 (en) | 2001-04-11 | 2003-05-15 | Amitabh Singh | Favorable modulation of health-related quality of life and health-related quality-adjusted time-to-progression of disease in patients with prostate cancer |
| US7297709B2 (en) | 2003-05-22 | 2007-11-20 | Abbott Laboratories | Indazole, benzisoxazole, and benzisothiazole kinase inhibitors |
| WO2006034094A1 (en) | 2004-09-17 | 2006-03-30 | Abbott Laboratories | Crystalline form 1 of atrasentan hxdrochloride |
| US9051301B2 (en) | 2004-09-17 | 2015-06-09 | Abbvie Inc. | Crystalline form of a drug |
| EP1802610A1 (en) * | 2004-09-17 | 2007-07-04 | Abbott Laboratories | Crystalline form 2 of atrasentan hydrochloride |
| US20060135596A1 (en) | 2004-09-17 | 2006-06-22 | Zhang Geoff G | Amorphous form of a drug |
| CA2644784A1 (en) * | 2006-03-13 | 2007-09-20 | Jinling Chen | Formulations of sitaxsentan sodium |
| US20080132710A1 (en) | 2006-12-04 | 2008-06-05 | Abbott Laboratories | Atrasentan hydrochloride crystalline form 2 |
| US20100184026A1 (en) | 2009-01-22 | 2010-07-22 | Abbott Laboratories | Companion Diagnostic Assays For Endothelin Receptor Antagonists |
| US8927009B2 (en) * | 2009-12-22 | 2015-01-06 | Abbvie Inc. | ABT-263 capsule |
| KR20110119108A (ko) | 2010-04-26 | 2011-11-02 | 울산대학교 산학협력단 | 포도씨 프로안토시아니딘 추출물을 유효성분으로 함유하는 폐 섬유화증 치료 및 예방용 약학조성물 |
| CN102114005B (zh) * | 2010-12-06 | 2012-12-12 | 武汉武药科技有限公司 | 一种波生坦胶囊及其制备方法 |
| US9364458B2 (en) * | 2013-07-08 | 2016-06-14 | Abbvie Inc. | Stabilized pharmaceutical dosage forms comprising atrasentan |
| US8962675B1 (en) * | 2013-09-12 | 2015-02-24 | Abbvie Inc. | Atrasentan mandelate salts |
-
2014
- 2014-07-07 US US14/324,603 patent/US9364458B2/en active Active
- 2014-07-07 SG SG11201600107RA patent/SG11201600107RA/en unknown
- 2014-07-07 CN CN201480048237.5A patent/CN105517541A/zh active Pending
- 2014-07-07 HK HK16112042.5A patent/HK1223825A1/zh unknown
- 2014-07-07 EP EP14741777.8A patent/EP3019158A1/en not_active Withdrawn
- 2014-07-07 KR KR1020167003426A patent/KR20160029125A/ko not_active Withdrawn
- 2014-07-07 SG SG10201700596PA patent/SG10201700596PA/en unknown
- 2014-07-07 MX MX2016000188A patent/MX2016000188A/es unknown
- 2014-07-07 PE PE2015002690A patent/PE20160221A1/es not_active Application Discontinuation
- 2014-07-07 JP JP2016525401A patent/JP2016530238A/ja active Pending
- 2014-07-07 AU AU2014287496A patent/AU2014287496A1/en not_active Abandoned
- 2014-07-07 CA CA2916033A patent/CA2916033C/en active Active
- 2014-07-07 WO PCT/US2014/045581 patent/WO2015006219A1/en not_active Ceased
- 2014-07-07 RU RU2016103764A patent/RU2016103764A/ru not_active Application Discontinuation
-
2015
- 2015-12-20 IL IL243242A patent/IL243242B/en active IP Right Grant
-
2016
- 2016-01-06 DO DO2016000003A patent/DOP2016000003A/es unknown
- 2016-01-06 PH PH12016500042A patent/PH12016500042A1/en unknown
- 2016-01-07 CL CL2016000027A patent/CL2016000027A1/es unknown
- 2016-01-19 CR CR20160037A patent/CR20160037A/es unknown
- 2016-02-05 EC ECIEPI20165195A patent/ECSP16005195A/es unknown
- 2016-04-05 CL CL2016000788A patent/CL2016000788A1/es unknown
- 2016-05-13 US US15/154,710 patent/US10016393B2/en active Active
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