JP2017525704A5 - - Google Patents
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- JP2017525704A5 JP2017525704A5 JP2017509739A JP2017509739A JP2017525704A5 JP 2017525704 A5 JP2017525704 A5 JP 2017525704A5 JP 2017509739 A JP2017509739 A JP 2017509739A JP 2017509739 A JP2017509739 A JP 2017509739A JP 2017525704 A5 JP2017525704 A5 JP 2017525704A5
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- JP
- Japan
- Prior art keywords
- seq
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- amino acid
- acid sequence
- polypeptide
- 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
- 239000000203 mixture Substances 0.000 claims description 28
- 229920001184 polypeptide Polymers 0.000 claims description 26
- 102000004196 processed proteins & peptides Human genes 0.000 claims description 26
- 108090000765 processed proteins & peptides Proteins 0.000 claims description 26
- 125000003275 alpha amino acid group Chemical group 0.000 claims description 24
- 125000000151 cysteine group Chemical group N[C@@H](CS)C(=O)* 0.000 claims description 24
- 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 description 20
- 229930195725 Mannitol Natural products 0.000 claims description 20
- 239000000594 mannitol Substances 0.000 claims description 20
- 235000010355 mannitol Nutrition 0.000 claims description 20
- 229930006000 Sucrose Natural products 0.000 claims description 19
- 239000005720 sucrose Substances 0.000 claims description 19
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 16
- 239000013011 aqueous formulation Substances 0.000 claims description 14
- 239000004475 Arginine Substances 0.000 claims description 13
- 229960003121 arginine Drugs 0.000 claims description 13
- 235000009697 arginine Nutrition 0.000 claims description 13
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 13
- 238000009472 formulation Methods 0.000 claims description 12
- KWTQSFXGGICVPE-WCCKRBBISA-N Arginine hydrochloride Chemical compound Cl.OC(=O)[C@@H](N)CCCN=C(N)N KWTQSFXGGICVPE-WCCKRBBISA-N 0.000 claims description 6
- 238000002360 preparation method Methods 0.000 claims description 6
- 239000002904 solvent Substances 0.000 claims description 5
- 239000003381 stabilizer Substances 0.000 claims description 5
- 229940123583 Factor Xa inhibitor Drugs 0.000 claims description 4
- 229940024606 amino acid Drugs 0.000 claims description 4
- 235000001014 amino acid Nutrition 0.000 claims description 4
- 150000001413 amino acids Chemical class 0.000 claims description 4
- 238000004108 freeze drying Methods 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 4
- 125000000637 arginyl group Chemical group N[C@@H](CCCNC(N)=N)C(=O)* 0.000 claims description 3
- 125000000185 sucrose group Chemical group 0.000 claims description 3
- 239000004094 surface-active agent Substances 0.000 claims description 3
- QNZCBYKSOIHPEH-UHFFFAOYSA-N Apixaban Chemical compound C1=CC(OC)=CC=C1N1C(C(=O)N(CC2)C=3C=CC(=CC=3)N3C(CCCC3)=O)=C2C(C(N)=O)=N1 QNZCBYKSOIHPEH-UHFFFAOYSA-N 0.000 claims description 2
- 125000000539 amino acid group Chemical group 0.000 claims description 2
- 229960003886 apixaban Drugs 0.000 claims description 2
- 239000003125 aqueous solvent Substances 0.000 claims description 2
- 229950011103 betrixaban Drugs 0.000 claims description 2
- XHOLNRLADUSQLD-UHFFFAOYSA-N betrixaban Chemical compound C=1C=C(Cl)C=NC=1NC(=O)C1=CC(OC)=CC=C1NC(=O)C1=CC=C(C(=N)N(C)C)C=C1 XHOLNRLADUSQLD-UHFFFAOYSA-N 0.000 claims description 2
- 230000000740 bleeding effect Effects 0.000 claims description 2
- 239000003112 inhibitor Substances 0.000 claims description 2
- 239000012931 lyophilized formulation Substances 0.000 claims description 2
- 238000012986 modification Methods 0.000 claims description 2
- 230000004048 modification Effects 0.000 claims description 2
- 235000018102 proteins Nutrition 0.000 claims description 2
- 108090000623 proteins and genes Proteins 0.000 claims description 2
- 102000004169 proteins and genes Human genes 0.000 claims description 2
- 108010014806 prothrombinase complex Proteins 0.000 claims description 2
- 229960001148 rivaroxaban Drugs 0.000 claims description 2
- KGFYHTZWPPHNLQ-AWEZNQCLSA-N rivaroxaban Chemical compound S1C(Cl)=CC=C1C(=O)NC[C@@H]1OC(=O)N(C=2C=CC(=CC=2)N2C(COCC2)=O)C1 KGFYHTZWPPHNLQ-AWEZNQCLSA-N 0.000 claims description 2
- 238000002560 therapeutic procedure Methods 0.000 claims description 2
- 239000003146 anticoagulant agent Substances 0.000 claims 1
- 229940127219 anticoagulant drug Drugs 0.000 claims 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 1
- 230000010100 anticoagulation Effects 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462039809P | 2014-08-20 | 2014-08-20 | |
| US62/039,809 | 2014-08-20 | ||
| PCT/US2015/046173 WO2016029061A1 (en) | 2014-08-20 | 2015-08-20 | Lyophilized formulations for factor xa antidote |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019165981A Division JP2019206595A (ja) | 2014-08-20 | 2019-09-12 | 第Ｘａ因子解毒剤の凍結乾燥製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2017525704A JP2017525704A (ja) | 2017-09-07 |
| JP2017525704A5 true JP2017525704A5 (enExample) | 2018-09-13 |
| JP6742986B2 JP6742986B2 (ja) | 2020-08-19 |
Family
ID=55351266
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017509739A Active JP6742986B2 (ja) | 2014-08-20 | 2015-08-20 | 第Ｘａ因子解毒剤の凍結乾燥製剤 |
| JP2019165981A Withdrawn JP2019206595A (ja) | 2014-08-20 | 2019-09-12 | 第Ｘａ因子解毒剤の凍結乾燥製剤 |
| JP2021172975A Active JP7416549B2 (ja) | 2014-08-20 | 2021-10-22 | 第Ｘａ因子解毒剤の凍結乾燥製剤 |
| JP2023146769A Pending JP2023158199A (ja) | 2014-08-20 | 2023-09-11 | 第Ｘａ因子解毒剤の凍結乾燥製剤 |
Family Applications After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019165981A Withdrawn JP2019206595A (ja) | 2014-08-20 | 2019-09-12 | 第Ｘａ因子解毒剤の凍結乾燥製剤 |
| JP2021172975A Active JP7416549B2 (ja) | 2014-08-20 | 2021-10-22 | 第Ｘａ因子解毒剤の凍結乾燥製剤 |
| JP2023146769A Pending JP2023158199A (ja) | 2014-08-20 | 2023-09-11 | 第Ｘａ因子解毒剤の凍結乾燥製剤 |
Country Status (14)
| Country | Link |
|---|---|
| US (6) | US20160237420A1 (enExample) |
| EP (2) | EP3750556A1 (enExample) |
| JP (4) | JP6742986B2 (enExample) |
| KR (3) | KR102867491B1 (enExample) |
| CN (2) | CN113171447B (enExample) |
| AU (3) | AU2015305413B2 (enExample) |
| CA (1) | CA2961739C (enExample) |
| DK (1) | DK3182993T3 (enExample) |
| EA (2) | EA036091B1 (enExample) |
| ES (1) | ES2814157T3 (enExample) |
| IL (2) | IL250413B (enExample) |
| SG (1) | SG11201701247RA (enExample) |
| WO (1) | WO2016029061A1 (enExample) |
| ZA (1) | ZA201701764B (enExample) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3121271B1 (en) * | 2009-03-30 | 2019-07-24 | Portola Pharmaceuticals, Inc. | Antidotes for factor xa inhibitors and methods of using the same |
| EA036091B1 (ru) | 2014-08-20 | 2020-09-25 | Портола Фармасьютикалз, Инк. | ВОДНЫЕ СОСТАВЫ АНТИДОТОВ ФАКТОРА Xa (fXa) ДЛЯ ПРЕДУПРЕЖДЕНИЯ ИЛИ УМЕНЬШЕНИЯ КРОВОТЕЧЕНИЯ И ИХ ПРИМЕНЕНИЕ |
| WO2017147522A1 (en) | 2016-02-24 | 2017-08-31 | Portola Pharmaceuticals, Inc. | Lyophilized formulations for factor xa antidote |
| CN110167575B (zh) * | 2016-06-17 | 2024-03-15 | 阿雷克森制药公司 | 因子xa衍生物的制备 |
| US11590237B2 (en) * | 2017-05-18 | 2023-02-28 | Merck Sharp & Dohme Llc | Pharmaceutical formulation comprising incretin-insulin conjugates |
| TWI840360B (zh) * | 2018-05-21 | 2024-05-01 | 日商中外製藥股份有限公司 | 密封於玻璃容器之凍結乾燥的製劑、套組、製造凍結乾燥製劑的方法、防止或減低凍結乾燥製劑的玻璃容器成霧的方法、及容器內面經過硫酸銨處理或ｖｉｓｔ處理之玻璃容器 |
| CN110760479A (zh) * | 2019-05-17 | 2020-02-07 | 上海交通大学医学院附属瑞金医院 | 靶向血小板表达的凝血因子Xa及其应用 |
Family Cites Families (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0675899B1 (en) | 1992-12-15 | 1999-03-17 | Corvas International, Inc. | NOVEL INHIBITORS OF FACTOR Xa |
| CZ307715B6 (cs) * | 1999-02-22 | 2019-03-06 | University Of Connecticut | Způsob lyofilizace vodné farmaceutické formulace faktoru VIII prosté albuminu |
| US6586574B1 (en) * | 1999-08-17 | 2003-07-01 | Nn A/S | Stabilization of freeze-dried cake |
| AU2001245353A1 (en) | 2000-02-29 | 2001-09-12 | Cor Therapeutics, Inc. | Benzamides and related inhibitors of factor xa |
| US6586584B2 (en) * | 2001-01-29 | 2003-07-01 | Becton, Dickinson And Company | Sequences and methods for detection of Hepatitis C virus |
| JP2008500942A (ja) * | 2003-01-08 | 2008-01-17 | カイロン コーポレイション | 組織因子経路インヒビターまたは組織因子経路インヒビター改変体を含有する安定化凍結乾燥組成物 |
| CN102336702B (zh) | 2005-11-08 | 2015-02-11 | 米伦纽姆医药公司 | Xa因子抑制剂n-(5-氯-2-吡啶基)-2-[[4-[(二甲氨基)亚氨基甲基]苯甲酰基]氨基]-5-甲氧基-苯甲酰胺的医药盐和多晶型 |
| JO3324B1 (ar) * | 2006-04-21 | 2019-03-13 | Amgen Inc | مركبات علاجية مجففة بالتبريد تتعلق بالعصارة الهضمية |
| PL2915564T3 (pl) * | 2007-09-28 | 2021-07-19 | Alexion Pharmaceuticals, Inc. | Antidota dla inhibitorów czynnika Xa i sposoby ich stosowania |
| PL2337580T3 (pl) | 2008-09-03 | 2012-08-31 | Octapharma Ag | Stabilizowane kompozycje czynnika VIII produkowanego metodami rekombinacji genetycznej |
| WO2010056765A2 (en) | 2008-11-14 | 2010-05-20 | Portola Pharmaceuticals, Inc. | Antidotes for factor xa inhibitors and methods of using the same in combination with blood coagulating agents |
| EP3121271B1 (en) * | 2009-03-30 | 2019-07-24 | Portola Pharmaceuticals, Inc. | Antidotes for factor xa inhibitors and methods of using the same |
| JP6163304B2 (ja) * | 2009-07-15 | 2017-07-12 | ポートラ ファーマシューティカルズ， インコーポレイテッド | 第Ｘａ因子インヒビターの解毒剤の単位用量処方物およびその使用方法 |
| EP2458990B1 (en) * | 2009-07-28 | 2016-03-30 | Merck Sharp & Dohme Corp. | Methods for producing high concentration lyophilized pharmaceutical formulations |
| US20130165459A1 (en) * | 2010-01-12 | 2013-06-27 | Norvartis Pharma Ag | Pharmaceutical composition and dosage forms of elinogrel and methods of use thereof |
| DK2561070T3 (en) * | 2010-04-20 | 2015-08-17 | Octapharma Ag | NEW STABILIZER FOR PHARMACEUTICAL PROTEINS |
| JP2013544271A (ja) * | 2010-12-03 | 2013-12-12 | ポートラ ファーマシューティカルズ， インコーポレイテッド | 式（ｉ）の化合物の薬学的組成物、投薬形態、および新規の形態、ならびにその使用方法 |
| CN103945863A (zh) * | 2011-08-01 | 2014-07-23 | 爱默蕾大学 | 包含配体的vlp及其相关方法 |
| WO2013049804A1 (en) * | 2011-09-30 | 2013-04-04 | The Children's Hospital Of Philadelphia | Compositions and methods for modulating hemostasis |
| GB201310946D0 (en) * | 2013-06-19 | 2013-07-31 | Cambridge Entpr Ltd | Antidote |
| EA036091B1 (ru) * | 2014-08-20 | 2020-09-25 | Портола Фармасьютикалз, Инк. | ВОДНЫЕ СОСТАВЫ АНТИДОТОВ ФАКТОРА Xa (fXa) ДЛЯ ПРЕДУПРЕЖДЕНИЯ ИЛИ УМЕНЬШЕНИЯ КРОВОТЕЧЕНИЯ И ИХ ПРИМЕНЕНИЕ |
-
2015
- 2015-08-20 EA EA201790415A patent/EA036091B1/ru unknown
- 2015-08-20 KR KR1020227045749A patent/KR102867491B1/ko active Active
- 2015-08-20 EA EA202091385A patent/EA202091385A3/ru unknown
- 2015-08-20 WO PCT/US2015/046173 patent/WO2016029061A1/en not_active Ceased
- 2015-08-20 CA CA2961739A patent/CA2961739C/en active Active
- 2015-08-20 KR KR1020177007503A patent/KR102482517B1/ko active Active
- 2015-08-20 ES ES15834421T patent/ES2814157T3/es active Active
- 2015-08-20 AU AU2015305413A patent/AU2015305413B2/en active Active
- 2015-08-20 DK DK15834421.8T patent/DK3182993T3/da active
- 2015-08-20 CN CN202110363277.0A patent/CN113171447B/zh active Active
- 2015-08-20 EP EP20170763.5A patent/EP3750556A1/en active Pending
- 2015-08-20 EP EP15834421.8A patent/EP3182993B1/en active Active
- 2015-08-20 SG SG11201701247RA patent/SG11201701247RA/en unknown
- 2015-08-20 CN CN201580048166.3A patent/CN107073082B/zh active Active
- 2015-08-20 JP JP2017509739A patent/JP6742986B2/ja active Active
- 2015-08-20 KR KR1020257032508A patent/KR20250150675A/ko active Pending
-
2016
- 2016-04-22 US US15/136,810 patent/US20160237420A1/en not_active Abandoned
-
2017
- 2017-02-02 IL IL250413A patent/IL250413B/en active IP Right Grant
- 2017-03-10 ZA ZA2017/01764A patent/ZA201701764B/en unknown
- 2017-11-21 US US15/820,265 patent/US20180320160A1/en not_active Abandoned
-
2019
- 2019-09-12 JP JP2019165981A patent/JP2019206595A/ja not_active Withdrawn
-
2020
- 2020-06-08 US US16/895,443 patent/US20200299667A1/en not_active Abandoned
- 2020-06-08 US US16/895,448 patent/US11028382B2/en active Active
- 2020-08-26 IL IL276960A patent/IL276960B/en unknown
- 2020-12-16 AU AU2020289768A patent/AU2020289768B2/en active Active
-
2021
- 2021-05-28 US US17/334,427 patent/US20210284986A1/en not_active Abandoned
- 2021-10-22 JP JP2021172975A patent/JP7416549B2/ja active Active
-
2023
- 2023-09-11 JP JP2023146769A patent/JP2023158199A/ja active Pending
-
2024
- 2024-09-13 AU AU2024219698A patent/AU2024219698A1/en active Pending
- 2024-11-05 US US18/937,646 patent/US20250163399A1/en active Pending
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