JP2015510939A5 - - Google Patents
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- JP2015510939A5 JP2015510939A5 JP2015501813A JP2015501813A JP2015510939A5 JP 2015510939 A5 JP2015510939 A5 JP 2015510939A5 JP 2015501813 A JP2015501813 A JP 2015501813A JP 2015501813 A JP2015501813 A JP 2015501813A JP 2015510939 A5 JP2015510939 A5 JP 2015510939A5
- Authority
- JP
- Japan
- Prior art keywords
- liquid composition
- administered
- volume
- less
- composition according
- 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 45
- 239000007788 liquid Substances 0.000 claims description 24
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 21
- YTKUWDBFDASYHO-UHFFFAOYSA-N bendamustine Chemical compound ClCCN(CCCl)C1=CC=C2N(C)C(CCCC(O)=O)=NC2=C1 YTKUWDBFDASYHO-UHFFFAOYSA-N 0.000 claims description 16
- 229960002707 bendamustine Drugs 0.000 claims description 16
- 239000002202 Polyethylene glycol Substances 0.000 claims description 9
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 9
- 229920001223 polyethylene glycol Polymers 0.000 claims description 9
- 239000002904 solvent Substances 0.000 claims description 8
- 206010028980 Neoplasm Diseases 0.000 claims description 7
- 201000011510 cancer Diseases 0.000 claims description 7
- 150000003839 salts Chemical class 0.000 claims description 6
- 239000011780 sodium chloride Substances 0.000 claims description 5
- 239000003963 antioxidant agent Substances 0.000 claims description 4
- 230000003078 antioxidant effect Effects 0.000 claims description 4
- 239000003085 diluting agent Substances 0.000 claims description 4
- 201000010099 disease Diseases 0.000 claims description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 3
- 230000003211 malignant effect Effects 0.000 claims description 3
- QCQCHGYLTSGIGX-GHXANHINSA-N 4-[[(3ar,5ar,5br,7ar,9s,11ar,11br,13as)-5a,5b,8,8,11a-pentamethyl-3a-[(5-methylpyridine-3-carbonyl)amino]-2-oxo-1-propan-2-yl-4,5,6,7,7a,9,10,11,11b,12,13,13a-dodecahydro-3h-cyclopenta[a]chrysen-9-yl]oxy]-2,2-dimethyl-4-oxobutanoic acid Chemical compound N([C@@]12CC[C@@]3(C)[C@]4(C)CC[C@H]5C(C)(C)[C@@H](OC(=O)CC(C)(C)C(O)=O)CC[C@]5(C)[C@H]4CC[C@@H]3C1=C(C(C2)=O)C(C)C)C(=O)C1=CN=CC(C)=C1 QCQCHGYLTSGIGX-GHXANHINSA-N 0.000 claims description 2
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 2
- 208000011821 Indolent B-cell non-Hodgkin lymphoma Diseases 0.000 claims description 2
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims description 2
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims description 2
- 208000032852 chronic lymphocytic leukemia Diseases 0.000 claims description 2
- 239000008121 dextrose Substances 0.000 claims description 2
- 230000036210 malignancy Effects 0.000 claims description 2
- PJUIMOJAAPLTRJ-UHFFFAOYSA-N monothioglycerol Chemical group OCC(O)CS PJUIMOJAAPLTRJ-UHFFFAOYSA-N 0.000 claims description 2
- JLFNLZLINWHATN-UHFFFAOYSA-N pentaethylene glycol Chemical compound OCCOCCOCCOCCOCCO JLFNLZLINWHATN-UHFFFAOYSA-N 0.000 claims description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 2
- 239000008215 water for injection Substances 0.000 claims description 2
- 238000000034 method Methods 0.000 description 30
- 230000015556 catabolic process Effects 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- ZHSKUOZOLHMKEA-UHFFFAOYSA-N 4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid;hydron;chloride Chemical compound Cl.ClCCN(CCCl)C1=CC=C2N(C)C(CCCC(O)=O)=NC2=C1 ZHSKUOZOLHMKEA-UHFFFAOYSA-N 0.000 description 1
- 239000013011 aqueous formulation Substances 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000007911 parenteral administration Methods 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 229940066958 treanda Drugs 0.000 description 1
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261613173P | 2012-03-20 | 2012-03-20 | |
| US61/613,173 | 2012-03-20 | ||
| US201261669889P | 2012-07-10 | 2012-07-10 | |
| US61/669,889 | 2012-07-10 | ||
| PCT/US2013/032289 WO2013142358A1 (en) | 2012-03-20 | 2013-03-15 | Formulations of bendamustine |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017224298A Division JP6570601B2 (ja) | 2012-03-20 | 2017-11-22 | ベンダムスチンの製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2015510939A JP2015510939A (ja) | 2015-04-13 |
| JP2015510939A5 true JP2015510939A5 (enExample) | 2016-04-14 |
| JP6250628B2 JP6250628B2 (ja) | 2017-12-20 |
Family
ID=49212372
Family Applications (8)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015501813A Active JP6250628B2 (ja) | 2012-03-20 | 2013-03-15 | ベンダムスチンの製剤 |
| JP2017224298A Active JP6570601B2 (ja) | 2012-03-20 | 2017-11-22 | ベンダムスチンの製剤 |
| JP2019144489A Withdrawn JP2019214592A (ja) | 2012-03-20 | 2019-08-06 | ベンダムスチンの製剤 |
| JP2021125009A Active JP7133070B2 (ja) | 2012-03-20 | 2021-07-30 | ベンダムスチンの製剤 |
| JP2022105476A Pending JP2022130629A (ja) | 2012-03-20 | 2022-06-30 | ベンダムスチンの製剤 |
| JP2022105477A Pending JP2022130630A (ja) | 2012-03-20 | 2022-06-30 | ベンダムスチンの製剤 |
| JP2022117843A Pending JP2022141895A (ja) | 2012-03-20 | 2022-07-25 | ベンダムスチンの製剤 |
| JP2024008381A Pending JP2024045290A (ja) | 2012-03-20 | 2024-01-24 | ベンダムスチンの製剤 |
Family Applications After (7)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017224298A Active JP6570601B2 (ja) | 2012-03-20 | 2017-11-22 | ベンダムスチンの製剤 |
| JP2019144489A Withdrawn JP2019214592A (ja) | 2012-03-20 | 2019-08-06 | ベンダムスチンの製剤 |
| JP2021125009A Active JP7133070B2 (ja) | 2012-03-20 | 2021-07-30 | ベンダムスチンの製剤 |
| JP2022105476A Pending JP2022130629A (ja) | 2012-03-20 | 2022-06-30 | ベンダムスチンの製剤 |
| JP2022105477A Pending JP2022130630A (ja) | 2012-03-20 | 2022-06-30 | ベンダムスチンの製剤 |
| JP2022117843A Pending JP2022141895A (ja) | 2012-03-20 | 2022-07-25 | ベンダムスチンの製剤 |
| JP2024008381A Pending JP2024045290A (ja) | 2012-03-20 | 2024-01-24 | ベンダムスチンの製剤 |
Country Status (15)
| Country | Link |
|---|---|
| US (20) | US9034908B2 (enExample) |
| EP (2) | EP2827862B1 (enExample) |
| JP (8) | JP6250628B2 (enExample) |
| CN (1) | CN104302291A (enExample) |
| CA (1) | CA2867295C (enExample) |
| DK (1) | DK2827862T3 (enExample) |
| ES (2) | ES2972227T3 (enExample) |
| FI (1) | FI2827862T3 (enExample) |
| HR (1) | HRP20240056T1 (enExample) |
| HU (1) | HUE064884T2 (enExample) |
| PL (1) | PL2827862T3 (enExample) |
| PT (1) | PT2827862T (enExample) |
| RS (1) | RS65177B1 (enExample) |
| SI (1) | SI2827862T1 (enExample) |
| WO (1) | WO2013142358A1 (enExample) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011094565A1 (en) | 2010-01-28 | 2011-08-04 | Eagle Pharmaceuticals, Inc. | Formulations of bendamustine |
| ES2972227T3 (es) * | 2012-03-20 | 2024-06-11 | Eagle Pharmaceuticals Inc | Formulaciones de bendamustina |
| US20230241218A1 (en) * | 2012-07-10 | 2023-08-03 | Eagle Pharmaceuticals, Inc. | Formulations of bendamustine |
| HRP20230276T1 (hr) | 2012-03-20 | 2023-04-28 | Eagle Pharmaceuticals, Inc. | Tekući pripravci bendamustina za uporabu u postupku liječenja stanja koja reagiraju na bendamustin kod pacijenata kojima za primjenu trebaju reducirani volumeni |
| CN109953954A (zh) | 2013-08-27 | 2019-07-02 | V·沃道里斯 | 苯达莫司汀医药组合物 |
| CN110772480B (zh) * | 2016-03-25 | 2022-05-17 | 南京百劲企业管理咨询有限公司 | 苯达莫司汀药剂组合物及应用 |
| US10905677B2 (en) | 2016-08-31 | 2021-02-02 | Navinta, Llc | Bendamustine solution formulations |
| US11826466B2 (en) | 2016-08-31 | 2023-11-28 | Navinta, Llc | Bendamustine solution formulations |
| EP3836921B1 (en) | 2018-08-17 | 2025-10-08 | Hospira Australia Pty Ltd | Liquid bendamustine pharmaceutical compositions |
| US11730815B2 (en) | 2018-11-26 | 2023-08-22 | Good Health, Llc | Stable liquid pharmaceutical compositions comprising bendamustine |
| WO2020236150A1 (en) * | 2019-05-20 | 2020-11-26 | MAIA Pharmaceuticals, Inc. | Ready-to-use bivalirudin compositions |
| US11992514B2 (en) | 2019-05-20 | 2024-05-28 | MAIA Pharmaceuticals, Inc. | Ready-to-use bivalirudin compositions |
| CA3145107A1 (en) * | 2020-04-09 | 2021-10-14 | Yue Jing | Bendamustine and cyclodextrin composition and use thereof |
| US11707450B1 (en) * | 2022-03-03 | 2023-07-25 | Slayback Pharma Llc | Stable pharmaceutical compositions of bendamustine |
Family Cites Families (45)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE159289C (enExample) | 1903-10-08 | 1905-03-16 | ||
| US4071620A (en) | 1977-01-10 | 1978-01-31 | American Home Products Corporation | Stabilization of oxygen sensitive dose forms |
| DD159289A1 (de) | 1981-06-01 | 1983-03-02 | Uwe Olthoff | Verfahren zur herstellung stabiler injektionsloesungen von n-lostverbindungen |
| DE3446873A1 (de) | 1984-12-21 | 1986-07-10 | Merckle Gmbh | Fluessige diclofenac-zubereitungen |
| US4879286A (en) | 1987-01-28 | 1989-11-07 | Lyphomed, Inc. | Cyclophosphamide |
| US5223515A (en) | 1988-08-18 | 1993-06-29 | Takeda Chemical Industries, Ltd. | Injectable solution containing a pyridyl methylsulfinylbenzimidazole |
| AU706890B2 (en) | 1994-01-24 | 1999-07-01 | Procter & Gamble Company, The | Process for solubilizing difficultly soluble pharmaceutical actives |
| KR20010020611A (ko) | 1997-07-01 | 2001-03-15 | 아테로제닉스, 인코포레이티드 | 항산화제에 의한 과증식질병 치료의 향상 |
| ES2373864T3 (es) | 1998-04-20 | 2012-02-09 | Eisai R&D Management Co., Ltd. | Composición estabilizada que contiene un compuesto de tipo bencimidazol. |
| AUPQ849900A0 (en) | 2000-06-30 | 2000-07-27 | Dbl Australia Pty Ltd. | Injectable composition |
| WO2002032427A1 (en) | 2000-10-20 | 2002-04-25 | Galephar M/F | Stable oral formulation containing benzimidazole derivative |
| RU2344821C2 (ru) | 2002-07-30 | 2009-01-27 | Уайт | Парентеральные композиции, содержащие гидроксиэфиры рапамицина |
| US20060035945A1 (en) | 2003-05-30 | 2006-02-16 | Giorgio Attardo | Triheterocyclic compounds, compositions, and methods for treating cancer or viral diseases |
| EP1814544A4 (en) | 2004-11-05 | 2009-12-02 | Cephalon Inc | CANCER TREATMENTS |
| SI1814517T1 (sl) | 2004-11-22 | 2010-12-31 | Venus Remedies Ltd | Nevodna tekoäśa parentalna aceklofenak formulacija |
| US8436190B2 (en) | 2005-01-14 | 2013-05-07 | Cephalon, Inc. | Bendamustine pharmaceutical compositions |
| EP1909824B1 (en) | 2005-04-08 | 2011-05-18 | Amylin Pharmaceuticals, Inc. | Pharmaceutical formulations comprising incretin peptide and aprotic polar solvent |
| JPWO2008020584A1 (ja) | 2006-08-14 | 2010-01-07 | エーザイ・アール・アンド・ディー・マネジメント株式会社 | 安定な凍結乾燥製剤 |
| JP5721949B2 (ja) | 2006-10-12 | 2015-05-20 | アステックス、セラピューティックス、リミテッドＡｓｔｅｘ Ｔｈｅｒａｐｅｕｔｉｃｓ Ｌｉｍｉｔｅｄ | 複合薬剤 |
| US8414909B2 (en) | 2006-11-20 | 2013-04-09 | Lutonix, Inc. | Drug releasing coatings for medical devices |
| DE102007003184A1 (de) | 2007-01-22 | 2008-07-24 | Orlowski, Michael, Dr. | Verfahren zur Beladung von strukturierten Oberflächen |
| US20090082416A1 (en) | 2007-09-25 | 2009-03-26 | Protia, Llc | Deuterium-enriched bendamustine |
| AR072777A1 (es) | 2008-03-26 | 2010-09-22 | Cephalon Inc | Formas solidas de clorhidrato de bendamustina |
| CN104224703A (zh) | 2008-09-25 | 2014-12-24 | 赛福伦公司 | 苯达莫司汀的液体配制品 |
| KR20110110293A (ko) | 2009-01-15 | 2011-10-06 | 세파론, 인코포레이티드 | 벤다무스틴 유리 염기의 신규 형태 |
| AU2010217297A1 (en) | 2009-02-25 | 2011-10-20 | Supratek Pharma, Inc. | Bendamustine cyclopolysaccharide compositions |
| US20100273730A1 (en) | 2009-04-27 | 2010-10-28 | Innopharmax, Inc. | Self-emulsifying pharmaceutical compositions of hydrophilic drugs and preparation thereof |
| JP2012525387A (ja) | 2009-04-28 | 2012-10-22 | セファロン、インク． | ベンダムスチンの経口製剤 |
| CN101584668A (zh) | 2009-06-19 | 2009-11-25 | 江苏奥赛康药业有限公司 | 盐酸苯达莫司汀冻干粉针剂 |
| WO2010148288A2 (en) | 2009-06-19 | 2010-12-23 | Lyotropic Therapeutics, Inc. | Pharmaceutical formulations with low aqueous levels of free unbound drug |
| US20110015245A1 (en) | 2009-07-20 | 2011-01-20 | Valery Alakhov | Bendamustine amphiphilic cationic compositions |
| US8389558B2 (en) | 2009-07-20 | 2013-03-05 | Supratek Pharma Inc. | Bendamustine amphiphilic anionic compositions |
| US7772274B1 (en) | 2009-10-19 | 2010-08-10 | Scidose, Llc | Docetaxel formulations with lipoic acid |
| WO2011094565A1 (en) | 2010-01-28 | 2011-08-04 | Eagle Pharmaceuticals, Inc. | Formulations of bendamustine |
| WO2011103150A2 (en) * | 2010-02-18 | 2011-08-25 | Cephalon, Inc. | Lyophilized preparations of bendamustine |
| JP5951600B2 (ja) | 2010-05-21 | 2016-07-13 | インフィニティー ファーマシューティカルズ， インコーポレイテッド | キナーゼ調節のための、化合物、組成物および方法 |
| US9655898B2 (en) | 2010-07-28 | 2017-05-23 | Eagle Pharmaceuticals, Inc. | Pharmaceutical compositions containing pemetrexed having extended storage stability |
| CN107353342B (zh) | 2011-12-05 | 2021-08-10 | X 博迪生物科学公司 | PDGF受体β结合多肽 |
| US20130210878A1 (en) * | 2012-01-24 | 2013-08-15 | Innopharma, Inc. | Bendamustine compositions and methods therefore |
| KR101951319B1 (ko) * | 2012-02-07 | 2019-02-22 | 삼성전자주식회사 | 가변 초점 렌즈 |
| CA2864118A1 (en) * | 2012-02-14 | 2013-08-22 | Eagle Pharmaceuticals, Inc. | Formulations of bendamustine |
| ES2972227T3 (es) * | 2012-03-20 | 2024-06-11 | Eagle Pharmaceuticals Inc | Formulaciones de bendamustina |
| HRP20230276T1 (hr) * | 2012-03-20 | 2023-04-28 | Eagle Pharmaceuticals, Inc. | Tekući pripravci bendamustina za uporabu u postupku liječenja stanja koja reagiraju na bendamustin kod pacijenata kojima za primjenu trebaju reducirani volumeni |
| US9587397B1 (en) * | 2015-09-29 | 2017-03-07 | John Milner McCary, SR. | Insulating and support assembly |
| US10052372B2 (en) * | 2016-05-24 | 2018-08-21 | Tessa Therapeutics Pte Ltd | T cell expansion |
-
2013
- 2013-03-15 ES ES13764989T patent/ES2972227T3/es active Active
- 2013-03-15 FI FIEP13764989.3T patent/FI2827862T3/fi active
- 2013-03-15 HR HRP20240056TT patent/HRP20240056T1/hr unknown
- 2013-03-15 HU HUE13764989A patent/HUE064884T2/hu unknown
- 2013-03-15 EP EP13764989.3A patent/EP2827862B1/en active Active
- 2013-03-15 EP EP23218288.1A patent/EP4360621B1/en active Active
- 2013-03-15 PT PT137649893T patent/PT2827862T/pt unknown
- 2013-03-15 PL PL13764989.3T patent/PL2827862T3/pl unknown
- 2013-03-15 CN CN201380023657.3A patent/CN104302291A/zh active Pending
- 2013-03-15 JP JP2015501813A patent/JP6250628B2/ja active Active
- 2013-03-15 DK DK13764989.3T patent/DK2827862T3/da active
- 2013-03-15 US US13/838,090 patent/US9034908B2/en active Active
- 2013-03-15 RS RS20240115A patent/RS65177B1/sr unknown
- 2013-03-15 CA CA2867295A patent/CA2867295C/en active Active
- 2013-03-15 WO PCT/US2013/032289 patent/WO2013142358A1/en not_active Ceased
- 2013-03-15 SI SI201332072T patent/SI2827862T1/sl unknown
- 2013-03-15 ES ES23218288T patent/ES3075492T3/es active Active
- 2013-12-05 US US14/097,904 patent/US20140275196A1/en not_active Abandoned
- 2013-12-05 US US14/098,094 patent/US20140094496A1/en not_active Abandoned
-
2015
- 2015-05-18 US US14/714,578 patent/US9144568B1/en active Active
- 2015-09-17 US US14/857,064 patent/US9597397B2/en active Active
-
2016
- 2016-01-28 US US15/008,819 patent/US9597398B2/en active Active
- 2016-01-28 US US15/008,827 patent/US9597399B2/en active Active
- 2016-06-16 US US15/184,464 patent/US9572887B2/en active Active
- 2016-06-16 US US15/184,488 patent/US9572888B2/en active Active
-
2017
- 2017-02-14 US US15/432,378 patent/US10052385B2/en active Active
- 2017-11-22 JP JP2017224298A patent/JP6570601B2/ja active Active
-
2018
- 2018-02-28 US US15/908,075 patent/US20180185488A1/en not_active Abandoned
- 2018-08-08 US US16/058,416 patent/US20180369383A1/en not_active Abandoned
-
2019
- 2019-03-04 US US16/291,401 patent/US20190192659A1/en not_active Abandoned
- 2019-08-06 JP JP2019144489A patent/JP2019214592A/ja not_active Withdrawn
- 2019-09-30 US US16/588,002 patent/US20200282057A1/en not_active Abandoned
- 2019-11-26 US US16/696,421 patent/US20200368355A1/en not_active Abandoned
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2020
- 2020-05-08 US US16/869,875 patent/US20210106686A1/en not_active Abandoned
-
2021
- 2021-07-30 JP JP2021125009A patent/JP7133070B2/ja active Active
-
2022
- 2022-02-24 US US17/679,883 patent/US20220323584A1/en not_active Abandoned
- 2022-05-10 US US17/740,990 patent/US20220265829A1/en not_active Abandoned
- 2022-06-30 JP JP2022105476A patent/JP2022130629A/ja active Pending
- 2022-06-30 JP JP2022105477A patent/JP2022130630A/ja active Pending
- 2022-07-25 JP JP2022117843A patent/JP2022141895A/ja active Pending
-
2023
- 2023-04-05 US US18/296,290 patent/US20230285563A1/en not_active Abandoned
-
2024
- 2024-01-24 JP JP2024008381A patent/JP2024045290A/ja active Pending
-
2025
- 2025-09-04 US US19/318,808 patent/US20260000767A1/en active Pending
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