JP2015506989A5 - - Google Patents
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- Publication number
- JP2015506989A5 JP2015506989A5 JP2014556835A JP2014556835A JP2015506989A5 JP 2015506989 A5 JP2015506989 A5 JP 2015506989A5 JP 2014556835 A JP2014556835 A JP 2014556835A JP 2014556835 A JP2014556835 A JP 2014556835A JP 2015506989 A5 JP2015506989 A5 JP 2015506989A5
- Authority
- JP
- Japan
- Prior art keywords
- bendamustine
- polyethylene glycol
- stable
- term storage
- containing composition
- 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
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 31
- YTKUWDBFDASYHO-UHFFFAOYSA-N bendamustine Chemical compound ClCCN(CCCl)C1=CC=C2N(C)C(CCCC(O)=O)=NC2=C1 YTKUWDBFDASYHO-UHFFFAOYSA-N 0.000 claims 31
- 229960002707 bendamustine Drugs 0.000 claims 31
- 239000000203 mixture Substances 0.000 claims 29
- 239000002202 Polyethylene glycol Substances 0.000 claims 24
- 229920001223 polyethylene glycol Polymers 0.000 claims 24
- 230000007774 longterm Effects 0.000 claims 23
- 238000004128 high performance liquid chromatography Methods 0.000 claims 8
- 239000012530 fluid Substances 0.000 claims 7
- -1 propylene glycol ester Chemical class 0.000 claims 7
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 6
- 150000002484 inorganic compounds Chemical class 0.000 claims 6
- 229910010272 inorganic material Inorganic materials 0.000 claims 6
- PJUIMOJAAPLTRJ-UHFFFAOYSA-N monothioglycerol Chemical compound OCC(O)CS PJUIMOJAAPLTRJ-UHFFFAOYSA-N 0.000 claims 6
- 150000002894 organic compounds Chemical class 0.000 claims 6
- 239000003963 antioxidant agent Substances 0.000 claims 5
- 230000003078 antioxidant effect Effects 0.000 claims 5
- 235000006708 antioxidants Nutrition 0.000 claims 5
- 150000002148 esters Chemical class 0.000 claims 5
- 150000003839 salts Chemical class 0.000 claims 5
- 229940035024 thioglycerol Drugs 0.000 claims 4
- 230000000087 stabilizing effect Effects 0.000 claims 3
- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 claims 2
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims 2
- 239000001632 sodium acetate Substances 0.000 claims 2
- 235000017281 sodium acetate Nutrition 0.000 claims 2
- IZFHEQBZOYJLPK-SSDOTTSWSA-N (R)-dihydrolipoic acid Chemical compound OC(=O)CCCC[C@@H](S)CCS IZFHEQBZOYJLPK-SSDOTTSWSA-N 0.000 claims 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims 1
- XUJNEKJLAYXESH-REOHCLBHSA-N L-Cysteine Chemical compound SC[C@H](N)C(O)=O XUJNEKJLAYXESH-REOHCLBHSA-N 0.000 claims 1
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims 1
- 150000007824 aliphatic compounds Chemical class 0.000 claims 1
- 150000001491 aromatic compounds Chemical class 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- XUJNEKJLAYXESH-UHFFFAOYSA-N cysteine Natural products SCC(N)C(O)=O XUJNEKJLAYXESH-UHFFFAOYSA-N 0.000 claims 1
- 235000018417 cysteine Nutrition 0.000 claims 1
- 229960002433 cysteine Drugs 0.000 claims 1
- ZBCBWPMODOFKDW-UHFFFAOYSA-N diethanolamine Chemical compound OCCNCCO ZBCBWPMODOFKDW-UHFFFAOYSA-N 0.000 claims 1
- WBZKQQHYRPRKNJ-UHFFFAOYSA-L disulfite Chemical compound [O-]S(=O)S([O-])(=O)=O WBZKQQHYRPRKNJ-UHFFFAOYSA-L 0.000 claims 1
- 150000002334 glycols Chemical class 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-M hydroxide Chemical compound [OH-] XLYOFNOQVPJJNP-UHFFFAOYSA-M 0.000 claims 1
- AGBQKNBQESQNJD-UHFFFAOYSA-M lipoate Chemical compound [O-]C(=O)CCCCC1CCSS1 AGBQKNBQESQNJD-UHFFFAOYSA-M 0.000 claims 1
- 235000019136 lipoic acid Nutrition 0.000 claims 1
- 229930182817 methionine Natural products 0.000 claims 1
- 229960004452 methionine Drugs 0.000 claims 1
- 235000006109 methionine Nutrition 0.000 claims 1
- 229910017464 nitrogen compound Inorganic materials 0.000 claims 1
- 150000002830 nitrogen compounds Chemical class 0.000 claims 1
- 125000002467 phosphate group Chemical class [H]OP(=O)(O[H])O[*] 0.000 claims 1
- 239000000473 propyl gallate Substances 0.000 claims 1
- 229940075579 propyl gallate Drugs 0.000 claims 1
- 235000010388 propyl gallate Nutrition 0.000 claims 1
- XWGJFPHUCFXLBL-UHFFFAOYSA-M rongalite Chemical compound [Na+].OCS([O-])=O XWGJFPHUCFXLBL-UHFFFAOYSA-M 0.000 claims 1
- 229960002663 thioctic acid Drugs 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261598729P | 2012-02-14 | 2012-02-14 | |
| US61/598,729 | 2012-02-14 | ||
| PCT/US2013/026187 WO2013123227A1 (en) | 2012-02-14 | 2013-02-14 | Formulations of bendamustine |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018010326A Division JP2018109005A (ja) | 2012-02-14 | 2018-01-25 | ベンダムスチン製剤 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2015506989A JP2015506989A (ja) | 2015-03-05 |
| JP2015506989A5 true JP2015506989A5 (cg-RX-API-DMAC7.html) | 2016-03-17 |
Family
ID=48946112
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014556835A Pending JP2015506989A (ja) | 2012-02-14 | 2013-02-14 | ベンダムスチン製剤 |
| JP2018010326A Pending JP2018109005A (ja) | 2012-02-14 | 2018-01-25 | ベンダムスチン製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018010326A Pending JP2018109005A (ja) | 2012-02-14 | 2018-01-25 | ベンダムスチン製剤 |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US20130210879A1 (cg-RX-API-DMAC7.html) |
| EP (1) | EP2814487A4 (cg-RX-API-DMAC7.html) |
| JP (2) | JP2015506989A (cg-RX-API-DMAC7.html) |
| CN (2) | CN104203235B (cg-RX-API-DMAC7.html) |
| CA (1) | CA2864118A1 (cg-RX-API-DMAC7.html) |
| WO (1) | WO2013123227A1 (cg-RX-API-DMAC7.html) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SMT201700043T1 (it) | 2010-01-28 | 2017-03-08 | Eagle Pharmaceuticals Inc | Formulazioni di bendamustina |
| US20230241218A1 (en) * | 2012-07-10 | 2023-08-03 | Eagle Pharmaceuticals, Inc. | Formulations of bendamustine |
| JP6250628B2 (ja) * | 2012-03-20 | 2017-12-20 | イーグル・ファーマシューティカルズ・インコーポレーテッド | ベンダムスチンの製剤 |
| CN104271135B (zh) | 2012-03-20 | 2017-05-17 | 赛多斯有限责任公司 | 在要求减少施用容量的患者中治疗苯达莫司汀响应性状况的方法 |
| EP3043648B1 (en) | 2013-08-27 | 2023-09-20 | Vasilios VOUDOURIS | Bendamustine pharmaceutical compositions |
| US9603930B2 (en) | 2014-12-04 | 2017-03-28 | Navinta, Llc | Liquid bendamustine formulation |
| JP2016141734A (ja) * | 2015-02-02 | 2016-08-08 | 三菱瓦斯化学株式会社 | ポリアセタール樹脂組成物及び成形体 |
| CN105726472B (zh) * | 2016-03-25 | 2019-12-13 | 南京康玻斯医药科技有限公司 | 苯达莫司汀药剂组合物及应用 |
| US11826466B2 (en) | 2016-08-31 | 2023-11-28 | Navinta, Llc | Bendamustine solution formulations |
| US10905677B2 (en) | 2016-08-31 | 2021-02-02 | Navinta, Llc | Bendamustine solution formulations |
| US10098862B1 (en) * | 2017-04-13 | 2018-10-16 | Onconova Therapeutics, Inc. | Formulations with enhanced stability and bioavailability for administration of (E)-2,6-dialkoxystyryl 4-substituted benzylsulfones |
| US11730815B2 (en) | 2018-11-26 | 2023-08-22 | Good Health, Llc | Stable liquid pharmaceutical compositions comprising bendamustine |
| JP2020090481A (ja) * | 2018-11-27 | 2020-06-11 | 日本化薬株式会社 | ベンダムスチンを含有する溶液製剤 |
| JP7235288B2 (ja) * | 2019-01-07 | 2023-03-08 | コーアイセイ株式会社 | ベンダムスチンの液体製剤 |
| CN110123747A (zh) * | 2019-04-26 | 2019-08-16 | 嘉兴市爵拓科技有限公司 | 苯达莫司汀的制剂 |
| CN111166722B (zh) * | 2019-12-07 | 2022-03-25 | 四川汇宇制药股份有限公司 | 一种注射用盐酸苯达莫司汀冻干前药液及其制备方法 |
| CN111557904A (zh) * | 2020-04-09 | 2020-08-21 | 比卡生物科技（广州）有限公司 | 苯达莫司汀组合物及其用途 |
| US11707450B1 (en) | 2022-03-03 | 2023-07-25 | Slayback Pharma Llc | Stable pharmaceutical compositions of bendamustine |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5223515A (en) * | 1988-08-18 | 1993-06-29 | Takeda Chemical Industries, Ltd. | Injectable solution containing a pyridyl methylsulfinylbenzimidazole |
| US8436190B2 (en) * | 2005-01-14 | 2013-05-07 | Cephalon, Inc. | Bendamustine pharmaceutical compositions |
| WO2007026771A1 (ja) * | 2005-08-31 | 2007-03-08 | Ono Pharmaceutical Co., Ltd. | 点滴用注射剤 |
| WO2008020584A1 (en) * | 2006-08-14 | 2008-02-21 | Eisai R & D Management Co., Ltd. | Stable lyophilized preparation |
| EP2073802A1 (en) * | 2006-10-12 | 2009-07-01 | Astex Therapeutics Limited | Pharmaceutical combinations |
| DE102007003184A1 (de) * | 2007-01-22 | 2008-07-24 | Orlowski, Michael, Dr. | Verfahren zur Beladung von strukturierten Oberflächen |
| CA2735899A1 (en) * | 2008-09-25 | 2010-04-01 | Cephalon, Inc. | Liquid formulations of bendamustine |
| 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 |
| SMT201700043T1 (it) * | 2010-01-28 | 2017-03-08 | Eagle Pharmaceuticals Inc | Formulazioni di bendamustina |
| JO3587B1 (ar) * | 2010-06-02 | 2020-07-05 | Astellas Deutschland Gmbh | أشكال جرعات بينداموستين عن طريق الفم |
| JP2013540104A (ja) * | 2010-07-28 | 2013-10-31 | イーグル・ファーマシューティカルズ・インコーポレーテッド | 延長された保存安定性を有するペメトレキセドを含有する医薬組成物 |
-
2013
- 2013-02-14 JP JP2014556835A patent/JP2015506989A/ja active Pending
- 2013-02-14 WO PCT/US2013/026187 patent/WO2013123227A1/en not_active Ceased
- 2013-02-14 CA CA2864118A patent/CA2864118A1/en not_active Abandoned
- 2013-02-14 EP EP13749829.1A patent/EP2814487A4/en not_active Withdrawn
- 2013-02-14 US US13/767,672 patent/US20130210879A1/en not_active Abandoned
- 2013-02-14 CN CN201380017489.7A patent/CN104203235B/zh not_active Expired - Fee Related
- 2013-02-14 CN CN201811307257.6A patent/CN109157535A/zh active Pending
-
2018
- 2018-01-25 JP JP2018010326A patent/JP2018109005A/ja active Pending
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