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 (enExample) | 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 (enExample) |
| EP (1) | EP2814487A4 (enExample) |
| JP (2) | JP2015506989A (enExample) |
| CN (2) | CN109157535A (enExample) |
| CA (1) | CA2864118A1 (enExample) |
| WO (1) | WO2013123227A1 (enExample) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2609106T5 (es) | 2010-01-28 | 2020-11-10 | Eagle Pharmaceuticals Inc | Formulaciones de bendamustina |
| US20230241218A1 (en) * | 2012-07-10 | 2023-08-03 | Eagle Pharmaceuticals, Inc. | Formulations of bendamustine |
| DK3533447T3 (da) | 2012-03-20 | 2023-04-24 | Eagle Pharmaceuticals Inc | Flydende bendamustinsammensætninger til anvendelse i fremgangsmåde til behandling af bendamustin-responsive tilstande hos patienter som kræver reducerede volumener til indgivelse |
| FI2827862T3 (fi) | 2012-03-20 | 2024-02-13 | Eagle Pharmaceuticals Inc | Bendamustiinin formulaatioita |
| CN105491886B (zh) | 2013-08-27 | 2019-01-29 | V·沃道里斯 | 苯达莫司汀医药组合物 |
| 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 |
| 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 |
| 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 |
| JPWO2007026771A1 (ja) * | 2005-08-31 | 2009-03-12 | 小野薬品工業株式会社 | 点滴用注射剤 |
| AU2007285215A1 (en) * | 2006-08-14 | 2008-02-21 | Eisai R & D Management Co., Ltd. | Stable lyophilized preparation |
| 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 |
| DE102007003184A1 (de) * | 2007-01-22 | 2008-07-24 | Orlowski, Michael, Dr. | Verfahren zur Beladung von strukturierten Oberflächen |
| WO2010036702A1 (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 |
| ES2609106T5 (es) * | 2010-01-28 | 2020-11-10 | Eagle Pharmaceuticals Inc | Formulaciones de bendamustina |
| CN103037851A (zh) * | 2010-06-02 | 2013-04-10 | 安斯泰来德国有限公司 | 苯达莫司汀的口服剂型 |
| US9655898B2 (en) * | 2010-07-28 | 2017-05-23 | Eagle Pharmaceuticals, Inc. | Pharmaceutical compositions containing pemetrexed having extended storage stability |
-
2013
- 2013-02-14 CN CN201811307257.6A patent/CN109157535A/zh 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 JP JP2014556835A patent/JP2015506989A/ja active Pending
- 2013-02-14 CN CN201380017489.7A patent/CN104203235B/zh not_active Expired - Fee Related
- 2013-02-14 US US13/767,672 patent/US20130210879A1/en not_active Abandoned
-
2018
- 2018-01-25 JP JP2018010326A patent/JP2018109005A/ja active Pending
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