CN104203235B - 苯达莫司汀的制剂 - Google Patents

苯达莫司汀的制剂 Download PDF

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Publication number
CN104203235B
CN104203235B CN201380017489.7A CN201380017489A CN104203235B CN 104203235 B CN104203235 B CN 104203235B CN 201380017489 A CN201380017489 A CN 201380017489A CN 104203235 B CN104203235 B CN 104203235B
Authority
CN
China
Prior art keywords
bendamustine
long
term storage
containing composition
stable
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.)
Expired - Fee Related
Application number
CN201380017489.7A
Other languages
English (en)
Chinese (zh)
Other versions
CN104203235A (zh
Inventor
纳格什·R·帕利普
菲利普·克里斯托夫·巴克斯顿
斯瑞坎斯·孙达拉姆
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Scidose LLC
Original Assignee
Eagle Pharmaceuticals Inc
Scidose LLC
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Eagle Pharmaceuticals Inc, Scidose LLC filed Critical Eagle Pharmaceuticals Inc
Priority to CN201811307257.6A priority Critical patent/CN109157535A/zh
Publication of CN104203235A publication Critical patent/CN104203235A/zh
Application granted granted Critical
Publication of CN104203235B publication Critical patent/CN104203235B/zh
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oncology (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CN201380017489.7A 2012-02-14 2013-02-14 苯达莫司汀的制剂 Expired - Fee Related CN104203235B (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201811307257.6A CN109157535A (zh) 2012-02-14 2013-02-14 苯达莫司汀的制剂

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
CN201811307257.6A Division CN109157535A (zh) 2012-02-14 2013-02-14 苯达莫司汀的制剂

Publications (2)

Publication Number Publication Date
CN104203235A CN104203235A (zh) 2014-12-10
CN104203235B true CN104203235B (zh) 2018-11-23

Family

ID=48946112

Family Applications (2)

Application Number Title Priority Date Filing Date
CN201811307257.6A Pending CN109157535A (zh) 2012-02-14 2013-02-14 苯达莫司汀的制剂
CN201380017489.7A Expired - Fee Related CN104203235B (zh) 2012-02-14 2013-02-14 苯达莫司汀的制剂

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CN201811307257.6A Pending CN109157535A (zh) 2012-02-14 2013-02-14 苯达莫司汀的制剂

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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE054836T2 (hu) 2010-01-28 2021-10-28 Eagle Pharmaceuticals Inc Bendamusztin kiszerelései
HRP20240056T1 (hr) * 2012-03-20 2024-03-29 Eagle Pharmaceuticals, Inc. Formulacije bendamustina
JP6224064B2 (ja) 2012-03-20 2017-11-01 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 低減された投与容量を必要とする患者におけるベンダムスチン応答性症状の治療方法
US20230241218A1 (en) * 2012-07-10 2023-08-03 Eagle Pharmaceuticals, Inc. Formulations of bendamustine
CN109953954A (zh) 2013-08-27 2019-07-02 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

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010036702A1 (en) * 2008-09-25 2010-04-01 Cephalon, Inc. Liquid formulations of bendamustine
WO2010126676A1 (en) * 2009-04-28 2010-11-04 Cephalon, Inc. Oral formulations of bendamustine

Family Cites Families (9)

* Cited by examiner, † Cited by third party
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
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
WO2008044029A1 (en) * 2006-10-12 2008-04-17 Astex Therapeutics Limited Pharmaceutical combinations
DE102007003184A1 (de) * 2007-01-22 2008-07-24 Orlowski, Michael, Dr. Verfahren zur Beladung von strukturierten Oberflächen
HUE054836T2 (hu) * 2010-01-28 2021-10-28 Eagle Pharmaceuticals Inc Bendamusztin kiszerelései
JP6209446B2 (ja) * 2010-06-02 2017-10-04 アステラス ドイチュランド ゲゼルシャフト ミット ベシュレンクテル ハフツング ベンダムスチンの経口投与形
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010036702A1 (en) * 2008-09-25 2010-04-01 Cephalon, Inc. Liquid formulations of bendamustine
WO2010126676A1 (en) * 2009-04-28 2010-11-04 Cephalon, Inc. Oral formulations of bendamustine

Also Published As

Publication number Publication date
JP2018109005A (ja) 2018-07-12
CN109157535A (zh) 2019-01-08
EP2814487A4 (en) 2015-07-15
CA2864118A1 (en) 2013-08-22
EP2814487A1 (en) 2014-12-24
JP2015506989A (ja) 2015-03-05
CN104203235A (zh) 2014-12-10
WO2013123227A1 (en) 2013-08-22
US20130210879A1 (en) 2013-08-15

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Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
ASS Succession or assignment of patent right

Owner name: SCIDOSE LLC

Free format text: FORMER OWNER: EAGLE PHARMACEUTICALS INC.

Effective date: 20150109

C41 Transfer of patent application or patent right or utility model
TA01 Transfer of patent application right

Effective date of registration: 20150109

Address after: The United States Massachusetts Saiai Moss City

Applicant after: SCIDOSE LLC

Address before: The United States of New Jersey Wudekelifu Lake

Applicant before: Eagle Pharmaceuticals, Inc.

C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant
CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20181123

CF01 Termination of patent right due to non-payment of annual fee