CA3108321A1 - Liquid bendamustine pharmaceutical compositions - Google Patents

Liquid bendamustine pharmaceutical compositions Download PDF

Info

Publication number
CA3108321A1
CA3108321A1 CA3108321A CA3108321A CA3108321A1 CA 3108321 A1 CA3108321 A1 CA 3108321A1 CA 3108321 A CA3108321 A CA 3108321A CA 3108321 A CA3108321 A CA 3108321A CA 3108321 A1 CA3108321 A1 CA 3108321A1
Authority
CA
Canada
Prior art keywords
pharmaceutical composition
bendamustine
water
amount
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.)
Pending
Application number
CA3108321A
Other languages
English (en)
French (fr)
Inventor
Andrew Malcolm Knill
Noel Norris
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.)
Hospira Australia Pty Ltd
Original Assignee
Hospira Australia Pty Ltd
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 Hospira Australia Pty Ltd filed Critical Hospira Australia Pty Ltd
Publication of CA3108321A1 publication Critical patent/CA3108321A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K47/06—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA3108321A 2018-08-17 2019-08-14 Liquid bendamustine pharmaceutical compositions Pending CA3108321A1 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201862764975P 2018-08-17 2018-08-17
US62/764,975 2018-08-17
US201862723725P 2018-08-28 2018-08-28
US62/723,725 2018-08-28
US201962815376P 2019-03-08 2019-03-08
US62/815,376 2019-03-08
PCT/IB2019/056903 WO2020035806A1 (en) 2018-08-17 2019-08-14 Liquid bendamustine pharmaceutical compositions

Publications (1)

Publication Number Publication Date
CA3108321A1 true CA3108321A1 (en) 2020-02-20

Family

ID=69525233

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3108321A Pending CA3108321A1 (en) 2018-08-17 2019-08-14 Liquid bendamustine pharmaceutical compositions

Country Status (7)

Country Link
US (1) US12246007B2 (https=)
EP (1) EP3836921B1 (https=)
JP (2) JP2021534253A (https=)
AU (1) AU2019321089A1 (https=)
CA (1) CA3108321A1 (https=)
ES (1) ES3055021T3 (https=)
WO (1) WO2020035806A1 (https=)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022508807A (ja) 2018-10-16 2022-01-19 ユーエス・ナノ・フード・アンド・ドラッグ・インコーポレーテッド 腫瘍内注射製剤
US11730815B2 (en) 2018-11-26 2023-08-22 Good Health, Llc Stable liquid pharmaceutical compositions comprising bendamustine
US11752165B2 (en) * 2020-04-13 2023-09-12 US Nano Food & Drug, Inc Basic chemotherapeutic intratumour injection formulation
CN121465991A (zh) * 2020-04-15 2026-02-06 卡希夫生物科学有限公司 卡非佐米的稳定的即稀释型制剂
GB202118175D0 (en) 2021-12-15 2022-01-26 Arecor Ltd Novel composition
US11707450B1 (en) * 2022-03-03 2023-07-25 Slayback Pharma Llc Stable pharmaceutical compositions of bendamustine
CN118415976A (zh) * 2024-05-09 2024-08-02 深圳开悦生命科技有限公司 多环化合物注射剂及其制备方法

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8436190B2 (en) 2005-01-14 2013-05-07 Cephalon, Inc. Bendamustine pharmaceutical compositions
AR072777A1 (es) 2008-03-26 2010-09-22 Cephalon Inc Formas solidas de clorhidrato de bendamustina
EP2326306A1 (en) 2008-09-25 2011-06-01 Cephalon, Inc. Liquid formulations of bendamustine
PL3158991T3 (pl) 2010-01-28 2021-09-27 Eagle Pharmaceuticals, Inc. Preparaty bendamustyny
US20130210878A1 (en) 2012-01-24 2013-08-15 Innopharma, Inc. Bendamustine compositions and methods therefore
CA2867295C (en) 2012-03-20 2020-08-11 Eagle Pharmaceuticals, Inc. Formulations of bendamustine
PL2827863T3 (pl) 2012-03-20 2019-07-31 Eagle Pharmaceuticals, Inc. Ciekła kompozycja do zastosowania w sposobie leczenia stanów reagujących na bendamustynę u pacjentów wymagających obniżonych objętości do podawania
US20160235717A1 (en) * 2013-10-11 2016-08-18 Luitpold Pharmaceuticals, Inc. Bendamustine pharmaceutical compositions
WO2016005995A2 (en) 2014-07-10 2016-01-14 Leiutis Pharmaceuticals Pvt. Ltd. Glycol free stable liquid compositions of bendamustine
WO2016059590A1 (en) 2014-10-16 2016-04-21 Piramal Enterprises Limited Stable injectable composition of small molecule drugs and process for its preparation
US9603930B2 (en) 2014-12-04 2017-03-28 Navinta, Llc Liquid bendamustine formulation
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
US20190151234A1 (en) * 2016-04-05 2019-05-23 Leiutis Pharmaceuticals Pvt. Ltd. Stable liquid pharmaceutical formulations of bendamustine
US10905677B2 (en) * 2016-08-31 2021-02-02 Navinta, Llc Bendamustine solution formulations

Also Published As

Publication number Publication date
EP3836921A1 (en) 2021-06-23
EP3836921C0 (en) 2025-10-08
EP3836921B1 (en) 2025-10-08
US12246007B2 (en) 2025-03-11
EP3836921A4 (en) 2022-04-20
JP2021534253A (ja) 2021-12-09
JP2024109878A (ja) 2024-08-14
US20210275500A1 (en) 2021-09-09
WO2020035806A1 (en) 2020-02-20
AU2019321089A1 (en) 2021-02-11
ES3055021T3 (en) 2026-02-09

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Effective date: 20210128