WO2011103150A3 - Lyophilized preparations of bendamustine - Google Patents

Lyophilized preparations of bendamustine Download PDF

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Publication number
WO2011103150A3
WO2011103150A3 PCT/US2011/025031 US2011025031W WO2011103150A3 WO 2011103150 A3 WO2011103150 A3 WO 2011103150A3 US 2011025031 W US2011025031 W US 2011025031W WO 2011103150 A3 WO2011103150 A3 WO 2011103150A3
Authority
WO
WIPO (PCT)
Prior art keywords
bendamustine
lyophilized preparations
lyophilized
preparations
cyclodextrins
Prior art date
Application number
PCT/US2011/025031
Other languages
French (fr)
Other versions
WO2011103150A2 (en
Inventor
Michael L. Cappola
Piyush R. Patel
Original Assignee
Cephalon, Inc.
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 Cephalon, Inc. filed Critical Cephalon, Inc.
Publication of WO2011103150A2 publication Critical patent/WO2011103150A2/en
Publication of WO2011103150A3 publication Critical patent/WO2011103150A3/en

Links

Classifications

    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Lyophilized preparations comprising bendamustine, and pharmaceutically acceptable salts thereof, and cyclodextrins are described, as well as methods for their production and use.
PCT/US2011/025031 2010-02-18 2011-02-16 Lyophilized preparations of bendamustine WO2011103150A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US30581210P 2010-02-18 2010-02-18
US61/305,812 2010-02-18

Publications (2)

Publication Number Publication Date
WO2011103150A2 WO2011103150A2 (en) 2011-08-25
WO2011103150A3 true WO2011103150A3 (en) 2011-11-10

Family

ID=44462002

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2011/025031 WO2011103150A2 (en) 2010-02-18 2011-02-16 Lyophilized preparations of bendamustine

Country Status (1)

Country Link
WO (1) WO2011103150A2 (en)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2875374T3 (en) 2010-01-28 2021-11-10 Eagle Pharmaceuticals Inc Bendamustine formulations
US8383663B2 (en) * 2010-07-19 2013-02-26 Supratek Pharma Inc. Bendamustine anionic-catioinic cyclopolysaccharide compositions
WO2012103226A2 (en) * 2011-01-25 2012-08-02 Dr. Reddy's Laboratories Ltd. Bendamustine formulations
WO2013102920A1 (en) * 2011-11-18 2013-07-11 Astron Research Limited Stable lyophilized formulation of bendamustine
US9872873B2 (en) 2012-02-06 2018-01-23 Fresenius Kabi Oncology Limited Process for preparing stable pharmaceutical compositions of compounds susceptible to hydrolysis
CN104302291A (en) * 2012-03-20 2015-01-21 鹰制药股份有限公司 Formulations of bendamustine
US20230241218A1 (en) * 2012-07-10 2023-08-03 Eagle Pharmaceuticals, Inc. Formulations of bendamustine
PL2732811T3 (en) 2012-11-19 2016-05-31 Oncotec Pharma Produktion Gmbh Method for producing a freeze-dried compound
JP6571657B2 (en) 2013-08-27 2019-09-04 ボウドウリス バシリオス Pharmaceutical composition of bendamustine
CN106102722A (en) 2014-03-13 2016-11-09 V·沃道里斯 Bendamustine solid dispersion and continuous transfusion
US10300018B2 (en) 2015-07-22 2019-05-28 Nitto Denko Corporation Compositions and methods for nanoparticle lyophile forms
US10532102B2 (en) 2016-08-19 2020-01-14 Foresee Pharmaceuticals Co., Ltd. Pharmaceutical composition and methods of uses
EP3691637A1 (en) * 2017-10-05 2020-08-12 TUBE Pharmaceuticals GmbH Oral bendamustine formulations
US11730815B2 (en) 2018-11-26 2023-08-22 Good Health, Llc Stable liquid pharmaceutical compositions comprising bendamustine

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006076620A2 (en) * 2005-01-14 2006-07-20 Cephalon, Inc. Bendamustine pharmaceutical compositions for lyophilisation
WO2010036702A1 (en) * 2008-09-25 2010-04-01 Cephalon, Inc. Liquid formulations of bendamustine
WO2010097700A1 (en) * 2009-02-25 2010-09-02 Supratek Pharma, Inc. Bendamustine cyclopolysaccharide compositions

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5002935A (en) 1987-12-30 1991-03-26 University Of Florida Improvements in redox systems for brain-targeted drug delivery
CA2013485C (en) 1990-03-06 1997-04-22 John Michael Gardlik Solid consumer product compositions containing small particle cyclodextrin complexes
US5874418A (en) 1997-05-05 1999-02-23 Cydex, Inc. Sulfoalkyl ether cyclodextrin based solid pharmaceutical formulations and their use

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006076620A2 (en) * 2005-01-14 2006-07-20 Cephalon, Inc. Bendamustine pharmaceutical compositions for lyophilisation
WO2010036702A1 (en) * 2008-09-25 2010-04-01 Cephalon, Inc. Liquid formulations of bendamustine
WO2010097700A1 (en) * 2009-02-25 2010-09-02 Supratek Pharma, Inc. Bendamustine cyclopolysaccharide compositions

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
RIBOSEPHARM: "Product monograph ribosepharm passage", PRODUCT MONOGRAPH RIBOSEPHARM, XX, XX, 1 January 2005 (2005-01-01), pages 3 - 73, XP002368437 *

Also Published As

Publication number Publication date
WO2011103150A2 (en) 2011-08-25

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