EA201800360A1 - METHOD FOR PRODUCING PHARMACEUTICAL COMPOSITION CONTAINING BENDAMUSTINE, PHARMACEUTICAL COMPOSITION OF BENDAMUSTIN - Google Patents

METHOD FOR PRODUCING PHARMACEUTICAL COMPOSITION CONTAINING BENDAMUSTINE, PHARMACEUTICAL COMPOSITION OF BENDAMUSTIN

Info

Publication number
EA201800360A1
EA201800360A1 EA201800360A EA201800360A EA201800360A1 EA 201800360 A1 EA201800360 A1 EA 201800360A1 EA 201800360 A EA201800360 A EA 201800360A EA 201800360 A EA201800360 A EA 201800360A EA 201800360 A1 EA201800360 A1 EA 201800360A1
Authority
EA
Eurasian Patent Office
Prior art keywords
pharmaceutical composition
bendamustin
composition containing
containing bendamustine
producing
Prior art date
Application number
EA201800360A
Other languages
Russian (ru)
Other versions
EA037673B1 (en
Inventor
Фернандо Прочазка
Эдгардо Кастанья
Эрнан Гомез
Original Assignee
Тютор С.А.С.И.Ф.И.А.
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 Тютор С.А.С.И.Ф.И.А. filed Critical Тютор С.А.С.И.Ф.И.А.
Priority to EA201800360A priority Critical patent/EA037673B1/en
Publication of EA201800360A1 publication Critical patent/EA201800360A1/en
Publication of EA037673B1 publication Critical patent/EA037673B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/02—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
    • 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
    • A61K9/14—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
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing

Landscapes

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

Abstract

В заявке описан способ получения фармацевтической композиции, содержащей в качестве действующего вещества бендамустина гидрохлорид, в форме лиофилизированного порошка для приготовления раствора для инъекций. Предпочтительно используют лиофилизированный порошок для приготовления раствора для инъекций во флаконах. Предложенный способ обеспечивает получение фармацевтической композиции с высокой стабильностью и низким содержанием примесей.The application describes a method for preparing a pharmaceutical composition containing bendamustine hydrochloride as an active ingredient in the form of a lyophilized powder for preparing a solution for injection. It is preferable to use a lyophilized powder for the preparation of solution for injection in vials. The proposed method provides a pharmaceutical composition with high stability and low content of impurities.

EA201800360A 2018-07-04 2018-07-04 Method of producing a pharmaceutical composition comprising bendamustine, pharmaceutical composition of bendamustine EA037673B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EA201800360A EA037673B1 (en) 2018-07-04 2018-07-04 Method of producing a pharmaceutical composition comprising bendamustine, pharmaceutical composition of bendamustine

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EA201800360A EA037673B1 (en) 2018-07-04 2018-07-04 Method of producing a pharmaceutical composition comprising bendamustine, pharmaceutical composition of bendamustine

Publications (2)

Publication Number Publication Date
EA201800360A1 true EA201800360A1 (en) 2020-01-31
EA037673B1 EA037673B1 (en) 2021-04-29

Family

ID=69374446

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201800360A EA037673B1 (en) 2018-07-04 2018-07-04 Method of producing a pharmaceutical composition comprising bendamustine, pharmaceutical composition of bendamustine

Country Status (1)

Country Link
EA (1) EA037673B1 (en)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR072777A1 (en) * 2008-03-26 2010-09-22 Cephalon Inc SOLID FORMS OF BENDAMUSTINE CHLORHYDRATE
WO2013102920A1 (en) * 2011-11-18 2013-07-11 Astron Research Limited Stable lyophilized formulation of bendamustine
WO2014170769A2 (en) * 2013-04-15 2014-10-23 Shilpa Medicare Limited Bendamustine lyophilized pharmaceutical compositions
ITMI20131013A1 (en) * 2013-06-19 2014-12-20 Chemi Spa LYOPHILIZED FORMULATIONS OF BENDAMUSTINA CHLORIDRATE

Also Published As

Publication number Publication date
EA037673B1 (en) 2021-04-29

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