EA201891350A1 - MEDICINE BASED ON KLOFARABIN - Google Patents

MEDICINE BASED ON KLOFARABIN

Info

Publication number
EA201891350A1
EA201891350A1 EA201891350A EA201891350A EA201891350A1 EA 201891350 A1 EA201891350 A1 EA 201891350A1 EA 201891350 A EA201891350 A EA 201891350A EA 201891350 A EA201891350 A EA 201891350A EA 201891350 A1 EA201891350 A1 EA 201891350A1
Authority
EA
Eurasian Patent Office
Prior art keywords
concentrate
composition
drug
solution
clofarabine
Prior art date
Application number
EA201891350A
Other languages
Russian (ru)
Inventor
Т.В. Трухачева
Т.М. Ермоленко
С.А. Будкевич
А.Д. Мурашко
К.А. Фроленков
Е.И. Квасюк
Original Assignee
Ооо "Центр Фармацевтических Исследований"
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 Ооо "Центр Фармацевтических Исследований" filed Critical Ооо "Центр Фармацевтических Исследований"
Priority to EA201891350A priority Critical patent/EA201891350A1/en
Publication of EA201891350A1 publication Critical patent/EA201891350A1/en

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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7084—Compounds having two nucleosides or nucleotides, e.g. nicotinamide-adenine dinucleotide, flavine-adenine dinucleotide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/42—Phosphorus; Compounds thereof
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Настоящее изобретение относится к медицине и фармацевтической промышленности и описывает составы стабильных жидких лекарственных средств на основе клофарабина, предназначенных для лечения онкологических заболеваний, в том числе для лечения пациентов с рефрактерными формами или рецидивами острого лейкоза: 1) концентрат и 2) раствор, предназначенный для инфузионного введения. Лекарственное средство содержит клофарабин в концентрации 0,08-1,2 мг/мл, одно- или двухзамещенные фосфаты калия или натрия в концентрациях от 0,5 до 15,0 мг/мл, для обеспечения изотоничности лекарственного средства в состав может добавляться натрия хлорид в концентрации, достаточной для достижения осмотичности раствора в пределах 120-400 миллиосмолей. Корректировка pH в пределах 5,5-8,0 для всех предлагаемых составов композиции осуществляется добавлением гидроокиси щелочного металла или кислоты ортофосфорной. Предлагаемый состав концентрата лекарственного средства на основе клофарабина отличается повышенной стабильностью, улучшенной технологией приготовления готового лекарственного средства. Состав также позволяет получать средство, пригодное непосредственно для внутривенного инфузионного введения, следовательно, не требуется асептических условий, необходимых при приготовлении перфузионного раствора из концентрата и исключается возможность ошибки медперсонала при приготовлении раствора для инфузионного введения путем разведения концентрата.The present invention relates to medicine and the pharmaceutical industry and describes the compositions of stable liquid drugs based on clofarabine intended for the treatment of cancer, including for the treatment of patients with refractory forms or relapses of acute leukemia: 1) a concentrate and 2) a solution intended for infusion introduction. The drug contains clofarabine in a concentration of 0.08-1.2 mg / ml, one- or two-substituted potassium or sodium phosphates in concentrations from 0.5 to 15.0 mg / ml, sodium chloride can be added to the composition to ensure the isotonicity of the drug in a concentration sufficient to achieve osmoticity of the solution in the range of 120-400 milliosmoles. The pH adjustment in the range of 5.5-8.0 for all proposed compositions of the composition is carried out by adding alkali metal hydroxide or phosphoric acid. The proposed composition of the drug concentrate based on clofarabine is characterized by increased stability, improved technology for the preparation of the finished drug. The composition also allows you to get a tool suitable directly for intravenous infusion, therefore, the aseptic conditions necessary for the preparation of a perfusion solution from a concentrate are not required and the possibility of medical personnel error in preparing a solution for infusion administration by diluting the concentrate is excluded.

EA201891350A 2018-07-04 2018-07-04 MEDICINE BASED ON KLOFARABIN EA201891350A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EA201891350A EA201891350A1 (en) 2018-07-04 2018-07-04 MEDICINE BASED ON KLOFARABIN

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EA201891350A EA201891350A1 (en) 2018-07-04 2018-07-04 MEDICINE BASED ON KLOFARABIN

Publications (1)

Publication Number Publication Date
EA201891350A1 true EA201891350A1 (en) 2020-01-31

Family

ID=69374447

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201891350A EA201891350A1 (en) 2018-07-04 2018-07-04 MEDICINE BASED ON KLOFARABIN

Country Status (1)

Country Link
EA (1) EA201891350A1 (en)

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