RU2006110563A - PHARMACEUTICAL COMPOSITION, METHOD OF ITS PRODUCTION AND THERAPEUTIC APPLICATION - Google Patents

PHARMACEUTICAL COMPOSITION, METHOD OF ITS PRODUCTION AND THERAPEUTIC APPLICATION Download PDF

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Publication number
RU2006110563A
RU2006110563A RU2006110563/15A RU2006110563A RU2006110563A RU 2006110563 A RU2006110563 A RU 2006110563A RU 2006110563/15 A RU2006110563/15 A RU 2006110563/15A RU 2006110563 A RU2006110563 A RU 2006110563A RU 2006110563 A RU2006110563 A RU 2006110563A
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RU
Russia
Prior art keywords
animal origin
pharmaceutical composition
oxaliplatin
sugar
alcohol
Prior art date
Application number
RU2006110563/15A
Other languages
Russian (ru)
Other versions
RU2329052C2 (en
Inventor
Борек ЗАЛУДЕК (CZ)
Борек Залудек
Ян БОЛЕСЛАВ (CZ)
Ян БОЛЕСЛАВ
Владимир КИСИЛЬКА (CZ)
Владимир Кисилька
Иржи ВЕРНЕР (CZ)
Иржи ВЕРНЕР
Гана БРЗОБОГАТА (CZ)
Гана БРЗОБОГАТА
Божена МАТЕЙКОВА (CZ)
Божена МАТЕЙКОВА
Милан КАКРДА (CZ)
Милан КАКРДА
Original Assignee
Плива-Лахема А.С. (Cz)
Плива-Лахема А.С.
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 Плива-Лахема А.С. (Cz), Плива-Лахема А.С. filed Critical Плива-Лахема А.С. (Cz)
Publication of RU2006110563A publication Critical patent/RU2006110563A/en
Application granted granted Critical
Publication of RU2329052C2 publication Critical patent/RU2329052C2/en

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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
    • A61K9/0012—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Claims (5)

1. Фармацевтическая композиция, полученная сублимационной сушкой в вакууме, содержащая оксалиплатин в качестве активного компонента, и фармацевтически приемлемый носитель, характеризующаяся тем, что носителем является по меньшей мере один спиртовой сахар неживотного происхождения, причем массовое отношение оксалиплатина к спиртовому сахару неживотного происхождения или спиртовым сахарам неживотного происхождения составляет от 1:3 до 1:7.1. The pharmaceutical composition obtained by freeze-drying in vacuum, containing oxaliplatin as an active ingredient, and a pharmaceutically acceptable carrier, characterized in that the carrier is at least one alcohol sugar of non-animal origin, and the mass ratio of oxaliplatin to alcohol sugar of non-animal origin or alcohol sugars non-animal origin ranges from 1: 3 to 1: 7. 2. Фармацевтическая композиция по п.1, характеризующаяся тем, что она содержит оксалиплатин и спиртовой сахар неживотного происхождения или спиртовые сахара неживотного происхождения в массовом соотношении 1:5.2. The pharmaceutical composition according to claim 1, characterized in that it contains oxaliplatin and alcohol sugar of non-animal origin or alcohol sugar of non-animal origin in a mass ratio of 1: 5. 3. Фармацевтическая композиция по п.1 или 2, характеризующаяся тем, что спиртовым сахаром неживотного происхождения является маннит.3. The pharmaceutical composition according to claim 1 or 2, characterized in that the alcohol sugar of non-animal origin is mannitol. 4. Способ получения фармацевтической композиции по п.1, характеризующийся тем, что стерильный водный раствор оксалиплатина и по меньшей мере одного спиртового сахара неживотного происхождения, содержащий оксалиплатин и спиртовой сахар неживотного происхождения или спиртовые сахара неживотного происхождения в массовом отношении от 1:3 до 1:7 при общей концентрации упомянутых соединений от 2,8 до 3,2 мас.%, вводят в сосуд в объеме, равном не более чем 60% доступного объема сосуда, после чего содержимое сосуда охлаждают до 2-8°С, затем замораживают при линейном снижении температуры 0,1-0,5°С/мин до конечной температуры от -35 до -45°С, оставляют при этой температуре в течение 1-6 ч и затем подвергают сублимационной сушке в вакууме.4. The method of obtaining the pharmaceutical composition according to claim 1, characterized in that a sterile aqueous solution of oxaliplatin and at least one alcoholic sugar of non-animal origin, containing oxaliplatin and alcohol sugar of non-animal origin or alcohol sugar of non-animal origin in a mass ratio of from 1: 3 to 1 : 7 at a total concentration of the compounds of 2.8 to 3.2 wt.%, Injected into the vessel in a volume equal to not more than 60% of the available volume of the vessel, after which the contents of the vessel are cooled to 2-8 ° C, then frozen When the linear temperature decrease 0,1-0,5 ° C / min to a final temperature of -35 to -45 ° C, left at this temperature for 1-6 hours and then freeze-dried in vacuo. 5. Применение фармацевтической композиции по пп.1-3 для лечения опухолей, чувствительных к оксалиплатину.5. The use of the pharmaceutical composition according to claims 1-3 for the treatment of tumors sensitive to oxaliplatin.
RU2006110563/15A 2003-09-02 2004-08-31 Pharmaceutical composition, production method and therapeutic application RU2329052C2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CZPV2003-2367 2003-09-02
CZ20032367A CZ300795B6 (en) 2003-09-02 2003-09-02 Pharmaceutical composition and process for its preparation

Publications (2)

Publication Number Publication Date
RU2006110563A true RU2006110563A (en) 2006-08-10
RU2329052C2 RU2329052C2 (en) 2008-07-20

Family

ID=34256928

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2006110563/15A RU2329052C2 (en) 2003-09-02 2004-08-31 Pharmaceutical composition, production method and therapeutic application

Country Status (6)

Country Link
EP (1) EP1663106A2 (en)
CA (1) CA2537610A1 (en)
CZ (1) CZ300795B6 (en)
PL (1) PL366975A1 (en)
RU (1) RU2329052C2 (en)
WO (1) WO2005020876A2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2009007801A (en) * 2007-01-22 2009-10-08 Pliva Lachema As Oxaliplatin pharmaceutical composition with alcoholic sugar-based buffer.
CZ300664B6 (en) * 2007-01-22 2009-07-15 Pliva-Lachema A. S. Sterile liquid pharmaceutical composition and process for preparing thereof

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU5416394A (en) * 1992-11-24 1994-06-22 Debiopharm S.A. Cisplatinum/oxaliplatinum combination
GB9804013D0 (en) * 1998-02-25 1998-04-22 Sanofi Sa Formulations
ES2206288T3 (en) * 1999-08-30 2004-05-16 Debiopharm S.A. STABLE PHARMACEUTICAL PREPARATION OF OXYLIPLATINE FOR PARENTERAL ADMINISTRATION.
DE10314377A1 (en) * 2003-03-28 2004-10-07 Stada Arzneimittel Ag Pharmaceutical composition useful for tumor therapy comprises water, oxaliplatin and an acid other than oxalic acid

Also Published As

Publication number Publication date
WO2005020876A2 (en) 2005-03-10
CZ300795B6 (en) 2009-08-12
PL366975A1 (en) 2005-03-07
WO2005020876A3 (en) 2005-06-09
CZ20032367A3 (en) 2005-04-13
EP1663106A2 (en) 2006-06-07
CA2537610A1 (en) 2005-03-10
RU2329052C2 (en) 2008-07-20

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Effective date: 20110713