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RU2006101589A - Композиция для белкового фармацевтического препарата без добавления человеческого альбумина (hsa) - Google Patents

Композиция для белкового фармацевтического препарата без добавления человеческого альбумина (hsa) Download PDF

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Publication number
RU2006101589A
RU2006101589A RU2006101589/15A RU2006101589A RU2006101589A RU 2006101589 A RU2006101589 A RU 2006101589A RU 2006101589/15 A RU2006101589/15 A RU 2006101589/15A RU 2006101589 A RU2006101589 A RU 2006101589A RU 2006101589 A RU2006101589 A RU 2006101589A
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composition
composition according
asparagine
glutamine
specified
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RU2006101589/15A
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RU2354366C2 (ru
Inventor
Юрген ФРЕВЕРТ (DE)
Юрген ФРЕВЕРТ
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Биотекон Терапеутикс Гмбх (De)
Биотекон Терапеутикс Гмбх
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/05Dipeptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02Muscle relaxants, e.g. for tetanus or cramps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/08Antiepileptics; Anticonvulsants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Neurology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurosurgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (13)

1. Композиция, свободная от человеческого сывороточного альбумина, для стабилизации белковых агентов в фармацевтических препаратах, содержащая следующие компоненты:
а) поверхностно-активное вещество, предпочтительно неионный детергент (поверхностно-активное вещество); и
б) смесь по меньшей мере двух аминокислот, где указанные по меньшей мере две аминокислоты представляют собой либо глутаминовую кислоту (Glu) и глутамин (Gln), либо аспарагиновую кислоту (Asp) и аспарагин (Asn).
2. Композиция по п.1, дополнительно содержащая по меньшей мере один из следующих компонентов:
в) дисахарид, предпочтительно сахарозу (тростниковый сахар), трегалозу или лактозу;
г) этилендиаминтетрауксусную кислоту (ЭДТА), предпочтительно в форме одной из ее солей, такой как Na4-ЭДТА.
3. Композиция по п.1 или 2, содержащая компоненты (а), (б) и (в), компоненты (а), (б) и (г) или компоненты (а), (б), (в) и (г).
4. Композиция по п.1, где указанная композиция либо растворима в водных средах, либо представлена в виде водного раствора.
5. Фармацевтическая композиция, содержащая белковый агент и композицию для стабилизации по любому из пп.1-4.
6. Фармацевтическая композиция по п.5, где указанная фармацевтическая композиция присутствует в виде порошка сублимационной или вакуумной сушки, который растворим в водных средах.
7. Фармацевтическая композиция по п.5 или 6, где указанный белковый агент представляет собой коагулирующий фактор, такой как фактор VIII (антигемофильный глобулин), цитокин, такой как интерферон, в частности интерферон альфа, бета или гамма, фермент, такой как урокиназа или стрептокиназа, активатор плазминогена или сверхчистый нейротоксин и нейротоксиновый комплекс, соответственно, из Closthdium botulinum, в частности из Clostridium botulinum типа А или В.
8. Композиция для стабилизации по п.1 или фармацевтическая композиция по п.5, где указанные по меньшей мере две аминокислоты представляют собой (1) аспарагиновую кислоту, аспарагин, глутаминовую кислоту, (2) аспарагиновую кислоту, аспарагин, глутамин, (3) аспарагиновую кислоту, глутаминовую кислоту, глутамин, (4) аспарагин, глутаминовую кислоту, глутамин, или (5) аспарагиновую кислоту, аспарагин, глутаминовую кислоту и глутамин.
9. Композиция по п.8, где концентрации индивидуальных аминокислот составляют в каждом случае от 20 до 200 мМ, более предпочтительно от 20 до 100 мМ, в частности 50 мМ.
10. Композиция по п.8 или 9, где указанное поверхностно-активное вещество представляет собой неионный детергент.
11. Композиция по п.8, где указанный неионный детергент представляет собой полисорбат, такой как полисорбат 20 или полисорбат 80, или полоксамер, такой как полоксамер 184 или 188.
12. Композиция по п.8, где указанный дисахарид представляет собой сахарозу, трегалозу или лактозу.
13. Композиция по п.8, где рН указанной композиции в растворе имеет значение от 5,0 до 8,5, в частности от 6,0 до 8,0, предпочтительно от 6,0 до 7,0 и 6,5, соответственно.
RU2006101589/15A 2003-07-22 2004-07-22 Композиция для белкового фармацевтического препарата без добавления человеческого сывороточного альбумина (hsa) RU2354366C2 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10333317A DE10333317A1 (de) 2003-07-22 2003-07-22 Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
DE10333317.7 2003-07-22

Related Child Applications (1)

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RU2008147818/15A Division RU2491927C2 (ru) 2003-07-22 2004-07-22 Композиция для белкового фармацевтического препарата без добавления человеческого сывороточного альбумина (hsa)

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RU2006101589A true RU2006101589A (ru) 2006-09-10
RU2354366C2 RU2354366C2 (ru) 2009-05-10

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RU2006101589/15A RU2354366C2 (ru) 2003-07-22 2004-07-22 Композиция для белкового фармацевтического препарата без добавления человеческого сывороточного альбумина (hsa)

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US (1) US7829525B2 (ru)
EP (1) EP1648485B2 (ru)
JP (1) JP4912147B2 (ru)
KR (1) KR101176579B1 (ru)
CN (1) CN100450542C (ru)
AT (1) ATE506071T1 (ru)
AU (1) AU2004257391B2 (ru)
BR (1) BRPI0412241A (ru)
CA (1) CA2532475C (ru)
DE (2) DE10333317A1 (ru)
ES (1) ES2363600T5 (ru)
IL (1) IL172835A (ru)
NO (1) NO20060772L (ru)
RU (2) RU2491927C2 (ru)
WO (1) WO2005007185A2 (ru)

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EP1648485A2 (de) 2006-04-26
ATE506071T1 (de) 2011-05-15
CN100450542C (zh) 2009-01-14
RU2491927C2 (ru) 2013-09-10
CN1826132A (zh) 2006-08-30
EP1648485B2 (de) 2014-09-24
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EP1648485B1 (de) 2011-04-20
IL172835A0 (en) 2006-06-11
WO2005007185A3 (de) 2005-05-12
JP4912147B2 (ja) 2012-04-11
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KR20060031697A (ko) 2006-04-12
BRPI0412241A (pt) 2006-10-17
US7829525B2 (en) 2010-11-09
ES2363600T3 (es) 2011-08-10
US20070134199A1 (en) 2007-06-14
RU2354366C2 (ru) 2009-05-10
DE502004012418D1 (de) 2011-06-01
KR101176579B1 (ko) 2012-08-23
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