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EA201390400A1 - СТАБИЛИЗАЦИЯ ИММУНОГЛОБУЛИНОВ С ПОМОЩЬЮ ВОДНОГО СОСТАВА С ГИСТИДИНОМ ПРИ pH ОТ СЛАБОКИСЛОГО ДО НЕЙТРАЛЬНОГО - Google Patents

СТАБИЛИЗАЦИЯ ИММУНОГЛОБУЛИНОВ С ПОМОЩЬЮ ВОДНОГО СОСТАВА С ГИСТИДИНОМ ПРИ pH ОТ СЛАБОКИСЛОГО ДО НЕЙТРАЛЬНОГО

Info

Publication number
EA201390400A1
EA201390400A1 EA201390400A EA201390400A EA201390400A1 EA 201390400 A1 EA201390400 A1 EA 201390400A1 EA 201390400 A EA201390400 A EA 201390400A EA 201390400 A EA201390400 A EA 201390400A EA 201390400 A1 EA201390400 A1 EA 201390400A1
Authority
EA
Eurasian Patent Office
Prior art keywords
neutral
immunohlobulins
hystidine
stabilization
help
Prior art date
Application number
EA201390400A
Other languages
English (en)
Other versions
EA027353B1 (ru
Inventor
Харальд Арно Буттервек
Бернхард Кельбль
Лючия Хофбауэр
Вольфганг Тешнер
Ханс-Петер Шварце
Original Assignee
Бакстер Интернэшнл Инк.
Бакстер Хелткэр С.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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=44721088&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA201390400(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Бакстер Интернэшнл Инк., Бакстер Хелткэр С.А. filed Critical Бакстер Интернэшнл Инк.
Publication of EA201390400A1 publication Critical patent/EA201390400A1/ru
Publication of EA027353B1 publication Critical patent/EA027353B1/ru

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/14Alkali metal chlorides; Alkaline earth metal chlorides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • 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
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

В настоящем изобретении предложены наряду с другими аспектами стабильные при хранении водные составы иммуноглобулинов с гистидином при рН в диапазоне от слабокислого до нейтрального. В настоящем изобретении также предложены способы стабилизации иммуноглобулиновых композиций путем приготовления их с гистидином при рН в диапазоне от слабокислого до нейтрального. Преимущественно способы и составы, описанные в настоящей заявке, позволяют получить стабильные водные композиции иммуноглобулинов при рН в диапазоне от слабокислого до нейтрального, подходящие для парентерального введения.
EA201390400A 2010-09-17 2011-09-16 СТАБИЛИЗАЦИЯ ИММУНОГЛОБУЛИНОВ С ПОМОЩЬЮ ВОДНОГО СОСТАВА С ГИСТИДИНОМ ПРИ pH ОТ СЛАБОКИСЛОГО ДО НЕЙТРАЛЬНОГО EA027353B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US38420910P 2010-09-17 2010-09-17
PCT/US2011/052053 WO2012037534A1 (en) 2010-09-17 2011-09-16 Stabilization of immunoglobulins through aqueous formulation with histidine at weak acidic to neutral ph

Publications (2)

Publication Number Publication Date
EA201390400A1 true EA201390400A1 (ru) 2013-08-30
EA027353B1 EA027353B1 (ru) 2017-07-31

Family

ID=44721088

Family Applications (2)

Application Number Title Priority Date Filing Date
EA201390400A EA027353B1 (ru) 2010-09-17 2011-09-16 СТАБИЛИЗАЦИЯ ИММУНОГЛОБУЛИНОВ С ПОМОЩЬЮ ВОДНОГО СОСТАВА С ГИСТИДИНОМ ПРИ pH ОТ СЛАБОКИСЛОГО ДО НЕЙТРАЛЬНОГО
EA201692397A EA032336B1 (ru) 2010-09-17 2011-09-16 Стабильная водная иммуноглобулиновая композиция и способ стабилизации иммуноглобулиновой композиции

Family Applications After (1)

Application Number Title Priority Date Filing Date
EA201692397A EA032336B1 (ru) 2010-09-17 2011-09-16 Стабильная водная иммуноглобулиновая композиция и способ стабилизации иммуноглобулиновой композиции

Country Status (23)

Country Link
US (4) US20120076779A1 (ru)
EP (3) EP4289445A3 (ru)
JP (4) JP6055412B2 (ru)
KR (1) KR101879885B1 (ru)
CN (2) CN104524566B (ru)
AR (3) AR083034A1 (ru)
AU (2) AU2011301803A1 (ru)
BR (1) BR112013006308B1 (ru)
CA (2) CA2810731A1 (ru)
CL (1) CL2013000724A1 (ru)
CO (1) CO6660498A2 (ru)
DK (1) DK2616090T3 (ru)
EA (2) EA027353B1 (ru)
ES (1) ES2959479T3 (ru)
FI (1) FI2616090T3 (ru)
IL (1) IL225093B (ru)
MX (1) MX351706B (ru)
MY (1) MY188828A (ru)
PL (1) PL2616090T3 (ru)
PT (1) PT2616090T (ru)
SG (1) SG188487A1 (ru)
TW (2) TWI621625B (ru)
WO (2) WO2012037534A1 (ru)

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EA201692397A1 (ru) 2017-08-31
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IL225093B (en) 2018-05-31
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EP2616090B1 (en) 2023-08-23
CO6660498A2 (es) 2013-04-30
JP2018203784A (ja) 2018-12-27
EA032336B1 (ru) 2019-05-31
CN104524566B (zh) 2018-08-07
CN104524566A (zh) 2015-04-22
US8795658B2 (en) 2014-08-05
TW201213342A (en) 2012-04-01
AR083035A1 (es) 2013-01-30
KR20130099956A (ko) 2013-09-06
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EP4289445A3 (en) 2024-02-21
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