DK2616090T3 - Stabilisering af immunoglobuliner gennem vandig formulering med histidin ved svag syre til neutral ph - Google Patents

Stabilisering af immunoglobuliner gennem vandig formulering med histidin ved svag syre til neutral ph Download PDF

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Publication number
DK2616090T3
DK2616090T3 DK11764040.9T DK11764040T DK2616090T3 DK 2616090 T3 DK2616090 T3 DK 2616090T3 DK 11764040 T DK11764040 T DK 11764040T DK 2616090 T3 DK2616090 T3 DK 2616090T3
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Denmark
Prior art keywords
immunoglobulins
histidine
stabilization
neutral
weak acid
Prior art date
Application number
DK11764040.9T
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English (en)
Inventor
Harald Arno Butterweck
Bernhard Kölbl
Wolfgang Teschner
Hans-Peter Schwarz
Lucia Gnauer
Original Assignee
Takeda Pharmaceuticals Co
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Application filed by Takeda Pharmaceuticals Co filed Critical Takeda Pharmaceuticals Co
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Publication of DK2616090T3 publication Critical patent/DK2616090T3/da

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (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)
DK11764040.9T 2010-09-17 2011-09-16 Stabilisering af immunoglobuliner gennem vandig formulering med histidin ved svag syre til neutral ph DK2616090T3 (da)

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 (1)

Publication Number Publication Date
DK2616090T3 true DK2616090T3 (da) 2023-09-18

Family

ID=44721088

Family Applications (1)

Application Number Title Priority Date Filing Date
DK11764040.9T DK2616090T3 (da) 2010-09-17 2011-09-16 Stabilisering af immunoglobuliner gennem vandig formulering med histidin ved svag syre til neutral ph

Country Status (23)

Country Link
US (4) US8795658B2 (da)
EP (3) EP4289445A3 (da)
JP (4) JP2013544762A (da)
KR (1) KR101879885B1 (da)
CN (2) CN103282042B (da)
AR (3) AR083034A1 (da)
AU (2) AU2011301803A1 (da)
BR (1) BR112013006308B1 (da)
CA (2) CA2810734A1 (da)
CL (1) CL2013000724A1 (da)
CO (1) CO6660498A2 (da)
DK (1) DK2616090T3 (da)
EA (2) EA027353B1 (da)
ES (1) ES2959479T3 (da)
FI (1) FI2616090T3 (da)
IL (1) IL225093B (da)
MX (1) MX351706B (da)
MY (1) MY188828A (da)
PL (1) PL2616090T3 (da)
PT (1) PT2616090T (da)
SG (1) SG188487A1 (da)
TW (2) TW201213342A (da)
WO (2) WO2012037530A1 (da)

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PL2616090T3 (pl) 2010-09-17 2023-12-18 Takeda Pharmaceutical Company Limited Stabilizowanie immunoglobulin poprzez wodną formulację z histydyną o ph od słabo kwaśnego do obojętnego

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Publication number Publication date
CN104524566A (zh) 2015-04-22
PT2616090T (pt) 2023-10-16
US20180250401A1 (en) 2018-09-06
JP2017071631A (ja) 2017-04-13
EA027353B1 (ru) 2017-07-31
CO6660498A2 (es) 2013-04-30
EP2616090B1 (en) 2023-08-23
AU2011301807C1 (en) 2016-02-11
IL225093B (en) 2018-05-31
CA2810731A1 (en) 2012-03-22
US20120076779A1 (en) 2012-03-29
MX351706B (es) 2017-10-25
AR083035A1 (es) 2013-01-30
US8795658B2 (en) 2014-08-05
CL2013000724A1 (es) 2014-03-21
US20120076772A1 (en) 2012-03-29
JP2018203784A (ja) 2018-12-27
US9855331B2 (en) 2018-01-02
WO2012037534A1 (en) 2012-03-22
TWI621625B (zh) 2018-04-21
CN103282042A (zh) 2013-09-04
BR112013006308B1 (pt) 2022-03-22
WO2012037530A1 (en) 2012-03-22
TW201217395A (en) 2012-05-01
AU2011301803A1 (en) 2013-03-21
MX2013003018A (es) 2013-06-28
PL2616090T3 (pl) 2023-12-18
JP2013544762A (ja) 2013-12-19
CN104524566B (zh) 2018-08-07
MY188828A (en) 2022-01-06
TW201213342A (en) 2012-04-01
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EA201390400A1 (ru) 2013-08-30
JP6055412B2 (ja) 2016-12-27
EA032336B1 (ru) 2019-05-31
EP2616090A1 (en) 2013-07-24
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AU2011301807B2 (en) 2015-07-30
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US20140370000A1 (en) 2014-12-18
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CA2810734A1 (en) 2012-03-22
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EP4289445A3 (en) 2024-02-21
FI2616090T3 (fi) 2023-09-21
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BR112013006308A2 (pt) 2016-06-07
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