MX351706B - Estabilizacion de inmunoglobulinas a traves de una formulacion acuosa con histidina a ph acido debil a neutro. - Google Patents

Estabilizacion de inmunoglobulinas a traves de una formulacion acuosa con histidina a ph acido debil a neutro.

Info

Publication number
MX351706B
MX351706B MX2013003018A MX2013003018A MX351706B MX 351706 B MX351706 B MX 351706B MX 2013003018 A MX2013003018 A MX 2013003018A MX 2013003018 A MX2013003018 A MX 2013003018A MX 351706 B MX351706 B MX 351706B
Authority
MX
Mexico
Prior art keywords
neutral
immunoglobulins
histidine
stabilization
aqueous formulation
Prior art date
Application number
MX2013003018A
Other languages
English (en)
Other versions
MX2013003018A (es
Inventor
Schwarz Hans-Peter
Teschner * Wolfgang
Arno Butterweck Harald
Kölbl Bernhard
Hofbauer Lucia
Original Assignee
Baxalta Inc
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 Baxalta Inc filed Critical Baxalta Inc
Publication of MX2013003018A publication Critical patent/MX2013003018A/es
Publication of MX351706B publication Critical patent/MX351706B/es

Links

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
    • A61K9/08—Solutions
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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

Landscapes

  • 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)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (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)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

La presente invención se refiere a una composición acuosa de inmunoglobulina estable durante el almacenamiento, caracterizada porque comprende: (a) una inmunoglobulina; (b) de 100 mM a 500 mM de histidina; (c) de 0 mM a 10 mM de un catión de metal alcalino; y (d) un pH de 5.5 a 7.0, en donde la composición es estable durante al menos 6 meses cuando se almacena a partir de 28°C a 32°C, y en donde la composición se considera estable siempre y cuando el porcentaje de inmunoglobulina en el estado agregado se mantenga por debajo del 2%, y en donde la composición no contiene un tensioactivo o azúcar.
MX2013003018A 2010-09-17 2011-09-16 Estabilizacion de inmunoglobulinas a traves de una formulacion acuosa con histidina a ph acido debil a neutro. MX351706B (es)

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
MX2013003018A MX2013003018A (es) 2013-06-28
MX351706B true MX351706B (es) 2017-10-25

Family

ID=44721088

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2013003018A MX351706B (es) 2010-09-17 2011-09-16 Estabilizacion de inmunoglobulinas a traves de una formulacion acuosa con histidina a ph acido debil a neutro.

Country Status (23)

Country Link
US (4) US20120076779A1 (es)
EP (3) EP2616090B8 (es)
JP (4) JP6055412B2 (es)
KR (1) KR101879885B1 (es)
CN (2) CN103282042B (es)
AR (3) AR083035A1 (es)
AU (2) AU2011301803A1 (es)
BR (1) BR112013006308B1 (es)
CA (2) CA2810731A1 (es)
CL (1) CL2013000724A1 (es)
CO (1) CO6660498A2 (es)
DK (1) DK2616090T3 (es)
EA (2) EA032336B1 (es)
ES (1) ES2959479T3 (es)
FI (1) FI2616090T3 (es)
IL (1) IL225093B (es)
MX (1) MX351706B (es)
MY (1) MY188828A (es)
PL (1) PL2616090T3 (es)
PT (1) PT2616090T (es)
SG (1) SG188487A1 (es)
TW (2) TW201213342A (es)
WO (2) WO2012037530A1 (es)

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Also Published As

Publication number Publication date
CN104524566B (zh) 2018-08-07
MX2013003018A (es) 2013-06-28
CL2013000724A1 (es) 2014-03-21
TWI621625B (zh) 2018-04-21
US20120076779A1 (en) 2012-03-29
US20180250401A1 (en) 2018-09-06
JP6055412B2 (ja) 2016-12-27
CN103282042B (zh) 2014-12-10
SG188487A1 (en) 2013-05-31
FI2616090T3 (fi) 2023-09-21
JP2013544763A (ja) 2013-12-19
ES2959479T3 (es) 2024-02-26
AU2011301807A1 (en) 2013-03-28
JP2018203784A (ja) 2018-12-27
AR083035A1 (es) 2013-01-30
AR122552A2 (es) 2022-09-21
US20140370000A1 (en) 2014-12-18
EA201692397A1 (ru) 2017-08-31
KR101879885B1 (ko) 2018-07-18
TW201213342A (en) 2012-04-01
AU2011301803A1 (en) 2013-03-21
CN104524566A (zh) 2015-04-22
US20120076772A1 (en) 2012-03-29
EA032336B1 (ru) 2019-05-31
CA2810734A1 (en) 2012-03-22
US9855331B2 (en) 2018-01-02
MY188828A (en) 2022-01-06
AR083034A1 (es) 2013-01-30
BR112013006308B1 (pt) 2022-03-22
CA2810731A1 (en) 2012-03-22
BR112013006308A2 (pt) 2016-06-07
EP2616090A1 (en) 2013-07-24
EP4289445A3 (en) 2024-02-21
EA027353B1 (ru) 2017-07-31
KR20130099956A (ko) 2013-09-06
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DK2616090T3 (da) 2023-09-18
JP2013544762A (ja) 2013-12-19
PT2616090T (pt) 2023-10-16
JP2017071631A (ja) 2017-04-13
EP2616091A1 (en) 2013-07-24
AU2011301807B2 (en) 2015-07-30
CO6660498A2 (es) 2013-04-30
TW201217395A (en) 2012-05-01
CN103282042A (zh) 2013-09-04
AU2011301807C1 (en) 2016-02-11
EP2616090B8 (en) 2023-10-04
PL2616090T3 (pl) 2023-12-18
EA201390400A1 (ru) 2013-08-30
US8795658B2 (en) 2014-08-05
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EP2616090B1 (en) 2023-08-23

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