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AR093297A1 - Formulacion liquida que comprende un compuesto neutralizante de gm-csf - Google Patents

Formulacion liquida que comprende un compuesto neutralizante de gm-csf

Info

Publication number
AR093297A1
AR093297A1 ARP130103964A ARP130103964A AR093297A1 AR 093297 A1 AR093297 A1 AR 093297A1 AR P130103964 A ARP130103964 A AR P130103964A AR P130103964 A ARP130103964 A AR P130103964A AR 093297 A1 AR093297 A1 AR 093297A1
Authority
AR
Argentina
Prior art keywords
neutralizing compound
csf neutralizing
composition according
formulation
buffer
Prior art date
Application number
ARP130103964A
Other languages
English (en)
Inventor
Molhoj Michael
Steinhilber Wolfram
Boehm Thomas
Urbig Thomas
Original Assignee
Amgen Res (Munich) Gmbh
Takeda Gmbh
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 Amgen Res (Munich) Gmbh, Takeda Gmbh filed Critical Amgen Res (Munich) Gmbh
Publication of AR093297A1 publication Critical patent/AR093297A1/es

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
    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • 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
    • A61K47/06Organic 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
    • 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
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/243Colony Stimulating Factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Pulmonology (AREA)
  • Endocrinology (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Formulaciones acuosas que comprenden un compuesto neutralizante de GM-CSF en concentraciones de al menos aproximadamente 20 mg/ml, un modificador de la tonicidad y un buffer, en donde la composición es estable. Los ingredientes de la formulación preferiblemente proveen estabilidad al compuesto neutralizante de GM-CSF en vista del almacenamiento a largo plazo. En un aspecto preferido, la formulación es para uso en terapia, preferiblemente para uso en el tratamiento de trastornos inflamatorios y autoinmunes, incluyendo preferiblemente trastornos alérgicos y psoriáticos, así como también trastornos artríticos y asmáticos. Adicionalmente, se provee un kit que comprende la formulación. Reivindicación 3: La composición de acuerdo con la reivindicación 1 ó 2, en donde el modificador de la tonicidad está seleccionado a partir de manitol, sorbitol, sacarosa y/o trehalosa. Reivindicación 4: La composición de acuerdo con una cualquiera de las reivindicaciones 1 a 3, en donde el buffer está seleccionado a partir de buffer de histidina, de acetato y/o de citrato. Reivindicación 9: La composición de acuerdo con una cualquiera de las reivindicaciones 1 a 8, en donde el compuesto neutralizante de GM-CSF está seleccionado a partir del grupo que consiste de un polipéptido, un péptido mimético, un ácido nucleico, y una molécula pequeña.
ARP130103964A 2012-10-31 2013-10-30 Formulacion liquida que comprende un compuesto neutralizante de gm-csf AR093297A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261720892P 2012-10-31 2012-10-31
EP12199191 2012-12-21

Publications (1)

Publication Number Publication Date
AR093297A1 true AR093297A1 (es) 2015-05-27

Family

ID=47504727

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP130103964A AR093297A1 (es) 2012-10-31 2013-10-30 Formulacion liquida que comprende un compuesto neutralizante de gm-csf

Country Status (15)

Country Link
US (2) US9919051B2 (es)
EP (2) EP2914290B1 (es)
JP (1) JP6346189B2 (es)
KR (1) KR102106914B1 (es)
CN (1) CN104768580B (es)
AR (1) AR093297A1 (es)
AU (1) AU2013340845B2 (es)
BR (1) BR112015009259B8 (es)
CA (1) CA2889307C (es)
EA (1) EA032829B1 (es)
HK (1) HK1214761A1 (es)
MX (1) MX363807B (es)
PH (1) PH12015500864A1 (es)
TW (1) TWI639440B (es)
WO (1) WO2014068026A1 (es)

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KR20220045064A (ko) 2013-08-30 2022-04-12 다케다 야쿠힌 고교 가부시키가이샤 류마티스성 관절염의 치료에서 또는 진통제로서 사용하기 위한 gm-csf 중화 항체
AR100268A1 (es) * 2014-05-07 2016-09-21 Takeda Gmbh Formulación líquida que comprende compuesto neutralizante de gm-csf
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Also Published As

Publication number Publication date
HK1214761A1 (zh) 2016-08-05
CA2889307C (en) 2021-11-23
US9919051B2 (en) 2018-03-20
CN104768580B (zh) 2018-11-02
PH12015500864B1 (en) 2015-06-22
MX2015005237A (es) 2015-10-29
JP2015536931A (ja) 2015-12-24
BR112015009259A2 (es) 2017-08-22
EA201590509A1 (ru) 2015-10-30
EP2914290B1 (en) 2020-04-01
EP3744344A1 (en) 2020-12-02
AU2013340845B2 (en) 2018-02-22
MX363807B (es) 2019-04-03
US20180207278A1 (en) 2018-07-26
BR112015009259B8 (pt) 2022-08-23
AU2013340845A1 (en) 2015-03-26
US20150314001A1 (en) 2015-11-05
US10758621B2 (en) 2020-09-01
BR112015009259B1 (pt) 2022-05-17
PH12015500864A1 (en) 2015-06-22
CN104768580A (zh) 2015-07-08
KR102106914B1 (ko) 2020-05-08
KR20150075083A (ko) 2015-07-02
EA032829B1 (ru) 2019-07-31
EP2914290A1 (en) 2015-09-09
TW201438735A (zh) 2014-10-16
TWI639440B (zh) 2018-11-01
CA2889307A1 (en) 2014-05-08
WO2014068026A1 (en) 2014-05-08
JP6346189B2 (ja) 2018-06-20

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