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PE20110302A1 - Formulacion farmaceutica de un anticuerpo contra p-selectina - Google Patents

Formulacion farmaceutica de un anticuerpo contra p-selectina

Info

Publication number
PE20110302A1
PE20110302A1 PE2011000614A PE2011000614A PE20110302A1 PE 20110302 A1 PE20110302 A1 PE 20110302A1 PE 2011000614 A PE2011000614 A PE 2011000614A PE 2011000614 A PE2011000614 A PE 2011000614A PE 20110302 A1 PE20110302 A1 PE 20110302A1
Authority
PE
Peru
Prior art keywords
selectin
antibody against
pharmaceutical formulation
composition
amount
Prior art date
Application number
PE2011000614A
Other languages
English (en)
Inventor
Ulla Grauschopf
Hanns-Christian Mahler
Oliver Boris Stauch
Original Assignee
Hoffmann La Roche
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 Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of PE20110302A1 publication Critical patent/PE20110302A1/es

Links

Classifications

    • 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
    • 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
    • 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
    • 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • 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
    • A61P37/08Antiallergic 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
    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2851Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72
    • C07K16/2854Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72 against selectins, e.g. CD62
    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

SE REFIERE A UNA FORMULACION FARMACEUTICA QUE COMPRENDE: A) UN ANTICUERPO CONTRA P-SELECTINA TAL COMO huMAb-P-SELECTINA QUE SE ENCUENTRA EN UNA CANTIDAD DE 1 A 200 MG/ML EN LA COMPOSICION; B) UN REGULADOR DE PH TAL COMO HISTIDINA EN UNA CANTIDAD DE 1 A 100 mM; C) UN AGENTE TENSIOACTIVO TAL COMO POLISORBATO EN UNA CANTIDAD DE 0.001 A 1% DE LA COMPOSICION; Y D) DE 10 A 500 mM DE UN ESTABILIZADOR O DE 5 A 500 mM DE UN AGENTE DE TONICIDAD TAL COMO TREHALOSA. DICHA COMPOSICION ES UNA FORMULACION LIQUIDA O LIOFILIZADA QUE TIENE UN PH DE 4.0 A 7.0 SIENDO UTIL EN EL TRATAMIENTO DE ASMA O ALERGIA
PE2011000614A 2008-09-19 2009-09-09 Formulacion farmaceutica de un anticuerpo contra p-selectina PE20110302A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP08164746 2008-09-19

Publications (1)

Publication Number Publication Date
PE20110302A1 true PE20110302A1 (es) 2011-05-21

Family

ID=41231968

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2011000614A PE20110302A1 (es) 2008-09-19 2009-09-09 Formulacion farmaceutica de un anticuerpo contra p-selectina

Country Status (16)

Country Link
US (4) US20100074903A1 (es)
EP (1) EP2328559B1 (es)
JP (2) JP5524967B2 (es)
KR (2) KR20110047232A (es)
CN (1) CN102159194A (es)
AU (1) AU2009294680A1 (es)
BR (1) BRPI0918419A2 (es)
CA (1) CA2736198A1 (es)
CL (1) CL2011000561A1 (es)
ES (1) ES2531385T3 (es)
IL (1) IL211190A0 (es)
MX (1) MX2011002402A (es)
PE (1) PE20110302A1 (es)
SG (1) SG2014011365A (es)
WO (1) WO2010031720A2 (es)
ZA (1) ZA201101343B (es)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
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JPH07110370B2 (ja) 1986-08-13 1995-11-29 昭和アルミニウム株式会社 温度制御自在な押出機のコンテナ
JO3672B1 (ar) 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).
US9345661B2 (en) 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
AR078161A1 (es) 2009-09-11 2011-10-19 Hoffmann La Roche Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento.
US9795674B2 (en) 2010-02-26 2017-10-24 Novo Nordisk A/S Stable antibody containing compositions
CA2800188A1 (en) 2010-05-28 2011-12-01 Novo Nordisk A/S Stable multi-dose compositions comprising an antibody and a preservative
MY158130A (en) * 2010-10-06 2016-08-30 Regeneron Pharma Stabilized formulations containing anti-interleukin-4 receptor )il-4r) antibodies
PH12013501576A1 (en) 2011-01-28 2013-09-30 Sanofi Biotechnology Pharmaceutical compositions comprising human antibodies to pcsk9
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
HK1198689A1 (en) 2011-10-25 2015-05-29 Prothena Biosciences Limited Antibody formulations and methods
AR090244A1 (es) 2012-03-08 2014-10-29 Hoffmann La Roche Formulacion de anticuerpo anti-selectina p
EP2968538A1 (en) * 2013-03-15 2016-01-20 Bayer HealthCare LLC Anti-prolactin receptor antibody formulations
CN113350278B (zh) * 2013-10-24 2023-03-24 阿斯利康(瑞典)有限公司 稳定的水性抗体配制品
GB201403775D0 (en) 2014-03-04 2014-04-16 Kymab Ltd Antibodies, uses & methods
CA2995645A1 (en) 2015-08-18 2017-02-23 Regeneron Pharmaceuticals, Inc. Anti-pcsk9 inhibitory antibodies for treating patients with hyperlipidemia undergoing lipoprotein apheresis
EP4606820A3 (en) * 2015-11-30 2025-10-29 Medimmune, LLC Optimized ratios of amino acids and sugars as amorphous stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
WO2017132827A1 (en) * 2016-02-02 2017-08-10 Innovent Biologics (Suzhou) Co., Ltd. Pd-1 antibodies
WO2017220988A1 (en) 2016-06-20 2017-12-28 Kymab Limited Multispecific antibodies for immuno-oncology
EP3534947A1 (en) 2016-11-03 2019-09-11 Kymab Limited Antibodies, combinations comprising antibodies, biomarkers, uses & methods
CA3049857A1 (en) 2017-01-11 2018-07-19 Celltrion Inc. Stable liquid formulation
CR20210435A (es) 2019-02-18 2021-09-20 Lilly Co Eli Formulación de anticuerpos terapéuticos
CN116963775A (zh) * 2021-03-03 2023-10-27 爱乐科斯公司 抗siglec-8抗体制剂

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US5800815A (en) * 1903-05-05 1998-09-01 Cytel Corporation Antibodies to P-selectin and their uses
US4783399A (en) 1984-05-04 1988-11-08 Scripps Clinic And Research Foundation Diagnostic system for the detection of cytomegalovirus
EP0606391B1 (en) 1991-09-30 1998-08-05 Biogen, Inc. Inhibition of vascular narrowing using anti-padgem antibodies
DE69332881T2 (de) 1992-05-05 2004-01-29 Aeres Biomedical Ltd Antikörper gegen p-selectin und ihre verwendung
DE69810481T2 (de) * 1997-06-13 2003-09-25 Genentech Inc., San Francisco Stabilisierte antikörperformulierung
ATE556591T1 (de) 2001-11-08 2012-05-15 Abbott Biotherapeutics Corp Stabile pharmazeutische flüssigformulierung von igg-antikörpern
US8188231B2 (en) * 2002-09-27 2012-05-29 Xencor, Inc. Optimized FC variants
US7317091B2 (en) * 2002-03-01 2008-01-08 Xencor, Inc. Optimized Fc variants
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EP1865986B1 (en) * 2005-03-08 2016-02-17 Pfizer Products Inc. Anti-ctla-4 antibody compositions
KR20080098504A (ko) * 2006-02-03 2008-11-10 메디뮨 엘엘씨 단백질 제제
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AR064220A1 (es) * 2006-12-11 2009-03-18 Hoffmann La Roche Formulacion liofilizada mab abeta

Also Published As

Publication number Publication date
JP5524967B2 (ja) 2014-06-18
KR20110047232A (ko) 2011-05-06
EP2328559B1 (en) 2015-01-07
MX2011002402A (es) 2011-04-05
US20130209478A1 (en) 2013-08-15
WO2010031720A2 (en) 2010-03-25
JP2014094958A (ja) 2014-05-22
ES2531385T3 (es) 2015-03-13
AU2009294680A1 (en) 2010-03-25
KR20140019035A (ko) 2014-02-13
US20140093512A1 (en) 2014-04-03
EP2328559A2 (en) 2011-06-08
US20120321638A1 (en) 2012-12-20
US20100074903A1 (en) 2010-03-25
ZA201101343B (en) 2011-11-30
CN102159194A (zh) 2011-08-17
CL2011000561A1 (es) 2011-09-02
CA2736198A1 (en) 2010-03-25
JP2012502942A (ja) 2012-02-02
IL211190A0 (en) 2011-04-28
WO2010031720A3 (en) 2010-09-23
BRPI0918419A2 (pt) 2015-11-24
SG2014011365A (en) 2014-05-29

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