UY36542A - Formulaciones farmacéuticas para anticuerpos anti-tnf-alfa - Google Patents

Formulaciones farmacéuticas para anticuerpos anti-tnf-alfa

Info

Publication number
UY36542A
UY36542A UY0001036542A UY36542A UY36542A UY 36542 A UY36542 A UY 36542A UY 0001036542 A UY0001036542 A UY 0001036542A UY 36542 A UY36542 A UY 36542A UY 36542 A UY36542 A UY 36542A
Authority
UY
Uruguay
Prior art keywords
citrate
acetate
tnf
pharmaceutical formulations
disaccharide
Prior art date
Application number
UY0001036542A
Other languages
English (en)
Inventor
Bañado Carlos
Bes Cédric
Mcgarvey Orla
Original Assignee
Mabxience S A
Mabxience Res S L
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 Mabxience S A, Mabxience Res S L filed Critical Mabxience S A
Publication of UY36542A publication Critical patent/UY36542A/es

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Composiciones acuosas estables de almacenamiento a largo plazo de: - anticuerpos contra factor de necrosis tumoral alfa (anti-TNFa (alfa)) - tampón acetato, citrato o citrato-acetato; y - excipiente, disacárido, poliol o combinación de los mismos; cuando la solución tampón comprende o consiste en acetato, comprende un disacárido a una concentración menor a 240 mM; cuando es citrato o citrato-acetato, comprende un poliol a una concentración entre 50 mM - 300 mM; y el pH de la composición entre 4,0 - 7,0. uso de dicha composición en tratamiento de enfermedades inflamatorias, métodos de obtención y dispositivos que la comprenden.
UY0001036542A 2015-01-28 2016-01-28 Formulaciones farmacéuticas para anticuerpos anti-tnf-alfa UY36542A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP15152923 2015-01-28

Publications (1)

Publication Number Publication Date
UY36542A true UY36542A (es) 2016-08-31

Family

ID=52464156

Family Applications (1)

Application Number Title Priority Date Filing Date
UY0001036542A UY36542A (es) 2015-01-28 2016-01-28 Formulaciones farmacéuticas para anticuerpos anti-tnf-alfa

Country Status (6)

Country Link
US (1) US20180016333A1 (es)
EP (1) EP3250598A1 (es)
AR (1) AR103544A1 (es)
TW (1) TW201636047A (es)
UY (1) UY36542A (es)
WO (1) WO2016120413A1 (es)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106170298B (zh) 2013-10-16 2024-01-09 前瞻疗法公司 用于提高抗体稳定性的缓冲液制剂
CA2944330A1 (en) * 2014-04-02 2015-10-08 Intas Pharmaceuticals Limited Liquid pharmaceutical composition of adalimumab
WO2016118707A1 (en) 2015-01-21 2016-07-28 Oncobiologics, Inc. Modulation of charge variants in a monoclonal antibody composition
US11285210B2 (en) 2016-02-03 2022-03-29 Outlook Therapeutics, Inc. Buffer formulations for enhanced antibody stability
EP3824906A1 (en) * 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
JOP20190162A1 (ar) * 2016-12-30 2019-06-27 Biocad Joint Stock Co تركيبة صيدلانية مائية من جسم مضاد لـ tnf? أحادي النسيلة معاود الارتباط الجيني
RU2665966C2 (ru) * 2016-12-30 2018-09-05 Закрытое Акционерное Общество "Биокад" Водная фармацевтическая композиция рекомбинантного моноклонального антитела к ФНОα
US11608357B2 (en) 2018-08-28 2023-03-21 Arecor Limited Stabilized antibody protein solutions
EP3372242A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
EP3372241A1 (en) * 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
KR20180106974A (ko) * 2017-03-16 2018-10-01 주식회사 엘지화학 항-tnf 알파 항체의 액상 제제
US11898184B2 (en) * 2017-09-07 2024-02-13 Sweet Sense Inc. Low glycemic sugar composition
MX2017016884A (es) * 2017-12-19 2019-06-20 Probiomed S A De C V Formulacion farmaceutica estable de una proteina anti-tnfa.
US20230173068A1 (en) * 2020-02-20 2023-06-08 Bio-Thera Solutions, Ltd. ANTI-TNF-a ANTIBODY FORMULATION, PREPARATION METHOD THEREFOR AND USE THEREOF

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2427211A4 (en) * 2009-05-04 2013-05-01 Abbott Biotech Ltd STABLE FORMULATIONS WITH HIGH PROTEIN CONCENTRATION OF ANTI-TNF-ALPHA HUMAN ANTIBODIES
GB201112429D0 (en) * 2011-07-19 2011-08-31 Glaxo Group Ltd Antigen-binding proteins with increased FcRn binding
JP2015519382A (ja) * 2012-06-12 2015-07-09 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 治療用抗体のための医薬処方物
SG10201705668XA (en) * 2012-09-07 2017-08-30 Coherus Biosciences Inc Stable aqueous formulations of adalimumab
US9844594B2 (en) * 2012-12-18 2017-12-19 Merck Sharp & Dohme Corp. Liquid formulations for an anti-TNF α antibody

Also Published As

Publication number Publication date
US20180016333A1 (en) 2018-01-18
AR103544A1 (es) 2017-05-17
WO2016120413A1 (en) 2016-08-04
EP3250598A1 (en) 2017-12-06
TW201636047A (zh) 2016-10-16

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