BR112021018727A2 - Formulações estabilizadas que contêm anticorpos anti il 33 - Google Patents

Formulações estabilizadas que contêm anticorpos anti il 33

Info

Publication number
BR112021018727A2
BR112021018727A2 BR112021018727A BR112021018727A BR112021018727A2 BR 112021018727 A2 BR112021018727 A2 BR 112021018727A2 BR 112021018727 A BR112021018727 A BR 112021018727A BR 112021018727 A BR112021018727 A BR 112021018727A BR 112021018727 A2 BR112021018727 A2 BR 112021018727A2
Authority
BR
Brazil
Prior art keywords
antibodies
formulations
antibody
contain anti
contain
Prior art date
Application number
BR112021018727A
Other languages
English (en)
Inventor
Dingjiang Liu
Qingyan Hu
Original Assignee
Regeneron Pharma
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 Regeneron Pharma filed Critical Regeneron Pharma
Publication of BR112021018727A2 publication Critical patent/BR112021018727A2/pt

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Classifications

    • 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
    • A61K47/16—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
    • 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • 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
    • C07K16/244—Interleukins [IL]
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Environmental & Geological Engineering (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

formulações estabilizadas que contêm anticorpos anti-il-35. a presente invenção refere-se a formulações farmacêuticas que compreendem um anticorpo que se liga especificamente à interleucina 33 humana (hil 33). as formulações podem conter, além de um anticorpo anti il 33, um tampão, pelo menos um aminoácido, pelo menos um açúcar ou pelo menos um tensoativo não iônico. as formulações farmacêuticas da presente invenção exibem um grau substancial de estabilidade de anticorpo após armazenamento durante diversos meses e após serem submetidas a estresses térmicos e outros estresses físicos.
BR112021018727A 2019-03-21 2020-03-20 Formulações estabilizadas que contêm anticorpos anti il 33 BR112021018727A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962821661P 2019-03-21 2019-03-21
PCT/US2020/023795 WO2020191270A1 (en) 2019-03-21 2020-03-20 Stabilized formulations containing anti-il-33 antibodies

Publications (1)

Publication Number Publication Date
BR112021018727A2 true BR112021018727A2 (pt) 2022-02-15

Family

ID=70228884

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021018727A BR112021018727A2 (pt) 2019-03-21 2020-03-20 Formulações estabilizadas que contêm anticorpos anti il 33

Country Status (17)

Country Link
US (2) US11596690B2 (pt)
EP (1) EP3941522A1 (pt)
JP (1) JP2022526292A (pt)
KR (1) KR20210141592A (pt)
CN (1) CN113573733A (pt)
AU (1) AU2020241882A1 (pt)
BR (1) BR112021018727A2 (pt)
CA (1) CA3133995A1 (pt)
CL (1) CL2021002440A1 (pt)
CO (1) CO2021011648A2 (pt)
EA (1) EA202192568A1 (pt)
IL (1) IL286024A (pt)
MA (1) MA55362A (pt)
MX (1) MX2021011137A (pt)
SG (1) SG11202109822XA (pt)
TW (1) TW202102260A (pt)
WO (1) WO2020191270A1 (pt)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3927729A4 (en) 2019-02-18 2023-10-11 Eli Lilly and Company THERAPEUTIC ANTIBODY FORMULATION
CN113842457B (zh) * 2021-11-04 2022-05-20 江苏荃信生物医药股份有限公司 包含抗人白介素-33单克隆抗体的液体制剂
WO2023077685A1 (zh) * 2021-11-04 2023-05-11 江苏荃信生物医药股份有限公司 包含抗人白介素-33单克隆抗体的浓缩溶液的制备方法及液体制剂

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0747045B2 (ja) 1986-10-15 1995-05-24 株式会社大協精工 積層した注射器用滑栓
JP3100727B2 (ja) 1992-01-23 2000-10-23 株式会社大協精工 変性ポリシロキサン組成物及び該組成物を被覆した衛生ゴム製品
JP3172057B2 (ja) 1995-04-05 2001-06-04 株式会社大協精工 ラミネートゴム栓
JP3512349B2 (ja) 1999-01-29 2004-03-29 株式会社大協精工 柱状ゴム要素の成形型
JP2002209975A (ja) 2001-01-19 2002-07-30 Daikyo Seiko Ltd 医薬バイアル用ラミネートゴム栓
NZ549040A (en) 2004-02-17 2009-07-31 Schering Corp Use for interleukin-33 (IL33) and the IL-33 receptor complex
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
GB0600351D0 (en) * 2006-01-10 2006-02-15 Weston Terence E Safe hypodermic needle
US8119771B2 (en) 2007-04-26 2012-02-21 The Provost, Fellow and Scholars of the College of the Holy and Undivided Trinity of Queen Elizabeth, Near Dublin Products for altering IL-33 activity and methods thereof
JP2010527936A (ja) 2007-05-18 2010-08-19 メディミューン，エルエルシー 炎症性疾患におけるｉｌ−３３
ES2655079T3 (es) 2009-09-10 2018-02-16 Merck Sharp & Dohme Corp. Uso de antagonistas de IL-33 para tratar enfermedades fibróticas
EA028945B1 (ru) * 2010-10-06 2018-01-31 Ридженерон Фармасьютикалз, Инк. СТАБИЛЬНЫЕ ЖИДКИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ АНТИТЕЛА К АЛЬФА РЕЦЕПТОРУ ЧЕЛОВЕЧЕСКОГО ИНТЕРЛЕЙКИНА-4 (hIL-4Rα)
JO3532B1 (ar) 2013-03-13 2020-07-05 Regeneron Pharma الأجسام المضادة لمضاد انترلوكين-33 واستعمالاتها
US10005834B2 (en) * 2015-10-06 2018-06-26 Regeneron Pharmaceuticals, Inc. Biomarkers related to interleukin-33 (IL-33)-mediated diseases and uses thereof
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Also Published As

Publication number Publication date
AU2020241882A1 (en) 2021-10-14
IL286024A (en) 2021-10-31
SG11202109822XA (en) 2021-10-28
US20200297845A1 (en) 2020-09-24
US20230346929A1 (en) 2023-11-02
CO2021011648A2 (es) 2021-09-30
WO2020191270A1 (en) 2020-09-24
CA3133995A1 (en) 2020-09-24
JP2022526292A (ja) 2022-05-24
CL2021002440A1 (es) 2022-04-22
US11596690B2 (en) 2023-03-07
CN113573733A (zh) 2021-10-29
MA55362A (fr) 2022-01-26
MX2021011137A (es) 2021-10-22
EP3941522A1 (en) 2022-01-26
KR20210141592A (ko) 2021-11-23
TW202102260A (zh) 2021-01-16
EA202192568A1 (ru) 2021-12-03

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