AR107708A1 - Formulaciones de antagonista de il-6 y sus usos - Google Patents

Formulaciones de antagonista de il-6 y sus usos

Info

Publication number
AR107708A1
AR107708A1 ARP170100456A ARP170100456A AR107708A1 AR 107708 A1 AR107708 A1 AR 107708A1 AR P170100456 A ARP170100456 A AR P170100456A AR P170100456 A ARP170100456 A AR P170100456A AR 107708 A1 AR107708 A1 AR 107708A1
Authority
AR
Argentina
Prior art keywords
seq
sequence
formulation
antibody
container
Prior art date
Application number
ARP170100456A
Other languages
English (en)
Original Assignee
Eleven Biotherapeutics Inc
F Hoffmann La Roche Ltd
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 Eleven Biotherapeutics Inc, F Hoffmann La Roche Ltd filed Critical Eleven Biotherapeutics Inc
Publication of AR107708A1 publication Critical patent/AR107708A1/es

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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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/14—Decongestants or antiallergics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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]
    • C07K16/248—IL-6
    • 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)
  • 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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Ophthalmology & Optometry (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)

Abstract

Se caracterizan en la presente composiciones farmacéuticas y formulaciones que contienen un antagonista de interleuquina 6 (IL-6), por ejemplo, una molécula de anticuerpo de IL-6, diseñado para administrar a un sujeto. Las composiciones farmacéuticas y formulaciones proporcionadas en la presente son apropiadas para usar en la fabricación de medicamentos o métodos de tratamiento de sujetos con enfermedades asociadas con IL-6, por ejemplo, enfermedades oculares asociadas con niveles elevados de IL-6. Reivindicación 1: Una formulación farmacéutica que comprende 1 - 100 mg/mL de un anticuerpo anti-IL-6 o su fragmento; 10 - 50 mM de histidina; 0,01% - 0,1% de polisorbato-20 (Tween-20), polisorbato-80 (Tween-80) o poloxámero 188; 1 - 150 mM de cloruro de sodio; y 1 - 10% de sorbitol; y en donde el pH de la formulación esta entre 5,5 y 7,5. Reivindicación 5: La formulación de acuerdo con cualquiera de las reivindicaciones 1 - 4, en donde el anticuerpo de IL-6 o su fragmento comprende una VH CDR1 que comprende la secuencia de SEQ ID Nº 19, una VH CDR2 que comprende la secuencia de SEQ ID Nº 20 y una VH CDR3 que comprende la secuencia de SEQ ID Nº 21. Reivindicación 6: La formulación de acuerdo con cualquiera de las reivindicaciones 1 - 5, en donde el anticuerpo de IL-6 o su fragmento también comprende una VL CDR1 que comprende la secuencia de SEQ ID Nº 22, una VL CDR2 que comprende la secuencia de SEQ ID Nº 23 y una VL CDR3 que comprende la secuencia de SEQ ID Nº 21. Reivindicación 42: La formulación de acuerdo con cualquiera de las reivindicaciones 1 - 41, en donde la formulación es apropiada para administración por vía intravítrea, intraocular o subconjuntival. Reivindicación 44: La formulación de acuerdo con cualquiera de las reivindicaciones 1 - 42, en donde la formulación es estable a una temperatura entre 2 a 8ºC durante al menos 6 meses. Reivindicación 47: El recipiente de acuerdo con cualquier reivindicación 45 ó 46, en donde el recipiente es un recipiente multidosis. Reivindicación 49: Un kit que comprende un recipiente o dispositivo que comprende la formulación de acuerdo con cualquiera de las reivindicaciones 1 a 44 y opcionalmente instrucciones para el uso.
ARP170100456A 2016-02-23 2017-02-23 Formulaciones de antagonista de il-6 y sus usos AR107708A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201662298774P 2016-02-23 2016-02-23

Publications (1)

Publication Number Publication Date
AR107708A1 true AR107708A1 (es) 2018-05-23

Family

ID=59685584

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP170100456A AR107708A1 (es) 2016-02-23 2017-02-23 Formulaciones de antagonista de il-6 y sus usos

Country Status (11)

Country Link
US (2) US20190046642A1 (es)
EP (1) EP3419599A4 (es)
JP (2) JP2019510078A (es)
KR (1) KR20180116359A (es)
CN (1) CN108718522A (es)
AR (1) AR107708A1 (es)
AU (1) AU2017223687A1 (es)
BR (1) BR112018017031A2 (es)
CA (1) CA3012350A1 (es)
MX (1) MX2018010032A (es)
WO (1) WO2017147293A1 (es)

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MX2020005630A (es) * 2017-11-30 2020-08-20 Bio Thera Solutions Ltd Formulacion liquida de anticuerpos humanizados para el tratamiento de enfermedades relacionadas con il-6.
CN112739378A (zh) * 2018-09-14 2021-04-30 田边三菱制药株式会社 含有人抗il-33单克隆抗体的医药用组合物
JP7411652B2 (ja) * 2018-10-31 2024-01-11 リヒター ゲデオン ニュイルヴァーノシャン ミューコェデー レースヴェーニュタールシャシャーグ 水性医薬製剤
WO2022026914A1 (en) * 2020-07-31 2022-02-03 Alamab Therapeutics, Inc. Anti-connexin antibody formulations
CN116261448A (zh) * 2020-08-19 2023-06-13 百奥泰生物制药股份有限公司 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂
KR20220028972A (ko) * 2020-08-31 2022-03-08 (주)셀트리온 안정한 약제학적 제제
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US20220241414A1 (en) 2022-08-04
WO2017147293A1 (en) 2017-08-31
CN108718522A (zh) 2018-10-30
MX2018010032A (es) 2019-03-11
BR112018017031A2 (pt) 2019-01-22
KR20180116359A (ko) 2018-10-24
CA3012350A1 (en) 2017-08-31
JP2022084922A (ja) 2022-06-07
US20190046642A1 (en) 2019-02-14
US12048746B2 (en) 2024-07-30

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