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BR112023027279A2 - Composições farmacêuticas líquidas - Google Patents

Composições farmacêuticas líquidas

Info

Publication number
BR112023027279A2
BR112023027279A2 BR112023027279A BR112023027279A BR112023027279A2 BR 112023027279 A2 BR112023027279 A2 BR 112023027279A2 BR 112023027279 A BR112023027279 A BR 112023027279A BR 112023027279 A BR112023027279 A BR 112023027279A BR 112023027279 A2 BR112023027279 A2 BR 112023027279A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical compositions
liquid pharmaceutical
histidine
antibody
surfactant
Prior art date
Application number
BR112023027279A
Other languages
English (en)
Inventor
Maria Schott Katharina
Rainer Sigl
Original Assignee
Formycon Ag
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 Formycon Ag filed Critical Formycon Ag
Publication of BR112023027279A2 publication Critical patent/BR112023027279A2/pt

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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

a presente invenção refere-se a composições farmacêuticas de um anticorpo anti-pd1 compreendendo um tampão de citrato, um ou mais aminoácidos diferentes da histidina e um tensoativo.
BR112023027279A 2021-06-23 2022-06-22 Composições farmacêuticas líquidas BR112023027279A2 (pt)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP21181269 2021-06-23
EP21200882 2021-10-05
EP22170678 2022-04-29
PCT/EP2022/067030 WO2022268887A1 (en) 2021-06-23 2022-06-22 Formulations of anti-pd1 antibodies

Publications (1)

Publication Number Publication Date
BR112023027279A2 true BR112023027279A2 (pt) 2024-03-12

Family

ID=82361217

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112023027279A BR112023027279A2 (pt) 2021-06-23 2022-06-22 Composições farmacêuticas líquidas

Country Status (8)

Country Link
US (1) US20240287185A1 (pt)
EP (1) EP4359001A1 (pt)
JP (1) JP2024527517A (pt)
KR (1) KR20240024941A (pt)
BR (1) BR112023027279A2 (pt)
CA (1) CA3220545A1 (pt)
MX (1) MX2023014616A (pt)
WO (1) WO2022268887A1 (pt)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024133625A1 (en) 2022-12-21 2024-06-27 Formycon Ag Formulations of anti-pd1 antibodies
WO2024171082A1 (en) * 2023-02-16 2024-08-22 Sun Pharmaceutical Industries Limited Stable protein compositions of anti-pd1 antibody

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3398612A1 (en) 2011-03-31 2018-11-07 Merck Sharp & Dohme Corp. Stable formulations of antibodies to human programmed death receptor pd-1 and related treatments
UA124259C2 (uk) 2015-09-28 2021-08-18 Сужоу Санкадіа Байофармасьютікалз Ко., Лтд. Фармацевтичне одержання стабільного анти-pd-1 антитіла та його застосування в медицині
CN107325180A (zh) * 2016-04-28 2017-11-07 上海抗体药物国家工程研究中心有限公司 一种适于皮下注射的抗人pd-1的单克隆抗体制剂
WO2018027524A1 (en) 2016-08-09 2018-02-15 Innovent Biologics (Suzhou) Co., Ltd. Pd-1 antibody formulation
US11603407B2 (en) 2017-04-06 2023-03-14 Regeneron Pharmaceuticals, Inc. Stable antibody formulation
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
US20190225689A1 (en) 2018-01-22 2019-07-25 Janssen Biotech, Inc. Methods of treating cancers with antagonistic anti-pd-1 antibodies
BR112020016331A8 (pt) 2018-02-13 2023-02-07 Merck Sharp & Dohme Métodos para tratar câncer com anticorpos anti-pd-1
CA3093036A1 (en) 2018-03-07 2019-09-12 Pfizer Inc. Anti-pd-1 antibody compositions
US20210380694A1 (en) 2018-11-07 2021-12-09 Merck Sharp & Dohme Corp. Stable formulations of programmed death receptor 1 (pd-1) antibodies and methods of use thereof
KR20220115803A (ko) 2019-12-13 2022-08-18 삼성바이오에피스 주식회사 안정한 항-pd-1 항체 약제학적 제제
WO2021123202A1 (en) 2019-12-20 2021-06-24 Formycon Ag Formulations of anti-pd1 antibodies
CN113117071B (zh) * 2020-01-15 2023-11-14 鲁南制药集团股份有限公司 一种无糖基化抗pd-1单克隆抗体的冻干制剂
TW202128131A (zh) * 2020-01-17 2021-08-01 大陸商信達生物制藥(蘇州)有限公司 重組抗程式性細胞死亡受體1和抗分化抗原簇137雙特異性抗體製劑及其用途

Also Published As

Publication number Publication date
WO2022268887A1 (en) 2022-12-29
KR20240024941A (ko) 2024-02-26
CA3220545A1 (en) 2022-12-29
EP4359001A1 (en) 2024-05-01
JP2024527517A (ja) 2024-07-25
US20240287185A1 (en) 2024-08-29
MX2023014616A (es) 2024-01-30

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