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AR125470A1 - Composición farmacéutica de pembrolizumab y su uso - Google Patents

Composición farmacéutica de pembrolizumab y su uso

Info

Publication number
AR125470A1
AR125470A1 ARP220101106A ARP220101106A AR125470A1 AR 125470 A1 AR125470 A1 AR 125470A1 AR P220101106 A ARP220101106 A AR P220101106A AR P220101106 A ARP220101106 A AR P220101106A AR 125470 A1 AR125470 A1 AR 125470A1
Authority
AR
Argentina
Prior art keywords
pembrolizumab
compositions
pharmaceutical composition
histidine
poloxamer
Prior art date
Application number
ARP220101106A
Other languages
English (en)
Inventor
Alina Aleksandrovna Kostandian
Anastasiia Alekseevna Andreeva
Ekaterina Aleksandrovna Lomkova
Aleksandr Olegovich Iakovlev
Dmitry Valentinovich Morozov
Original Assignee
Joint Stock Company “Biocad”
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
Priority claimed from RU2021112111A external-priority patent/RU2791857C2/ru
Application filed by Joint Stock Company “Biocad” filed Critical Joint Stock Company “Biocad”
Publication of AR125470A1 publication Critical patent/AR125470A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • 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
    • A61K9/14Particulate 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
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
    • C07K16/2803Immunoglobulins [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
    • C07K16/2818Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La invención se refiere al campo de la farmacia y la medicina, específicamente a las composiciones farmacéuticas del anticuerpo anti-PD-1 pembrolizumab, que pueden ser composiciones acuosas o liofilizadas. La invención se refiere además al uso de dichas composiciones para el tratamiento de neoplasias malignas o enfermedades infecciosas, así como al uso de dichas composiciones para producir un medicamento destinado a tratar neoplasias malignas o enfermedades infecciosas. Reivindicación 1: Una composición farmacéutica de pembrolizumab que comprende: (i) pembrolizumab; (ii) histidina (iii) clorhidrato de histidina monohidratado; (iv) glicina; (v) trehalosa y poloxamer 188, o prolina; y (vi) agua para inyección. Reivindicación 9: La composición farmacéutica según la reivindicación 1, que comprende: (i) 5 - 50 mg/ml de pembrolizumab; (ii) 0,087 - 0,432 mg/ml de histidina; (iii) 0,464 - 0,931 mg/ml de clorhidrato de histidina monohidratado; (iv) 1 - 2 mg/ml de glicina; (v) 70 - 130 mg/ml de trehalosa y 0,8 - 1,2 mg/ml de poloxamer 188, o 20 - 34 mg/ml de prolina; y (vi) agua para inyección a 1 ml.
ARP220101106A 2021-04-27 2022-04-27 Composición farmacéutica de pembrolizumab y su uso AR125470A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
RU2021112111A RU2791857C2 (ru) 2021-04-27 Фармацевтическая композиция пембролизумаба и ее применение

Publications (1)

Publication Number Publication Date
AR125470A1 true AR125470A1 (es) 2023-07-19

Family

ID=83848424

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP220101106A AR125470A1 (es) 2021-04-27 2022-04-27 Composición farmacéutica de pembrolizumab y su uso

Country Status (12)

Country Link
EP (1) EP4329729A4 (es)
CN (1) CN117835965A (es)
AR (1) AR125470A1 (es)
CL (1) CL2023003209A1 (es)
CO (1) CO2023014166A2 (es)
CR (1) CR20230527A (es)
EC (1) ECSP23081880A (es)
MA (1) MA62939A1 (es)
MX (1) MX2023012745A (es)
PE (1) PE20250072A1 (es)
TW (1) TW202308692A (es)
WO (1) WO2022231481A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2024221025A1 (en) * 2023-02-16 2025-08-21 Sun Pharmaceutical Industries Limited Stable protein compositions of anti-pd1 antibody

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK3283107T3 (da) * 2015-04-17 2020-08-31 Bristol Myers Squibb Co Sammensætninger omfattende en kombination af ipilimumab og nivolumab
US11608357B2 (en) * 2018-08-28 2023-03-21 Arecor Limited Stabilized antibody protein solutions
JOP20190260A1 (ar) * 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
CA3063324A1 (en) * 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
EP3876978A4 (en) * 2018-11-07 2022-09-28 Merck Sharp & Dohme Corp. STABLE FORMULATIONS OF PROGRAMMED DEATH RECEPTOR 1 (PD-1) ANTIBODIES AND METHODS OF USE THEREOF

Also Published As

Publication number Publication date
CO2023014166A2 (es) 2024-02-05
EP4329729A1 (en) 2024-03-06
WO2022231481A1 (en) 2022-11-03
CR20230527A (es) 2024-02-13
PE20250072A1 (es) 2025-01-13
CN117835965A (zh) 2024-04-05
CL2023003209A1 (es) 2024-05-31
MX2023012745A (es) 2023-11-09
TW202308692A (zh) 2023-03-01
MA62939A1 (fr) 2024-02-29
ECSP23081880A (es) 2023-11-30
EP4329729A4 (en) 2025-04-02

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