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CL2023003209A1 - Pharmaceutical composition of pembrolizumab and its use - Google Patents

Pharmaceutical composition of pembrolizumab and its use

Info

Publication number
CL2023003209A1
CL2023003209A1 CL2023003209A CL2023003209A CL2023003209A1 CL 2023003209 A1 CL2023003209 A1 CL 2023003209A1 CL 2023003209 A CL2023003209 A CL 2023003209A CL 2023003209 A CL2023003209 A CL 2023003209A CL 2023003209 A1 CL2023003209 A1 CL 2023003209A1
Authority
CL
Chile
Prior art keywords
compositions
pembrolizumab
pharmaceutical composition
infectious diseases
malignant neoplasms
Prior art date
Application number
CL2023003209A
Other languages
Spanish (es)
Inventor
Valentinovich MOROZOV Dmitry
Aleksandrovna Kostandian Alina
Alekseevna ANDREEVA Anastasiia
Aleksandrovna Lomkova Ekaterina
Olegovich Iakovlev Aleksandr
Original Assignee
Biocad Joint Stock Co
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/en
Application filed by Biocad Joint Stock Co filed Critical Biocad Joint Stock Co
Publication of CL2023003209A1 publication Critical patent/CL2023003209A1/en

Links

Classifications

    • 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
    • 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
    • A61K47/10—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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
    • 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

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)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Oncology (AREA)
  • Genetics & Genomics (AREA)
  • Communicable Diseases (AREA)
  • Microbiology (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 infecciosasThe invention relates to the field of pharmacy and medicine, specifically to the pharmaceutical compositions of the anti-PD-1 antibody pembrolizumab, which can be aqueous or lyophilized compositions. The invention further relates to the use of said compositions for the treatment of malignant neoplasms or infectious diseases, as well as to the use of said compositions to produce a medicament intended to treat malignant neoplasms or infectious diseases.

CL2023003209A 2021-04-27 2023-10-26 Pharmaceutical composition of pembrolizumab and its use CL2023003209A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
RU2021112111A RU2791857C2 (en) 2021-04-27 Pharmaceutical composition of pembrolizumab and use thereof

Publications (1)

Publication Number Publication Date
CL2023003209A1 true CL2023003209A1 (en) 2024-05-31

Family

ID=83848424

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2023003209A CL2023003209A1 (en) 2021-04-27 2023-10-26 Pharmaceutical composition of pembrolizumab and its use

Country Status (12)

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

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
NZ735820A (en) * 2015-04-17 2025-02-28 Bristol Myers Squibb Co Compositions comprising a combination of an anti-pd-1 antibody and another antibody
US11608357B2 (en) * 2018-08-28 2023-03-21 Arecor Limited Stabilized antibody protein solutions
JOP20190260A1 (en) * 2017-05-02 2019-10-31 Merck Sharp & Dohme Stable formulations of programmed death receptor 1 (pd-1) antibodies and methods of use thereof
EP3624846B1 (en) * 2017-05-16 2024-08-07 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity including a combination of nicotinic acid and tryoptophan
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

Also Published As

Publication number Publication date
PE20250072A1 (en) 2025-01-13
WO2022231481A1 (en) 2022-11-03
CN117835965A (en) 2024-04-05
MA62939A1 (en) 2024-02-29
CR20230527A (en) 2024-02-13
CO2023014166A2 (en) 2024-02-05
AR125470A1 (en) 2023-07-19
EP4329729A4 (en) 2025-04-02
TW202308692A (en) 2023-03-01
MX2023012745A (en) 2023-11-09
EP4329729A1 (en) 2024-03-06
ECSP23081880A (en) 2023-11-30

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