CO2020013571A2 - Formulaciones estables de anticuerpos terapéuticos - Google Patents

Formulaciones estables de anticuerpos terapéuticos

Info

Publication number
CO2020013571A2
CO2020013571A2 CONC2020/0013571A CO2020013571A CO2020013571A2 CO 2020013571 A2 CO2020013571 A2 CO 2020013571A2 CO 2020013571 A CO2020013571 A CO 2020013571A CO 2020013571 A2 CO2020013571 A2 CO 2020013571A2
Authority
CO
Colombia
Prior art keywords
therapeutic antibodies
stable formulations
formulation
stable
devoid
Prior art date
Application number
CONC2020/0013571A
Other languages
English (en)
Inventor
Murali Jayaraman
Anuja Chandrasekar
Original Assignee
Dr Reddy’s Laboratories 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 Dr Reddy’s Laboratories Ltd filed Critical Dr Reddy’s Laboratories Ltd
Publication of CO2020013571A2 publication Critical patent/CO2020013571A2/es

Links

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
    • A61K47/22—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
    • A61K9/14—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
    • 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
    • C07K16/2839—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 integrin superfamily
    • 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

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)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

La presente invención divulga una formulación farmacéutica estable de un anticuerpo, en la que la formulación contiene tampón, tensioactivo y azúcar, y en la que la formulación carece de aminoácidos libres y sales.
CONC2020/0013571A 2018-04-10 2020-10-28 Formulaciones estables de anticuerpos terapéuticos CO2020013571A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201841013647 2018-04-10
PCT/IN2019/050293 WO2019198101A1 (en) 2018-04-10 2019-04-10 Stable formulations of therapeutic antibody

Publications (1)

Publication Number Publication Date
CO2020013571A2 true CO2020013571A2 (es) 2021-01-18

Family

ID=68164106

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2020/0013571A CO2020013571A2 (es) 2018-04-10 2020-10-28 Formulaciones estables de anticuerpos terapéuticos

Country Status (10)

Country Link
US (1) US20210401982A1 (es)
EP (1) EP3773696A4 (es)
JP (1) JP2021521171A (es)
CN (1) CN112292146A (es)
AU (1) AU2019251453A1 (es)
BR (1) BR112020020703A2 (es)
CO (1) CO2020013571A2 (es)
SG (1) SG11202009876TA (es)
WO (1) WO2019198101A1 (es)
ZA (1) ZA202006264B (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3773695A4 (en) * 2018-04-10 2021-12-22 Dr. Reddy's Laboratories Ltd. STABLE ANTIBODY FORMULATION
EP4346899A1 (en) * 2021-06-04 2024-04-10 Polpharma Biologics S.A. Vedolizumab formulation
WO2023126411A1 (en) * 2021-12-27 2023-07-06 Polpharma Biologics S.A. Vedolizumab formulation
WO2024098180A1 (en) * 2022-11-07 2024-05-16 Wuxi Biologics (Hong Kong) Limited Pharmaceutical compositions comprising anti-human tslp receptor antibodies and methods of using the same

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090208492A1 (en) * 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
PT2234600E (pt) * 2007-12-21 2014-09-25 Hoffmann La Roche Formulação de anticorpos
UA116189C2 (uk) * 2011-05-02 2018-02-26 Мілленніум Фармасьютікалз, Інк. КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА
UY34054A (es) * 2011-05-02 2012-11-30 Millennium Pharm Inc FORMULACIÓN PARA ANTICUERPO ANTI-a(alfa)4B(Beta)7

Also Published As

Publication number Publication date
EP3773696A4 (en) 2021-12-29
US20210401982A1 (en) 2021-12-30
CN112292146A (zh) 2021-01-29
EP3773696A1 (en) 2021-02-17
ZA202006264B (en) 2022-09-28
JP2021521171A (ja) 2021-08-26
AU2019251453A2 (en) 2020-12-03
BR112020020703A2 (pt) 2021-01-12
SG11202009876TA (en) 2020-11-27
WO2019198101A1 (en) 2019-10-17
AU2019251453A1 (en) 2020-11-26

Similar Documents

Publication Publication Date Title
CO2020013571A2 (es) Formulaciones estables de anticuerpos terapéuticos
AR111455A1 (es) Formulación estable de anticuerpo
CL2020002012A1 (es) Formulaciones de anticuerpos humanos anti-rankl y métodos de uso de estas. (divisional solicitud 201903032)
CL2018000226A1 (es) Mezcla de péptidos (divisional solicitud 201601405)
MX2020008219A (es) Formulacion farmaceutica de ph bajo.
CR20190400A (es) Formulaciones de anticuerpo monoclonal anti-vrs
CU20190015A7 (es) Formulaciones de anticuerpos inhibidores de masp-2 altamente concentrados, de baja viscosidad y composiciones farmacéuticas que las comprenden
CY1124521T1 (el) Σκευασματα αντισωματος anti-cd19
CL2019002716A1 (es) Métodos y composiciones para la reducción de inmunogenicidad
BR112017004393A2 (pt) formulações de anticorpo
MA54052A (fr) Formulation d'anticorps
CO2021010697A2 (es) Formulación de anticuerpos terapéuticos
MA54139A (fr) Formulation d'anticorps
CL2023000486A1 (es) Formulación farmacéutica que comprende un bite, anticuerpo biespecífico y metionina
CL2023002797A1 (es) Formulaciones y composiciones farmacéuticas que comprenden una proteína de unión a antígeno enmascarada
AR113534A1 (es) Formulación
CO2020016008A2 (es) Formulación de proteína de fusión estable
AR087094A1 (es) Formulaciones que estabilizan proteinas
CO2020013552A2 (es) Formulación de anticuerpos
MX2020004675A (es) Formulaciones de alcohol de seda.
CO2022005737A2 (es) Formulación estable de anticuerpo de integrina
CO2020013545A2 (es) Formulación estable de anticuerpos
CO2020016014A2 (es) Formulación de proteína de fusión ctla4-ig
CL2020001705A1 (es) Composición acuosa que comprende ácido 2-(dimetil-1h-pirazol-1-il) succínico y amoníaco.
MA55809A (fr) Formulation d'anticorps anti-il-6