BR112020020703A2 - Formulações farmacêuticas estáveis de um anticorpo e do anticorpo ¿lfa4¿eta7 . - Google Patents

Formulações farmacêuticas estáveis de um anticorpo e do anticorpo ¿lfa4¿eta7 . Download PDF

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Publication number
BR112020020703A2
BR112020020703A2 BR112020020703-9A BR112020020703A BR112020020703A2 BR 112020020703 A2 BR112020020703 A2 BR 112020020703A2 BR 112020020703 A BR112020020703 A BR 112020020703A BR 112020020703 A2 BR112020020703 A2 BR 112020020703A2
Authority
BR
Brazil
Prior art keywords
antibody
vedolizumab
formulation
vmab
formulations
Prior art date
Application number
BR112020020703-9A
Other languages
English (en)
Portuguese (pt)
Inventor
Murali JAYARAMAN
Anuja Chandrasekar
Original Assignee
Dr. Reddy's Laboratories Limited
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 Limited filed Critical Dr. Reddy's Laboratories Limited
Publication of BR112020020703A2 publication Critical patent/BR112020020703A2/pt

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Classifications

    • 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
    • A61K47/22Heterocyclic 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
    • A61K9/14Particulate 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839Immunoglobulins [IG], 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
    • 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

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)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
BR112020020703-9A 2018-04-10 2019-04-10 Formulações farmacêuticas estáveis de um anticorpo e do anticorpo ¿lfa4¿eta7 . BR112020020703A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201841013647 2018-04-10
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
BR112020020703A2 true BR112020020703A2 (pt) 2021-01-12

Family

ID=68164106

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112020020703-9A BR112020020703A2 (pt) 2018-04-10 2019-04-10 Formulações farmacêuticas estáveis de um anticorpo e do anticorpo ¿lfa4¿eta7 .

Country Status (10)

Country Link
US (1) US12433947B2 (https=)
EP (1) EP3773696A4 (https=)
JP (1) JP2021521171A (https=)
CN (1) CN112292146A (https=)
AU (1) AU2019251453A1 (https=)
BR (1) BR112020020703A2 (https=)
CO (1) CO2020013571A2 (https=)
SG (1) SG11202009876TA (https=)
WO (1) WO2019198101A1 (https=)
ZA (1) ZA202006264B (https=)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG10202012778YA (en) 2015-12-18 2021-01-28 Astellas Pharma Inc Pharmaceutical composition comprising anti-human tslp receptor antibody
WO2019198099A1 (en) * 2018-04-10 2019-10-17 Dr. Reddy's Laboratories Limited Stable antibody 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
EP4259192A4 (en) * 2020-12-09 2024-11-20 Dr. Reddy's Laboratories Limited STABLE AQUEOUS BUFFER-FREE FORMULATION OF AN INTEGRIN ANTIBODY
EP4346899A1 (en) * 2021-06-04 2024-04-10 Polpharma Biologics S.A. Vedolizumab formulation
EP4717712A2 (en) * 2021-12-27 2026-04-01 Polpharma Biologics S.A. Vedolizumab formulation
TW202432601A (zh) 2022-11-07 2024-08-16 美商上游生物公司 包含抗人類tslp受體抗體之醫藥組成物及其使用方法
WO2024249568A1 (en) 2023-05-30 2024-12-05 Paragon Therapeutics, Inc. Alpha4beta7 integrin antibody compositions and methods of use
CN121889424A (zh) 2023-08-14 2026-04-17 派拉冈医疗公司 α4β7整联蛋白结合蛋白及使用方法

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK2236154T3 (en) 2003-02-10 2018-06-25 Biogen Ma Inc IMMUNOGLOBULIN INFORMATION AND METHOD OF PREPARING IT
NZ595526A (en) * 2007-06-14 2013-03-28 Biogen Idec Inc Pharmaceutical composition comprising a vla-4 binding antibody, a phosphate buffer and a surfactant
US20090208492A1 (en) * 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
BRPI0820819B1 (pt) * 2007-12-21 2021-06-08 F. Hoffmann-La Roche Ag formulação de anticorpos humanizados b-ly 1 e seu uso
UA116189C2 (uk) 2011-05-02 2018-02-26 Мілленніум Фармасьютікалз, Інк. КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА
MX367097B (es) * 2011-05-02 2019-08-05 Millennium Pharm Inc FORMULACION PARA ANTICUERPO ANTI-A4ß7.
TWI752912B (zh) 2015-07-17 2022-01-21 美商寇西勒斯生物科技股份有限公司 那他珠單抗的穩定水性調配物
CN114375307B (zh) 2019-06-10 2025-12-05 武田药品工业株式会社 产生抗α4β7抗体的方法

Also Published As

Publication number Publication date
EP3773696A1 (en) 2021-02-17
CN112292146A (zh) 2021-01-29
JP2021521171A (ja) 2021-08-26
US12433947B2 (en) 2025-10-07
US20210401982A1 (en) 2021-12-30
WO2019198101A1 (en) 2019-10-17
ZA202006264B (en) 2022-09-28
CO2020013571A2 (es) 2021-01-18
EP3773696A4 (en) 2021-12-29
AU2019251453A2 (en) 2020-12-03
AU2019251453A1 (en) 2020-11-26
SG11202009876TA (en) 2020-11-27

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Legal Events

Date Code Title Description
B350 Update of information on the portal [chapter 15.35 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 5A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2770 DE 06-02-2024 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.