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MX389818B - Composicion de estabilidad mejorada de etanercept. - Google Patents

Composicion de estabilidad mejorada de etanercept.

Info

Publication number
MX389818B
MX389818B MX2015010517A MX2015010517A MX389818B MX 389818 B MX389818 B MX 389818B MX 2015010517 A MX2015010517 A MX 2015010517A MX 2015010517 A MX2015010517 A MX 2015010517A MX 389818 B MX389818 B MX 389818B
Authority
MX
Mexico
Prior art keywords
etanercept
enhanced stability
stability composition
composition
byproducts
Prior art date
Application number
MX2015010517A
Other languages
English (en)
Other versions
MX2015010517A (es
Inventor
ROMERO DE TERREROS Francisco Kuri BREÑA
Original Assignee
Landsteiner Scient S A De C V
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=57983405&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX389818(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Landsteiner Scient S A De C V filed Critical Landsteiner Scient S A De C V
Priority to MX2015010517A priority Critical patent/MX389818B/es
Priority to PCT/MX2016/000082 priority patent/WO2017026881A1/es
Priority to DK16835520.4T priority patent/DK3335729T3/da
Priority to PT168355204T priority patent/PT3335729T/pt
Priority to ES16835520T priority patent/ES2956008T3/es
Priority to EP16835520.4A priority patent/EP3335729B1/en
Priority to BR112018002970A priority patent/BR112018002970A2/pt
Priority to JP2018507544A priority patent/JP6852049B2/ja
Publication of MX2015010517A publication Critical patent/MX2015010517A/es
Priority to CONC2018/0002575A priority patent/CO2018002575A2/es
Publication of MX389818B publication Critical patent/MX389818B/es

Links

Classifications

    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/26—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
    • A61K9/08—Solutions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7151—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

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)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Toxicology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

La presente invención se refiere a una composición líquida de etanercept, caracterizada porque comprende 50 mg de Etanercept; 5.3 mg de disódico heptahidratado: 2.4 mg de fosfato monobásico monosódico monohidratado; 5.84 mg de cloruro de sodio; 10mg de sacarosa; 2 mg de manitol y 1ml de agua purificada grado inyectable.
MX2015010517A 2015-08-13 2015-08-13 Composicion de estabilidad mejorada de etanercept. MX389818B (es)

Priority Applications (9)

Application Number Priority Date Filing Date Title
MX2015010517A MX389818B (es) 2015-08-13 2015-08-13 Composicion de estabilidad mejorada de etanercept.
JP2018507544A JP6852049B2 (ja) 2015-08-13 2016-08-09 改善された安定性を有するエタネルセプト組成物
ES16835520T ES2956008T3 (es) 2015-08-13 2016-08-09 Composición de estabilidad mejorada de Etanercept
DK16835520.4T DK3335729T3 (da) 2015-08-13 2016-08-09 Etanercept-sammensætning med forbedret stabilitet
PT168355204T PT3335729T (pt) 2015-08-13 2016-08-09 Composição de etanercept com estabilidade melhorada
PCT/MX2016/000082 WO2017026881A1 (es) 2015-08-13 2016-08-09 Composición de estabilidad mejorada de etanercept
EP16835520.4A EP3335729B1 (en) 2015-08-13 2016-08-09 Etanercept composition having improved stability
BR112018002970A BR112018002970A2 (pt) 2015-08-13 2016-08-09 composição de estabilidade melhorada de etanercept
CONC2018/0002575A CO2018002575A2 (es) 2015-08-13 2018-03-12 Composición de estabilidad mejorada de etanercept

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
MX2015010517A MX389818B (es) 2015-08-13 2015-08-13 Composicion de estabilidad mejorada de etanercept.

Publications (2)

Publication Number Publication Date
MX2015010517A MX2015010517A (es) 2017-02-13
MX389818B true MX389818B (es) 2025-03-20

Family

ID=57983405

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2015010517A MX389818B (es) 2015-08-13 2015-08-13 Composicion de estabilidad mejorada de etanercept.

Country Status (9)

Country Link
EP (1) EP3335729B1 (es)
JP (1) JP6852049B2 (es)
BR (1) BR112018002970A2 (es)
CO (1) CO2018002575A2 (es)
DK (1) DK3335729T3 (es)
ES (1) ES2956008T3 (es)
MX (1) MX389818B (es)
PT (1) PT3335729T (es)
WO (1) WO2017026881A1 (es)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT1946776T (pt) * 2002-02-27 2017-03-17 Immunex Corp Composição de tnfr-fc estabilizada compreendendo arginina
UY34105A (es) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
US10485869B2 (en) * 2011-10-18 2019-11-26 Coherus Biosciences, Inc. Etanercept formulations stabilized with meglumine
EA026410B1 (ru) * 2011-10-18 2017-04-28 Кохерус Байосайенсис, Инк. Композиции этанерцепта, стабилизированные комбинациями сахаров и полиолов
BR112015000203A2 (pt) * 2012-07-09 2017-06-27 Coherus Biosciences Inc formulações de etanercept que exibem redução marcada em partículas sub-visíveis
AU2013336279B2 (en) * 2012-10-26 2018-07-19 Lupin Limited Stable pharmaceutical composition of TNFR:Fc fusion protein

Also Published As

Publication number Publication date
ES2956008T3 (es) 2023-12-11
CO2018002575A2 (es) 2018-06-12
BR112018002970A2 (pt) 2019-03-19
WO2017026881A1 (es) 2017-02-16
MX2015010517A (es) 2017-02-13
JP6852049B2 (ja) 2021-03-31
EP3335729A4 (en) 2019-06-05
DK3335729T3 (da) 2023-07-10
EP3335729A1 (en) 2018-06-20
JP2018527343A (ja) 2018-09-20
EP3335729B1 (en) 2023-06-28
PT3335729T (pt) 2023-09-26

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