BR112018002970A2 - composição de estabilidade melhorada de etanercept - Google Patents

composição de estabilidade melhorada de etanercept

Info

Publication number
BR112018002970A2
BR112018002970A2 BR112018002970A BR112018002970A BR112018002970A2 BR 112018002970 A2 BR112018002970 A2 BR 112018002970A2 BR 112018002970 A BR112018002970 A BR 112018002970A BR 112018002970 A BR112018002970 A BR 112018002970A BR 112018002970 A2 BR112018002970 A2 BR 112018002970A2
Authority
BR
Brazil
Prior art keywords
etanercept
improved stability
stability composition
stable
composition
Prior art date
Application number
BR112018002970A
Other languages
English (en)
Inventor
Kuri Breña Romero De Terreros Francisco
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=BR112018002970(A2) "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
Publication of BR112018002970A2 publication Critical patent/BR112018002970A2/pt

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

Abstract

a presente invenção refere-se a uma formulação líquida estável de etanercept que reduz eficientemente a produção de subprodutos de etanercept, mantendo de forma estável a eficácia farmacêutica do medicamento durante o armazenamento a longo prazo. a composição líquida da invenção é proporcionada em seringas pré-cheias prontas para seu uso imediato em áreas que requerem tratamento com etanercept.
BR112018002970A 2015-08-13 2016-08-09 composição de estabilidade melhorada de etanercept BR112018002970A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
MX2015010517A MX2015010517A (es) 2015-08-13 2015-08-13 Composicion de estabilidad mejorada de etanercept.
PCT/MX2016/000082 WO2017026881A1 (es) 2015-08-13 2016-08-09 Composición de estabilidad mejorada de etanercept

Publications (1)

Publication Number Publication Date
BR112018002970A2 true BR112018002970A2 (pt) 2019-03-19

Family

ID=57983405

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018002970A BR112018002970A2 (pt) 2015-08-13 2016-08-09 composição de estabilidade melhorada de etanercept

Country Status (9)

Country Link
EP (1) EP3335729B1 (pt)
JP (1) JP6852049B2 (pt)
BR (1) BR112018002970A2 (pt)
CO (1) CO2018002575A2 (pt)
DK (1) DK3335729T3 (pt)
ES (1) ES2956008T3 (pt)
MX (1) MX2015010517A (pt)
PT (1) PT3335729T (pt)
WO (1) WO2017026881A1 (pt)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE402716T1 (de) * 2002-02-27 2008-08-15 Immunex Corp Stabilisierte tnfr-fc formulierung mit arginin
UY34105A (es) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
US10493151B2 (en) * 2011-10-18 2019-12-03 Coherus Biosciences, Inc. Etanercept formulations stabilized with sodium chloride
TW201325606A (zh) * 2011-10-18 2013-07-01 Coherus Biosciences Inc 用氯化鈉穩定化之依那西普調配物
JP2015525762A (ja) * 2012-07-09 2015-09-07 コヒラス・バイオサイエンシズ・インコーポレイテッド エタネルセプトの安定な水性製剤
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
JP6852049B2 (ja) 2021-03-31
JP2018527343A (ja) 2018-09-20
MX2015010517A (es) 2017-02-13
EP3335729A1 (en) 2018-06-20
WO2017026881A1 (es) 2017-02-16
ES2956008T3 (es) 2023-12-11
EP3335729B1 (en) 2023-06-28
EP3335729A4 (en) 2019-06-05
CO2018002575A2 (es) 2018-06-12
PT3335729T (pt) 2023-09-26
DK3335729T3 (da) 2023-07-10

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Legal Events

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

Free format text: NOTIFICACAO DE DEVOLUCAO DO PEDIDO EM FUNCAO DA REVOGACAO DO ART. 229-C DA LEI NO 9.279, DE 1996, POR FORCA DA LEI NO 14.195, DE 2021

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]