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AR088379A1 - Formulaciones de etanercept estabilizadas con iones metalicos - Google Patents

Formulaciones de etanercept estabilizadas con iones metalicos

Info

Publication number
AR088379A1
AR088379A1 ARP120103885A ARP120103885A AR088379A1 AR 088379 A1 AR088379 A1 AR 088379A1 AR P120103885 A ARP120103885 A AR P120103885A AR P120103885 A ARP120103885 A AR P120103885A AR 088379 A1 AR088379 A1 AR 088379A1
Authority
AR
Argentina
Prior art keywords
formulations
metal ions
etanercept stabilized
etanercept
stabilized
Prior art date
Application number
ARP120103885A
Other languages
English (en)
Original Assignee
Coherus Biosciences Inc
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 Coherus Biosciences Inc filed Critical Coherus Biosciences Inc
Publication of AR088379A1 publication Critical patent/AR088379A1/es

Links

Classifications

    • 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
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    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
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    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/191—Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta
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    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
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    • 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
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    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
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    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • 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
    • 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]
    • A—HUMAN NECESSITIES
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    • 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
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/81—Protease inhibitors
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Cell Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Rheumatology (AREA)
  • Pulmonology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Reproductive Health (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Gynecology & Obstetrics (AREA)

Abstract

Composiciones farmacéuticas acuosas estabilizadas para el almacenamiento a largo plazo del etanercept.
ARP120103885A 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con iones metalicos AR088379A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161548518P 2011-10-18 2011-10-18
US201261669480P 2012-07-09 2012-07-09

Publications (1)

Publication Number Publication Date
AR088379A1 true AR088379A1 (es) 2014-05-28

Family

ID=48136153

Family Applications (6)

Application Number Title Priority Date Filing Date
ARP120103887A AR088381A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con meglumina
ARP120103884A AR088460A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con aminoacidos
ARP120103889A AR088383A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con combinaciones de azucares y polioles
ARP120103885A AR088379A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con iones metalicos
ARP120103888A AR088382A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con xilitol
ARP120103886A AR088380A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con cloruro de sodio

Family Applications Before (3)

Application Number Title Priority Date Filing Date
ARP120103887A AR088381A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con meglumina
ARP120103884A AR088460A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con aminoacidos
ARP120103889A AR088383A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con combinaciones de azucares y polioles

Family Applications After (2)

Application Number Title Priority Date Filing Date
ARP120103888A AR088382A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con xilitol
ARP120103886A AR088380A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con cloruro de sodio

Country Status (28)

Country Link
US (21) US9302002B2 (es)
EP (6) EP2768525B1 (es)
JP (6) JP6104922B2 (es)
KR (7) KR20140091707A (es)
CN (6) CN104010658A (es)
AR (6) AR088381A1 (es)
AU (6) AU2012326084B2 (es)
BR (6) BR112014009131A8 (es)
CA (6) CA2851642A1 (es)
CY (1) CY1121843T1 (es)
DK (1) DK2768525T3 (es)
EA (6) EA028520B1 (es)
ES (1) ES2734070T3 (es)
HK (3) HK1200718A1 (es)
HR (1) HRP20191215T1 (es)
HU (1) HUE045624T2 (es)
IL (6) IL231826A0 (es)
IN (3) IN2014CN02527A (es)
LT (1) LT2768525T (es)
MX (7) MX2014004733A (es)
PL (1) PL2768525T3 (es)
PT (1) PT2768525T (es)
RS (1) RS59179B1 (es)
SG (6) SG11201401562RA (es)
SI (1) SI2768525T1 (es)
SM (1) SMT201900422T1 (es)
TW (6) TW201325606A (es)
WO (6) WO2013059412A1 (es)

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US10493151B2 (en) 2011-10-18 2019-12-03 Coherus Biosciences, Inc. Etanercept formulations stabilized with sodium chloride
US9302002B2 (en) * 2011-10-18 2016-04-05 Coherus Biosciences, Inc. Etanercept formulations stabilized with combinations of sugars and polyols
CA2878508A1 (en) 2012-07-09 2014-01-16 Coherus Biosciences, Inc. Etanercept formulations exhibiting marked reduction in sub-visible particles
PL2895188T3 (pl) * 2012-09-11 2018-06-29 Coherus Biosciences, Inc. Prawidłowo pofałdowany etanercept o wysokiej czystości i doskonałej wydajności
HK1221163A1 (zh) * 2013-05-02 2017-05-26 Mabxience, S.A. Tnfr:fc融合多肽的替代配方
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CA2926089C (en) * 2013-10-24 2022-08-30 Medimmune, Llc Stable, aqueous antibody formulations
JP6798882B2 (ja) 2013-11-29 2020-12-09 アレス トレーディング ソシエテ アノニム ＴＮＦＲ及びＦｃ領域を含む融合タンパク質の液体製剤
IS3008B (is) * 2014-05-14 2018-12-15 Calor ehf Stöðgandi lausnir fyrir prótín og peptíð
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
WO2015196091A1 (en) 2014-06-20 2015-12-23 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
JP6781508B2 (ja) 2014-11-18 2020-11-04 塩野義製薬株式会社 安定化されたペプチド組成物
AU2015371381A1 (en) * 2014-12-22 2017-07-20 Ares Trading S.A. Liquid pharmaceutical composition
EP3236942A1 (en) * 2014-12-23 2017-11-01 Drug Discovery Laboratory AS Protein compositions and use thereof
US10988527B2 (en) 2014-12-31 2021-04-27 Lg Chem, Ltd. Method for preparing TNFR-Fc fusion protein containing target content of impurities
CN104694355B (zh) * 2015-03-20 2016-09-28 吉林大学 葛根护肝保健酒及其制备方法
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