AR088380A1 - Formulaciones de etanercept estabilizadas con cloruro de sodio - Google Patents

Formulaciones de etanercept estabilizadas con cloruro de sodio

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Publication number
AR088380A1
AR088380A1 ARP120103886A ARP120103886A AR088380A1 AR 088380 A1 AR088380 A1 AR 088380A1 AR P120103886 A ARP120103886 A AR P120103886A AR P120103886 A ARP120103886 A AR P120103886A AR 088380 A1 AR088380 A1 AR 088380A1
Authority
AR
Argentina
Prior art keywords
composition
weight
sodium chloride
peak
etanercept
Prior art date
Application number
ARP120103886A
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English (en)
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Coherus Biosciences Inc
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Publication date
Application filed by Coherus Biosciences Inc filed Critical Coherus Biosciences Inc
Publication of AR088380A1 publication Critical patent/AR088380A1/es

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    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • A—HUMAN NECESSITIES
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    • 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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    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
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    • 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
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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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    • A61K47/16—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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    • A61K47/50—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
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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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    • A61K9/00—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
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    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
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    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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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
    • 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
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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

Abstract

Reivindicación 1: Una formulación acuosa de etanercept estabilizada para reducir la inestabilidad, la agregación, el plegamiento incorrecto y/o la fragmentación de etanercept, dicha formulación comprende aproximadamente 25 a aproximadamente 75 mg/mI de etanercept y uno o más estabilizantes, en donde los estabilizantes se seleccionan entre el grupo que consiste de (i) cloruro de sodio y (ii) cloruro de sodio en combinación con sacarosa o trehalosa; y (iii) una combinación de cloruro de sodio, sacarosa y trehalosa. Reivindicación 2: La composición de acuerdo con la reivindicación 1, la cual además comprende uno o más componentes adicionales seleccionados entre: una solución tampón, un modificador de la tonicidad y un excipiente. Reivindicación 3: La composición de acuerdo con la reivindicación 2, en la cual el estabilizante consiste básicamente de cualquiera de: (a) cloruro de sodio; o (b) cloruro de sodio en combinación con sacarosa; o (c) cloruro de sodio en combinación con trehalosa; y en la cual formulación, opcionalmente, está libre o básicamente libre de arginina, y la formulación obtiene una estabilidad de almacenamiento a largo plazo caracterizada por al menos uno de: análisis de SEC a M₃ o T₂ o T₄ de: contenido de monómero mayor que aproximadamente 90%; contenido de agregados menor que aproximadamente 3% en peso; y el contenido de fragmento 3 menor que aproximadamente 5% en peso: y análisis de HIC a M₃ o T₂ o T₄ en donde la cantidad de la composición representada por el pico 1 del cromatograma de HIC es menor que aproximadamente 3% en peso; la cantidad de la composición representada por el pico 2 del cromatograma de HIC es mayor que 80% en peso; y la cantidad de la composición representada por el pico 3 del cromatograma de HIC es menor que aproximadamente 20% en peso. Reivindicación 11: La composición de acuerdo con la reivindicación 2, la cual comprende: aproximadamente 50 mg/mI de etanercept; aproximadamente 120 mM de cloruro de sodio; aproximadamente 10 a 30 mM de fosfato de sodio; aproximadamente 1% en peso de sacarosa; aproximadamente 5 mM de arginina, y que tiene pH de aproximadamente 6,3 a 6,5. Reivindicación 16: La composición de acuerdo con la reivindicación 1, la cual no contiene arginina, o está básicamente libre de arginina, en la que la composición, a M₃ o T₂ o T₄ obtiene una estabilidad de almacenamiento a largo plazo que cumple uno o ambos de los siguientes criterios: (A) estabilidad comparable a, o mejor que, el etanercept disponible en el comercio y comercializado con la marca comercial Enbrel®, medida por (i) análisis de SEC de las cantidades de agregado(s), monómero y fragmento 3 en la composición (como se define en la memoria descriptiva) y (ii) análisis de HIC de cantidades de material en la composición correspondientes a los picos 1, 2 y 3 del cromatograma de HIC (como se define en la memoria descriptiva); y (B) un cromatograma de HIC en el que (i) el pico 3 está ausente, o básicamente ausente y (ii) el pico 2 representa mayor que aproximadamente 95% en peso de la composición; un cromatograma de SEC que contiene básicamente ningún pico correspondiente al(a los) agregado(s); y un cromatograma de SEC en el que el contenido de monómero representa por lo menos aproximadamente 95% en peso de la composición.
ARP120103886A 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con cloruro de sodio AR088380A1 (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
AR088380A1 true AR088380A1 (es) 2014-05-28

Family

ID=48136153

Family Applications (6)

Application Number Title Priority Date Filing Date
ARP120103884A AR088460A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con aminoacidos
ARP120103886A AR088380A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con cloruro de sodio
ARP120103888A AR088382A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con xilitol
ARP120103887A AR088381A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con meglumina
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

Family Applications Before (1)

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ARP120103884A AR088460A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con aminoacidos

Family Applications After (4)

Application Number Title Priority Date Filing Date
ARP120103888A AR088382A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con xilitol
ARP120103887A AR088381A1 (es) 2011-10-18 2012-10-18 Formulaciones de etanercept estabilizadas con meglumina
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

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US (21) US9393305B2 (es)
EP (6) EP2768533A4 (es)
JP (6) JP6110393B2 (es)
KR (7) KR20140091705A (es)
CN (6) CN103998060B (es)
AR (6) AR088460A1 (es)
AU (6) AU2012326084B2 (es)
BR (6) BR112014009131A8 (es)
CA (6) CA2851642A1 (es)
CY (1) CY1121843T1 (es)
DK (1) DK2768525T3 (es)
EA (6) EA026410B1 (es)
ES (1) ES2734070T3 (es)
HK (6) HK1200720A1 (es)
HR (1) HRP20191215T1 (es)
HU (1) HUE045624T2 (es)
IL (6) IL231829A0 (es)
IN (3) IN2014CN02527A (es)
LT (1) LT2768525T (es)
MX (7) MX2014004725A (es)
PL (1) PL2768525T3 (es)
PT (1) PT2768525T (es)
RS (1) RS59179B1 (es)
SG (6) SG11201401517VA (es)
SI (1) SI2768525T1 (es)
TW (6) TWI619504B (es)
WO (6) WO2013059410A1 (es)

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US9393305B2 (en) * 2011-10-18 2016-07-19 Coherus Biosciences, Inc. Etanercept formulations stabilized with xylitol
US10493151B2 (en) 2011-10-18 2019-12-03 Coherus Biosciences, Inc. Etanercept formulations stabilized with sodium chloride
MX2015000337A (es) 2012-07-09 2015-09-25 Coherus Biosciences Inc Formulaciones de etanercept que exhiben reduccion notable en particulas subvisibles.
WO2014043103A1 (en) * 2012-09-11 2014-03-20 Coherus Biosciences, Inc. Correctly folded etanercept in high purity and excellent yield
WO2014177548A1 (en) * 2013-05-02 2014-11-06 Mabxience, S.A. Alternative formulations for tnfr: fc fusion polypeptides
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