HK1200719A1 - Etanercept formulations stabilized with metal ions - Google Patents

Etanercept formulations stabilized with metal ions

Info

Publication number
HK1200719A1
HK1200719A1 HK15101254.2A HK15101254A HK1200719A1 HK 1200719 A1 HK1200719 A1 HK 1200719A1 HK 15101254 A HK15101254 A HK 15101254A HK 1200719 A1 HK1200719 A1 HK 1200719A1
Authority
HK
Hong Kong
Prior art keywords
metal ions
etanercept formulations
formulations stabilized
stabilized
etanercept
Prior art date
Application number
HK15101254.2A
Other languages
English (en)
Chinese (zh)
Inventor
馬克．曼寧
布萊恩．墨菲
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 HK1200719A1 publication Critical patent/HK1200719A1/xx

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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
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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
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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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    • 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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    • A61K47/16—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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    • A61K9/0012—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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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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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    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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
    • A61K47/08—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
    • 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
    • A61K9/14—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
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Rheumatology (AREA)
  • Pulmonology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Reproductive Health (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
HK15101254.2A 2011-10-18 2015-02-05 Etanercept formulations stabilized with metal ions HK1200719A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161548518P 2011-10-18 2011-10-18
US201261669480P 2012-07-09 2012-07-09
PCT/US2012/060739 WO2013059406A1 (fr) 2011-10-18 2012-10-18 Formulations d'étanercept stabilisées par des ions métalliques

Publications (1)

Publication Number Publication Date
HK1200719A1 true HK1200719A1 (en) 2015-08-14

Family

ID=48136153

Family Applications (6)

Application Number Title Priority Date Filing Date
HK15101254.2A HK1200719A1 (en) 2011-10-18 2015-02-05 Etanercept formulations stabilized with metal ions
HK15101255.1A HK1200851A1 (en) 2011-10-18 2015-02-05 Etanercept formulations stabilized with amino acids
HK15101256.0A HK1200720A1 (en) 2011-10-18 2015-02-05 Etanercept formulations stabilized with combinations of sugars and polyols
HK15101258.8A HK1200722A1 (en) 2011-10-18 2015-02-05 Etanercept formulations stabilized with meglumine
HK15101253.3A HK1200718A1 (en) 2011-10-18 2015-02-05 Etanercept formulations stabilized with sodium chloride
HK15101257.9A HK1200721A1 (en) 2011-10-18 2015-02-05 Etanercept formulations stabilized with xylitol

Family Applications After (5)

Application Number Title Priority Date Filing Date
HK15101255.1A HK1200851A1 (en) 2011-10-18 2015-02-05 Etanercept formulations stabilized with amino acids
HK15101256.0A HK1200720A1 (en) 2011-10-18 2015-02-05 Etanercept formulations stabilized with combinations of sugars and polyols
HK15101258.8A HK1200722A1 (en) 2011-10-18 2015-02-05 Etanercept formulations stabilized with meglumine
HK15101253.3A HK1200718A1 (en) 2011-10-18 2015-02-05 Etanercept formulations stabilized with sodium chloride
HK15101257.9A HK1200721A1 (en) 2011-10-18 2015-02-05 Etanercept formulations stabilized with xylitol

Country Status (27)

Country Link
US (21) US9302002B2 (fr)
EP (6) EP2768525B1 (fr)
JP (6) JP6104922B2 (fr)
KR (7) KR20140091706A (fr)
CN (6) CN104010654B (fr)
AR (6) AR088380A1 (fr)
AU (6) AU2012326170B2 (fr)
BR (6) BR112014009031A2 (fr)
CA (6) CA2851646A1 (fr)
CY (1) CY1121843T1 (fr)
DK (1) DK2768525T3 (fr)
EA (6) EA028520B1 (fr)
ES (1) ES2734070T3 (fr)
HK (6) HK1200719A1 (fr)
HR (1) HRP20191215T1 (fr)
HU (1) HUE045624T2 (fr)
IL (6) IL231827A0 (fr)
IN (3) IN2014CN02592A (fr)
LT (1) LT2768525T (fr)
MX (7) MX2014004725A (fr)
PL (1) PL2768525T3 (fr)
PT (1) PT2768525T (fr)
RS (1) RS59179B1 (fr)
SG (6) SG11201401519RA (fr)
SI (1) SI2768525T1 (fr)
TW (6) TW201325606A (fr)
WO (6) WO2013059407A1 (fr)

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BRPI0611901A2 (pt) 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
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
US10493151B2 (en) 2011-10-18 2019-12-03 Coherus Biosciences, Inc. Etanercept formulations stabilized with sodium chloride
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
CA2882551A1 (fr) 2012-09-11 2014-03-20 Coherus Biosciences, Inc. Etanercept correctement replie de purete elevee avec un excellent rendement
CN105873601A (zh) * 2013-05-02 2016-08-17 马柏克辛斯公司 TNFR:Fc融合多肽的替代配方
WO2015056613A1 (fr) * 2013-10-15 2015-04-23 Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 Préparation aqueuse de polypeptide stabilisée
MX2016004605A (es) * 2013-10-24 2016-11-14 Astrazeneca Ab Formulaciones de anticuerpos estables acuosas.
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
WO2015196091A1 (fr) 2014-06-20 2015-12-23 Reform Biologics, Llc Composés excipient réduisant la viscosité pour formulations à base de protéines
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
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
CN107205925B (zh) * 2014-12-22 2020-12-11 阿雷斯贸易股份有限公司 液体药物组合物
WO2016103034A1 (fr) * 2014-12-23 2016-06-30 Drug Discovery Laboratory As Compositions de protéines et leur utilisation
RU2670166C1 (ru) * 2014-12-31 2018-10-18 ЭлДжи КЕМ, ЛТД. Способ получения слитого белка tnfr-fc с заданным содержанием примесей
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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