HUE045624T2 - Magnézium ionokkal stabilizált etanercept készítmények - Google Patents

Magnézium ionokkal stabilizált etanercept készítmények

Info

Publication number
HUE045624T2
HUE045624T2 HUE12842352A HUE12842352A HUE045624T2 HU E045624 T2 HUE045624 T2 HU E045624T2 HU E12842352 A HUE12842352 A HU E12842352A HU E12842352 A HUE12842352 A HU E12842352A HU E045624 T2 HUE045624 T2 HU E045624T2
Authority
HU
Hungary
Prior art keywords
magnesium ions
etanercept formulations
formulations stabilized
stabilized
etanercept
Prior art date
Application number
HUE12842352A
Other languages
English (en)
Hungarian (hu)
Inventor
Mark Manning
Brian Murphy
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 HUE045624T2 publication Critical patent/HUE045624T2/hu

Links

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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
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    • 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
    • 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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/191—Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta
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    • 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
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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
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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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    • 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]
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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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    • 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

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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)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Toxicology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Reproductive Health (AREA)
  • Inorganic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Gynecology & Obstetrics (AREA)
  • Diabetes (AREA)
HUE12842352A 2011-10-18 2012-10-18 Magnézium ionokkal stabilizált etanercept készítmények HUE045624T2 (hu)

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
HUE045624T2 true HUE045624T2 (hu) 2020-01-28

Family

ID=48136153

Family Applications (1)

Application Number Title Priority Date Filing Date
HUE12842352A HUE045624T2 (hu) 2011-10-18 2012-10-18 Magnézium ionokkal stabilizált etanercept készítmények

Country Status (28)

Country Link
US (21) US9801942B2 (en:Method)
EP (6) EP2768531A4 (en:Method)
JP (6) JP6104922B2 (en:Method)
KR (7) KR20140079491A (en:Method)
CN (6) CN104010657A (en:Method)
AR (6) AR088380A1 (en:Method)
AU (6) AU2012326168B2 (en:Method)
BR (6) BR112014009031A2 (en:Method)
CA (6) CA2851635A1 (en:Method)
CY (1) CY1121843T1 (en:Method)
DK (1) DK2768525T3 (en:Method)
EA (6) EA026410B1 (en:Method)
ES (1) ES2734070T3 (en:Method)
HK (3) HK1200721A1 (en:Method)
HR (1) HRP20191215T1 (en:Method)
HU (1) HUE045624T2 (en:Method)
IL (6) IL231824A0 (en:Method)
IN (3) IN2014CN02592A (en:Method)
LT (1) LT2768525T (en:Method)
MX (7) MX2014004725A (en:Method)
PL (1) PL2768525T3 (en:Method)
PT (1) PT2768525T (en:Method)
RS (1) RS59179B1 (en:Method)
SG (6) SG11201401562RA (en:Method)
SI (1) SI2768525T1 (en:Method)
SM (1) SMT201900422T1 (en:Method)
TW (6) TWI644681B (en:Method)
WO (6) WO2013059412A1 (en:Method)

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TWI644681B (zh) * 2011-10-18 2018-12-21 美商柯赫勒斯生物科學有限公司 用金屬離子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
HK1209343A1 (en) 2012-07-09 2016-04-01 Coherus Biosciences, Inc. Etanercept formulations exhibiting marked reduction in sub-visible particles
RS57013B1 (sr) 2012-09-11 2018-05-31 Coherus Biosciences Inc Korektno savijeni etanercept sa visokom čistoćom i odličnim prinosom
US20160106844A1 (en) * 2013-05-02 2016-04-21 Mabxience, S.A. Alternative formulations for tnfr: fc fusion polypeptides
WO2015056613A1 (ja) * 2013-10-15 2015-04-23 Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 安定化されたポリペプチド水性製剤
KR102109053B1 (ko) * 2013-10-24 2020-05-13 아스트라제네카 아베 안정한 수성 항체 제제
BR112016011224A2 (pt) * 2013-11-29 2017-09-19 Ares Trading Sa Formulação líquida de uma proteína de fusão que compreende tnfr e região de fc
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
US20160074515A1 (en) 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
US20180200325A1 (en) * 2014-11-18 2018-07-19 Shionogi & Co., Ltd. Stabilized peptide composition
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
WO2016108569A1 (ko) * 2014-12-31 2016-07-07 주식회사 엘지생명과학 목적하는 함량으로 불순물을 포함하는 tnfr-fc 융합 단백질의 제조방법
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
MX389818B (es) * 2015-08-13 2025-03-20 Landsteiner Scient S A De C V Composicion de estabilidad mejorada de etanercept.
JP5938762B1 (ja) * 2015-09-01 2016-06-22 日揮株式会社 マイクロカプセル製剤及びその製造方法
CN105748414A (zh) * 2016-03-02 2016-07-13 张光泉 抗感染米卡芬净冻干组合物及其制备方法
JPWO2017179683A1 (ja) * 2016-04-15 2019-02-21 Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 ミカファンギンの安定化された医薬組成物
CN109982685B (zh) * 2016-10-21 2022-03-11 美国安进公司 药物配制品及其制备方法
WO2018080196A2 (ko) 2016-10-28 2018-05-03 (주)셀트리온 안정한 약제학적 제제
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