SI2768525T1 - Formulacije etanercepta, stabilizirane z magnezijevimi ioni - Google Patents

Formulacije etanercepta, stabilizirane z magnezijevimi ioni

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Publication number
SI2768525T1
SI2768525T1 SI201231635T SI201231635T SI2768525T1 SI 2768525 T1 SI2768525 T1 SI 2768525T1 SI 201231635 T SI201231635 T SI 201231635T SI 201231635 T SI201231635 T SI 201231635T SI 2768525 T1 SI2768525 T1 SI 2768525T1
Authority
SI
Slovenia
Prior art keywords
magnesium ions
etanercept formulations
formulations stabilized
stabilized
etanercept
Prior art date
Application number
SI201231635T
Other languages
English (en)
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 SI2768525T1 publication Critical patent/SI2768525T1/sl

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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
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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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    • A61K39/395—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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    • A61K47/16—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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    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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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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    • 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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    • 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
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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
    • 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
SI201231635T 2011-10-18 2012-10-18 Formulacije etanercepta, stabilizirane z magnezijevimi ioni SI2768525T1 (sl)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201161548518P 2011-10-18 2011-10-18
US201261669480P 2012-07-09 2012-07-09
EP12842352.2A EP2768525B1 (en) 2011-10-18 2012-10-18 Etanercept formulations stabilized with magnesium ions
PCT/US2012/060739 WO2013059406A1 (en) 2011-10-18 2012-10-18 Etanercept formulations stabilized with metal ions

Publications (1)

Publication Number Publication Date
SI2768525T1 true SI2768525T1 (sl) 2019-10-30

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SI201231635T SI2768525T1 (sl) 2011-10-18 2012-10-18 Formulacije etanercepta, stabilizirane z magnezijevimi ioni

Country Status (27)

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

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IS3008B (is) * 2014-05-14 2018-12-15 Calor ehf Stöðgandi lausnir fyrir prótín og peptíð
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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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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
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MX2017013995A (es) * 2017-10-31 2019-05-01 Probiomed S A De C V Formulacion farmaceutica estable de una proteina de fusion.
EP3718531A4 (en) * 2017-11-30 2023-08-16 Bio-Thera Solutions, Ltd. LIQUID PREPARATION OF A HUMANIZED ANTIBODY FOR THE TREATMENT OF IL-6-RELATED DISEASES
KR102494021B1 (ko) * 2017-12-22 2023-02-06 삼성바이오에피스 주식회사 Vegf 길항제를 포함하는 액상 조성물
CA3042126A1 (en) 2018-05-03 2019-11-03 Michael A. Portman Methods of treating kawasaki disease
CN111228225B (zh) * 2018-11-28 2022-08-26 鲁南制药集团股份有限公司 一种重组人肿瘤坏死因子受体-Fc融合蛋白冻干制剂
GB201911461D0 (en) * 2019-08-09 2019-09-25 Arecor Ltd Novel composition
JP2023502777A (ja) * 2019-11-26 2023-01-25 コメラ ライフ サイエンシズ，インコーポレイテッド バイオポリマー製剤のための賦形剤化合物
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CN114788809B (zh) * 2022-01-25 2023-04-14 江苏广承药业有限公司 一种氯雷他定液体制剂

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