IN2014CN02527A - - Google Patents

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Publication number
IN2014CN02527A
IN2014CN02527A IN2527CHN2014A IN2014CN02527A IN 2014CN02527 A IN2014CN02527 A IN 2014CN02527A IN 2527CHN2014 A IN2527CHN2014 A IN 2527CHN2014A IN 2014CN02527 A IN2014CN02527 A IN 2014CN02527A
Authority
IN
India
Prior art keywords
methods
etanercept
compositions
stabilized
administration
Prior art date
Application number
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 IN2014CN02527A publication Critical patent/IN2014CN02527A/en

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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
    • 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
    • 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
    • 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
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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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    • A61K47/00—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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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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    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
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    • A—HUMAN NECESSITIES
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    • 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
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • 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
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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
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (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)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Genetics & Genomics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Reproductive Health (AREA)
  • Inorganic Chemistry (AREA)
  • Pregnancy & Childbirth (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
IN2527CHN2014 2011-10-18 2012-10-18 IN2014CN02527A (el)

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/US2012/060738 WO2013059405A1 (en) 2011-10-18 2012-10-18 Etanercept formulations stabilized with amino acids

Publications (1)

Publication Number Publication Date
IN2014CN02527A true IN2014CN02527A (el) 2015-06-26

Family

ID=48136153

Family Applications (3)

Application Number Title Priority Date Filing Date
IN2592CHN2014 IN2014CN02592A (el) 2011-10-18 2012-10-18
IN2591CHN2014 IN2014CN02591A (el) 2011-10-18 2012-10-18
IN2527CHN2014 IN2014CN02527A (el) 2011-10-18 2012-10-18

Family Applications Before (2)

Application Number Title Priority Date Filing Date
IN2592CHN2014 IN2014CN02592A (el) 2011-10-18 2012-10-18
IN2591CHN2014 IN2014CN02591A (el) 2011-10-18 2012-10-18

Country Status (27)

Country Link
US (21) US9801942B2 (el)
EP (6) EP2768525B1 (el)
JP (6) JP6104922B2 (el)
KR (7) KR20140091707A (el)
CN (6) CN103998060B (el)
AR (6) AR088382A1 (el)
AU (6) AU2012326168B2 (el)
BR (6) BR112014009022A2 (el)
CA (6) CA2851639C (el)
CY (1) CY1121843T1 (el)
DK (1) DK2768525T3 (el)
EA (6) EA027325B1 (el)
ES (1) ES2734070T3 (el)
HK (6) HK1200721A1 (el)
HR (1) HRP20191215T1 (el)
HU (1) HUE045624T2 (el)
IL (6) IL231824A0 (el)
IN (3) IN2014CN02592A (el)
LT (1) LT2768525T (el)
MX (7) MX2014004728A (el)
PL (1) PL2768525T3 (el)
PT (1) PT2768525T (el)
RS (1) RS59179B1 (el)
SG (6) SG11201401562RA (el)
SI (1) SI2768525T1 (el)
TW (6) TW201325606A (el)
WO (6) WO2013059412A1 (el)

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EP1909831A4 (en) 2005-06-14 2013-02-20 Amgen Inc PREPARATIONS OF SPONTANEOUS TAMPING PROTEINS
SG11201401562RA (en) * 2011-10-18 2014-09-26 Coherus Biosciences Inc Etanercept formulations stabilized with sodium chloride
US10485869B2 (en) 2011-10-18 2019-11-26 Coherus Biosciences, Inc. Etanercept formulations stabilized with meglumine
CN104661651A (zh) * 2012-07-09 2015-05-27 科荣生生物科学公司 表现出不溶性微粒显著减少的依那西普制剂
ES2657377T3 (es) * 2012-09-11 2018-03-05 Coherus Biosciences, Inc. Etanercept plegado correctamente con alta pureza y excelente rendimiento
CA2911068A1 (en) * 2013-05-02 2014-11-06 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
CN113350278B (zh) * 2013-10-24 2023-03-24 阿斯利康(瑞典)有限公司 稳定的水性抗体配制品
CA2930227C (en) * 2013-11-29 2021-09-28 Ares Trading S.A. A liquid formulation of a fusion protein comprising tnfr and fc region
IS3008B (is) * 2014-05-14 2018-12-15 Calor ehf Stöðgandi lausnir fyrir prótín og peptíð
WO2015196091A1 (en) 2014-06-20 2015-12-23 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
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
US20180200325A1 (en) * 2014-11-18 2018-07-19 Shionogi & Co., Ltd. Stabilized peptide composition
EP3236990B1 (en) * 2014-12-22 2020-09-02 Ares Trading S.A. Liquid pharmaceutical composition
WO2016103034A1 (en) * 2014-12-23 2016-06-30 Drug Discovery Laboratory As Protein compositions and use thereof
MX2017008633A (es) 2014-12-31 2018-04-26 Lg Chemical Ltd Procedimiento para preparar una proteina de fusion tnfr-fc que contiene un contenido objetivo de impurezas.
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
MX2015010517A (es) * 2015-08-13 2017-02-13 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
JP6884858B2 (ja) 2016-10-21 2021-06-09 アムジエン・インコーポレーテツド 医薬製剤及びその製造方法
KR20180046888A (ko) 2016-10-28 2018-05-09 (주)셀트리온 안정한 약제학적 제제
MX2017013995A (es) * 2017-10-31 2019-05-01 Probiomed S A De C V Formulacion farmaceutica estable de una proteina de fusion.
CN111110842B (zh) * 2017-11-30 2020-12-11 百奥泰生物制药股份有限公司 一种治疗il-6相关疾病的人源化抗体的液体制剂
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