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PL2919801T3 - Stabilna kompozycja farmaceutyczna białka fuzyjnego TNFR:FC etanerceptu - Google Patents

Stabilna kompozycja farmaceutyczna białka fuzyjnego TNFR:FC etanerceptu

Info

Publication number
PL2919801T3
PL2919801T3 PL13795585T PL13795585T PL2919801T3 PL 2919801 T3 PL2919801 T3 PL 2919801T3 PL 13795585 T PL13795585 T PL 13795585T PL 13795585 T PL13795585 T PL 13795585T PL 2919801 T3 PL2919801 T3 PL 2919801T3
Authority
PL
Poland
Prior art keywords
tnfr
pharmaceutical composition
fusion protein
stable pharmaceutical
protein etanercept
Prior art date
Application number
PL13795585T
Other languages
English (en)
Inventor
Anjali Deepak Apte-Deshpande
Vaibhav Dyaneshwar Deokar
Rustom Sorab Mody
Original Assignee
Lupin Atlantis Holdings, Sa
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 Lupin Atlantis Holdings, Sa filed Critical Lupin Atlantis Holdings, Sa
Publication of PL2919801T3 publication Critical patent/PL2919801T3/pl

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K19/00Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Rheumatology (AREA)
  • Toxicology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Inorganic Chemistry (AREA)
PL13795585T 2012-10-26 2013-10-24 Stabilna kompozycja farmaceutyczna białka fuzyjnego TNFR:FC etanerceptu PL2919801T3 (pl)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN1235KO2012 2012-10-26
IN1236KO2012 2012-10-26
EP13795585.2A EP2919801B1 (en) 2012-10-26 2013-10-24 Stable pharmaceutical composition of the tnfr:fc fusion protein etanercept
PCT/IB2013/059612 WO2014064637A1 (en) 2012-10-26 2013-10-24 Stable pharmaceutical composition of tnfr:fc fusion protein

Publications (1)

Publication Number Publication Date
PL2919801T3 true PL2919801T3 (pl) 2021-01-25

Family

ID=54208810

Family Applications (1)

Application Number Title Priority Date Filing Date
PL13795585T PL2919801T3 (pl) 2012-10-26 2013-10-24 Stabilna kompozycja farmaceutyczna białka fuzyjnego TNFR:FC etanerceptu

Country Status (14)

Country Link
US (2) US10058589B2 (pl)
EP (1) EP2919801B1 (pl)
JP (1) JP6431844B2 (pl)
KR (1) KR102132050B1 (pl)
CN (1) CN104936607A (pl)
AU (1) AU2013336279B2 (pl)
BR (1) BR112015009462A2 (pl)
CA (1) CA2889271A1 (pl)
ES (1) ES2806946T3 (pl)
MX (1) MX366622B (pl)
PL (1) PL2919801T3 (pl)
PT (1) PT2919801T (pl)
RU (1) RU2664691C2 (pl)
WO (1) WO2014064637A1 (pl)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA012801B1 (ru) 2005-06-14 2009-12-30 Эмджен Инк. Самобуферирующиеся композиции белков
RU2663727C2 (ru) * 2013-05-02 2018-08-08 Мабксьенсе С.А. Альтернативные составы для химерных полипептидов tnfr:fc
JP6480154B2 (ja) * 2014-11-06 2019-03-06 持田製薬株式会社 エタネルセプトの凍結乾燥製剤
MX2015010517A (es) * 2015-08-13 2017-02-13 Landsteiner Scient S A De C V Composicion de estabilidad mejorada de etanercept.
US20190060241A1 (en) * 2016-04-13 2019-02-28 Medimmune, Llc Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
KR102413592B1 (ko) * 2016-10-21 2022-06-27 암젠 인크 약학적 제형 및 그의 제조 방법
CA3071930A1 (en) * 2017-08-08 2019-02-14 Csl Behring Ag Hemopexin formulations
US11253569B2 (en) 2018-05-03 2022-02-22 Seattle Children's Hospital Methods of treating Kawasaki Disease
WO2022264097A1 (en) 2021-06-17 2022-12-22 Lupin Limited Pharmaceutical composition of anti-tumour necrosis factor (anti-tnf) agent for management of infectious diseases caused by coronaviruses

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5215743A (en) 1988-04-13 1993-06-01 Maninder Singh Tumor necrosis factor formulations
US5997856A (en) * 1988-10-05 1999-12-07 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
DE4239877C1 (de) * 1992-11-27 1994-03-17 Boehringer Ingelheim Int Stabilisierte Superoxid-Dismutase (SOD)-Zusammensetzung
DE59805732D1 (de) * 1997-09-23 2002-10-31 Rentschler Biotech Gmbh Flüssige interferon-beta-formulierungen
ES2311094T3 (es) 2002-02-27 2009-02-01 Immunex Corporation Composicion estabilizada de tnfr-fc que comprende arginina.
US20040033228A1 (en) * 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
WO2004075918A1 (en) 2003-02-28 2004-09-10 Ares Trading S.A. Liquid formulations of tumor necrosis factor-binding proteins
ES2310122B1 (es) * 2007-04-20 2009-10-30 Instituto Cientifico Y Tecnologico De Navarra, S.A Nanoparticulas que comprenden una ciclodextrina y una molecula biologicamente activa y sus aplicaciones.
US9296806B2 (en) * 2008-04-30 2016-03-29 Wockhardt Limited Processes for refolding of insulin
NZ613809A (en) * 2009-05-04 2015-02-27 Abbvie Biotechnology Ltd Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
RU2600847C2 (ru) * 2010-05-10 2016-10-27 Интас Биофармасьютикалс Лимитед Жидкий состав полипептидов, содержащих fc-домен иммуноглобулина
RS55385B1 (sr) * 2010-11-11 2017-03-31 Abbvie Biotechnology Ltd Tečna formulacija anti-tnfalfa antitela visoke koncentracije
BR112013026883A2 (pt) * 2011-04-20 2021-12-07 Sandoz Ag Composição farmacêutica, kit compreendendo uma composição e método de produção de uma composição farmacêutica

Also Published As

Publication number Publication date
EP2919801B1 (en) 2020-04-29
CN104936607A (zh) 2015-09-23
RU2664691C2 (ru) 2018-08-21
MX366622B (es) 2019-07-16
MX2015005231A (es) 2015-10-29
KR102132050B1 (ko) 2020-07-10
BR112015009462A2 (pt) 2017-07-04
US20150283241A1 (en) 2015-10-08
CA2889271A1 (en) 2014-05-01
AU2013336279B2 (en) 2018-07-19
KR20150074069A (ko) 2015-07-01
JP2015535237A (ja) 2015-12-10
US20180236030A1 (en) 2018-08-23
EP2919801A1 (en) 2015-09-23
RU2015119603A (ru) 2016-12-20
WO2014064637A1 (en) 2014-05-01
AU2013336279A1 (en) 2015-05-14
ES2806946T3 (es) 2021-02-19
JP6431844B2 (ja) 2018-11-28
US10058589B2 (en) 2018-08-28
PT2919801T (pt) 2020-07-30

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