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MX2015005231A - Composicion farmaceutica estable de la proteina de fusion tnfr:fc. - Google Patents

Composicion farmaceutica estable de la proteina de fusion tnfr:fc.

Info

Publication number
MX2015005231A
MX2015005231A MX2015005231A MX2015005231A MX2015005231A MX 2015005231 A MX2015005231 A MX 2015005231A MX 2015005231 A MX2015005231 A MX 2015005231A MX 2015005231 A MX2015005231 A MX 2015005231A MX 2015005231 A MX2015005231 A MX 2015005231A
Authority
MX
Mexico
Prior art keywords
tnfr
fusion protein
stable pharmaceutical
pharmaceutical composition
relates
Prior art date
Application number
MX2015005231A
Other languages
English (en)
Other versions
MX366622B (es
Inventor
Vaibhav Dyaneshwar Deokar
Rustom Sorab Mody
Anjali Deepak Apte-Deshpande
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 MX2015005231A publication Critical patent/MX2015005231A/es
Publication of MX366622B publication Critical patent/MX366622B/es

Links

Classifications

    • 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
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • 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
    • 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
    • A61K9/19—Particulate 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (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)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Rheumatology (AREA)
  • Toxicology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (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)

Abstract

La presente invención se refiere a composiciones farmacéuticas estables que comprenden proteína de fusión Fc de receptor de factor de necrosis tumoral (TNFR:Fc). Más concretamente, se refiere a composiciones farmacéuticas estables que comprenden proteína de fusión Fc de receptor de factor de necrosis tumoral (TNFR:Fc), tampón de fosfato-citrato. También se refiere a los métodos de fabricación de la composición, método de administración y paquetes que contienen la misma.
MX2015005231A 2012-10-26 2013-10-24 Composicion farmaceutica estable de la proteina de fusion tnfr:fc. MX366622B (es)

Applications Claiming Priority (3)

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

Publications (2)

Publication Number Publication Date
MX2015005231A true MX2015005231A (es) 2015-10-29
MX366622B MX366622B (es) 2019-07-16

Family

ID=54208810

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2015005231A MX366622B (es) 2012-10-26 2013-10-24 Composicion farmaceutica estable de la proteina de fusion tnfr:fc.

Country Status (14)

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

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2776657T3 (es) 2005-06-14 2020-07-31 Amgen Inc Formulaciones de proteínas autotamponantes
US20160106844A1 (en) * 2013-05-02 2016-04-21 Mabxience, S.A. Alternative formulations for tnfr: fc fusion polypeptides
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
MX389818B (es) * 2015-08-13 2025-03-20 Landsteiner Scient S A De C V Composicion de estabilidad mejorada de etanercept.
ES2962373T3 (es) * 2016-04-13 2024-03-18 Medimmune Llc Uso de aminoácidos como compuestos estabilizadores en composiciones farmacéuticas que contienen altas concentraciones de agentes terapéuticos basados en proteínas
CA3040899A1 (en) * 2016-10-21 2018-04-26 Amgen Inc. Pharmaceutical formulations and methods of making the same
IL272167B2 (en) * 2017-08-08 2024-02-01 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
ES2223017T5 (es) * 1997-09-23 2010-10-15 Rentschler Biotechnologie Gmbh Formulaciones liquidas de un interferon beta.
PT1946776T (pt) * 2002-02-27 2017-03-17 Immunex Corp Composição de tnfr-fc estabilizada compreendendo arginina
US20040033228A1 (en) * 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
PL213501B1 (pl) 2003-02-28 2013-03-29 Ares Trading Sa Wodny preparat bialka wiazacego czynnik martwicy nowotworu i sposób jego wytwarzania
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.
JP5677938B2 (ja) * 2008-04-30 2015-02-25 ウォックハート リサーチ センター インシュリンの再折りたたみ方法
CN102458469B (zh) * 2009-05-04 2014-12-24 艾伯维生物技术有限公司 人抗TNF-α抗体的稳定高蛋白质浓度制剂
CN102946858B (zh) * 2010-05-10 2015-09-30 英塔斯制药有限公司 含有免疫球蛋白Fc的多肽的液体制剂
AU2011325974B2 (en) 2010-11-11 2016-10-27 Abbvie Biotechnology Ltd. Improved high concentration anti-TNFalpha antibody liquid formulations
JP5996631B2 (ja) * 2011-04-20 2016-09-21 サンド・アクチエンゲゼルシヤフト ＴＮＦＲ：Ｆｃ融合タンパク質の安定した医薬液剤

Also Published As

Publication number Publication date
WO2014064637A1 (en) 2014-05-01
MX366622B (es) 2019-07-16
US20150283241A1 (en) 2015-10-08
KR20150074069A (ko) 2015-07-01
RU2664691C2 (ru) 2018-08-21
PL2919801T3 (pl) 2021-01-25
AU2013336279A1 (en) 2015-05-14
RU2015119603A (ru) 2016-12-20
CN104936607A (zh) 2015-09-23
ES2806946T3 (es) 2021-02-19
AU2013336279B2 (en) 2018-07-19
JP6431844B2 (ja) 2018-11-28
US10058589B2 (en) 2018-08-28
EP2919801B1 (en) 2020-04-29
US20180236030A1 (en) 2018-08-23
EP2919801A1 (en) 2015-09-23
BR112015009462A2 (pt) 2017-07-04
JP2015535237A (ja) 2015-12-10
CA2889271A1 (en) 2014-05-01
KR102132050B1 (ko) 2020-07-10
PT2919801T (pt) 2020-07-30

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