RU2664691C2 - Стабильная фармацевтическая композиция на основе слитого белка tnfr:fc - Google Patents

Стабильная фармацевтическая композиция на основе слитого белка tnfr:fc Download PDF

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Publication number
RU2664691C2
RU2664691C2 RU2015119603A RU2015119603A RU2664691C2 RU 2664691 C2 RU2664691 C2 RU 2664691C2 RU 2015119603 A RU2015119603 A RU 2015119603A RU 2015119603 A RU2015119603 A RU 2015119603A RU 2664691 C2 RU2664691 C2 RU 2664691C2
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Russia
Prior art keywords
pharmaceutical composition
etanercept
stable pharmaceutical
composition
present
Prior art date
Application number
RU2015119603A
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English (en)
Russian (ru)
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RU2015119603A (ru
Inventor
Анджали Деепак Апте-Дешпанде
Ваибхав Дьянешвар ДЕОКАР
Рустом Сораб Моди
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Люпин Лимитед
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Publication of RU2015119603A publication Critical patent/RU2015119603A/ru
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Publication of RU2664691C2 publication Critical patent/RU2664691C2/ru

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    • 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
    • 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
    • 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

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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)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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)
  • Genetics & Genomics (AREA)
  • Biophysics (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)
RU2015119603A 2012-10-26 2013-10-24 Стабильная фармацевтическая композиция на основе слитого белка tnfr:fc RU2664691C2 (ru)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
IN1235KO2012 2012-10-26
IN1235/KOL/2012 2012-10-26
IN1236/KOL/2012 2012-10-26
IN1236KO2012 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
RU2015119603A RU2015119603A (ru) 2016-12-20
RU2664691C2 true RU2664691C2 (ru) 2018-08-21

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
RU2015119603A RU2664691C2 (ru) 2012-10-26 2013-10-24 Стабильная фармацевтическая композиция на основе слитого белка tnfr:fc

Country Status (14)

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

Families Citing this family (10)

* 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
HK1221163A1 (zh) * 2013-05-02 2017-05-26 Mabxience, S.A. Tnfr:fc融合多肽的替代配方
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
EP3528787B1 (en) 2016-10-21 2026-01-07 Amgen Inc. Pharmaceutical formulations and methods of making the same
CA3071930A1 (en) * 2017-08-08 2019-02-14 Csl Behring Ag Hemopexin formulations
CA3042126A1 (en) 2018-05-03 2019-11-03 Seattle Children's Hospital (dba Seattle Children's Research Institute) 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
WO2025245826A1 (zh) * 2024-05-31 2025-12-04 荣昌生物制药(烟台)股份有限公司 环糊精及其衍生物作为保护剂在制备TACI-Fc融合蛋白液体药物制剂中的用途

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009133529A2 (en) * 2008-04-30 2009-11-05 Wockhardt Research Centre Processes for refolding of insulin
WO2011141926A2 (en) * 2010-05-10 2011-11-17 Intas Biopharmaceuticals Limited Liquid formulation of polypeptides containing an fc domain of an immunoglobulin
RU2460518C2 (ru) * 2007-04-20 2012-09-10 Институто Сьентифико И Текнолохико Де Наварра, С.А. Наночастицы, включающие циклодекстрин и биологически активную молекулу, и их применение

Family Cites Families (10)

* 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
PL215168B1 (pl) * 2002-02-27 2013-10-31 Immunex Corp Formulacja polipeptydowa
US20040033228A1 (en) * 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
ES2304602T3 (es) 2003-02-28 2008-10-16 Ares Trading S.A. Formulaciones liquidas de la proteina de union al factor de necrosis tumoral tbp-1.
RU2560701C2 (ru) * 2009-05-04 2015-08-20 Эббви Байотекнолоджи Лтд. Стабильные композиции с высокими концентрациями белков антител человека против tnf-альфа
AU2011325974B2 (en) * 2010-11-11 2016-10-27 Abbvie Biotechnology Ltd. Improved high concentration anti-TNFalpha antibody liquid formulations
EP2699265B1 (en) * 2011-04-20 2019-10-16 Sandoz AG STABLE PHARMACEUTICAL LIQUID FORMULATIONS OF THE FUSION PROTEIN TNFR:Fc

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2460518C2 (ru) * 2007-04-20 2012-09-10 Институто Сьентифико И Текнолохико Де Наварра, С.А. Наночастицы, включающие циклодекстрин и биологически активную молекулу, и их применение
WO2009133529A2 (en) * 2008-04-30 2009-11-05 Wockhardt Research Centre Processes for refolding of insulin
WO2011141926A2 (en) * 2010-05-10 2011-11-17 Intas Biopharmaceuticals Limited Liquid formulation of polypeptides containing an fc domain of an immunoglobulin

Also Published As

Publication number Publication date
EP2919801A1 (en) 2015-09-23
CA2889271A1 (en) 2014-05-01
JP6431844B2 (ja) 2018-11-28
KR20150074069A (ko) 2015-07-01
US10058589B2 (en) 2018-08-28
AU2013336279A1 (en) 2015-05-14
MX2015005231A (es) 2015-10-29
US20150283241A1 (en) 2015-10-08
RU2015119603A (ru) 2016-12-20
WO2014064637A1 (en) 2014-05-01
BR112015009462A2 (pt) 2017-07-04
MX366622B (es) 2019-07-16
PL2919801T3 (pl) 2021-01-25
KR102132050B1 (ko) 2020-07-10
AU2013336279B2 (en) 2018-07-19
ES2806946T3 (es) 2021-02-19
CN104936607A (zh) 2015-09-23
JP2015535237A (ja) 2015-12-10
PT2919801T (pt) 2020-07-30
US20180236030A1 (en) 2018-08-23
EP2919801B1 (en) 2020-04-29

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