CN104936607A - 稳定的TNFR:Fc融合蛋白药物组合物 - Google Patents

稳定的TNFR:Fc融合蛋白药物组合物 Download PDF

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Publication number
CN104936607A
CN104936607A CN201380062888.5A CN201380062888A CN104936607A CN 104936607 A CN104936607 A CN 104936607A CN 201380062888 A CN201380062888 A CN 201380062888A CN 104936607 A CN104936607 A CN 104936607A
Authority
CN
China
Prior art keywords
compositions
pharmaceutical composition
citrate buffer
sucrose
tnfr
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CN201380062888.5A
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English (en)
Chinese (zh)
Inventor
A·D·艾普特-德什潘德
V·D·德奥卡尔
R·S·莫迪
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lupin Ltd
Original Assignee
Lupin Ltd
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 Ltd filed Critical Lupin Ltd
Publication of CN104936607A publication Critical patent/CN104936607A/zh
Pending legal-status Critical Current

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    • 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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (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)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Rheumatology (AREA)
  • Toxicology (AREA)
  • Microbiology (AREA)
  • Mycology (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)
CN201380062888.5A 2012-10-26 2013-10-24 稳定的TNFR:Fc融合蛋白药物组合物 Pending CN104936607A (zh)

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 (1)

Publication Number Publication Date
CN104936607A true CN104936607A (zh) 2015-09-23

Family

ID=54208810

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201380062888.5A Pending CN104936607A (zh) 2012-10-26 2013-10-24 稳定的TNFR:Fc融合蛋白药物组合物

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)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

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
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

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011141926A2 (en) * 2010-05-10 2011-11-17 Intas Biopharmaceuticals Limited Liquid formulation of polypeptides containing an fc domain of an immunoglobulin
WO2012065072A2 (en) * 2010-11-11 2012-05-18 Abbott Biotechnology Ltd. IMPROVED HIGH CONCENTRATION ANTI-TNFα ANTIBODY LIQUID FORMULATIONS

Family Cites Families (11)

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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.
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.
CA2724510C (en) * 2008-04-30 2015-10-27 Wockhardt Research Centre Processes for refolding of insulin
RU2560701C2 (ru) * 2009-05-04 2015-08-20 Эббви Байотекнолоджи Лтд. Стабильные композиции с высокими концентрациями белков антител человека против tnf-альфа
EP2699265B1 (en) * 2011-04-20 2019-10-16 Sandoz AG STABLE PHARMACEUTICAL LIQUID FORMULATIONS OF THE FUSION PROTEIN TNFR:Fc

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011141926A2 (en) * 2010-05-10 2011-11-17 Intas Biopharmaceuticals Limited Liquid formulation of polypeptides containing an fc domain of an immunoglobulin
WO2012065072A2 (en) * 2010-11-11 2012-05-18 Abbott Biotechnology Ltd. IMPROVED HIGH CONCENTRATION ANTI-TNFα ANTIBODY LIQUID FORMULATIONS

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
YOSHIKO KITA,ET AL: "Salts and Glycine Increase Reversibility and Decrease Aggregation during Thermal Unfolding of Ribonuclease-A", 《BIOSCI.BIOTECHNOL.BIOCHEM.》 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Also Published As

Publication number Publication date
RU2664691C2 (ru) 2018-08-21
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
JP2015535237A (ja) 2015-12-10
PT2919801T (pt) 2020-07-30
US20180236030A1 (en) 2018-08-23
EP2919801B1 (en) 2020-04-29

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SE01 Entry into force of request for substantive examination
RJ01 Rejection of invention patent application after publication
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Application publication date: 20150923