ES2395035T3 - Formulaciones de antagonistas de la IL-1 - Google Patents

Formulaciones de antagonistas de la IL-1 Download PDF

Info

Publication number
ES2395035T3
ES2395035T3 ES05789252T ES05789252T ES2395035T3 ES 2395035 T3 ES2395035 T3 ES 2395035T3 ES 05789252 T ES05789252 T ES 05789252T ES 05789252 T ES05789252 T ES 05789252T ES 2395035 T3 ES2395035 T3 ES 2395035T3
Authority
ES
Spain
Prior art keywords
formulation
lyophilized
approximately
antagonist
reconstituted
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.)
Expired - Lifetime
Application number
ES05789252T
Other languages
English (en)
Spanish (es)
Inventor
Daniel Dix
Katherine Bowers
Goolcharran Chimanlall
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.)
Regeneron Pharmaceuticals Inc
Original Assignee
Regeneron Pharmaceuticals 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 Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Application granted granted Critical
Publication of ES2395035T3 publication Critical patent/ES2395035T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K38/1703Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • 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
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/20Interleukins [IL]
    • A61K38/2006IL-1
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/54Interleukins [IL]
    • C07K14/545IL-1
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers

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)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Dermatology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
ES05789252T 2004-08-17 2005-08-17 Formulaciones de antagonistas de la IL-1 Expired - Lifetime ES2395035T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US60213704P 2004-08-17 2004-08-17
US602137P 2004-08-17
PCT/US2005/029428 WO2006023665A2 (en) 2004-08-17 2005-08-17 Il-1 antagonist formulations

Publications (1)

Publication Number Publication Date
ES2395035T3 true ES2395035T3 (es) 2013-02-07

Family

ID=35968186

Family Applications (1)

Application Number Title Priority Date Filing Date
ES05789252T Expired - Lifetime ES2395035T3 (es) 2004-08-17 2005-08-17 Formulaciones de antagonistas de la IL-1

Country Status (14)

Country Link
US (1) US7365165B2 (enExample)
EP (2) EP2311871A3 (enExample)
JP (2) JP4948410B2 (enExample)
CN (1) CN101014617B (enExample)
AU (1) AU2005277357B2 (enExample)
BR (1) BRPI0514411B8 (enExample)
CA (1) CA2576519C (enExample)
DK (1) DK1778723T3 (enExample)
ES (1) ES2395035T3 (enExample)
PL (1) PL1778723T3 (enExample)
PT (1) PT1778723E (enExample)
SI (1) SI1778723T1 (enExample)
WO (1) WO2006023665A2 (enExample)
ZA (1) ZA200701529B (enExample)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2107069B1 (en) 2003-08-05 2013-01-16 Novo Nordisk A/S Novel insulin derivatives
EP2505593A1 (en) 2005-12-28 2012-10-03 Novo Nordisk A/S Compositions comprising an acylated insulin and zinc and method of making the said compositions
US7608261B2 (en) 2006-06-16 2009-10-27 Regeneron Pharmacuticals, Inc. VEGF antagonist formulations suitable for intravitreal administration
CA2687246A1 (en) * 2007-06-01 2008-12-11 Acologix, Inc. High temperature stable peptide formulation
CN101677947B (zh) 2007-06-13 2013-07-17 诺沃-诺迪斯克有限公司 包含胰岛素衍生物的药物制剂
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
US9492375B2 (en) 2008-07-23 2016-11-15 Warsaw Orthopedic, Inc. Foam carrier for bone grafting
AU2009309623B9 (en) 2008-10-30 2014-10-02 Novo Nordisk A/S Treating diabetes melitus using insulin injections with less than daily injection frequency
US8853150B2 (en) 2010-07-29 2014-10-07 Eleven Biotherapeutics, Inc. Chimeric IL-1 receptor type I antagonists
RU2013123515A (ru) 2010-10-27 2014-12-10 Ново Нордиск А/С Лечение сахарного диабета с помощью инъекций инсулина, вводимых с различными интервалами
RU2768492C2 (ru) 2011-11-18 2022-03-24 Ридженерон Фармасьютикалз, Инк. Полимерные белковые микрочастицы
AU2012330497B2 (en) 2012-04-04 2016-08-04 Polaris Group Methods of treating with arginine deiminase
WO2014035361A1 (en) * 2012-08-26 2014-03-06 R-PHARM, CJSC (Closed Joint Stock Company) IL-1β INHIBITOR COMPOSITION AND USE THEREOF
SG10201707477SA (en) 2013-03-13 2017-10-30 Eleven Biotherapeutics Inc Chimeric cytokine formulations for ocular delivery
WO2014177623A1 (en) 2013-04-30 2014-11-06 Novo Nordisk A/S Novel administration regime
CN109982716B (zh) 2016-09-16 2024-05-10 白血球保健股份有限公司 在加工过程中稳定生物制药药物产品的新方法
JP7051132B2 (ja) 2016-09-16 2022-04-11 ロイコケア・アクチェンゲゼルシャフト ワクチン接種または遺伝子治療のための効率的なウイルスベクターベースの組成物を得るための新規方法
EP3534963B1 (en) 2016-11-02 2024-04-17 Polaris Group Formulations of pegylated arginine deiminase
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin
US12343383B2 (en) 2019-07-12 2025-07-01 Novo Nordisk A/S High concentration insulin formulation

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2309692A (en) * 1991-07-03 1993-02-11 Cryolife, Inc. Method for stabilization of biomaterials
JP3822383B2 (ja) * 1993-12-17 2006-09-20 持田製薬株式会社 可溶性トロンボモジュリン含有組成物
AU695129B2 (en) * 1995-02-06 1998-08-06 Genetics Institute, Llc Formulations for IL-12
US5763401A (en) * 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
JP4172842B2 (ja) * 1997-05-02 2008-10-29 生化学工業株式会社 コンドロイチナーゼ組成物
US6436897B2 (en) 1998-06-01 2002-08-20 Celtrix Pharmaceuticals, Inc. Pharmaceutical formulations for IGF/IGFBP
US6927044B2 (en) 1998-09-25 2005-08-09 Regeneron Pharmaceuticals, Inc. IL-1 receptor based cytokine traps
US6472179B2 (en) * 1998-09-25 2002-10-29 Regeneron Pharmaceuticals, Inc. Receptor based antagonists and methods of making and using
US20030113316A1 (en) * 2001-07-25 2003-06-19 Kaisheva Elizabet A. Stable lyophilized pharmaceutical formulation of IgG antibodies
DE10204792A1 (de) * 2002-02-06 2003-08-14 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Immuncytokine
WO2004062646A1 (en) * 2003-01-08 2004-07-29 Chiron Corporation Stabilized lyophilized compositions comprising tissue factor pathway inhibitor or tissue factor pathway inhibitor variants

Also Published As

Publication number Publication date
CN101014617B (zh) 2011-03-30
WO2006023665A2 (en) 2006-03-02
BRPI0514411A (pt) 2008-06-10
CA2576519A1 (en) 2006-03-02
US7365165B2 (en) 2008-04-29
CN101014617A (zh) 2007-08-08
JP2008510716A (ja) 2008-04-10
JP4948410B2 (ja) 2012-06-06
ZA200701529B (en) 2008-09-25
BRPI0514411B1 (pt) 2020-09-15
AU2005277357A1 (en) 2006-03-02
HK1105421A1 (en) 2008-02-15
PL1778723T3 (pl) 2013-03-29
WO2006023665A3 (en) 2006-08-03
JP2012121894A (ja) 2012-06-28
EP2311871A2 (en) 2011-04-20
DK1778723T3 (da) 2012-12-03
EP2311871A3 (en) 2012-08-08
AU2005277357B2 (en) 2011-08-04
US20060040852A1 (en) 2006-02-23
CA2576519C (en) 2013-05-21
PT1778723E (pt) 2013-01-25
EP1778723A2 (en) 2007-05-02
SI1778723T1 (sl) 2013-02-28
BRPI0514411B8 (pt) 2021-05-25
EP1778723B1 (en) 2012-11-14

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