AU2005277357B2 - IL-1 antagonist formulations - Google Patents

IL-1 antagonist formulations Download PDF

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Publication number
AU2005277357B2
AU2005277357B2 AU2005277357A AU2005277357A AU2005277357B2 AU 2005277357 B2 AU2005277357 B2 AU 2005277357B2 AU 2005277357 A AU2005277357 A AU 2005277357A AU 2005277357 A AU2005277357 A AU 2005277357A AU 2005277357 B2 AU2005277357 B2 AU 2005277357B2
Authority
AU
Australia
Prior art keywords
formulation
antagonist
lyophilized
sucrose
trap
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.)
Ceased
Application number
AU2005277357A
Other languages
English (en)
Other versions
AU2005277357A1 (en
Inventor
Katherine Bowers
Goolcharran Chimanlall
Daniel Dix
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
Publication of AU2005277357A1 publication Critical patent/AU2005277357A1/en
Application granted granted Critical
Publication of AU2005277357B2 publication Critical patent/AU2005277357B2/en
Anticipated expiration legal-status Critical
Ceased 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)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
AU2005277357A 2004-08-17 2005-08-17 IL-1 antagonist formulations Ceased AU2005277357B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US60213704P 2004-08-17 2004-08-17
US60/602,137 2004-08-17
PCT/US2005/029428 WO2006023665A2 (en) 2004-08-17 2005-08-17 Il-1 antagonist formulations

Publications (2)

Publication Number Publication Date
AU2005277357A1 AU2005277357A1 (en) 2006-03-02
AU2005277357B2 true AU2005277357B2 (en) 2011-08-04

Family

ID=35968186

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2005277357A Ceased AU2005277357B2 (en) 2004-08-17 2005-08-17 IL-1 antagonist formulations

Country Status (14)

Country Link
US (1) US7365165B2 (enExample)
EP (2) EP1778723B1 (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
WO2005012347A2 (en) 2003-08-05 2005-02-10 Novo Nordisk A/S Novel insulin derivatives
PT1969004E (pt) 2005-12-28 2011-11-25 Novo Nordisk As Composições que compreendem uma insulina acilada e zinco e método para criar tais composições
RU2432155C3 (ru) 2006-06-16 2017-11-17 Ридженерон Фармасьютикалз, Инк. Составы антагониста vegf, подходящие для интравитреального введения
JP2010530846A (ja) * 2007-06-01 2010-09-16 アコロジックス インコーポレイティッド 高温で安定なペプチド製剤
US9034818B2 (en) 2007-06-13 2015-05-19 Novo Nordisk A/S Pharmaceutical formulations comprising an insulin derivative
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
ES2607003T3 (es) 2008-10-30 2017-03-28 Novo Nordisk A/S Tratamiento de diabetes mellitus utilizando inyecciones de insulina con una frecuencia de inyección inferior a la diaria
PL2598526T4 (pl) 2010-07-29 2019-05-31 Eleven Biotherapeutics Inc Agoniści i antagoniści receptora typu i chimerycznej interleukiny il-1
JP6049625B2 (ja) 2010-10-27 2016-12-21 ノヴォ ノルディスク アー/エス 様々な注射間隔を用いて施されるインスリン注射を使用する、真性糖尿病の治療
PT3574897T (pt) 2011-11-18 2022-04-06 Regeneron Pharma Formulação de libertação prolongada compreendendo micropartículas de proteína polimérica para utilização no vítreo do olho para o tratamento de distúrbios oculares vasculares
EP4582090A3 (en) * 2012-04-04 2025-09-17 Polaris Group Composition comprising pegylated arginine deiminase
WO2014035361A1 (en) * 2012-08-26 2014-03-06 R-PHARM, CJSC (Closed Joint Stock Company) IL-1β INHIBITOR COMPOSITION AND USE THEREOF
CN107693781B (zh) 2013-03-13 2021-11-09 巴扎德制药公司 用于眼部递送的嵌合细胞因子制剂
US10137172B2 (en) 2013-04-30 2018-11-27 Novo Nordisk A/S Administration regime
KR20190053908A (ko) 2016-09-16 2019-05-20 로이코케어 아게 가공 동안 바이오 의약품의 안정화를 위한 신규한 방법
EP3512939A1 (en) 2016-09-16 2019-07-24 Leukocare AG A novel method for obtaining efficient viral vector-based compositions for vaccination or gene therapy
WO2018085551A2 (en) 2016-11-02 2018-05-11 Polaris Group Formulations of pegylated arginine deiminase
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin
CN114096269B (zh) 2019-07-12 2024-06-11 诺和诺德股份有限公司 高浓度胰岛素制剂

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993000807A1 (en) * 1991-07-03 1993-01-21 Cryolife, Inc. Method for stabilization of biomaterials
US20030143697A1 (en) * 1998-09-25 2003-07-31 Neil Stahl Receptor based antagonists and methods of making and using

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
ATE216590T1 (de) * 1995-02-06 2002-05-15 Genetics Inst Arzneimittelformulierungen für 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
US6472179B2 (en) * 1998-09-25 2002-10-29 Regeneron Pharmaceuticals, Inc. Receptor based antagonists and methods of making and using
CA2454587C (en) * 2001-07-25 2012-11-13 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
DE10204792A1 (de) * 2002-02-06 2003-08-14 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Immuncytokine
ES2311789T3 (es) * 2003-01-08 2009-02-16 Novartis Vaccines And Diagnostics, Inc. Composiciones liofilizadas estabilizadas que comprenden inhibidor de la via del factor tisular o variantes del inhibidor de la via del factor tisular.

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993000807A1 (en) * 1991-07-03 1993-01-21 Cryolife, Inc. Method for stabilization of biomaterials
US20030143697A1 (en) * 1998-09-25 2003-07-31 Neil Stahl Receptor based antagonists and methods of making and using

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
CARPENTER J.F et al. Pharmaceutical Research. 1997. 14(8): 969-975 *
CHANGE BYEONG S et al. Archives of Biochemistry and Biophysics. 1996. 331(2): 249-258 *
KATAYAMA DERRICK S et al. Journal of Pharmaceutical Sciences. 2004. 93(10): 2609-2623 *
WANG WEI. International Journal of Pharmaceutics. 1999. 185(2): 129-188 *
WEBB S.D et al. Journal of Pharmaceutical Sciences. 2002. 91(2): 543-558 *

Also Published As

Publication number Publication date
EP1778723A2 (en) 2007-05-02
BRPI0514411B8 (pt) 2021-05-25
ES2395035T3 (es) 2013-02-07
EP2311871A3 (en) 2012-08-08
ZA200701529B (en) 2008-09-25
CN101014617A (zh) 2007-08-08
PT1778723E (pt) 2013-01-25
BRPI0514411B1 (pt) 2020-09-15
JP2012121894A (ja) 2012-06-28
DK1778723T3 (da) 2012-12-03
JP2008510716A (ja) 2008-04-10
CN101014617B (zh) 2011-03-30
US20060040852A1 (en) 2006-02-23
US7365165B2 (en) 2008-04-29
WO2006023665A2 (en) 2006-03-02
AU2005277357A1 (en) 2006-03-02
CA2576519A1 (en) 2006-03-02
CA2576519C (en) 2013-05-21
PL1778723T3 (pl) 2013-03-29
EP1778723B1 (en) 2012-11-14
HK1105421A1 (en) 2008-02-15
BRPI0514411A (pt) 2008-06-10
WO2006023665A3 (en) 2006-08-03
EP2311871A2 (en) 2011-04-20
SI1778723T1 (sl) 2013-02-28
JP4948410B2 (ja) 2012-06-06

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Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired