AU2005277357B2 - IL-1 antagonist formulations - Google Patents

IL-1 antagonist formulations Download PDF

Info

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)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (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 (https=)
EP (2) EP2311871A3 (https=)
JP (2) JP4948410B2 (https=)
CN (1) CN101014617B (https=)
AU (1) AU2005277357B2 (https=)
BR (1) BRPI0514411B8 (https=)
CA (1) CA2576519C (https=)
DK (1) DK1778723T3 (https=)
ES (1) ES2395035T3 (https=)
PL (1) PL1778723T3 (https=)
PT (1) PT1778723E (https=)
SI (1) SI1778723T1 (https=)
WO (1) WO2006023665A2 (https=)
ZA (1) ZA200701529B (https=)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2531988C (en) 2003-08-05 2016-06-28 Novo Nordisk A/S Novel insulin derivatives
ES2371361T3 (es) 2005-12-28 2011-12-30 Novo Nordisk A/S Composiciones que comprenden una insulina acilada y zinc y método de producción de dichas composiciones.
CA2654510C (en) 2006-06-16 2015-03-17 Regeneron Pharmaceuticals, Inc. Vegf antagonist formulations suitable for intravitreal administration
US7879805B2 (en) * 2007-06-01 2011-02-01 Acologix, Inc. High temperature stable peptide formulation
JP5552046B2 (ja) 2007-06-13 2014-07-16 ノボ・ノルデイスク・エー/エス インスリン誘導体を含有する薬学的製剤
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
JP4959005B2 (ja) 2008-10-30 2012-06-20 ノボ・ノルデイスク・エー/エス 毎日の注射頻度より少ないインスリン注射での真性糖尿病の治療
ES2952394T3 (es) 2010-07-29 2023-10-31 Buzzard Pharmaceuticals AB Antagonistas quiméricos del receptor IL-1 de tipo I
DK2632478T3 (da) 2010-10-27 2019-10-07 Novo Nordisk As Behandling af diabetes melitus under anvendelse af insulinindsprøjtninger indgivet med varierende indsprøjtningsintervaller
ES2985784T3 (es) 2011-11-18 2024-11-07 Regeneron Pharma Micropartículas de proteínas recubiertas con polímeros para formulaciones de liberación prolongada para su uso en el humor vítreo del ojo para tratar trastornos oculares vasculares
EP2834262B1 (en) * 2012-04-04 2020-09-02 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
EP2968468B1 (en) 2013-03-13 2021-07-14 Buzzard Pharmaceuticals AB Chimeric cytokine formulations for ocular delivery
EP2991672A1 (en) 2013-04-30 2016-03-09 Novo Nordisk A/S Novel administration regime
US11166915B2 (en) 2016-09-16 2021-11-09 Leukocare Ag Method for obtaining efficient viral vector-based compositions for vaccination or gene therapy
KR20190053908A (ko) 2016-09-16 2019-05-20 로이코케어 아게 가공 동안 바이오 의약품의 안정화를 위한 신규한 방법
TWI784982B (zh) 2016-11-02 2022-12-01 開曼群島商北極星藥業集團股份有限公司 聚乙二醇化精胺酸脫亞胺酶之調配物
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

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
JP2000510813A (ja) * 1995-02-06 2000-08-22 ジェネテイックス・インスティテュート・インコーポレイテッド Il−12用処方
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
MXPA04000747A (es) * 2001-07-25 2004-07-08 Protein Desing Labs Inc Formulacion farmaceutica liofilizada estable de anticuerpos igg.
DE10204792A1 (de) * 2002-02-06 2003-08-14 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Immuncytokine
CA2512680A1 (en) * 2003-01-08 2004-07-29 Chiron Corporation Stabilized lyophilized compositions comprising tissue factor pathway inhibitor or tissue factor pathway inhibitor variants

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

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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