ATE476967T1 - Stabile pegylierte interferon-formulierung - Google Patents

Stabile pegylierte interferon-formulierung

Info

Publication number
ATE476967T1
ATE476967T1 AT05785190T AT05785190T ATE476967T1 AT E476967 T1 ATE476967 T1 AT E476967T1 AT 05785190 T AT05785190 T AT 05785190T AT 05785190 T AT05785190 T AT 05785190T AT E476967 T1 ATE476967 T1 AT E476967T1
Authority
AT
Austria
Prior art keywords
pegylated interferon
formulations
interferon formulation
stable pegylated
stable
Prior art date
Application number
AT05785190T
Other languages
English (en)
Inventor
Mohammed Shameem
Anita Dabbara
Original Assignee
Schering Corp
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 Schering Corp filed Critical Schering Corp
Application granted granted Critical
Publication of ATE476967T1 publication Critical patent/ATE476967T1/de

Links

Classifications

    • 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
    • A61K38/21Interferons [IFN]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7012Compounds having a free or esterified carboxyl group attached, directly or through a carbon chain, to a carbon atom of the saccharide radical, e.g. glucuronic acid, neuraminic acid
    • 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
    • A61K38/21Interferons [IFN]
    • A61K38/212IFN-alpha
    • 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
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
AT05785190T 2004-08-12 2005-08-11 Stabile pegylierte interferon-formulierung ATE476967T1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US60084604P 2004-08-12 2004-08-12
PCT/US2005/028441 WO2006020720A2 (en) 2004-08-12 2005-08-11 Stable pegylated interferon formulation

Publications (1)

Publication Number Publication Date
ATE476967T1 true ATE476967T1 (de) 2010-08-15

Family

ID=35885766

Family Applications (1)

Application Number Title Priority Date Filing Date
AT05785190T ATE476967T1 (de) 2004-08-12 2005-08-11 Stabile pegylierte interferon-formulierung

Country Status (15)

Country Link
US (1) US7632491B2 (de)
EP (1) EP1796647B1 (de)
JP (1) JP4971160B2 (de)
KR (1) KR20070045244A (de)
CN (1) CN101039660B (de)
AT (1) ATE476967T1 (de)
AU (1) AU2005272862B2 (de)
BR (1) BRPI0513332A (de)
CA (1) CA2576549C (de)
DE (1) DE602005022895D1 (de)
ES (1) ES2349472T3 (de)
MX (1) MX2007001663A (de)
NO (1) NO20071341L (de)
WO (1) WO2006020720A2 (de)
ZA (1) ZA200701154B (de)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
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EP2107069B1 (de) 2003-08-05 2013-01-16 Novo Nordisk A/S Neuartige Insulinderivate
US20090074882A1 (en) 2005-12-28 2009-03-19 Novo Nordisk A/S Insulin compositions and method of making a composition
PL2097068T3 (pl) 2006-11-24 2013-12-31 Cadila Healthcare Ltd Preparaty koniugatów PEG-interferon alfa
ATE512660T1 (de) 2007-03-05 2011-07-15 Cadila Healthcare Ltd Zusammensetzungen mit peg-interferon-alpha- konjugaten und raffinose als kryoschutzmittel
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
BRPI0821029A2 (pt) * 2007-12-20 2015-06-16 Merck Serono Sa Fomulações de peg-interferon-beta
ES2968301T3 (es) * 2008-08-05 2024-05-08 Wyeth Llc Liofilización por encima del colapso
KR20110085985A (ko) 2008-10-30 2011-07-27 노보 노르디스크 에이/에스 하루 한번 주사 빈도보다 적은 인슐린 주사를 사용한 진성 당뇨병의 치료
WO2010064258A2 (en) * 2008-12-01 2010-06-10 Intas Biopharmaceuticals Limited Pharmaceutical formulations of interferon conjugates
BR112013010345A2 (pt) 2010-10-27 2017-07-25 Novo Nordisk As tratamento de diabetes melitus usando as injeções de insulina administradas com intervalos de variação da injeção
WO2012118687A1 (en) * 2011-02-28 2012-09-07 Merck Sharp & Dohme Corp. Manually operated injector with restricted injection sequence
SI2701720T1 (sl) 2011-04-28 2017-11-30 Oncopeptides Ab Liofilizirani pripravek citotoksičnih dipeptidov
KR20150074167A (ko) * 2012-10-26 2015-07-01 루핀 리미티드 Peg 인터페론 알파-2b의 안정한 약학 조성물
HK1217633A1 (zh) * 2013-01-15 2017-01-20 Teva Pharmaceutical Industries Ltd. 冻乾方法
CN103054818B (zh) * 2013-01-28 2014-03-05 苏州二叶制药有限公司 一种优质高效的冷冻干燥技术
JP2016519127A (ja) 2013-04-30 2016-06-30 ノヴォ ノルディスク アー/エス 新規投与レジメン
GB201513010D0 (en) * 2015-07-23 2015-09-09 Glaxosmithkline Biolog Sa Novel formulation
FI126979B (en) * 2016-02-29 2017-09-15 Faron Pharmaceuticals Oy Lyophilized pharmaceutical formulation and its use
CN108379561B (zh) * 2018-03-01 2021-11-26 修正生物医药(杭州)研究院有限公司 一种聚乙二醇化尿酸氧化酶冻干粉剂及其制备方法
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin
KR102562968B1 (ko) * 2018-11-01 2023-08-04 주식회사 셀비온 붕소 중성자 포획 치료용 파라-보로노페닐알라닌 조성물 및 이의 제조방법
US12343383B2 (en) 2019-07-12 2025-07-01 Novo Nordisk A/S High concentration insulin formulation
CN112245570A (zh) * 2019-07-22 2021-01-22 厦门特宝生物工程股份有限公司 一种基于干扰素的疾病治疗方法
CN112807281A (zh) * 2019-10-31 2021-05-18 南京海维医药科技有限公司 包含血管紧张素ii的稳定组合物及其制备方法、使用方法
CA3194975A1 (en) * 2020-09-11 2022-03-17 University Of Pittsburgh - Of The Commonwealth System Of Higher Education Methods for preparation of a terminally sterilized hydrogel or colloidal suspension derived from extracellular matrix, and uses thereof
CN113797318B (zh) * 2021-10-26 2023-06-30 深圳科兴药业有限公司 一种干扰素组合物及其制备方法和应用

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3262575D1 (en) * 1981-12-23 1985-04-18 Schering Corp Stabilised interferon formulations and their preparation
CA2024046A1 (en) 1989-09-28 1991-03-29 Alberto Ferro Stabilized leukocyte-interferons
US5595732A (en) * 1991-03-25 1997-01-21 Hoffmann-La Roche Inc. Polyethylene-protein conjugates
US5382657A (en) 1992-08-26 1995-01-17 Hoffmann-La Roche Inc. Peg-interferon conjugates
US5951974A (en) 1993-11-10 1999-09-14 Enzon, Inc. Interferon polymer conjugates
DE69430251T2 (de) 1993-11-10 2002-11-07 Enzon, Inc. Verbesserte interferon-polymerkonjugate
US5766582A (en) 1994-10-11 1998-06-16 Schering Corporation Stable, aqueous alfa interferon solution formulations
US5738846A (en) 1994-11-10 1998-04-14 Enzon, Inc. Interferon polymer conjugates and process for preparing the same
US5691298A (en) * 1994-12-14 1997-11-25 The Procter & Gamble Company Ester oligomers suitable as soil release agents in detergent compositions
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
TW426523B (en) 1995-04-06 2001-03-21 Hoffmann La Roche Interferon solution
US5908621A (en) 1995-11-02 1999-06-01 Schering Corporation Polyethylene glycol modified interferon therapy
TW517067B (en) 1996-05-31 2003-01-11 Hoffmann La Roche Interferon conjugates
JP3643034B2 (ja) * 1998-03-26 2005-04-27 シェーリング コーポレイション PEG−インターフェロンα結合体の保護のための処方物
US6180096B1 (en) * 1998-03-26 2001-01-30 Schering Corporation Formulations for protection of peg-interferon alpha conjugates
HUP0202525A3 (en) * 1999-08-13 2003-11-28 Hoffmann La Roche Mycophenolate mofetil in association with peg-ifn-alpha, medicaments and kit comprising thereof
US6887462B2 (en) * 2001-04-09 2005-05-03 Chiron Corporation HSA-free formulations of interferon-beta
AU2002346686A1 (en) * 2001-12-07 2003-06-23 Intermune, Inc. Compositions and method for treating hepatitis virus infection

Also Published As

Publication number Publication date
HK1103977A1 (en) 2008-01-04
NO20071341L (no) 2007-03-12
WO2006020720A3 (en) 2006-06-01
CN101039660A (zh) 2007-09-19
AU2005272862A1 (en) 2006-02-23
JP4971160B2 (ja) 2012-07-11
ZA200701154B (en) 2008-08-27
EP1796647A2 (de) 2007-06-20
US7632491B2 (en) 2009-12-15
US20060051320A1 (en) 2006-03-09
KR20070045244A (ko) 2007-05-02
EP1796647B1 (de) 2010-08-11
MX2007001663A (es) 2007-04-10
CA2576549A1 (en) 2006-02-23
BRPI0513332A (pt) 2008-05-06
WO2006020720A2 (en) 2006-02-23
JP2008509919A (ja) 2008-04-03
CA2576549C (en) 2011-01-18
ES2349472T3 (es) 2011-01-03
DE602005022895D1 (de) 2010-09-23
CN101039660B (zh) 2010-10-06
AU2005272862B2 (en) 2011-03-10

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