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NO20071341L - Stabilt, pegylert interferonpreparat. - Google Patents

Stabilt, pegylert interferonpreparat.

Info

Publication number
NO20071341L
NO20071341L NO20071341A NO20071341A NO20071341L NO 20071341 L NO20071341 L NO 20071341L NO 20071341 A NO20071341 A NO 20071341A NO 20071341 A NO20071341 A NO 20071341A NO 20071341 L NO20071341 L NO 20071341L
Authority
NO
Norway
Prior art keywords
pegylated interferon
formulations
stable
interferon preparation
preparation
Prior art date
Application number
NO20071341A
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
Publication of NO20071341L publication Critical patent/NO20071341L/no

Links

Classifications

    • 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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7012—Compounds 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
    • 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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A61K38/212—IFN-alpha
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal 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
    • A61K47/51—Medicinal 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
    • A61K47/56—Medicinal 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
    • A61K47/59—Medicinal 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
    • A61K47/60—Medicinal 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
    • 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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)

Abstract

Den foreliggende oppfinnelse vedrører lyofiliserte preparater med pegylert interferon som fremstilles ved å anvende trehalose som kryobeskyttelsesmiddel. Preparatene har et lavt vanninnhold, noe som hjelper til å stabilisere det pegylerte interferon under lagring av preparatene ved romtemperatur. I tillegg er det tilveiebrakt fremgangsmåter for fremstilling av disse preparatene.
NO20071341A 2004-08-12 2007-03-12 Stabilt, pegylert interferonpreparat. NO20071341L (no)

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
NO20071341L true NO20071341L (no) 2007-03-12

Family

ID=35885766

Family Applications (1)

Application Number Title Priority Date Filing Date
NO20071341A NO20071341L (no) 2004-08-12 2007-03-12 Stabilt, pegylert interferonpreparat.

Country Status (15)

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

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BRPI0413276B8 (pt) 2003-08-05 2021-05-25 Novo Nordisk As derivado de insulina, complexo de zinco do mesmo, e, composição farmacêutica
DK1969004T3 (da) 2005-12-28 2011-11-28 Novo Nordisk As Insulinsammensætninger og metode til at lave en sammensætning
WO2008062481A2 (en) * 2006-11-24 2008-05-29 Cadila Healthcare Limited Formulations of peg-interferon alpha conjugates
JP5179521B2 (ja) * 2007-03-05 2013-04-10 カディラ・ヘルスケア・リミテッド ペグ‐インターフェロンアルファ接合体および凍結保護剤としてラフィノースを含む組成物
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
KR20100099298A (ko) * 2007-12-20 2010-09-10 메르크 세로노 에스. 에이. Ｐｅｇ­인터페론­베타 제형
EP3572073B1 (en) * 2008-08-05 2023-12-20 Wyeth LLC Lyophilization above collapse
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
WO2010064258A2 (en) * 2008-12-01 2010-06-10 Intas Biopharmaceuticals Limited Pharmaceutical formulations of interferon conjugates
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
WO2012118687A1 (en) * 2011-02-28 2012-09-07 Merck Sharp & Dohme Corp. Manually operated injector with restricted injection sequence
RS63747B1 (sr) 2011-04-28 2022-12-30 Oncopeptides Ab Liofilizovani preparat citotoksičnih dipeptida
MX2015005230A (es) * 2012-10-26 2015-08-14 Lupin Ltd Composicion farmaceutica estable de peginterferon alfa-2b.
US20140199286A1 (en) * 2013-01-15 2014-07-17 Teva Pharmaceutical Industries, Ltd. Lyophilization process
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
WO2014177623A1 (en) 2013-04-30 2014-11-06 Novo Nordisk A/S Novel administration regime
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
WO2021009027A1 (en) 2019-07-12 2021-01-21 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
US20230364301A1 (en) * 2020-09-11 2023-11-16 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

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Also Published As

Publication number Publication date
ES2349472T3 (es) 2011-01-03
BRPI0513332A (pt) 2008-05-06
AU2005272862B2 (en) 2011-03-10
CA2576549C (en) 2011-01-18
MX2007001663A (es) 2007-04-10
JP4971160B2 (ja) 2012-07-11
DE602005022895D1 (de) 2010-09-23
JP2008509919A (ja) 2008-04-03
US20060051320A1 (en) 2006-03-09
KR20070045244A (ko) 2007-05-02
HK1103977A1 (en) 2008-01-04
CN101039660A (zh) 2007-09-19
US7632491B2 (en) 2009-12-15
WO2006020720A2 (en) 2006-02-23
AU2005272862A1 (en) 2006-02-23
EP1796647B1 (en) 2010-08-11
EP1796647A2 (en) 2007-06-20
CA2576549A1 (en) 2006-02-23
ATE476967T1 (de) 2010-08-15
ZA200701154B (en) 2008-08-27
CN101039660B (zh) 2010-10-06
WO2006020720A3 (en) 2006-06-01

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