BRPI0513332A - formulação de interferon peguilado estável - Google Patents

formulação de interferon peguilado estável

Info

Publication number
BRPI0513332A
BRPI0513332A BRPI0513332-7A BRPI0513332A BRPI0513332A BR PI0513332 A BRPI0513332 A BR PI0513332A BR PI0513332 A BRPI0513332 A BR PI0513332A BR PI0513332 A BRPI0513332 A BR PI0513332A
Authority
BR
Brazil
Prior art keywords
pegylated interferon
formulations
interferon formulation
stable pegylated
stable
Prior art date
Application number
BRPI0513332-7A
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 BRPI0513332A publication Critical patent/BRPI0513332A/pt

Links

Classifications

    • 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]
    • 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)
  • 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)

Abstract

FORMULAçãO DE INTERFERON PEGUILADO ESTáVEL.A presente invenção refere-se à formulações liofilizadas de interferon peguilado as quais são preparadas usando trealose como um crioprotetor. As formulações têm um baixo teor de umidade, o que ajuda a estabilizar o interferon peguilado durante armazenamento das formulações em temperatura ambiente. Além disso, métodos para o preparo dessas formulações são proporcionados.
BRPI0513332-7A 2004-08-12 2005-08-11 formulação de interferon peguilado estável BRPI0513332A (pt)

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
BRPI0513332A true BRPI0513332A (pt) 2008-05-06

Family

ID=35885766

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0513332-7A BRPI0513332A (pt) 2004-08-12 2005-08-11 formulação de interferon peguilado estável

Country Status (15)

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

Families Citing this family (26)

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EP2107069B1 (en) 2003-08-05 2013-01-16 Novo Nordisk A/S Novel insulin derivatives
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

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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
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US5766582A (en) 1994-10-11 1998-06-16 Schering Corporation Stable, aqueous alfa interferon solution formulations
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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
ATE476967T1 (de) 2010-08-15
AU2005272862A1 (en) 2006-02-23
JP4971160B2 (ja) 2012-07-11
ZA200701154B (en) 2008-08-27
EP1796647A2 (en) 2007-06-20
US7632491B2 (en) 2009-12-15
US20060051320A1 (en) 2006-03-09
KR20070045244A (ko) 2007-05-02
EP1796647B1 (en) 2010-08-11
MX2007001663A (es) 2007-04-10
CA2576549A1 (en) 2006-02-23
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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Legal Events

Date Code Title Description
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 7A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: NAO APRESENTADA A GUIA DE CUMPRIMENTO DE EXIGENCIA. REFERENTE A 7A ANUIDADE.

B15K Others concerning applications: alteration of classification

Ipc: A61K 31/7012 (2006.01), A61K 9/00 (2006.01), A61K