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

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 (16)

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)
HK (1) HK1103977A1 (pt)
MX (1) MX2007001663A (pt)
NO (1) NO20071341L (pt)
WO (1) WO2006020720A2 (pt)
ZA (1) ZA200701154B (pt)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0413276B8 (pt) 2003-08-05 2021-05-25 Novo Nordisk As derivado de insulina, complexo de zinco do mesmo, e, composição farmacêutica
EP2505593A1 (en) 2005-12-28 2012-10-03 Novo Nordisk A/S Compositions comprising an acylated insulin and zinc and method of making the said compositions
EP2422770A1 (en) * 2006-11-24 2012-02-29 Cadila Healthcare Limited Formulations of peg-interferon alpha conjugates
ES2365832T3 (es) 2007-03-05 2011-10-11 Cadila Healthcare Limited Composiciones que comprenden conjugados de peg-interferón alfa y rafinosa como crioprotector.
WO2008152106A1 (en) 2007-06-13 2008-12-18 Novo Nordisk A/S Pharmaceutical formulation comprising an insulin derivative
WO2009080699A2 (en) * 2007-12-20 2009-07-02 Merck Serono S.A. Peg-interferon-beta formulations
US9884019B2 (en) * 2008-08-05 2018-02-06 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
RU2013123515A (ru) 2010-10-27 2014-12-10 Ново Нордиск А/С Лечение сахарного диабета с помощью инъекций инсулина, вводимых с различными интервалами
WO2012118687A1 (en) * 2011-02-28 2012-09-07 Merck Sharp & Dohme Corp. Manually operated injector with restricted injection sequence
US20140128462A1 (en) 2011-04-28 2014-05-08 Oncopeptides Ab Lyophilized preparation of cytotoxic dipeptides
JP2015535238A (ja) * 2012-10-26 2015-12-10 ルピン・リミテッドＬｕｐｉｎ Ｌｉｍｉｔｅｄ ペグインターフェロンα−２ｂの安定な医薬組成物
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
US10137172B2 (en) 2013-04-30 2018-11-27 Novo Nordisk A/S 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 use thereof
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
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
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
EP0082481B2 (en) * 1981-12-23 1990-09-12 Schering Corporation Stabilised alpha-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
DK0730470T3 (da) 1993-11-10 2002-06-03 Enzon Inc Forbedrede interferonpolymerkonjugater
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
WO1996024369A1 (en) 1995-02-06 1996-08-15 Genetics Institute, Inc. Formulations for il-12
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
US6180096B1 (en) * 1998-03-26 2001-01-30 Schering Corporation Formulations for protection of peg-interferon alpha conjugates
EP1066059B1 (en) * 1998-03-26 2005-06-15 Schering Corporation Formulations for protection of peg-interferon alpha conjugates
BR0013252A (pt) * 1999-08-13 2002-04-16 Hoffmann La Roche Micofenolato mofetila em associação com peg-ifn-alfa
US6887462B2 (en) * 2001-04-09 2005-05-03 Chiron Corporation HSA-free formulations of interferon-beta
US20050095224A1 (en) * 2001-12-07 2005-05-05 Ramachandran Radhakrishnan Compositions and method for treating hepatitis virus infection

Also Published As

Publication number Publication date
ZA200701154B (en) 2008-08-27
NO20071341L (no) 2007-03-12
MX2007001663A (es) 2007-04-10
ES2349472T3 (es) 2011-01-03
CN101039660B (zh) 2010-10-06
JP2008509919A (ja) 2008-04-03
WO2006020720A3 (en) 2006-06-01
AU2005272862B2 (en) 2011-03-10
US20060051320A1 (en) 2006-03-09
CN101039660A (zh) 2007-09-19
US7632491B2 (en) 2009-12-15
CA2576549C (en) 2011-01-18
WO2006020720A2 (en) 2006-02-23
HK1103977A1 (en) 2008-01-04
JP4971160B2 (ja) 2012-07-11
CA2576549A1 (en) 2006-02-23
KR20070045244A (ko) 2007-05-02
EP1796647B1 (en) 2010-08-11
DE602005022895D1 (de) 2010-09-23
EP1796647A2 (en) 2007-06-20
AU2005272862A1 (en) 2006-02-23
ATE476967T1 (de) 2010-08-15

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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