EA200970509A1 - Композиции конъюгатов пэг-интерферон альфа - Google Patents

Композиции конъюгатов пэг-интерферон альфа

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Publication number
EA200970509A1
EA200970509A1 EA200970509A EA200970509A EA200970509A1 EA 200970509 A1 EA200970509 A1 EA 200970509A1 EA 200970509 A EA200970509 A EA 200970509A EA 200970509 A EA200970509 A EA 200970509A EA 200970509 A1 EA200970509 A1 EA 200970509A1
Authority
EA
Eurasian Patent Office
Prior art keywords
peg
interferon alpha
compositions
alpha conjugates
present
Prior art date
Application number
EA200970509A
Other languages
English (en)
Other versions
EA018440B1 (ru
Inventor
Санджай Бандиопадхиай
Венкатесан Натараджан
Санджив Кумар Мендиратта
Панкадж Раманбхай Пател
Original Assignee
Кадила Хелзкэр Лимитед
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 Кадила Хелзкэр Лимитед filed Critical Кадила Хелзкэр Лимитед
Publication of EA200970509A1 publication Critical patent/EA200970509A1/ru
Publication of EA018440B1 publication Critical patent/EA018440B1/ru

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    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Virology (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Biotechnology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Настоящее изобретение относится к новым лиофилизованным и стабилизированным составам конъюгатов ПЭГ-интерферон альфа и к способу их получения. Новые составы конъюгатов ПЭГ-интерферон альфа, о которых сообщают авторы настоящего изобретения, требуют меньшего цикла лиофилизации и являются более конкурентоспособными.
EA200970509A 2006-11-24 2007-11-16 Композиции конъюгатов пэг-интерферон альфа EA018440B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1936MU2006 2006-11-24
PCT/IN2007/000549 WO2008062481A2 (en) 2006-11-24 2007-11-16 Formulations of peg-interferon alpha conjugates

Publications (2)

Publication Number Publication Date
EA200970509A1 true EA200970509A1 (ru) 2009-12-30
EA018440B1 EA018440B1 (ru) 2013-08-30

Family

ID=39430186

Family Applications (1)

Application Number Title Priority Date Filing Date
EA200970509A EA018440B1 (ru) 2006-11-24 2007-11-16 Композиции конъюгатов пэг-интерферон альфа

Country Status (12)

Country Link
US (1) US8367054B2 (ru)
EP (2) EP2422770A1 (ru)
JP (2) JP5138699B2 (ru)
BR (1) BRPI0717674A2 (ru)
DK (1) DK2097068T3 (ru)
EA (1) EA018440B1 (ru)
ES (1) ES2431054T3 (ru)
HK (1) HK1134774A1 (ru)
PL (1) PL2097068T3 (ru)
PT (1) PT2097068E (ru)
WO (1) WO2008062481A2 (ru)
ZA (1) ZA200903636B (ru)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2431054T3 (es) * 2006-11-24 2013-11-22 Cadila Healthcare Limited Formulaciones de los conjugados de PEG-interferón alfa
WO2010064258A2 (en) * 2008-12-01 2010-06-10 Intas Biopharmaceuticals Limited Pharmaceutical formulations of interferon conjugates
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
US9212357B2 (en) 2012-12-03 2015-12-15 Omrix Biopharmaceuticals Ltd. Thrombin solution and methods of use thereof
WO2014199373A1 (en) * 2013-06-09 2014-12-18 Efranat Ltd. Compositions comprising gc- macrophage activating factor and uses thereof
RU2572800C1 (ru) * 2014-09-22 2016-01-20 Закрытое Акционерное Общество "Биокад" Новый состав, содержащий конъюгат пэг и интерферон-альфа-2бета, обладающий сниженной болезненностью при введении
CN104940902B (zh) * 2015-05-29 2018-08-10 北京凯因科技股份有限公司 一种聚乙二醇集成干扰素变异体的稳定溶液
US11690799B2 (en) 2018-04-19 2023-07-04 Lts Lohmann Therapie-Systeme Ag Microneedle system for applying interferon
MX2020011004A (es) * 2018-04-19 2020-11-09 Lts Lohmann Therapie Systeme Ag Sistema de microagujas para la aplicacion de interferon.
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)

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Publication number Priority date Publication date Assignee Title
US4179337A (en) * 1973-07-20 1979-12-18 Davis Frank F Non-immunogenic polypeptides
EP0082481B2 (en) * 1981-12-23 1990-09-12 Schering Corporation Stabilised alpha-interferon formulations and their preparation
US4917888A (en) * 1985-06-26 1990-04-17 Cetus Corporation Solubilization of immunotoxins for pharmaceutical compositions using polymer conjugation
US4766106A (en) 1985-06-26 1988-08-23 Cetus Corporation Solubilization of proteins for pharmaceutical compositions using polymer conjugation
US5324844A (en) 1989-04-19 1994-06-28 Enzon, Inc. Active carbonates of polyalkylene oxides for modification of polypeptides
KR960705579A (ko) * 1993-11-10 1996-11-08 에릭에스. 딕커 개선된 인터페론 중합체 결합체(Improved interferon polymer conjugates)
US5951974A (en) 1993-11-10 1999-09-14 Enzon, Inc. Interferon polymer conjugates
ATE216590T1 (de) * 1995-02-06 2002-05-15 Genetics Inst Arzneimittelformulierungen für il-12
JPH1121250A (ja) * 1997-07-02 1999-01-26 Kyowa Hakko Kogyo Co Ltd 医薬製剤
US5981709A (en) 1997-12-19 1999-11-09 Enzon, Inc. α-interferon-polymer-conjugates having enhanced biological activity and methods of preparing the same
US6180096B1 (en) * 1998-03-26 2001-01-30 Schering Corporation Formulations for protection of peg-interferon alpha conjugates
US20040161776A1 (en) * 2001-10-23 2004-08-19 Maddon Paul J. PSMA formulations and uses thereof
JP2005517648A (ja) * 2001-12-07 2005-06-16 インターミューン インコーポレイテッド 肝炎ウイルス感染症を治療するための組成物および方法
WO2004060406A2 (en) * 2002-12-31 2004-07-22 Nektar Therapeutics Al, Corporation Polymeric reagents comprising a ketone or a related functional group
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WO2005084303A2 (en) * 2004-03-01 2005-09-15 Enzon Pharmaceuticals, Inc. Interferon-beta polymer conjugates
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ES2431054T3 (es) * 2006-11-24 2013-11-22 Cadila Healthcare Limited Formulaciones de los conjugados de PEG-interferón alfa

Also Published As

Publication number Publication date
WO2008062481A3 (en) 2008-12-11
US8367054B2 (en) 2013-02-05
EP2097068B1 (en) 2013-09-04
EA018440B1 (ru) 2013-08-30
ES2431054T3 (es) 2013-11-22
PT2097068E (pt) 2013-10-23
EP2097068A2 (en) 2009-09-09
DK2097068T3 (da) 2013-10-28
HK1134774A1 (en) 2010-05-14
JP2010510978A (ja) 2010-04-08
US20100074865A1 (en) 2010-03-25
EP2422770A1 (en) 2012-02-29
JP2012250995A (ja) 2012-12-20
WO2008062481A2 (en) 2008-05-29
PL2097068T3 (pl) 2013-12-31
JP5138699B2 (ja) 2013-02-06
BRPI0717674A2 (pt) 2014-04-08
ZA200903636B (en) 2010-07-28

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Legal Events

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MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): AM AZ BY KZ KG MD TJ TM RU