JP2013543872A - インターフェロン−βの安定に保存される組成物 - Google Patents

インターフェロン−βの安定に保存される組成物 Download PDF

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Publication number
JP2013543872A
JP2013543872A JP2013540105A JP2013540105A JP2013543872A JP 2013543872 A JP2013543872 A JP 2013543872A JP 2013540105 A JP2013540105 A JP 2013540105A JP 2013540105 A JP2013540105 A JP 2013540105A JP 2013543872 A JP2013543872 A JP 2013543872A
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JP
Japan
Prior art keywords
composition
interferon
concentration
formulation
sucrose
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2013540105A
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English (en)
Japanese (ja)
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JP2013543872A5 (enExample
Inventor
ブラデル マルク
バイドヤ アニサ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biogen Inc
Biogen MA Inc
Original Assignee
Biogen Inc
Biogen Idec Inc
Biogen Idec MA Inc
Biogen MA Inc
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 Biogen Inc, Biogen Idec Inc, Biogen Idec MA Inc, Biogen MA Inc filed Critical Biogen Inc
Publication of JP2013543872A publication Critical patent/JP2013543872A/ja
Publication of JP2013543872A5 publication Critical patent/JP2013543872A5/ja
Pending legal-status Critical Current

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    • 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]
    • A61K38/215—IFN-beta
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2013540105A 2010-11-22 2011-11-22 インターフェロン−βの安定に保存される組成物 Pending JP2013543872A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US41629110P 2010-11-22 2010-11-22
US61/416,291 2010-11-22
PCT/US2011/061759 WO2012071366A1 (en) 2010-11-22 2011-11-22 Stable preserved compositions if interferon-beta

Publications (2)

Publication Number Publication Date
JP2013543872A true JP2013543872A (ja) 2013-12-09
JP2013543872A5 JP2013543872A5 (enExample) 2014-01-30

Family

ID=46146183

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2013540105A Pending JP2013543872A (ja) 2010-11-22 2011-11-22 インターフェロン−βの安定に保存される組成物

Country Status (7)

Country Link
US (1) US20120269770A1 (enExample)
EP (1) EP2643469A1 (enExample)
JP (1) JP2013543872A (enExample)
AU (1) AU2011331992A1 (enExample)
CA (1) CA2818671A1 (enExample)
MX (1) MX2013005699A (enExample)
WO (1) WO2012071366A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20180114018A (ko) * 2016-02-29 2018-10-17 파론 파머수티컬스 오와이 동결 건조된 약학적 제제 및 그의 용도

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014130811A1 (en) * 2013-02-22 2014-08-28 Biogen Idec Ma Inc Interferon beta formulation
WO2016163764A2 (ko) * 2015-04-07 2016-10-13 에이비온 주식회사 인터페론 베타 변이체의 안정화 제제

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH10500125A (ja) * 1994-05-16 1998-01-06 アプライド リサーチ システムズ エーアールエス ホールディング ナームロゼ ベノートスハップ ＩＦＮ−β液体製剤
JP2008500996A (ja) * 2004-06-01 2008-01-17 アレス トレーディング ソシエテ アノニム 安定化したインターフェロン液体製剤
WO2009080699A2 (en) * 2007-12-20 2009-07-02 Merck Serono S.A. Peg-interferon-beta formulations

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6887462B2 (en) * 2001-04-09 2005-05-03 Chiron Corporation HSA-free formulations of interferon-beta

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH10500125A (ja) * 1994-05-16 1998-01-06 アプライド リサーチ システムズ エーアールエス ホールディング ナームロゼ ベノートスハップ ＩＦＮ−β液体製剤
JP2008500996A (ja) * 2004-06-01 2008-01-17 アレス トレーディング ソシエテ アノニム 安定化したインターフェロン液体製剤
WO2009080699A2 (en) * 2007-12-20 2009-07-02 Merck Serono S.A. Peg-interferon-beta formulations

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20180114018A (ko) * 2016-02-29 2018-10-17 파론 파머수티컬스 오와이 동결 건조된 약학적 제제 및 그의 용도
JP2019513123A (ja) * 2016-02-29 2019-05-23 ファロン ファーマシューティカルズ オサケ ユキチュア 凍結医薬製剤およびその使用
KR102821435B1 (ko) * 2016-02-29 2025-06-17 파론 파머수티컬스 오와이 동결 건조된 약학적 제제 및 그의 용도

Also Published As

Publication number Publication date
WO2012071366A8 (en) 2013-06-20
WO2012071366A1 (en) 2012-05-31
US20120269770A1 (en) 2012-10-25
AU2011331992A1 (en) 2013-06-13
MX2013005699A (es) 2013-08-27
EP2643469A1 (en) 2013-10-02
CA2818671A1 (en) 2012-05-31

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