CY1112820T1 - Φαρμακοτεχνικες μορφες της ρεg-ιντερφερονης-βητα - Google Patents

Φαρμακοτεχνικες μορφες της ρεg-ιντερφερονης-βητα

Info

Publication number
CY1112820T1
CY1112820T1 CY20121100509T CY121100509T CY1112820T1 CY 1112820 T1 CY1112820 T1 CY 1112820T1 CY 20121100509 T CY20121100509 T CY 20121100509T CY 121100509 T CY121100509 T CY 121100509T CY 1112820 T1 CY1112820 T1 CY 1112820T1
Authority
CY
Cyprus
Prior art keywords
interferonis
reg
beta
pharmaceutical forms
surfactant
Prior art date
Application number
CY20121100509T
Other languages
English (en)
Inventor
Rio Alessandra Del
Joel Richard
Original Assignee
Merck Serono Sa
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 Merck Serono Sa filed Critical Merck Serono Sa
Publication of CY1112820T1 publication Critical patent/CY1112820T1/el

Links

Classifications

    • 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
    • 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
    • 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]
    • A61K38/215—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
    • A61K47/26—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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/555—Interferons [IFN]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/555—Interferons [IFN]
    • C07K14/565—IFN-beta
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Η εφεύρεση σχετίζεται με μία υγρή φαρμακευτική σύνθεση η οποία περιλαμβάνει μία πεγκυλιωμένη ΙFΝ-β (ΡΕG-ΙFΝ-β), ένα έκδοχο, μία επιφανειοδραστική ουσία και ένα ρυθμιστικό διάλυμα όπου το εν λόγω έκδοχο είναι μία πολυόλη, όπου η εν λόγω επιφανειοδραστική ουσία είναι μία μη ιοντική επιφανειοδραστική ουσία και όπου το εν λόγω ρυθμιστικό διάλυμα είναι ένα ρυθμιστικό διάλυμα οξικού νατρίου.
CY20121100509T 2007-12-20 2012-06-06 Φαρμακοτεχνικες μορφες της ρεg-ιντερφερονης-βητα CY1112820T1 (el)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP07150258 2007-12-20
US1025808P 2008-01-07 2008-01-07
EP08863833A EP2234645B1 (en) 2007-12-20 2008-12-18 Peg-interferon-beta formulations

Publications (1)

Publication Number Publication Date
CY1112820T1 true CY1112820T1 (el) 2016-02-10

Family

ID=39760852

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20121100509T CY1112820T1 (el) 2007-12-20 2012-06-06 Φαρμακοτεχνικες μορφες της ρεg-ιντερφερονης-βητα

Country Status (20)

Country Link
US (1) US9138403B2 (el)
EP (1) EP2234645B1 (el)
JP (2) JP5563475B2 (el)
KR (1) KR20100099298A (el)
CN (1) CN101878043A (el)
AT (1) ATE555812T1 (el)
AU (1) AU2008340058A1 (el)
BR (1) BRPI0821029A2 (el)
CY (1) CY1112820T1 (el)
DK (1) DK2234645T3 (el)
EA (1) EA201070773A1 (el)
ES (1) ES2387236T3 (el)
HR (1) HRP20120483T1 (el)
IL (1) IL206441A0 (el)
PL (1) PL2234645T3 (el)
PT (1) PT2234645E (el)
RS (1) RS52417B (el)
SI (1) SI2234645T1 (el)
WO (1) WO2009080699A2 (el)
ZA (1) ZA201001908B (el)

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WO2016052584A1 (ja) * 2014-09-30 2016-04-07 東レ株式会社 ポリエチレングリコール修飾インターフェロン－βの検出及び定量に使用する試料液の前処理方法、ポリエチレングリコール修飾インターフェロン－βの検出方法及び定量方法
SG11201703646SA (en) * 2014-11-10 2017-06-29 Glaxosmithkline Intellectual Property (No 2) Ltd Combination long acting compositions and methods for hepatitis c
WO2016163764A2 (ko) * 2015-04-07 2016-10-13 에이비온 주식회사 인터페론 베타 변이체의 안정화 제제
KR101943160B1 (ko) * 2016-10-06 2019-01-30 에이비온 주식회사 인터페론 베타 변이체의 안정화 제제
CN116023466B (zh) * 2023-03-30 2023-06-27 北京生物制品研究所有限责任公司 纯化PEG修饰重组人干扰素β1b蛋白的方法

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Also Published As

Publication number Publication date
SI2234645T1 (sl) 2012-07-31
IL206441A0 (en) 2010-12-30
CN101878043A (zh) 2010-11-03
ZA201001908B (en) 2011-05-25
US9138403B2 (en) 2015-09-22
BRPI0821029A2 (pt) 2015-06-16
ATE555812T1 (de) 2012-05-15
JP5563475B2 (ja) 2014-07-30
WO2009080699A3 (en) 2009-11-26
JP2014159445A (ja) 2014-09-04
US20100239529A1 (en) 2010-09-23
KR20100099298A (ko) 2010-09-10
RS52417B (en) 2013-02-28
EA201070773A1 (ru) 2010-12-30
PL2234645T3 (pl) 2012-10-31
AU2008340058A1 (en) 2009-07-02
HRP20120483T1 (hr) 2012-07-31
EP2234645B1 (en) 2012-05-02
PT2234645E (pt) 2012-05-21
ES2387236T3 (es) 2012-09-18
EP2234645A2 (en) 2010-10-06
JP2011506562A (ja) 2011-03-03
WO2009080699A2 (en) 2009-07-02
DK2234645T3 (da) 2012-07-09

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