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CY1112193T1 - Σταθεροποιημενα υγρα σκευασματα ιντερφερονης - Google Patents

Σταθεροποιημενα υγρα σκευασματα ιντερφερονης

Info

Publication number
CY1112193T1
CY1112193T1 CY20111101217T CY111101217T CY1112193T1 CY 1112193 T1 CY1112193 T1 CY 1112193T1 CY 20111101217 T CY20111101217 T CY 20111101217T CY 111101217 T CY111101217 T CY 111101217T CY 1112193 T1 CY1112193 T1 CY 1112193T1
Authority
CY
Cyprus
Prior art keywords
interferon
stabilized liquid
cyclodextrin
room temperature
formulations
Prior art date
Application number
CY20111101217T
Other languages
English (en)
Inventor
Curto Maria Dorly Del
Original Assignee
Ares Trading S.A.
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 Ares Trading S.A. filed Critical Ares Trading S.A.
Publication of CY1112193T1 publication Critical patent/CY1112193T1/el

Links

Classifications

    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators

Landscapes

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

Abstract

Στην παρούσα περιγράφεται σταθεροποιημένη υγρή φαρμακευτική σύνθεση η οποία περιέχει μια ιντερφερόνη (IFN) ή μια ισόμορφη, μουτεΐνη, συντηγμένη πρωτεΐνη, λειτουργικό παράγωγο, ενεργό θραύσμα ή άλας αυτής, όπου το εν λόγω σκεύασμα είναι ένα διάλυμα το οποίο περιλαμβάνει ένα ρυθμιστικό διάλυμα, μια κυκλοδεξτρίνη, έναν παράγοντα ισοτονικότητας και ένα αντιοξειδωτικό. Κατά προτίμηση, η ιντερφερόνη είναι η ιντερφερόνη-β-1α και η κυκλοδεξτρίνη είναι η HPBCD. Αυτά τα σκευάσματα είναι ευσταθή σε θερμοκρασία δωματίου, επιφέροντας έτσι το πλεονέκτημα του χαμηλότερου κόστους για την αποθήκευση του σκευάσματος και της αυξημένης ασφάλειας για τον ασθενή σε ότι αφορά σε πιθανά «λάθη» κατά το χειρισμό. Είναι γεγονός ότι εάν αυτά τα σκευάσματα είναι ευσταθή σε θερμοκρασία δωματίου μειώνεται ο κίνδυνος σχηματισμού προϊόντος αποικοδόμησης που δυνητικά ευθύνονται για δυσμενείς παρενέργειες (π.χ. ανοσογονικότητα).
CY20111101217T 2003-12-11 2011-12-06 Σταθεροποιημενα υγρα σκευασματα ιντερφερονης CY1112193T1 (el)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP03104646 2003-12-11
EP04103349 2004-07-13
EP04820468A EP1691825B1 (en) 2003-12-11 2004-12-10 Stabilized interferon liquid formulations

Publications (1)

Publication Number Publication Date
CY1112193T1 true CY1112193T1 (el) 2015-12-09

Family

ID=34702349

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20111101217T CY1112193T1 (el) 2003-12-11 2011-12-06 Σταθεροποιημενα υγρα σκευασματα ιντερφερονης

Country Status (18)

Country Link
US (1) US7846427B2 (el)
EP (1) EP1691825B1 (el)
JP (1) JP4658961B2 (el)
AT (1) ATE526032T1 (el)
AU (1) AU2004298781B2 (el)
BR (1) BRPI0416980A (el)
CA (1) CA2547822A1 (el)
CY (1) CY1112193T1 (el)
DK (1) DK1691825T3 (el)
ES (1) ES2374530T3 (el)
HR (1) HRP20110699T1 (el)
IL (1) IL176021A0 (el)
NO (1) NO20063108L (el)
PL (1) PL1691825T3 (el)
PT (1) PT1691825E (el)
RS (1) RS52218B (el)
SI (1) SI1691825T1 (el)
WO (1) WO2005058346A1 (el)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI272948B (en) * 2003-05-01 2007-02-11 Ares Trading Sa HSA-free stabilized interferon liquid formulations
ZA200609412B (en) * 2004-05-17 2008-07-30 Ares Trading Sa Hydrogel interferon formulations
US7632492B2 (en) 2006-05-02 2009-12-15 Allozyne, Inc. Modified human interferon-β polypeptides
WO2008137471A2 (en) 2007-05-02 2008-11-13 Ambrx, Inc. Modified interferon beta polypeptides and their uses
CA2692165A1 (en) 2007-06-25 2008-12-31 Amgen Inc. Compositions of specific binding agents to hepatocyte growth factor
CA2707840A1 (en) 2007-08-20 2009-02-26 Allozyne, Inc. Amino acid substituted molecules
CN101878043A (zh) * 2007-12-20 2010-11-03 默克雪兰诺有限公司 PEG-干扰素-β制剂
US20100203014A1 (en) * 2009-02-04 2010-08-12 Aegis Therapeutics Llc Zwitterionic buffered acidic peptide and protein formulations
CN104768569A (zh) 2012-10-26 2015-07-08 鲁平有限公司 具有PEG干扰素α-2b的稳定的药物组合物
GB201604124D0 (en) * 2016-03-10 2016-04-27 Ucb Biopharma Sprl Pharmaceutical formulation
US11628137B2 (en) * 2017-09-27 2023-04-18 Novartis Ag Parenteral formulation comprising siponimod
CN111494611A (zh) * 2020-06-08 2020-08-07 长春生物制品研究所有限责任公司 一种卡式瓶多剂量笔式注射组合包装的干扰素注射液
CN113797317B (zh) * 2021-10-26 2024-01-09 科兴生物制药股份有限公司 一种组合物及其制备方法和应用

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5997856A (en) * 1988-10-05 1999-12-07 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
US6582728B1 (en) 1992-07-08 2003-06-24 Inhale Therapeutic Systems, Inc. Spray drying of macromolecules to produce inhaleable dry powders
US5814485A (en) * 1995-06-06 1998-09-29 Chiron Corporation Production of interferon-β (IFN-β) in E. coli
US5858001A (en) * 1995-12-11 1999-01-12 Elan Medical Technologies Limited Cartridge-based drug delivery device
US6299869B1 (en) * 1997-12-08 2001-10-09 Genentech, Inc. Human interferon-epsilon: a type I interferon
US6887462B2 (en) * 2001-04-09 2005-05-03 Chiron Corporation HSA-free formulations of interferon-beta
MXPA03011793A (es) * 2001-06-29 2004-04-02 Maxygen Holdings Ltd Formulaciones de interferon.
TWI272948B (en) 2003-05-01 2007-02-11 Ares Trading Sa HSA-free stabilized interferon liquid formulations
ZA200609412B (en) 2004-05-17 2008-07-30 Ares Trading Sa Hydrogel interferon formulations
BRPI0510526A (pt) 2004-06-01 2007-10-30 Ares Trading Sa formulações lìquidas estabilizadas de interferon

Also Published As

Publication number Publication date
AU2004298781B2 (en) 2010-04-01
ATE526032T1 (de) 2011-10-15
US7846427B2 (en) 2010-12-07
ES2374530T3 (es) 2012-02-17
EP1691825B1 (en) 2011-09-28
EP1691825A1 (en) 2006-08-23
CA2547822A1 (en) 2005-06-30
IL176021A0 (en) 2006-10-05
NO20063108L (no) 2006-07-04
RS52218B (sr) 2012-10-31
AU2004298781A1 (en) 2005-06-30
JP4658961B2 (ja) 2011-03-23
PL1691825T3 (pl) 2012-02-29
HRP20110699T1 (hr) 2011-10-31
JP2007513925A (ja) 2007-05-31
DK1691825T3 (da) 2011-12-05
BRPI0416980A (pt) 2007-02-21
SI1691825T1 (sl) 2011-12-30
WO2005058346A1 (en) 2005-06-30
US20070104682A1 (en) 2007-05-10
PT1691825E (pt) 2011-10-12

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