CY1121411T1 - Σταθερες φαρμακοτεχνικες μορφες πολυπεπτιδιων και χρησεις αυτων - Google Patents

Σταθερες φαρμακοτεχνικες μορφες πολυπεπτιδιων και χρησεις αυτων

Info

Publication number
CY1121411T1
CY1121411T1 CY20191100137T CY191100137T CY1121411T1 CY 1121411 T1 CY1121411 T1 CY 1121411T1 CY 20191100137 T CY20191100137 T CY 20191100137T CY 191100137 T CY191100137 T CY 191100137T CY 1121411 T1 CY1121411 T1 CY 1121411T1
Authority
CY
Cyprus
Prior art keywords
formulations
formulation
tween
polypeptides
pharmaceutical
Prior art date
Application number
CY20191100137T
Other languages
English (en)
Inventor
Ann BRIGÉ
Christine Labeur
Veronique De Brabandere
Original Assignee
Ablynx N.V.
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 Ablynx N.V. filed Critical Ablynx N.V.
Publication of CY1121411T1 publication Critical patent/CY1121411T1/el

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Παρέχονται φαρμακοτεχνικές μορφές οι οποίες περιέχουν μονές μεταβλητές περιοχές με καλή διαλυτότητα και καλή σταθερότητα κάτω από διαφορετικές συνθήκες αποθήκευσης, μεταφοράς και συνθήκες τάσης. Οι φαρμακοτεχνικές μορφές είναι χρήσιμες ως φαρμακευτική φαρμακοτεχνική μορφή. Η φαρμακοτεχνική μορφή αποτελείται από έναν υδατικό φορέα με pΗ 5.5 έως 8.0, ένα ρυθμιστικό που επιλέγεται από την ομάδα που αποτελείται από ιστιδίνη με pΗ 6.0-6.5, hepes με pΗ 7.0-8.0, MES με pΗ 6.0, ηλεκτρικό με pΗ 6.0-6.5 και οξικό με pΗ 5,5-6.0, ένα έκδοχο, και/ή ένα επιφανειοδραστικό που επιλέγεται από Tween 80, Tween 20 και πολοξαμερή. Η φαρμακοτεχνική μορφή χαρακτηρίζεται περαιτέρω από το ότι έχει συγκέντρωση ανόργανου άλατος 150 mM ή χαμηλότερη. Η εφεύρεση περαιτέρω αφορά περιέκτες και φαρμακευτικές μονάδες που αποτελούνται από τέτοιες φαρμακοτεχνικές μορφές και μεθόδους για την παρασκευή και προφυλακτικές και θεραπευτικές χρήσεις των φαρμακοτεχνικών μορφών και φαρμακευτικών μονάδων της εφεύρεσης.
CY20191100137T 2009-09-03 2019-01-31 Σταθερες φαρμακοτεχνικες μορφες πολυπεπτιδιων και χρησεις αυτων CY1121411T1 (el)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US27581609P 2009-09-03 2009-09-03
US28450209P 2009-12-18 2009-12-18
EP10747896.8A EP2473528B1 (en) 2009-09-03 2010-09-03 Stable formulations of polypeptides and uses thereof
PCT/EP2010/062975 WO2011026948A1 (en) 2009-09-03 2010-09-03 Stable formulations of polypeptides and uses thereof

Publications (1)

Publication Number Publication Date
CY1121411T1 true CY1121411T1 (el) 2020-05-29

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CY20191100137T CY1121411T1 (el) 2009-09-03 2019-01-31 Σταθερες φαρμακοτεχνικες μορφες πολυπεπτιδιων και χρησεις αυτων

Country Status (12)

Country Link
US (2) US20120244158A1 (el)
EP (5) EP2805731B1 (el)
CY (1) CY1121411T1 (el)
DK (2) DK2473527T3 (el)
ES (3) ES2531083T3 (el)
HK (1) HK1204284A1 (el)
HR (1) HRP20190137T1 (el)
LT (1) LT2805731T (el)
PL (2) PL2473528T3 (el)
PT (3) PT2473527T (el)
SI (1) SI2805731T1 (el)
WO (2) WO2011026948A1 (el)

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EP3438126A1 (en) 2019-02-06
EP3438126B1 (en) 2020-08-19
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US20120244158A1 (en) 2012-09-27
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