CY1120488T1 - Υγρη φαρμακευτικη συνθεση - Google Patents

Υγρη φαρμακευτικη συνθεση

Info

Publication number
CY1120488T1
CY1120488T1 CY20181100812T CY181100812T CY1120488T1 CY 1120488 T1 CY1120488 T1 CY 1120488T1 CY 20181100812 T CY20181100812 T CY 20181100812T CY 181100812 T CY181100812 T CY 181100812T CY 1120488 T1 CY1120488 T1 CY 1120488T1
Authority
CY
Cyprus
Prior art keywords
histidine
saccharide
adalimumab
pharmaceutical composition
ingredients
Prior art date
Application number
CY20181100812T
Other languages
English (en)
Inventor
Gianluca Rinaldi
Silvia Fratarcangeli
Alessandra Del Rio
Original Assignee
Fresenius Kabi Deutschland Gmbh
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50774705&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CY1120488(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Fresenius Kabi Deutschland Gmbh filed Critical Fresenius Kabi Deutschland Gmbh
Publication of CY1120488T1 publication Critical patent/CY1120488T1/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
    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • A61K47/16—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
    • 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
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • 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
    • 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
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/14—Decongestants or antiallergics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Diabetes (AREA)
  • Ophthalmology & Optometry (AREA)
  • Hematology (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Η παρούσα εφεύρεση αναφέρεται σε νέες υγρές φαρμακευτικές συνθέσεις αδαλιμουμάμπης, οι οποίες περιλαμβάνουν αδαλιμουμάμπη ή βιοομοειδή αυτής, ένα ρυθμιστικό παράγοντα ιστιδίνης όπως ιστιδίνη (ή ρυθμιστικό σύστημα ιστιδίνης όπως ιστιδίνη/ιμιδαζολιο-ιστιδίνη) και έναν σακχαρικό σταθεροποιητή όπως τρεαλόζη. Ένας τέτοιος συνδυασμός συστατικών παρέχει σκευάσματα με σταθερότητα (π.χ. κατά την αποθήκευση και όταν εκτίθενται σε καταπόνηση) η οποία είναι παρόμοια ή καλύτερη σε σχέση με συνθέσεις γνωστές στην τεχνική και απαιτεί λιγότερα συστατικά. Τέτοιες πρόοδοι θα βοηθήσουν ώστε οι θεραπείες με αδαλιμουμάμπης να γίνουν ευρύτερα διαθέσιμες με χαμηλότερο κόστος και θα παρατείνουν τη βιωσιμότητα των προπληρωμένων συσκευών χορήγησης (π.χ. προγεμισμένες σύριγγες) για τη μείωση των περιττών αποβλήτων του φαρμάκου.
CY20181100812T 2014-05-23 2018-08-06 Υγρη φαρμακευτικη συνθεση CY1120488T1 (el)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP14169754.0A EP2946766B1 (en) 2014-05-23 2014-05-23 Liquid pharmaceutical composition
PCT/EP2015/060817 WO2015177058A1 (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition

Publications (1)

Publication Number Publication Date
CY1120488T1 true CY1120488T1 (el) 2019-07-10

Family

ID=50774705

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20181100812T CY1120488T1 (el) 2014-05-23 2018-08-06 Υγρη φαρμακευτικη συνθεση

Country Status (20)

Country Link
US (5) US10493152B2 (el)
EP (5) EP2946766B1 (el)
JP (3) JP2017516847A (el)
CN (2) CN106659781A (el)
AU (4) AU2015263246B2 (el)
CA (2) CA2947487C (el)
CY (1) CY1120488T1 (el)
DE (1) DE23189888T1 (el)
DK (3) DK3148510T3 (el)
ES (4) ES2572919T3 (el)
HK (1) HK1257026A1 (el)
HR (1) HRP20181226T1 (el)
HU (1) HUE040097T2 (el)
IL (1) IL249117B1 (el)
LT (1) LT3148510T (el)
PL (1) PL3148510T3 (el)
PT (1) PT3148510T (el)
RS (1) RS57772B1 (el)
SI (1) SI3148510T1 (el)
WO (1) WO2015177058A1 (el)

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Also Published As

Publication number Publication date
LT3148510T (lt) 2018-10-10
RS57772B1 (sr) 2018-12-31
CN108785670A (zh) 2018-11-13
EP3148510A1 (en) 2017-04-05
JP2017516847A (ja) 2017-06-22
JP2022003091A (ja) 2022-01-11
AU2015263246B2 (en) 2018-06-21
DK201800070Y8 (da) 2019-07-09
CN106659781A (zh) 2017-05-10
US20210023215A1 (en) 2021-01-28
IL249117B1 (en) 2024-07-01
AU2018222887A1 (en) 2018-09-13
HUE040097T2 (hu) 2019-02-28
ES2572919T3 (es) 2016-06-03
DK201800070U1 (da) 2018-09-18
PL3148510T3 (pl) 2018-11-30
HRP20181226T1 (hr) 2018-10-19
CA3050875A1 (en) 2015-11-26
DK201800071U1 (da) 2018-12-05
WO2015177058A1 (en) 2015-11-26
US10772961B2 (en) 2020-09-15
EP2946766B1 (en) 2016-03-02
US11752209B2 (en) 2023-09-12
US10493152B2 (en) 2019-12-03
JP6962984B2 (ja) 2021-11-05
SI3148510T1 (sl) 2018-10-30
AU2020201090A1 (en) 2020-03-05
ES2683194T3 (es) 2018-09-25
DK3148510T3 (en) 2018-07-16
EP3403646B1 (en) 2022-09-28
JP2020033361A (ja) 2020-03-05
ES2928738T3 (es) 2022-11-22
DK201800070Y4 (da) 2018-12-13
EP3148510B1 (en) 2018-06-27
EP2946766A1 (en) 2015-11-25
US11752208B2 (en) 2023-09-12
EP3659582B1 (en) 2023-08-16
US20200085948A1 (en) 2020-03-19
AU2018222887B2 (en) 2020-02-27
EP4249060A2 (en) 2023-09-27
DK201800071Y4 (da) 2018-12-13
ES2955316T3 (es) 2023-11-30
EP3659582A1 (en) 2020-06-03
PT3148510T (pt) 2018-09-28
HK1257026A1 (zh) 2019-10-11
DE23189888T1 (de) 2024-03-21
US20230061801A1 (en) 2023-03-02
EP3403646A1 (en) 2018-11-21
US20230338527A1 (en) 2023-10-26
US12109267B2 (en) 2024-10-08
CA2947487C (en) 2019-09-24
AU2020201090B2 (en) 2022-03-10
AU2022203863A1 (en) 2022-06-23
CA2947487A1 (en) 2015-11-26
IL249117A0 (en) 2017-01-31
EP4249060A3 (en) 2024-01-03
AU2015263246A1 (en) 2016-11-17
US20170189527A1 (en) 2017-07-06

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