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CY1124493T1 - Υγρη φαρμακευτικη συνθεση - Google Patents

Υγρη φαρμακευτικη συνθεση

Info

Publication number
CY1124493T1
CY1124493T1 CY20201100843T CY201100843T CY1124493T1 CY 1124493 T1 CY1124493 T1 CY 1124493T1 CY 20201100843 T CY20201100843 T CY 20201100843T CY 201100843 T CY201100843 T CY 201100843T CY 1124493 T1 CY1124493 T1 CY 1124493T1
Authority
CY
Cyprus
Prior art keywords
adalimumab
liquid pharmaceutical
ingredients
pharmaceutical composition
citrate
Prior art date
Application number
CY20201100843T
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=50774706&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CY1124493(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 CY1124493T1 publication Critical patent/CY1124493T1/el

Links

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
    • A61K47/06—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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

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

Abstract

Η παρούσα εφεύρεση σχετίζεται με καινοτόμες υγρές φαρμακευτικές συνθέσεις αδαλιμουμάμπης, οι οποίες περιλαμβάνουν αδαλιμουμάμπη ή ένα βιοομοειδές αυτής, έναν ρυθμιστικό παράγοντα/σύστημα κιτρικών, όπως το κιτρικό νάτριο/κιτρικό οξύ και έναν σταθεροποιητή σακχάρου, όπως η τρεαλόζη. Ένας τέτοιος συνδυασμός συστατικών παρέχει φαρμακοτεχνικές μορφές οι οποίες διαθέτουν σταθερότητα (π.χ. κατά την αποθήκευση και όταν εκτίθενται σε καταπόνηση) συγκρίσιμη με ή βελτιώνουν εκείνες οι οποίες είναι γνωστές στην επιστήμη και περιλαμβάνουν λιγότερα συστατικά στοιχεία. Τέτοιες πρόοδοι θα βοηθήσουν τις θεραπευτικές αγωγές που περιλαμβάνουν την αδαλιμουμάμπη να καταστούν ευρύτερα διαθέσιμες σε χαμηλότερο κόστος και θα παρατείνουν τη βιωσιμότητα των προφορτωμένων συσκευών χορήγησης (π.χ. προπληρωμένες σύριγγες), προκειμένου να μειωθούν τα περιττά απόβλητα του φαρμάκου.
CY20201100843T 2014-05-23 2020-09-08 Υγρη φαρμακευτικη συνθεση CY1124493T1 (el)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP14169755.7A EP2946767B1 (en) 2014-05-23 2014-05-23 Liquid pharmaceutical composition
PCT/EP2015/060818 WO2015177059A1 (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition

Publications (1)

Publication Number Publication Date
CY1124493T1 true CY1124493T1 (el) 2022-03-24

Family

ID=50774706

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20201100843T CY1124493T1 (el) 2014-05-23 2020-09-08 Υγρη φαρμακευτικη συνθεση

Country Status (18)

Country Link
US (2) US10426833B2 (el)
EP (4) EP2946767B1 (el)
JP (3) JP2017516848A (el)
CN (2) CN106535935A (el)
AU (3) AU2015263247A1 (el)
CA (2) CA3104940A1 (el)
CY (1) CY1124493T1 (el)
DK (3) DK3145488T3 (el)
ES (2) ES2607489T3 (el)
HK (1) HK1231391A1 (el)
HR (1) HRP20201242T1 (el)
HU (1) HUE050779T2 (el)
IL (2) IL277241B (el)
LT (1) LT3145488T (el)
PT (1) PT3145488T (el)
RS (1) RS60801B1 (el)
SI (1) SI3145488T1 (el)
WO (1) WO2015177059A1 (el)

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WO2017177160A1 (en) 2016-04-07 2017-10-12 Nevakar Llc Formulation for use in a method of treatment of pain
CN110831621A (zh) * 2017-04-18 2020-02-21 雷迪博士实验室有限公司 稳定的液体药物组合物
EP3691748A4 (en) 2017-10-03 2021-07-07 Nevakar, Inc ACETAMINOPHEN-PREGABALIN COMBINATIONS AND METHODS OF TREATMENT OF PAIN
MX2017016884A (es) * 2017-12-19 2019-06-20 Probiomed S A De C V Formulacion farmaceutica estable de una proteina anti-tnfa.
US20210299255A1 (en) * 2018-07-20 2021-09-30 Momenta Pharmaceuticals, Inc. Compositions of fcrn antibodies and methods of use thereof
WO2024077246A1 (en) * 2022-10-07 2024-04-11 Annexon, Inc. Formulations for anti-c1q antibodies

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Also Published As

Publication number Publication date
DK202000038U1 (da) 2020-05-18
EP2946767B1 (en) 2016-10-05
AU2020204269A1 (en) 2020-07-16
CN111939257A (zh) 2020-11-17
ES2607489T3 (es) 2017-03-31
CA2948746A1 (en) 2015-11-26
AU2020286276A1 (en) 2021-01-14
HK1231391A1 (zh) 2017-12-22
US10426833B2 (en) 2019-10-01
US20170182162A1 (en) 2017-06-29
EP3145488A1 (en) 2017-03-29
IL249116A0 (en) 2017-01-31
DK3145488T3 (da) 2020-08-10
EP3145488B1 (en) 2020-07-22
AU2015263247A1 (en) 2016-12-01
PT3145488T (pt) 2020-09-01
AU2020204269B2 (en) 2020-09-17
IL249116B (en) 2020-09-30
RS60801B1 (sr) 2020-10-30
JP2021107399A (ja) 2021-07-29
IL277241A (en) 2020-10-29
JP2022174082A (ja) 2022-11-22
ES2815598T3 (es) 2021-03-30
CA3104940A1 (en) 2015-11-26
JP2017516848A (ja) 2017-06-22
AU2020286276B2 (en) 2023-06-01
DK202000038Y3 (da) 2020-07-10
DK202000030Y3 (da) 2020-05-26
CN106535935A (zh) 2017-03-22
EP3741358A1 (en) 2020-11-25
EP2946767A1 (en) 2015-11-25
EP3939566A1 (en) 2022-01-19
WO2015177059A1 (en) 2015-11-26
US20200155677A1 (en) 2020-05-21
SI3145488T1 (sl) 2020-10-30
HUE050779T2 (hu) 2021-01-28
IL277241B (en) 2022-08-01
CA2948746C (en) 2021-01-12
LT3145488T (lt) 2020-11-25
HRP20201242T1 (hr) 2020-11-13
DK202000030U1 (da) 2020-04-28

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