SI1324776T2 - Koncentrirane proteinske formulacije z zmanjšano viskoznostjo - Google Patents

Koncentrirane proteinske formulacije z zmanjšano viskoznostjo Download PDF

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Publication number
SI1324776T2
SI1324776T2 SI200130952T SI200130952T SI1324776T2 SI 1324776 T2 SI1324776 T2 SI 1324776T2 SI 200130952 T SI200130952 T SI 200130952T SI 200130952 T SI200130952 T SI 200130952T SI 1324776 T2 SI1324776 T2 SI 1324776T2
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Slovenia
Prior art keywords
formulation
salt
rhumab
buffer
amount
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SI200130952T
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English (en)
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SI1324776T1 (sl
Inventor
Jun Liu
Steven J. Shire
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Genentech, Inc.
Novartis Ag
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26933147&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=SI1324776(T2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech, Inc., Novartis Ag filed Critical Genentech, Inc.
Publication of SI1324776T1 publication Critical patent/SI1324776T1/sl
Publication of SI1324776T2 publication Critical patent/SI1324776T2/sl

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    • 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
    • A61K47/12—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
    • A61K47/16—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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/80—Elimination or reduction of contamination by undersired ferments, e.g. aseptic cultivation

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (25)

  1. Koncentrirane proteinske formulacije z zmanjšano viskoznostjo Patentni zahtevki
    1. Stabilna tekoča formulacija, ki obsega imunoglobulin v količini najmanj 80 mg/ml in sol in/ali pufer v količini najmanj 100 mM in ima kinematično λ viskoznost 50 mm /s ali manj pri 25 °C, kjer je imunoglobulin protitelo rhuMAb-E25, rhuMAb-E26 ali rhuMAb-E27 in kjer sol ni natrijev klorid.
  2. 2. Formulacija po zahtevku 1, ki obsega: (a) sol in/ali pufer v količini 100-200 mM ali (b) sol in/ali pufer v količini 200 mM.
  3. 3. Formulacija po zahtevku 1, kjer sta sol in/ali pufer izvedena iz: (a) organske ali anorganske kisline in kovine ali amina, ki tvori bazo, ali (b) aminokisline.
  4. 4. Formulacija po zahtevku 3, kjer: (a) kovina, ki tvori bazo, je izbrana iz skupine, ki jo sestavljajo alkalijske kovine, zemeljskoalkalijske kovine, Al, Zn in Fe, ali (b) amin, ki tvori bazo, je NR/, kjer je R neodvisno H ali Ci.4-alkil.
  5. 5. Formulacija po zahtevku 1, kjer je sol in/ali pufer izveden iz aminokisline.
  6. 6. Formulacija po zahtevku 1, kjer je sol izbrana iz skupine, ki jo sestavljajo natrijev tiocianat, amonijev tiocianat, amonijev sulfat, amonijev klorid, kalcijev klorid, arginin hidroklorid, cinkov klorid in natrijev acetat.
  7. 7. Formulacij a po zahtevku 1, ki: (a) ima kinematično viskoznost 40 mm2/s ali manj pri 25 °C ali (b) ima kinematično viskoznost 30 mm2/s ali manj pri 25 °C ali (c) ima kinematično viskoznost 20 mm2/s ali manj pri 25 °C ali (d) ima kinematično viskoznost 10-30 mm2/s pri 25 °C.
  8. 8. Formulacija po zahtevku 1, ki nadalje obsega lioprotektant.
  9. 9. Formulacija po zahtevku 8, kjer je lioprotektant sladkor.
  10. 10. Formulacija po zahtevku 9, kjer je sladkor saharoza ali trehaloza.
  11. 11. Formulacija po zahtevku 9, ki obsega sladkor v količini 60-300 mM.
  12. 12. Formulacija po zahtevku 1, ki nadalje obsega surfaktant.
  13. 13. Formulacija po zahtevku 1, ki je hipertonična.
  14. 14. Formulacija po zahtevku 1, ki je rekonstituirana formulacija.
  15. 15. Formulacija po zahtevku 14, kjer je koncentracija imunoglobulinskega proteina v rekonstruirani formulaciji 2-40-krat večja kot koncentracija imunoglobulinskega proteina v zmesi pred liofilizacijo.
  16. 16. Formulacija po zahtevku 1, kije tekoča farmacevtska formulacija.
  17. 17. Formulacija po zahtevku 16, kije za subkutano dajanje.
  18. 18. Postopek za zmanjšanje kinematične viskoznosti formulacije, ki vsebuje imunoglobulin v količini najmanj 80 mg/ml, ki obsega dodatek soli in/ali pufra v količini najmanj 100 mM, kjer je imunoglobulin protitelo rhuMAb-E25, rhuMAb-E26 ali rhuMAb-E27 in kjer sol ni natrijev klorid.
  19. 19. Postopek po zahtevku 18, kjer je sol izbrana iz skupine, ki jo sestavljajo natrijev tiocianat, amonijev tiocianat, amonijev sulfat, amonijev klorid, kalcijev klorid in arginin hidroklorid.
  20. 20. Postopek po zahtevku 18, kjer je formulacija rekonstruirana formulacija.
  21. 21. Postopek po zahtevku 18, kjer je formulacija hipertonična.
  22. 22. Postopek po zahtevku 20, kjer je koncentracija proteina v rekonstituirani formulaciji 2-40-krat večja kot koncentracija proteina v zmesi pred liofilizacijo.
  23. 23. Postopek po zahtevku 18, kjer je kinematična viskoznost formulacije zmanjšana na 50 mm2/s ali manj, kot je ugotovljeno pri 25 °C.
  24. 24. Izdelek, ki obsega vsebnik, ki vsebuje formulacijo po katerem koli od zahtevkov 1-17.
  25. 25. Izdelek po zahtevku 24, ki nadalje obsega navodila za dajanje formulacije.
SI200130952T 2000-10-12 2001-10-04 Koncentrirane proteinske formulacije z zmanjšano viskoznostjo SI1324776T2 (sl)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US24010700P 2000-10-12 2000-10-12
US29383401P 2001-05-24 2001-05-24
EP01981824.4A EP1324776B2 (en) 2000-10-12 2001-10-04 Reduced-viscosity concentrated protein formulations
PCT/US2001/042487 WO2002030463A2 (en) 2000-10-12 2001-10-04 Reduced-viscosity concentrated protein formulations

Publications (2)

Publication Number Publication Date
SI1324776T1 SI1324776T1 (sl) 2010-01-29
SI1324776T2 true SI1324776T2 (sl) 2018-06-29

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US (3) US6875432B2 (sl)
EP (2) EP2116265B1 (sl)
JP (2) JP4340062B2 (sl)
AT (1) ATE442862T2 (sl)
AU (2) AU2002213441B2 (sl)
CA (1) CA2423227C (sl)
CY (1) CY1110547T1 (sl)
DE (1) DE60139944D1 (sl)
DK (1) DK1324776T4 (sl)
ES (1) ES2332402T5 (sl)
IL (3) IL155002A0 (sl)
PT (1) PT1324776E (sl)
SI (1) SI1324776T2 (sl)
WO (1) WO2002030463A2 (sl)

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