PHARMACEUTICAL COMPOSITIONS FOR ANTIBODIES AND MAKING AND USING THE SAME

PHARMACEUTICAL COMPOSITIONS FOR ANTIBODIES AND MAKING AND USING THE SAME

A stable pharmaceutical formulation comprising: an antibody comprising a polypeptide having a canine CH2, CH3, IgG Fc region variant, or a canine FcRn-binding region thereof; a buffering agent at a pH in the range of from 4.5 to 7.0; a tonicity and/or stabilizing agent; a chelating agent; and a surf...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: Sampathkumar, Krishnan, Huang, Chi-Ting
Format: Patent
Sprache:eng
Schlagworte:
CHEMISTRY
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
METALLURGY
ORGANIC CHEMISTRY
PEPTIDES
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Beschreibung
Zusammenfassung:A stable pharmaceutical formulation comprising: an antibody comprising a polypeptide having a canine CH2, CH3, IgG Fc region variant, or a canine FcRn-binding region thereof; a buffering agent at a pH in the range of from 4.5 to 7.0; a tonicity and/or stabilizing agent; a chelating agent; and a surfactant; wherein the formulation retains stability for up to twenty-four months in solution and is suitable for oral, rectal, transmucosal, intestinal, or parenteral administration.