FGF-21 FORMULATIONS

The present application provides pharmaceutical formulations comprising a FGF-21 polypeptide, e.g., a modified FGF-21 polypeptide such as PEG-FGF-21, and one or more stabilizers such as the chelator DPTA. The formulations can be can further stabilized by including a surfactant such as polysorbate 80...

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Bibliographische Detailangaben
Hauptverfasser: PALM, THOMAS, KHOSSRAVI, MEHRNAZ, PATKE, SANKET
Format: Patent
Sprache:eng ; fre
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Zusammenfassung:The present application provides pharmaceutical formulations comprising a FGF-21 polypeptide, e.g., a modified FGF-21 polypeptide such as PEG-FGF-21, and one or more stabilizers such as the chelator DPTA. The formulations can be can further stabilized by including a surfactant such as polysorbate 80 and/or adjusting the pH to about 7.1. Also provided are methods of manufacture, methods of treatment, and kits. La présente invention concerne des formulations pharmaceutiques comprenant un polypeptide FGF-21, par exemple un polypeptide FGF-21 modifié tel que le PEG-FGF-21, et un ou plusieurs stabilisants tels que le chélateur DPTA. Ces formulations peuvent être en outre stabilisées en incorporant un tensioactif tel que le polysorbate 80 et/ou en ajustant le pH à environ 7,1. L'invention concerne également des procédés de fabrication, des procédés de traitement et des kits.