FORMULATIONS OF COPANLISIB

The present invention relates to: a method of preparing a stable, copanlisib-containing aqueous bulk solution suitable for lyophilisation and for therapeutic applications; a stable, copanlisib-containing bulk solution, of increased solubility which is directly suitable for lyophilisation; a method o...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Hauptverfasser: JACOBS, TIA, FREUNDLIEB, JULIA
Format: Patent
Sprache:eng ; srp
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Beschreibung
Zusammenfassung:The present invention relates to: a method of preparing a stable, copanlisib-containing aqueous bulk solution suitable for lyophilisation and for therapeutic applications; a stable, copanlisib-containing bulk solution, of increased solubility which is directly suitable for lyophilisation; a method of lyophilizing such a copanlisib-containing aqueous bulk solution; a stable, lyophilized, copanlisib-containing solid, in particular powder or cake, particularly containing a therapeutic dose of copanlisib in one or two containers, particularly one sealed container; a method of reconstituting such lyophilisates; and a stable, reconstituted, copanlisib-containing solution of increased solubility, suitable for further dilution and for therapeutic applications.