| abstract |
The present invention relates to: a method for preparing a stable, aqueous, bulk solution containing copanlisib suitable for lyophilization and for therapeutic applications; a stable, higher solubility, copanlisib-containing bulk solution which is directly suitable for lyophilization; a method for freeze-drying such an aqueous bulk solution containing copanlisib; a stable, lyophilized, copanlisib-containing solid, in particular powder or cake, particularly containing a therapeutic dose of copanlisib in one or two containers, particularly in a sealed container; a method for the reconstitution of said lyophilisates; and a reconstituted, stable solution containing higher solubility copanlisib, suitable for further dilution and therapeutic applications. |