| abstract |
The present invention relates to: a method of preparing a stable, copanlisib-containing, aqueous bulk solution suitable for lyophilization and therapeutic applications; a bulk solution, containing copanlisib, stable, of higher solubility which is directly suitable for lyophilization; a method for freeze-drying such an aqueous bulk solution containing copanlisib; a stable, lyophilized solid containing copanlisib, 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 reconstitution of said lyophilisates; and a stable, reconstituted solution containing copanlisib of higher solubility, suitable for further dilution and for therapeutic applications. |