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US 9,308,174 B2Granted
Lyophilized formulations of bendamustine hydrochloride
AssigneeChemi S.p.A.
InventorsStefano Turchetta, Maurizio Zenoni, Paolo Brandi
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Abstract
New formulations of bendamustine hydrochloride having HPLC purity higher than 99% obtained through the lyophilization of aqueous solutions without organic solvents, are described.
Claims15
Process to obtain lyophilized bendamustine hydrochloride free from organic solvents and with a purity of at least 99%, said process comprising
- dissolving bendamustine hydrochloride in an aqueous solution comprising at least one excipient to obtain a pre-lyophilized solution, wherein the ratio bendamustine hydrochloride to excipients is 10:12 and
- lyophilizing said pre-lyophilized solution,
- thereby obtaining said lyophilized bendamustine hydrochloride free from organic solvents and with a purity of at least 99%.
A lyophilized formulation of bendamustine hydrochloride devoid of residual organic solvents and having a HPLC purity of at least 99%, wherein the ratio bendamustine hydrochloride to excipient is 10:12.
Dependencies are inferred from the claim text.