Bendamustine pharmaceutical compositions
The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.
1. A pharmaceutical composition comprising bendamustine or bendamustine hydrochloride, mannitol, tertiary-butyl alcohol and water.
2. The pharmaceutical composition according to claim 1 , wherein said bendamustine or bendamustine hydrochloride is present at a concentration of about 12 to 17 mg/ml, said mannitol is present at a concentration of about 20-30 mg/ml, and said tertiary-butyl alcohol is present at a concentration of about 10-50% (v/v).
3. The pharmaceutical composition according to claim 2 , wherein said bendamustine or bendamustine hydrochloride is present at a concentration of about 15 mg/ml, said mannitol is present at a concentration of about 25.5. mg/ml, and said tertiary-butyl alcohol is present at a concentration of about 30% (v/v).
4. A lyophilized pharmaceutical composition made from the pharmaceutical composition according to claim 1 .
5. The lyophilized pharmaceutical composition according to claim 4 , wherein said bendamustine or bendamustine hydrochloride is present in said pharmaceutical composition at a concentration of about 12 to 17 mg/ml, said mannitol is present in said pharmaceutical composition at a concentration of about 20-30 mg/ml, and said tertiary-butyl alcohol is present in said pharmaceutical composition at a concentration of about 10-50% (v/v).
6. The lyophilized pharmaceutical composition according to claim 5 , wherein said bendamustine or bendamustine hydrochloride is present in said pharmaceutical composition at a concentration of about 15 mg/ml, said mannitol is present in said pharmaceutical composition at a concentration of about 25.5 mg/ml, and said tertiary-butyl alcohol is present in said pharmaceutical composition at a concentration of about 30% (v/v).
7. The lyophilized pharmaceutical composition according to claim 4 containing not more than about 0.5% bendamustine ethylester.
8. The lyophilized pharmaceutical composition according to claim 5 containing not more than about 0.5% bendamustine ethylester.
9. The lyophilized pharmaceutical composition according to claim 6 containing not more than about 0.5% bendamustine ethylester.