Optimization of Tertiary Butyl Alcohol in the Bulk Formulations of Bendamustine Hydrochloride Injection

B-cell chronic lymphocytic leukemia (B-CLL), also known as chronic lymphoid leukemia (CLL), is themost common type of leukemia. Leukemias are cancers of the white blood cells (leukocytes). CLLaffects B cell lymphocytes. B cells originate in the bone marrow, develop in the lymph nodes, andnormally fight infection by producing antibodies. Bendamustine (INN, trade names Ribomustin andTreanda; also known as SDX-105) is a nitrogen mustard used in the treatment of chronic lymphocyticleukemias (CLL) and lymphomas. It belongs to the family of drugs called alkylating agents. It is alsobeing studied for the treatment of sarcoma1. Bendamustine Hydrochloride is commercially available inthe market as lyophilizzed dosage form. Also enough literature is available that BendamustineHydrochloride is very unstable in the liquid dosage form. It undergoes hydrolytic degradation in thepresence of water2. Hence an attempt for developing a simple, aqueous and non aqueous basedBendamustine Hydrochloride formulations have been attempted.