Abstract

FORMULATION AND IN-VITRO EVALUATION OF ANTI CANCER FORMULATION USING LYOPHYLIZATION TECHNIQUE WITH CYCLODEXTRIN DERIVATIVE

China Babu Bairu* and Dr. Avinash Dundigalla

ABSTRACT

The purpose of present study was to enhance the stability of bendamustine hydrochloride (API) in parenteral formulation by employing Lyophylization and various excipients. Excipients utilized were commonly approved and proved to be compatible with active ingredients from the studies of ultra violet spectroscopy (U.V). In the present study, the anticancer drug was formulated as lyophilized dosage form using excipients mainly Mannitol as bulking agent and Sulfo butyl ether β-Cyclodextrin(SBE-β-CD) is a complexing agent. Drug description, identification, assay, melting point, solubility, osmolarity, solution stability, pH stability and compatibility with different excipients were determined. It was found that API was water soluble and degraded within 24 hours in solution form at normal room temperature and 6 days at cold conditions following the trend the lyophilized API formulation with moisture content of 6% to 7%was found to be more stable with good cake than with anhydrous form. Sulfo butyl ether β-Cyclodextrin(SBE-β-CD) played a crucial role in the Lyophylization. Rubber closure compatibility studies were performed by inverting the vial position. Stability studies were performed in pH range of 3.2 to 2.9. Drug in solution form was found to be stable for 48 hours in cold conditions and reconstituted solution is to be used within 48 hours. Finally, formulation containing Sulfo butyl ether β-Cyclodextrin(SBE-β-CD) agent is gave better results as complexing agent as well as solubility enhancer. Accelerated stability studies were performed and optimized formulation was developed.

Keywords: Bendamustine, Sulfobutylether?-Cyclodextrin(SBE-?-CD), Lyophilization, Compatibility studies.