PREPARATION OF A MORE STABLE LYOPHILIZED BCG-T WITH THE SAME BIOPOTENTIAL FOR BLADDER CANCER IMMUNOTHERAPY

Abstract

BCG-T is a new trend for immunotherapy of bladder cancer as an alternative to chemotherapy. The available product is liquid form of a limited stability profile. The present study aims to prepare a lyophilized form of BCG-T using different stabilizer namely Na glutamate and lactose. Stability of pharmaceutical lyophilized injection dosage form compared with the liquid form was assessed revealing that the Na glutamate and lactose stabilized BCG-T was significantly more stable than BCG-T in the liquid formula. Also, the dry weight and relative humidity and safety of both Na glutamate and lactose stabilized BCG-T were insignificantly different from the liquid form (P >0.05).