Formulation and Evaluation of Capecitabine Immediate Release Tablets

The present investigation was to develop immediate release (IR) tablet formulations of Capecitabine an anti-cancer drug, using Hydroxy Propyl Methyl Cellulose (HPMC E5) as binding agent. The tablets were prepared by wet granulation process and evaluated for various physico-chemical/mechanical parameters. Among the formulations the optimised formulation was identified by comparing dissolution profiles with innovator. The formulation containing 97.5mg MCC (Avicel PH 101) as filler and 20mg HPMC E5 as binder gave a bioequivalent dissolution profile as innovator over a period of 60min (100.8%). The dissolution data of optimized formulation was also evaluated for drug release kinetics and mechanisms. The significant factor for optimised formulation and innovator was evaluated.