Chitosan microspheres of diclofenac sodium, II: In vitro and in vivo evaluation.

A biodegradable diclofenac sodium (DS) microsphere system using chitosan has been characterized and evaluated in vitro and in vivo. The particle size distribution and drug content was determined. The release rate data were investigated by using zero-order, first-order, Hixson-Crowel and Higuchi kinetics. The optimum DS-Chitosan microsphere formulation, empty chitosan microspheres, sustained release commercial product and plain drug were evaluated for pharmacological activity. The ulcerogenic index in rabbits was also determined.