Abstract

Diclofenac sodium was formulated as dual coated enteric spheres for Intestinal specific drug delivery using enteric polymers like cellulose acetate phthalate and ethyl cellulose. The dual coating was given using a new process composed of wet granulation and thermal change methods using both the polymers. The new process was analyzed for its capability to produce spheres of uniform size, good flow ability, uniform drug loading, and maximum entrapment efficacy and the absence of interaction between drug and process parameters as well as polymers. In vitro release study was carried out in simulated gastric fluid for first 2 h and In simulated intestinal fluid for next 6 h. The best formulation B3, which contained cellulose acetate phthalate and ethyl cellulose in the concentration of 10:90 at 1:1.5 drug-polymer ratio was further evaluated using in vivo models for its Pharmacodynamic efficacy and ulcerogenicity.