FORMULATION AND EVALUATION OF ENTERIC COATED ELEMENTARY OSMOTIC PUMP (ECEOP) TABLETS OF DICLOFENAC SODIUM

The objective of this study was to formulate a Novel drug delivery device that is capable of releasing the drug in controlled kinetics through the oral route, bypassing the acidic environment of the stomach. Therefore, it was planned to develop an osmotic device with an enteric coating. It was projected to enhance the strength of the semi-permeable membrane for the osmotic device to control drug release for a longer time at controlled release kinetics. The formulations were designed and optimized by using OFAT design to find out the best formulation. The drug release rate was taken up to 8 h, and a comparative study of drug release with a marketed product was carried out. The drug release kinetics showed the optimized device to follow zero-order release kinetics. The FT-IR studies revealed that no physicochemical interaction between excipients and drugs. Stability studies showed that optimized formulation was stable. The observed drug release pattern was found significantly similar at a later stage to release the pattern of a marketed product. The formulated tablets of Diclofenac Sodium were found to be therapeutically safe, which did not release any drug content in an acidic medium for a predetermined time, but it released the drug in a sustained manner in alkaline medium. It was capable of releasing the drug 80.33% in 6 h, which is almost similar to a film-coated sustained-release marketed formulation, which was capable of releasing the drug 82.78% in 6 h.