FORMULATION AND EVALUATION OF FAST DISSOLVING TABLETS CONTAINING TASTE-MASKED MICROSPHERES OF DICLOFENAC SODIUM FOR SUSTAINED RELEASE

Diclofenac sodium (DCS), a non-steroidal antiinflammatory drug used for posttraumatic pain and rheumatoid arthritis, has bitter taste. Thus formulating orally dissolving tablet containing taste-masked microspheres of diclofenac sodium is extremely advantageous and challenge. Taste-masked microsphers were prepared using Eudragit EPO (EEPO) in different ratios. The physicochemical properties of the prepared microsphers were evaluated. The prepared taste-masked microspheres were formulated in orally dissolving tablets (ODTs) using different superdisintegrants. The effect of superdisinitegrant on in-vitro release of drug was studied. The obtained data showed that the ratio of drug: polymer influenced both the microsphere size and the drug release from Eudragit EPO microspheres. Increasing this ratio resulted in increasing the size of microspheres and slowed the release of the drug in both 0.1 N HCl and phosphate buffer (pH 6.8). The orally dissolved tablets containing microsphere of a ratio 1: 4 drug to polymer exhibited acceptable hardness, friability, drug content and disintegration time 11 seconds. Moreover, the drug had sustained release rate from its-loaded orally dissolving tablets containing EEPo micropsheres. Orally dissolving tablets containing crosspovidone showed higher release as compared with other superdisintegrants. Furthermore, the orally dissolving tablets showed high degree of palatability in tested volunteers.