COMPARATIVE PHARMACOKINETIC EVALUATION OF COMPRESSED SUPPOSITORIES OFDICLOFENAC SODIUM IN HUMANS

Diclofenac sodium (CAS 15307-79-6) suppositories were formulated using polyethylene glycol 4000 as the base by dispersing the drug in the mo lten base, congealing the mass, followed by pulverization, sieving and subsequent compression of the resultant granules. These suppositories were evaluated with respect to their pharmacokinetic behaviour in 12 healthy, male human volunteers. The results were compared with those o btained after oral administration of a commercial enteric coated table t. Bioequivalence between rectal suppositories and commercial tablets was observed with respect to AUC(0-infinity), and C-max. However, t(ma x) differed significantly (p < 0.05) in case of rectal administration (0.625 +/- 0.065 h) compared to oral tablet (1.58 +/- 0.06 h). The rel ative rectal bioavailability was 107.19 +/- 3.2.