COMPARATIVE-STUDY OF BUCCOADHESIVE FORMULATIONS AND SUBLINGUAL CAPSULES OF NIFEDIPINE

The pharmacodynamics of nifedipine administered via the oral mucosa was investigated in hypertensive patients. The effect of two buccoadhesive formulations, tablets and films, was compared with the commercially available sublingual capsule in a complete cross-over study in six patients. All three formulations elicited onset of action 10 min after administration. The sublingual capsule and the buccoadhesive film revealed peak response at 30 min. The buccoadhesive tablet, however, exhibited a delayed peak response at 45 min. Analysis of variance indicated that, although time-dependent differences in the formulations were suggested, there was no significant difference in the overall effect produced by the three formulations. The results of the study suggest that the buccoadhesive formulations of nifedipine were comparable in performance with the sublingual capsule.