Abstract:

The aim of the present work was to prepare and evaluate sublingual fast dissolving niosomal films containing Nifedipine with the purpose to achieve quick onset of action. Niosomes are utilized for prolonged release of the drug, and its film increases bioavailability via the sublingual route. Niosomes were prepared using span 60 and cholesterol at different drug to surfactant ratios. The niosomes were characterized for particle size and zeta-potential. The selected niosomal formulation was incorporated into polymeric films using hydroxypropyl methyl cellulose E15 and methyl cellulose as film-forming polymers and crosspovidone, croscarmelose sodium and sodium starch glycollite as superdisintegrants to produce six formulations. The physical characteristics of the prepared films were studied, in addition to evaluating the in vitro drug release and stability. The formulation F6 containing the methyl cellulose and sodium starch glycolate as good film forming polymer and superdisintegrant respectively  was found to be the best formulation showing  good film forming capacity, tensile strength and % cumulative drug release of 93.91±0.648% after 9 minutes. The kinetic data analysis showed that it follows zero order models by non fickian release mechanism. These results indicate that the fast dissolving niosomal film could be a promising delivery system to enhance the bioavailability and prolong the therapeutic effect of Nifedipine.