Application of Fulvic Acid as a Pemeation Enhancer for Buccal Drug Delivery of Sumatriptan Succinate

The aim of the present study was to prepare buccoadhesive sustained release tablets of sumatriptan succinate using novel permeation enhancer to release the drug for extended period of time with reduction in dosing frequency. In the present work sumatriptan succinate was used as a model drug and interaction studies performed using FTIR spectroscopy and DSC revealed that there was no drug, polymer and permeation enhancer interaction. Fulvic acid was extracted from shilajit by using resins. Fulvic acid was characterized by various spectroscopic techniques. Buccoadhesive sustained release tablets of sumatriptan succinate with novel permeation enhancer were prepared by direct compression method using bioadhesive polymers like carbopol 934 and HPMC. The physical characteristics like surface pH, swelling index, in vitro mucoadhesion strength, in vitro drug release and in vitro permeation of formulated tablets were shown to be dependent on characteristics and composition of bioadhesive materials used. The in vitro release study showed 99.88% of drug release with fulvic acid, respectively. Fulvic acid containing tablet has shown enhancement in permeation of drug of 93 % in 12 hours across buccal mucosa in comparison with plain sumatriptan succinate tablet. Sumatriptan succinate release from the buccoadhesive system was extended and exhibited a non fickian drug release kinetics approaching to first order as the values of release rate exponent varied between 0.97 to 0.99 resulting in a regulated and complete release until 8 hours.