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FORMULATION AND EVALUATION OF SUMATRIPTAN SUCCINATE NASAL IN-SITU GEL USING FULVIC ACID AS NOVEL PERMEATION ENHANCER

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Author(s): Shyam D. Badgujar

Journal: International Journal of Pharmaceutical Research and Development
ISSN 0974-9446

Volume: 2;
Issue: 8;
Start page: 7;
Date: 2010;
Original page

Keywords: Sumatriptan succinate | fulvic acid | pluronic PF127 and carbopol 974P

ABSTRACT
Sumatriptan succinate is a 5-HT1D (5-hydroxy tryptamine 1D)-receptor agonist, used in the treatment of migraine and cluster headache Sumatriptan succinate has been shown to have a low oral bioavailability in human volunteers (15%) because of high first pass metabolism.. Subcutaneous administration is an alternative; however, dislike of injections or inability to self-administer by this route makes subcutaneous treatment unacceptable to some individuals. These all above things justify a need of nasal drug delivery. To improve the nasal retention time of Sumatriptan succinate, it has been formulated as in situ mucoadhesive gel by using Pluronic PF127 and carbopol 974P. The objective of this work was to improve the nasal bioavailability of Sumatriptan succinate by increasing its nasal retention time as well as by means of nasal permeation. Nasal permeation of Sumatriptan succinate was improved by using fulvic acid extracted from Shilajit as a novel permeation enhancer. For the same the nasal in situ gel of Sumatriptan succinate and its complex with fulvic acid extracted from shilajit was made by cold method. The prepared in-situ gel was evaluated for gelation temperature, drug content, mucoadhesive force, gel strength and viscosity measurement. Further insitu gels prepared with and without permeation enhancer (Fulvic acid) were evaluated for its In vitro drug diffusion study by Fran’s Diffusion Cell. The data of In vitro drug diffusion study of insitu gel prepared with and without permeation enhancer showed non Fickian or anomalous diffusion mechanism. The optimized batch C3 and F3 of insitu gel prepared with and without permeation enhancer respectively shows drug release in a controlled manner with higher permeation rate for 250min.. The drug permeation study across sheep nasal mucosa was conducted using C3 and F3 batch. The study showed that the insitu gel having fulvic acid have a significantly higher permeability as compared to the insitu gel which do not contain the fulvic acid. The higher permeation rate of C3 formulation as compare to F3 formulation is might be due to polymeric polyphenolic nature of fulvic acid because of which it have a tendency to interact with number of component resulting in higher permeation rate.

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