Formulation and In Vivo, In Vitro, Ex-Vivo Evaluation of Gallic Acid Loaded Floating Mucoadhesive System (Research Article)

Author(s): Lalit Thakre and Shubhangi Aher*

Abstract: Despite major breakthroughs in therapy over the past few decades, peptic ulcer disease has remained a prevalent disease. The objective of this research was to formulate Gallic acid loaded floating mucoadhesive microsphere for treating peptic ulcer by full factorial design approach. Two factor three level factorial design was used for optimisation of formulation.GA loaded microsphere was developed by ionic gelation method using sodium alginate and calcium chloride. Various Polymer and crosslinking agent were screened out of which Sodium bicarbonate, Eudragit L100 and Guar gum were selected for development of formulation. Drug: Polymer ratio, stirring speed were selected as two independent factors. These two factors were investigated at three levels. Entrapment efficiency and percent drug release were dependent factors and satisfactory results found for all experimental batches. Amongst all the experimental batches an optimized batch was obtained and further characterized for micromeritic properties, SEM analysis, DSC analysis, in-vitro dissolution studies, anti-microbial activities, antioxidant assay, ex-vivo mucoadhesion. The further in-vivo evaluation showed that animals treated with an optimized formulation with gallic acid showed significant inhibition of peptic ulcers. Stability study of optimized formulation showed that tablets were stable at 25±2℃ and 5±3℃. It was concluded that floating mucoadhesive microsphere containing Gallic acid could be a promising strategy for treating peptic ulcers.

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