Formulation and Evaluation of Unidirection Bucco- Adhesive Tablet of Sumatriptan Succinate for Migraine Disorder

The objective of this research work was to formulate and evaluate PEO WSR 301 bucco-adhesive tablet in combination with Carbopol 934p for controlled release of Sumatriptan Succinate. To bypass high hepatic first pass metabolism, unidirection bucco-adhesive tablet is selected dosage form for the experimental work. Initially preliminary trials were carried out for the selection of excipients and their relative quantity for incorporation in the dosage form. From the results, Polyethylene oxide-PEO WSR 301 (mucoadhesive polymer) and Carbopol 934p (control release) were selected as a suitable excipients for experimentation. Composition of the mucoadhesive tablet was optimized using 3² full factorial design where amount of PEO WSR 301 (X1) and amount of Carbopol 934p (X2) were taken as independent variables and mucoadhesive strength, Drug release at 6 hour and % swelling index taken as response variables. The formulations of design batches were characterized for post compression parameters like weight variation, hardness, thickness, friability, Drug content, swelling index, ex-vivo Mucoadhesive strength, and surface pH, drug release at 6 hr., ex-vivo residence time, and curve fitting analysis. The optimized formulation was obtained using Minitab software based on desirability value. Characterization of optimized batch was carried out by, ex-vivo permeation study. From the results of meting point, DSC and FTIR study the drug and its compatibility with other excipients was confirmed. λmax of Sumatriptan Succinate was found to be 227 nm and linearity was 0.9995. Mucoadhesive strength and swelling index were in range of 0.25-0.43 N and 45-50% respectively. Drug release at 6hr. was in the range of 87-95%. The Bucco-adhesive of Sumatriptan succinate provides good concept to bypass the extensive hepatic first-pass metabolism. Formulated tablet using PEO-WSR 301 and Carbopol 934p showed good mucoadhesion, release profile, swelling index and permeation behavior. The Sumatriptan Succinate unidirection bucco-adhesive tablet is a promising approach for the effective treatment of disease as it provides control drug release in 6 hr.