FORMULATION, DEVELOPMENT AND EVALUATION OF FEBUXOSTAT LOADED FAST MOUTH DISSOLVING STRIP FOR THE TREATMENT OF GOUT

This study’s objective is to formulate and develop a fast mouth dissolving strip which will contains a febuxostat as an API against gout disease. This strip is made by utilizing solvent casting method. To the manufacturing of febuxostat fast mouth dissolving strip, a two-factor (2³) factorial design was used. The independent factors for the fast mouth dissolving strip were percentage of HPMC and PEG 400, whereas dependent variables were percentage of cumulative drug release and disintegration time. Febuxostat fast mouth dissolving strip was evaluated through organoleptic properties, thickness, moisture content and moisture uptake, drug content uniformity, weight uniformity, tensile strength, disintegration test, folding endurance, surface pH, swelling index, in-vitro drug release. In-vivo bioavailability study, stability study performed on the optimized batch B6. Disintegration time for optimized batch found that 15 seconds. The strips were white in color and plane in texture. The thickness of optimized batch found that 0.24 mm, the drug content uniformity was 87.99 % of optimized batch which was calculated by dissolving strip for number of hours. A reduction in first pass metabolism that increases in absorption into the systemic circulation, maximum drug release of optimized batch is 67.96 % obtained by calculating absorbance which were got from in-vitro dissolution study. The stability formulation was tested under accelerated temperature and humidified condition, at second month of stability test drug content was found that 72.85 ± 4.59, disintegration time17.2 ± 0.964 and surface pH6.39 ± 0.01. Febuxostat fast mouth dissolving strips were successfully formulated by the solvent-casting method.