Development and Evaluation of Fast Dissolving Oral Films of Mefenamic Acid for the Management of Fever

Abstract:

The marketed formulations of Mefenamic Acid (MA) used for the treatment of fever in the paediatric population are reported to have several drawbacks. This study aimed to develop and evaluate the mefenamic acid–loaded oral dispersible films which may be a better alternative than the existing formulations. The solubility of mefenamic acid was enhanced by forming inclusion complexes with β cyclodextrin. The best ratio for the mefenamic acid-β cyclodextrin inclusion complex, 1:0.5 was selected based on the drug content and in vitro drug release. Fourier transform Infrared spectroscopy and scanning electron microscopy analysis was performed on the complex. The oral dispersible films were developed by solvent casting method and evaluated for parameters such as average weight, thickness, pH, folding endurance, percentage moisture uptake and loss, drug content, in vitro disintegration time and drug release. The statistical analysis of the data suggested that oral dispersible films with 4% w/v of crospovidone (coded P3) as the best. Drug content (95.46±0.93%), disintegration time (28.6±2.0 s), cumulative percentage drug release (97.41±0.68% in 180 s), and all other investigated parameters of P3 were well within the acceptable limit. The in vitro dissolution profile of P3 showed no significant difference from the marketed mefenamic acid suspension and has a good stability profile at in-house testing conditions. The data obtained from this investigation revealed that mefenamic acid oral dispersible films could act as an excellent alternative to existing marketed paediatric formulations.

Keywords: Oral dispersible films, Mefenamic acid, β Cyclodextrin, Paediatric, Kneading method, Solvent casting.