Optimization of novel self-microemulsifying mouth dissolving films by response surface methodology

This paper report the development of a new dosage form - self-microemulsifying mouth dissolving films, which can improve the oral bioavailability of water insoluble drugs and have good compliance. A three factor, three-level Box-Behnken design was used for optimizing formulation, investigated the effect of amounts of microcrystalline cellulose, low-substituted hydroxypropyl cellulose and hypromellose on the weight, disintegration time, cumulative release of indomethacin after 2 min, microemulsified particle size and stretchability. Optimized self- microemulsifying mouth dissolving films could fast disintegrate in (17.09 ± 0.72) s; obtain microemulsified particle size at (28.81 ± 3.26) nm; and release in vitro at 2 min to (66.18 ± 1.94)%. Self-microemulsifying mouth dissolving films with broad application prospects have good compliance, strong tensile and can be released rapidly in the mouth through fast self-microemulsifying.