Optimization of novel self-microemulsifying mouth dissolving films by response surface methodology.
- Author:
Lu XIAO
;
Tao YI
;
Ying LIU
;
Di HUAN
;
Jikui HE
- Publication Type:Journal Article
- From:
Acta Pharmaceutica Sinica
2011;46(5):586-91
- CountryChina
- Language:Chinese
-
Abstract:
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.