Xiao Lu, Yi Tao, Liu Ying, Huan Di, He Ji-kui
School of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China.
Yao Xue Xue Bao. 2011 May;46(5):586-91.
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.
本文报道了一种新型剂型——自微乳化口腔崩解膜的研制，其可提高水不溶性药物的口服生物利用度且具有良好的顺应性。采用三因素三水平的Box-Behnken设计优化处方，考察微晶纤维素、低取代羟丙基纤维素和羟丙甲纤维素用量对重量、崩解时间、吲哚美辛2分钟累积释放度、微乳化粒径及拉伸性的影响。优化后的自微乳化口腔崩解膜能在(17.09±0.72)s内快速崩解；微乳化粒径为(28.81±3.26)nm；2分钟体外释放度为(66.18±1.94)%。自微乳化口腔崩解膜顺应性良好、拉伸性强，通过快速自微乳化可在口腔中迅速释放，具有广阔的应用前景。
