Solid self-emulsifying drug delivery system (S-SEDDS) for improved dissolution rate of fenofibrate.

Purpose: The aim of this work was to develop and characterise S-SEDDS containing fenofibrate (FF) for dissolution enhancement.

Methods: The self-emulsifying pre-concentrate was prepared by using different proportion of Labrafac WL1349 as oily phase, Cremophor EL as surfactants and Gelucire 44/14 as co-surfactant. The prepared pre-concentrate was solidified with PEG 6000. For comparison, formulations containing TPGS as surfactant and solidifier were prepared and studied.

Results: The cremophor/PEG and TPGS based S-SEDDS formulations containing 10 and 15% w/w FF when dispersed in water, formed nanoemulsion with a size range of 150-200 nm. FF was present in the crystalline state in the formulations. The formulations containing 10% w/w FF showed 90-100% dissolution in 60 min whereas the untreated FF showed only 2-4% dissolution.

Conclusion: A novel S-SEDDS was developed for FF using cremophor/PEG and TPGS. The dissolution of FF was enhanced by approximately 20-fold in SGF pH 1.2.