Lipid based formulation approach for BCS class-II drug: Modafinil in the treatment of ADHD

Abstract The aim of study was to formulate self-microemulsifying drug delivery systems for modafinil. It was also an objective to optimize formulation parameters and evaluate developed formulation for its in vitro, ex vivo and in vivo performances. Solubility of modafinil was determined in various vehicles (oil, surfactant and co-surfactant) and selected excipients were used for phase diagram. D-optimal mixture experimental design was applied to optimize the formulation variables; oil phase X1 (Clove oil), surfactant X2 (Tween-80) and co-surfactant X3 (Polyethylene glycol-400). The optimized batch had smaller globule size ( In vivo pharmacokinetic study revealed its higher Cmax, AUC and relative bioavailability (Fr) compared to the suspension and marketed formulation. Furthermore, this formulation demonstrated significant improvement (p