Abstract The aim of the present investigation is to preparation, Development & Characterization of Self Nanoemulsifying Drug Delivery for Fenofibrate. Accurately weighed Fenofibrate was placed in a glass vial, and required quantity of oil, surfactant, and co-surfactant were added. The mixture was mixed by gentle stirring and vortex mixing at 40ºC on a magnetic stirrer at 200rpm, until Fenofibrate was dissolved. Capmul MCM was found satisfactory as oil, Cremophor RH 40 and Transcutol-P were found best as surfactant and cosurfactant on basis of solubility data. Selection of oil, surfactant and cosurfactant. The preliminary trials were carried out using different concentration of Capmul MCM oil, Cremophor RH 40 and Transcutol-P (3:1). On the basis of results of preliminary trials for selection of lipid vehicle, the concentration of Capmul MCM oil (X1) and Concentration of Cremophor RH 40: Transcutol-P (3:1) (X2) were taken as independent variables at three levels. In vitro drug release study was carried out for the formulations, Aliquots were collected periodically (10, 15, 20, 30, 45, 60 minutes) and replaced with fresh dissolution medium. Aliquots, after filtration through 0.45μ PVDF filter paper, were analyzed by HPLC at 248nm for Fenofibrate content. The study indicated that Cremophor RH 40 (HLB: 15) and Labrasol (HLB: 12) had very good ability to emulsify Capmul MCM oil followed by Tween 80 (HLB: 15), whereas, Cremophor EL (HLB: 13) and Labrafac PG (HLB: 1) appeared to be poor emulsifier for Capmul MCM oil. Fenofibrate and Excipients were mixed in 1:1 ratio. It was analysed at 40ºC/75% RH at Initial and 1 month by IR Spectroscopy. The 32 factorial design was employed using concentration of Capmul MCM oil and concentration of surfactant/Cosurfactant as independent variable X1 and X2 respectively. The Globule size (GS) (Y1), Polydispersity index (PDI) (Y2), Zeta potential (Y3), drug release at 15 minutes of Fenofibrate (Y4). SNEDDS is best suited for dosage for development of poorly soluble drugs. Fenofibrate are BCS class II drugs having low solubility and high permeability.
Keywords Formulation, Development, Characterization, Self-Nano emulsifying, Drug Delivery, Fenofibrate.