ABSTRACT
The present study deals with the development and characterization of selfnanoemulsifying drug delivery system (SNEDDS) to improve the oral bioavailability of water insoluble Biopharmaceutical Classification System (BCS) Class II drug ketoconazole (KTZ). The solubility of KTZ in various oils was determined to identify the oil phase of SNEDDS. Various surfactants and cosurfactants were screened for their ability to emulsify the selected oil. Pseudoternary phase diagrams were constructed to identify the efficient self-emulsification region. SNEDDS were further evaluated for their macroscopic characteristics, refractive index, percentage transmittance, emulsification time, drug content, droplet size determination, and in vitro drug release study in comparison with pure drug and a marketed tablet formulation. The optimized formulation was composed of KTZ (60 mg), Triacetin (0.3% wt/wt), Tween 80 (2.205% wt/wt), PEG 400, and n-butanol (0.675% w/w). The mean droplet size and emulsification time was found to be 177.49 nm and 10 seconds, respectively. The in vitro dissolution of KTZ from SNEDDS was found to be significantly higher (95.4±2.07) in comparison to the marketed tablet (64.8±1.36) and pure drug (52.5±1.65) in 0.1 N HCl as dissolution medium. The results indicate that SNEDDS of KTZ, owing to its nanosized has potential to enhance the absorption of drug due to its higher dissolution.
