Development and optimization of indomethacin nanosuspensions using design of experiment approaches

Objective: In this study, it was aimed to prepare nanosuspensions that contains Indomethacin which is a BCS class II drug. To assess the cumulative impact of the chosen variables on the nanosuspension properties, a 34 factorial design was applied and particle size and distributions were examined. Material and Method: In the study, the solvent/antisolvent method was used in the preparation of the suspensions. 34 factorial design. Design-Expert software was used for evaluation of the prepared formulations in order to obtain the best formulation. PVA ratio, PVA molecular weight, solvent/antisolvent ratio, and ethanol/PEG ratio were used as independent design parameters, and their effects on particle size and distribution were examined. Result and Discussion: Nanosuspensions were successfully prepared by the solvent/antisolvent method. Particle size and polydispersity index of the nanosuspensions were found to be affected by both molecular weight and percentage of PVA in the anti-solvent phase (p ˂ 0.05). 0.2% PVA; molecular weight of 31 000 for PVA and the solvent-antisolvent ratio as 3:50 were found to be the optimal parameters for the nanosuspension formulations. The particle size and polydispersity of optimum formulation was found 301.5 ± 31.1 nm and 0.159 ± 0.035, respectively. Keywords: Factorial design, indomethacin, nanosuspension, solvent/antisolvent method