Evaluation of Formulation Parameters for Development of Aceclofenac Nanosuspension Using Doe Statistical Tool

Abstract

InThe objective of present study was to identify and evaluate formulation variables affecting characteristics of nanosuspension formulations. Full factorial design experimental methodology was used for development of aceclofenac nanosuspension. Formulation factors evaluated were drug to polymer (Polyvinyl alcohol) ratio, amount of surfactant (Sodium dodecyl sulphate) relative to drug and solvent employed for carrying the drug. Total 18 formulations were prepared and their saturation solubility in distilled water and z average particle size were regarded as responses in this study. The response surface methodology utilizing polynomial equation was used to quantify the effect of each formulation variables. All three variables exerted significant effect on particle size and saturation solubility. Optimized nanosuspensions were obtained using numerical optimization technique by the desirability approach. The optimum formulation parameters were found to be 400% w/w of drug to polymer ratio and 7.5% w/w of amount of SDS for both solvents. The best optimized formulation obtained from ethanol showed significantly improved saturation solubility 255.39 µg/ml, particle size 477.7 nm and better dissolution efficiency (DE05) 59.77%. The absence of interactions between drug and polymers was confirmed by Fourier transform infrared (FTIR) spectroscopy. The results demonstrated that polyvinyl alcohol was successfully employed for the development of nanosuspension of aceclofenac with higher dissolution efficiency leading to better oral bioavailability.