DEVELOPMENT AND OPTIMIZATION OF RANITIDINE HYDROCHLORIDE NANOSPHERS BY 32 FACTORIAL DESIGN

Abstract

The preparation and physico-chemical evaluation of ranitidine hydrochloride loaded namosphers as per 32 Factorial Design are describe the eudragit s (X1) and polaxamer338 solution (X2) as a stabilizing agent were used as independent variables where Particle size (PS) (Y1), Entrapment Efficiency (EE) (Y2) and % Drug Release at 12th h (REL)(Y3) were taken as dependant variables. Rantidine nanosphers were prepared by nanoprecipetation method. The results showed the method as reproducible, easy and efficient is the entrapment of drug as well as formation of spherical nanosphers. Effect of polymer concentration was also evaluated with respect to their % drug entrapment efficiency. The in vitro release studies indicated the rantidine-loaded eudragite s nanosphers provide sustained drug release over a period of 12h. The f5 optimized batch was shown particle size 195 nm, EE59 and57% drug release at 12th h. Infrared spectroscopy analysis revealed that there was no known chemical interaction between drug and polymer. Hence, this investigation demonstrated the potential of the experimental design in understanding the effect of the formulation variables on the quality of ranitidine nanosphers.