IMPLICATION OF CENTRAL COMPOSITE DESIGN IN THE DEVELOPMENT OF SIMVASTATIN-LOADED NANOSPONGES

Objective: The present study’s objective was to apply a central composite design develop the simvastatin-loaded nanosponge formulation improve its oral bioavailability. Methods: With help of expert (State-Ease version 13.0.1), selected for nanosponges by using defined concentration Eudragit L-100 (X1) and PVA (X2) as independent variables particle size (Y1), percent (%) entrapment efficiency (EE) (Y2), in vitro drug release (Y3) dependent variables. Fourteen (SF1-SF14) formulations were prepared emulsion solvent evaporation evaluated surface morphology, size, drug-excipient compatibility, %EE, % release. optimized model (SF14) obtained from vivo pharmacokinetics animal models. Results: SF14 formulated morphology (shape size) particle, EE, release, kinetics. showed 163±0.45 nm, 80.54 %±0.57 97.13%±0.38 at 8h. kinetics followed zero-order Higuchi mechanisms with non-fiction diffusion. In results Cmax, Tmax, AUC0-t, AUC0-α, MRT0-α 0.175 µg/ml, 6 h, 1.561 µg/mlh, 1.755 11.77 respectively. Conclusion: indicated significant increase bioavailability compared standard drugs. experimentally designed have been successfully developed, parameters show that Simvastatin is promising delivery through route.