Optimized Formulation of Levofloxacin Gastric Floating Tablet by Box-Behnken Design

OBJECTIVE To explore the potential of utilization Box-Behnken design/response surface methodology in the optimization of levofloxacin gastric floating drug delivery system(GFDDS). METHODS Levofloxacin was selected as model drug and tablets were prepared by conventional wet granulation method. The influence of three different sustained-release matrixes such as HPMC K4M, Carbopol 934P and sodium alginate (SA) on the drug released characteristic at varied times and floating capability was performed by establishing second-order equation which was used to estimate the relationship between the independent and the dependent variables. The possibly optimal formulation was predicted by Box-Behnken design. The drug released mechanism of the tablet were studied by model-fitted of drug released with different equations. RESULTS Optimized formulation of famotidine gastric floating tablets was selected as 30% HPMC K4M, 12.3% Carbopol 934P and 28.6% SA. Bias between the observed and predicted values were little. A non-Fickian mechanism was found to be predominant, which indicated that water diffusion as well as polymer rearrangement played an essential role in drug release. CONCLUSION The quadratic mathematical model developed by Box-Behnken design could be used to optimize formulation of levofloxacin gastric floating tablets.