DEVELOPMENT AND IN VITRO RELEASE KINETIC STUDIES OF EXTENDED RELEASE CEFUROXIME AXETIL MATRIX TABLETS BASED ON HYDROPHILIC POLYMERS

The purpose of this investigation was to design and develop extended release hydrophilic matrix tablets of cefuroxime axetil by using high viscosity grade hydroxypropyl methylcellulose (Methocel K4M CR) along with Methocel E5LV and E50LV in different concentrations. Nine different formulations (F1 - F9) were prepared by direct compression technique and tested for physicochemical evaluation and in vitro dissolution studies in different media. The dissolution data of optimized formulations (F5 - F9) were subjected to ANOVA-based model, model-independent and model dependent method and R Gui (R) applied for stability studies. Physical parameters were found to be within the acceptable range of USP36 / NF31. The formulation F9 (K4M CR 8% and E50V 2%) exhibited the highest percentage of drug release and a mean dissolution time with considerable swelling index and low AIC values in all dissolution media studied was taken as reference formulation for Dunnett's t-test and f1, f2 test. In vitro release kinetics results indicated a non-Fickian diffusion controlled drug release mechanism and was best fitted into Korsmeyer-Peppas equation (R-2 = 0.937 - 0.999). The rate of drug release was found to be increased as the fraction of the polymer decreased from 30% - 10%. For instance the matrix tablets containing 10% of K4M CR (F5) alone and in combination with E5LV and E50LV (F6 - F9) showed an extended release pattern up to 12 hrs. It appears that K4M CR (lower concentration) in combination with E5LV and E50LV can be effectively used for controlling the release rate of cefuroxime axetil.