ABSTRACT
An oral sustained-release floating tablet formulation of metformin HCl was designed and developed. Effervescence and swelling properties were attributed on the developed tablets by sodium bicarbonate and HPMC-PEO polymer combination, respectively. Tablet composition was optimized by response surface methodology [RSM]. Seventeen [17] trial formulations were analyzed according to Box-Behnken design of experiment where polymer content of HPMC and PEO at 1: 4 ratio [A], amount of sodium bi-carbonate [B], and amount of SSG [C] were adopted as independent variables. Floating lag time in sec [Y[1]], cumulative percent drug released at 1 h [Y[2]] and 12 h [Y[3]] were chosen as response variables. Tablets from the optimized formulation were also stored at accelerated stability condition [40°C and 75% RH] for 3 months to assess their stability profile. RSM could efficiently optimize the tablet composition with excellent prediction ability. In-vitro drug release until 12 h, floating lag time, and duration of floating were dependent on the amount of three selected independent variables. Optimized tablets remained floating for more than 24 h with a floating lag time of less than 4 min. Based on best fitting method, optimized formulation was found to follow Korsmeyer-Peppas release kinetic. Accelerated stability study revealed that optimized formulation was stable for three months without any major changes in assay, dissolution profile, floating lag time and other physical properties