The present work is aimed to study the pharmacokinetic parameters of optimized repaglinide floating drug delivery system (FDDS) by 24 factorial designs,followed by comparison with a commercially available formulation.The main effects and interactions of formulation variables were studied by using normal and pareto charts.The optimized formulation shows a fickian diffusion drug release mechanism.Pharmacokinetic parameters of the designed drug delivery system were evaluated in rabbit models.Mean while a simple,specific high performance liquid chromatographic method was developed and validated as per biopharmaceutical specifications,the linearity was observed at the range of 110-550 ng/mL (r2 =0.999).By using methanol-phosphate buffer (pH 2.5) (70∶30,v/v) as mobile phase at the flow rate of 1.0 mL/min the validation shows a better retention time of 5.2 min for repaglinide.And the same validation method was used for pharmacokinetic profile analysis of repaglinide marketed products and FDDS.The comparative pharmacokinetic results such as tmax,half-life,area under the curve,mean residence times were increased significantly for the repaglinide in FDDS than the marketed product of repaglinide except Cmax and elimination rate constant.
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