简介：Thepresentworkisaimedtostudythepharmacokineticparametersofoptimizedrepaglinidefloatingdrugdeliverysystem(FDDS)by24factorialdesigns,followedbycomparisonwithacommerciallyavailableformulation.Themaineffectsandinteractionsofformulationvariableswerestudiedbyusingnormalandparetocharts.Theoptimizedformulationshowsafickiandiffusiondrugreleasemechanism.Pharmacokineticparametersofthedesigneddrugdeliverysystemwereevaluatedinrabbitmodels.Meanwhileasimple,specifichighperformanceliquidchromatographicmethodwasdevelopedandvalidatedasperbiopharmaceuticalspecifications,thelinearitywasobservedattherangeof110-550ng/mL(r2=0.999).Byusingmethanol-phosphatebuffer(pH2.5)(70:30,v/v)asmobilephaseattheflowrateof1.0mL/minthevalidationshowsabetterretentiontimeof5.2minforrepaglinide.AndthesamevalidationmethodwasusedforpharmacokineticprofileanalysisofrepaglinidemarketedproductsandFDDS.Thecomparativepharmacokineticresultssuchastmax,half-life,areaunderthecurve,meanresidencetimeswereincreasedsignificantlyfortherepaglinideinFDDSthanthemarketedproductofrepaglinideexceptCmaxandeliminationrateconstant.