Preparation of novel metformin hydrochloride osmotic pump controlled release tablets and study on pharmacokinetics in Beagle dogs

Objective:To prepare novel large-dose metformin hydrochloride osmotic pump controlled release tablets,and to investigate the pharmacokinetics of the marketed metformin hydrochloride tablets and the self-made ones in Beagle dogs and the in vitro-in vivo correlation.Methods:Polyethylene oxide(PEO) was used as suspension agent and SDS was applied as surfactant.The similarity factor f2 was used to evaluate the release behavior between the self-made formulation and marketed tablets.In the cross-over study of single-dose and multiple-dose,the in vivo pharmacokinetics of the self-made formulation and the marketed tablets were studied in Beagle dogs.Results: Compared to marketed metformin hydrochloride tablets,the f2 value was 75.0.The relative bioavailabilities of the self-made formulation after single-dose and multiple-dose administration were(101.31±15.81)% and(99.46±12.55)%,respectively.Conclusion: Compared with the marketed tablets,self-made metformin hydrochloride osmotic pump controlled release tablets have similar pharmacokinetic profile and bioavailability.