Preparation of propranolol hydrochloride osmotic pump controlled release tablets and their pharmacokinetics in Beagle dogs

Objective:To prepare propranolol hydrochloride osmotic pump controlled release tablets,and investigate its pharmacokinetics in Beagle dogs and in vitro-in vivo correlation.Methods:In vitro drug release was determined by UV spectrophotometer.Serum concentration of propranolol hydrochloride in conventional tablets and osmotic pump tablet(OPT) administrated orally was determined by method.Pharmacokinetic parameters were calculated using DAS 2.0 software,and the correlation was studied by in vitro dissolution and in vivo pharmacokinetics with Wanger-Nelson method.Results:In vitro accumulative release dissolution was over 90% in 24 h.Main pharmacokinetic parameters of conventional tablet and OPT were obtained respectively:T max(6.617±0.754)and(3.000±0.632)h;t 1/2(6.518±2.923)and(3.214 ±0.584)h;C max(259.202±32.206)and(749.582±55.402)ng ·mL-1;AUC 0～∞(2 543.043±361.971)and(2 708.350±385.545)ng ·h ·mL-1.Conclusion:Plasma drug concentration of propranolol hydrochloride osmotic pump controlled release tablet was steady.Effective plasma drug concentration kept a longer time compared with that of conventional tablet.