Demonstration of bioequivalence between ventasol syrup and ventolin syrup in humans and in dogs

ABSTRACT

Ventasol syrup, a new locally produced salbutamol formulation, was compared with the standard salbutamol formulation, ventolin syrup, for determination of oral bioequivalence in stable asthmatic human subjects and in dogs. On separate occasions, each subject received a single 10 ml oral dose of each formulation containing 4 mg salbutamol. In the human subjects, statistically similar peak plasma concentrations of salbutamol were obtained (196ñ7ng/ml for ventasol syrup and 185ñ6ng/ml for ventolin syrup) 3 hours after oral administration of the formulations. From the ratio of the AUC 0-y for the formulations (1.04), a relative oral bioavailability of 104 percent, indicating equivalent total salbutamol output, was also obtained in the human subjects. Similarly, in the dogs, the formulations produced statistically equivalent peak plasma concentrations of salbutamol (259ñ24ng/ml for ventasol syrup and 285ñ29ng/ml for ventolin syrup) 3 hours after oral administration. Also, from the ratio of AUC 0-y for the formulation (1.02), a relative oral bioavailability of 102 percent, indicating similar total salbutamol output, was obtained in the dogs. From these results, it is concluded that oral bioequivolence between ventasol syrup and ventolin syrup was demonstrated in human subjects and in dogs. (AU)