Bioavailability of Salbutamol Sulfate Orally Disintegrating Tablets in Healthy Subjects

OBJECTIVE:To study the relative bioavailability and pharmacokinetics of salbutamol sulfate orally disinteˉgrating tablets.METHODS:A single dose of8mg salbutamol sulfate orally disintegrating tablets or commercial salbutamol tablets was administered in a randomized crossover design in18volunteers and the plasma concentrations of salbutamol were determined by HPLC.The pharmacokinetic parameters were calculated with3p97pharmacokinetic program and the bioequivˉalency was evaluated.RESULTS:The concentration-time curve of two preparations fitted to two-compartment model.The peak plasma levels(C max )of salbutamol sulfate orally disintegrating tablet and commercial salbutamol sulfate tablet were(17.65±6.48)ng/ml and(16.60±6.21)ng/ml,respectively.The peak time(T max )were(1.92±1.18)h and(2.03±1.17)h and AUC 0～24 were(127.23±32.41)ng/(h·ml)and(131.42±37.73)ng/(h·ml),respectively.The relative bioavailability of salbu_ tamol sulfate orally disintegrating tablet was(99.32±15.58)%.CONCLUSION:The results of two one-side tests suggests that salbutamol sulfate orally disintegrating tablet is bioequivalent to the commercial salbutamol tablet.