Pharmacokinetics and Relative Bioavailability of Ambroxol Hydrochloride Aerosol and Injection

Abstract

To compare the pharmacokinetics and relative bioavailability of ambroxol hydrochloride (AH) aerosol and injection, the volunteers were subjected to single-dose crossover inhalation (injection) of 100 mg AH aerosol (injection). The drug concentrations in plasma were determined by HPLC. The areas under curve (AUC) of the two formulations were compared by the three-factor analysis of variance and the bi-directional one-side t test. The C max, t max, t1/2β and AUC values of the aerosol group and the injection group were (154.75±26.12) and (157.39±26.09) ng/ml, (1.12±0.34) and (1.29±0.33) h, (6.98±1.62) and (7.75±1.26) h, and (1593.02±290.45) and (1438±132.46) h•ng/ml, respectively. The bioavailabilities of AH aerosol and injection were the same, and the relative bioavailability of the aerosol was (96.52±11.44)%.