Revista chilena de enfermedades respiratorias
versão On-line ISSN 0717-7348
SAAVEDRA S., IVÁN et al. BIOAVAILABILITY COMPARISON BETWEEN A CHILEAN GENERIC PREPARATION OF AMBROXOL AND THE ORIGINAL PRODUCT. Rev. chil. enferm. respir. [online]. 2003, vol.19, n.1, pp. 21-27. ISSN 0717-7348. doi: 10.4067/S0717-73482003000100004.
Objectives: To assess the relative bioavailability of two oral formulations of ambroxol commercialized in Chile, a generic syrup and the original product, MucosolvanR from Boehringer Ingelheim. Methods: A randomized, cross-over and double blind study was performed in twelve healthy volunteers who received a single oral dose of either Mucosolvan (90 mg) or the generic formulation with at least a 14 day washout period between each single dose. Multiple blood samples were collected after each dose, the plasma ambroxol concentrations were determined by a validated High Performance Liquid Chromatography assay. Results: The 95% confidence intervals for all parameters were within the accepted range of 80-125% for bioequivalence, suggested by the US FDA. Non statistically significant differences were found in the mean parameters of bioequivalence: mean peak concentration (Cmax), area under the curve calculated from time zero to a determined time (AUC0-t), and area under the curve calculated from time zero to infinity (AUC0-oo), or in other parameters like: time to reach Cmax (tmax), rate of absorption (Ka), rate of elimination (Ke), elimination half life (t1/2), and clearance (Cl). Conclusion: Pharmacokinetic results concluded that both formulations of ambroxol are bioequivalent and consequently the preparations can be considered interchangeable between them.
Palavras-chave : Bioavailability; Bioequivalence; Ambroxol syrup.