Bioequivalencia de una formulación nacional de Ambroxol
Author
SAAVEDRA S.,IVÁN
GAETE G.,LEONARDO
CARRILLO C.,MITZY
ORTIZ O.,MARIO
ÁVILA C.,LUIS
LEYTON M,SANTIAGO
ROJAS G.,LILA
GALLARDO M,NICOLÁS
MUÑOZ B.,FERNANDO
SALDAÑA V.,ADIELA
Abstract
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 (t max), 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.