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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

Full text
https://scielo.conicyt.cl/scielo.php?script=sci_arttext&pid=S0717-73482003000100004
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.
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Discipline
Artes, Arquitectura y UrbanismoCiencias Agrarias, Forestales y VeterinariasCiencias Exactas y NaturalesCiencias SocialesDerechoEconomía y AdministraciónFilosofía y HumanidadesIngenieríaMedicinaMultidisciplinarias
Institutions
Universidad de ChileUniversidad Católica de ChileUniversidad de Santiago de ChileUniversidad de ConcepciónUniversidad Austral de ChileUniversidad Católica de ValparaísoUniversidad del Bio BioUniversidad de ValparaísoUniversidad Católica del Nortemore

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