Bioequivalencia de una formulación nacional de Ambroxol

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 re...

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Autores principales:	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
Lenguaje:	Spanish / Castilian
Publicado:	Sociedad Chilena de Enfermedades Respiratorias 2003
Materias:	Bioavailability Bioequivalence Ambroxol syrup
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-73482003000100004
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spelling	oai:scielo:S0717-734820030001000042003-04-16Bioequivalencia de una formulación nacional de AmbroxolSAAVEDRA S.,IVÁNGAETE G.,LEONARDOCARRILLO C.,MITZYORTIZ O.,MARIOÁVILA C.,LUISLEYTON M,SANTIAGOROJAS G.,LILAGALLARDO M,NICOLÁSMUÑOZ B.,FERNANDOSALDAÑA V.,ADIELA Bioavailability Bioequivalence Ambroxol syrup 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.info:eu-repo/semantics/openAccessSociedad Chilena de Enfermedades RespiratoriasRevista chilena de enfermedades respiratorias v.19 n.1 20032003-03-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-73482003000100004es10.4067/S0717-73482003000100004
institution	Scielo Chile
collection	Scielo Chile
language	Spanish / Castilian
topic	Bioavailability Bioequivalence Ambroxol syrup
spellingShingle	Bioavailability Bioequivalence Ambroxol syrup 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 Bioequivalencia de una formulación nacional de Ambroxol
description	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.
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
author_facet	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
author_sort	SAAVEDRA S.,IVÁN
title	Bioequivalencia de una formulación nacional de Ambroxol
title_short	Bioequivalencia de una formulación nacional de Ambroxol
title_full	Bioequivalencia de una formulación nacional de Ambroxol
title_fullStr	Bioequivalencia de una formulación nacional de Ambroxol
title_full_unstemmed	Bioequivalencia de una formulación nacional de Ambroxol
title_sort	bioequivalencia de una formulación nacional de ambroxol
publisher	Sociedad Chilena de Enfermedades Respiratorias
publishDate	2003
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-73482003000100004
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Bioequivalencia de una formulación nacional de Ambroxol

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