Guaifenesin Pharmacokinetics Following Single‐Dose Oral Administration in Children Aged 2 to 17 Years

This study characterized guaifenesin pharmacokinetics in children aged 2 to 17 years (n = 40) who received a single oral dose of guaifenesin (age‐based doses of 100‐400 mg) 2 hours after breakfast. Plasma samples were obtained before and for 8 hours after dosing and analyzed for guaifenesin using li...

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Autores principales: Thompson, Gary A., Solomon, Gail, Albrecht, Helmut H., Reitberg, Donald P., Guenin, Eric
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5066754/
https://www.ncbi.nlm.nih.gov/pubmed/26632082
http://dx.doi.org/10.1002/jcph.682
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author Thompson, Gary A.
Solomon, Gail
Albrecht, Helmut H.
Reitberg, Donald P.
Guenin, Eric
author_facet Thompson, Gary A.
Solomon, Gail
Albrecht, Helmut H.
Reitberg, Donald P.
Guenin, Eric
author_sort Thompson, Gary A.
collection PubMed
description This study characterized guaifenesin pharmacokinetics in children aged 2 to 17 years (n = 40) who received a single oral dose of guaifenesin (age‐based doses of 100‐400 mg) 2 hours after breakfast. Plasma samples were obtained before and for 8 hours after dosing and analyzed for guaifenesin using liquid chromatography‐tandem mass spectrometry. Pharmacokinetic parameters were estimated using noncompartmental methods, relationships with age were assessed using linear regression, and dose proportionality was assessed on 95% confidence intervals. Based on the upper dose recommended in the monograph (for both children and adolescents), area under the curve from time zero to infinity and maximum plasma concentration both increased with age. However, when comparing the upper dose for children aged 2 to 11 years with the lower dose for adolescents aged 12 to 17 years, similar systemic exposure was observed. As expected due to increasing body size, oral clearance (CL(o)) and terminal volume of distribution (V(z)/F) increased with age. Due to a larger increase in V(z)/F than CL(o), an increase in terminal exponential half‐life was also observed. Allometric scaling indicated no maturation‐related changes in CL(o) and V(z)/F.
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spelling pubmed-50667542016-11-01 Guaifenesin Pharmacokinetics Following Single‐Dose Oral Administration in Children Aged 2 to 17 Years Thompson, Gary A. Solomon, Gail Albrecht, Helmut H. Reitberg, Donald P. Guenin, Eric J Clin Pharmacol Pediatric Pharmacology This study characterized guaifenesin pharmacokinetics in children aged 2 to 17 years (n = 40) who received a single oral dose of guaifenesin (age‐based doses of 100‐400 mg) 2 hours after breakfast. Plasma samples were obtained before and for 8 hours after dosing and analyzed for guaifenesin using liquid chromatography‐tandem mass spectrometry. Pharmacokinetic parameters were estimated using noncompartmental methods, relationships with age were assessed using linear regression, and dose proportionality was assessed on 95% confidence intervals. Based on the upper dose recommended in the monograph (for both children and adolescents), area under the curve from time zero to infinity and maximum plasma concentration both increased with age. However, when comparing the upper dose for children aged 2 to 11 years with the lower dose for adolescents aged 12 to 17 years, similar systemic exposure was observed. As expected due to increasing body size, oral clearance (CL(o)) and terminal volume of distribution (V(z)/F) increased with age. Due to a larger increase in V(z)/F than CL(o), an increase in terminal exponential half‐life was also observed. Allometric scaling indicated no maturation‐related changes in CL(o) and V(z)/F. John Wiley and Sons Inc. 2016-01-24 2016-07 /pmc/articles/PMC5066754/ /pubmed/26632082 http://dx.doi.org/10.1002/jcph.682 Text en © 2016, The Authors. The Journal of Clinical Pharmacology Published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Pediatric Pharmacology
Thompson, Gary A.
Solomon, Gail
Albrecht, Helmut H.
Reitberg, Donald P.
Guenin, Eric
Guaifenesin Pharmacokinetics Following Single‐Dose Oral Administration in Children Aged 2 to 17 Years
title Guaifenesin Pharmacokinetics Following Single‐Dose Oral Administration in Children Aged 2 to 17 Years
title_full Guaifenesin Pharmacokinetics Following Single‐Dose Oral Administration in Children Aged 2 to 17 Years
title_fullStr Guaifenesin Pharmacokinetics Following Single‐Dose Oral Administration in Children Aged 2 to 17 Years
title_full_unstemmed Guaifenesin Pharmacokinetics Following Single‐Dose Oral Administration in Children Aged 2 to 17 Years
title_short Guaifenesin Pharmacokinetics Following Single‐Dose Oral Administration in Children Aged 2 to 17 Years
title_sort guaifenesin pharmacokinetics following single‐dose oral administration in children aged 2 to 17 years
topic Pediatric Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5066754/
https://www.ncbi.nlm.nih.gov/pubmed/26632082
http://dx.doi.org/10.1002/jcph.682
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