Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for...

Autores: Hunzicker, Gabriel Alejandro; Hein, Gustavo Juan; Baldo, Matias Nicolas; Hernández, Silvia Raquel; Altamirano, Jorgelina Cecilia
Año de publicación: 2016
Idioma: inglés
Tipo de recurso: artículo
Estado: versión publicada
Descripción: A pharmacokinetic study based on single oral administration of Tenofovir disoproxil fumarate 300 mg (tablets) to Argentinean male volunteers under fasting conditions is presented. The obtained values for test and reference products were 238±62 and 261±73 ng mL-1 for Cmax; 1658±466 and 1801±529 ng mL-1 h for AUC0–48h; 1845±579 and 2015±639 ng mL-1 h for AUC0–∞, respectively. The 90% confidence intervals obtained by analysis of variance were 85.0-97.2% for ln-Cmax, 87.2-97.9% for ln-AUC0–48h and 85.5-98.1% for ln-AUC0–∞, which are within the acceptance range of 80-125%. Both products were bioequivalent in terms of rate and extent of drug absorption and therefore interchangeable. The analytical methodology was optimized and validated for determination of Emtricitabine (FTC), Lamivudine (3TC) and Tenofovir (TFV) in human plasma samples; which is the pharmaceutical combination most commonly used for treating HIV-infected patients. The analytical methodology was based on solid phase extraction (SPE) using Oasis® MCX mixed-mode cartridges coupled to Liquid Chromatography and electrospray tandem mass spectrometry (LC-ESI-MS/MS). The analytical methodology was validated according to the US Food and Drug Administration guidelines. Under optimized conditions, the analytical methodology lead to work within a clinical of 11-5434, 11-5452 and 13-397 ng mL-1 for FTC, 3TC and TFV, respectively; resulting wider than others previously reported. The intra and inter batch precision (%RSD) across three validation runs was less than 14%. The accuracy determined at four QC levels (LOQ, Low, Middle and High) was within 13%, in terms of percent relative error.
Fil: Hunzicker, Gabriel Alejandro. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina
Fil: Hein, Gustavo Juan. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe. Instituto de Ciencias Veterinarias del Litoral. Universidad Nacional del Litoral. Facultad de Ciencias Veterinarias. Instituto de Ciencias Veterinarias del Litoral; Argentina
Fil: Baldo, Matias Nicolas. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe. Instituto de Ciencias Veterinarias del Litoral. Universidad Nacional del Litoral. Facultad de Ciencias Veterinarias. Instituto de Ciencias Veterinarias del Litoral; Argentina
Fil: Hernández, Silvia Raquel. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina
Fil: Altamirano, Jorgelina Cecilia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Mendoza. Instituto Argentino de Nivología, Glaciología y Ciencias Ambientales. Provincia de Mendoza. Instituto Argentino de Nivología, Glaciología y Ciencias Ambientales. Universidad Nacional de Cuyo. Instituto Argentino de Nivología, Glaciología y Ciencias Ambientales; Argentina
Materia: Pharmacokinetic
BIOEQUIVALENCE
LC-ESI-MS/MS
Emtricitabine
Lamivudine
Tenofovir
HIV
Nivel de accesibilidad: acceso abierto
Condiciones de uso: https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
Institución: Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador: oai:ri.conicet.gov.ar:11336/60833

Acceder

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network_name_str	CONICET Digital (CONICET)
spelling	Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for determination of Emtricitabine, Lamivudine and Tenofovir in human plasmaHunzicker, Gabriel AlejandroHein, Gustavo JuanBaldo, Matias NicolasHernández, Silvia RaquelAltamirano, Jorgelina CeciliaPharmacokineticBIOEQUIVALENCELC-ESI-MS/MSEmtricitabineLamivudineTenofovirHIVhttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1A pharmacokinetic study based on single oral administration of Tenofovir disoproxil fumarate 300 mg (tablets) to Argentinean male volunteers under fasting conditions is presented. The obtained values for test and reference products were 238±62 and 261±73 ng mL-1 for Cmax; 1658±466 and 1801±529 ng mL-1 h for AUC0–48h; 1845±579 and 2015±639 ng mL-1 h for AUC0–∞, respectively. The 90% confidence intervals obtained by analysis of variance were 85.0-97.2% for ln-Cmax, 87.2-97.9% for ln-AUC0–48h and 85.5-98.1% for ln-AUC0–∞, which are within the acceptance range of 80-125%. Both products were bioequivalent in terms of rate and extent of drug absorption and therefore interchangeable. The analytical methodology was optimized and validated for determination of Emtricitabine (FTC), Lamivudine (3TC) and Tenofovir (TFV) in human plasma samples; which is the pharmaceutical combination most commonly used for treating HIV-infected patients. The analytical methodology was based on solid phase extraction (SPE) using Oasis® MCX mixed-mode cartridges coupled to Liquid Chromatography and electrospray tandem mass spectrometry (LC-ESI-MS/MS). The analytical methodology was validated according to the US Food and Drug Administration guidelines. Under optimized conditions, the analytical methodology lead to work within a clinical of 11-5434, 11-5452 and 13-397 ng mL-1 for FTC, 3TC and TFV, respectively; resulting wider than others previously reported. The intra and inter batch precision (%RSD) across three validation runs was less than 14%. The accuracy determined at four QC levels (LOQ, Low, Middle and High) was within 13%, in terms of percent relative error.Fil: Hunzicker, Gabriel Alejandro. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; ArgentinaFil: Hein, Gustavo Juan. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe. Instituto de Ciencias Veterinarias del Litoral. Universidad Nacional del Litoral. Facultad de Ciencias Veterinarias. Instituto de Ciencias Veterinarias del Litoral; ArgentinaFil: Baldo, Matias Nicolas. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe. Instituto de Ciencias Veterinarias del Litoral. Universidad Nacional del Litoral. Facultad de Ciencias Veterinarias. Instituto de Ciencias Veterinarias del Litoral; ArgentinaFil: Hernández, Silvia Raquel. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; ArgentinaFil: Altamirano, Jorgelina Cecilia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Mendoza. Instituto Argentino de Nivología, Glaciología y Ciencias Ambientales. Provincia de Mendoza. Instituto Argentino de Nivología, Glaciología y Ciencias Ambientales. Universidad Nacional de Cuyo. Instituto Argentino de Nivología, Glaciología y Ciencias Ambientales; ArgentinaPharmaceutical and Chemical Journal2016-12info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/60833Hunzicker, Gabriel Alejandro; Hein, Gustavo Juan; Baldo, Matias Nicolas; Hernández, Silvia Raquel; Altamirano, Jorgelina Cecilia; Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for determination of Emtricitabine, Lamivudine and Tenofovir in human plasma; Pharmaceutical and Chemical Journal; Pharmaceutical and Chemical Journal; 3; 4; 12-2016; 157-1682349-7092CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://tpcj.org/pharmacokinetic-and-bioequivalence-study-of-tenofovir-disoproxil-fumarate-under-fasting-conditions-on-argentine-healthy-volunteers-optimization-and-validation-of-spe-lc-msms-for-determination-of-emtinfo:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-15T14:56:57Zoai:ri.conicet.gov.ar:11336/60833instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-10-15 14:56:58.059CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv	Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for determination of Emtricitabine, Lamivudine and Tenofovir in human plasma
title	Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for determination of Emtricitabine, Lamivudine and Tenofovir in human plasma
spellingShingle	Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for determination of Emtricitabine, Lamivudine and Tenofovir in human plasma Hunzicker, Gabriel Alejandro Pharmacokinetic BIOEQUIVALENCE LC-ESI-MS/MS Emtricitabine Lamivudine Tenofovir HIV
title_short	Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for determination of Emtricitabine, Lamivudine and Tenofovir in human plasma
title_full	Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for determination of Emtricitabine, Lamivudine and Tenofovir in human plasma
title_fullStr	Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for determination of Emtricitabine, Lamivudine and Tenofovir in human plasma
title_full_unstemmed	Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for determination of Emtricitabine, Lamivudine and Tenofovir in human plasma
title_sort	Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for determination of Emtricitabine, Lamivudine and Tenofovir in human plasma
dc.creator.none.fl_str_mv	Hunzicker, Gabriel Alejandro Hein, Gustavo Juan Baldo, Matias Nicolas Hernández, Silvia Raquel Altamirano, Jorgelina Cecilia
author	Hunzicker, Gabriel Alejandro
author_facet	Hunzicker, Gabriel Alejandro Hein, Gustavo Juan Baldo, Matias Nicolas Hernández, Silvia Raquel Altamirano, Jorgelina Cecilia
author_role	author
author2	Hein, Gustavo Juan Baldo, Matias Nicolas Hernández, Silvia Raquel Altamirano, Jorgelina Cecilia
author2_role	author author author author
dc.subject.none.fl_str_mv	Pharmacokinetic BIOEQUIVALENCE LC-ESI-MS/MS Emtricitabine Lamivudine Tenofovir HIV
topic	Pharmacokinetic BIOEQUIVALENCE LC-ESI-MS/MS Emtricitabine Lamivudine Tenofovir HIV
purl_subject.fl_str_mv	https://purl.org/becyt/ford/1.4 https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv	A pharmacokinetic study based on single oral administration of Tenofovir disoproxil fumarate 300 mg (tablets) to Argentinean male volunteers under fasting conditions is presented. The obtained values for test and reference products were 238±62 and 261±73 ng mL-1 for Cmax; 1658±466 and 1801±529 ng mL-1 h for AUC0–48h; 1845±579 and 2015±639 ng mL-1 h for AUC0–∞, respectively. The 90% confidence intervals obtained by analysis of variance were 85.0-97.2% for ln-Cmax, 87.2-97.9% for ln-AUC0–48h and 85.5-98.1% for ln-AUC0–∞, which are within the acceptance range of 80-125%. Both products were bioequivalent in terms of rate and extent of drug absorption and therefore interchangeable. The analytical methodology was optimized and validated for determination of Emtricitabine (FTC), Lamivudine (3TC) and Tenofovir (TFV) in human plasma samples; which is the pharmaceutical combination most commonly used for treating HIV-infected patients. The analytical methodology was based on solid phase extraction (SPE) using Oasis® MCX mixed-mode cartridges coupled to Liquid Chromatography and electrospray tandem mass spectrometry (LC-ESI-MS/MS). The analytical methodology was validated according to the US Food and Drug Administration guidelines. Under optimized conditions, the analytical methodology lead to work within a clinical of 11-5434, 11-5452 and 13-397 ng mL-1 for FTC, 3TC and TFV, respectively; resulting wider than others previously reported. The intra and inter batch precision (%RSD) across three validation runs was less than 14%. The accuracy determined at four QC levels (LOQ, Low, Middle and High) was within 13%, in terms of percent relative error. Fil: Hunzicker, Gabriel Alejandro. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina Fil: Hein, Gustavo Juan. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe. Instituto de Ciencias Veterinarias del Litoral. Universidad Nacional del Litoral. Facultad de Ciencias Veterinarias. Instituto de Ciencias Veterinarias del Litoral; Argentina Fil: Baldo, Matias Nicolas. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe. Instituto de Ciencias Veterinarias del Litoral. Universidad Nacional del Litoral. Facultad de Ciencias Veterinarias. Instituto de Ciencias Veterinarias del Litoral; Argentina Fil: Hernández, Silvia Raquel. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina Fil: Altamirano, Jorgelina Cecilia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Mendoza. Instituto Argentino de Nivología, Glaciología y Ciencias Ambientales. Provincia de Mendoza. Instituto Argentino de Nivología, Glaciología y Ciencias Ambientales. Universidad Nacional de Cuyo. Instituto Argentino de Nivología, Glaciología y Ciencias Ambientales; Argentina
description	A pharmacokinetic study based on single oral administration of Tenofovir disoproxil fumarate 300 mg (tablets) to Argentinean male volunteers under fasting conditions is presented. The obtained values for test and reference products were 238±62 and 261±73 ng mL-1 for Cmax; 1658±466 and 1801±529 ng mL-1 h for AUC0–48h; 1845±579 and 2015±639 ng mL-1 h for AUC0–∞, respectively. The 90% confidence intervals obtained by analysis of variance were 85.0-97.2% for ln-Cmax, 87.2-97.9% for ln-AUC0–48h and 85.5-98.1% for ln-AUC0–∞, which are within the acceptance range of 80-125%. Both products were bioequivalent in terms of rate and extent of drug absorption and therefore interchangeable. The analytical methodology was optimized and validated for determination of Emtricitabine (FTC), Lamivudine (3TC) and Tenofovir (TFV) in human plasma samples; which is the pharmaceutical combination most commonly used for treating HIV-infected patients. The analytical methodology was based on solid phase extraction (SPE) using Oasis® MCX mixed-mode cartridges coupled to Liquid Chromatography and electrospray tandem mass spectrometry (LC-ESI-MS/MS). The analytical methodology was validated according to the US Food and Drug Administration guidelines. Under optimized conditions, the analytical methodology lead to work within a clinical of 11-5434, 11-5452 and 13-397 ng mL-1 for FTC, 3TC and TFV, respectively; resulting wider than others previously reported. The intra and inter batch precision (%RSD) across three validation runs was less than 14%. The accuracy determined at four QC levels (LOQ, Low, Middle and High) was within 13%, in terms of percent relative error.
publishDate	2016
dc.date.none.fl_str_mv	2016-12
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://purl.org/coar/resource_type/c_6501 info:ar-repo/semantics/articulo
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	http://hdl.handle.net/11336/60833 Hunzicker, Gabriel Alejandro; Hein, Gustavo Juan; Baldo, Matias Nicolas; Hernández, Silvia Raquel; Altamirano, Jorgelina Cecilia; Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for determination of Emtricitabine, Lamivudine and Tenofovir in human plasma; Pharmaceutical and Chemical Journal; Pharmaceutical and Chemical Journal; 3; 4; 12-2016; 157-168 2349-7092 CONICET Digital CONICET
url	http://hdl.handle.net/11336/60833
identifier_str_mv	Hunzicker, Gabriel Alejandro; Hein, Gustavo Juan; Baldo, Matias Nicolas; Hernández, Silvia Raquel; Altamirano, Jorgelina Cecilia; Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for determination of Emtricitabine, Lamivudine and Tenofovir in human plasma; Pharmaceutical and Chemical Journal; Pharmaceutical and Chemical Journal; 3; 4; 12-2016; 157-168 2349-7092 CONICET Digital CONICET
dc.language.none.fl_str_mv	eng
language	eng
dc.relation.none.fl_str_mv	info:eu-repo/semantics/altIdentifier/url/http://tpcj.org/pharmacokinetic-and-bioequivalence-study-of-tenofovir-disoproxil-fumarate-under-fasting-conditions-on-argentine-healthy-volunteers-optimization-and-validation-of-spe-lc-msms-for-determination-of-emt
dc.rights.none.fl_str_mv	info:eu-repo/semantics/openAccess https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv	openAccess
rights_invalid_str_mv	https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv	application/pdf application/pdf application/pdf
dc.publisher.none.fl_str_mv	Pharmaceutical and Chemical Journal
publisher.none.fl_str_mv	Pharmaceutical and Chemical Journal
dc.source.none.fl_str_mv	reponame:CONICET Digital (CONICET) instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str	CONICET Digital (CONICET)
collection	CONICET Digital (CONICET)
instname_str	Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv	CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv	dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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Pharmacokinetic and bioequivalence study of Tenofovir Disoproxil Fumarate under fasting conditions on Argentine healthy-volunteers. Optimization and validation of SPE-LC-MS/MS for...

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