Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study

Autores
Rivulgo, Virginia Margarita; Sparo, Mónica; Ceci, Mónica; Fumuso, Elida; Confalonieri, Alejandra; Delpech, Gastón; Sanchez Bruni, Sergio Fabian
Año de publicación
2013
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Azithromycin(AZM)therapeutic failure and relapses of patients treated with generic -35 formulations have been observed in clinical practice.The main goal of this research was 36 to compare in a pre-clinical study the serum exposure and lung tissue concentrationof 37 two commercial formulations AZM-based in murine model. The current study involved 38 264 healthy Balb-C.Mice were divided in two groups (n=44): Animals of Group A 39 (Reference Formulation ?R-) were orally treated with AZM suspension at 10 mg/kg of 40 b.w.Experimental animals of Group B (Generic formulation ?G-) received identical 41 treatment than Group A with a generic formulation AZM-based.The study was repeated 42 twice as Phase II and III. Serum and lung tissue samples were taken 24 hpost treatment.43 Validated microbiological assay was used to determine the serum pharmacokinetic and 44 lung distribution of AZM.45 After the pharmacokinetic analysis was observed a similar serum exposure for both46 formulations of AZM assayed. In contrast, statistical differences (p< 0.001)were 47 obtained after comparing the concentrations of both formulations in lung tissue, being48 the values obtained for AUC and Cmax (AZM-R-)+1586 and 122%respectively,than 49 those obtained for AZM-G-in lung. These differences may indicate large differences on 50 the distribution process of both formulations, which may explain the lack of 51 efficacy/therapeutic failure observed on clinical practice.
Fil: Rivulgo, Virginia Margarita. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Tandil. Centro de Investigacion Veterinaria de Tandil; Argentina
Fil: Sparo, Mónica. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina
Fil: Ceci, Mónica. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina
Fil: Fumuso, Elida. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Tandil. Centro de Investigacion Veterinaria de Tandil; Argentina
Fil: Confalonieri, Alejandra. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Tandil. Centro de Investigacion Veterinaria de Tandil; Argentina
Fil: Delpech, Gastón. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina
Fil: Sanchez Bruni, Sergio Fabian. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Tandil. Centro de Investigacion Veterinaria de Tandil; Argentina
Materia
AZITHROMYCIN
GENERICS
MICE
LUNG
PHARMACOKINETICS
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/7339
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/7339
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical StudyRivulgo, Virginia MargaritaSparo, MónicaCeci, MónicaFumuso, ElidaConfalonieri, AlejandraDelpech, GastónSanchez Bruni, Sergio FabianAZITHROMYCINGENERICSMICELUNGPHARMACOKINETICShttps://purl.org/becyt/ford/4.3https://purl.org/becyt/ford/4Azithromycin(AZM)therapeutic failure and relapses of patients treated with generic -35 formulations have been observed in clinical practice.The main goal of this research was 36 to compare in a pre-clinical study the serum exposure and lung tissue concentrationof 37 two commercial formulations AZM-based in murine model. The current study involved 38 264 healthy Balb-C.Mice were divided in two groups (n=44): Animals of Group A 39 (Reference Formulation ?R-) were orally treated with AZM suspension at 10 mg/kg of 40 b.w.Experimental animals of Group B (Generic formulation ?G-) received identical 41 treatment than Group A with a generic formulation AZM-based.The study was repeated 42 twice as Phase II and III. Serum and lung tissue samples were taken 24 hpost treatment.43 Validated microbiological assay was used to determine the serum pharmacokinetic and 44 lung distribution of AZM.45 After the pharmacokinetic analysis was observed a similar serum exposure for both46 formulations of AZM assayed. In contrast, statistical differences (p< 0.001)were 47 obtained after comparing the concentrations of both formulations in lung tissue, being48 the values obtained for AUC and Cmax (AZM-R-)+1586 and 122%respectively,than 49 those obtained for AZM-G-in lung. These differences may indicate large differences on 50 the distribution process of both formulations, which may explain the lack of 51 efficacy/therapeutic failure observed on clinical practice.Fil: Rivulgo, Virginia Margarita. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Tandil. Centro de Investigacion Veterinaria de Tandil; ArgentinaFil: Sparo, Mónica. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; ArgentinaFil: Ceci, Mónica. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; ArgentinaFil: Fumuso, Elida. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Tandil. Centro de Investigacion Veterinaria de Tandil; ArgentinaFil: Confalonieri, Alejandra. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Tandil. Centro de Investigacion Veterinaria de Tandil; ArgentinaFil: Delpech, Gastón. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; ArgentinaFil: Sanchez Bruni, Sergio Fabian. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Tandil. Centro de Investigacion Veterinaria de Tandil; ArgentinaHindawi Publishing Corporation2013-09info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/7339Rivulgo, Virginia Margarita; Sparo, Mónica; Ceci, Mónica; Fumuso, Elida; Confalonieri, Alejandra; et al.; Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study; Hindawi Publishing Corporation; Biomed Central International; 2013; 9-2013; 392010-3920102314-6141enginfo:eu-repo/semantics/altIdentifier/url/http://www.hindawi.com/journals/bmri/2013/392010/info:eu-repo/semantics/altIdentifier/doi/10.1155/2013/392010info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T09:53:17Zoai:ri.conicet.gov.ar:11336/7339instacron: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:34982025-09-29 09:53:17.918CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study
title Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study
spellingShingle Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study
Rivulgo, Virginia Margarita
AZITHROMYCIN
GENERICS
MICE
LUNG
PHARMACOKINETICS
title_short Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study
title_full Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study
title_fullStr Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study
title_full_unstemmed Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study
title_sort Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study
dc.creator.none.fl_str_mv Rivulgo, Virginia Margarita
Sparo, Mónica
Ceci, Mónica
Fumuso, Elida
Confalonieri, Alejandra
Delpech, Gastón
Sanchez Bruni, Sergio Fabian
author Rivulgo, Virginia Margarita
author_facet Rivulgo, Virginia Margarita
Sparo, Mónica
Ceci, Mónica
Fumuso, Elida
Confalonieri, Alejandra
Delpech, Gastón
Sanchez Bruni, Sergio Fabian
author_role author
author2 Sparo, Mónica
Ceci, Mónica
Fumuso, Elida
Confalonieri, Alejandra
Delpech, Gastón
Sanchez Bruni, Sergio Fabian
author2_role author
author
author
author
author
author
dc.subject.none.fl_str_mv AZITHROMYCIN
GENERICS
MICE
LUNG
PHARMACOKINETICS
topic AZITHROMYCIN
GENERICS
MICE
LUNG
PHARMACOKINETICS
purl_subject.fl_str_mv https://purl.org/becyt/ford/4.3
https://purl.org/becyt/ford/4
dc.description.none.fl_txt_mv Azithromycin(AZM)therapeutic failure and relapses of patients treated with generic -35 formulations have been observed in clinical practice.The main goal of this research was 36 to compare in a pre-clinical study the serum exposure and lung tissue concentrationof 37 two commercial formulations AZM-based in murine model. The current study involved 38 264 healthy Balb-C.Mice were divided in two groups (n=44): Animals of Group A 39 (Reference Formulation ?R-) were orally treated with AZM suspension at 10 mg/kg of 40 b.w.Experimental animals of Group B (Generic formulation ?G-) received identical 41 treatment than Group A with a generic formulation AZM-based.The study was repeated 42 twice as Phase II and III. Serum and lung tissue samples were taken 24 hpost treatment.43 Validated microbiological assay was used to determine the serum pharmacokinetic and 44 lung distribution of AZM.45 After the pharmacokinetic analysis was observed a similar serum exposure for both46 formulations of AZM assayed. In contrast, statistical differences (p< 0.001)were 47 obtained after comparing the concentrations of both formulations in lung tissue, being48 the values obtained for AUC and Cmax (AZM-R-)+1586 and 122%respectively,than 49 those obtained for AZM-G-in lung. These differences may indicate large differences on 50 the distribution process of both formulations, which may explain the lack of 51 efficacy/therapeutic failure observed on clinical practice.
Fil: Rivulgo, Virginia Margarita. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Tandil. Centro de Investigacion Veterinaria de Tandil; Argentina
Fil: Sparo, Mónica. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina
Fil: Ceci, Mónica. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina
Fil: Fumuso, Elida. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Tandil. Centro de Investigacion Veterinaria de Tandil; Argentina
Fil: Confalonieri, Alejandra. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Tandil. Centro de Investigacion Veterinaria de Tandil; Argentina
Fil: Delpech, Gastón. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina
Fil: Sanchez Bruni, Sergio Fabian. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Tandil. Centro de Investigacion Veterinaria de Tandil; Argentina
description Azithromycin(AZM)therapeutic failure and relapses of patients treated with generic -35 formulations have been observed in clinical practice.The main goal of this research was 36 to compare in a pre-clinical study the serum exposure and lung tissue concentrationof 37 two commercial formulations AZM-based in murine model. The current study involved 38 264 healthy Balb-C.Mice were divided in two groups (n=44): Animals of Group A 39 (Reference Formulation ?R-) were orally treated with AZM suspension at 10 mg/kg of 40 b.w.Experimental animals of Group B (Generic formulation ?G-) received identical 41 treatment than Group A with a generic formulation AZM-based.The study was repeated 42 twice as Phase II and III. Serum and lung tissue samples were taken 24 hpost treatment.43 Validated microbiological assay was used to determine the serum pharmacokinetic and 44 lung distribution of AZM.45 After the pharmacokinetic analysis was observed a similar serum exposure for both46 formulations of AZM assayed. In contrast, statistical differences (p< 0.001)were 47 obtained after comparing the concentrations of both formulations in lung tissue, being48 the values obtained for AUC and Cmax (AZM-R-)+1586 and 122%respectively,than 49 those obtained for AZM-G-in lung. These differences may indicate large differences on 50 the distribution process of both formulations, which may explain the lack of 51 efficacy/therapeutic failure observed on clinical practice.
publishDate 2013
dc.date.none.fl_str_mv 2013-09
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/11336/7339
Rivulgo, Virginia Margarita; Sparo, Mónica; Ceci, Mónica; Fumuso, Elida; Confalonieri, Alejandra; et al.; Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study; Hindawi Publishing Corporation; Biomed Central International; 2013; 9-2013; 392010-392010
2314-6141
url http://hdl.handle.net/11336/7339
identifier_str_mv Rivulgo, Virginia Margarita; Sparo, Mónica; Ceci, Mónica; Fumuso, Elida; Confalonieri, Alejandra; et al.; Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study; Hindawi Publishing Corporation; Biomed Central International; 2013; 9-2013; 392010-392010
2314-6141
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/http://www.hindawi.com/journals/bmri/2013/392010/
info:eu-repo/semantics/altIdentifier/doi/10.1155/2013/392010
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Hindawi Publishing Corporation
publisher.none.fl_str_mv Hindawi Publishing Corporation
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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score 13.069144

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