Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina

Autores
Varillas, María Alejandra; Brevedan, Marta Ingrid Victoria; González Vidal, Noelia Luján
Año de publicación
2018
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Hydrochlorothiazide (HCTZ) is a diuretic used to treat hypertension, which belongs to Class III of the Biopharmaceutics Classification System. The present study aimed to evaluate critical quality parameters of HCTZ solid oral dosage forms on the Argentine pharmaceutical market. For this purpose, evaluation of labels and patient information leaflets, description and mean weight of tablets, uniformity of dosage units, assay, hardness, friability, disintegration and dissolution tests were carried out, in compliance with the Argentine Pharmacopeia. The dissolution efficiency (DE) was obtained from the area under the drug dissolution curve, and the profiles were compared statistically by ANOVA. All samples met criteria for the assay, uniformity of dosage units, friability, hardness, disintegration tests, and dissolution test in Stage 1. Sample D presented the lowest dissolution performance, in terms of DE values, with highly significant differences in comparison with the rest of the evaluated samples; however, the results of this study indicate that HCTZ tablets available in Argentina successfully pass all established quality control tests and can be considered pharmaceutical equivalents.
Fil: Varillas, M.A. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: Brevedan. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Materia
DISSOLUTION
HYDROCHLOROTHIAZIDE
PHARMACEUTICAL EQUIVALENCE
DISSOLUTION EFFICENCY
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/93602
Acceder
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network_name_str CONICET Digital (CONICET)
spelling Pharmaceutical equivalence of Hydrochlorothiazide tablets in ArgentinaVarillas, María AlejandraBrevedan, Marta Ingrid VictoriaGonzález Vidal, Noelia LujánDISSOLUTIONHYDROCHLOROTHIAZIDEPHARMACEUTICAL EQUIVALENCEDISSOLUTION EFFICENCYhttps://purl.org/becyt/ford/2.11https://purl.org/becyt/ford/2Hydrochlorothiazide (HCTZ) is a diuretic used to treat hypertension, which belongs to Class III of the Biopharmaceutics Classification System. The present study aimed to evaluate critical quality parameters of HCTZ solid oral dosage forms on the Argentine pharmaceutical market. For this purpose, evaluation of labels and patient information leaflets, description and mean weight of tablets, uniformity of dosage units, assay, hardness, friability, disintegration and dissolution tests were carried out, in compliance with the Argentine Pharmacopeia. The dissolution efficiency (DE) was obtained from the area under the drug dissolution curve, and the profiles were compared statistically by ANOVA. All samples met criteria for the assay, uniformity of dosage units, friability, hardness, disintegration tests, and dissolution test in Stage 1. Sample D presented the lowest dissolution performance, in terms of DE values, with highly significant differences in comparison with the rest of the evaluated samples; however, the results of this study indicate that HCTZ tablets available in Argentina successfully pass all established quality control tests and can be considered pharmaceutical equivalents.Fil: Varillas, M.A. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: Brevedan. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaDissolution Technologies, Inc2018-03info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/93602Varillas, María Alejandra; Brevedan, Marta Ingrid Victoria; González Vidal, Noelia Luján; Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina; Dissolution Technologies, Inc; Dissolution Technologies; 25; 4; 3-2018; 22-271521-298XCONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://dissolutiontech.com/info:eu-repo/semantics/altIdentifier/doi/10.14227/DT250418P22info:eu-repo/semantics/altIdentifier/url/http://dissolutiontech.com/issues/201811/DT201811_A04.pdfinfo:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T09:43:58Zoai:ri.conicet.gov.ar:11336/93602instacron: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:34982025-09-03 09:43:58.569CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina
title Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina
spellingShingle Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina
Varillas, María Alejandra
DISSOLUTION
HYDROCHLOROTHIAZIDE
PHARMACEUTICAL EQUIVALENCE
DISSOLUTION EFFICENCY
title_short Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina
title_full Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina
title_fullStr Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina
title_full_unstemmed Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina
title_sort Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina
dc.creator.none.fl_str_mv Varillas, María Alejandra
Brevedan, Marta Ingrid Victoria
González Vidal, Noelia Luján
author Varillas, María Alejandra
author_facet Varillas, María Alejandra
Brevedan, Marta Ingrid Victoria
González Vidal, Noelia Luján
author_role author
author2 Brevedan, Marta Ingrid Victoria
González Vidal, Noelia Luján
author2_role author
author
dc.subject.none.fl_str_mv DISSOLUTION
HYDROCHLOROTHIAZIDE
PHARMACEUTICAL EQUIVALENCE
DISSOLUTION EFFICENCY
topic DISSOLUTION
HYDROCHLOROTHIAZIDE
PHARMACEUTICAL EQUIVALENCE
DISSOLUTION EFFICENCY
purl_subject.fl_str_mv https://purl.org/becyt/ford/2.11
https://purl.org/becyt/ford/2
dc.description.none.fl_txt_mv Hydrochlorothiazide (HCTZ) is a diuretic used to treat hypertension, which belongs to Class III of the Biopharmaceutics Classification System. The present study aimed to evaluate critical quality parameters of HCTZ solid oral dosage forms on the Argentine pharmaceutical market. For this purpose, evaluation of labels and patient information leaflets, description and mean weight of tablets, uniformity of dosage units, assay, hardness, friability, disintegration and dissolution tests were carried out, in compliance with the Argentine Pharmacopeia. The dissolution efficiency (DE) was obtained from the area under the drug dissolution curve, and the profiles were compared statistically by ANOVA. All samples met criteria for the assay, uniformity of dosage units, friability, hardness, disintegration tests, and dissolution test in Stage 1. Sample D presented the lowest dissolution performance, in terms of DE values, with highly significant differences in comparison with the rest of the evaluated samples; however, the results of this study indicate that HCTZ tablets available in Argentina successfully pass all established quality control tests and can be considered pharmaceutical equivalents.
Fil: Varillas, M.A. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: Brevedan. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
description Hydrochlorothiazide (HCTZ) is a diuretic used to treat hypertension, which belongs to Class III of the Biopharmaceutics Classification System. The present study aimed to evaluate critical quality parameters of HCTZ solid oral dosage forms on the Argentine pharmaceutical market. For this purpose, evaluation of labels and patient information leaflets, description and mean weight of tablets, uniformity of dosage units, assay, hardness, friability, disintegration and dissolution tests were carried out, in compliance with the Argentine Pharmacopeia. The dissolution efficiency (DE) was obtained from the area under the drug dissolution curve, and the profiles were compared statistically by ANOVA. All samples met criteria for the assay, uniformity of dosage units, friability, hardness, disintegration tests, and dissolution test in Stage 1. Sample D presented the lowest dissolution performance, in terms of DE values, with highly significant differences in comparison with the rest of the evaluated samples; however, the results of this study indicate that HCTZ tablets available in Argentina successfully pass all established quality control tests and can be considered pharmaceutical equivalents.
publishDate 2018
dc.date.none.fl_str_mv 2018-03
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/11336/93602
Varillas, María Alejandra; Brevedan, Marta Ingrid Victoria; González Vidal, Noelia Luján; Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina; Dissolution Technologies, Inc; Dissolution Technologies; 25; 4; 3-2018; 22-27
1521-298X
CONICET Digital
CONICET
url http://hdl.handle.net/11336/93602
identifier_str_mv Varillas, María Alejandra; Brevedan, Marta Ingrid Victoria; González Vidal, Noelia Luján; Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina; Dissolution Technologies, Inc; Dissolution Technologies; 25; 4; 3-2018; 22-27
1521-298X
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://dissolutiontech.com/
info:eu-repo/semantics/altIdentifier/doi/10.14227/DT250418P22
info:eu-repo/semantics/altIdentifier/url/http://dissolutiontech.com/issues/201811/DT201811_A04.pdf
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
dc.publisher.none.fl_str_mv Dissolution Technologies, Inc
publisher.none.fl_str_mv Dissolution Technologies, Inc
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 13.13397

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