Pharmaceutical equivalence and stability of Furosemide tablets in Argentina

Autores
Brevedan, Marta Ingrid Victoria; Varillas, María Alejandra; González Vidal, Noelia Luján
Año de publicación
2019
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Furosemide is a widely used diuretic, indicated in the treatment of hypertension and edema. This active pharmaceutical ingredient is classified as Class IV in the Biopharmaceutical Classification System. The World Health Organization recommends an oral dose of 40 mg. The aim of the present work was to evaluate and compare critical quality attributes, including in vitro dissolution characteristics, of eight furosemide tablet brands of Argentine market, and determine their pharmaceutical equivalence. Furthermore, this research aimed to evaluate the effect of storage (twelve months after natural aging conditions) over those critical properties. At time zero of analysis, all evaluated samples fulfilled specifications for friability, hardness, disintegration, assay, uniformity of dosage units and dissolution tests. After storage, all formulations fulfilled the assay and dissolution test specifications, with no statistical differences recorded for the obtained results. Comparison of dissolution profiles was also assessed in terms of the model independent parameter called dissolution efficiency. Highly significant differences were recorded between reference and four multisource formulations. The same differences were found at the beginning of the study (time zero) and after one year of storage. One product presented the lowest dissolution efficiency results, associated to highly significant differences when compared to the other formulations. However, the obtained results reveal that the evaluated samples complied with codified quality control tests, and consequently can be qualified as pharmaceutical equivalents. Natural aging conditions clearly not affected the stability of the evaluated products.
Fil: Brevedan, Marta Ingrid Victoria. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: Varillas, María Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: González Vidal, Noelia Luján. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentina
Materia
DISSOLUTION
FUROSEMIDE
PHARMACEUTICAL EQUIVALENCE
STABILITY
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:11336/113198
Acceder
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network_acronym_str CONICETDig
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network_name_str CONICET Digital (CONICET)
spelling Pharmaceutical equivalence and stability of Furosemide tablets in ArgentinaBrevedan, Marta Ingrid VictoriaVarillas, María AlejandraGonzález Vidal, Noelia LujánDISSOLUTIONFUROSEMIDEPHARMACEUTICAL EQUIVALENCESTABILITYhttps://purl.org/becyt/ford/2.11https://purl.org/becyt/ford/2https://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3https://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1Furosemide is a widely used diuretic, indicated in the treatment of hypertension and edema. This active pharmaceutical ingredient is classified as Class IV in the Biopharmaceutical Classification System. The World Health Organization recommends an oral dose of 40 mg. The aim of the present work was to evaluate and compare critical quality attributes, including in vitro dissolution characteristics, of eight furosemide tablet brands of Argentine market, and determine their pharmaceutical equivalence. Furthermore, this research aimed to evaluate the effect of storage (twelve months after natural aging conditions) over those critical properties. At time zero of analysis, all evaluated samples fulfilled specifications for friability, hardness, disintegration, assay, uniformity of dosage units and dissolution tests. After storage, all formulations fulfilled the assay and dissolution test specifications, with no statistical differences recorded for the obtained results. Comparison of dissolution profiles was also assessed in terms of the model independent parameter called dissolution efficiency. Highly significant differences were recorded between reference and four multisource formulations. The same differences were found at the beginning of the study (time zero) and after one year of storage. One product presented the lowest dissolution efficiency results, associated to highly significant differences when compared to the other formulations. However, the obtained results reveal that the evaluated samples complied with codified quality control tests, and consequently can be qualified as pharmaceutical equivalents. Natural aging conditions clearly not affected the stability of the evaluated products.Fil: Brevedan, Marta Ingrid Victoria. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: Varillas, María Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: González Vidal, Noelia Luján. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; ArgentinaDissolution Technologies, Inc2019-11info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/113198Brevedan, Marta Ingrid Victoria; Varillas, María Alejandra; González Vidal, Noelia Luján; Pharmaceutical equivalence and stability of Furosemide tablets in Argentina; Dissolution Technologies, Inc; Dissolution Technologies; 26; 4; 11-2019; 30-371521-298XCONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.14227/DT260419P30info:eu-repo/semantics/altIdentifier/url/http://dissolutiontech.com/info:eu-repo/semantics/altIdentifier/url/http://dissolutiontech.com/issues/201911/DT201911_A05.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 Técnicas2025-09-03T09:47:05Zoai:ri.conicet.gov.ar:11336/113198instacron: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 09:47:06.297CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Pharmaceutical equivalence and stability of Furosemide tablets in Argentina
title Pharmaceutical equivalence and stability of Furosemide tablets in Argentina
spellingShingle Pharmaceutical equivalence and stability of Furosemide tablets in Argentina
Brevedan, Marta Ingrid Victoria
DISSOLUTION
FUROSEMIDE
PHARMACEUTICAL EQUIVALENCE
STABILITY
title_short Pharmaceutical equivalence and stability of Furosemide tablets in Argentina
title_full Pharmaceutical equivalence and stability of Furosemide tablets in Argentina
title_fullStr Pharmaceutical equivalence and stability of Furosemide tablets in Argentina
title_full_unstemmed Pharmaceutical equivalence and stability of Furosemide tablets in Argentina
title_sort Pharmaceutical equivalence and stability of Furosemide tablets in Argentina
dc.creator.none.fl_str_mv Brevedan, Marta Ingrid Victoria
Varillas, María Alejandra
González Vidal, Noelia Luján
author Brevedan, Marta Ingrid Victoria
author_facet Brevedan, Marta Ingrid Victoria
Varillas, María Alejandra
González Vidal, Noelia Luján
author_role author
author2 Varillas, María Alejandra
González Vidal, Noelia Luján
author2_role author
author
dc.subject.none.fl_str_mv DISSOLUTION
FUROSEMIDE
PHARMACEUTICAL EQUIVALENCE
STABILITY
topic DISSOLUTION
FUROSEMIDE
PHARMACEUTICAL EQUIVALENCE
STABILITY
purl_subject.fl_str_mv https://purl.org/becyt/ford/2.11
https://purl.org/becyt/ford/2
https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv Furosemide is a widely used diuretic, indicated in the treatment of hypertension and edema. This active pharmaceutical ingredient is classified as Class IV in the Biopharmaceutical Classification System. The World Health Organization recommends an oral dose of 40 mg. The aim of the present work was to evaluate and compare critical quality attributes, including in vitro dissolution characteristics, of eight furosemide tablet brands of Argentine market, and determine their pharmaceutical equivalence. Furthermore, this research aimed to evaluate the effect of storage (twelve months after natural aging conditions) over those critical properties. At time zero of analysis, all evaluated samples fulfilled specifications for friability, hardness, disintegration, assay, uniformity of dosage units and dissolution tests. After storage, all formulations fulfilled the assay and dissolution test specifications, with no statistical differences recorded for the obtained results. Comparison of dissolution profiles was also assessed in terms of the model independent parameter called dissolution efficiency. Highly significant differences were recorded between reference and four multisource formulations. The same differences were found at the beginning of the study (time zero) and after one year of storage. One product presented the lowest dissolution efficiency results, associated to highly significant differences when compared to the other formulations. However, the obtained results reveal that the evaluated samples complied with codified quality control tests, and consequently can be qualified as pharmaceutical equivalents. Natural aging conditions clearly not affected the stability of the evaluated products.
Fil: Brevedan, Marta Ingrid Victoria. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: Varillas, María Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: González Vidal, Noelia Luján. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentina
description Furosemide is a widely used diuretic, indicated in the treatment of hypertension and edema. This active pharmaceutical ingredient is classified as Class IV in the Biopharmaceutical Classification System. The World Health Organization recommends an oral dose of 40 mg. The aim of the present work was to evaluate and compare critical quality attributes, including in vitro dissolution characteristics, of eight furosemide tablet brands of Argentine market, and determine their pharmaceutical equivalence. Furthermore, this research aimed to evaluate the effect of storage (twelve months after natural aging conditions) over those critical properties. At time zero of analysis, all evaluated samples fulfilled specifications for friability, hardness, disintegration, assay, uniformity of dosage units and dissolution tests. After storage, all formulations fulfilled the assay and dissolution test specifications, with no statistical differences recorded for the obtained results. Comparison of dissolution profiles was also assessed in terms of the model independent parameter called dissolution efficiency. Highly significant differences were recorded between reference and four multisource formulations. The same differences were found at the beginning of the study (time zero) and after one year of storage. One product presented the lowest dissolution efficiency results, associated to highly significant differences when compared to the other formulations. However, the obtained results reveal that the evaluated samples complied with codified quality control tests, and consequently can be qualified as pharmaceutical equivalents. Natural aging conditions clearly not affected the stability of the evaluated products.
publishDate 2019
dc.date.none.fl_str_mv 2019-11
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/11336/113198
Brevedan, Marta Ingrid Victoria; Varillas, María Alejandra; González Vidal, Noelia Luján; Pharmaceutical equivalence and stability of Furosemide tablets in Argentina; Dissolution Technologies, Inc; Dissolution Technologies; 26; 4; 11-2019; 30-37
1521-298X
CONICET Digital
CONICET
url http://hdl.handle.net/11336/113198
identifier_str_mv Brevedan, Marta Ingrid Victoria; Varillas, María Alejandra; González Vidal, Noelia Luján; Pharmaceutical equivalence and stability of Furosemide tablets in Argentina; Dissolution Technologies, Inc; Dissolution Technologies; 26; 4; 11-2019; 30-37
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/doi/10.14227/DT260419P30
info:eu-repo/semantics/altIdentifier/url/http://dissolutiontech.com/
info:eu-repo/semantics/altIdentifier/url/http://dissolutiontech.com/issues/201911/DT201911_A05.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
_version_ 1842268836857905152
score 13.13397

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