Comparative assessment of critical quality attributes of sildenafil tablets

Autores
Brevedan, Marta Ingrid Victoria; Varillas, María Alejandra; González Vidal, Noelia Luján
Año de publicación
2021
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Sildenafil citrate is a selective inhibitor of the enzyme phosphodiesterase type 5, used to treat erectile dysfunction in adults and pulmonary hypertension, mainly in children. This work aimed to perform a comparative study of sildenafil tablets marketed in Argentina and establish their pharmaceutical equivalence. Eight commercial formulations (immediate-release tablets) containing 50 mg of sildenafil were analyzed according to United States and Argentinian Pharmacopoeial guidelines. The assay was performed by UV spectrophotometry in 0.01 N hydrochloric acid. Similar conditions were used for dissolution tests, which were carried out in a basket apparatus at 100 rpm. All samples met pharmacopeial specifications for acceptance (i.e., assay, content uniformity, hardness, friability, disintegration, and in vitro dissolution) for immediate-release dosage forms. When compared to the reference formulation, a statistically significant difference was noted for dissolution efficiency in one case (sample F). Based on the obtained results, it is possible to conclude that the evaluated formulations of sildenafil can be considered pharmaceutical equivalents.
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. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Materia
DISSOLUTION PROFILES
PHARMACEUTICAL EQUIVALENCE
SILDENAFIL TABLETS
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:11336/149674
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/149674
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Comparative assessment of critical quality attributes of sildenafil tabletsBrevedan, Marta Ingrid VictoriaVarillas, María AlejandraGonzález Vidal, Noelia LujánDISSOLUTION PROFILESPHARMACEUTICAL EQUIVALENCESILDENAFIL TABLETShttps://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/1Sildenafil citrate is a selective inhibitor of the enzyme phosphodiesterase type 5, used to treat erectile dysfunction in adults and pulmonary hypertension, mainly in children. This work aimed to perform a comparative study of sildenafil tablets marketed in Argentina and establish their pharmaceutical equivalence. Eight commercial formulations (immediate-release tablets) containing 50 mg of sildenafil were analyzed according to United States and Argentinian Pharmacopoeial guidelines. The assay was performed by UV spectrophotometry in 0.01 N hydrochloric acid. Similar conditions were used for dissolution tests, which were carried out in a basket apparatus at 100 rpm. All samples met pharmacopeial specifications for acceptance (i.e., assay, content uniformity, hardness, friability, disintegration, and in vitro dissolution) for immediate-release dosage forms. When compared to the reference formulation, a statistically significant difference was noted for dissolution efficiency in one case (sample F). Based on the obtained results, it is possible to conclude that the evaluated formulations of sildenafil can be considered pharmaceutical equivalents.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. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaDissolution Technologies, Inc2021-02info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/149674Brevedan, Marta Ingrid Victoria; Varillas, María Alejandra; González Vidal, Noelia Luján; Comparative assessment of critical quality attributes of sildenafil tablets; Dissolution Technologies, Inc; Dissolution Technologies; 28; 1; 2-2021; 1-81521-298XCONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://dissolutiontech.com/issues/202102/20-00015Sildenafil.pdfinfo:eu-repo/semantics/altIdentifier/doi/10.14227/DT280121PGC1info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:16:11Zoai:ri.conicet.gov.ar:11336/149674instacron: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 10:16:12.013CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Comparative assessment of critical quality attributes of sildenafil tablets
title Comparative assessment of critical quality attributes of sildenafil tablets
spellingShingle Comparative assessment of critical quality attributes of sildenafil tablets
Brevedan, Marta Ingrid Victoria
DISSOLUTION PROFILES
PHARMACEUTICAL EQUIVALENCE
SILDENAFIL TABLETS
title_short Comparative assessment of critical quality attributes of sildenafil tablets
title_full Comparative assessment of critical quality attributes of sildenafil tablets
title_fullStr Comparative assessment of critical quality attributes of sildenafil tablets
title_full_unstemmed Comparative assessment of critical quality attributes of sildenafil tablets
title_sort Comparative assessment of critical quality attributes of sildenafil tablets
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 PROFILES
PHARMACEUTICAL EQUIVALENCE
SILDENAFIL TABLETS
topic DISSOLUTION PROFILES
PHARMACEUTICAL EQUIVALENCE
SILDENAFIL TABLETS
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 Sildenafil citrate is a selective inhibitor of the enzyme phosphodiesterase type 5, used to treat erectile dysfunction in adults and pulmonary hypertension, mainly in children. This work aimed to perform a comparative study of sildenafil tablets marketed in Argentina and establish their pharmaceutical equivalence. Eight commercial formulations (immediate-release tablets) containing 50 mg of sildenafil were analyzed according to United States and Argentinian Pharmacopoeial guidelines. The assay was performed by UV spectrophotometry in 0.01 N hydrochloric acid. Similar conditions were used for dissolution tests, which were carried out in a basket apparatus at 100 rpm. All samples met pharmacopeial specifications for acceptance (i.e., assay, content uniformity, hardness, friability, disintegration, and in vitro dissolution) for immediate-release dosage forms. When compared to the reference formulation, a statistically significant difference was noted for dissolution efficiency in one case (sample F). Based on the obtained results, it is possible to conclude that the evaluated formulations of sildenafil can be considered pharmaceutical equivalents.
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. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
description Sildenafil citrate is a selective inhibitor of the enzyme phosphodiesterase type 5, used to treat erectile dysfunction in adults and pulmonary hypertension, mainly in children. This work aimed to perform a comparative study of sildenafil tablets marketed in Argentina and establish their pharmaceutical equivalence. Eight commercial formulations (immediate-release tablets) containing 50 mg of sildenafil were analyzed according to United States and Argentinian Pharmacopoeial guidelines. The assay was performed by UV spectrophotometry in 0.01 N hydrochloric acid. Similar conditions were used for dissolution tests, which were carried out in a basket apparatus at 100 rpm. All samples met pharmacopeial specifications for acceptance (i.e., assay, content uniformity, hardness, friability, disintegration, and in vitro dissolution) for immediate-release dosage forms. When compared to the reference formulation, a statistically significant difference was noted for dissolution efficiency in one case (sample F). Based on the obtained results, it is possible to conclude that the evaluated formulations of sildenafil can be considered pharmaceutical equivalents.
publishDate 2021
dc.date.none.fl_str_mv 2021-02
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/11336/149674
Brevedan, Marta Ingrid Victoria; Varillas, María Alejandra; González Vidal, Noelia Luján; Comparative assessment of critical quality attributes of sildenafil tablets; Dissolution Technologies, Inc; Dissolution Technologies; 28; 1; 2-2021; 1-8
1521-298X
CONICET Digital
CONICET
url http://hdl.handle.net/11336/149674
identifier_str_mv Brevedan, Marta Ingrid Victoria; Varillas, María Alejandra; González Vidal, Noelia Luján; Comparative assessment of critical quality attributes of sildenafil tablets; Dissolution Technologies, Inc; Dissolution Technologies; 28; 1; 2-2021; 1-8
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/issues/202102/20-00015Sildenafil.pdf
info:eu-repo/semantics/altIdentifier/doi/10.14227/DT280121PGC1
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 13.070432

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