Comparative Study of Metformin Hydrochloride Tablets in Argentina

Autores
Brevedan, Marta Ingrid Victoria; Varillas, María Alejandra; González Vidal, Noelia Luján
Año de publicación
2024
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Metformin, a class III drug in the Biopharmaceutics Classification System, is an orally administered drug used to lower blood glucose concentrations in patients with non-insulin-dependent diabetes mellitus. Different quality parameters were assayed for Metformin immediate-release tablets (500 mg), obtained from pharmacies in Argentina, in order to compare the commercially available samples, ascertain pharmaceutical equivalence and interchangeability. Label evaluation, hardness, friability, disintegration time, uniformity of dosage units, assay and in vitro dissolution were assessed in accordance with the Argentine Pharmacopeia requirements. Mathematical and statistical comparative models were used to characterize the dissolution profiles obtained under physiological conditions. All evaluated products fulfilled the pharmaceutical equivalence criteria. Nevertheless, the biowaiver scheme could not be applied since not all formulations, including the reference product, fulfilled the very rapidly dissolving criterion applicable to Class III drug 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. 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
BIOWAIVER
DISSOLUTION PROFILES
IMMEDIATE RELEASE TABLETS
PHARMACEUTICAL EQUIVALENCE
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:11336/277661
Acceder
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repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Comparative Study of Metformin Hydrochloride Tablets in ArgentinaBrevedan, Marta Ingrid VictoriaVarillas, María AlejandraGonzález Vidal, Noelia LujánBIOWAIVERDISSOLUTION PROFILESIMMEDIATE RELEASE TABLETSPHARMACEUTICAL EQUIVALENCEhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3https://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1https://purl.org/becyt/ford/1.7https://purl.org/becyt/ford/1Metformin, a class III drug in the Biopharmaceutics Classification System, is an orally administered drug used to lower blood glucose concentrations in patients with non-insulin-dependent diabetes mellitus. Different quality parameters were assayed for Metformin immediate-release tablets (500 mg), obtained from pharmacies in Argentina, in order to compare the commercially available samples, ascertain pharmaceutical equivalence and interchangeability. Label evaluation, hardness, friability, disintegration time, uniformity of dosage units, assay and in vitro dissolution were assessed in accordance with the Argentine Pharmacopeia requirements. Mathematical and statistical comparative models were used to characterize the dissolution profiles obtained under physiological conditions. All evaluated products fulfilled the pharmaceutical equivalence criteria. Nevertheless, the biowaiver scheme could not be applied since not all formulations, including the reference product, fulfilled the very rapidly dissolving criterion applicable to Class III drug 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. 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, Inc2024-08info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/277661Brevedan, Marta Ingrid Victoria; Varillas, María Alejandra; González Vidal, Noelia Luján; Comparative Study of Metformin Hydrochloride Tablets in Argentina; Dissolution Technologies, Inc; Dissolution Technologies; 31; 3; 8-2024; 36-451521-298XCONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://dissolutiontech.com/issues/202408/Metformin.pdfinfo:eu-repo/semantics/altIdentifier/doi/10.14227/DT310224PGC37info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-12-23T13:28:12Zoai:ri.conicet.gov.ar:11336/277661instacron: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:34982025-12-23 13:28:13.186CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Comparative Study of Metformin Hydrochloride Tablets in Argentina
title Comparative Study of Metformin Hydrochloride Tablets in Argentina
spellingShingle Comparative Study of Metformin Hydrochloride Tablets in Argentina
Brevedan, Marta Ingrid Victoria
BIOWAIVER
DISSOLUTION PROFILES
IMMEDIATE RELEASE TABLETS
PHARMACEUTICAL EQUIVALENCE
title_short Comparative Study of Metformin Hydrochloride Tablets in Argentina
title_full Comparative Study of Metformin Hydrochloride Tablets in Argentina
title_fullStr Comparative Study of Metformin Hydrochloride Tablets in Argentina
title_full_unstemmed Comparative Study of Metformin Hydrochloride Tablets in Argentina
title_sort Comparative Study of Metformin Hydrochloride 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 BIOWAIVER
DISSOLUTION PROFILES
IMMEDIATE RELEASE TABLETS
PHARMACEUTICAL EQUIVALENCE
topic BIOWAIVER
DISSOLUTION PROFILES
IMMEDIATE RELEASE TABLETS
PHARMACEUTICAL EQUIVALENCE
purl_subject.fl_str_mv 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
https://purl.org/becyt/ford/1.7
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv Metformin, a class III drug in the Biopharmaceutics Classification System, is an orally administered drug used to lower blood glucose concentrations in patients with non-insulin-dependent diabetes mellitus. Different quality parameters were assayed for Metformin immediate-release tablets (500 mg), obtained from pharmacies in Argentina, in order to compare the commercially available samples, ascertain pharmaceutical equivalence and interchangeability. Label evaluation, hardness, friability, disintegration time, uniformity of dosage units, assay and in vitro dissolution were assessed in accordance with the Argentine Pharmacopeia requirements. Mathematical and statistical comparative models were used to characterize the dissolution profiles obtained under physiological conditions. All evaluated products fulfilled the pharmaceutical equivalence criteria. Nevertheless, the biowaiver scheme could not be applied since not all formulations, including the reference product, fulfilled the very rapidly dissolving criterion applicable to Class III drug 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. 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 Metformin, a class III drug in the Biopharmaceutics Classification System, is an orally administered drug used to lower blood glucose concentrations in patients with non-insulin-dependent diabetes mellitus. Different quality parameters were assayed for Metformin immediate-release tablets (500 mg), obtained from pharmacies in Argentina, in order to compare the commercially available samples, ascertain pharmaceutical equivalence and interchangeability. Label evaluation, hardness, friability, disintegration time, uniformity of dosage units, assay and in vitro dissolution were assessed in accordance with the Argentine Pharmacopeia requirements. Mathematical and statistical comparative models were used to characterize the dissolution profiles obtained under physiological conditions. All evaluated products fulfilled the pharmaceutical equivalence criteria. Nevertheless, the biowaiver scheme could not be applied since not all formulations, including the reference product, fulfilled the very rapidly dissolving criterion applicable to Class III drug products.
publishDate 2024
dc.date.none.fl_str_mv 2024-08
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/11336/277661
Brevedan, Marta Ingrid Victoria; Varillas, María Alejandra; González Vidal, Noelia Luján; Comparative Study of Metformin Hydrochloride Tablets in Argentina; Dissolution Technologies, Inc; Dissolution Technologies; 31; 3; 8-2024; 36-45
1521-298X
CONICET Digital
CONICET
url http://hdl.handle.net/11336/277661
identifier_str_mv Brevedan, Marta Ingrid Victoria; Varillas, María Alejandra; González Vidal, Noelia Luján; Comparative Study of Metformin Hydrochloride Tablets in Argentina; Dissolution Technologies, Inc; Dissolution Technologies; 31; 3; 8-2024; 36-45
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/https://dissolutiontech.com/issues/202408/Metformin.pdf
info:eu-repo/semantics/altIdentifier/doi/10.14227/DT310224PGC37
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_ 1852335165237362688
score 12.952241

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