Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets

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
Dissolution studies have evolved from a simple quality control test to a surrogate of in vivo interchangeability. Pharmaceutical equivalents are drug formulations with the same molar amount of the same active pharmaceutical ingredient (API), in the same dosage form, meet comparable quality standards, and are intended to be administered by the same route. Pharmaceutical equivalents imply therapeutical equivalence when, after administration, their effects are essentially the same; these effects can be demonstrated by bioequivalence studies or, in some cases, by in vitro studies based on the Biopharmaceutics Classification System. In this scheme, biowaivers are recommended for immediate-release solid oral dosage forms containing Class 3 drugs (like Metoclopramide) using dissolution testing as a surrogate for in vivo bioequivalence studies, with special consideration regarding excipient composition. The present work aimed to compare in vitro dissolution characteristics and other critical quality attributes of Metoclopramide tablets purchased in Argentina to establish their pharmaceutical equivalence and similarity. All evaluated products fulfill the pharmaceutical equivalence criteria. Three of the tested products and the reference formulation complied with the criteria for ‘very rapidly dissolving,’ so they could be described as essentially similar. Nevertheless, it is important to have access to additional information about the excipient composition of these formulations to assure a safe interchangeability process for this Class 3 drug.
Fil: Varillas, Maria Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: Brevedan, Marta ingrid Victoria. 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
BIOWAIVER
DISSOLUTION
INTERCHANGEABILITY
METOCLOPRAMIDE
SIMILARITY
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:11336/94733
Acceder
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network_acronym_str CONICETDig
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network_name_str CONICET Digital (CONICET)
spelling Pharmaceutical Equivalence and Similarity Studies of Metoclopramide TabletsVarillas, María AlejandraBrevedan, Marta Ingrid VictoriaGonzález Vidal, Noelia LujánBIOWAIVERDISSOLUTIONINTERCHANGEABILITYMETOCLOPRAMIDESIMILARITYhttps://purl.org/becyt/ford/2.11https://purl.org/becyt/ford/2Dissolution studies have evolved from a simple quality control test to a surrogate of in vivo interchangeability. Pharmaceutical equivalents are drug formulations with the same molar amount of the same active pharmaceutical ingredient (API), in the same dosage form, meet comparable quality standards, and are intended to be administered by the same route. Pharmaceutical equivalents imply therapeutical equivalence when, after administration, their effects are essentially the same; these effects can be demonstrated by bioequivalence studies or, in some cases, by in vitro studies based on the Biopharmaceutics Classification System. In this scheme, biowaivers are recommended for immediate-release solid oral dosage forms containing Class 3 drugs (like Metoclopramide) using dissolution testing as a surrogate for in vivo bioequivalence studies, with special consideration regarding excipient composition. The present work aimed to compare in vitro dissolution characteristics and other critical quality attributes of Metoclopramide tablets purchased in Argentina to establish their pharmaceutical equivalence and similarity. All evaluated products fulfill the pharmaceutical equivalence criteria. Three of the tested products and the reference formulation complied with the criteria for ‘very rapidly dissolving,’ so they could be described as essentially similar. Nevertheless, it is important to have access to additional information about the excipient composition of these formulations to assure a safe interchangeability process for this Class 3 drug.Fil: Varillas, Maria Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: Brevedan, Marta ingrid Victoria. 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, Inc2018-02info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/94733Varillas, María Alejandra; Brevedan, Marta Ingrid Victoria; González Vidal, Noelia Luján; Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets; Dissolution Technologies, Inc; Dissolution Technologies; 25; 1; 2-2018; 14-211521-298XCONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://www.dissolutiontech.com/issues/201802/DT201802_A02.pdfinfo:eu-repo/semantics/altIdentifier/doi/10.14227/DT250118P14info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T10:08:14Zoai:ri.conicet.gov.ar:11336/94733instacron: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 10:08:14.9CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets
title Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets
spellingShingle Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets
Varillas, María Alejandra
BIOWAIVER
DISSOLUTION
INTERCHANGEABILITY
METOCLOPRAMIDE
SIMILARITY
title_short Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets
title_full Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets
title_fullStr Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets
title_full_unstemmed Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets
title_sort Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets
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 BIOWAIVER
DISSOLUTION
INTERCHANGEABILITY
METOCLOPRAMIDE
SIMILARITY
topic BIOWAIVER
DISSOLUTION
INTERCHANGEABILITY
METOCLOPRAMIDE
SIMILARITY
purl_subject.fl_str_mv https://purl.org/becyt/ford/2.11
https://purl.org/becyt/ford/2
dc.description.none.fl_txt_mv Dissolution studies have evolved from a simple quality control test to a surrogate of in vivo interchangeability. Pharmaceutical equivalents are drug formulations with the same molar amount of the same active pharmaceutical ingredient (API), in the same dosage form, meet comparable quality standards, and are intended to be administered by the same route. Pharmaceutical equivalents imply therapeutical equivalence when, after administration, their effects are essentially the same; these effects can be demonstrated by bioequivalence studies or, in some cases, by in vitro studies based on the Biopharmaceutics Classification System. In this scheme, biowaivers are recommended for immediate-release solid oral dosage forms containing Class 3 drugs (like Metoclopramide) using dissolution testing as a surrogate for in vivo bioequivalence studies, with special consideration regarding excipient composition. The present work aimed to compare in vitro dissolution characteristics and other critical quality attributes of Metoclopramide tablets purchased in Argentina to establish their pharmaceutical equivalence and similarity. All evaluated products fulfill the pharmaceutical equivalence criteria. Three of the tested products and the reference formulation complied with the criteria for ‘very rapidly dissolving,’ so they could be described as essentially similar. Nevertheless, it is important to have access to additional information about the excipient composition of these formulations to assure a safe interchangeability process for this Class 3 drug.
Fil: Varillas, Maria Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: Brevedan, Marta ingrid Victoria. 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 Dissolution studies have evolved from a simple quality control test to a surrogate of in vivo interchangeability. Pharmaceutical equivalents are drug formulations with the same molar amount of the same active pharmaceutical ingredient (API), in the same dosage form, meet comparable quality standards, and are intended to be administered by the same route. Pharmaceutical equivalents imply therapeutical equivalence when, after administration, their effects are essentially the same; these effects can be demonstrated by bioequivalence studies or, in some cases, by in vitro studies based on the Biopharmaceutics Classification System. In this scheme, biowaivers are recommended for immediate-release solid oral dosage forms containing Class 3 drugs (like Metoclopramide) using dissolution testing as a surrogate for in vivo bioequivalence studies, with special consideration regarding excipient composition. The present work aimed to compare in vitro dissolution characteristics and other critical quality attributes of Metoclopramide tablets purchased in Argentina to establish their pharmaceutical equivalence and similarity. All evaluated products fulfill the pharmaceutical equivalence criteria. Three of the tested products and the reference formulation complied with the criteria for ‘very rapidly dissolving,’ so they could be described as essentially similar. Nevertheless, it is important to have access to additional information about the excipient composition of these formulations to assure a safe interchangeability process for this Class 3 drug.
publishDate 2018
dc.date.none.fl_str_mv 2018-02
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/11336/94733
Varillas, María Alejandra; Brevedan, Marta Ingrid Victoria; González Vidal, Noelia Luján; Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets; Dissolution Technologies, Inc; Dissolution Technologies; 25; 1; 2-2018; 14-21
1521-298X
CONICET Digital
CONICET
url http://hdl.handle.net/11336/94733
identifier_str_mv Varillas, María Alejandra; Brevedan, Marta Ingrid Victoria; González Vidal, Noelia Luján; Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets; Dissolution Technologies, Inc; Dissolution Technologies; 25; 1; 2-2018; 14-21
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://www.dissolutiontech.com/issues/201802/DT201802_A02.pdf
info:eu-repo/semantics/altIdentifier/doi/10.14227/DT250118P14
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_ 1842270037013954560
score 13.13397

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