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dc.contributor.author
Varillas, María Alejandra
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dc.contributor.author
Brevedan, Marta Ingrid Victoria
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dc.contributor.author
González Vidal, Noelia Luján
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dc.date.available
2020-01-15T15:12:29Z
dc.date.issued
2018-02
dc.identifier.citation
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
dc.identifier.issn
1521-298X
dc.identifier.uri
http://hdl.handle.net/11336/94733
dc.description.abstract
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.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Dissolution Technologies, Inc
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dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.subject
BIOWAIVER
dc.subject
DISSOLUTION
dc.subject
INTERCHANGEABILITY
dc.subject
METOCLOPRAMIDE
dc.subject
SIMILARITY
dc.subject.classification
Otras Ingenierías y Tecnologías
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dc.subject.classification
Otras Ingenierías y Tecnologías
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dc.subject.classification
INGENIERÍAS Y TECNOLOGÍAS
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dc.title
Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2019-10-22T18:01:47Z
dc.journal.volume
25
dc.journal.number
1
dc.journal.pagination
14-21
dc.journal.pais
Estados Unidos
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dc.journal.ciudad
Hockessin, Delaware (USA)
dc.description.fil
Fil: Varillas, Maria Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
dc.description.fil
Fil: Brevedan, Marta ingrid Victoria. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
dc.description.fil
Fil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
dc.journal.title
Dissolution Technologies
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dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/http://www.dissolutiontech.com/issues/201802/DT201802_A02.pdf
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.14227/DT250118P14
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