Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina

Autores
Simionato, Laura Daniela; Petrone, Luciana; Baldut, Mariela; Bonafede, Silvina Laura; Segall, Adriana Ines
Año de publicación
2018
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
In this work, the dissolution profiles of nine meloxicam tablet brands marketed in Argentina have been evaluated. As meloxicam is a Class 2 Biopharmaceutical Classification System (BSC) drug, interchangeability between commercial products must be demonstrated through in vivo bioequivalence studies. However, in our country, such studies remain to be performed. Dissolution studies have been performed according to USP 38 and evaluated by fitting experimental data to the zero and first-order, the Hixson-Crowell, the Higuchi, and the Weibull model-dependent methods. To test the pertinence of these release models, the Akaike Information Criteria (AIC) were used. All brands satisfied the dissolution profiles (phosphate buffer, pH 7.5) established in the USP. The comparison between the dissolution profiles was carried out by model-dependent and model-independent methods. The Weibull model provided the best kinetic curve adjustment. Brands I, II, IV and VI had the best fitting, with the maximum determination coefficient and the smallest AIC values. Model-independent methods included ratio test and the fit factors. The Dissolution Efficiency (DE) and Mean Dissolution Time (MDT) were analysed with ANOVA and the DGC method. In both cases, brand I did not show similarity with the rest of the brands. Using fit factors, only brands I, II and V were similar to each other. Significant differences were found among the in vitro dissolution profiles of meloxicam tablets belonging to the nine brands. As meloxicam is a class 2 BCS drug, interchangeability between commercial products must be demonstrated through in vivo bioequivalence studies. However, in Argentina, such studies remain to be performed. Our results demonstrate that caution must be exercised as regards interchangeability of generic products.
Fil: Simionato, Laura Daniela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Petrone, Luciana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Baldut, Mariela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Bonafede, Silvina Laura. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Segall, Adriana Ines. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Materia
COMMERCIAL PRODUCTS
DISSOLUTION PROFILES
MELOXICAM
MODEL-DEPENDENT METHOD
MODEL-INDEPENDENT METHOD
TABLETS
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/99367
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/99367
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, ArgentinaSimionato, Laura DanielaPetrone, LucianaBaldut, MarielaBonafede, Silvina LauraSegall, Adriana InesCOMMERCIAL PRODUCTSDISSOLUTION PROFILESMELOXICAMMODEL-DEPENDENT METHODMODEL-INDEPENDENT METHODTABLETShttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3In this work, the dissolution profiles of nine meloxicam tablet brands marketed in Argentina have been evaluated. As meloxicam is a Class 2 Biopharmaceutical Classification System (BSC) drug, interchangeability between commercial products must be demonstrated through in vivo bioequivalence studies. However, in our country, such studies remain to be performed. Dissolution studies have been performed according to USP 38 and evaluated by fitting experimental data to the zero and first-order, the Hixson-Crowell, the Higuchi, and the Weibull model-dependent methods. To test the pertinence of these release models, the Akaike Information Criteria (AIC) were used. All brands satisfied the dissolution profiles (phosphate buffer, pH 7.5) established in the USP. The comparison between the dissolution profiles was carried out by model-dependent and model-independent methods. The Weibull model provided the best kinetic curve adjustment. Brands I, II, IV and VI had the best fitting, with the maximum determination coefficient and the smallest AIC values. Model-independent methods included ratio test and the fit factors. The Dissolution Efficiency (DE) and Mean Dissolution Time (MDT) were analysed with ANOVA and the DGC method. In both cases, brand I did not show similarity with the rest of the brands. Using fit factors, only brands I, II and V were similar to each other. Significant differences were found among the in vitro dissolution profiles of meloxicam tablets belonging to the nine brands. As meloxicam is a class 2 BCS drug, interchangeability between commercial products must be demonstrated through in vivo bioequivalence studies. However, in Argentina, such studies remain to be performed. Our results demonstrate that caution must be exercised as regards interchangeability of generic products.Fil: Simionato, Laura Daniela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; ArgentinaFil: Petrone, Luciana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; ArgentinaFil: Baldut, Mariela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; ArgentinaFil: Bonafede, Silvina Laura. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; ArgentinaFil: Segall, Adriana Ines. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaElsevier2018-05info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/99367Simionato, Laura Daniela; Petrone, Luciana; Baldut, Mariela; Bonafede, Silvina Laura; Segall, Adriana Ines; Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina; Elsevier; Saudi Pharmaceutical Journal; 26; 4; 5-2018; 578-5841319-0164CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.jsps.2018.01.015info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S1319016418300227info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T09:46:13Zoai:ri.conicet.gov.ar:11336/99367instacron: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 09:46:13.426CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina
title Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina
spellingShingle Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina
Simionato, Laura Daniela
COMMERCIAL PRODUCTS
DISSOLUTION PROFILES
MELOXICAM
MODEL-DEPENDENT METHOD
MODEL-INDEPENDENT METHOD
TABLETS
title_short Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina
title_full Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina
title_fullStr Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina
title_full_unstemmed Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina
title_sort Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina
dc.creator.none.fl_str_mv Simionato, Laura Daniela
Petrone, Luciana
Baldut, Mariela
Bonafede, Silvina Laura
Segall, Adriana Ines
author Simionato, Laura Daniela
author_facet Simionato, Laura Daniela
Petrone, Luciana
Baldut, Mariela
Bonafede, Silvina Laura
Segall, Adriana Ines
author_role author
author2 Petrone, Luciana
Baldut, Mariela
Bonafede, Silvina Laura
Segall, Adriana Ines
author2_role author
author
author
author
dc.subject.none.fl_str_mv COMMERCIAL PRODUCTS
DISSOLUTION PROFILES
MELOXICAM
MODEL-DEPENDENT METHOD
MODEL-INDEPENDENT METHOD
TABLETS
topic COMMERCIAL PRODUCTS
DISSOLUTION PROFILES
MELOXICAM
MODEL-DEPENDENT METHOD
MODEL-INDEPENDENT METHOD
TABLETS
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv In this work, the dissolution profiles of nine meloxicam tablet brands marketed in Argentina have been evaluated. As meloxicam is a Class 2 Biopharmaceutical Classification System (BSC) drug, interchangeability between commercial products must be demonstrated through in vivo bioequivalence studies. However, in our country, such studies remain to be performed. Dissolution studies have been performed according to USP 38 and evaluated by fitting experimental data to the zero and first-order, the Hixson-Crowell, the Higuchi, and the Weibull model-dependent methods. To test the pertinence of these release models, the Akaike Information Criteria (AIC) were used. All brands satisfied the dissolution profiles (phosphate buffer, pH 7.5) established in the USP. The comparison between the dissolution profiles was carried out by model-dependent and model-independent methods. The Weibull model provided the best kinetic curve adjustment. Brands I, II, IV and VI had the best fitting, with the maximum determination coefficient and the smallest AIC values. Model-independent methods included ratio test and the fit factors. The Dissolution Efficiency (DE) and Mean Dissolution Time (MDT) were analysed with ANOVA and the DGC method. In both cases, brand I did not show similarity with the rest of the brands. Using fit factors, only brands I, II and V were similar to each other. Significant differences were found among the in vitro dissolution profiles of meloxicam tablets belonging to the nine brands. As meloxicam is a class 2 BCS drug, interchangeability between commercial products must be demonstrated through in vivo bioequivalence studies. However, in Argentina, such studies remain to be performed. Our results demonstrate that caution must be exercised as regards interchangeability of generic products.
Fil: Simionato, Laura Daniela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Petrone, Luciana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Baldut, Mariela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Bonafede, Silvina Laura. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Segall, Adriana Ines. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
description In this work, the dissolution profiles of nine meloxicam tablet brands marketed in Argentina have been evaluated. As meloxicam is a Class 2 Biopharmaceutical Classification System (BSC) drug, interchangeability between commercial products must be demonstrated through in vivo bioequivalence studies. However, in our country, such studies remain to be performed. Dissolution studies have been performed according to USP 38 and evaluated by fitting experimental data to the zero and first-order, the Hixson-Crowell, the Higuchi, and the Weibull model-dependent methods. To test the pertinence of these release models, the Akaike Information Criteria (AIC) were used. All brands satisfied the dissolution profiles (phosphate buffer, pH 7.5) established in the USP. The comparison between the dissolution profiles was carried out by model-dependent and model-independent methods. The Weibull model provided the best kinetic curve adjustment. Brands I, II, IV and VI had the best fitting, with the maximum determination coefficient and the smallest AIC values. Model-independent methods included ratio test and the fit factors. The Dissolution Efficiency (DE) and Mean Dissolution Time (MDT) were analysed with ANOVA and the DGC method. In both cases, brand I did not show similarity with the rest of the brands. Using fit factors, only brands I, II and V were similar to each other. Significant differences were found among the in vitro dissolution profiles of meloxicam tablets belonging to the nine brands. As meloxicam is a class 2 BCS drug, interchangeability between commercial products must be demonstrated through in vivo bioequivalence studies. However, in Argentina, such studies remain to be performed. Our results demonstrate that caution must be exercised as regards interchangeability of generic products.
publishDate 2018
dc.date.none.fl_str_mv 2018-05
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/11336/99367
Simionato, Laura Daniela; Petrone, Luciana; Baldut, Mariela; Bonafede, Silvina Laura; Segall, Adriana Ines; Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina; Elsevier; Saudi Pharmaceutical Journal; 26; 4; 5-2018; 578-584
1319-0164
CONICET Digital
CONICET
url http://hdl.handle.net/11336/99367
identifier_str_mv Simionato, Laura Daniela; Petrone, Luciana; Baldut, Mariela; Bonafede, Silvina Laura; Segall, Adriana Ines; Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina; Elsevier; Saudi Pharmaceutical Journal; 26; 4; 5-2018; 578-584
1319-0164
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1016/j.jsps.2018.01.015
info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S1319016418300227
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
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 13.13397

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