Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approach

Autores
Ruiz, María Esperanza; Volonté, Maria Guillermina
Año de publicación
2014
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
The aims of the present study were to evaluate the performance of the main methods proposed for the comparison of percentage dissolved versus time curves and to recommend a more biorelevant combined approach for the comparison of dissolution profiles of multisource drug products. In vitro dissolution tests of four brands of oxcarbazepine (OxCBZ) tablets were performed, and the resulting profiles were compared by model-independent, model-dependent, and ANOVA-based statistical methods. After a careful analysis of the results, some methods were chosen and applied to the comparison of dissolution profiles of four brands of carbamazepine (CBZ) tablets and two brands of phenytoin (PHT) capsules. Finally, these in vitro results were qualitatively correlated with the corresponding in vivo results previously obtained with the same CBZ and PHT products assayed in healthy volunteers. The analysis of the dissolution data obtained with OxCBZ tablets allowed discarding the ANOVA-based statistical methods since in all cases they were over-discriminating from a biopharmaceutical point of view. The remaining comparison methods were applied to in vitro profiles of CBZ and PHT products and the results correlated with in vivo data. The most suitable methods for the biopharmaceutical comparison of in vitro dissolution profiles were the model-independent ones, and among them, the best correlations were the f2 similarity factor along with a measure of the dissolution extent (e.g., area under the curve). This combined approach gives a robust and informative result with the most biopharmaceutical relevance.
Fil: Ruiz, María Esperanza. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico La Plata. Centro de Investigación y Desarrollo en Ciencias Aplicadas; Argentina
Fil: Volonté, Maria Guillermina. Universidad Nacional de la Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Catedra de Control de Calidad de Medicamentos; Argentina
Materia
BIOPHARMACEUTICAL
DISSOLUTION PROFILE
DISSOLUTION RATE
IN VITRO-IN VIVO CORRELATION
SIMILARITY FACTOR
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:11336/2916
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/2916
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approachRuiz, María EsperanzaVolonté, Maria GuillerminaBIOPHARMACEUTICALDISSOLUTION PROFILEDISSOLUTION RATEIN VITRO-IN VIVO CORRELATIONSIMILARITY FACTORhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3The aims of the present study were to evaluate the performance of the main methods proposed for the comparison of percentage dissolved versus time curves and to recommend a more biorelevant combined approach for the comparison of dissolution profiles of multisource drug products. In vitro dissolution tests of four brands of oxcarbazepine (OxCBZ) tablets were performed, and the resulting profiles were compared by model-independent, model-dependent, and ANOVA-based statistical methods. After a careful analysis of the results, some methods were chosen and applied to the comparison of dissolution profiles of four brands of carbamazepine (CBZ) tablets and two brands of phenytoin (PHT) capsules. Finally, these in vitro results were qualitatively correlated with the corresponding in vivo results previously obtained with the same CBZ and PHT products assayed in healthy volunteers. The analysis of the dissolution data obtained with OxCBZ tablets allowed discarding the ANOVA-based statistical methods since in all cases they were over-discriminating from a biopharmaceutical point of view. The remaining comparison methods were applied to in vitro profiles of CBZ and PHT products and the results correlated with in vivo data. The most suitable methods for the biopharmaceutical comparison of in vitro dissolution profiles were the model-independent ones, and among them, the best correlations were the f2 similarity factor along with a measure of the dissolution extent (e.g., area under the curve). This combined approach gives a robust and informative result with the most biopharmaceutical relevance.Fil: Ruiz, María Esperanza. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico La Plata. Centro de Investigación y Desarrollo en Ciencias Aplicadas; ArgentinaFil: Volonté, Maria Guillermina. Universidad Nacional de la Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Catedra de Control de Calidad de Medicamentos; ArgentinaDissolution Technologies, Inc2014-02info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/2916Ruiz, María Esperanza; Volonté, Maria Guillermina; Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approach; Dissolution Technologies, Inc; Dissolution Technologies; 21; 1; 2-2014; 32-431521-298Xenginfo:eu-repo/semantics/altIdentifier/doi/10.14227/DT210114P32info:eu-repo/semantics/altIdentifier/url/http://www.dissolutiontech.com/DTresour/BackIssuefldr/DT201402_A04.pdfinfo:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-15T15:19:44Zoai:ri.conicet.gov.ar:11336/2916instacron: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:34982025-10-15 15:19:45.276CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approach
title Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approach
spellingShingle Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approach
Ruiz, María Esperanza
BIOPHARMACEUTICAL
DISSOLUTION PROFILE
DISSOLUTION RATE
IN VITRO-IN VIVO CORRELATION
SIMILARITY FACTOR
title_short Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approach
title_full Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approach
title_fullStr Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approach
title_full_unstemmed Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approach
title_sort Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approach
dc.creator.none.fl_str_mv Ruiz, María Esperanza
Volonté, Maria Guillermina
author Ruiz, María Esperanza
author_facet Ruiz, María Esperanza
Volonté, Maria Guillermina
author_role author
author2 Volonté, Maria Guillermina
author2_role author
dc.subject.none.fl_str_mv BIOPHARMACEUTICAL
DISSOLUTION PROFILE
DISSOLUTION RATE
IN VITRO-IN VIVO CORRELATION
SIMILARITY FACTOR
topic BIOPHARMACEUTICAL
DISSOLUTION PROFILE
DISSOLUTION RATE
IN VITRO-IN VIVO CORRELATION
SIMILARITY FACTOR
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv The aims of the present study were to evaluate the performance of the main methods proposed for the comparison of percentage dissolved versus time curves and to recommend a more biorelevant combined approach for the comparison of dissolution profiles of multisource drug products. In vitro dissolution tests of four brands of oxcarbazepine (OxCBZ) tablets were performed, and the resulting profiles were compared by model-independent, model-dependent, and ANOVA-based statistical methods. After a careful analysis of the results, some methods were chosen and applied to the comparison of dissolution profiles of four brands of carbamazepine (CBZ) tablets and two brands of phenytoin (PHT) capsules. Finally, these in vitro results were qualitatively correlated with the corresponding in vivo results previously obtained with the same CBZ and PHT products assayed in healthy volunteers. The analysis of the dissolution data obtained with OxCBZ tablets allowed discarding the ANOVA-based statistical methods since in all cases they were over-discriminating from a biopharmaceutical point of view. The remaining comparison methods were applied to in vitro profiles of CBZ and PHT products and the results correlated with in vivo data. The most suitable methods for the biopharmaceutical comparison of in vitro dissolution profiles were the model-independent ones, and among them, the best correlations were the f2 similarity factor along with a measure of the dissolution extent (e.g., area under the curve). This combined approach gives a robust and informative result with the most biopharmaceutical relevance.
Fil: Ruiz, María Esperanza. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico La Plata. Centro de Investigación y Desarrollo en Ciencias Aplicadas; Argentina
Fil: Volonté, Maria Guillermina. Universidad Nacional de la Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Catedra de Control de Calidad de Medicamentos; Argentina
description The aims of the present study were to evaluate the performance of the main methods proposed for the comparison of percentage dissolved versus time curves and to recommend a more biorelevant combined approach for the comparison of dissolution profiles of multisource drug products. In vitro dissolution tests of four brands of oxcarbazepine (OxCBZ) tablets were performed, and the resulting profiles were compared by model-independent, model-dependent, and ANOVA-based statistical methods. After a careful analysis of the results, some methods were chosen and applied to the comparison of dissolution profiles of four brands of carbamazepine (CBZ) tablets and two brands of phenytoin (PHT) capsules. Finally, these in vitro results were qualitatively correlated with the corresponding in vivo results previously obtained with the same CBZ and PHT products assayed in healthy volunteers. The analysis of the dissolution data obtained with OxCBZ tablets allowed discarding the ANOVA-based statistical methods since in all cases they were over-discriminating from a biopharmaceutical point of view. The remaining comparison methods were applied to in vitro profiles of CBZ and PHT products and the results correlated with in vivo data. The most suitable methods for the biopharmaceutical comparison of in vitro dissolution profiles were the model-independent ones, and among them, the best correlations were the f2 similarity factor along with a measure of the dissolution extent (e.g., area under the curve). This combined approach gives a robust and informative result with the most biopharmaceutical relevance.
publishDate 2014
dc.date.none.fl_str_mv 2014-02
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/11336/2916
Ruiz, María Esperanza; Volonté, Maria Guillermina; Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approach; Dissolution Technologies, Inc; Dissolution Technologies; 21; 1; 2-2014; 32-43
1521-298X
url http://hdl.handle.net/11336/2916
identifier_str_mv Ruiz, María Esperanza; Volonté, Maria Guillermina; Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approach; Dissolution Technologies, Inc; Dissolution Technologies; 21; 1; 2-2014; 32-43
1521-298X
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.14227/DT210114P32
info:eu-repo/semantics/altIdentifier/url/http://www.dissolutiontech.com/DTresour/BackIssuefldr/DT201402_A04.pdf
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_ 1846083346584567808
score 13.22299

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