Biopharmaceutical relevance of dissolution profile comparison: Proposal of a combined approach

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 dissolutio...

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Detalles Bibliográficos
Autores principales:	Ruiz, María Esperanza, Volonté, María Guillermina
Formato:	Articulo
Lenguaje:	Inglés
Publicado:	2014
Materias:	Química Biopharmaceutical Dissolution profile Dissolution rate In vitro-in vivo correlation Similarity factor
Acceso en línea:	http://sedici.unlp.edu.ar/handle/10915/85198
Aporte de:	SEDICI (UNLP) de Universidad Nacional de La Plata

id	I19-R120-10915-85198
record_format	dspace
institution	Universidad Nacional de La Plata
institution_str	I-19
repository_str	R-120
collection	SEDICI (UNLP)
language	Inglés
topic	Química Biopharmaceutical Dissolution profile Dissolution rate In vitro-in vivo correlation Similarity factor
spellingShingle	Química Biopharmaceutical Dissolution profile Dissolution rate In vitro-in vivo correlation Similarity factor Ruiz, María Esperanza Volonté, María Guillermina Biopharmaceutical relevance of dissolution profile comparison: Proposal of a combined approach
topic_facet	Química Biopharmaceutical Dissolution profile Dissolution rate In vitro-in vivo correlation Similarity factor
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.
format	Articulo Articulo
author	Ruiz, María Esperanza Volonté, María Guillermina
author_facet	Ruiz, María Esperanza Volonté, María Guillermina
author_sort	Ruiz, María Esperanza
title	Biopharmaceutical relevance of dissolution profile comparison: Proposal of a combined approach
title_short	Biopharmaceutical relevance of dissolution profile comparison: Proposal of a combined approach
title_full	Biopharmaceutical relevance of dissolution profile comparison: Proposal of a combined approach
title_fullStr	Biopharmaceutical relevance of dissolution profile comparison: Proposal of a combined approach
title_full_unstemmed	Biopharmaceutical relevance of dissolution profile comparison: Proposal of a combined approach
title_sort	biopharmaceutical relevance of dissolution profile comparison: proposal of a combined approach
publishDate	2014
url	http://sedici.unlp.edu.ar/handle/10915/85198
work_keys_str_mv	AT ruizmariaesperanza biopharmaceuticalrelevanceofdissolutionprofilecomparisonproposalofacombinedapproach AT volontemariaguillermina biopharmaceuticalrelevanceofdissolutionprofilecomparisonproposalofacombinedapproach
bdutipo_str	Repositorios
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Biopharmaceutical relevance of dissolution profile comparison: Proposal of a combined approach

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