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dc.contributor.author
Ruiz, María Esperanza  
dc.contributor.author
Volonté, Maria Guillermina  
dc.date.available
2015-11-24T20:11:51Z  
dc.date.issued
2014-02  
dc.identifier.citation
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; 32-42  
dc.identifier.issn
1521-298X  
dc.identifier.uri
http://hdl.handle.net/11336/2916  
dc.description.abstract
The aim of the present study was to analyze comparatively the performance of the main methods proposed for the comparison of percent dissolved vs. time curves, and to propose a more biorrelevant 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. When 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 proved to be the model independent ones, and among them the best correlations were found for 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.  
dc.format
application/pdf  
dc.language.iso
eng  
dc.publisher
Dissolution Technologies, Inc  
dc.rights
info:eu-repo/semantics/openAccess  
dc.rights
Atribución-NoComercial-CompartirIgual 2.5 Argentina (CC BY-NC-SA 2.5 AR)  
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/  
dc.subject
Dissolution Profiles  
dc.subject
Comparison Methods  
dc.subject
F2 Factor  
dc.subject
Biorelevance  
dc.subject.classification
Otras Ciencias de la Salud  
dc.subject.classification
Ciencias de la Salud  
dc.subject.classification
CIENCIAS MÉDICAS Y DE LA SALUD  
dc.title
Biopharmaceutical relevance of the comparison of dissolution profiles: proposal of a combined approach  
dc.type
info:eu-repo/semantics/article  
dc.type
info:ar-repo/semantics/artículo  
dc.type
info:eu-repo/semantics/publishedVersion  
dc.date.updated
2016-03-30 10:35:44.97925-03  
dc.journal.volume
21  
dc.journal.number
1  
dc.journal.pagination
32-42  
dc.journal.pais
Usa  
dc.journal.ciudad
Hockessin  
dc.description.fil
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  
dc.description.fil
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  
dc.journal.title
Dissolution Technologies  
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/10.14227/DT210114P32  
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.14227/DT210114P32  
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/http://www.dissolutiontech.com/DTresour/BackIssuefldr/DT201402_A04.pdf