Mebendazole crystal forms in tablet formulations : An ATR-FTIR/chemometrics approach to polymorph assignment

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dc.citation.titleJournal of Pharmaceutical and Biomedical Analysises
dc.citation.volume122es
dc.creatorCalvo, Natalia Lorena
dc.creatorKaufman, Teodoro Saúl
dc.creatorMaggio, Rubén Mariano
dc.date.accessioned2018-02-04T21:00:00Z
dc.date.available2018-02-04T21:00:00Z
dc.date.issued2016-04-15
dc.descriptionStructural polymorphism of active pharmaceutical ingredients (API) is a relevant concern for the modern pharmaceutical industry, since different polymorphic forms may display dissimilar properties, critically affecting the performance of the corresponding drug products. Mebendazole (MEB) is a widely used broad spectrum anthelmintic drug of the benzimidazole class, which exhibits structural polymorphism (Forms A–C). Form C, which displays the best pharmaceutical profile, is the recommended one for clinical use. The polymorphs of MEB were prepared and characterized by spectroscopic, calorimetric and microscopic means. The polymorphs were employed to develop a suitable chemometrics-assisted sample display model based on the first two principal components of their ATR-FTIR spectra in the 4000–600 cm−1 region. The model was internally and externally validated employing the leave-one-out procedure and an external validation set, respectively. Its suitability for revealing the polymorphic identity of MEB in tablets was successfully assessed analyzing commercial tablets under different physical forms (whole, powdered, dried, sieved and aged). It was concluded that the ATR-FTIR/PCA (principal component analysis) association is a fast, efficient and non-destructive technique for assigning the solid-state forms of MEB in its drug products, with minimum sample pre-treatment.es
dc.description.filFil: Calvo, Natalia Lorena. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Departamento de Química Orgánica. Análisis Farmacéutico. Instituto de Química Rosario (IQUIR-CONICET); Argentina.es
dc.description.filFil: Kaufman, Teodoro Saúl. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Departamento de Química Orgánica. Análisis Farmacéutico. Instituto de Química Rosario (IQUIR-CONICET); Argentina.es
dc.description.filFil: Maggio, Rubén Mariano. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Departamento de Química Orgánica. Análisis Farmacéutico. Instituto de Química Rosario (IQUIR-CONICET); Argentina.es
dc.description.sponsorshipSecretaría de Ciencia Tecnología e Innovación (SECTeI)es
dc.description.sponsorshipConsejo Nacional de Investigaciones Científicas y Técnicas (CONICET)es
dc.description.sponsorshipAgencia Nacional de Promoción Científica y Tecnológica (ANPCyT)es
dc.description.sponsorshipUniversidad Nacional de Rosario. Secretaría de Ciencia y Tecnología.es
dc.formatapplication/pdf
dc.format.extent157–165es
dc.identifier.issn0731-7085es
dc.identifier.urihttp://hdl.handle.net/2133/10497
dc.language.isoenges
dc.publisherElsevieres
dc.relation.publisherversionhttps://www.sciencedirect.com/science/article/pii/S0731708516300358?via%3Dihubes
dc.relation.publisherversionhttps://doi.org/10.1016/j.jpba.2016.01.035es
dc.rightsopenAccesses
dc.rights.holderElsevieres
dc.rights.holderUniversidad Nacional de Rosarioes
dc.rights.holderCalvo, Natalia Lorenaes
dc.rights.holderKaufman, Teodoro Saúles
dc.rights.holderMaggio, Rubén Marianoes
dc.rights.textAttribution-NonCommercial-NoDerivs 3.0 Unported (CC BY-NC-ND 3.0)es
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/3.0/*
dc.subjectMebendazolees
dc.subjectATR-FTIR/chemometricses
dc.subjectCrystal Polymorphismes
dc.subjectPrincipal Component Analysises
dc.subjectForm Assignmentes
dc.titleMebendazole crystal forms in tablet formulations : An ATR-FTIR/chemometrics approach to polymorph assignmentes
dc.typearticle
dc.typeartículo
dc.typepublishedVersion
dc.type.collectionarticulo
dc.type.versionpublishedVersiones

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