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

Structural 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...

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Autores principales: Calvo, Natalia Lorena, Kaufman, Teodoro Saúl, Maggio, Rubén Mariano
Formato: article artículo publishedVersion
Lenguaje:Inglés
Publicado: Elsevier 2018
Materias:
Mebendazole
ATR-FTIR/chemometrics
Crystal Polymorphism
Principal Component Analysis
Form Assignment
Acceso en línea:http://hdl.handle.net/2133/10497
http://hdl.handle.net/2133/10497
Aporte de:
Repositorio Hipermedial de la Universidad Nacional de Rosario (UNR) de Universidad Nacional de Rosario
id I15-R121-2133-10497
record_format dspace
institution Universidad Nacional de Rosario
institution_str I-15
repository_str R-121
collection Repositorio Hipermedial de la Universidad Nacional de Rosario (UNR)
language Inglés
orig_language_str_mv eng
topic Mebendazole
ATR-FTIR/chemometrics
Crystal Polymorphism
Principal Component Analysis
Form Assignment
spellingShingle Mebendazole
ATR-FTIR/chemometrics
Crystal Polymorphism
Principal Component Analysis
Form Assignment
Calvo, Natalia Lorena
Kaufman, Teodoro Saúl
Maggio, Rubén Mariano
Mebendazole crystal forms in tablet formulations : An ATR-FTIR/chemometrics approach to polymorph assignment
topic_facet Mebendazole
ATR-FTIR/chemometrics
Crystal Polymorphism
Principal Component Analysis
Form Assignment
description Structural 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.
format article
artículo
publishedVersion
author Calvo, Natalia Lorena
Kaufman, Teodoro Saúl
Maggio, Rubén Mariano
author_facet Calvo, Natalia Lorena
Kaufman, Teodoro Saúl
Maggio, Rubén Mariano
author_sort Calvo, Natalia Lorena
title Mebendazole crystal forms in tablet formulations : An ATR-FTIR/chemometrics approach to polymorph assignment
title_short Mebendazole crystal forms in tablet formulations : An ATR-FTIR/chemometrics approach to polymorph assignment
title_full Mebendazole crystal forms in tablet formulations : An ATR-FTIR/chemometrics approach to polymorph assignment
title_fullStr Mebendazole crystal forms in tablet formulations : An ATR-FTIR/chemometrics approach to polymorph assignment
title_full_unstemmed Mebendazole crystal forms in tablet formulations : An ATR-FTIR/chemometrics approach to polymorph assignment
title_sort mebendazole crystal forms in tablet formulations : an atr-ftir/chemometrics approach to polymorph assignment
publisher Elsevier
publishDate 2018
url http://hdl.handle.net/2133/10497
http://hdl.handle.net/2133/10497
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AT kaufmanteodorosaul mebendazolecrystalformsintabletformulationsanatrftirchemometricsapproachtopolymorphassignment
AT maggiorubenmariano mebendazolecrystalformsintabletformulationsanatrftirchemometricsapproachtopolymorphassignment
bdutipo_str Repositorios
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