Monitoring the polymorphic transformation on the surface of carbamazepine tablets generated by heating using near-infrared chemical imaging and chemometric methodologies

Terra, Luciana A.; Poppi, Ronei J.

doi:10.1016/j.chemolab.2013.10.009

Cited by 21 publications

(15 citation statements)

References 19 publications

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“…NIR spectroscopic imaging combined with matrixaugmented MCR analysis was shown to be a suitable method for quantifying the concentrations of two carbamazepine polymorphs, forms I and III, on tablet surfaces and for monitoring the thermally induced form III → I conversion by recording concentration distribution maps at different time intervals [126]. Using the 7800 -5400 cm -1 spectral range that encompasses the first overtones of C-H stretching vibrations and the double-first overtones of the symmetric and asymmetric NH2 stretching vibrations, a calibration model with errors of < 5 % was obtained.…”

Section: Polymorphic Transformationsmentioning

confidence: 99%

Application of Vibrational Spectroscopy to Study Solid-state Transformations of Pharmaceuticals

Erxleben

2016

CPD

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Understanding the properties, stability and transformations of the solid-state forms of an active pharmaceutical ingredient (API) in the development pipeline is of crucial importance for process-development, formulation development and FDA approval. Investigation of the polymorphism and polymorphic stability is a routine part of the preformulation studies. Vibrational spectroscopy allows the real-time in situ monitoring of phase transformations and probes intermolecular interactions between API molecules, between API and polymer in amorphous solid dispersions or between API and coformer in cocrystals or coamorphous systems and thus plays a major role in efforts to gain a predictive understanding of the relative stability of solid-state forms and formulations. Infrared (IR), near-infrared (NIR) and Raman spectroscopies, alone or in combination with other analytical methods, are important tools for studying transformations between different crystalline forms, between the crystalline and amorphous form, between hydrate and anhydrous form and for investigating solid-state cocrystal formation. The development of simple-to-use and cost-effective instruments on the one hand and recent technological advances such as access to the low-frequency Raman range down to 5 cm-1, on the other, have led to an exponential growth of the literature in the field. This review discusses the application of IR, NIR and Raman spectroscopies in the study of solid-state transformations with a focus on the literature published over the last eight years.

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Section: Polymorphic Transformationsmentioning

confidence: 99%

Application of Vibrational Spectroscopy to Study Solid-state Transformations of Pharmaceuticals

Erxleben

2016

CPD

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“…Some multivariate methods, without the need for any prior information, have drawn much interesting and have developed rapidly. Multivariate curve resolution (MCR) is the most frequently used because it can not only acquire spatial information but can also interpret chemical images . NIR‐CI in combination with MCR were utilized to rapidly identify low API (about 1%, w / w ) in commercial Lorazepam tablets .…”

Section: Nir‐ci Applications To the Western Solid Dosage Formsmentioning

confidence: 99%

“…Multivariate curve resolution (MCR) is the most frequently used because it can not only acquire spatial information but can also interpret chemical images. [64] NIR-CI in combination with MCR were utilized to rapidly identify low API (about 1%, w/w) in commercial Lorazepam tablets. [12] In addition, MCR and parallel factor analysis (PARAFAC) models were utlized to obtain spatial distribution information about the polymorphic transformation of carbamazepine tablets in the dynamic process and MCR was found to be more reliable and accurate.…”

Section: Identification Of Componentsmentioning

confidence: 99%

“…[12] In addition, MCR and parallel factor analysis (PARAFAC) models were utlized to obtain spatial distribution information about the polymorphic transformation of carbamazepine tablets in the dynamic process and MCR was found to be more reliable and accurate. [64] NIR-CI has been used to successfully identify solid dosage forms and to assess its quality through blister packaging. Qualified and damp Aspirin tablets were rapidly discriminated through blister packs.…”

Section: Identification Of Componentsmentioning

confidence: 99%

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PAT: From Western solid dosage forms to Chinese materia medica preparations using NIR‐CI

Zhou

et al. 2015

Drug Testing and Analysis

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Near-infrared chemical imaging (NIR-CI) is an emerging technology that combines traditional near-infrared spectroscopy with chemical imaging. Therefore, NIR-CI can extract spectral information from pharmaceutical products and simultaneously visualize the spatial distribution of chemical components. The rapid and non-destructive features of NIR-CI make it an attractive process analytical technology (PAT) for identifying and monitoring critical control parameters during the pharmaceutical manufacturing process. This review mainly focuses on the pharmaceutical applications of NIR-CI in each unit operation during the manufacturing processes, from the Western solid dosage forms to the Chinese materia medica preparations. Finally, future applications of chemical imaging in the pharmaceutical industry are discussed.

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“…By using near-infrared spectroscopy as a spectroscopic method, measurements of samples can be performed accurately, non-destructively and rapidly. Hyperspectral imaging has been applied to prediction of protein and fat content in cheeses (Burger and Geladi, 2006), estimation of fruit yield in citrus (Ye et al, 2006), mapping piroxicam polymorphs (Rocha et al, 2011), assessment of regional leaf area index (Canisius and Fernandes, 2012), food authentication (Ottavian et al, 2012), discrimination between polylactic acid and polyethylene terephthalate (Ulrici et al, 2013) and monitoring of polymorphic transformation (Terra and Poppi, 2014). Pre-treatment (Esquerre et al, 2012) and spatial resolution (Offroy et al, 2012) have been discussed as well.…”

Section: Introductionmentioning

confidence: 98%

Classification of drug tablets using hyperspectral imaging and wavelength selection with a GAWLS method modified for classification

Kaneko

Funatsu

2015

International Journal of Pharmaceutics

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Right drug tablets must be brought to the right places. We apply hyperspectral imaging, which can measure infrared spectra at many points on a two-dimensional plane, to classify tablets correctly. The k-nearest neighbor algorithm (kNN) is employed to classify tablets using a database including their spectra and true classes. Although classification accuracy is not 100%, we can correctly classify tablets overall, since spectra at many points are measured with spectroscopy and misclassification at some points does not have much influence on the final tablet classification result. In addition, we propose a wavelength selection method for classification. Genetic algorithm-based wavelength selection is applied to classification and combined with kNN, and thus, not wavelengths but wavelength-regions can be selected in classification problems. Through a case study, we confirmed that the proposed method could classify three kinds of tablets correctly and select appropriate wavelength-regions.

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Monitoring the polymorphic transformation on the surface of carbamazepine tablets generated by heating using near-infrared chemical imaging and chemometric methodologies

Cited by 21 publications

References 19 publications

Application of Vibrational Spectroscopy to Study Solid-state Transformations of Pharmaceuticals

Application of Vibrational Spectroscopy to Study Solid-state Transformations of Pharmaceuticals

PAT: From Western solid dosage forms to Chinese materia medica preparations using NIR‐CI

Classification of drug tablets using hyperspectral imaging and wavelength selection with a GAWLS method modified for classification

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