Characterization of Pharmaceutical Powder Blends by NIR Chemical Imaging

Ma, Hua; Anderson, Carl A.

doi:10.1002/jps.21230

Cited by 80 publications

(44 citation statements)

References 34 publications

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“…The chemical images generated from the PLS model gave a good indication about the homogeneity of the coating. NIR-CI was also able to characterize the blending process of pharmaceutical powder samples (Ma et al, 2007). In this study, the powder sample was formed by mixing acetaminophen (the API), MCC, and lactose monohydrate in a mini-blender, and the spectral data from different blends were collected by NIR spectroscopy (1400-1675 nm).…”

Section: Api and Excipient Identificationmentioning

confidence: 99%

“…The collected data contribute to qualitative and quantitative information (also known as chemical imaging, CI) about pharmaceutical tablets, enabling the collection of high fidelity, spatially resolved pictures of the chemistry of the sample. A variety of NIR chemical imaging (NIR-CI) applications are documented in the pharmaceutical field, including the study of homogeneity of powder samples (Ma et al, 2007), particle size determination (Li et al, 2008), determination of concentrations, and distribution of components in solid tablets and content uniformity (Cruz et al, 2011). NIR hyperspectral CI is the most widely used qualitative analysis method that provides information about the chemical distribution in the drug samples, such as the API and excipient ingredients (Palou et al, 2012).…”

Section: Introductionmentioning

confidence: 99%

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Spectroscopic Techniques for Nondestructive Quality Inspection of Pharmaceutical Products: A Review

Kandpal

Park

Tewari

et al. 2015

Journal of Biosystems Engineering

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Spectroscopy is an emerging technology for the quality assessment of pharmaceutical samples, from tablet manufacturing to final quality assurance. The traditional methods for the quality management of pharmaceutical tablets are time consuming and destructive, while spectroscopic techniques allow rapid analysis in a non-destructive manner. The advantage of spectroscopy is that it collects both spatial and spectral information (called hyperspectral imaging), which is useful for the chemical imaging of pharmaceutical samples. These chemical images provide both qualitative and quantitative information on tablet samples. In the pharmaceutics, spectroscopic techniques are used for a variety of applications, such as analysis of the homogeneity of powder samples as well as determination of particle size, product composition, and the concentration, uniformity, and distribution of the active pharmaceutical ingredient in solid tablets. This review paper presents an introduction to the applications of various spectroscopic techniques such as hyperspectroscopy and vibrational spectroscopies (Raman spectroscopy, FT-NIR, and IR spectroscopy) for the quality and safety assessment of pharmaceutical solid dosage forms. In addition, various chemometric techniques that are highly essential for analyzing the spectroscopic data of pharmaceutical samples are also reviewed.

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Section: Api and Excipient Identificationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Spectroscopic Techniques for Nondestructive Quality Inspection of Pharmaceutical Products: A Review

Kandpal

Park

Tewari

et al. 2015

Journal of Biosystems Engineering

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“…The applications of NIR-CI include the assessment of homogeneity of mixture during the blending process, [4][5][6][7] the visualization of spatial distribution of components in intermediate and¯nal product, 8,9 the discrimination of counterfeit pharmaceutical products, [10][11][12] etc. More pharmaceutical applications of NIR-CI technique can refer to previous reviews.…”

Section: Introductionmentioning

confidence: 99%

Near-infrared chemical imaging for quantitative analysis of chlorpheniramine maleate and distribution homogeneity assessment in pharmaceutical formulations

Zhou

Zhang

et al. 2016

J. Innov. Opt. Health Sci.

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Near infrared chemical imaging (NIR-CI) combines conventional near infrared (NIR) spectroscopy with chemical imaging, thus provides spectral and spatial information simultaneously. It could be utilized to visualize the spatial distribution of the ingredients in a sample. The data acquired using NIR-CI instrument are hyperspectral data cube (hypercube) containing thousands of spectra. Chemometric methodologies are necessary to transform spectral information into chemical information. Partial least squares (PLS) method was performed to extract chemical information of chlorpheniramine maleate in pharmaceutical formulations. A series of samples which consisted of di®erent CPM concentrations (w/w) were compressed and hypercube data were measured. The spectra extracted from the hypercube were used to establish the PLS model of CPM. The results of the model were R 2 val 0.981, RMSEC 0.384%, RMSECV 0.483%, RMSEP 0.631%, indicating that this model was reliable.

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“…The principal multivariate method used to analyze NIR imaging data is the principal component analysis (PCA), however, PCA cannot be directly used as a prediction method for concentraion. 14,15,[24][25][26][27][28][29][30][31] Other multivariate method is the classical least squares regression (CLS). 18,22,32 CLS only requires the pure compound spectrum of each constituent in the sample in order to find their concentration by multivariate regression, but it does not work well if there are high noise levels and a high number of compounds in the sample.…”

Section: Introductionmentioning

confidence: 99%

“…32,36,37 For quantification, most of works present PLS models built using pure spectra and do not take into account possible spectral changes due to interactions of the compounds. 14,15,19,26,[38][39][40][41] PLS is employed in few works to quantify compounds by NIR imaging using a calibration set, 18,[42][43][44] and none of them presented interval PLS (iPLS) to calculate concentration maps (chemical images) in tablets.…”

Section: Introductionmentioning

confidence: 99%

A quantitative method using near infrared imaging spectroscopy for determination of surface composition of tablet dosage forms: an example of spirolactone tablets

Carneiro¹,

Poppi²

2012

J. Braz. Chem. Soc.

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Neste trabalho, a espectroscopia de imagens no infravermelho próximo (NIR) foi empregada no estudo da distribuição do princípio ativo (API) espironolactona e seus excipientes em comprimidos. As análises foram realizadas utilizando resolução espacial de 50 µm, analisando 16 mm 2 de cada comprimido padrão. Modelos de mínimos quadrados parciais por intervalo (iPLS) foram utilizados para quantificação dos excipientes e API em cada pixel afim de obter mapas de concentração para cada composto. Foram obtidos erros de quantificação entre 0,49 e 1,26% quando realizada a validação cruzada utilizando a média espectral de cada comprimido. Esses modelos de calibração foram utilizados para prever a concentração individual de cada componente em cada pixel. A concentração média de todos os pixels, para cada composto, produziu erros entre 0,05 e 1,06%. Estes resultados indicaram que os modelos estavam aptos a quantificar todos os compostos em cada pixel, individualmente. Esta aproximação necessita ser realizada uma vez que não é possível conhecer a composição real em cada pixel.In this work, near infrared (NIR) imaging spectroscopy was employed in the study of the distribution of the active pharmaceutical ingredient (API) spironolactone and its excipients in tablets. Analyses were performed using 50 µm spatial resolution to analyze 16 mm 2 of each standard tablet. Interval partial least squares models were used for API and excipients quantification in every pixel in order to obtain concentration maps for each compound. It was obtained errors of quantification between 0.49 and 1.26% when performed the cross-validation using spectral average of each tablet. These calibration models were used to predict individual concentration of each compound in the tablet, in every pixel. The average concentration of all pixels, for each compound yield errors, was between 0.05 and 1.06%. These results indicate that the models were able to quantify all compounds in each pixel. This approach is necessary since it is not possible to know the real concentration of each compound in the pixels.

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Characterization of Pharmaceutical Powder Blends by NIR Chemical Imaging

Cited by 80 publications

References 34 publications

Spectroscopic Techniques for Nondestructive Quality Inspection of Pharmaceutical Products: A Review

Spectroscopic Techniques for Nondestructive Quality Inspection of Pharmaceutical Products: A Review

Near-infrared chemical imaging for quantitative analysis of chlorpheniramine maleate and distribution homogeneity assessment in pharmaceutical formulations

A quantitative method using near infrared imaging spectroscopy for determination of surface composition of tablet dosage forms: an example of spirolactone tablets

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