Dynamic Calibration for the In-Line NIR Monitoring of Film Thickness of Pharmaceutical Tablets Processed in a Fluid-Bed Coater

Lee, Min-Jeong; Park, Cho-Rong; Kim, Ah-Young; Kwon, Byung-Soo; Bang, Kyu-Ho; Cho, Young-Sang; Jeong, Myung-Yung; Choi, Guang-Jin

doi:10.1002/jps.21795

Cited by 35 publications

(15 citation statements)

References 19 publications

(22 reference statements)

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“…Pre-processing of spectral data allows for spectral correction by increasing the signal and minimizing undesired information including baseline drifts, scatter variation, path-length variation, and background noise. The most common pretreatment techniques (Table 1) used in pharmaceutical data processing include multiplicative scatter correction (MSC) (Virtanen et al, 2008;Lee et al, 2009;Cairos et al, 2009;Puchert et al 2010;Neves et al, 2010), standard normal variate (SNV) (Virtanen et al, 2008;Cairos et al, 2009;Cruz et al, 2011), and Savitzky-Golay filtering (Virtanen Palou et al (2012) et al , 2008;Cairos et al, 2009;Puchert et al, 2010;Gendre et al, 2011;Corredor et al, 2011;Cruz et al, 2011;Neves et al, 2012). Briefly, the purpose of MSC is to correct the scatter level of the spectra by elimination of the spectral difference of the data (Puchert et al, 2010).…”

Section: Mathematical Pretreatmentsmentioning

confidence: 99%

“…It was found that the Raman spectral data were correlated with the average weight gain of tablets during coating process. Lee et al (2009) developed an in-line FT-NIR monitoring system (714-2500 nm) for film coating measurements. The fiber optic diffuse reflectance probe of this system was mounted onto the FB vessel, for real-time spectral acquisition of tablet samples.…”

Section: Coating Processmentioning

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: Mathematical Pretreatmentsmentioning

confidence: 99%

Section: Coating Processmentioning

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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“…When NIR spectra were selected and analyzed for each time point, a dynamic calibration technique was applied to determine the optimal number of data points to take into account. 25 The detailed procedure is not provided here. In this study, the best correlation was achieved when nine spectra were chosen from the complete set of in-line NIR spectra.…”

Section: Basic Analysis and Characterizationmentioning

confidence: 99%

Quantitative In-Line Monitoring of Solvent-Mediated Polymorphic Transformation of Sulfamerazine by Near-Infrared Spectroscopy

Lee

Seo

Wang

et al. 2012

Journal of Pharmaceutical Sciences

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“…Several studies investigated process analytical technology (PAT) applications for the monitoring of coating processes. Most techniques directly rely on the detection of the coating material, including near-infrared spectroscopy (NIRS) (6)(7)(8)(9), Raman spectroscopy (10)(11)(12), and Terahertz pulsed imaging (13). In a series of papers, we recently reported the use of optical coherence tomography (OCT) as a powerful method for in-line measurement of coating thickness and variability (14)(15)(16).…”

Section: Introductionmentioning

confidence: 99%

Monitoring of a Hot Melt Coating Process via a Novel Multipoint Near-Infrared Spectrometer

et al. 2016

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Abstract. The aim of the present work was to develop a PAT strategy for the supervision of hot melt coating processes. Optical fibers were placed at various positions in the process chamber of a fluid bed device. Experiments were performed to determine the most suitable position for in-line process monitoring, taking into account such requirements as a good signal to noise ratio, the mitigation of dead zones, the ability to monitor the product over the entire process, and reproducibility. The experimental evidence suggested that the position at medium fluid bed height, looking towards the center, i.e., normal to particle movement, proved to be the most reliable position. In this study, the advantages of multipoint monitoring are shown, and an in-line-implementation was created. This enabled the real-time supervision of the process, including the fast detection of inhomogeneities and disturbances in the process chamber, and the compensation of sensor malfunction. In addition, a model for estimating the particle size distribution via NIR was successfully created. This ensures that the quality of the product and the endpoint of the coating process can be determined correctly.

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Dynamic Calibration for the In-Line NIR Monitoring of Film Thickness of Pharmaceutical Tablets Processed in a Fluid-Bed Coater

Cited by 35 publications

References 19 publications

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

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

Quantitative In-Line Monitoring of Solvent-Mediated Polymorphic Transformation of Sulfamerazine by Near-Infrared Spectroscopy

Monitoring of a Hot Melt Coating Process via a Novel Multipoint Near-Infrared Spectrometer

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