Real-time predictions of drug release and end point detection of a coating operation by in-line near infrared measurements

Gendre, Claire; Boiret, Mathieu; Genty, Muriel; Chaminade, Pierre; Péan, Jean Manuel

doi:10.1016/j.ijpharm.2011.09.036

Cited by 54 publications

(18 citation statements)

References 22 publications

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“…The simplest way to calibrate an in-line method is to acquire real-time spectra through the entire process length along with collecting samples at regular intervals. The response values obtained through reference methods are correlated with the spectral data, considering the process time as a link between the two [38][39][40]. More extensive calibrations also evaluate the effect of sample presentation, changing process, and formulation parameters, to challenge the robustness of the methods.…”

Section: Calibration Strategy For Calibration In-line Monitoring Methodsmentioning

confidence: 99%

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Tomuță¹,

Porfire²,

Casian³

et al. 2018

Calibration and Validation of Analytical Methods - A Sampling of Current Approaches

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Vibrational spectroscopy, namely near infrared (NIR) and Raman spectroscopy, is based on the interaction between the electromagnetic radiation and matter. The technique is sensitive to chemical and physical properties and delivers a wide range of information about the analyzed sample, but in order to extract the information, multivariate calibration of the spectral data is required. The main goal of this work will be to present in detail the available multivariate calibration strategy for development of NIR and Raman spectroscopic methods, which was successfully applied in pharmaceutics.

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Section: Calibration Strategy For Calibration In-line Monitoring Methodsmentioning

confidence: 99%

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Tomuță¹,

Porfire²,

Casian³

et al. 2018

Calibration and Validation of Analytical Methods - A Sampling of Current Approaches

View full text Add to dashboard Cite

show abstract

“…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%

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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“…It has previously been reported that NIR spectroscopy can predict dissolution rate. [29][30][31] Therefore, it is suggested that the measurement of NIR spectra provides a good prediction of the dissolution rate properties of ceftriaxone sodium powders. The loading vector shows which variable is combined by the formation of the coordinate axis of the factor, and which phenomenon is attributed to calibration model.…”

Section: )mentioning

confidence: 99%

Comparison of the Dissolution Rate of Ceftriaxone Sodium Preparations for Injection

Tange

Hattori

Otsuka

et al. 2013

CHEMICAL & PHARMACEUTICAL BULLETIN

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This study aimed to compare the dissolution rate of eight different formulations of ceftriaxone sodium preparation for injection, the original product and seven generic versions. The dissolution time was measured precisely as the point at which the freeze-dried ceftriaxone sodium preparation became a transparent solution on the addition of 0.9% sodium chloride solution. To investigate whether differences in the crystalline structure may explain the differences in dissolution rates, the eight products were subjected to X-ray diffraction (XRD) and differential scanning calorimetry (DSC). Powder surface characteristics were examined, including surface area, amount of water adsorbed, water interactions and morphology. The measurement of near-infrared spectroscopy of powder preparations was conducted, and we predicted dissolution time by partial least squares (PLS). The dissolution time of the eight products were different. There were no differences in XRD and DSC findings between the original and generic products, surface characteristics, i.e., surface area, morphology etc., were different between preparations. On near-infrared (NIR) spectroscopy, a good relationship was demonstrated between the actual and predicted dissolution time for each ceftriaxone preparation. The difference in dissolution time between the eight products was due to differences in powder surface characteristics, such as water interaction and crystal shape. Finally, it was shown that the dissolution rates of the products could be predicted by NIR analysis.Key words dissolution rate; near-infrared spectroscopy; X-ray diffraction; differential scanning calorimetry; generic drug; powder property Dissolution properties are important in the formulation design of pharmaceutical preparations, and improvement in dissolution rate is a critical issue in drug development for nonparenteral preparations. There are a number of mathematical models for dissolution profile.

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Real-time predictions of drug release and end point detection of a coating operation by in-line near infrared measurements

Cited by 54 publications

References 22 publications

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

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

Comparison of the Dissolution Rate of Ceftriaxone Sodium Preparations for Injection

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