Quality by Design, Part III: Study of Curing Process of Sustained Release Coated Products using NIR Spectroscopy

Tabasi, Simin Hassannejad; Fahmy, Raafat; Bensley, Dennis; O'Brien, Charles; Hoag, Stephen W.

doi:10.1002/jps.21420

Cited by 25 publications

(8 citation statements)

References 15 publications

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“…Near‐infrared spectroscopy is another analytical technique gaining popularity for analyzing excipient variability and functionality . Gabrielsson et al used NIR to quantify the amount of lot‐to‐lot variability and its impact on the performance of a new drug product.…”

Section: Excipient Variability Analysismentioning

confidence: 99%

Excipient Variability and Its Impact on Dosage Form Functionality

Dave

Saoji

Raut

et al. 2015

Journal of Pharmaceutical Sciences

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Section: Excipient Variability Analysismentioning

confidence: 99%

Excipient Variability and Its Impact on Dosage Form Functionality

Dave

Saoji

Raut

et al. 2015

Journal of Pharmaceutical Sciences

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“…tablets or capsules) are released from the product, dissolve within the gastrointestinal (GI) tract fluid and are absorbed by the blood stream to reach their desired target (Palmieri et al, 2007). The rate of drug dissolution is strongly dependent on numerous factors namely API type, excipient type, coating, hardness, instrumentation, and media buffer (Tabasi et al, 2008;Nissankararao et al, 2013). Hence, verification of the drug quality with a dissolution test is crucial for quality and safety concerns.…”

Section: Drug Dissolutionmentioning

confidence: 99%

“…The ability to predict the drug dissolution profile has been evaluated in several studies (Donoso et al, 2004;Otsuka et al, 2007;Tabasi et al, 2008Tabasi et al, , 2009). Some of the recent studies are presented here.…”

Section: Drug Dissolutionmentioning

confidence: 99%

“…The results demonstrated a good correlation coefficient value of 0.98 with root mean square error of prediction (RMSEP) of 8.63% for the prediction of the rifampicin component, while the prediction accuracy of the other three components was lower. Tabasi et al (2008) predicted the drug release for theophylline tablets at different time periods (2,4,8,24, and 48 h) by using NIR spectroscopy, with a curing temperature of 40°C. The obtained   values were 0.90 and 0.96 for calibration and validation sets with standard error (SE) of 1.12 % and 0.94%, respectively.…”

Section: Drug Dissolutionmentioning

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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“…Nevertheless, some noticeable batch‐to‐batch variation was observed. The film thickness of Eudragit coating on orbifloxacin formulation tablets was monitored by NIRS 17–19. Coated tablet samples were gathered and divided for three separate actions; calibration, validation and prediction.…”

Section: Introductionmentioning

confidence: 99%