Continuous monitoring of API content, API distribution and crushing strength after tableting via near-infrared chemical imaging

Wahl, Patrick; Pucher, I.; Scheibelhofer, Otto; Kerschhaggl, M.; Sacher, Stephan; Khinast, Johannes G.

doi:10.1016/j.ijpharm.2016.12.003

Cited by 23 publications

(14 citation statements)

References 30 publications

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“…One PAT tool that is often used to monitor the active pharmaceutical ingredient (API) content is Near-Infrared (NIR) spectroscopy. Examples of this technique have previously been presented for molten blends (Markl et al, 2013;Wahl et al, 2013), for powder blends and tablets (Järvinen et al, 2013), for powder blends (Martínez et al, 2013), for the final blend in the feed frame of a tablet press (De Leersnyder et al, 2018;Ward et al, 2013) and for tablets with NIR chemical imaging (Wahl et al, 2017). When a continuous process is designed using QbD principles, and coupled with PAT tools, the amount of rejected product can be minimized through both increased quality and the ability to reject only a part of a batch in case an unexpected disturbance occurs.…”

Section: Introductionmentioning

confidence: 99%

Measurement of residence time distributions and material tracking on three continuous manufacturing lines

Karttunen

Hörmann

Leersnyder

et al. 2019

International Journal of Pharmaceutics

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Over the recent decade, benefits of continuous manufacturing (CM) of pharmaceutical products have been acknowledged widely. In contrast to batch processes, the product is not physically separated into batches in CM, which creates a few challenges. Product release is done for batches that should have a uniform quality over time, materials need to be tracked along the line, and locations to reject product must be established. To enable these, the residence time distributions (RTDs) of all unit operations must be known. In this paper, three CM tableting lines, each employing a different granulation technique, were investigated. The RTDs of their main unit operations were characterized, utilizing different measurement techniques successfully. All of these RTD measurement techniques could have been performed in any of the lines. The differences were related to the techniques themselves. Overall, external tracer with in-line Near-Infrared detection or color tracer with video recording proved most usable techniques, with few limitations. The RTDs for full lines were calculated by convoluting the unit operation RTDs, which enables material tracking through entire lines. The lines exhibited both truly continuous and quasi-continuous unit operations. Quasi-continuous unit operations divide the material stream into lots that can be utilized for tracking and rejection.

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Section: Introductionmentioning

confidence: 99%

Measurement of residence time distributions and material tracking on three continuous manufacturing lines

Karttunen

Hörmann

Leersnyder

et al. 2019

International Journal of Pharmaceutics

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“…It has been executed in the tablet for API content monitoring in 2017, where the Ulbricht sphere was applied to generate homogeneous illumination. 12…”

Section: System Compositionmentioning

confidence: 99%

“…When accompanied by mobile conveyor or moving stage, it is ideally suitable for inline application. 12,13 While for the poor spatial resolution, staring imaging is favored for wide-¯eld measurements that do not need re¯ned images. 14,15…”

Section: Imaging Principlementioning

confidence: 99%

“…Wahl et al were interested in the suitability of NIR imaging system in tablet manufacturing and built an inline system. 12 They successfully achieved the continuous monitoring of component quantitation, component distribution and crushing strength. The continuous system was built by a°at belt conveyor of tablet transporting and a spectral detector that was located directly over the conveyor at a distance of ca.…”

Section: Tabletingmentioning

confidence: 99%

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Recent advancement of chemical imaging in pharmaceutical quality control: From final product testing to industrial utilization

Liu

2019

J. Innov. Opt. Health Sci.

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Chemical imaging (CI) possesses a strong ability of pharmaceutical analysis. Its great strength relies on the integration of traditional spectroscopy (one dimension) and imaging technique (two dimensions) to generate three-dimensional data hypercubes. Data pre-processing or processing methods are proposed to analyze vast data matrixes and thereby realizing different research objectives. In this review paper, various pharmaceutical applications of quality control over the past few years are summed up in two groups of final product test and industrial utilization. The scope of “quality control” here includes traditional analytical use, process understanding and manufactural control. Finally, two major challenges about undesirable sample geometry and lengthy acquisition time are discussed for prospective commercial or industrial application.

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“…Moreover, research has led to improvements in the development of process control methods using multivariate analysis such as partial least squares (PLS) regression. [20][21][22][23] Khorasani developed an API distribution and content for both roller-compacted ribbons and tablets using NIR imaging combined with in-line PCA and PLS models. 20 The good quantitative result of Mg-stearate and API in a tablet has also been reported by using CLS and MCR-ALS.…”

Section: Introductionmentioning

confidence: 99%

An identification method for defective tablets by distribution analysis of near infrared imaging

Ishikawa

Murayama

Genkawa

et al. 2019

J. Spectral Imaging

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The present study aims to suggest a method to identify defective tablets by near infrared (NIR) imaging. A newly developed portable imaging system (D-NIRs) was used in this study, in which the spectrometer is equipped with a high- density photodiode array detector to record high-quality spectra with 1.25 nm spectral resolution. This system is highly portable and allows an image of a target tablet to be developed in approximately 10 s. Normal tablets containing 0.1–20 % magnesium stearate, ascorbic acid, corn starch and talc were prepared. NIR spectra in the 950–1700 nm region of each pixel in a tablet were measured, and NIR images were generated from the second derivative of the spectra at 1213 nm. It was confirmed that the spectral distribution in a tablet passed as a normal distribution by the goodness-of-fit test (p ≤ 0.05). Consequently, the average of the spectra obtained from each pixel of the whole tablet was used to predict the concentration of magnesium stearate. The quantitative accuracy of the prediction model by the second derivative spectra achieved R2 = 0.931 and RMSE = 1.90 %. Defective tablets were prepared with localised magnesium stearate. The skewness of the second derivative in the defective tablet was larger than that of the standard distribution. Specifically, the distribution of defective tablets was biased to the right as compared to the standard distribution. The results of the presented study suggest that spectral imaging combined with distribution analysis is an effective method to identify defective tablets.

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Continuous monitoring of API content, API distribution and crushing strength after tableting via near-infrared chemical imaging

Cited by 23 publications

References 30 publications

Measurement of residence time distributions and material tracking on three continuous manufacturing lines

Measurement of residence time distributions and material tracking on three continuous manufacturing lines

Recent advancement of chemical imaging in pharmaceutical quality control: From final product testing to industrial utilization

An identification method for defective tablets by distribution analysis of near infrared imaging

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