Enabling real time release testing by NIR prediction of dissolution of tablets made by continuous direct compression (CDC)

Pawar, Pallavi; Wang, Yifan; Keyvan, Golshid; Callegari, Gerardo; Cuitiño, Alberto M.; Muzzio, Fernando J.

doi:10.1016/j.ijpharm.2016.08.033

Cited by 66 publications

(32 citation statements)

References 36 publications

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“…However, there are so far only a few studies on the interaction of multiple material properties and process parameters in integrated whole train continuous mixing and direct compression process systems (Järvinen M.A. et al, 2013a;Järvinen K. et al, 2013b;Engisch and Muzzio 2015;Ervasti et al, 2015;Lakio et al, 2016;Pawar et al, 2016;Van Snick et al 2017a, 2017b The authors of the present work have previously concluded that material properties have a great effect on the properties of tablets manufactured in a whole train continuous mixing and direct compression line (Ervasti et al, 2015;Lakio et al, 2016). Notably, these recent results indicate that the integrated continuous mixing and direct compression could efficiently handle very challenging material compositions and consistently deliver intended output quality even for advanced tablet functionalities such as extended release performance (Ervasti et al, 2015;Lakio et al, 2016;Van Snick et al, 2017a).…”

Section: Accepted Manuscriptmentioning

confidence: 99%

Provoking an end-to-end continuous direct compression line with raw materials prone to segregation

Lakio

Ervasti

Tajarobi

et al. 2017

European Journal of Pharmaceutical Sciences

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Continuous manufacturing of solid oral dosage forms is promising for increasing the efficiency and quality of pharmaceutical production and products. In this study a whole train continuous direct compression (CDC) line has been provoked using challenging formulations typically prone to segregation in batch powder processing. Industrial compositions including components with variable size, bulk density and cohesive nature were selected. An experimental design, including variables such as API/mannitol particle size, API amount, powder feed rate and mixer speed, enabled the output quality of the provoked process to be assessed. Contrary to previous studies, a broader range of finished tablet quality attributes were probed, including content, uniformity of content, tensile strength as well as release performance. Overall, the continuous direct compression line was found to be a capable and efficient manufacturing process for the challenging compositions studied and surprisingly tolerable to handle the materials susceptible to segregation in typical batch settings. As expected, and given the 'fixed' apparatus configuration used in this study, the particulate material properties were found to have the most significant impact on the finished tablet quality attributes. The results emphasize the importance for taking a holistic approach when developing the operational windows and the strategy for control, e.g. by integrating the appropriate material properties, the actual apparatus design, and the relevant formulation design. The CDC line's ability to handle cohesive materials also seem to be one of the key advantages, thus confirming the recent promising results from other continuous direct compression studies.

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Section: Accepted Manuscriptmentioning

confidence: 99%

Provoking an end-to-end continuous direct compression line with raw materials prone to segregation

Lakio

Ervasti

Tajarobi

et al. 2017

European Journal of Pharmaceutical Sciences

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“…A number of quality measures are associated with tablets, one being dissolution rate. Pawar et al [17] applied NIR to determine the dissolution rate by relating principal components from the spectra to curve fit coefficients predicting the dissolution profile. While applied for a range of line operating parameters and API concentration variations, more general applicability remains to be demonstrated for different APIs and formulations.…”

Section: On-line Process Measurementmentioning

confidence: 99%

Opportunities for Process Control and Quality Assurance Using Online NIR Analysis to a Continuous Wet Granulation Tableting Line

et al. 2018

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This paper investigates the application of on-line near infra-red measurements as a means to measure blend uniformity in a continuous tableting line. Underlying all the monitoring and control methods is the ability to measure key tablet properties on-line at a rate suitable for control purposes. The use of NIR to determine any deviations in blend uniformity is demonstrated by interpreting the relevant spectral signature allowing quantitative information to be acquired for process monitoring and quality assurance. In addition to demonstrating the functionality of the NIR probe, the practical issues arising in the application are discussed. The composition of the blend was measured using an NIR probe over a range of concentrations and the results were calculated comparing sub unit dose scale of scrutiny of small populations. This was compared with predicted product quality for whole tablets over the whole production period. This technique has demonstrated how data collected online can be used to successfully predict the quality of the whole production run for the purposes of real time product quality assurance.

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“…3 These different operations can elicit significant changes in material attributes which must be monitored to ensure final product quality. Near infrared (NIR) spectroscopy based PAT applications have been developed for monitoring operations such as blending, 4-7 granulation, 8-10 drying 11,12 and continuous mixing followed by compression, 13 coating 14 and end product testing, [14][15][16][17][18][19] where it has proven to be advantageous over conventional in-process sampling and testing methods. In addition to these key operations, consistent diefilling is important to meet tablet quality attributes.…”

Section: Nir Spectroscopy As a Pat Tool For Tablet Manufacturingmentioning

confidence: 99%

Concentration monitoring with near infrared chemical imaging in a tableting press

Dalvi

Fauteux‐Lefebvre

Guay

et al. 2018

J. Spectral Imaging

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Monitoring powder potency and homogeneity is important in achieving real-time release testing in a continuous tablet manufacturing operation. If quality related issues are encountered, monitoring powder potency inside a feed frame offers a last opportunity to intervene in the process before tablet compression. Feed frame monitoring methods based on near infrared (NIR) spectroscopy have been increasingly reported in recent years. New process analytical tools with the potential of being deployed alone or in combination with NIR spectroscopy for feed frame monitoring are now available commercially. The present study evaluated the potential of near infrared chemical imaging (NIR CI) for in-line monitoring of a prototype pharmaceutical composition containing ascorbic acid (AA), microcrystalline cellulose and dicalcium phosphate. NIR spectroscopy was the reference method. In-line calibration models based on partial least square regression were developed and validated with a range of AA concentrations. The ability of NIR spectroscopy and NIR CI to predict concentrations in test runs was ascertained both independently and in combination. NIR CI, with a single bandpass filter, predicted AA concentrations—present at commercially relevant concentrations—with acceptable accuracy. Comparative results showed that NIR CI has the potential for in-line monitoring of blend concentrations inside feed frames. In addition to the advantage of increased sample size, it also has the potential to detect segregation inside feed frames.

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Enabling real time release testing by NIR prediction of dissolution of tablets made by continuous direct compression (CDC)

Cited by 66 publications

References 36 publications

Provoking an end-to-end continuous direct compression line with raw materials prone to segregation

Provoking an end-to-end continuous direct compression line with raw materials prone to segregation

Opportunities for Process Control and Quality Assurance Using Online NIR Analysis to a Continuous Wet Granulation Tableting Line

Concentration monitoring with near infrared chemical imaging in a tableting press

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