Application of in-line near infrared spectroscopy and multivariate batch modeling for process monitoring in fluid bed granulation

Kona, Ravikanth; Qu, Haibin; Mattes, Robert A.; Jancsik, Béla; Fahmy, Raafat; Hoag, Stephen W.

doi:10.1016/j.ijpharm.2013.04.039

Cited by 58 publications

(35 citation statements)

References 14 publications

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“…The dry powder feeder was operated at an air pressure of 20 psi and a sample size of 3 g. The granule mean diameter was determined by measuring the D[4,3] which are the particle sizes at the 40 th and 30 th of the cumulative undersize distribution [17]. The particle size distribution is performed by determination the span according to the following equation:…”

Section: Granule Mean Diameter and Particle Size Distributionmentioning

confidence: 99%

Screening the fluid bed granulation process variables and moisture content determination of pharmaceutical granules by NIR Spectroscopy

et al. 2017

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Section: Granule Mean Diameter and Particle Size Distributionmentioning

confidence: 99%

Screening the fluid bed granulation process variables and moisture content determination of pharmaceutical granules by NIR Spectroscopy

et al. 2017

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“…Thus, the endpoint of a successfully coated batch is 1. More details on such batch models can be found in literature (27,28). SNV normalized spectra over nearly the whole spectral range (1100-1800 nm) were used for the prediction of coating.…”

Section: Coating Prediction Via Plsmentioning

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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“…Due to their small size (17 mm × 6 mm size), they can be placed at various locations in and around the granulator for accurate monitoring. These loggers are self-powered by a lithium battery and internally consist of a microprocessor, a capacitive humidity sensor and a quartz clock, all enclosed in a hermetically sealed stainless steel housing, hence these data loggers can be chemically sterilized and depyrogenated and each data logger's calibration is National Institute of Standards and Technology (NIST) traceable (Kona et al, 2013).…”

Section: Introductionmentioning

confidence: 99%

Process analytical technology (PAT) approach to the formulation of thermosensitive protein-loaded pellets: Multi-point monitoring of temperature in a high-shear pelletization

Kristó

Kovács

Kelemen

et al. 2016

European Journal of Pharmaceutical Sciences

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In the literature there are some publications about the effect of impeller and chopper speeds on product parameters. However, there is no information about the effect of temperature. Therefore our main aim was the investigation of elevated temperature and temperature distribution during pelletization in a high shear granulator according to process analytical technology. During our experimental work, pellets containing pepsin were formulated with a high-shear granulator. A specially designed chamber (Opulus Ltd.) was used for pelletization. This chamber contained four PyroButton-TH® sensors built in the wall and three PyroDiff® sensors 1, 2 and 3 cm from the wall. The sensors were located in three different heights. The impeller and chopper speeds were set on the basis of 3 2 factorial design. The temperature was measured continuously in 7 different points during pelletization and the results were compared with the temperature values measured by the thermal sensor of the high-shear granulator. The optimization parameters were enzyme activity, average size, breaking hardness, surface free energy and aspect ratio. One of the novelties was the application of the specially designed chamber (Opulus Ltd.) for monitoring the temperature continuously in 7 different points during high-shear granulation. The other novelty of this study was the evaluation of the effect of temperature on the properties of pellets containing protein during high-shear pelletization.

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Application of in-line near infrared spectroscopy and multivariate batch modeling for process monitoring in fluid bed granulation

Cited by 58 publications

References 14 publications

Screening the fluid bed granulation process variables and moisture content determination of pharmaceutical granules by NIR Spectroscopy

Screening the fluid bed granulation process variables and moisture content determination of pharmaceutical granules by NIR Spectroscopy

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

Process analytical technology (PAT) approach to the formulation of thermosensitive protein-loaded pellets: Multi-point monitoring of temperature in a high-shear pelletization

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