Development of a Process Analytical Technology (PAT) for in-line monitoring of film thickness and mass of coating materials during a pan coating operation

Gendre, Claire; Genty, Muriel; Boiret, Mathieu; Julien, M.-H.; Meunier, Loïc; Lecoq, Olivier; Baron, Michel; Chaminade, Pierre; Péan, Jean Manuel

doi:10.1016/j.ejps.2011.04.017

Cited by 59 publications

(27 citation statements)

References 29 publications

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“…However, the fluorescence of certain coating materials can be a major obstacle with regard to Raman spectroscopy (10)(11)(12). Using a correct data pretreatment and reference analytics, successful real-time prediction of coating thickness, uniformity, and drug release via NIRS were reported (9,18). NIRS was also extensively investigated in connection with fast and non-destructive particle size monitoring during granulation processes, typically combined with moisture content determination (20).…”

Section: Introductionmentioning

confidence: 99%

“…Several studies investigated process analytical technology (PAT) applications for the monitoring of coating processes. Most techniques directly rely on the detection of the coating material, including near-infrared spectroscopy (NIRS) (6)(7)(8)(9), Raman spectroscopy (10)(11)(12), and Terahertz pulsed imaging (13). In a series of papers, we recently reported the use of optical coherence tomography (OCT) as a powerful method for in-line measurement of coating thickness and variability (14)(15)(16).…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2016

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“…Other research has examined the thickness of the coating layer, which may affect the dissolution profile of the drug product. [1][2][3][4][5][6][7] However, the number of reports focusing on tablet chipping or cracking during the coating process remains low. [8][9][10][11] Mueller et al developed a method for the prediction of tablet velocity using a round shaped pan coater coating from laboratory scale to 200 kg scale.…”

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confidence: 99%

Tablet Velocity Measurement and Prediction in the Pharmaceutical Film Coating Process

Suzuki

Yokohama

Minami

et al. 2016

CHEMICAL & PHARMACEUTICAL BULLETIN

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The purpose of this study was to measure the tablet velocity in pan coating machines during the film coating process in order to understand the impact of the batch size (laboratory to commercial scale), coating machine type (DRIACOATER, HICOATER ® and AQUA COATER ® ) and manufacturing conditions on tablet velocity. We used a high speed camera and particle image velocimetry to measure the tablet velocity in the coating pans. It was observed that increasing batch sizes resulted in increased tablet velocities under the same rotation number because of the differences in circumferential rotation speeds. We also observed the tendency that increase in the filling ratio of tablets resulted in an increased tablet velocity for all coating machines. Statistical analysis was used to make a tablet velocity predictive equation by employing the filling ratio and rotation speed as the parameters from these measured values. The correlation coefficients of predicted value and experimental value were more than 0.959 in each machine. Using the predictive equation to determine tablet velocities, the manufacturing conditions of previous products were reviewed, and it was found that the tablet velocities of commercial scales, in which tablet chipping and breakage problems had occurred, were higher than those of pilot scales or laboratory scales.

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“…[3][4][5][6][7][8] However, in the process controls using spectroscopic analysis, a large amount of experimental data and human resources are required for developing models. Additionally, a large amount of data are also required for the maintenance of the model after development.…”

mentioning

confidence: 99%

“…1,2) Process analytical technology (PAT) using near infrared spectroscopy (NIR) or Raman spectroscopy has been widely evaluated for the in-line measurement of the water content of tablets, the coated film thickness and other related qualities. [3][4][5][6][7][8] However, in the process controls using spectroscopic analysis, a large amount of experimental data and human resources are required for developing models. Additionally, a large amount of data are also required for the maintenance of the model after development.…”

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confidence: 99%

A Novel Scale Up Model for Prediction of Pharmaceutical Film Coating Process Parameters

Suzuki

Minami

et al. 2016

CHEMICAL & PHARMACEUTICAL BULLETIN

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In the pharmaceutical tablet film coating process, we clarified that a difference in exhaust air relative humidity can be used to detect differences in process parameters values, the relative humidity of exhaust air was different under different atmospheric air humidity conditions even though all setting values of the manufacturing process parameters were the same, and the water content of tablets was correlated with the exhaust air relative humidity. Based on this experimental data, the exhaust air relative humidity index (EHI), which is an empirical equation that includes as functional parameters the pan coater type, heated air flow rate, spray rate of coating suspension, saturated water vapor pressure at heated air temperature, and partial water vapor pressure at atmospheric air pressure, was developed. The predictive values of exhaust relative humidity using EHI were in good correlation with the experimental data (correlation coefficient of 0.966) in all datasets. EHI was verified using the date of seven different drug products of different manufacturing scales. The EHI model will support formulation researchers by enabling them to set film coating process parameters when the batch size or pan coater type changes, and without the time and expense of further extensive testing.Key words pan coater; exhaust air relative humidity index (EHI); scale up; drying ability; atmospheric air; tablet water content In general, pharmaceutical film coatings are applied in order to protect core tablets from light or for masking the taste of the active pharmaceutical ingredients. Therefore, the surface state of the coating layer is important to maintain the expected performance. During the coating process, however, the coating layer surface state is affected by the water content of the tablets. In a conventional approach, the water content of drug products is maintained at the validated level by monitoring the product's temperature and/or the exhaust air temperature during the coating process. In a scale up study, the batch scale and manufacturing equipment are changed according to the progress of the process development stage. At each stage, the water content of drug products is constantly monitored and well-controlled to secure the consistency of the drug product's quality. In this approach, numerous experiments are necessary to optimize the process parameters in each batch scale. As a result, the costs of materials, human resources, and time for development will become considerable.Recently, continuous manufacturing systems, which are based on a no-scale up concept of the drug products, have been proposed and evaluated.1,2) Process analytical technology (PAT) using near infrared spectroscopy (NIR) or Raman spectroscopy has been widely evaluated for the in-line measurement of the water content of tablets, the coated film thickness and other related qualities. [3][4][5][6][7][8] However, in the process controls using spectroscopic analysis, a large amount of experimental data and human resources are required for developing m...

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Development of a Process Analytical Technology (PAT) for in-line monitoring of film thickness and mass of coating materials during a pan coating operation

Cited by 59 publications

References 29 publications

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

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

Tablet Velocity Measurement and Prediction in the Pharmaceutical Film Coating Process

A Novel Scale Up Model for Prediction of Pharmaceutical Film Coating Process Parameters

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