Shedding light on coatings: Real-time monitoring of coating quality at industrial scale

Sacher, Stephan; Wahl, Patrick; Weißensteiner, Michael; Wolfgang, Matthias; Pokhilchuk, Yekaterina; Looser, Bernd; Thies, Jochen; Raffa, Andrea; Khinast, Johannes G.

doi:10.1016/j.ijpharm.2019.05.048

Cited by 32 publications

(15 citation statements)

References 29 publications

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“…Optical Coherence Tomography (OCT) is also increasingly applied to pharmaceutical film coatings, allowing fast and non-destructive analysis of coating thickness and quality via high-resolution cross-sectional images [ 116 ]. Sacher et al [ 117 ] demonstrated the applicability of OCT in an industrial-scale pan coating process for real time monitoring of tablet coating quality (thickness, homogeneity, and roughness). OCT yields high-resolution images to assess both inter- and intra- tablet coating homogeneity and support active process control [ 117 ].…”

Section: Recent Technology and Tools Used To Characterize Coated Tmentioning

confidence: 99%

“…Sacher et al [ 117 ] demonstrated the applicability of OCT in an industrial-scale pan coating process for real time monitoring of tablet coating quality (thickness, homogeneity, and roughness). OCT yields high-resolution images to assess both inter- and intra- tablet coating homogeneity and support active process control [ 117 ].…”

Section: Recent Technology and Tools Used To Characterize Coated Tmentioning

confidence: 99%

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Pharmaceutical Application of Tablet Film Coating

et al. 2020

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Tablet film coating is a common but critical process providing various functionalities to tablets, thereby meeting diverse clinical needs and increasing the value of oral solid dosage forms. Tablet film coating is a technology-driven process and the evolution of coated dosage forms relies on advancements in coating technology, equipment, analytical techniques, and coating materials. Although multiple coating techniques are developed for solvent-based or solvent-free coating processes, each method has advantages and disadvantages that may require continuous technical refinement. In the film coating process, intra- and inter-batch coating uniformity of tablets is critical to ensure the quality of the final product, especially for active film coating containing active pharmaceutical ingredients in the coating layer. In addition to experimental evaluation, computational modeling is also actively pursued to predict the influence of operation parameters on the quality of the final product and optimize process variables of tablet film coating. The concerted efforts of experiments and computational modeling can save time and cost in optimizing the tablet coating process. This review provides a brief overview of tablet film coating technology and modeling approaches with a focus on recent advancements in pharmaceutical applications.

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Section: Recent Technology and Tools Used To Characterize Coated Tmentioning

confidence: 99%

Section: Recent Technology and Tools Used To Characterize Coated Tmentioning

confidence: 99%

Pharmaceutical Application of Tablet Film Coating

et al. 2020

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“…Besides the already mentioned Raman spectroscopy [ 5 , 6 , 7 , 9 , 10 , 11 , 12 ], further PAT tools were developed to monitor the coating thickness during the coating process. To be mentioned are near infrared spectroscopy [ 13 , 14 , 15 , 16 , 17 , 18 ], terahertz-pulsed technology [ 10 , 19 , 20 , 21 , 22 , 23 , 24 ], optical coherence tomography [ 22 , 25 , 26 , 27 ] and visual imaging techniques [ 1 , 28 , 29 , 30 ]. Most of these process analyzers generate large volumes of multidimensional data.…”

Section: Introductionmentioning

confidence: 99%

Raman Spectroscopy as a PAT-Tool for Film-Coating Processes: In-Line Predictions Using one PLS Model for Different Cores

2020

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Although Raman spectroscopy has been described as a potential process analytical technique for tablet coating, it has rarely been transferred from academic studies to commercial manufacturing applications. The reasons for this are probably not only the high level of process understanding and experience with multivariate data analysis required, but also the product-dependent elaborate model-building. Hence, this study represents a feasibility study to investigate, whether subtraction of core spectra is a suitable approach to generate versatile models for one specific coating that can be applied on a multitude of different tablet cores. Raman spectroscopy was used to predict the application of coatings on three different tablet cores using PLS regression. The obtained spectra were preprocessed, and differential spectra were calculated by subtraction of the core spectrum from each inline spectrum. Normalization ensured comparability between the spectral data of the different cores. It was shown that in general it is possible to build models for a specific coating suspension that can predict the application of this suspension on different cores. In the presence of a strong Raman marker (TiO2), promising results were obtained. Without the presence of a strong Raman marker this modeling approach is to be considered critical.

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“…Continuous manufacturing (CM) is increasingly applied in the pharmaceutical industry (1,2). In comparison to batch production, it enables a higher throughput while simultaneously decreasing the waste and energy consumption and production costs (3). Since the inline measurements are typically intrinsic to the process design, CM allows enhanced process control (4).…”

Section: Introductionmentioning

confidence: 99%

“…Uniformity can be assessed by comparing the weight of the film-coated tablet to the mean tablet core weight or via spectroscopy methods, such as terahertz or Raman probe. Also, Optical Coherence Tomography (OCT) is increasingly used as a novel real-time option (3,9).…”

Section: Introductionmentioning

confidence: 99%

Validating a Numerical Simulation of the ConsiGma(R) Coater

Boehling

Jacevic

Detobel³

et al. 2020

AAPS PharmSciTech

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Continuous manufacturing is increasingly used in the pharmaceutical industry, as it promises to deliver better product quality while simultaneously increasing production flexibility. GEA developed a semi-continuous tablet coater which can be integrated into a continuous tableting line, accelerating the switch from traditional batch production to the continuous mode of operation. The latter offers certain advantages over batch production, e.g., operational flexibility, increased process/product quality, and decreased cost. However, process understanding is the key element for process control. In this regard, computational tools can improve the fundamental understanding and process performance, especially those related to new processes, such as continuous tablet coating where process mechanics remain unclear. The discrete element method (DEM) and computational fluid dynamics (CFD) are two methods that allow transition from empirical process design to a mechanistic understanding of the individual process units. The developed coupling model allows to track the heat, mass, and momentum exchange between the tablet and fluid phase. The goal of this work was to develop and validate a high-fidelity CFD-DEM simulation model of the tablet coating process in the GEA ConsiGma® coater. After the model development, simulation results for the tablet movement, coating quality, and heat and mass transfer during the coating process were validated and compared to the experimental outcomes. The experimental and simulation results agreed well on all accounts measured, indicating that the model can be used in further studies to investigate the operating space of the continuous tablet coating process.

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Shedding light on coatings: Real-time monitoring of coating quality at industrial scale

Cited by 32 publications

References 29 publications

Pharmaceutical Application of Tablet Film Coating

Pharmaceutical Application of Tablet Film Coating

Raman Spectroscopy as a PAT-Tool for Film-Coating Processes: In-Line Predictions Using one PLS Model for Different Cores

Validating a Numerical Simulation of the ConsiGma(R) Coater

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