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The effect of lubrication on density distributions of roller compacted ribbons
09 Jun 2023 | Contributor(s):: Miguelez-Moran, A. M, Seville, J. P. K.
Roller compaction is a continuous dry granulation process for producing free flowing granules in order to increase the bulk density and uniformity of pharmaceutical formulations. It is a complicated process due to the diversity of powder blends and processing parameters involved. The properties...
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Roller compaction: Infrared thermography as a PAT for monitoring powder flow from feeding to compaction zone
09 Jun 2023 | Contributor(s):: Yu, Mingzhe, Omar, Chalak, Weidemann, Marcus, Schmidt, Alexander, Litster, James D., Salman, Agba D.
Roller compaction is a continuous dry granulation process, in which powder is compressed by two counter-rotating rollers. During this process, the powder feeding to the compaction zone has a significant effect on product quality. This work investigates the flow of powder from the feeding zone to...
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Recent progress in continuous manufacturing of oral solid dosage forms
09 Jun 2023 | Contributor(s):: Vanhoorne, Valérie, Vervaet, Chris
Continuous drug product manufacturing is slowly being implemented in the pharmaceutical industry. Although the benefits related to the quality and cost of continuous manufacturing are widely recognized, several challenges hampered the widespread introduction of continuous manufacturing of drug...
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Practical application of roller compaction process modeling
09 Jun 2023 | Contributor(s):: Reynolds, Gavin, Ingale, Rohit Roberts, Ron Kothari, Sanjeev, Gururajan, Bindhu
Very limited work has been reported on comparing the performance of the roller compaction process at different scales. The majority of the approaches highlighted in the literature discuss the applicability of using confined uniaxial compaction for predicting the performance of the roller...
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Nondestructive measurements of the compact strength and the particle-size distribution after milling of roller compacted powders by near-infrared spectroscopy
09 Jun 2023 | Contributor(s):: Gupta, A, Peck, GE, Miller, RW, Morris, KR
Compact strength and the particle-size distribution of milled roller compacted compacts were correlated to the slope of the best-fit line through near-infrared spectra for samples prepared under different roll speeds and feed rates. The above correlations were found to hold for compacts prepared...
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Modeling and Control of Roller Compaction for Pharmaceutical Manufacturing. Part I: Process Dynamics and Control Framework
09 Jun 2023 | Contributor(s):: Hsu, Shuo-Huan, Venkatasubramanian, Venkat, Reklaitis, Gintaras V.
We derive a dynamic model for roller compaction process based on Johanson’s rolling theory, which is used to predict the stress and density profiles during the compaction and the material balance equation which describes the roll gap change. The proposed model considers the relationship between...
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Model-based approach to the design of pharmaceutical roller-compaction processes
09 Jun 2023 | Contributor(s):: Toson, Peter, Lopes, Diogo G. Paus, Raphael Kumar, Ashish, Geens, Jeroen, Stibale, Sandy, Quodbach, Julian, Kleinebudde, Peter, Hsiao, Wen-Kai, Khinast, Johannes
This work presents a new model based approach to process design and scale-up within the same equipment of a roller compaction process. The prediction of the operating space is not performed fully in-silico, but uses low-throughput experiments as input. This low-throughput data is utilized in an...
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Laser triangulation as a fast and reliable method for determining ribbon solid fraction; focus on accuracy, precision, and measurement time
09 Jun 2023 | Contributor(s):: Lillotte, Tim D, Bebernik, Paul, Keck, Johanna, Bommer, Moritz, Schroeder, Daniela, Wagner, Karl G.
Roller compaction and dry granulation represent well-established unit operations in the pharmaceutical industry. The ribbon solid fraction is classified as a critical quality attribute, that directly impacts final product quality and performance. The development and evaluation of novel methods...
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Investigation of the variability of NIR in-line monitoring of roller compaction process by using Fast Fourier Transform (FFT) analysis
09 Jun 2023 | Contributor(s):: Feng, Tao, Wang, Feng, Pinal, Rodolfo, Wassgren, Carl, Carvajal, M. Teresa
The purpose of this Research Article was to investigate the variability of the roller compaction process while monitoring in-line with near-infrared (NIR) spectroscopy. In this paper, a pragmatic method in determining this variability of in-line NIR monitoring roller compaction process was...
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Implementation of an online thermal imaging to study the effect of process parameters of roller compactor
09 Jun 2023 | Contributor(s):: Omar, Chalak S., Hounslow, Michael J., Salman, Agba D.
During roller compaction, not only the properties of the primary powder affect the product quality but also the process parameters. Any change in the process parameters during roller compaction will result in changing the properties of the ribbon. In this study, the temperature of the ribbon...
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Converting a batch based high -shear granulation process to a continuous dry granulation process; a demonstration with ketoprofen tablets
09 Jun 2023 | Contributor(s):: Taipale-Kovalainen, Krista, Ketolainen, Jarkko, Korhonen, Ossi, Ervasti, Tuomas
When one wishes to convert a batch based manufacturing process of an existing tablet product to a continuous process, there are several available strategies which can be adopted. Theoretically, the most straightforward way would be to proceed with the corresponding processing principles, for...
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Continuous granulation in the pharmaceutical industry
09 Jun 2023 | Contributor(s):: Vervaet, C, Remon, JP
Traditionally the manufacturing of pharmaceutical dosage forms has been a batch-wise process and continuous processes have limited applications in a pharmaceutical manufacturing plant. However, several factors (reduction of cost, improved process efficiency, optimal use of equipment, flexibility...
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Application of Near-Infrared Spectroscopy in Real-Time Monitoring of Product Attributes of Ribbed Roller Compacted Flakes
09 Jun 2023 | Contributor(s):: Samanta, Asim Kumar, Karande, Atul D., Ng, Ka Yun, Heng, Paul Wan Sia
This study assessed the utility of near-infrared (NIR) spectroscopy for the real-time monitoring of content uniformity and critical quality attributes (tensile strength, Young's modulus, and relative density) of ribbed roller compacted flakes made by axially corrugated or ribbed rolls. A...
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Evaluation of three approaches for real-time monitoring of roller compaction with near-infrared spectroscopy
09 Jun 2023 | Contributor(s):: Acevedo, D., Muliadi, A., Giridhar, A., Litster, J. D., Romañach, R. J.
Three different approaches have been evaluated for monitoring ribbon density through real-time near-infrared spectroscopy measurements. The roll compactor was operated to produce microcrystalline cellulose (MCC) ribbons of varying densities. The first approach used the slope of the spectra which...
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An engineering study on the enhanced control and operation of continuous manufacturing of pharmaceutical tablets via roller compaction
09 Jun 2023 | Contributor(s):: R Singh, M Ierapetritou, R Ramachandran
A novel manufacturing strategy based on continuous processing integrated with online monitoring tools coupled with efficient automatic feedback control system is highly desired for efficient Quality by Design (QbD) based manufacturing ofthe next generation of pharmaceutical products with optimal...
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A systematic study of the impact of changes of roller compactor equipment on granule and tablet properties
09 Jun 2023 | Contributor(s):: Haeffler, Gunnar, Schmidt, Leonard, Lakio, Satu, Reynolds, Gavin, Odman, Jonas, Tajarobi, Pirjo
Typical industrial development of roller compaction processes include changes in scale from laboratory to pilot and then further to production scale and also changes in equipment design due to equipment availability in different manufacturing facilities. Transfer and scale-up of roller compaction...