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A hybrid model for multipoint real time potency observation in continuous direct compression manufacturing operations

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Abstract
The ongoing transition from batch to continuous manufacturing offers both challenges and opportunities in the field of oral solid dosage form production. In turn, Process Analytical Technology (PAT) offers a path towards the successful deployment of continuous tablet manufacturing in rotary tablet presses. One promising PAT tool for this endeavour is the NIR-derived potency measurement. However, the high degree of noise in the data may hamper the extraction of useful information. For this reason, this work focused on the implementation of an adaptive Kalman filter algorithm that incorporates and reconciles the potency prediction given by one or more NIR probes with those of a semi-mechanistic compartmental model developed for the application at hand. This approach allowed for more robust concentration estimations. Furthermore, it was observed that potency levels in multiple locations in the studied tablet press (including those in the finished tablets) could be appropriately inferred using a single in-line measurement data stream. This methodology thus opens the door to advanced process control applications.
Keywords
Pharmaceutical Science, PAT, NIR, Extended Kalman Filter, RTD compartmental modelling, Continuous pharmaceutical manufacturing, NEAR-INFRARED SPECTROSCOPY, CONTENT UNIFORMITY, KALMAN-FILTER, RAMAN-SPECTROSCOPY, BLEND UNIFORMITY, STATE ESTIMATION, NIR, TABLETS, TRANSMISSION, BATCH

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MLA
Gallo Molina, Juan Pablo, et al. “A Hybrid Model for Multipoint Real Time Potency Observation in Continuous Direct Compression Manufacturing Operations.” INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 613, 2022, doi:10.1016/j.ijpharm.2021.121385.
APA
Gallo Molina, J. P., Cogoni, G., Peeters, E., Rao Ambati, S., & Nopens, I. (2022). A hybrid model for multipoint real time potency observation in continuous direct compression manufacturing operations. INTERNATIONAL JOURNAL OF PHARMACEUTICS, 613. https://doi.org/10.1016/j.ijpharm.2021.121385
Chicago author-date
Gallo Molina, Juan Pablo, Giuseppe Cogoni, Elisabeth Peeters, Seshagiri Rao Ambati, and Ingmar Nopens. 2022. “A Hybrid Model for Multipoint Real Time Potency Observation in Continuous Direct Compression Manufacturing Operations.” INTERNATIONAL JOURNAL OF PHARMACEUTICS 613. https://doi.org/10.1016/j.ijpharm.2021.121385.
Chicago author-date (all authors)
Gallo Molina, Juan Pablo, Giuseppe Cogoni, Elisabeth Peeters, Seshagiri Rao Ambati, and Ingmar Nopens. 2022. “A Hybrid Model for Multipoint Real Time Potency Observation in Continuous Direct Compression Manufacturing Operations.” INTERNATIONAL JOURNAL OF PHARMACEUTICS 613. doi:10.1016/j.ijpharm.2021.121385.
Vancouver
1.
Gallo Molina JP, Cogoni G, Peeters E, Rao Ambati S, Nopens I. A hybrid model for multipoint real time potency observation in continuous direct compression manufacturing operations. INTERNATIONAL JOURNAL OF PHARMACEUTICS. 2022;613.
IEEE
[1]
J. P. Gallo Molina, G. Cogoni, E. Peeters, S. Rao Ambati, and I. Nopens, “A hybrid model for multipoint real time potency observation in continuous direct compression manufacturing operations,” INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 613, 2022.
@article{8731305,
  abstract     = {{The ongoing transition from batch to continuous manufacturing offers both challenges and opportunities in the field of oral solid dosage form production. In turn, Process Analytical Technology (PAT) offers a path towards the successful deployment of continuous tablet manufacturing in rotary tablet presses. One promising PAT tool for this endeavour is the NIR-derived potency measurement. However, the high degree of noise in the data may hamper the extraction of useful information. For this reason, this work focused on the implementation of an adaptive Kalman filter algorithm that incorporates and reconciles the potency prediction given by one or more NIR probes with those of a semi-mechanistic compartmental model developed for the application at hand. This approach allowed for more robust concentration estimations. Furthermore, it was observed that potency levels in multiple locations in the studied tablet press (including those in the finished tablets) could be appropriately inferred using a single in-line measurement data stream. This methodology thus opens the door to advanced process control applications.}},
  articleno    = {{121385}},
  author       = {{Gallo Molina, Juan Pablo and Cogoni, Giuseppe and Peeters, Elisabeth and Rao Ambati, Seshagiri and Nopens, Ingmar}},
  issn         = {{0378-5173}},
  journal      = {{INTERNATIONAL JOURNAL OF PHARMACEUTICS}},
  keywords     = {{Pharmaceutical Science,PAT,NIR,Extended Kalman Filter,RTD compartmental modelling,Continuous pharmaceutical manufacturing,NEAR-INFRARED SPECTROSCOPY,CONTENT UNIFORMITY,KALMAN-FILTER,RAMAN-SPECTROSCOPY,BLEND UNIFORMITY,STATE ESTIMATION,NIR,TABLETS,TRANSMISSION,BATCH}},
  language     = {{eng}},
  pages        = {{12}},
  title        = {{A hybrid model for multipoint real time potency observation in continuous direct compression manufacturing operations}},
  url          = {{http://dx.doi.org/10.1016/j.ijpharm.2021.121385}},
  volume       = {{613}},
  year         = {{2022}},
}

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