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Real-time assessment of critical quality attributes of a continuous granulation process

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Abstract
There exists the intention to shift pharmaceutical manufacturing of solid dosage forms from traditional batch production towards continuous production. The currently applied conventional quality control systems, based on sampling and time-consuming off-line analyses in analytical laboratories, would annul the advantages of continuous processing. It is clear that real-time quality assessment and control is indispensable for continuous production. This manuscript evaluates strengths and weaknesses of several complementary Process Analytical Technology (PAT) tools implemented in a continuous wet granulation process, which is part of a fully continuous from powder-to-tablet production line. The use of Raman and NIR-spectroscopy and a particle size distribution analyzer is evaluated for the real-time monitoring of critical parameters during the continuous wet agglomeration of an anhydrous theophylline− lactose blend. The solid state characteristics and particle size of the granules were analyzed in real-time and the critical process parameters influencing these granule characteristics were identified. The temperature of the granulator barrel, the amount of granulation liquid added and, to a lesser extent, the powder feed rate were the parameters influencing the solid state of the active pharmaceutical ingredient (API). A higher barrel temperature and a higher powder feed rate, resulted in larger granules.
Keywords
TWIN-SCREW EXTRUDER, PAT, NIR-spectroscopy, particle size analysis, continuous granulation, Raman Spectroscopy, WET-GRANULATION, PHARMACEUTICAL GRANULES, HYDRATE FORMATION, THEOPHYLLINE, SPECTROSCOPY, EXTRUSION, EXCIPIENTS, BATCH, FORMS

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Chicago
Fonteyne, Margot, Jurgen Vercruysse, Damián Córdoba Díaz, Delphine Gildemyn, Chris Vervaet, Jean Paul Remon, and Thomas De Beer. 2013. “Real-time Assessment of Critical Quality Attributes of a Continuous Granulation Process.” Pharmaceutical Development and Technology 18 (1): 85–97.
APA
Fonteyne, M., Vercruysse, J., Córdoba Díaz, D., Gildemyn, D., Vervaet, C., Remon, J. P., & De Beer, T. (2013). Real-time assessment of critical quality attributes of a continuous granulation process. PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, 18(1), 85–97.
Vancouver
1.
Fonteyne M, Vercruysse J, Córdoba Díaz D, Gildemyn D, Vervaet C, Remon JP, et al. Real-time assessment of critical quality attributes of a continuous granulation process. PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY. 2013;18(1):85–97.
MLA
Fonteyne, Margot, Jurgen Vercruysse, Damián Córdoba Díaz, et al. “Real-time Assessment of Critical Quality Attributes of a Continuous Granulation Process.” PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY 18.1 (2013): 85–97. Print.
@article{2154541,
  abstract     = {There exists the intention to shift pharmaceutical manufacturing of solid dosage forms from traditional batch production towards continuous production. The currently applied conventional quality control systems, based on sampling and time-consuming off-line analyses in analytical laboratories, would annul the advantages of continuous processing. It is clear that real-time quality assessment and control is indispensable for continuous production. This manuscript evaluates strengths and weaknesses of several complementary Process Analytical Technology (PAT) tools implemented in a continuous wet granulation process, which is part of a fully continuous from powder-to-tablet production line. The use of Raman and NIR-spectroscopy and a particle size distribution analyzer is evaluated for the real-time monitoring of critical parameters during the continuous wet agglomeration of an anhydrous theophylline\ensuremath{-} lactose blend. The solid state characteristics and particle size of the granules were analyzed in real-time and the critical process parameters influencing these granule characteristics were identified. The temperature of the granulator barrel, the amount of granulation liquid added and, to a lesser extent, the powder feed rate were the parameters influencing the solid state of the active pharmaceutical ingredient (API). A higher barrel temperature and a higher powder feed rate, resulted in larger granules.},
  author       = {Fonteyne, Margot and Vercruysse, Jurgen and C{\'o}rdoba D{\'i}az, Dami{\'a}n and Gildemyn, Delphine and Vervaet, Chris and Remon, Jean Paul and De Beer, Thomas},
  issn         = {1083-7450},
  journal      = {PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY},
  keyword      = {TWIN-SCREW EXTRUDER,PAT,NIR-spectroscopy,particle size analysis,continuous granulation,Raman Spectroscopy,WET-GRANULATION,PHARMACEUTICAL GRANULES,HYDRATE FORMATION,THEOPHYLLINE,SPECTROSCOPY,EXTRUSION,EXCIPIENTS,BATCH,FORMS},
  language     = {eng},
  number       = {1},
  pages        = {85--97},
  title        = {Real-time assessment of critical quality attributes of a continuous granulation process},
  url          = {http://dx.doi.org/10.3109/10837450.2011.627869},
  volume       = {18},
  year         = {2013},
}

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