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Mechanistic modelling of infrared mediated energy transfer during the primary drying step of a continuous freeze-drying process

Pieter-Jan Van Bockstal UGent, Séverine Mortier UGent, Laurens De Meyer UGent, Jos Corver, Chris Vervaet UGent, Ingmar Nopens UGent and Thomas De Beer UGent (2017) European Journal of Pharmaceutics and Biopharmaceutics . 114. p.11-21
abstract
Conventional pharmaceutical fieeze-drying is an inefficient and expensive batch-wise process, associated with several disadvantages leading to an uncontrolled end product variability. The proposed continuous alternative, based on spinning the vials during freezing and on optimal energy supply during drying, strongly increases process efficiency and improves product quality (uniformity). The heat transfer during continuous drying of the spin frozen vials is provided via non-contact infrared (IR) radiation. The energy transfer to the spin frozen vials should be optimised to maximise the drying efficiency while avoiding cake collapse. Therefore, a mechanistic model was developed which allows computing the optimal, dynamic IR heater temperature in function of the primary drying progress and which, hence, also allows predicting the primary drying endpoint based on the applied dynamic IR heater temperature. The model was validated by drying spin frozen vials containing the model formulation (3.9 mL in lOR vials) according to the computed IR heater temperature profile. In total, 6 validation experiments were conducted. The primary drying endpoint was experimentally determined via in-line near-infrared (NIR) spectroscopy and compared with the endpoint predicted by the model (50 min). The mean ratio of the experimental drying time to the predicted value was 0.91, indicating a good agreement between the model predictions and the experimental data. The end product had an elegant product appearance (visual inspection) and an acceptable residual moisture content (Karl Fischer).
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
Continuous freeze-drying, Spin freezing, Infrared radiation, Mechanistic modelling
journal title
European Journal of Pharmaceutics and Biopharmaceutics
editor
Pieter-Jan Van Bockstal UGent
volume
114
pages
11 pages
publisher
Elsevier BV
ISSN
0939-6411
DOI
10.1016/j.ejpb.2017.01.001
language
English
UGent publication?
yes
classification
U
copyright statement
I have transferred the copyright for this publication to the publisher
id
8550682
handle
http://hdl.handle.net/1854/LU-8550682
alternative location
https://ac.els-cdn.com/S0939641116307421/1-s2.0-S0939641116307421-main.pdf?_tid=6f429a1a-1306-11e8-a0af-00000aab0f27&acdnat=1518778079_70498e8a1007937aca22da25c69e6d90
date created
2018-02-16 10:45:11
date last changed
2018-03-16 12:34:19
@article{8550682,
  abstract     = {Conventional pharmaceutical fieeze-drying is an inefficient and expensive batch-wise process, associated with several disadvantages leading to an uncontrolled end product variability. The proposed continuous alternative, based on spinning the vials during freezing and on optimal energy supply during drying, strongly increases process efficiency and improves product quality (uniformity). The heat transfer during continuous drying of the spin frozen vials is provided via non-contact infrared (IR) radiation. The energy transfer to the spin frozen vials should be optimised to maximise the drying efficiency while avoiding cake collapse. Therefore, a mechanistic model was developed which allows computing the optimal, dynamic IR heater temperature in function of the primary drying progress and which, hence, also allows predicting the primary drying endpoint based on the applied dynamic IR heater temperature. The model was validated by drying spin frozen vials containing the model formulation (3.9 mL in lOR vials) according to the computed IR heater temperature profile. In total, 6 validation experiments were conducted. The primary drying endpoint was experimentally determined via in-line near-infrared (NIR) spectroscopy and compared with the endpoint predicted by the model (50 min). The mean ratio of the experimental drying time to the predicted value was 0.91, indicating a good agreement between the model predictions and the experimental data. The end product had an elegant product appearance (visual inspection) and an acceptable residual moisture content (Karl Fischer).},
  author       = {Van Bockstal, Pieter-Jan and Mortier, S{\'e}verine and De Meyer, Laurens and Corver, Jos and Vervaet, Chris and Nopens, Ingmar and De Beer, Thomas},
  editor       = {Van Bockstal, Pieter-Jan},
  issn         = {0939-6411},
  journal      = {European Journal of Pharmaceutics and Biopharmaceutics },
  keyword      = {Continuous freeze-drying,Spin freezing,Infrared radiation,Mechanistic modelling},
  language     = {eng},
  pages        = {11--21},
  publisher    = {Elsevier BV},
  title        = {Mechanistic modelling of infrared mediated energy transfer during the primary drying step of a continuous freeze-drying process},
  url          = {http://dx.doi.org/10.1016/j.ejpb.2017.01.001},
  volume       = {114},
  year         = {2017},
}

Chicago
Van Bockstal, Pieter-Jan, Séverine Mortier, Laurens De Meyer, Jos Corver, Chris Vervaet, Ingmar Nopens, and Thomas De Beer. 2017. “Mechanistic Modelling of Infrared Mediated Energy Transfer During the Primary Drying Step of a Continuous Freeze-drying Process.” Ed. Pieter-Jan Van Bockstal. European Journal of Pharmaceutics and Biopharmaceutics 114: 11–21.
APA
Van Bockstal, P.-J., Mortier, S., De Meyer, L., Corver, J., Vervaet, C., Nopens, I., & De Beer, T. (2017). Mechanistic modelling of infrared mediated energy transfer during the primary drying step of a continuous freeze-drying process. (P.-J. Van Bockstal, Ed.)European Journal of Pharmaceutics and Biopharmaceutics , 114, 11–21.
Vancouver
1.
Van Bockstal P-J, Mortier S, De Meyer L, Corver J, Vervaet C, Nopens I, et al. Mechanistic modelling of infrared mediated energy transfer during the primary drying step of a continuous freeze-drying process. Van Bockstal P-J, editor. European Journal of Pharmaceutics and Biopharmaceutics . Elsevier BV; 2017;114:11–21.
MLA
Van Bockstal, Pieter-Jan, Séverine Mortier, Laurens De Meyer, et al. “Mechanistic Modelling of Infrared Mediated Energy Transfer During the Primary Drying Step of a Continuous Freeze-drying Process.” Ed. Pieter-Jan Van Bockstal. European Journal of Pharmaceutics and Biopharmaceutics 114 (2017): 11–21. Print.