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Dual chamber cartridges in a continuous pharmaceutical freeze-drying concept : determination of the optimal dynamic infrared heater temperature during primary drying

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Abstract
The applicability of DCCs in a continuous freeze-drying concept based on spin freezing and infrared heating was evaluated. Maximum applicable filling volume was evaluated. Secondly the mechanistic model for the determination of the optimal dynamic infrared heater temperature during primary drying of regular vials during continuous freeze-drying was adapted and validated for DCCs. Finally, since spin frozen DCCs may be more prone to choked flow due to the small neck opening and the large product surface area, it was evaluated if the choked flow constraints in the model could be increased to improve the efficiency of the drying process. The experiments revealed that the maximum allowable filling volume for spin freezing at the current experimental setup was 0.8 ml which is 80% of the maximum filling volume. Applying the mechanistic model for the determination of the optimal dynamic infrared heater temperature during primary drying of the studied DCCs and experimentally verifying this determined infrared heater temperature trajectory resulted in an elegant freeze-dried product without visual signs of collapse. The experimentally determined primary drying time agreed with the one calculated based on the mechanistic model. Choked flow did not occur during the continuous freeze-drying of DCCs containing 3% sucrose or 3% mannitol.
Keywords
DESIGN, Continuous freeze-drying, Dual chamber cartridge, Infrared radiation, Choked flow, Spin freezing

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MLA
De Meyer, Laurens, et al. “Dual Chamber Cartridges in a Continuous Pharmaceutical Freeze-Drying Concept : Determination of the Optimal Dynamic Infrared Heater Temperature during Primary Drying.” INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 570, 2019, doi:10.1016/j.ijpharm.2019.118631.
APA
De Meyer, L., Lammens, J., Vanbillemont, B., Van Bockstal, P.-J., Corver, J., Vervaet, C., … De Beer, T. (2019). Dual chamber cartridges in a continuous pharmaceutical freeze-drying concept : determination of the optimal dynamic infrared heater temperature during primary drying. INTERNATIONAL JOURNAL OF PHARMACEUTICS, 570. https://doi.org/10.1016/j.ijpharm.2019.118631
Chicago author-date
De Meyer, Laurens, Joris Lammens, Brecht Vanbillemont, Pieter-Jan Van Bockstal, Jos Corver, Chris Vervaet, Wolfgang Friess, and Thomas De Beer. 2019. “Dual Chamber Cartridges in a Continuous Pharmaceutical Freeze-Drying Concept : Determination of the Optimal Dynamic Infrared Heater Temperature during Primary Drying.” INTERNATIONAL JOURNAL OF PHARMACEUTICS 570. https://doi.org/10.1016/j.ijpharm.2019.118631.
Chicago author-date (all authors)
De Meyer, Laurens, Joris Lammens, Brecht Vanbillemont, Pieter-Jan Van Bockstal, Jos Corver, Chris Vervaet, Wolfgang Friess, and Thomas De Beer. 2019. “Dual Chamber Cartridges in a Continuous Pharmaceutical Freeze-Drying Concept : Determination of the Optimal Dynamic Infrared Heater Temperature during Primary Drying.” INTERNATIONAL JOURNAL OF PHARMACEUTICS 570. doi:10.1016/j.ijpharm.2019.118631.
Vancouver
1.
De Meyer L, Lammens J, Vanbillemont B, Van Bockstal P-J, Corver J, Vervaet C, et al. Dual chamber cartridges in a continuous pharmaceutical freeze-drying concept : determination of the optimal dynamic infrared heater temperature during primary drying. INTERNATIONAL JOURNAL OF PHARMACEUTICS. 2019;570.
IEEE
[1]
L. De Meyer et al., “Dual chamber cartridges in a continuous pharmaceutical freeze-drying concept : determination of the optimal dynamic infrared heater temperature during primary drying,” INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 570, 2019.
@article{8655321,
  abstract     = {{The applicability of DCCs in a continuous freeze-drying concept based on spin freezing and infrared heating was evaluated. Maximum applicable filling volume was evaluated. Secondly the mechanistic model for the determination of the optimal dynamic infrared heater temperature during primary drying of regular vials during continuous freeze-drying was adapted and validated for DCCs. Finally, since spin frozen DCCs may be more prone to choked flow due to the small neck opening and the large product surface area, it was evaluated if the choked flow constraints in the model could be increased to improve the efficiency of the drying process. The experiments revealed that the maximum allowable filling volume for spin freezing at the current experimental setup was 0.8 ml which is 80% of the maximum filling volume. Applying the mechanistic model for the determination of the optimal dynamic infrared heater temperature during primary drying of the studied DCCs and experimentally verifying this determined infrared heater temperature trajectory resulted in an elegant freeze-dried product without visual signs of collapse. The experimentally determined primary drying time agreed with the one calculated based on the mechanistic model. Choked flow did not occur during the continuous freeze-drying of DCCs containing 3% sucrose or 3% mannitol.}},
  articleno    = {{118631}},
  author       = {{De Meyer, Laurens and Lammens, Joris and Vanbillemont, Brecht and Van Bockstal, Pieter-Jan and Corver, Jos and Vervaet, Chris and Friess, Wolfgang and De Beer, Thomas}},
  issn         = {{0378-5173}},
  journal      = {{INTERNATIONAL JOURNAL OF PHARMACEUTICS}},
  keywords     = {{DESIGN,Continuous freeze-drying,Dual chamber cartridge,Infrared radiation,Choked flow,Spin freezing}},
  language     = {{eng}},
  pages        = {{10}},
  title        = {{Dual chamber cartridges in a continuous pharmaceutical freeze-drying concept : determination of the optimal dynamic infrared heater temperature during primary drying}},
  url          = {{http://dx.doi.org/10.1016/j.ijpharm.2019.118631}},
  volume       = {{570}},
  year         = {{2019}},
}

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