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Noncontact Infrared-Mediated Heat Transfer During Continuous Freeze-Drying of Unit Doses.

Authors
  • Van Bockstal, Pieter-Jan1
  • De Meyer, Laurens1
  • Corver, Jos1
  • Vervaet, Chris2
  • De Beer, Thomas3
  • 1 Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent 9000, Belgium. , (Belgium)
  • 2 Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Ghent University, Ghent 9000, Belgium. , (Belgium)
  • 3 Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent 9000, Belgium. Electronic address: [email protected] , (Belgium)
Type
Published Article
Journal
Journal of Pharmaceutical Sciences
Publisher
Elsevier
Publication Date
Jan 01, 2017
Volume
106
Issue
1
Pages
71–82
Identifiers
DOI: 10.1016/j.xphs.2016.05.003
PMID: 27321237
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Recently, an innovative continuous freeze-drying concept for unit doses was proposed, based on spinning the vials during freezing. An efficient heat transfer during drying is essential to continuously process these spin frozen vials. Therefore, the applicability of noncontact infrared (IR) radiation was examined. The impact of several process and formulation variables on the mass of sublimed ice after 15 min of primary drying (i.e., sublimation rate) and the total drying time was examined. Two experimental designs were performed in which electrical power to the IR heaters, distance between the IR heaters and the spin frozen vial, chamber pressure, product layer thickness, and 5 model formulations were included as factors. A near-infrared spectroscopy method was developed to determine the end point of primary and secondary drying. The sublimation rate was mainly influenced by the electrical power to the IR heaters and the distance between the IR heaters and the vial. The layer thickness had the largest effect on total drying time. The chamber pressure and the 5 model formulations had no significant impact on sublimation rate and total drying time, respectively. This study shows that IR radiation is suitable to provide the energy during the continuous processing of spin frozen vials. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

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