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From Batch to Continuous: Freeze-Drying of Suspended Vials for Pharmaceuticals in Unit-Doses

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<mark>Journal publication date</mark>30/01/2019
<mark>Journal</mark>Industrial and Engineering Chemistry Research
Issue number4
Volume58
Number of pages15
Pages (from-to)1635-1649
Publication StatusPublished
<mark>Original language</mark>English

Abstract

In response to the current trend in the pharmaceutical industry, a new concept for the freeze-drying of pharmaceuticals in unit-doses is presented: the continuous freeze-drying/lyophilization of suspended vials. This configuration makes it possible to set up a continuous freeze-drying process that produces a final product with similar characteristics to those traditionally obtained by means of the batch process but which avoids the drawbacks of conventional, batch freeze-drying. The feasibility and advantages of this new concept are presented in this work. Continuous freeze-drying has been found to improve heat transfer uniformity and reduce the primary drying duration by 2-4 times. As far as the structure of lyophilized products is concerned, SEM micrographs of the lyophilized samples showed that this technology improves vial-to-vial and intravial homogeneity.