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.
From batch to continuous: freeze-drying of suspended vials for pharmaceuticals in unit-doses / Capozzi, Luigi C.; Trout, Bernhardt L.; Pisano, Roberto. - In: INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH. - ISSN 0888-5885. - STAMPA. - 58:4(2019), pp. 1635-1649. [10.1021/acs.iecr.8b02886]
From batch to continuous: freeze-drying of suspended vials for pharmaceuticals in unit-doses
Capozzi, Luigi C.;Pisano, Roberto
2019
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.File | Dimensione | Formato | |
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https://hdl.handle.net/11583/2731507
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