Analytical, Modelling, and Experimental Studies of the Primary and Secondary Drying Stages of the Freeze-Drying of Pharmaceutical Crystalline and Amorphous Solutes

Abstract

A theory is constructed to describe quantitatively the dynamic behaviour of the primary and secondary drying stages of the freeze-drying of pharmaceutical crystalline and amorphous solutes. Dynamic and spatially multi-dimensional mathematical models of the primary and secondary drying stages of the freeze-drying of pharmaceutical crystalline and amorphous solutes are constructed and analyzed for (a) bulk freeze-drying in trays, and (b) lyophilization in vials. The models account for the removal of free and bound (sorbed) water and could also provide the geometric shape of the moving interface and its position. By using a pilot freeze-dryer, experimental data for the freeze-drying of Cloxacillin Monosodium Salt and Skim Milk in trays are obtained. The comparison of the theoretical results with the experimental data shows that the agreement between experiment and theory is good. The theoretical models presented in this work could be used to develop design conditions, operating conditions, and control strategies that could provide high drying rates and high quality assurance for the pharmaceutical material being freeze-dried. © 1994, Taylor & Francis Group, LLC. All rights reserved.

Department(s)

Chemical and Biochemical Engineering

International Standard Serial Number (ISSN)

1532-2300; 0737-3937

Document Type

Article - Journal

Document Version

Citation

File Type

text

Language(s)

English

Rights

© 2024 Taylor and Francis Group; Taylor and Francis, All rights reserved.

Publication Date

01 Jan 1994

Link to Full Text

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