Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2487668 | Journal of Pharmaceutical Sciences | 2007 | 6 Pages |
Abstract
The purpose of this study was to evaluate sodium chlorideâsucrose frozen solutions with regard to sodium chloride crystallization and vial strain. Sodium chlorideâsucrose solutions were studied using Differential Scanning Calorimetry (DSC) and a strain gauge instrumented vial. The sodium chloride concentration was varied with a fixed concentration of sucrose to identify a composition where crystallization was observed during heating and this composition was examined using the strainâgauged vials. DSC heating thermograms of a 1:1 (w/w) ratio of sodium chloride-sucrose solution show a sodium chloride crystallization exotherm at approximately â45°C. Examination of this composition in a strainâgauged vial shows an increase in strain, which corresponds to the temperature of the exotherm. Vial breakage is a phenomenon reported for mannitol containing solutions, which is associated with crystallization of mannitol in frozen solution. These data also suggest that vial strain and breakage is associated with the crystallization of solutes and the crystallization of water, which is released from the amorphous phase to form ice, and volume expansion. The results demonstrate the importance of understanding effect of excipient ratios, specifically in systems containing crystallizing and nonâcrystallizing excipients, and thermal history when developing freezeâdried formulations. © 2007 WileyâLiss, Inc. and the American Pharmacists Association J Pharm Sci 96: 1848-1853, 2007
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Authors
N. Milton, G. Gopalrathnam, G.D. Craig, D.S. Mishra, M.L. Roy, L. Yu,