Free volume of lyophilized formulations containing polysaccharides with varying dextrose equivalent

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Abstract
This study investigates the influence of polysaccharides with varying dextrose equivalent on the free volume and pharmaceutical stability of lyophilized formulations. Free volume, estimated from the ortho-positronium pick-off annihilation lifetime using positron annihilation lifetime spectroscopy, was used as a proxy for the molecular mobility of the formulation matrices and their stability. Formulations containing polysaccharides with higher dextrose equivalent, such as maltodextrin, exhibited reduced free volume and enhanced stability. Furthermore, the addition of a sugar or a polyol to these formulations was found to be effective, producing even smaller free volume. These findings underscore the potential for rational excipient design based on the dextrose equivalent to improve formulation stability.

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