A novel dosage form (xerogel pill) with dose-adjusting and swallow-assisting functions has been developed by using the drop freeze-drying (DFD) technique. The pills were small spherical dosage forms with a bilayer structure consisting of an inner drug core and an outer dried-gel layer, but did not have enough physical strength due to their porous structure. In our previous research, the strength of pills has been significantly improved by blending one of oligosaccharides as an excipient, which causes candy forming (candization) under humidification. As an alternative approach to hardening the pills, we attempted to make the pills heavier by increasing the sugar alcohol concentration in the droplets during the DFD process. Mannitol (MNT) and erythritol (ERT) were co-applied as a filler of the pill to avoid the solubility limitation in water. It was found the resultant pills have enough physical durability for practical use, and maintain the original lubricant sliding performance during motion under wet conditions. In addition, the xerogel pills can be gelled and disintegrated quickly in the oral cavity, regardless of their formulation (sugar alcohol loading or their ratio). The novel product is expected to be commercialized as a new dosage form in the pediatric and geriatric fields.
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