Modulating hygroscopicity and compression performance in chewable mannitol-xylitol tablets: Effects of relative humidity and magnesium stearate

Abstract

This study aims to investigate the effects of the relative humidity and formulation ratio on the hygroscopicity, tableting performance, and physical stability of polyols (mannitol and xylitol) as fillers in chewable tablets. To address the issues of hygroscopicity and sticking during tableting of chewable tablets containing polyol fillers, a systematic analysis was conducted by adjusting the ratio of mannitol and xylitol, and adding magnesium stearate (Mgst) as lubricant. The study investigated changes in hygroscopicity of the powder blends, tablet compressive force (F), and increment in ejection force (ΔEF) under varying humidity and formulation conditions. The porosity, tensile strength, and disintegration time of the tablets were also measured and analyzed to investigate the effects of humidity and formulation factors on tablet quality. The results indicate that increasing the mannitol content significantly reduces the hygroscopicity and moisture content of the powder blends. Higher levels of Mgst and mannitol improve the sticking issues in compression. However, an increase in mannitol content may decrease tablet porosity, leading to a longer disintegration time. Under high humidity conditions, increasing the amounts of mannitol can reduce the polymorphic transformation tendency of xylitol and enhance the hardness stability of the chewable tablets. This study reveals the significant effects of relative humidity and the mannitol-xylitol ratio on powder hygroscopicity, compaction performance, and tablet quality, providing a theoretical basis for optimizing formulations containing polyol fillers under controlled humidity conditions. The findings offer important references for adjusting process parameters in actual production, with particular guidance on improving tablet physical stability, anti-sticking performance, and disintegration control.