The effect of relative humidity and formulation variables on chewable xylitol-sorbitol tablets.

Changing relative humidity levels challenge the manufacturing of chewable xylitol-sorbitol based tablets. The aim of the study is to investigate how the formulation of chewable xylitol-sorbitol tablets affects the properties of the powder blends and the tablets in an environment of different relative humidity levels. In all, 30 batches containing different ratios of sorbitol, xylitol and magnesium stearate were prepared at three different relative humidity levels. Powder blends were made into tablets using an instrumented eccentric tableting machine. To demonstrate the effect of variables on powder blend and tablet properties, multiple linear regression analysis was performed. It was found that xylitol-sorbitol powder blends and tablets benefitted from the large amount of magnesium stearate, and the high lubricant level negatively affected the quality of the tablets only at high relative humidity. In the presence of high environmental humidity, the amount of sorbitol in the powder mixture must be limited in order to prevent sticking whereas at low relative humidity, higher content of sorbitol is needed to decrease the friability of tablets. Results indicate that alternating relative humidity levels truly challenge the production of xylitol-sorbitol based tablets and if the humidity is not controllable, there is a need for additional filler-binders.