Role of binders in moisture-induced hardness increase in compressed tablets and its effect on in vitro disintegration and dissolution.

The role of commonly used binders in the moisture-induced hardness increase in compressed tablets containing lactose as a major excipient was studied. Tablets compressed from granulations containing different binders at different moisture levels increased in hardness after overnight exposure to ambient room conditions. The results suggest that this hardness increase is related linearly to the amount of moisture loss from the tablets after compression. The magnitude of the hardness increase is related to the type and concentration of the binder used in wet granulation. The moisture-induced hardness increase in tablets prepared from granulations containing different binders had no effect on the tablet disintegration time and in vitro drug dissolution.