The Effect of Low- and High-Humidity Aging on the Hardness, Disintegration Time and Dissolution Rate of Tribasic Calcium Phosphate-Based Tablets

Abstract

The effect of low- and high-humidity aging on hardness, disintegration time and dissolution rate of tribasic calcium phosphate-based tablets prepared at different initial moisture levels was studied. The tablet hardness, disintegration time and dissolution rate of the drug changed only slightly on aging under low humidity when the moisture contents at the time of compression were low. At higher initial moisture levels, the tablet disintegration time decreased and the dissolution rate increased, although no change in tablet hardness occurred on aging under low humidity. The tablets containing lower initial moisture decreased in hardness, increased in disintegration time and decreased in dissolution rate on aging under high humidity. A small or variable change in hardness, a large increase in the disintegration time and a large decrease in the dissolution rate was seen in tablets containing higher initial moisture contents on aging under high humidity. The results indicate that the moisture content of the tablet granulation at the time of compression and moisture gained during aging plays a significantly important role on hardness, disintegration time and dissolution rate of tribasic calcium phosphate-based tablets.