EFFECT OF PRODUCTION-RELATED VARIATIONS IN HARDNESS AND MOISTURE-CONTENT ON THE SORPTION CHARACTERISTICS OF TABLETS

Two placebo tablet formulations with conventional tablet excipients we re prepared using a wet granulation method. For each formulation, the granule drying and tablet compression processes were varied to produce tablets with three different hardness levels and three different mois ture contents. The tablets were stored at 25-degrees-C, at seven diffe rent relative humidity levels. When the samples had attained their equ ilibrium moisture content, the sorption isotherms were determined and then correlated with the changes in hardness, thickness, diameter and disintegration time which had taken place simultaneously. The results showed that sorption characteristics were significantly affected by va riations in initial moisture content but not by variations in initial hardness. The potential usefulness of these results for predicting the physical stability of tablet formulations was examined by repeating t he sorption studies under three different sets of storage conditions.