EFFECTS OF HUMIDITY AND TEMPERATURE ON IN-VITRO DISSOLUTION OF CARBAMAZEPINE TABLETS

The rate and extent of dissolution of various approved marketed carbam azepine (CBZ) tablets exposed to 33, 52, 75, and 97% relative humiditi es at both room temperature and 40-degrees-C, and saturated water vapo r at room temperature were compared to fresh unstressed tablets. The d issolution data indicate that exposure of CBZ tablets to high humidity and temperature can have a profound effect on tablet disintegration a nd dissolution. The dissolution rates of some batches of CBZ products exposed to 97% humidity at 40-degrees-C or saturated water vapor at ro om temperature were drastically reduced in only 6-7 days.