Effects of Humidity and Temperature on In Vitro Dissolution of Carbamazepine Tablets

□ The rate and extent of dissolution of various approved marketed carbamazepine (CBZ) tablets exposed to 33,52,75, and 97% relative humidities at both room temperature and 40 °C, and saturated water vapor at room temperature were compared to fresh unstressed tablets. The dissolution data indicate that exposure of CBZ tablets to high humidity and temperature can have a profound effect on tablet disinte-gration and dissolution. The dissolution rates of some batches of CBZ products exposed to 97% humidity at 40 °C or saturated water vapor at room temperature were drastically reduced in only 6—7 days.