Wang J T, Shiu G K, Ong-Chen T, Viswanathan C T, Skelly J P
Biopharmaceutics Research Branch, Food and Drug Administration, Washington, DC 20204.
J Pharm Sci. 1993 Oct;82(10):1002-5.
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 degrees 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 disintegration and dissolution. The dissolution rates of some batches of CBZ products exposed to 97% humidity at 40 degrees C or saturated water vapor at room temperature were drastically reduced in only 6-7 days.
将各种已批准上市的卡马西平（CBZ）片剂在室温和40摄氏度下分别暴露于相对湿度为33%、52%、75%和97%的环境中，以及在室温下暴露于饱和水蒸气环境中，然后将其溶解速率和程度与新鲜的未受应力的片剂进行比较。溶解数据表明，CBZ片剂暴露于高湿度和高温环境中会对片剂的崩解和溶解产生深远影响。一些批次的CBZ产品在40摄氏度下暴露于97%湿度环境或在室温下暴露于饱和水蒸气环境中，仅6 - 7天其溶解速率就大幅降低。
