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

被引:19
作者
WANG, JT
SHIU, GK
TING, OC
VISWANATHAN, CT
SKELLY, JP
机构
[1] US FDA,OFF GENER DRUGS,200 C ST,SOUTH WEST,WASHINGTON,DC 20204
[2] US FDA,BIOPHARMACEUT RES BRANCH,WASHINGTON,DC 20204
[3] US FDA,OFF RES RESOURCES,ROCKVILLE,MD 20857
关键词
D O I
10.1002/jps.2600821006
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
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.
引用
收藏
页码:1002 / 1005
页数:4
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