抄録
In this study, we examined the stability of Artist, Ubretid, Cardenalin, J Zoloft, Nu-Lotan, Micardis and Renivace tablets after removal from the press through package (PTP). Stability information for these tablets after removal from PTP is insufficient, although these tablets are frequently in clinical use. Test formulations were stored for 3 and 6 months at room temperature and humidity without artificial control, under fluorescent light and exposed to the atmosphere. These stabilities were evaluated by visual inspection, residual rate, a hardness test and a dissolution test. The content of the unchanged drug in Nu-Lotan tablets was significantly decreased at the 3rd and 6th months. Moreover, the tendency of content decreasing in Cardenalin and Renivace tablets was observed at the 3rd and 6th months. Hardness change was observed in Ubretid tablets at the 6th month. A significant reduction in hardness and an appearance change at the 3rd and 6th months were observed in the Renivace tablets. Moreover, mean dissolution time (MDT) of these tablets was significantly shortened. The change in quality of tablets after removal from PTP could cause a change in the effects and pharmacokinetic profiles of these drugs. Therefore, it is considered that the stability information in the unpackaged state requires enhancement.
