2012 年 38 巻 9 号 p. 568-575
Orally disintegrating (OD) tablets have become widely used in clinical practice for the purpose of enhancing patient convenience and compliance. However, for 0.2-mg tamsulosin hydrochloride OD tablets packed by an automatic tablet packing machine under humid conditions, there is insufficient information about the quality of the tablets after the packages are opened and they are dispensed. The stability of tamsulosin hydrochloride OD tablets was examined after storage for 24 hrs, 14 days after opening the tablet packages, and 28 days after one-dose packaging of 5 companies under humid (25℃, 75% relative humidity) and non-humid conditions. After being stored under humid conditions for 24 hrs and 14 days after opening the tablet packages, the OD tablets of 2 companies were greatly affected in terms of their thickness, weight, and hardness as compared with the packed tablets that did not come into contact with humidity. Next, the tablets of one company stored for 28 days after one-dose packaging were found to be greatly impaired in relation to their hardness and friability, with the tablets partly broken along their edges. In conclusion, 4 products could be dispensed by an automatic tablet-packing machine and preserved using one-dose packaging under humid conditions. However, one among the 5 tested products should be used carefully in storage under humid conditions.