粉末製剤の開栓・開封後の保存時における安定性評価 : インタビューフォームによる現状調査

The stability of powdery dosage forms of drugs prepared by unsealing the packages was investigated. For 247 articles purchased by the Yamanashi Medical University Hospital, the variables related to the evaluation of stability after unsealing these packages and investigating the contents based of an “Interview Form”. A longterm preservation test was carried out on 153 items (94%), and the mean length of the test was about 36 months. The acceleration and the severity tests were carried out using 17 items (10.4%) and 114 items (69.9%), respectively. The mean conditions of the acceleration test was 40°C/6 months, which agreed with the guidelines proposed by the “Drug Manufacturing Guidelines”. On the other hand, for the severity test, certain conditions for the evaluation could not be arranged, and testing was carried out under various conditions. In order to improve the efficiency of dispensing and the quality of life for patients, a further increased standardization of the testing conditions is recommended.