ソフトカプセルの硬さの数値化と温度,湿度の影響

概要

論文の詳細を見る
We investigated the cause of the softening of soft capsules in the present study and also established a method for the determination of soft capsule hardness using a durometer, an instrument used in JIS (Japanese Industrial Standards), as a means of testing toughness. The results obtained were more or less consistent with the tactile impression of the capsules. Under various humidity conditions, after removal from the press-through package (FTP), capsules showed softening within a few days, in a humidity-dependent manner, and temperature enhanced softening. For soft capsules kept in the FTP at room temperature, almost no change in softness was observed as a result of being isolated from humidity. Compared with soft capsules removed from the FTP, however, when under high temperature conditions, soft capsules still in the FTP exhibited enhanced softening. When the conditions were restored to the initial ones (room temperature, approximately 30% relative humidity) softened soft capsules tended to regain their toughness, except for those that were markedly softened or deformed. In other words, the present study clarified that changes in soft capsule toughness were due to absorption or desorption of moisture and temperature changes. In addition, the softening and hardening of soft capsules was found to be largely reversible.
日本医療薬学会の論文
2008-06-10