内容液飛散事例に基づく一般用軟カプセル製剤の取り扱い上の利便性に対する夏季環境の影響評価

抄録

We investigated the impact of temperature and humidity on the convenience of handling over-the-counter (OTC) soft capsule drugs. Following a report of capsule rupture and liquid leakage in Product A, we performed controlled experiments using five products, including Product A. Capsules in the press-through packaging were stored under various conditions (20℃ or 35℃; high or low humidity) and evaluated for elongation rate under pressure, rupture rate, moisture absorption, and ease of removal from press-through packaging.

Product A was significantly susceptible to high temperature and humidity conditions; all capsules ruptured after 14 days at 35℃ and high humidity. Moisture absorption was 2.40％, which was significantly higher than that of all other products (0.53％ – 1.26％), except for Product D (3.23％). Deformation under 10 N pressure increased markedly for Product A (1.575-fold), whereas the other products showed minimal change. Sensory testing revealed a substantial decline in the ease of removal of Product A (0.75 points vs. 5.0 at baseline): 17 of 24 capsules leaked during handling.

In conclusion, a certain commercially available product is suggested to exhibit changes in physical properties and handling convenience. Because purchasers may store OTC drugs for a long time, establishing information that enables pharmacists or registered sellers of OTC drugs to provide appropriate advice is necessary.