ゼラチンを用いたグミ製剤の調製

抄録

Drugs for oral ingestion are taken with water although package inserts often do not state this expectation explicity. It is, however, not uncommon that water is not available when oral drugs are to be administered to children who have developed acute fever or that patients refuse to take drugs because of their bitter taste, and hence cannot be treated appropriately. Bearing this in mind, we have recently developed, on a test scale, a preparation (named “Gummi Drug”) of acetaminophen (AAP) mixed in Gummi (a soft gel-type candy) as an orally administered medicine which can be taken without water and does not taste bitter. A Gummi Drug was manufactured under different conditions to explore the optimum conditions for preparing that which should be uniformaly distributed in the vehicle. We found that a suspension-type Gummi Drug (mixed AAP powder, named “SUS-Gummi”) of AAP can be manufactured with high distribution uniformity when the active ingredient is added at a temperature of 50°C and the drug is subjected to 24-h aging at 10°C using a plastic plate. In the case of a dissolution-type Gummi Drug (mixed after dissolving AAP in ethanol, named “DIS-Gummi”) of AAP, we also found that a method of manufacturing with high distribution uniformity was additional heating of 60°C and the same aging condition with SUS-Gummi. We suggest that DIS-Gummi was superior to SUS-Gummi in terms of uniform distribution, although about 0.5% ethanol remained in the former preparation.