Studies on Development of Dosage Form for Pediatric Use (No.4) Time Courses of Plasma Concentration of Acetaminophen after Oral Administration of Gummi Drug and Powder Preparation in Dogs

Abstract

In order to achieve an increased compliance in infant patients, we have developed a dosage form which is masticable, has no bitter taste, and can be administered to infant patients without water. Gummi is defined as a gel confectionery made of sugars and gelatin, and Gummi Drug is defined as a gel preparation manufactured by adding a drug to Gummi. We have previously reported the method to prepare Gummi Drug of acetaminophen (AAP), characteristics in the release of AAP from Gummi Drug and the stability of Gummi Drug.^1-3)

In this study, we administered an 8-fold divided, masticated model of Gummi Drug (8DG) and an AAP powder preparation to dogs orally. The plasma concentration changes of AAP were followed, and the pharmacokinetic parameters in the 8DG and AAP powder preparation were calculated.

The AUC_0-6, AUC_0-∞ and C_max after the administration of 8DG were found to be lower than those after the administration of AAP powder preparation, and the T_max after the administration of 8DG was longer than that after the administration of AAP powder preparation. However, there was no statistically significant difference in the pharmacokinetic parameters between 8DG and AAP powder preparation. Variations in the plasma concentration after the administration of 8DG were smaller than those after the administration of AAP powder preparation, suggesting that constant absorption of AAP in the digestive tract was achieved from 8DG.