Abstract

Drug-loss in both the dispensing process and the ingestion of powdered-form tacrolimus (PGpowder) was studied, relating the therapeutic drug monitoring of tacrolimus in pediatric patients who have undergones a living-related donor liver transplantation. To simulate drug-loss during the ingestion PG-powder, three ingestion procedures were used ; i. e. a direct ingestion method, and two methods using either a medication-pipette or a medication-cup after suspending the drug with a 10% glucose solution.The drug-loss resulting from dispensing process was always within 1%. The weight variation of the powders divided by an automatic packaging machine for dispensing was found to be within 4%. The drug-loss resulting from the ingestion procedure was approximately 7% with the direct ingestion method, however, a large loss (ca. 15%) was observed in the case of the medication-cup procedure. This fact suggests that variations in the ingestion procedures therefore affect the blood concentration of tacrolimus.We thus conclude that a clear understanding of drug-loss in both the dispensing process and ingestion procedure before PG-powder administration is essential in order to perform appropriate therapeutic drug monitoring of tacrolimus to pediatric patients who have difficulty in swallowing capsules.

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