抄録
In April 2015, the system of Foods with Functional Claims (FFC) was launched and consumers expected health benefits from
the FFC whose function was supported by scientific evidence. As the FFC guideline requires food manufacturers to keep the
amount of a functional component in the product more than the labeling amount, it is also desirable to test its disintegration and
dissolution in order to ensure the effectiveness of the FFC products. In this study, we focused on FFC products containing piperine
and monoglucosyl hesperidin as functional substances to perform the weigh variation, disintegration, and dissolution tests. In the
disintegration tests, two products (MGH-3 and 4) in uncoated tablet form failed to meet the acceptance criteria for drugs listed in
the Japanese Pharmacopoeia as well as for dietary supplements listed in the United States Pharmacopoeia. The dissolution test
method for FFC products needed modification from the general Pharmacopoeial method in order to evaporate and concentrate
the analyte. The dissolution rates of 5 FFC products dissolved in 1 or 2 hours in water were 82 ～ 118% of the labeled content and
at least 2 products met the acceptance criteria for dietary supplements listed in the United States Pharmacopoeia. These results
indicated that some FFCs products were put on the market with evidence-based functions despite the lack of disintegration.
Additionally, more investigation and discussion must be done for developing an adequate dissolution test method and criteria for
FFC products.
