Abstract
Background Functional claim-associated foods contain raw materials that contribute to enhancing health in Japan. However, certain foods with functional claims fail to meet the disintegration test (DT) criteria of the Japanese Pharmacopoeia (JP). Objective This study assessed the quality of tablet-type, functional claim-associated foods containing Salacia-derived salacinol, using DT and weight variation (WV) tests. Methods DT and WV were conducted on functional foods (A, B, and C) sourced from three companies using samples stored either at room temperature (RT: 22-27 ℃) or in an incubator at 40 ± 2 °C and 75% ± 5% in relative humidity accelerated conditions (AC) for one, two, and four weeks, respectively. Results Samples A and C were compliant under all WV test conditions, whereas sample B was compliant except when stored in AC. DT results indicated compliance for sample A upon immediate opening and on storing for two and four weeks at RT, sample B for four weeks at RT, and sample C upon immediate opening, all AC, and stored for two and four weeks at RT. Conclusions Varied disintegration times may affect the release of functionally active ingredients into the body and their absorption from the gastrointestinal tract, potentially compromising their intended health benefits.