Abstract
In the previous paper (Jap. J. Hosp. Pharm., 9 (1), 14, 1983) it was reported that the commercially available ubidecarenone tablets showed various dissolution rates in the newly devised dissolution test, though they met the disintegration and content uniformity tests in J. P. X. In order to investigate the relationship between the results of such dissolution test and bioavailability of the tablets, 3 kinds of 10 mg ubidecarenone tablets, A-10-T1, A-10-T2, and B-10-SCT1 of which dissolution rates (min for T50) were high (0.5), medium (1.0) and low (10), respectively, were administered to healthy male subjects in dose of 2 tablets 3 times daily after meals for 8 to 14 days. Bioavailability of the tablets was evaluated on the basis of plasma levels of ubidecarenone (Ubiquinone-10, CoQ10).
When compared by a cross-over experiment using 14 subjects, A-10-T1 and B-10-SCT1 increased plasma levels of CoQ10 to 1.87 and 1.13 times after 4 days, and to 2.20 and 1.20 times after 8 days as high as the control level. On the other hand, when A-10-T2 was administered to 9 subjects, plasma levels of CoQ10 were 1.44 times after 4 days, 1.70 times after 7 days, and 1.61 times after 14 days higher than those of the control. Thus, the increase of plasma levels of CoQ10 by these three tablets corresponded with their dissolution rates. Consequently, it was suggested that the dissolution test described in the previous report is useful for estimation of bioavailability as well as quality control of ubidecarenone tablets.
