Evaluation on Disintegration Tests of Rapidly-Disintegrating Tablets.

The present study was aimed at establishing a method to evaluate the disintegration of commercially available rapidly-disintegrating tablets. We performed disintegration tests using three procedures based on JP XIV : using an accessory disk on the usual basket, not using an accessory disk on the usual basket, and using the Distopper® which is an apparatus for recognizing the disintegration time using an electron sensor. The coefficient of variation (C.V.) values were over 20% in both the tests with and without an accessory disk on the usual basket, whereas those in the test using the Distopper® were less than 20%. We next investigated the disintegration time of the tablets put on the tongue in five healthy volunteers. A significant correlation between the in vitro test using the Distopper® and the in vivo test using the volunteers in the disintegration time was observed (r= 0.60, p< 0.05). The correlation increased when their disintegration times were limited to within 30 sec (r = 0.75, p< 0.001). These results suggest that the disintegration test of the rapidly-disintegrating tablets using the Distopper® accurately reflects the disintegration profiles in the oral cavity.