速崩壊錠の崩壊試験法に関する検討

概要

論文の詳細を見る
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^<[O!R]> 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^<[O!R]> were less than 20% . We next investigated the disintegration time of the tablets put on the tongue in frve healthy volunteers. A significant correlation between the in vitro test using the Distopper^<[O!R]> 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, pp<0. 001). These results suggest that the disintegration test of the rapidly-disintegrating tablets using the Distopper^<[O!R]> accurately reflects the disintegration profiles in the oral cavity.
日本医療薬学会の論文
2001-12-10