Evaluation on Disintegration Tests of Rapidly-Disintegrating Tablets

• Published in: Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences) Vol. 27; no. 6; pp. 553 - 558
• Main Authors: Ogata, Kenji, Takamura, Norito, Kashiwagi, Satsuki, Hamada, Ryuichiro, Kodama, Hirofumi, Arimori, Kazuhiko
• Format: Journal Article
• Language: Japanese; English
• Published: Japanese Society of Pharmaceutical Health Care and Sciences 2001
• Subjects: disintegration test; disintegration time; Distopper; rapidly-disintegrating tablet
• ISSN: 1346-342X; 1882-1499
• DOI: 10.5649/jjphcs.27.553

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.