Effect of a superdisintegrant on disintegration of orally disintegrating tablets determined by simulated wetting test and in vitrodisintegration test.

Abstract

The disintegration time is critical for characterizing orally disintegrating tablets (ODTs), according to regulatory standards. The current study aimed to assess the effect of superdisintegrants such as sodium starch glycolate, croscarmellose sodium, and crospovidone on the disintegration of ODTs using simulated wetting and in vitro disintegration tests. The results showed that the wetting time of ODTs containing sodium starch glycolate and croscarmellose sodium was 17 - 21 s, but the wetting time of ODTs containing crospovidone was 9 - 12 s. In contrast, there was no significant difference in in vitro disintegration time among ODTs using different disintegrants (ca. 14 to 18 s) The quick wetting time of ODTs with crospovidone may be attributed to strong capillary characteristics of crospovidone. It is suggested that determining the disintegration time of ODTs just through simulated wetting test is insufficient and may lead to biases. As a result of the findings, it is recommended that an additional disintegration test, imitating saliva fluid absorption and tablet breaking, to provide a more precise evaluation of ODTs.