Assessment of buccal absorption of cilostazol 100-mg orally disintegrated tablets in healthy adult male subjects

Cilostazol orally disintegrated tablets (ODT) are a newly developed formulation for easier swallowing by patients with swallowing disorders that make it difficult for them to take tablets with water. The buccal absorption of cilostazol ODT was evaluated in an open-label, randomized, 2-treatment, 2-period crossover study in 14 healthy adult male subjects by comparison of when one cilostazol ODT was disintegrated in the mouth and swallowed and when it was held in the mouth for 3 minutes without swallowing and then spit out. The mean ratios of the AUC _60h and C _max for non-swallowing administration to those for swallowing administration were respectively 0.99% and 1.28%, both being lower than 5%, the judgment criteria for buccal absorption, and the recovery of cilostazol in the saliva and rinsing water collected from non-swallowing administration was 101.00%, being higher than the criteria of 95%. As the ratios of the AUC _60h and C _max for non-swallowing administration to those for swallowing administration met the judgment criteria, it was concluded that buccal absorption of cilostazol does not contribute to bioavailability when cilostazol ODT are orally administered.