Assessment of buccal absorption of cilostazol 20% powder in healthy adult male subjects

Setsuo Hasegawa, Kazunori Saito, Michiko Kainuma, Kazuhiro Matsuki, Yoshinobu Yasuda, Seong Ryul Kim Kim, Naoko Shimofurutani, Eiichi Saitoh

Research output: Contribution to journalArticlepeer-review

Abstract

Cilostazol 20% powder is an orally disintegrated formulation that was newly developed for easier swallowing by patients with swallowing disorders that make it difficult for them to take cilostazol tablets with water. The buccal absorption of cilostazol 20% powder was evaluated in an open-label, randomized, 2-treatment, 2-period crossover study in 14 healthy adult male subjects by comparison of when cilostazol 20% powder was disintegrated in the mouth and swallowed and when it was held in the mouth for 3 minutes without swallowing and then spit out. Although the concentration of cilostazol recovered in the saliva and rinsing water collected from non-swallowing administration was 92.04%, being lower than the criteria of 95%, the mean ratios of the AUC60h and Cmax for non-swallowing administration to those for swallowing administration were respectively 0.05% and 0.08%, both being lower than 5%, the judgment criteria for buccal absorption. As the ratios of the AUC60h and Cmax 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 20% powder is orally administrated.

Original languageEnglish
Pages (from-to)73-79
Number of pages7
JournalJapanese Pharmacology and Therapeutics
Volume35
Issue number1
Publication statusPublished - 01-12-2007

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

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