Clinical Evaluation of Rapidly Disintegrating Tablets in Patients with Mild Dysphagia.
2003
Rapidly disintegrating tablets (“EMP-tablet”, developed by Eisai, Co., Ltd.) are developed based on a formulation that is expected to make the swallowing of medicines easier for patients with mild dysphagia. To evaluate the sensation of the oral administration of such “EMP-tablets”, the authors conducted a study in patients with mild dysphagia. After the administration of both “EMP-tablets” and uncoated compressed tablets of consisting of the same components and the same appearance (plain tablet), the sensation of their oral administration and other benefits such as size and so on, were compared for both tablets.The 25 subjects with mild dysphagia, who participated in the trial were asked to respond to the question “which tablet was easier to swallow?”. The rate of positive responses for the “EMP-tablet” was 76%, which was significantly better (p=0.0013) than the response for the “plain tablet”. Regarding the question about the size of a tablet, although only 28% responded “It is no problem” before oral administration, the response improved to 80% after oral administration. In addition, there was also a statistically significant difference (p=0.0096) in the ratio of patients who required less water for the oral intake of “EMP-tablets” than “plain tablets” (60% vs 16%).Consequently, in patients with mild dysphagia, the clinical benefits of “EMP-tablets” were clearly observed regarding the level of satisfaction during oral administration (tablet size and so on, as well as the required amount of drinking water) in comparison to “plain tablets”.
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