Evaluation of Preference for Swallowing with Gel-coated Tablets

Abstract

Objective:　In this study, we devised and created tablets coated with a gel agent to facilitate their movement through the pharynx. Gel formulations have been marketed for this purpose; however, no studies have examined the ease of swallowing of these formulations in humans. Therefore, we used non-gel and gel formulations that lacked medicinal ingredients and compared the preference for swallowing by a sensory evaluation.

Methods:　A total of 100 subjects (28 males and 72 females, average age 29.0±9.7 years old) were selected; the subjects were healthy adults with normal swallowing functions. Four types of samples were tested: non-gel-based deformed tablets and mini tablets (hereafter, mini tabs) and gel-based deformed tablets and mini tabs. Tablets were randomly assigned to subjects and evaluated for preference for swallowing as: easy, simple, hard, and unable to swallow. The subjects also made a direct comparison between non-gel and gel formulations for each dosage form.

Results:　When the ease of swallowing of non-gel and gel formulations was compared for each dosage form using the Wilcoxon signed-rank test in three stages of “easy, simple, hard, or unable to swallow,” we found that both dosage forms of gel formulations were easier to swallow than the non-gel formulations (p＜0.05). The magnitude of the effect of the gel coating was moderate (r＝0.45) in deformed tablets and high (r＝ 0.60) in mini tabs. When directly compared using the χ² goodness of fit test, “gel formulations are easy to swallow” in both dosage forms was significantly higher than the sum of “non-gel formulations are easy to swallow” and “no difference” (p＜0.05).

Conclusion:　In healthy adults, both dosage forms of gel formulations were easier to swallow than nongel formulations. With the gel formulation, the tablets are in a state similar to being wrapped in jelly, which is believed to be the reason why they facilitate movement through the pharynx.