Evaluation of Mucosal Tolerability by DDS through Nasal Mucosa Assessment in Case of Elcatonin

Abstract

Mucosal tolerability of a nasal spray containing elcatonin and absorption enhancer was assessed both in vitro and in vivo; (1) using the cultured human ciliated cells obtained during sinusitis surgery, results were analyzed under a differential interference microscope combined with a high speed video system, (2) using 9 healthy volunteers, the degree of local symptomatic irritation was evaluated, and the time course of the effect on mucociliary transport and rhinomanometry and plasma concentration of elcatonin and absorption enhancer after administration was determined. According to an analysis based on cell culture, nasal spray directly damage ciliated cells to an extent similar to other drugs already in clinical use. The trial on volunteers showed no harmful effects except for a slight stinging sensation and nasal discharge for a few minutes immediately after administration. Based on these results, the harmful effect of this nasal spray on the nasal mucosa seemed to be no greater than that of drugs commonly given intranasal administration currently in clinical use.