Local tolerance of a sublingual nicotine tablet, an open single-centre study.
Nicotine replacement therapy (NRT) is now widely used in various forms of administration to aid cessation of tobacco use. In this smoking cessation programme, a new tablet formulation has been compared to and found bioequivalent to the existing one. The present trial was performed in order to investigate the local tolerance of the new sublingual tablet. The study was performed as a prospective follow-up study of 16 weeks' duration on smokers using the new tablet, Nicorette® Microtab, over a period of 12 weeks. Fifty smokers were included in the study and the oral mucosa was inspected and photographed at each visit. At 12 weeks, participants were asked for their consent to take a biopsy from the site of application. Compliance with tablet use was high, with participants using an average of 12 tablets/day throughout the 12 week treatment period. Adverse events related to treatment were mild and tolerable. The changes observed were classified as being induced by frictional stimuli, with no changes to the deeper layers of the epithelium, and no thickening of the basal layers of the epithelium. The new tablet was considered well tolerated during the course of this study, with a benign local effect on the mucous membrane that was consistent with lesions that are reversible in nature.