A controlled release pilocarpine buccal insert in the treatment of Sjogren's syndrome

Objectives To assess the efficacy of a novel hydrogel polymer buccal insert containing 5 mg pilocarpine in releasing the pilocarpine in a controlled fashion over a three hour period, and to assess the effects of this on quantitative tear and saliva production and the acceptability of the insert to the patient. Design This was an open, uncontrolled pilot study for which Ethics Committee approval was obtained prior to starting. Hydrogel buccal inserts containing 5 mg pilocarpine were used three times a day for seven days. Setting The Department of Oral Medicine, Glasgow Dental Hospital & School. Subjects Eight patients with Sjogren's syndrome. Main outcome measures Changes over baseline in ( 1) Schirmer test, ( 2) whole saliva flow rate, ( 3) oral comfort score ( VAS), ( 4) ocular comfort score ( VAS), ( 5) patient acceptability. Results The buccal inserts successfully released in excess of 85% of their 5 mg pilocarpine load over three hours. There was a general improvement in oral and ocular comfort scores assessed by visual linear analogue scale, and saliva and tear production generally increased. The inserts were well tolerated by all patients except one ( who wore dentures). Adverse events were few and none was serious. Conclusion This novel form of buccal pilocarpine delivery demonstrated potential for use in treating patients with Sjogren's syndrome.