Ulcerative colitis is primarily a disease of non-smokers. 1±3 Two-thirds of ex-smokers with ulcerative colitis SUMMARY Background: Ulcerative colitis is predominantly a disease of non-smokers, and transdermal nicotine is therapeutic but often results in side-effects. Administration of nicotine as a liquid rectal enema results in less systemic nicotine absorption. Aim: To determine the safety and clinical response of nicotine tartrate liquid enemas for active left-side ulcerative colitis in a pilot study. Methods: Ten non-smoking patients with mildly to moderately active left-sided ulcerative colitis unresponsive to ®rst-line therapy were treated in an open protocol with nightly nicotine tartrate liquid enemas at a dose of 3 mg nicotine base for 1 week then 6 mg for 3 weeks. Clinical assessments were determined at baseline and 4 weeks by endoscopy, physician assessment and a patient diary of daily symptoms. Peak and trough serum nicotine and trough plasma cotinine were determined by gas chromatography/mass spectrometry and high performance liquid chromatography, respectively. Results: After 4 weeks of treatment, 5/7 patients (71%) showed clinical and sigmoidoscopic improvement (per

SUMMARYBackground: Ulcerative colitis is predominantly a disease of non-smokers, and transdermal nicotine is therapeutic but often results in side-effects. Administration of nicotine tartrate as a liquid enema decreases systemic nicotine absorption and may be effective for treatment of active distal ulcerative colitis. Ileocolonic delivery of nicotine tartrate via a delayed release oral capsule would be the preferred route to deliver nicotine to the colon. Aim: To determine the bioavailability and pharmacokinetic parameters of delayed-release oral nicotine tartrate capsules (Eudragit S100 coated) at doses of 3 mg and 6 mg nicotine. Methods: Twenty healthy human subjects received delayed-release oral nicotine tartrate at one of two doses (each group n 10): 3 mg and 6 mg nicotine. All subjects also received intravenous nicotine tartrate (at a dose of 15 lg nicotine base/kg) during a separate study period. Serum nicotine concentrations were determined by gas chromatography±mass spectrometry. In addition, concentrations of serum cotinine (major nicotine metabolite) were determined by high-

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