The bioequivalent and effect of nicotine formulation gum on smoking cessation

Abstract

Objective: To compare the absorption rate of nicotine in volunteer blood, and determine the clinical trial on smoking cessation. Material and Method: This method using reverse phase C18 column and buffer pH 5.05 as the mobile phase, flow rate 0.9 ml/min. The UV-visible detector found the retention time of nicotine in gum and volunteer blood was 5.0756 min. The linear calibration curves of nicotine in human blood were obtained over the concentration range of 2.0-20.0 μg/ml. The coefficient variability for Nicotine gum 6.74% (2 mg/g). Extraction recovery was over 86% in blood, correlation coefficient of determination (r2) > 0.9999 and the detection limit 0.0060 μg/ml. The 24 healthy volunteer men, 27 to 55 years of age, were habitual cigarette smokers. They were randomized into two groups,12 subjects chewed two 2 mg pieces, Nicomild-2 Sugar Free Gum (Millimed, Thailand), the other chewed two 2 mg, pieces, Nicorette Sugar Free(Pharmacia AB, Helsingborg, Sweden.)Volunteers' blood samples were withdrawn at 0, 15, 30, 40 min, concentration of nicotine in blood were measured by HPLC. The 199 subjects were openly recruited under the project of "The smoking cessation for Phor Laung" (5-December). All of them received Nicomild-2 (nicotine polyestex gum) between November 2007 and December 2007. Results: The absorption rate of nicotine in volunteers' blood Nicomild-2 and Nicorette at 0, 15, 30,40 minutes were 0, 51.84, 26.73, 21.012 and 0, 56.603, 21.83, 15.183 (ng / min). Both of them were found to have maximum absorption rate at 15 minutes. When comparing the maximum absorption rate at 15 minute of Nicomild-2 (sugar free) with Nicorette (sugar free) didn't have significant differences detected. Treatment with nicotine polyestex gum were reported 65.3% (130/199) at 4 weeks compared with failure 30.15% (60/199)[ 65.3% vs 30.15%; p = 0.005]. The authors found 9 (4.5%) subjects successfully quit smoking free nicotine replacement therapy (NRT).