Abstract
Nicotine Mint Flavored Chewing Gums are used to aid smokers wishing to quit or reduce prior to quitting. The aim of these two studies was to determine the bioequivalence of two test and two reference formulations of Nicotine 2 mg and 4 mg Mint Flavored Chewing Gum. Both of these two studies were single dose, randomized, 2-period, 2âsequence, laboratory-blinded, crossover design conducted in two different set of 54 healthy adult Indian male subjects each under fasting conditions with a washout period of 8 days (for 2 mg study) and 9 days (for 4 mg study). Study formulations were administered after a 10-hour overnight fast. Blood samples for pharmacokinetic profiling were taken post-dose up to 24 hours. Safety was evaluated through the assessment of adverse events, and laboratory tests. Plasma concentrations of Nicotine were determined with a validated LC-MS/MS method. Bioequivalence between the products was determined by calculating 90% confidence intervals (90% CI) for the ratio of Cmax and AUC0-t values for the test and reference products, using logarithmic transformed data. The 90% CI of Nicotine were 93.71-113.45, 89.95-112.68 and 92.90-115.98 for Cmax, AUC0-t and AUC0-∞ respectively for Nicotine 2 mg Mint Flavored Chewing Gum study. The 90% CI of Nicotine were 88.68-102.76, 91.48-109.00 and 91.14-111.66 for Cmax, AUC0-t and AUC0-∞ respectively for Nicotine 4 mg Mint Flavored Chewing Gum study. Since the 90% CI for Cmax and AUC0-t were within the 80-125% interval, it was concluded that the two test and two reference formulations of Nicotine 2 mg and 4 mg Mint Flavored Chewing Gum are bioequivalent in their rate and extent of absorption.
Highlights
Smoking is the leading preventable cause of illness and premature death worldwide and increases the risk for cancer, cardiovascular and lung diseases, among others
Nicotine replacement therapy (NRT) helps smokers quit by providing nicotine at levels usually lower than those obtained through smoking and without the toxins contained in tobacco smoke
A total of 54 subjects were recruited in nicotine 2 mg chewing gum study, but only 47 subjects completed the study. 2 subjects dropped out from the study before dosing of period-1 and 5 subjects dropped out from the study before dosing of period-2 for personal reasons
Summary
Smoking is the leading preventable cause of illness and premature death worldwide and increases the risk for cancer, cardiovascular and lung diseases, among others. Some medications have been proven to help people to quit, with three licensed for this purpose in Europe and the USA: nicotine replacement therapy (NRT), bupropion, and varenicline. Nicotine replacement therapy (NRT) helps smokers quit by providing nicotine at levels usually lower than those obtained through smoking and without the toxins contained in tobacco smoke. If the patient smokes 20 or less cigarettes a day, 2 mg nicotine gum is indicated. The pharmacokinetics of Nicotine were evaluated in 54 healthy male subjects in both the two studies The aim of these two studies was to determine the Bioequivalence and to compare the pharmacokinetics of two test and two reference formulations of Nicotine 2 mg and 4 mg Mint Flavored Chewing Gum. Received January 04, 2016; Accepted January 10, 2016; Published January 17, 2016
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