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Pharmacokinetic characterization of three novel 4-mg nicotine lozenges?.

ABSTRACT: Nicotine replacement therapy (NRT) increases the probability of smoking cessation. This study was conducted to determine if three prototype 4-mg nicotine lozenges produced locally in India were bioequivalent to a globally marketed reference product, Nicorette® 4-mg nicotine lozenge.Healthy adult smokers (N = 39) were treated with three prototype 4-mg nicotine lozenges in comparison with a reference 4-mg lozenge in this single-center, randomized, open-label, single-dose, 4-way crossover study. Pharmacokinetic sampling was obtained to test for bioequivalence using maximal plasma concentration (Cmax) and extent of absorption (AUC0-t). Secondarily, AUC;0-?, time to maximal plasma concentration (tmax), half-life (T1/2), elimination rate constant (Kel), and safety of the prototype lozenges versus the reference lozenge were compared.Each prototype 4-mg nicotine lozenge was found to be bioequivalent to the reference 4-mg nicotine lozenge based on the ratio of geometric means and 90% confidence intervals for Cmax, AUC0-t, and AUC;0-?. Although tmax; was significantly longer for prototype III, all four lozenges achieved maximum plasma nicotine concentrations at a median of 1.5 hours. The safety profiles of the three prototype 4-mg lozenges did not differ from that of the 4-mg reference product.Each prototype 4-mg nicotine lozenge was bioequivalent to the reference 4-mg nicotine lozenge and was well tolerated. Furthermore, as these bioequivalent prototypes differed in in-vitro dissolution profiles, these data suggest that performance from the in -vitro method deployed is not a firm predictor of pharmacokinetic behavior.?.

SUBMITTER: Sukhija M

PROVIDER: S-EPMC5822134 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Pharmacokinetic characterization of three novel 4-mg nicotine lozenges .

Sukhija Manpreet M Srivastava Reena R Kaushik Aditya A

International journal of clinical pharmacology and therapeutics 20180301 3

<h4>Objective</h4>Nicotine replacement therapy (NRT) increases the probability of smoking cessation. This study was conducted to determine if three prototype 4-mg nicotine lozenges produced locally in India were bioequivalent to a globally marketed reference product, Nicorette® 4-mg nicotine lozenge.<h4>Materials and methods</h4>Healthy adult smokers (N = 39) were treated with three prototype 4-mg nicotine lozenges in comparison with a reference 4-mg lozenge in this single-center, randomized, op ...[more]

PMID: 29350176

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Project description:BackgroundLozenges containing lidocaine and cetylpyridinium chloride (CPC) are commonly used for the treatment of sore throat. The lidocaine acts locally to provide pain relief and the CPC has an antiseptic effect. Mebucaine CL, a well-established fixed-combination sore throat lozenge, contains 1 mg lidocaine and 2 mg CPC. Single-agent lozenges containing 8 mg lidocaine have also been demonstrated to be significantly superior to placebo in confirmatory pain intensity assessments. This study compared a new lozenge formulation, containing 8 mg lidocaine and 2 mg CPC, with the currently marketed lozenge for the treatment and relief of sore throat symptoms in subjects diagnosed with a sore throat due to an upper respiratory tract infection (URTI).MethodsIn this double-blind parallel-group study, 250 adults with a sore throat due to an URTI were randomized to receive a single lozenge containing either 8 mg lidocaine + 2 mg CPC (n = 125) or 1 mg lidocaine + 2 mg CPC (n = 125). The primary efficacy endpoint of the study was the change in sore throat pain intensity (STPI) between baseline (immediately pre-treatment) and the 2-h post-dose assessment, measured on a 100 mm visual analog scale. STPI was measured at baseline and regular intervals up to 240 min after the lozenge was administered (evaluated in clinic). Any difficulty in swallowing and time to onset and duration of the analgesic effect were also assessed.ResultsNo increase in efficacy was demonstrated with the higher dose of lidocaine. The difference in the 2-h post-dose change in STPI was not statistically significant between the treatments. There was only one statistically significant difference between the treatments in all of the efficacy outcomes assessed: pain relief scores at 4 h post-dose were higher with 1 mg lidocaine + 2 mg CPC than with 8 mg lidocaine + 2 mg CPC (P = 0.0461). The most commonly reported adverse event (AE) was a headache; the only other AE experienced by more than one subject was throat irritation. No severe adverse events were reported during the assessment period.ConclusionsThe modest difference in the pattern of effectiveness between the two treatments observed in this study does not support use of the 8 mg lidocaine + 2 mg CPC lozenge.Trial registrationClinicalTrials.gov, NCT01265446 . Registered on 20 December 2010.

Project description:IntroductionE-cigarette e-liquid nicotine concentrations typically are labeled as mg/mL or percent nicotine. We examined whether these metrics accurately convey nicotine strength to young e-cigarette users and if youth can compare concentrations presented in mg/mL and percent nicotine.Aims and methodsEight hundred and twenty-one adolescent and young adult e-cigarette users participated in the survey. Participants rated nicotine concentration strengths presented as mg/mL (0-60 mg/mL) and percent nicotine (0%-6%) from "no nicotine" to "very high nicotine." Participants also viewed pairs of nicotine concentrations (eg, 18 mg/mL vs. 5%) and indicated which concentration was stronger or if the concentrations were equivalent.ResultsOn average, participants correctly identified 5.92 (2.68) of 18 nicotine strengths, correctly identifying strengths labeled as mg/mL (3.47 [2.03]) more often than percent nicotine (2.45 [1.38], p < .001). Excluding nicotine-free, participants rated concentrations presented as mg/mL as stronger, more addictive, and more harmful than equivalent concentrations presented as percent nicotine. Participants seldom correctly identified that one concentration was stronger or that both were equivalent (7.58 [5.88] of 19 pairings), although they more often correctly identified the stronger concentration when it was presented in mg/mL (4.02 [SD = 3.01]) than in percent nicotine (2.53 [2.73], p < .001). The most consistent predictor of correct answers on these tasks was familiarity with using both products labeled as mg/mL and labeled as percent nicotine.ConclusionsYoung e-cigarette users had difficulty understanding nicotine concentrations labeled using the most common metrics, raising concerns about inadvertent exposure to high nicotine levels and suggesting that a more intuitive labeling approach is needed.ImplicationsThis study extends prior work showing that young e-cigarette users often are uncertain whether the e-liquids they use contain nicotine by demonstrating that adolescents and young adults have difficulty understanding nicotine concentrations labeled using the two most common metrics (mg/mL and percent nicotine). Errors generally underestimated nicotine strength, and users were not able to accurately compare nicotine concentrations presented as mg/mL and percent nicotine. Difficulty understanding labeling metrics persisted even after accounting for user characteristics like age and vaping experience, suggesting that a novel, easy to understand labeling system is needed to convey information about nicotine strength accurately.

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Pharmacokinetic characterization of three novel 4-mg nicotine lozenges?.

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Pharmacokinetic characterization of three novel 4-mg nicotine lozenges .

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Pharmacokinetic characterization of three novel 4-mg nicotine lozenges?.

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Pharmacokinetic characterization of three novel 4-mg nicotine lozenges .

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OmicsDI is part of the ELIXIR infrastructure

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Pharmacokinetic characterization of three novel 4-mg nicotine lozenges .