A Randomized Crossover Clinical Study to Assess the Effect of Oral Nicotine Pouches Used for Different Durations on Plasma Nicotine Pharmacokinetics in Healthy Oral Pouch Consumers.

ABSTRACT: Oral nicotine pouches (NPs), although addictive and not risk-free, have potential application for a tobacco harm reduction approach. This study aims to further characterize their ability to deliver nicotine effectively. This randomized seven-way crossover PK study in healthy oral pouch consumers evaluated 11 and 20 mg NPs used for 10, 20, and 30 min, and for 30 min with expulsion of saliva. Used pouches were analyzed for extracted nicotine, flavor components, and sweeteners. The C_max and AUC_0-4 h increased with nicotine strength and usage time (18.9-21.6 and 26.7-33.6 ng/mL; 24.6-43.0 and 36.4 to 65.6 h ng/mL for the 11 and 20 mg NPs, respectively). Extracted nicotine was greater for the 11-mg than for the 20-mg NP, (10 min, 28.0% vs. 22.4%; 20 min, 35.8% vs. 29.6%; 3

SUBMITTER: Azzopardi D 

PROVIDER: S-EPMC12709140 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature