Comparative study of calcium sulphate and cellulose based nicotine pouch on pharmacokinetics, pulse rate and nicotine extraction

Abstract This study presents a comparative analysis of nicotine pouches using calcium sulphate and cellulose as carrier materials. A randomized, controlled, cross-over nicotine pharmacokinetic study of 12 healthy volunteer subjects with the primary objective to evaluate the pharmacokinetics, pulse rate, and nicotine extraction efficiency of three different formulations: SERATEK 3 mg, SERATEK 6 mg, and dry ZYN 6 mg was conducted. SERATEK formulations utilized calcium sulphate, while ZYN contained cellulose as nicotine carrier. The study aims to address the need for rapid nicotine uptake, akin to facilitate replacement of smoking or vaping, by developing an innovative nicotine pouch with enhanced bioavailability. Results indicate that SERATEK formulations provide a faster initial release and higher nicotine uptake compared to ZYN, particularly within the first 5 min of use. ZYN showed about 60% uptake compared to SERATEK 6 mg and 90% compared to SERATEK 3 mg This rapid uptake is attributed to higher pH for nicotine loaded into calcium sulphate granules in the SERATEK formulations. In addition a slower dissolution rate of nicotine bitartrate in ZYN compared to SERATEK. The findings suggest that calcium sulphate-based nicotine pouches could offer a more effective alternative to traditional nicotine delivery methods, potentially driving a shift from smoking and vaping to nicotine pouches. Clinical trial registration The study has been registered at clinicaltrials.gov with ID: NCT06170138 at 2023-11-24.