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TSRC, Tob. Sci. Res. Conf., 2022, 75, abstr. 51

Comparison of two apparatuses for nicotine dissolution testing in smokeless tobacco and tobacco-free nicotine containing portioned products

SPANN N.(1); CUNNINGHAM C.K.(1); WINNER T.L.(1); SHAH V.(2)
(1) R.J. Reynolds Tobacco Company, Winston-Salem, NC, USA; (2) Sotax Corporation, Westborough, MA, USA

Nicotine dissolution from oral tobacco products is required (as applicable) per FDA final rules for pre-market tobacco applications (PMTA) and substantial equivalence (SE) applications. Applications should demonstrate nicotine release profiles in percent per minute to characterize the amount of nicotine dissolved into the given media for a method over time. To date, there is no consensus method to measure the release rates of nicotine in tobacco products, particularly smokeless tobacco products. Traditional smokeless (loose and portioned moist snuff) products, Swedish-style snus products and tobacco-free nicotine containing portioned products were analyzed for nicotine dissolution rates using the U.S Pharmacopeia basket apparatus (Apparatus 1) and the flow-through cell apparatus (Apparatus 4). The nicotine release profiles of each product, using each apparatus, were compared using the difference factor (f1) and similarity factor (f2), according to the FDA’s Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms. It was determined that either apparatus is suitable for determining the rate of nicotine dissolution and that equivalency between the two apparatuses is dependent on sample matrix.