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...