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TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 107

Method comparisons for particle size distribution and nicotine dissolution profiles in smokeless tobacco products

CUNNINGHAM C.K.(1); HANNA S.N.(1); KELLER C.L.(1); MEADOWS T.R.(2)
(1) RAI Services Company, Winston-Salem, NC, USA; (2) R.J. Reynolds Tobacco Company, Winston-Salem, NC, USA

In the ever-evolving regulatory environment in which tobacco manufacturers now operate, the need for innovation in regulatory research and method development is continual. One example of such research needs is a method for determining and comparing the tobacco particle size of products for regulatory purposes. If there are significant differences in particle size identified within the regulatory review process, scientists must justify these differences do not raise different questions of public health and as such, additional methods must be used and/or developed to respond accordingly. This work examined the particle size distributions of various smokeless tobacco products, including moist snuff tobacco and portioned moist snuff tobacco products. Additionally, nicotine dissolution was used to determine the correlation between particle size and rate of release of nicotine (if any) in a buffer solution. Particle size was determined via a sieve method utilizing multiple screen sizes in tandem to determine the particle size distribution of the tobacco products evaluated. Nicotine dissolution analysis was performed utilizing a dissolution apparatus 1 (App1; rotating basket) system under minimal rotation with an ammonium phosphate buffer solution (pH 7.4). Discussion will include statistical comparison of particle size distributions and corresponding dissolution profile comparisons, as well as dissolution analysis of portioned vs. non-portioned smokeless tobacco products. The relevance of particle size and surface area of smokeless tobacco products as compared to pharmaceuticals will also be discussed.