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TSRC, Tob. Sci. Res. Conf., 2021, 74, abstr. 65

Dissolution testing of a novel non-tobacco long cut and pouch nicotine product

CARMINES E.(1); FRAISSINET L.(1); MARTIN A.(2); HANSON M.(3)
(1) Chemular Inc., Hudson, MI, USA; (2) Enthalpy Analytical, Richmond, VA, USA; (3) Black Buffalo Inc., Chicago, IL, USA

Smokeless tobacco products contain TSNAs and other HPHCs. Black Buffalo Inc. has designed a novel smokeless product that is based on a proprietary common non-tobacco agricultural commodity. The non-tobacco leaf is cured and processed like tobacco but does not contain TSNAs or PAHs. Tobacco derived nicotine is sprayed over the processed leaf. The products are available in two forms: loose (Long Cut) and fleece-portioned (Pouches). The filler material inside the Pouches products is the same as that used for the Long Cut products. Black Buffalo’s products are designed to emulate the organoleptic, ritualistic, and pharmacokinetic aspects of traditional smokeless products. The Black Buffalo products and two market comparators Copenhagen Long Cut Wintergreen and General Snus Wintergreen Portion White Large were tested by using methods similar to those described for dissolution testing of pharmaceuticals. The USP-4 apparatus was used with artificial saliva. Samples of all the study products were placed in the apparatus flow-through cells at a constant temperature of 37°C. A pump delivered a constant flow of artificial saliva for 100 minutes. The flow was sampled throughout the release period. The method followed the approach of Miller et al. 2020. The dissolution rate was faster for the Long Cut products (8% per minute) as compared to 1.67% per minute for the Pouch products. The dissolution extent (mg/unit) was similar for the Black Buffalo Long Cut products (range 7.0 to 9.2) as compared to Copenhagen Long Cut (8.7). The dissolution extent for the Black Buffalo Pouches was similar to the Long Cut products (7.8 – 8.7) but greater than the General Snus market comparator (4.4).