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TSRC, Tob. Sci. Res. Conf., 2015, 69, abstr. 57

Pharmacopeia dissolution technique for the determination of nicotine and flavor release from smokeless tobacco products

MILLER J.; MILLER H.; SCHIBETTA R.; BROWN A.; DANIELSON T.; WAGNER K.A.; FLORA J.W.
Altria Client Services, Richmond, VA USA

Smoking machines were first developed to generate smoke from cigarettes for the purpose of comparing cigarette tar and nicotine yields under consistent conditions. Smoking machines with standardized puffing protocols have been used to measure the components in cigarette smoke for decades. There are no standardized methods for measuring the release of components in smokeless tobacco. The objective of this work was to develop a standardized dissolution technique for smokeless tobacco products using a SOTAX CE7 Smart USP-4 flow-through dissolution apparatus. The flow-through dissolution apparatus was configured for off-line collection of USP artificial saliva (no enzymes) with a pH of 6.8. The flow rate was 4 mL/minute, temperature was held at 37°C and fractions were collected (e.g., every 4 minutes) for 60 minute. The dissolution fractions were analyzed by GC/MS for flavor and nicotine release from pouch moist smokeless tobacco (MST) and snus products. Rates of release showed a quadratic distribution and a faster release of nicotine and flavors for pouch MST compared to snus. This technique demonstrated excellent reproducibility and can be applied to measure a variety of constituents that are released from smokeless tobacco for comparative and regulatory reporting purposes.