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Potential Application of USP Paddle and Basket Dissolution Methods in Discriminating for Portioned Moist Snuff and Snus Smokeless Tobacco Products

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Abstract

The focus of the study was to develop discriminatory dissolution methods for portioned snus and moist snuff sub-categories of smokeless tobacco products (STPs) using USP basket and paddle apparatuses. Skoal Classic Wintergreen (SCW) and CORESTA CRP1.1 pouches were used as test products. The dissolution was performed at 10, 20, 30, 40, and 50 rpm basket or paddle speed in 500 ml artificial saliva pH 6.8. The products were also characterized for assay, pH, particle size, and loss on drying. The dissolution profiles were evaluated for amount/% of nicotine dissolved, time to reach plateau, and profiles comparison by f2 and f1 factors. The nicotine assay was 13.3 ± 0.2 and 7.6 ± 0.1 mg/pouch for SCW and CRP1.1, respectively. The nicotine dissolved in 30 min from SCW and CRP1.1 were 38.4–81.8 and 37.6–88.1, and 50.5–64.9 and 72.3–92.1% by paddle and basket methods, respectively. The f2 and f1 values were ≤ 39.2 and ≥ 42.1 and ≤ 43.2 and ≥ 34.1 for basket methods and paddle methods. RSD were less than 20% at all points of dissolution profiles, and dissolution plateau were achieved in 30 min at some of the tested conditions. In summary, dissolution methods based on basket and paddle can be used as a performance test for STPs.

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Acknowledgments

We would like to acknowledge Drs. Mimy Young, Charles Feng, Todd Cecil of the Division of Product Science, Office of Science, Center for Tobacco Products, Food and Drug Administration, for their constructive comments and suggestions.

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Authors and Affiliations

  1. Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, Reynolds Medical Building, Suite 159, College Station, Texas, 77843-1114, USA

    Ziyaur Rahman, Sathish Dharani, Tahir Khuroo & Mansoor A. Khan

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  1. Ziyaur Rahman
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  2. Sathish Dharani
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  3. Tahir Khuroo
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  4. Mansoor A. Khan
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Correspondence to Mansoor A. Khan.

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Rahman, Z., Dharani, S., Khuroo, T. et al. Potential Application of USP Paddle and Basket Dissolution Methods in Discriminating for Portioned Moist Snuff and Snus Smokeless Tobacco Products. AAPS PharmSciTech 22, 51 (2021). https://doi.org/10.1208/s12249-020-01894-8

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