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Nicotine Gums Mastication: Method Development and Product Comparisons

Received: 13 June 2022     Accepted: 28 June 2022     Published: 5 July 2022
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Abstract

Nicotine gums are a class of oral tobacco products that are tobacco-leaf free and come in a variety of flavors and different nicotine strengths. The release of nicotine from these gums is mainly triggered by a chewing process to create new surfaces for the continuous release of nicotine. The rate of nicotine release from these products strongly depends on the nicotine form, product physicochemical characteristics, and mastication parameters used to chew the products. In this work, we developed a discriminatory mastication method to study the release of nicotine from a variety of nicotine gum products using the European Pharmacopoeia (Ch. 2. 9. 25, apparatus B), DRT3 chewing apparatus. Mastication parameters including chewing stroke frequency and jaw gapping distance were systematically investigated. The optimized mastication method was used to characterize the release profiles of nicotine from three commercially available nicotine gum products, including Nicorette, Lucy, and Rogue gums. The cumulative percent nicotine release rates were found to be dependent on the product characteristics, showing differences when comparing Rogue to Lucy and Nicorette gums, and similarities when comparing Nicorette to Lucy gum products. Furthermore, the nicotine release profiles obtained from the same product brand at different nicotine strengths and flavors were found to be equivalent. These observations were further confirmed by analyzing the nicotine release profiles to calculate the difference factor (f1) and similarity factor (f2). The developed mastication method can be used as an important tool for product-to-product comparison, guiding product design, determining relative product performance, ensuring consistency during the manufacturing process, and supporting regulatory reporting.

Published in Science Journal of Analytical Chemistry (Volume 10, Issue 3)
DOI 10.11648/j.sjac.20221003.11
Page(s) 32-39
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2022. Published by Science Publishing Group

Keywords

Nicotine Gums, Mastication, UPLC-PDA, Nicotine Release Rates, Method Development

References
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[2] Aldeek, F. and M. A. Sarkar, Method Development and Applications for Reduced-Risk Products. Separations, 2022. 9 (3): p. 78.
[3] Johnson, M. W., W. K. Bickel, and A. P. Kirshenbaum, Substitutes for tobacco smoking: a behavioral economic analysis of nicotine gum, denicotinized cigarettes, and nicotine-containing cigarettes. Drug and Alcohol Dependence, 2004. 74 (3): p. 253-264.
[4] Fagerström, K. O. and K. Bridgman, Tobacco harm reduction: The need for new products that can compete with cigarettes. Addictive Behaviors, 2014. 39 (3): p. 507-511.
[5] Cyrus-Miller, H., et al. Characterization of Chew and Park Oral Tobacco Derived Nicotine Products. in Society For Research On Nicotine and Tobacco 27th Annual Meeting. 2021. Virtual.
[6] LUCY. Lucy Chew+Park ingredients. 2022 [cited 2022 April 7]; Available from: https://help.lucy.co/article/zii0mp8gc7-lucy-chew-park-ingredients
[7] Rogue Holdings, L. What type of nicotine is in Rogue? Is it different from other products? 2021 [cited 2022 April 7]; Available from: https://help.roguenicotine.com/hc/en-us/articles/360054561834-What-type-of-nicotine-is-in-Rogue-Is-it-different-from-other-products-
[8] Rogue Holdings, L. What ingredients are in Rogue? 2021 [cited 2022 April 7]; Available from: https://help.roguenicotine.com/hc/en-us/articles/360056384713-What-ingredients-are-in-Rogue-
[9] GlaxoSmithKline Group of Companies. Nicorette & NicoDerm Ingredients. 2022 [cited 2022 April 7]; Available from: https://www.nicorette.com/usage-science/ingredients/
[10] Centers for Disease Control and Prevention. How to Use Nicotine Gum. 2021 [cited 2022 April 7]; Available from: https://www.cdc.gov/tobacco/campaign/tips/quit-smoking/quit-smoking-medications/how-to-use-quit-smoking-medicines/how-to-use-nicotine-gum.html
[11] European Pharmacopoeia, Dissolution Test for Medicated Chewing Gums, General Monograph 2.9.25. 2012, European directorate for the quality of medicines, Council of Europe, Strasbourg. France.
[12] United States Pharmacopeia and National Formulary USP 41–NF 36, Nicotine Polacrilex Gum Monographs. 2018, The United States Pharmacopeial Convention, Inc., Rockville, MD.
[13] The United States Pharmacopeial Convention, Stage 6 Monograph Harmonization, 711 Dissolution. 2011. Available: https://www.usp.org/sites/default/files/usp/document/harmonization/gen-method/stage_6_monograph_25_feb_2011.pdf
[14] Gajendran, J., J. Kraemer, and P. Langguth. Suitability of In Vitro Drug Release Methodology for Medicated Chewing Gums through Demonstration of In Vitro In Vivo Relationship. in American Association of Pharmaceutical Scientists Annual Meeting and Exposition. 2009. Los Angeles, CA.
[15] Zieschang, L., et al., In Vitro Performance Testing of Medicated Chewing Gums. Dissolution Technologies, 2018. 25: p. 64-69.
[16] ERWEKA GmbH. Chewing Gum Tester DRT. 2022 [cited 2022 April 5]; Available from: https://www.erweka.com/products/dissolution-testers/chewing-gum-tester.html#
[17] Aslani, A. and S. Rafiei, Design, formulation and evaluation of nicotine chewing gum. Adv Biomed Res, 2012. 1: p. 57.
[18] Morjaria, Y., et al., In Vitro Release of Nicotine From Chewing Gum Formulations. Dissolution Technologies, 2004. 11: p. 12-15.
[19] Gajendran, J., J. Kraemer, and P. Langguth, In vivo predictive release methods for medicated chewing gums. Biopharm Drug Dispos, 2012. 33 (7): p. 417-24.
[20] Kvist, C., et al., Apparatus for studying in vitro drug release from medicated chewing gums. Int J Pharm, 1999. 189 (1): p. 57-65.
[21] Food and Drug Administration, Center for Tobacco Products, and Office of Science, Dissolution as a Critical Comparison of Smokeless Product Performance: SE Requirements and Recommendations for the Review of Dissolution Studies. 2016, Department of Health and Human Services.
[22] Miller, J. H., et al., Method development and validation of dissolution testing for nicotine release from smokeless tobacco products using flow-through cell apparatus and UPLC-PDA. J Chromatogr B Analyt Technol Biomed Life Sci, 2020. 1141: p. 122012.
[23] German Institute for Standardization, Determination Of The Colourfastness Of Articles For Common Use - Part 1: Test With Artificial Saliva. 2002, DIN V 53160-1 2002-10.
[24] Wang, Y., et al., Statistical comparison of dissolution profiles. Drug Development and Industrial Pharmacy, 2016. 42 (5): p. 796-807.
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Cite This Article
  • APA Style

    Fadi Aldeek, Vanessa Lopez, John H. Miller, Feng Gao. (2022). Nicotine Gums Mastication: Method Development and Product Comparisons. Science Journal of Analytical Chemistry, 10(3), 32-39. https://doi.org/10.11648/j.sjac.20221003.11

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    ACS Style

    Fadi Aldeek; Vanessa Lopez; John H. Miller; Feng Gao. Nicotine Gums Mastication: Method Development and Product Comparisons. Sci. J. Anal. Chem. 2022, 10(3), 32-39. doi: 10.11648/j.sjac.20221003.11

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    AMA Style

    Fadi Aldeek, Vanessa Lopez, John H. Miller, Feng Gao. Nicotine Gums Mastication: Method Development and Product Comparisons. Sci J Anal Chem. 2022;10(3):32-39. doi: 10.11648/j.sjac.20221003.11

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  • @article{10.11648/j.sjac.20221003.11,
      author = {Fadi Aldeek and Vanessa Lopez and John H. Miller and Feng Gao},
      title = {Nicotine Gums Mastication: Method Development and Product Comparisons},
      journal = {Science Journal of Analytical Chemistry},
      volume = {10},
      number = {3},
      pages = {32-39},
      doi = {10.11648/j.sjac.20221003.11},
      url = {https://doi.org/10.11648/j.sjac.20221003.11},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.sjac.20221003.11},
      abstract = {Nicotine gums are a class of oral tobacco products that are tobacco-leaf free and come in a variety of flavors and different nicotine strengths. The release of nicotine from these gums is mainly triggered by a chewing process to create new surfaces for the continuous release of nicotine. The rate of nicotine release from these products strongly depends on the nicotine form, product physicochemical characteristics, and mastication parameters used to chew the products. In this work, we developed a discriminatory mastication method to study the release of nicotine from a variety of nicotine gum products using the European Pharmacopoeia (Ch. 2. 9. 25, apparatus B), DRT3 chewing apparatus. Mastication parameters including chewing stroke frequency and jaw gapping distance were systematically investigated. The optimized mastication method was used to characterize the release profiles of nicotine from three commercially available nicotine gum products, including Nicorette, Lucy, and Rogue gums. The cumulative percent nicotine release rates were found to be dependent on the product characteristics, showing differences when comparing Rogue to Lucy and Nicorette gums, and similarities when comparing Nicorette to Lucy gum products. Furthermore, the nicotine release profiles obtained from the same product brand at different nicotine strengths and flavors were found to be equivalent. These observations were further confirmed by analyzing the nicotine release profiles to calculate the difference factor (f1) and similarity factor (f2). The developed mastication method can be used as an important tool for product-to-product comparison, guiding product design, determining relative product performance, ensuring consistency during the manufacturing process, and supporting regulatory reporting.},
     year = {2022}
    }
    

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  • TY  - JOUR
    T1  - Nicotine Gums Mastication: Method Development and Product Comparisons
    AU  - Fadi Aldeek
    AU  - Vanessa Lopez
    AU  - John H. Miller
    AU  - Feng Gao
    Y1  - 2022/07/05
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    N1  - https://doi.org/10.11648/j.sjac.20221003.11
    DO  - 10.11648/j.sjac.20221003.11
    T2  - Science Journal of Analytical Chemistry
    JF  - Science Journal of Analytical Chemistry
    JO  - Science Journal of Analytical Chemistry
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    EP  - 39
    PB  - Science Publishing Group
    SN  - 2376-8053
    UR  - https://doi.org/10.11648/j.sjac.20221003.11
    AB  - Nicotine gums are a class of oral tobacco products that are tobacco-leaf free and come in a variety of flavors and different nicotine strengths. The release of nicotine from these gums is mainly triggered by a chewing process to create new surfaces for the continuous release of nicotine. The rate of nicotine release from these products strongly depends on the nicotine form, product physicochemical characteristics, and mastication parameters used to chew the products. In this work, we developed a discriminatory mastication method to study the release of nicotine from a variety of nicotine gum products using the European Pharmacopoeia (Ch. 2. 9. 25, apparatus B), DRT3 chewing apparatus. Mastication parameters including chewing stroke frequency and jaw gapping distance were systematically investigated. The optimized mastication method was used to characterize the release profiles of nicotine from three commercially available nicotine gum products, including Nicorette, Lucy, and Rogue gums. The cumulative percent nicotine release rates were found to be dependent on the product characteristics, showing differences when comparing Rogue to Lucy and Nicorette gums, and similarities when comparing Nicorette to Lucy gum products. Furthermore, the nicotine release profiles obtained from the same product brand at different nicotine strengths and flavors were found to be equivalent. These observations were further confirmed by analyzing the nicotine release profiles to calculate the difference factor (f1) and similarity factor (f2). The developed mastication method can be used as an important tool for product-to-product comparison, guiding product design, determining relative product performance, ensuring consistency during the manufacturing process, and supporting regulatory reporting.
    VL  - 10
    IS  - 3
    ER  - 

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Author Information
  • Altria Client Services LLC, Richmond, USA

  • Altria Client Services LLC, Richmond, USA

  • Altria Client Services LLC, Richmond, USA

  • Altria Client Services LLC, Richmond, USA

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