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), 2024. Published by Science Publishing Group |
Nicotine Gums, Mastication, UPLC-PDA, Nicotine Release Rates, Method Development
| [1] | Ling, P. M., et al., Moving targets: how the rapidly changing tobacco and nicotine landscape creates advertising and promotion policy challenges. Tobacco Control, 2022. 31 (2): p. 222. |
| [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. |
| [25] | FDA, Guidance for Industry: Dissolution testing of immediate release solid oral dosage forms. 1997. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dissolution-testing-immediate-release-solid-oral-dosage-forms |
| [26] | European Pharmacopoeia, General monograph on dosage forms. Chewing gums, medicated, drug release. 2002, European directorate for the quality of medicines, Council of Europe, Strasbourg. France. |
| [27] | Aldeek, F., et al., Dissolution Testing of Nicotine Release from OTDN Pouches: Product Characterization and Product-to-Product Comparison. Separations, 2021. 8 (1). |
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
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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Download@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}
}
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 PY - 2022 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 SP - 32 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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