Method development and validation of dissolution testing for nicotine release from smokeless tobacco products using flow-through cell apparatus and UPLC-PDA

Miller, John H.; Danielson, Tim; Pithawalla, Yezdi B.; Brown, Anthony P.; Wilkinson, Celeste T.; Wagner, Karl A.; Aldeek, Fadi

doi:10.1016/j.jchromb.2020.122012

Cited by 19 publications

(13 citation statements)

References 43 publications

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“…Several different in vitro nicotine release methods have been proposed that are able to discriminate between different STPs, but common for these methods is that they all seem to substantially overpredict the nicotine release in vivo [13,20]. Therefore, this work sought to develop a discriminative and biorelevant in vitro method for nicotine release/dissolution from OTDN pouches and snus products and validate this with in vivo nicotine extraction data.…”

Section: Resultsmentioning

confidence: 99%

“…For STPs, such as snus and moist snuff, only limited literature on development of dissolution methods that are designed to discriminate between OTDN products or simulate in vivo nicotine release is available [10][11][12][13][14][15]. One of these studies utilizing the US Pharmacopeia type 4 apparatus (USP-4) (flow-through cell) method was able to discriminate between moist snuff and OTDN pouches [15].…”

Section: Introductionmentioning

confidence: 99%

“…One of these studies utilizing the US Pharmacopeia type 4 apparatus (USP-4) (flow-through cell) method was able to discriminate between moist snuff and OTDN pouches [15]. However, this method saw a 77% nicotine release from a Swedish-style snus pouch after 30 min, which greatly differs from the in vivo situation where only 31-46% nicotine extraction from the same product is reported after 1 h [13,[16][17][18]. As the amount of agitation on the products in the USP-4 is minimal, this inconsistency could be due to the amount of flow/volume of artificial saliva used in this method (4 mL/min) which is almost 10-fold higher than the unstimulated saliva flow rate (0.5 mL/min) [19].…”

Section: Introductionmentioning

confidence: 99%

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Introducing a Novel Biorelevant In Vitro Dissolution Method for the Assessment of Nicotine Release from Oral Tobacco-Derived Nicotine (OTDN) and Snus Products

Knopp

Kiil-Nielsen

Masser³

et al. 2022

Separations

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The rate at which oral tobacco-derived nicotine (OTDN) and snus pouches release nicotine into saliva is crucial to determine product performance. As no standardized method is available for this purpose, this study sought to develop a biorelevant dissolution method that could both discriminate between different products and predict in vivo behavior. Using a μDISS Profiler™ as a surrogate for the US Pharmacopoeia standard apparatuses and a custom-made sinker, nicotine release from an OTDN pouch product (ZYN® Dry Smooth) and a snus product (General® Pouched Snus White Portion Large) was determined in biorelevant volumes (10 mL) of artificial saliva. In addition, nicotine extraction in vivo was measured for both products. Strikingly, the method showed distinct dissolution curves for OTDN and snus pouches, and the nicotine release observed in vitro did not significantly differ from the nicotine extracted in vivo. The custom-made sinker was designed to accommodate both loose and pouched oral tobacco/nicotine products, and thus the proposed in vitro dissolution method is suitable to assess nicotine release from OTDN and snus pouches. Apart from providing individual dissolution curves, the method was also able to predict in vivo nicotine extraction. Thus, this method could serve as a (biorelevant) monograph for product equivalence studies.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Introducing a Novel Biorelevant In Vitro Dissolution Method for the Assessment of Nicotine Release from Oral Tobacco-Derived Nicotine (OTDN) and Snus Products

Knopp

Kiil-Nielsen

Masser³

et al. 2022

Separations

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“…This can be justified by pH restrictions, the nature of LC columns and complexity of the tobacco matrix that hinders analysis using this technique. In this sense, only a sensitive ultra-performance liquid chromatography coupled with photodiode array detector (UPLC-PDA) method was tested for quantitation of nicotine released from a variety of STPs, using a smart flow-through system and artificial saliva as dissolution medium (Miller et al 2020). Although significant advances have taken place in the last few years, many studies related to development of methods for nicotine analysis in tobacco and derived products had been established before the last 20 years.…”

Section: Nicotinementioning

confidence: 99%

Trends in Analytical Methods for Analysis of Tobacco Products: An Overview

Costa

Vasconcelos²,

Moura³

et al. 2022

R. Eletr. TECCEN

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Abstract. Currently, due to the strong trends in policies to reduce smoking, several concerns related to quality control and regulation of tobacco products have been raised, as a great variety of products are available to consumers in the market. Considering that development of robust and selective analytical methods for tobacco and derivative products has been an important and necessary task over the years, however laborious, due to the complexity of the matrices. This work presents an overview of advances, innovation, and trends in analytical methods, focused on the chromatographic analysis of nicotine, tobacco-specific nitrosamines (TSNAs), humectants, pesticides, polycyclic aromatic hydrocarbons (PAHs) and sugars in different tobacco products. Gas chromatography (GC) coupled with different detectors is widely used to analyze nicotine, humectants and TSNAs in tobacco leaves and derivative products, while liquid chromatography-tandem mass spectrometry (LC-MS/MS) has been frequently used to analyze TSNAs in mainstream cigarette smoke and smokeless tobacco products. Pesticides were mainly analyzed in tobacco using GC or LC coupled with mass detector (MS), while PAHs and sugars were generally analyzed in tobacco and smoke using LC-MS and GC-MS techniques, respectively. In addition to already established methods and despite the lack of a worldwide standardization of methods, significant efforts have been made to develop analytical procedures for a wide variety of tobacco products, with a broad range of innovative chromatographic methods available. In this sense, a potential trend is the possibility of simultaneous determination of multiple components aiming to reduce the analysis time. The present study examined the main works that developed or improved analytical methods for identifying and quantifying priority compounds in different tobacco matrices and aims to contribute to future research with this objective, in addition, to promoting standardization of technical terms used in this analytical area. It is noteworthy that some of the methods mentioned here have not been validated and further studies are needed in order to obtain reproducible analytical methods for regulatory purposes. Keywords: chromatography analyses; tobacco leaves; cigarette; cigarette smoke; smokeless tobacco products.

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“…Literature reported USP apparatus 4 for dissolution testing of STP reference products. 14 In this study, we developed and validated a discriminatory nicotine achieved on a Poroshell-120, C18, 4.6 £ 50 mm, 2.7 mm (Agilent Technologies, Wilmington, DE, US) column and a C18, 2.1 £ 4.6 mm (<3 mm packing) SecurityGuard TM Ultra cartridge (Phenomenex, Torrance, CA, USA). The flow rate of mobile phase A (5 mM ammonium acetate pH 5.5) and mobile phase B (methanol) was 0.45 ml/min.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation Of A Discriminatory Dissolution Method for Portioned Moist Snuff and Snus

Rahman

Mohamed

Dharani

et al. 2022

Journal of Pharmaceutical Sciences

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Method development and validation of dissolution testing for nicotine release from smokeless tobacco products using flow-through cell apparatus and UPLC-PDA

Cited by 19 publications

References 43 publications

Introducing a Novel Biorelevant In Vitro Dissolution Method for the Assessment of Nicotine Release from Oral Tobacco-Derived Nicotine (OTDN) and Snus Products

Introducing a Novel Biorelevant In Vitro Dissolution Method for the Assessment of Nicotine Release from Oral Tobacco-Derived Nicotine (OTDN) and Snus Products

Trends in Analytical Methods for Analysis of Tobacco Products: An Overview

Development and Validation Of A Discriminatory Dissolution Method for Portioned Moist Snuff and Snus

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