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Using a physiologically relevant model to identify the effect of filler materials on nicotine delivery from oral nicotine pouches

Award Number: R03DA066757
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2028

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Using a physiologically relevant model to identify the effect of filler materials on nicotine delivery from oral nicotine pouches - ABSTRACT Oral nicotine pouches (ONPs), a novel tobacco product class, are designed to deliver nicotine to consumers through oral absorption rather than inhalation. Current clinical approaches suggest that nicotine delivery rates are slower from ONPs than from combustible cigarettes and that ONPs are ineffective substitution products for people who use electronic nicotine delivery systems (ENDS). With continued technological innovation and evolution of products, ONPs that can deliver nicotine more rapidly may increase appeal and the potential for addiction. Federal regulators are responsible for determining whether new ONPs are ‘appropriate for the protection of public health’ as determined by weighing ‘the risks and benefits to the population as a whole, including users and nonusers of the tobacco product.’ This is ultimately decided based upon physical and chemical properties reported by manufacturers. Yet critically, the impact of individual ONP characteristics on delivering nicotine has not been systematically investigated. While a variety of ingredients are used, each ONP incorporates the formulations on a carrier (filler), which itself is not intended to dissolve or absorb in the mouth. Emerging industry development of novel filler materials with reportedly faster nicotine delivery illustrates the importance of fillers to ONP performance. Clinical approaches are not well-suited to test the effect of filler or other individual properties on delivery. Therefore, new laboratory-based physiologically relevant models that measure the release of nicotine into saliva, a proxy measure of nicotine dose and delivery, are necessary to understand the role of the filler in delivering nicotine. We hypothesize that filler material is a critical ONP characteristic affecting nicotine release and other physical and chemical characteristics of ONPs (e.g., nicotine content, filler amount, moisture, and pH) differentially interact with various filler materials to impact nicotine release. To fill this knowledge gap, we will systematically evaluate different filler materials independently and in combination with other product characteristics on the rate and total nicotine release in biorelevant simulated saliva using a physiologically relevant model that mimics human ONP use. By comparing release profiles between laboratory-prepared experimental pouches and commercial ONPs, we aim to develop predictive models based on individual characteristics in combination with filler materials. Results from this study will provide impactful knowledge for regulators in protecting public health, and for the research community to better understand which characteristics most effectively enhance nicotine delivery, which in turn informs future clinically based ONP assessments.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $130,125 )
2026	2026	HEALTH RESEARCH, INC.	665 ELM ST	BUFFALO	NY	14203	ERIE	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	1	9/16/2026	NEW	$130,125
														Subtotal = $130,125

Grand Total All Awards = $130,125

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Using a physiologically relevant model to identify the effect of filler materials on nicotine delivery from oral nicotine pouches

Award Number: R03DA066757

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2028

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