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Nicotine delivery to rodent with lung alveolar region-targeted aerosol technology

Award Number: R44DA031578
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2011
PERIOD OF PERFORMANCE END DATE: 05/31/2017

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Nicotine delivery to rodent with lung alveolar region-targeted aerosol technology - DESCRIPTION (provided by applicant): Our completed SBIR Phase I project (R43 DA031578) was in response to NIH PA11-096, PHS 2011-02 'Omnibus solicitation for SBIR/STTR Grant Application' under NIDA 2, "Development of Alternate Drug Delivery Dosage Forms for Drugs Abuse Studies." We have developed an alveolar region-targeted aerosol/inhalation method for nicotine delivery to rodents and developed devices with specialized software that enable this new method to be used effectively. In both the nose-only device and free-moving exposure chambers, the aerosol droplet size distribution is within the respirable diameter range. By physically imitating the properties of cigarette smoke, aerosol inhalation produces nicotine PK in both the arterial and venous blood resembling the PK profile of humans smoking cigarettes. This noninvasive method overcomes the limitations of current nicotine delivery methods. We have demonstrated that this novel method and device enable rapid delivery of a controllable amount of nicotine into systemic circulation and induces dose-dependent behavioral responses. The goal of this Phase II project is to translate the prototypes into commercialized products-"AeroDeliver(R)". Three Specific Aims are as follows: Aim 1. Develop and scale up a commercial product series of integrated aerosol inhalation systems including nose-only exposure devices and free-moving exposure chambers. We will create the integrated hardware and software, and scale up to simultaneously operate 16 AeroDeliver(R) systems. Aim 2. Further develop the novel alveolar region-targeted aerosol inhalation method for chronic intermittent nicotine exposure and validate it with animal testing. The device and protocol will be evaluated and validated using animal testing and by measuring plasma nicotine concentrations that simulate the PK profile in moderate to heavy human smokers. We will verify nicotine aerosol deposition in the lungs in vivo by positron emission tomography (PET) with radioactive labeled nicotine aerosol. Aim 3. Establish nicotine aerosol self-administration paradigms in drug dependence and reinforcement studies. The system will have positive and negative levers (for rats) or nosepoke sensors (for mice) for performance choice. The system will also perform fixed ratio (FR) and progressive ratio (PR) reinforcement schedules. We will evaluate the system in rodent experiments and compare the operation and results with conventional i.v. nicotine self-administration methods that use currently available commercial devices. In the course of animal testing, we will also develop an experimental "cookbook" with standardized protocols to facilitate comparison of results generated by different laboratories. Our products -AeroDeliver(R) system will be a powerful toolkit for studies of nicotine addiction, toxicology, teratogenicity and tobacco-related diseases, and ultimately, for facilitation of new therapeutic discovery. Furthermore, the significant potential for these toolkits to be used for other drugs of abuse such as marijuana, cocaine, and heroin will expand the market size for our products.


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: 2020 ( Subtotal = -$12 )
2020	2014	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Drug Use and Addiction Research Programs	000	3	10/1/2019	NON-COMPETING CONTINUATION	-$12
														Subtotal = -$12

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2014	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Drug Use and Addiction Research Programs	000	3	9/16/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $0 )
2016	2014	AFASCI INC	2633 MARTINEZ DRIVE	BURLINGAME	CA	94010	SAN MATEO	USA	Drug Use and Addiction Research Programs	000	3	6/2/2016	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2014 ( Subtotal = $484,537 )
2014	2014	AFASCI INC	2633 MARTINEZ DRIVE	BURLINGAME	CA	94010	SAN MATEO	USA	Drug Use and Addiction Research Programs	000	3	5/16/2014	NON-COMPETING CONTINUATION	$484,537
														Subtotal = $484,537

Issue Date FY: 2013 ( Subtotal = $506,122 )
2013	2013	AFASCI INC	2633 MARTINEZ DRIVE	BURLINGAME	CA	94010	SAN MATEO	USA	Drug Use and Addiction Research Programs	000	2	5/1/2013	COMPETING CONTINUATION	$506,122
														Subtotal = $506,122

Grand Total All Awards = $990,647

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Nicotine delivery to rodent with lung alveolar region-targeted aerosol technology

Award Number: R44DA031578

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2011

PERIOD OF PERFORMANCE END DATE: 05/31/2017

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