Product Design
Ultrasonic Generation of An Aqueous Nicotine Aerosol for Subjective Testing
Abstract
Proposes changes to nicotine aerosol pH may affect subjective responses of impact and physiology. Outlines research plans to generate aerosol nicotine at controlled pH, describes the aerosol generator, includes schematics and states the aerosol composition is the same as aqueous. Indicates the nicotine concentration and pH can be adjusted, lists materials and methods and compares the physical characteristics of ultrasonic aerosol to cigarette smoke. Concludes an aerosol generation system for testing aqueous nicotine has been developed, the test protocol is refined and other substances may be tested using this protocol.
Fields
- Author
- Lipowicz, P.J.
- Hypothesis
- Free Nicotine
- Toxicity and consumer intake
Development of scientifically valid procedures for measuring biological activity and neurological effects of nicotine and smoke constituents.- Nicotine transport, transfer, and uptake
Design changes which alter nicotine delivery or effect how the product causes and maintains dependence, including transfer of nicotine from tobacco to smoke, and uptake into the body.- Measuring human smoking behavior
Measuring the effects of changes in human smoking behavior on intake of nicotine and smoke constituents. - Toxicity and consumer intake
- Keyword
- Acidity (Low pH)
- Aerosol
- Bound nicotine (Protonated or ionized nicotine)
- Delivery modification
- Depth of inhalation
- Dose-response
- Free nicotine (Unprotonated or unionized nicotine)
- Human testing
- Impact (Throat grab)
- Mouth feel (Mouthfull)
- Nicotine delivery (Smoke nicotine or nicotine yield)
- Nicotine manipulation
- Per puff delivery
Per puff tar, per puff nicotine, and per puff CO- Puff volume (Puff amount)
- Sensory response
- Aerosol
- Smoke Constituent
- Nicotine
- Design Component
- Nicotine content (Tobacco nicotine content)Total nicotine in the unburnt tobacco rod
- Nicotine transfer efficiency (NTE)
- Named Organization
- Devilbiss
- Technology/Method
- Aqueous nicotine aerosol
- Subject
- Pressure Drop (Design)
- aerosol (technology)
- Experimental Technology (Technology)
- nicotine technology
- Particle Size (Technology)
- pH Manipulation (Technology)
- Puff Parameters (Measures)
- Effects—Smoking Behavior (Effects)
- Test/Inhalation (Testing)
- aerosol (technology)
Document Images
ULTRASONIC GENE ZATION OF AN AQUEOUS
NICOTINE AEROSOL FOR SUBJECTIVE TESTING
Peter J. Lipowicz
2 April 1991
HYPOTHESIS:
SUBJECTIVE RESPONSE TO NICOTINE AEROSOL CAN
BE ALTERED BY CHANGING AEROSOL PH
• Impact
• Physiological response
• Protonated nicotine vs. basic nicotine
RESEARCH PLAN
• Generate nicotine aerosol at controlled~ pH
• Measure subjective response with panelists
• Determine validity of hypothesis
• Determine applicability of hypothesis
CHARACTERISTICS OF THE IDEAL
AEROSOL GENERATOR
• Subjectively neutral matrix
• Controllable and sufficient nicotine concentration
• Controllable aerosol pH
• Steady and reproducible output
• Amenable to panelist testing
THE ULTRASONIC AEROSOL GENERATOR
• Generates aqueous solution
• Aerosol composition is same as solution composition
• Nicotine concentration of solution can be varied
• pH of solution can be adjusted with addition of acid
• Can generate high concentrations,
• Compact commercial units available
G.n4rator
R.stfrotr (E):
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ISSUES IN THE DEVELOPMENT OF THE TEST PROTOCOL
• Nicotine level -- 20'to 30 ug per puff
• Acid to adjust pH -- phosphoric acid
• Measurement of aerosol pH -- pH paper
• Isotonicity of solution -- not controlled
• Sterility of solution -- filter sterilized
• Sterility of generator -- autoclaved'~
• Nicotine concentration in aerosol -- spectrophotometry
• Venting excess aerosol -- installed hood in Frank Gullotta's
laboratory
• Sampling prodecure
• Reproducibility of aerosol production
• Physical nature of aerosol
REQUIREMENTS OF SAMPLING PROCEDURE
• Simplicity
• Delivers controlled volume of aerosol
• Similarity to cigarette
-- inhalation by puffs
-- puff volume
-- pressure drop
-- size of mouth end
STABILITY AND REPRODUCIBILITY
OF AEROSOL OUTPUT
• Required so that nicotine level can be controlled
• Medium rate ( 1 g/min ) is not reproducible
-- varies for different aqueous solutions
• High rate(4.5 g/min ) isbetter-- less affected by solution composition
COlVIP ' !SON OF PHYSICAL CHARACTERISTICS
OF ULTRASONIC AEROSOL AND CIGARETTE SMOKE
• Particle size
• Deposition in the respiratory tract
• Stability
SIZE D~ISTRIBUTION OF UL'I'RAS'ONIC AEROSOL FROM
DEVILBISS ULTRA-NEB 99
lob
2020126848
Figure 13.12 Water droplet lifetimes as function of droplet size for 0, 50, and 100%
relative humidity at 20° C.
GOALS OF PRELIMINARY TFSTING'
• Adjust nicotine solution concentration
• Specify certain pH levels
• Adjust pressure drop in sampling tube
CURRENT PROCEDURE
• Make 200 ml of 0.01 M nicotine(0.17%)! in~ water
• Adjust pH of solution to range of 6 to 9' with phosphoric acid
• Filter sterilize solution
• Sterilize ultrasonic nebulizer in autoclave
• Generate aerosol at highest power setting ( 4.5 g/min )
• Confirm nicotine level in aerosol ( 30 ug per puff }.
• Subject samples every 30 sec for next 4 - 6 min
CITRRENT STATUS
• Aerosol generator is set up~ in Frank Gullotta'slaboratory
(T426)
• We are testing different procedures for measuring nicotine
concentration in the aerosol
• Preliminary subjective testing has not begun
CONCLUSIONS
• We have developed an aerosol generation system for subjective
testing of an aqueous nicotine aerosol
• We have resolved the major issues concerning, the test protocol
• Once in place, this protocol can serve as the basis for
protocols to test other substances
