Altria Group, Inc. · NYSE:MO
Altria — Technical Presentation (September 2019)
14 slides from Altria's technical presentation, Sep 17, 2019
Slide 1: Preclinical Testing of Flavors in E-vapor Products Part 4: Flavor Transfer from Liquid to Aerosol
Preclinical Testing of Flavors in E-vapor Products Part 4: Flavor Transfer from the Liquid to the Aerosol for Inhalation Exposure Jingjie Zhang Tobacco Science Research Conference September 17, 2019 Jingjie Zhang | Regulatory Affairs | Altria Client Services l TSRC Sep 17, 2019 I FINAL 1
Slide 2: Overview
Overview Preclinical testing of flavors in e-vapor products, Part 1: selection of representative flavor mixtures for toxicological evaluations using a structural grouping approach Preclinical testing of flavors in e-vapor products, Part 2: preparation and stability characterization of representa
Slide 3: Overview
Overview Preclinical Application Part 3 In-vitro Pre-start Part 4 Aerosol Exposure In-vivo PG: propylene glycol VG: vegetable glycerol Jingjie Zhang | Regulatory Affairs | Altria Client Services l TSRC Sep 17, 2019 I FINAL 3
Slide 4: Objective
Objective To generate aerosols using designated test formulations To characterize the generated aerosols To confirm the flavor transfer from formulation to aerosols Jingjie Zhang | Regulatory Affairs | Altria Client Services l TSRC Sep 17, 2019 I FINAL 4
Slide 5: Aerosol Generation
Aerosol Generation Test Formulation with and without nicotine CAG: Capillary Aerosol Generator Jingjie Zhang | Regulatory Affairs | Altria Client Services l TSRC Sep 17, 2019 I FINAL 5
Slide 6: Aerosol Size Distribution
Aerosol Size Distribution Method - Cascade impactor Test Formulation w/ Test Formulation w/o Nicotine Nicotine (n = 4) (n = 4) MMAD (µm) 0.97 ± 0.07 1.23 ± 0.06 GSD 1.77 ± 0.18 1.82 ± 0.13 Jingjie Zhang | Regulatory Affairs | Altria Client Services l TSRC Sep 17, 2019 I FINAL 6
Slide 7: Aerosol Sampling for Chemical Analysis
Aerosol Sampling for Chemical Analysis Analyte of Interest Cambridge Filter Pad Impinger Aerosol Mass 44 mm No Nicotine, PG, Glycerin 44 mm No Selected Carbonyls 44 mm DNPH derivatization solution Selected Flavors 55 mm Ethanol (-70°C) pH No Fritted; KCl solution Mass Flow CAG Vacuum Controller Mixi
Slide 8: Analytical Characterization
Analytical Characterization Test Formulation w/ Nicotine (N = 3) Test Formulation w/o Nicotine (N = 3) Analyte Liquid Aerosol Transferb Liquid Aerosol Transferb Aerosol Mass (mg) NA 98.1±2.0 NA NA 108.2±1.8 NA Ethanol (mg/g) 20.44±0.13 BLOQ NA 20.19±0.23 BLOQ NA Glycerol (mg/g) 144.3±0.3 146.2±2.1a
Slide 9: Flavor Transfer
Flavor Transfer Test formulations contained 38 flavors. 22 out of 38 (Lab 1) were analyzed in both the liquid and the aerosol. Jingjie Zhang | Regulatory Affairs | Altria Client Services l TSRC Sep 17, 2019 I FINAL 9
Slide 10: Selected Carbonyls in the Aerosol
Selected Carbonyls in the Aerosol Carrier Blank High w/ Nicotine High w/o Nicotine (PG/VG/Nicotine/ (n = 3) (n = 3) (n = 3) Water) (n = 3) Aerosol Mass (mg) 100 mg 107.2 ± 5.4 106.7 ± 1.3 116.1 ± 1.5 Formaldehyde (µg/g) c < LOQ 8.71 ± 0.57 4.98 ± 0.15 5.88 ± 0.24 Acetaldehyde (µg/g) c 3.09 ± 0.11 8.
Slide 11: Acetaldehyde as Measured by DNPH Derivatization
1,1-Diethoxyethane in Pre-blend Ic Detected as Acetaldehyde Impinger for carbonyl sampling 1,1-diethoxyethane H [H+] detected as acetaldehyde O O 2,4-DNPH in the carbonyl analysis 1,1-Diethoxyethane Acetaldehyde - 2, 4-DNPH (Acetal; CAS: 105-57-7) due to the sampling limitation Approximation (abov
Slide 12: pH of the Aerosol
pH of the Aerosol Test Formulation w/o Nic Test Formulation w/ Nic Liquid pH (n = 3) 4.6 7.7 Aerosol pH (n = 3) 4.7 7.6 pH adjustment in the formulation? Test Formulation w/o Nic (pH adj. w/ NaOH) Liquid pH (n = 1) 7.1 Aerosol pH (n=3) 4.6 Always characterize the test atmosphere After <1 hr for conf
Slide 13: Summary
Summary Flavor transfer from liquid formulation into the aerosol was confirmed. Particle size for both formulations (high with and without nicotine) tested were in the desired range (MMAD<1.6 µm, GSD<2). Nicotine, PG and glycerol matched in formulations and CAG aerosol for the test formulation
Slide 14: Acknowledgements
Acknowledgements Altria Client Services, Richmond, Virginia, USA Cameron Smith Chase Anderson Nicholas McCutcheon John Miller K. Monica Lee Kimberly Ehman l Regulatory Affairs l Altria Client Services l TSRC Sept 17, 2019 l Final 14
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