U.S. patent application number 15/638609 was filed with the patent office on 2018-03-29 for vaporizable tobacco wax compositions and container thereof.
This patent application is currently assigned to BOND STREET MANUFACTURING LLC (a Florida LLC). The applicant listed for this patent is BOND STREET MANUFACTURING LLC (a Florida LLC). Invention is credited to Joseph Fuisz, Seamus Henry.
Application Number | 20180084823 15/638609 |
Document ID | / |
Family ID | 61687080 |
Filed Date | 2018-03-29 |
United States Patent
Application |
20180084823 |
Kind Code |
A1 |
Fuisz; Joseph ; et
al. |
March 29, 2018 |
Vaporizable Tobacco Wax Compositions and Container thereof
Abstract
The invention relates to tobacco wax compositions suitable for
use in a vaporizer. The tobacco wax may comprise additional
excipients including vapor agents, penetration agents, buffer
agents, and rheological agents. The composition contains nicotine.
The tobacco wax composition leaves a minimum of residue in the
vaporizer when used. In another aspect, the invention relates to a
portion-sized container ("pod") of a tobacco wax composition for
administration to a mammal or person. The pod is intended for use
in a personal (or other) vaporizer.
Inventors: |
Fuisz; Joseph; (Surfside,
FL) ; Henry; Seamus; (Ft Lauderdale, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BOND STREET MANUFACTURING LLC (a Florida LLC) |
Surfside |
FL |
US |
|
|
Assignee: |
BOND STREET MANUFACTURING LLC (a
Florida LLC)
Surfside
FL
|
Family ID: |
61687080 |
Appl. No.: |
15/638609 |
Filed: |
June 30, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15276902 |
Sep 27, 2016 |
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15638609 |
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15403472 |
Jan 11, 2017 |
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15276902 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A24F 47/002 20130101;
A24B 15/167 20161101; A24B 15/243 20130101; A24B 15/32 20130101;
A24B 15/24 20130101 |
International
Class: |
A24B 15/16 20060101
A24B015/16; A24B 15/32 20060101 A24B015/32; A24B 15/24 20060101
A24B015/24; A24F 47/00 20060101 A24F047/00 |
Claims
1) A system for vaporizing a tobacco wax composition, comprising
tobacco wax and at least one a vapor agent, wherein said tobacco
composition is contained in a pod.
2) The invention of claim 1 wherein the tobacco wax composition has
a nicotine content of greater than 2%.
3) The invention of claim 1, wherein the pod comprises ceramic.
4) The invention of claim 1, wherein the tobacco wax composition
comprises at least one selected from the group of: an emulsifying
agent, or a surfactant, and the tobacco wax composition is
substantially free of separation of the tobacco wax from the vapor
agent.
5) The invention of claim 1, wherein the pod has a top porous
layer.
6) The invention of claim 1, wherein the mouthpiece has a
sleeve.
7) The invention of claim 2, wherein system has vapor emissions
with TSNA levels below quantifiable limits on a per puff basis,
when measured using: 55 mL puff/30 sec interval/3 sec duration, and
the quantifiable limit is 0.20 ng/puff
8) The invention of claim 2, wherein the system as formaldehyde
emissions of below quantifiable limits on a per puff basis, when
measured using 55 mL puff/30 sec interval/3 sec duration, and the
quantifiable limit is 0.20 .mu.L/puff
9) A heat not burn tobacco product, which comprises 30% or more
tobacco wax.
10) The product of claim 9, wherein the heat not burn tobacco
product substantially vaporizes as a temperature of less than 350
F.
Description
[0001] This application is a continuation-in-part of application
Ser. Nos. 15/276,902 and 15/403,472 filed Sep. 27, 2016 and Jan.
11, 2017 respectively.
[0002] This invention is directed towards tobacco wax, including
methods of manufacture, tobacco wax compositions, and the
vaporization of tobacco wax for use in a vaporizer-inhalation
device. The present invention also relates to a portion-sized
container ("pod") of a tobacco wax composition for administration
to a mammal or person. The pod is intended for use in a personal
(or other) vaporizer.
BACKGROUND
[0003] In 1926, Samual Amster of Richmond, Ky. described the
extraction of a "wax like substance" from tobacco using a hot water
process and then subjecting the resulting liquor to an evaporative
step. Despite this extraction, Amster teaches that the (extracted)
tobacco "may still be employed for smoking and chewing tobacco."
Amster teaches the use of the tobacco "wax like substance" in
candles, shoe polishes and varnish (U.S. Pat. No. 1,624,155).
[0004] In 1936, James Garner of Mount Lebanon, Pa., described a
method to de-nicotinize tobacco, whereby ammonia treated tobacco is
subjected to a butane-solvent based extraction method. When the
butane is evaporated, "there is left a mass of nicotine and tobacco
wax which together may amount to as much as 6-8% by weight of the
tobacco used . . . . Tobacco wax or resin is dark brown in color,
burns with the production of acrid fumes, and has a strong odor
resembling that of an "old" pipe." The tobacco wax may be used as
an insecticide or may be "returned to the residual tobacco leaves
and also to untreated tobacco leaves to impart thereto desirable
flavors." Like Amster, Garner teaches that the extracted tobacco is
still suitable use in smoking and other tobacco products (U.S. Pat.
No. 2,128,043).
[0005] Despite this eighty year old work, Applicants are not aware
that the teachings of Amster or Garner have been used in commercial
processes or products.
[0006] Entering the present era, Keritsis et al (assigned to Philip
Morris) (U.S. Pat. No. 4,936,920) (1990) mentions tobacco wax in a
list of saccharides and polysaccharides that may be used as a
bonding agent when making manufactured tobacco (more typically
referred to as reconstituted tobacco sheet).
[0007] Renaud et al., in U.S. Pat. No. 8,863,754 (assigned to
Philip Morris) (2014) describe compositions for heat not burn
applications. The patent mentions tobacco wax in a reference to
degradation products the presence of which evidences (unwanted)
combustion: "Isoprene is a pyrolysis product of isoprenoid
compounds present in tobacco, for example in certain tobacco waxes,
and can be present in the aerosol only if the strands of
homogenized tobacco material are heated to a temperature
substantially higher than that required to generate an aerosol.
Thus, isoprene yield can be taken as representative of the amount
of homogenized tobacco material that is "over heated."" Nothing in
the disclosure indicates that tobacco wax has been purposefully
used in this composition or otherwise present than through the
natural presence of wax in the tobacco used to manufacture the
"homogenized tobacco material." Applicant understands the substrate
described in this art to be a reconstituted tobacco sheet intended
for use in heat not burn applications.
[0008] Brown et al. (assigned to Lorillard) (U.S. Pat. No.
9,038,644) (2015) teaches tobacco wax for use as a phase transition
material to impart reduced ignition propensity to a cigarette. The
wax is applied to the cigarette paper using high precision wax jet
printing.
THE PRESENT INVENTION
[0009] Each of U.S. Pat. No. 1,624,155; U.S. Pat. No. 2,128,043;
U.S. Pat. No. 4,936,920; U.S. Pat. No. 4,936,920; U.S. Pat. No.
8,863,754; and U.S. Pat. No. 9,038,644, is expressly incorporated
herein together with all citations in these references.
[0010] The vaporization of nicotine containing liquids is well
known and popular, including using devices such as electronic
cigarettes and tank-style (and non tank) personal vaporizers.
Typically such compositions include USP (99.9% pure) nicotine oil
as an ingredient, though zero-liquids without any nicotine are also
used.
[0011] Heat not burn tobacco systems are known in the tobacco
industry. Heat not burn systems like Pax Lab's Pax.RTM. and Philip
Morris' IQOS.RTM. (as well as earlier versions of IQOS.RTM. sold as
Heatbar.RTM. and Accord.RTM.) heat tobacco compositions
substantially without burning the tobacco, thereby aerosolizing
volatile constituents of the tobacco composition. After use, the
non-vaporized components of the tobacco composition remain minus
those components what were successfully vaporized (or inadvertently
burned).
[0012] In the case of both Pax.RTM. and IQOS.RTM. this residue is
substantial and represents the substantial mass of the original
tobacco composition.
[0013] Philip Morris International (PMI) describes the rationale
behind heat not burn systems thusly: "[t]he concept behind
`heat-not-burn` is that heating tobacco, rather than burning it,
reduces or eliminates the formation of many of the compounds that
are produced at the high temperatures associated with combustion.
Research has demonstrated that most of the harmful and potentially
harmful constituents (HPHCs) in cigarette smoke are formed by
thermal breakdown of the tobacco when it is burned. Heat-not-burn
therefore offers the possibility of significantly reducing both the
number and the levels of HPHCs generated by tobacco products,
whilst retaining an acceptable sensory experience for current adult
smokers" (from pmiscience.com).
[0014] Now, some criticism has been leveled against heat not burn
systems, which ostensibly is premised on the notion that tobacco
and heat will always tend lead to toxicant formation. Stephen
Stotesbury, head of scientific and regulatory affairs for Imperial
Tobacco has been quoted saying about Philip Morris International's
IQOS [heat not burn] system: "There's a lot of black crud in the
iQOS device after using it . . . . It smells like an ashtray."
Perhaps not surprisingly, Imperial Tobacco has stated it will not
develop a heat not burn product--presumably to rely solely on its
electronic nicotine delivery systems (ENDS).
[0015] Pax is a loose-leaf style vaporizer for use with "loose-leaf
plant material" supplied by the user herself
(https://www.paxvapor.com/support/pax-2-faq/#can-i-use-liquids-in-pax-2).
An earlier heat not burn composition--Pax Labs' Ploom.RTM. used a
tobacco-humectant composition contained in nescafe style
pod--however this product has been discontinued.
[0016] Philip Morris' IQOS is a more sophisticated product wherein
the user uses a manufacturer-supplied "cigarette" in the heating
device. The cigarette itself is comprised of reconstituted tobacco
sheet made with high amounts of humectant (glycerin) that, together
with other volatiles, create a vapor like experience when used.
[0017] Applicants believe the composition of the reconstituted
sheet used in IQOS is akin to that described in WO2016050472A1,
assigned to Philip Morris. One of the present inventors has
extensive experience working with film and sheet systems,
principally for pharmaceutical applications and is a named inventor
on Fuisz et al. U.S. Pat. Nos. 9,108,340; 8,906,277; 8,685,437;
8,663,687; 8,652,378; 8,617,589; 8,613,285; 8,603,514; 8,241,661;
8,017,150; 7,972,618; 7,897,080; 7,824,588; 7,666,337; and
7,425,292.
[0018] Heat not burn systems are associated with reduced HPHCs as
stated by the PMIScience excerpt above. The toxicant profile of
burning tobacco is well understood. Researchers have estimated that
cigarette smoke contains 7,357 chemical compounds from many
different classes (Warnatz, J, U Maas and R W Dibble. Combustion:
physical and chemical fundamentals, modeling and simulation,
experiments, pollutant formation. 2006). There is broad scientific
agreement that several of the major classes of chemicals in the
combustion emissions of burned tobacco are toxic and carcinogenic
(Rodgman, A, and T A Perfetti. The chemical components of tobacco
and tobacco smoke. 2013: CRC press).
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 is a perspective view showing a heating chamber
containing a tobacco wax composition.
[0020] FIG. 2 is an exploded perspective of the heating chamber sub
assembly, including a ceramic heating chamber.
[0021] FIG. 3 is a cross-sectional view of the heating chamber
containing a tobacco wax composition.
[0022] FIG. 4 is a cross section of the wall of the heating chamber
casing.
[0023] FIG. 5 is a cross section of the receiver for the heating
chamber, including the battery connection section.
[0024] FIG. 6 is a cross section of the electrode.
[0025] FIG. 7 is a cress section of the electrode insulator.
[0026] FIG. 8 is a perspective view of a ceramic pod showing a
printed or coated heating element and positive and negative
electrical contacts.
[0027] FIG. 9 is an exploded perspective view of a pod, a porous
layer, and a barrier layer.
DETAILED DESCRIPTION
[0028] The present invention teaches a composition that comprises
tobacco wax and other ingredients suitable for vaporization and use
by a mammal. Applicants have found that the vaporization of a
tobacco wax based composition provides excellent organaleptics and
nicotine delivery. Moreover, unlike existing heat not burn
compositions, applicants have found tobacco wax compositions of the
present invention vaporize substantially in their entirety (i.e.
substantially without residue).
[0029] Tobacco wax based compositions allow for a heat-not-burn
tobacco product that is not a readily flowable liquid, and does not
require specialized reconstituted sheet production or use, or use
conventional tobacco leaf products (like Pax).
[0030] It is an aim of the present invention to allow for a heat
not burn tobacco product which does not have, or substantially does
not comprise, reconstituted tobacco sheet.
[0031] The role of plant wax for plants is understood. Plants
secrete waxes into and on the surface of their cuticles as a way to
control evaporation, wettability and hydration. The epicuticular
waxes of plants are mixtures of substituted long-chain aliphatic
hydrocarbons, containing alkanes, alkyl esters, fatty acids,
primary and secondary alcohols, diols, ketones, aldehydes. From the
commercial perspective, the most important plant wax is carnauba
wax, a hard wax obtained from the Brazilian palm Copernicia
prunifera.
[0032] B. R. Jordan describes tobacco wax as consisting of three
major components: straight chain hydrocarbon (C27-C33 comprising
59%); branched-chain hydrocarbons (C25-C32 comprising 38%) and
fatty acids (C14-C18 comprising 3%) (Advances in Botanical
Research, Vol 22, "UV-B Radiation: A Molecular Perspective, hereby
incorporated by reference as if fully set forth herein).
[0033] Various processes for extracting wax from plant materials
can be employed in connection with the present invention. These
extraction methods include, without limitation, subcritical CO2
extraction; supercritical CO2 extraction; supercritical extraction
with additional (non-CO2) solvents; maceration; digestion (a heated
form of maceration); decoction; percolation; hot continuous
extraction (Soxlet); Aqueous Alcoholic Extraction by Fermentation;
Counter-current Extraction; Ultrasound Extraction (Sonication); and
the Phytonics Process. This list is non-limitative as skilled
artisans will appreciate and other suitable extraction methods may
be employed. Solvents used may be polar or non-polar. Various
combinations and/or sequential series of these methods can be
used.
[0034] The non-limitative preferred embodiment is supercritical CO2
extraction. The use of supercritical CO2 extraction to
de-nicotinize tobacco is disclosed in Howell et al U.S. Pat. No.
8,887,737 (2014), which is hereby incorporated by reference as if
fully set forth herein.
[0035] Extraction, including the preferred embodiment supercritical
CO2 extraction, can be used to generate several partitions form
tobacco, broadly speaking, including oils and waxes. Both of these
partitions contain nicotine. The wax partition yield should exceed
1.5% of the starting tobacco weight, preferably 2% or greater, most
preferably 4% or greater.
[0036] All forms of tobacco may be used including tobacco leaf,
stem, and waste tobacco dust. Blends of tobacco may be employed.
Cigar tobaccos may be employed. Tobacco varieties with high
nicotine content are preferred. Because the extraction process may
bring flavors and aromas from the leaf into the wax and oil, the
tobacco inputs may be selected in whole or in part for taste.
[0037] It is contemplated that the tobacco blending process will be
carried out prior to extraction, or after extraction. For example,
a blend may be made of one or more tobaccos (e.g. flue cured,
burley and Turkish) and extraction made therefrom. Alternatively,
the three tobaccos of the prior example may be separately
extracted, and blended to taste and other characteristics using the
extracted wax partitions (and oil partitions, optionally) of each
extracted tobacco type.
[0038] It is important to note that extraction techniques to remove
the wax partition may also function to extract undesired TSNA's
from tobacco. In particular, supercritical CO2 extraction may
solubilize TSNA's from the tobacco, concentrating them in the
resulting wax and oil partitions. Since it is desirable to minimize
TSNA's in the final product, it is desirable to use tobacco inputs
with very low TSNA's. This will result in a product with low TSNA's
without the need for optional pre or post processing steps to
remove TSNA's from the wax partition. Preferably, the tobacco input
have a TSNA level below 3 ppm, more preferable below 2 ppm, still
more preferably below 1 ppm, and even more preferably below 0.3
ppm).
[0039] Extraction parameters may impact the nature of the wax
partition, including various parameters including flavor, nicotine
levels, TSNA levels, and the rheology of the wax partition itself.
In certain embodiments, it may be desirable to extract a
non-flowable wax partition, or a substantially non-flowable wax
partition. The wax partition may be viscous and somewhat flowable
in certain embodiments.
[0040] It is expressly contemplated that oils may be mixed into the
resulting wax to increase the yield of wax and nicotine. High shear
mixers (and other mixing methods) may be used for this purpose.
Preferably, the mass of the oil partition added to the wax
partition will be less than or about 75% of the mass of the wax
partition, preferably less than or about 30% and most preferably
less than 15% of the mass of the wax partition (measured by mass).
The oil partition can serve to increase nicotine, enhance flavor,
increase vapor production and generally extend the yield from
tobacco. However, TSNA levels may concentrate in the oil partition,
and so it is desirable to specifically monitor the TSNA level of
the oil partition when considering the desired combination of the
two partitions.
[0041] Additional excipients may be employed to develop a final
composition for vaporization.
[0042] Vapor agents may be added to the wax. Vapor agents increase
the vapor from the composition when heated. Vapor agents may
include, without limitation, vegetable glycerin, non-vegetable
forms of glycerin, propylene glycol, polyethylene glycol,
polysorbates including polysorbate 20 (polyoxyethylene sorbitan
monolaurate), polysorbate 40 (polyoxyethylene (20) sorbitan
monlopalmitate), polysorbate 60 (polyoxyethylene sorbitan
monostearate) and polysorbate 80 (polyoxyethylene sorbitan
monooleate.), and other agents suitable for increasing the "vapor"
from a heated composition. Vapor agents may be added to about 70%
of the composition (by mass), preferably 30-60% of the composition
(by mass), most preferably 45-55% (by mass) of the composition.
Lower levels of vapor agents may also be employed, resulting in a
stronger, more concentrated final composition. Above 60%, the final
composition may become too flowable for certain vaporization
devices.
[0043] In certain embodiments, substantially all of the vapor agent
employed is vegetable glycerin. This is because vegetable glycerin
has a relatively high viscosity, and flowability of the final
composition is undesired in certain embodiments. For example, a
flowable composition may "spill" out of the heating chamber when a
vaporizer is left on its side. Of course, film formers and gelling
agents may optionally be employed to increase viscosity as
needed.
[0044] High shear mixing is important to ensure uniform
distribution of the vapor agent (or other added excipient) in the
composition. The tobacco wax may tend towards hydrophobicity, which
may present mixing challenges. The use of an emulsifying agent may
be desired to assist in emulsifying the mixed composition. Without
limitation, the following emulsifying agents are examples of
emulsifying agents that may be employed: agar, albumin, alginates,
casein, ceatyl alcohol, cholic acid, desoxycholic acid, diacetyl
tartaric acid esters, egg yolk, glycerol, gums, carrageenan,
lecithin, mono- and diglycerides, monosodium phosphate,
monostearate, ox bile extract, propylene glycol, soaps, or
taurocholic acid (or its sodium salt). As a practical matter,
non-glycerol emulsifying agents are preferred.
[0045] Similarly, surfactants may be employed in certain
embodiments to promote mixing. Surfactants lower tension between a
surface and a liquid or between two or more immiscible substances.
Anionic surfactants contain anionic functional groups at their
head, such as sulfate, sulfonate, phosphate, and carboxylates.
Prominent alkyl sulfates include ammonium lauryl sulfate, sodium
lauryl sulfate (sodium dodecyl sulfate, SLS, or SDS), and the
related alkyl-ether sulfates sodium laureth sulfate (sodium lauryl
ether sulfate or SLES), and sodium myreth sulfate. Others include:
Docusate (dioctyl sodium sulfosuccinate) Perfluorooctanesulfonate
(PFOS) Perfluorobutanesulfonate, Alkyl-aryl ether phosphates, and
Alkyl ether phosphates. Carboxylates are the most common
surfactants and comprise the alkyl carboxylates (soaps), such as
sodium stearate. More specialized species include sodium lauroyl
sarcosinate and carboxylate-based fluorosurfactants such as
perfluorononanoate, perfluorooctanoate (PFOA or PFO). Certain
surfactants contain cationic head groups. Zwitterionic (amphoteric)
surfactants have both cationic and anionic centers attached to the
same molecule. The cationic part is based on primary, secondary, or
tertiary amines or quaternary ammonium cations. The anionic part
can be more variable and include sulfonates, as in the sultaines
CHAPS (3-[(3-Cholamidopropyl)dimethylammonio]-1-propanesulfonate)
and cocamidopropyl hydroxysultaine. Betaines such as cocamidopropyl
betaine have a carboxylate with the ammonium. The most common
biological zwitterionic surfactants have a phosphate anion with an
amine or ammonium, such and the phospholipids phosphatidylserine,
phosphatidylethanolamine, phosphatidylcholine, and sphingomyelins.
Many long chain alcohols exhibit some surfactant properties.
Prominent among these are the fatty alcohols, cetyl alcohol,
stearyl alcohol, and cetostearyl alcohol (consisting predominantly
of cetyl and stearyl alcohols), and oleyl alcohol.
[0046] In certain embodiments, a wetting agent may be employed. A
wetting agent is a surfactant that, when dissolved in water, lowers
the advancing contact angle, aids in displacing an air phase at the
surface, and replaces it with a liquid phase. Examples of
application of wetting to pharmacy and medicine include the
displacement of air from the surface of sulfur, charcoal, and other
powders for the purpose of dispersing these drugs in liquid
vehicles; the displacement of air from the matrix of cotton pads
and bandages so that medicinal solutions can be absorbed for
application to various body areas; the displacement of dirt and
debris by the use of detergents in the washing of wounds; and the
application of medicinal lotions and sprays to surface of skin and
mucous membranes Polysborbate (Tween) is a nonionic surfactant and
emulsifier that is particularly useful in connection with certain
embodiments of the present invention. Various Tweens can be used,
including inter alia Tween 20 and Tween 80.
[0047] Tobacco leaf may be added to the wax composition, in any
known form, including without limitation shreds, dust, particles
and the like. Said tobacco leaf may be leaf from which the tobacco
wax was extracted in certain embodiments. Tobacco leaf, including
reconstituted tobacco leaf, may be present from 0.01 to 30% mass of
the composition in certain embodiments.
[0048] The nicotine content of the final composition is preferably
less than 12%, more preferably less than 7.5% and most preferably
1.5-4% (by mass). Low nicotine compositions with nicotine less than
1.5% may also be made for users seeking lower nicotine delivery.
Nicotine, natural or synthetic, may be added where the tobacco
extraction yields a less than desired level. The product can be
made from low-nicotine containing tobacco to achieve a low nicotine
level, or otherwise subject to known processes to dinicotinize the
composition or starting input tobacco.
[0049] Flavors may be added to the wax. Flavors may be synthetic or
natural. For purposes hereunder, menthol, wintergreen, peppermint
and similar oils used in menthol tobacco products are understood to
be flavors, together with traditional flavors (e.g. grape, cherry
etc). Menthol crystals may be employed. Tobacco flavors, and
traditional tobacco top flavors may be used to impart a rich
tobacco flavor. Sustained release flavors, coated particle flavor
systems, and flavor capsules with volatile flavors may all be
employed. Flavors may preferably comprise 0.5% to 20% of the final
composition. Special concern should be paid to miscibility of the
flavor with the wax composition.
[0050] Penetration agent(s) may be added to the tobacco wax. By
penetration agents, we mean an agent that promotes transfer of the
active--i.e., a substance that enhances absorption through the
mucosa, mucosal coating and epithelium. otherwise known (see U.S.
Patent Application Publication No. 2006/0257463 A1, the content of
which is incorporated herein by reference). The penetration agent
may comprise but is not limited to polyethylene glycol (PEG),
diethylene glycol monoethyl ether (Transcutol), 23-lauryl ether,
aprotinin, azone, benzalkomin chloride, cetylperidium chloride,
cetylmethylarnmonium bromide, dextran sulfate, lauric acid, lauric
acid/propylene glycol, lysophosphatilcholine, menthol,
methoxysalicylate, oleic acid, phosphandylcholine, polyoxyethylene,
polysorbate 80, sodium EDTA, sodium glycholated, sodium
glycodeoxycholate, sodium lauryl sulfate, sodium salicylate, sodium
taurocholate, sodium taurodeoxycholate, sulfoxides, and various
alkyl glycosides or, as described in U.S. Patent Application
Publication No. 2006/0257463, bile salts, such as sodium
deoxycholate, sodium glycodeoxycholate, sodium taurocholate and
sodium glycocholate, surfactants such as sodium lauryl sulfate,
polysorbate 80, laureth-9, benzalkonium chloride, cetylpyridinium
chloride and polyoxyethylene monoalkyl ethers such as the BRIJ.RTM.
and MYRJ.RTM. series, benzoic acids, such as sodium salicylate and
methoxy salicylate, fatty acids, such as lauric acid, oleic acid,
undecanoic acid and methyl oleate, fatty alcohols, such as octanol
and nonanol, laurocaprarn, the polyols, propylene glycol and
glycerin, cyclodextrins, the sulfoxides, such as dimethyl sulfoxide
and dodecyl methyl sulfoxide, the terpenes, such as menthol, thymol
and limonene, urea, chitosan and other natural and synthetic
polymers. Preferably, the penetration agent is selected to be
capable of transfer through vaporization.
[0051] Buffer agents may be added to the tobacco wax, including
without limitation to create static or a dynamic buffer systems.
Preferably, the buffer agent is used to raise the pH of the mouth
in order to increase nicotine absorption in the buccal cavity in a
manner which is based on pka and the Henderson Hasselbach equation.
For nicotine, preferably, the pH of the mouth is increased to 7 to
10, preferably 7.8 to 10, most preferably from 8.5 to 9.5.
Preferably, the buffer agent increases the pH of the oral cavity
for a period of ten minutes or more after administration
[0052] Buffering agents may be used to control pH, including
without limitation, sodium bicarbonate, potassium bicarbonate,
sodium carbonate, potassium carbonate, calcium carbonate,
dipotassium phosphate, potassium citrate, sodium phosphate and any
other such buffer system. The buffer system may be designed to
dynamically control the pH of the product taking into consideration
the effect of saliva during use, i.e., a dynamic buffer system.
Examples of buffer systems to obtain the preferred pH include
dibasic sodium phosphate and monobasic sodium phosphate. Both are
FDA accepted buffer materials used and listed in the inactive
ingredients list. For example, for a pH of 7, the ratio of
monobasic/dibasic can be 4.6/8.6; for a pH of 7.5 the ratio of
monobasic/dibasic can be 1.9/11.9; and for a pH of 8.0 the ratio of
monobasic/dibasic can be 0.6/13.4. These are mathematically
calculated buffer numbers and will need to be adjusted according to
the other ingredients added to the formula. Thus this dynamic
buffer range is adjusted by the amounts of the buffer system since
saliva is freshly renewable in the mouth. See Fuisz U.S. Patent
Application Publication Nos. 2009/0098192 A1 and US 2011/0318390 A1
discussing dynamic buffering and incorporated herein by
reference.
[0053] Nicotine salts may be employed in certain embodiments. This
involves complexing nicotine with an acid, to form a salt. Suitable
acids may include without limitation: pyruvic acid, salicylic acid,
sorbic acid, lauric acid, levulinic acid, or benzoic acid. U.S.
Pat. No. 9,215,895 (Nicotine salt formulations for aerosol devices
and methods thereof) is hereby incorporated by reference as if
fully stated herein. In a preferred embodiment, the extracted
nicotine oil is complexed with an acid and then mixed with the wax
partition. The nicotine salt may also be mixed with glycerin and
then mixed with the wax. In still other embodiments, the acid is
complexed with the wax partition to form the salt.
[0054] Crystallization inhibitors may be employed, including inter
alia to avoid precipitation of the nicotine salt when the acid is
complexed with the nicotine. Crystallization inhibitors are
described in US 2016/0038406 (Chemically stable and oromucosally
absorbable gel compositions of a pharmaceutical active agent in a
multi-chambered delivery system).
[0055] Preservatives may be added to the tobacco wax to preserve
freshness and inhibit microbial growth.
[0056] A pasteurization process step may be employed, inter alia,
to prohibit microbial growth.
[0057] Preferably, the composition has maintains a wax like or
relatively high viscosity and/or consistency despite the addition
of any excipients. It is generally advantageous that the tobacco
wax composition does not readily flow until under heavy-vaporizing
heat. However, it may be beneficial to adjust the rheological
properties of the tobacco wax composition. For example, a reduced
viscosity and or surface tension may be desired for various
reasons, such as packaging convenience (e.g a squeezable tube may
be easier to use with reduced viscosity). The use of PG as a vapor
agent may serve this purposes, having a much lower viscosity than
vegetable glycerin.
[0058] It may also be beneficial to increase viscosity, for example
to prevent flow off a flat heating surface (e.g. a hookah platform.
Etc.). Rheology agents may employed to adjust the viscosity,
surface tension and other rheological properties of the final
product. Suitable excipients including film formers, gelling
agents, and surfactants. In certain embodiments, film formers are
used 0.01%-20%, gelling agents are used 0.01%-20%, and surfactant
0.01%-5%. Where film formers and gelling agents are employed, a
solvent may be used and then removed as appropriate.
[0059] The resulting wax composition may be used by itself, or
mixed with other vaporizable compositions both solid and liquid
formats. Such mixing may be done by the manufacturer or by the
user. Liquid formats including without limitation e-liquid type
products. Solid formats include without limitation other waxes from
tobacco or other plant or botanical materials. Mixing can also take
place by blending the plant or botanical materials which are
subjected to the extraction process.
[0060] The wax composition of the present invention is intended to
be vaporized. Suitable devices include any device capable of
sufficiently heating the composition to cause it to vaporize and
still not substantially burn the composition. Non-limitative
examples of suitable devices include devices marketed as dry herb
vaporizers. Suitable temperature ranges for the vaporizer heating
element range from temperature needed to vaporize the composition
and below the auto ignition temperature of the composition.
[0061] Suitable battery parameters ranging from 1 Amp continuous
output to 30 Amp continuous output.
[0062] The wax composition of the present invention is
substantially vaporizable, meaning that it will be substantially
vaporized when heated in a suitable device. It is desirable in
certain embodiments that residue is minimized, including inter alia
to avoid the need to clean the device between uses. Where a pod is
used, residue is of less concern, since the pod is regularly
replaced by the user.
[0063] The tobacco wax composition of the present invention when
vaporized, emits lower levels or HPHC's than conventional tobacco
products, e.g. cigarettes. The tobacco wax composition, when used
in a suitable vaporizer, results in less than 25%, on average, of
the levels of HPHC's from a US-sold Marlboro Red (using comparable
methods to measure e.g. Canadian method), preferable less than 10%
and more preferably less than 5% and even more preferable less than
1%. Ideally, as disclosed in the examples, toxicants measure below
quantifable limits. It is desirable to mitigate the levels of
tobacco specific nitrosamines in the composition. The tobacco wax
composition has TNSA levels preferably less than 10 parts per
million (ppm, more preferably less than 3 ppm, most preferably less
than 1 ppm. As shown in the examples, when vaporized the emissions
of the tobacco wax composition may result in TSNA levels below
quantifiable limits.
[0064] Inventors have discovered surprising results in emissions
testing of a tobacco wax composition, in the form negligible levels
of formaldehyde, which has been associated with the relatively low
heating temperatures of heat not burn products.
[0065] In another aspect, the present invention relates to a
portion-sized container ("pod") of a tobacco wax composition for
administration to a mammal or person. The pod is intended for use
in a personal (or other) vaporizer.
[0066] The pod is most commonly in a cup like shape. The top is
commonly open, and temporarily covered by a covering that is
removed just prior to, or in connection with use of the portion
sized container.
[0067] By portion-sized, the portion may be for multiple uses and
sessions by the user. The tobacco wax composition portion may range
from 1 mg to 3 grams, preferably from 250 mg to 2 grams, most
preferably 400 mg to 1.2 grams.
[0068] The pod is received, or mated to a receiving chamber. The
receiving chamber comprises--or is adjacent to--the heating system.
The receiving chamber and pod are shaped to maintain close contact,
with the absence or substantial absence of air between the two
respective surfaces (so the pod surfaces are substantially in
contact with the receiving chamber). This promotes heat transfer
from the receiving chamber to the pod.
[0069] Preferably, the receiving chamber comprises a ceramic type
material (e.g. porcelain or ceramic). In certain embodiments, the
ceramic type material is a positive temperature coefficient (PTC)
ceramic, allowing the receiving chamber itself to serve as a
heating element or heat source.
[0070] In certain embodiments, the PTC ceramic (or comparable
receiving chamber material) is composed such that the Curie point
discourages or retards heating of the tobacco wax composition above
a high (upper) threshold.
[0071] In another preferred embodiment, heating element(s) are
coated and/or printed (or otherwise applied) directly onto the
ceramic heating chamber. Such an approach enables various heating
element patterns and shapes to readily be made, which will
generally be optimizes for desired heating characteristics (e.g.
even heating, speed of heating). Such application of the heating
element may similarly be performed on non-ceramic heating
chambers.
[0072] High threshold s may be associated with toxicant and
degradant production and are to be avoided regardless of the method
in which the receiving chamber is heated. It is preferable that the
tobacco wax composition in the pod not be heated to greater than
750 F, preferably less than 550 F, more preferably less than 450 F,
still more preferably less than 350 F, still more preferably less
than 325 F, and most preferably under 300 F. Relatively low
temperatures may be employed given the propensity of the tobacco
wax composition of the present invention to vaporize. A preferred
operating temperature range is 225 F to 350 F, or 250 F to one of
the temperature bounds set forth in this paragraph. In any case, in
the preferred embodiment, a upper threshold temperature is not
exceeded, or not generally or likely to be exceeded in normal
consumer use.
[0073] At the same time, it is desirable that that the device be
capable of rapidly reaching operating temperatures (without
overshooting target operating temperatures or exceeding high
threshold temperatures), or otherwise sufficient temperatures.
Preferably, the device is capable of heating the tobacco wax
composition in the pod reach the preferred operating temperature
range rapidly, meaning in less than 10 seconds, preferably in less
than 5 seconds, more preferably in less than 2 seconds, most
preferably in less than 1 second.
[0074] By "otherwise sufficient temperatures" Applicants refer to
temperature at which the tobacco wax composition readily
vaporizes.
[0075] In contrast, the leading commercial heat not burn product,
Philip Morris' IQOS system, requires approximately 20 seconds for
the IQOS device containing the heat stick, to reach operating
temperatures (see IQOS operating instructions, available here:
https://www.pmiscience.com/sites/default/files/appendix_3_-ths_safety_war-
nings_and_instructions.pdf). After reaching operating temperature,
the entire heat stick must be used within "approximately six
minutes" (id). Moreover, the IQOS device must be recharged in its
charging case after each use: "After each session your IQOS holder
must be recharged" (id). The IQOS holder has a larger battery
capacity. Again, according to the same source, "The IQOS pocket
charger can recharge your IQOS holder up to 20 times before it must
be recharged itself" (id). Again per the operating instructions,
each Heatstick provides approximately fourteen puffs (id). Because
the Heatstick comprises reconstituted tobacco that is pierced by
the IQOS heating blade, when heated the reconstituted tobacco will
tend to lose plasticity, and may adhere or otherwise crumble into
or stick to the IQOS device after use. Accordingly, IQOS provides
extensive instructions on how to "release any Heatstick fragments"
(id). This description of IQOS provides a number of difficulties
for a user: the need to wait twenty seconds for the device to reach
operating temperature; the need to consumer the entire heat stick
within six minutes, need to recharge from the larger battery back
(the "holder") every fourteen puffs.
[0076] It is an object of the present invention to traverse these
issues by allowing virtually instant vapor from the tobacco wax
composition, and to allow a vapor pen using a standard on-off
heating scheme.
[0077] While ignition of the tobacco wax composition is unlikely,
it is an express intention that the tobacco wax not be ignited or
otherwise burned by or in the device. A review of the emissions
data contained in the examples below, including the absence of
toxicants, confirms that the tobacco wax composition of the present
invention experience substantially no combustion at temperatures
sufficient to vaporize the tobacco wax composition. In the
examples, sufficiency of temperature to vaporize the tobacco wax
composition is evidenced by the mass-loss during the puff emissions
tests.
[0078] Airflow is an important feature of a vaporizer system, for
the user experience.
[0079] In many embodiments, tt is desirable to have no or
effectively no bottom airflow into the cup. Bottom airflow is the
primary design currently used in cigarettes and vapor pens. Bottom
airflow directs air directly over the heating coil (where vapor is
created). The wick for e-liquid helps to prevent leaking of the
e-liquid.
[0080] In a system for the tobacco wax composition, wicking is not
possible. The tobacco wax composition will simply not wick as a
conventional e-liquid will. Moreover, an unplugged bottom hole is
problematic with tobacco wax. This is because hot wax will tend to
leak down, re-solidify and clog the bottom airflow (leakage of a
conventional e-liquid in a convention tank is unpleasant but does
not clog the device in a disabling manner). Moreover, the now solid
tobacco wax is fairly difficult to remove. Side airflow, and/or top
airflow is less likely to clog and is thus preferred (either in
whole, in part, or substantially). Top airflow has the benefit that
xxx.
[0081] In both top and side airflow, turbulence is relied upon to
mix air currents with vapor, since the prevailing airflow is
towards the mouthpiece (and the vacuum created by the user's
inhalation).
[0082] In the present invention, the tobacco wax composition
containing pod is heated. Vapor forms--often at the bottom and
sides of the pod closest to the heat, and the wax product is
vaporized (and climbs through the top of the wax product).
[0083] The closer the airflow is to the top of the tobacco wax
composition product, the easier it is for turbulence to join the
vapor into the prevailing airflow. Thus it is desirable to have
side airflow occur in relatively close proximity to the top of the
composition product level. However, if the side airflow is too
close to the top of the composition product level then the side
airflow holes will be more prone to blockage.
[0084] Side airflow may enter through the sides of the pod. In this
embodiment, the pod itself has holes that correspond to side
airholes located in the sides of the receiving chamber (and
permitting airflow, being connected to the outside of the
vaporizer). Such side holes in the pod are covered prior to use (to
protect the product), and such cover is removed by the user prior
to use or automatically by the device.
[0085] It is also possible for the device to create side airholes
in the pod material (as opposed to removing the covering from
pre-formed airholes), where a relatively weak material is used that
can be readily punctured.
[0086] The side airflow must enter above the tobacco wax
composition product fill level (as distinct from the top of the
pod).
[0087] The product fill level must be calibrated to the location of
the side airholes, if any, in the sides of the pod. Side airflow
(and airholes) may also enter from the side of the receiving
chamber above the top of the pod. Where there are side airholes
above the top of the pod, similarly the product fill level is still
calibrated to the distance from the product fill to the airholes.
If the distance is too short, blockage is more likely. Similarly,
if the distance is too long vapor production will be lessened. In
certain non-limitative embodiments, the side airholes are less than
4 mm from the starting product fill level, preferably less than 2
mm from the starting product fill level, preferably more than 0.5
mm from the starting fill level, more preferably more than 1 mm
from the starting fill level.
[0088] Side airholes may be directed downwards (i.e. at a downwards
trajectory) to increase the air vortices and turbulence.
[0089] Airholes may be protected from wax blockage in a number of
ways. First, a physical obstruction may be employed (e.g. a
physical lip). Such physical obstructions can make it harder for
melted wax to flow into the airhole (particularly when the user
physically moves the pen during use--for example, starting with a
vaporizer perpendicular to the flow and then moving the vaporizer
to a parallel position for use). Similarly, materials (including
coatings) may be selected to minimize or direct the flow of liquid
wax away from the airholes to prevent blockage. Physical channels
(e.g.) grooves may be similarly employed to direct the flow if
liquid wax away from the airholes.
[0090] Placement of airhole locations can be oriented to avoid or
reduce blockage. Typically, the personal vaporizer may be raised to
mouth of a user and held parallel to the ground when used. However,
in a conventional vaporizer, there is no way to predict how the
vaporizer will be oriented by the user. A conventional heat button
can be readily used by the thumb or an opposing finger, and is not
a good predictor for orientation (although the user will typically
have the battery button pointing up or down). The mouthpiece
however can be shaped in such a way that is intuitive to the user
to orient the vaporizer in a certain direction (as a non-limitative
example, a plastic cigarillo tip is typically formed in a way that
a user would know how to orient the cigarillo). In this embodiment,
the side airholes can be oriented such that the airholes are biased
to the up-wards plane when the vaporizer is oriented parallel to
the ground plane (since we know how the user will orient the
vaporizer because of the mouthpiece. For example, three airholes
may be used (in the receiving chamber potentially with aligned pod
holes) that are positioned with a bias against the downward side
(meaning the airholes are biased towards the upward side when the
device is uses as expected including through use of a shaped or
marked mouthpiece).
[0091] The vaporizer, pod and/or receiving chamber may have up to
ten side airholes, preferably 2-6 side airholes most preferably 3-5
side airholes. Where a mesh or similar covers the airhole opening,
the number of airholes would be understood to be the number of air
channels.
[0092] The device may similarly be marked or shaped on a part of
the device other than the mouthpiece to indicate a desired
orientation (with corresponding placement of airholes as described
above to reduce blockage potential). For example and without
limitation, shape indentations may be provided to signal a desired
holding of the device in the hand.
[0093] In certain non-limitative embodiments, the pod has a
diameter of 3-15 mm, preferably 6-10 mm (with a corresponding
internal diameter for the receiving chamber).
[0094] In certain non-limitative embodiments, the pod has a height
of 0.5 to 22 mm, preferably 2 to 10 mm (with a corresponding size
for the receiving chamber).
[0095] In certain embodiments, the pod itself may comprise the
heating chamber, optionally including the heating element as a
component of the pod. While this embodiment may be more costly to
manufacture (as compared with a pod that merely mates with a
heating chamber), such embodiment offers the advantage of providing
a fresh heating elements with each pod. Such advantage may be
associated with increased puff consistency since degradation of the
heating element is avoided through less use (i.e. replacement or
substantial replacement with each new pod).
[0096] Heated tobacco wax compositions in a pod can be explosive
(in terms of physical motion--not ignition) when wax at the bottom
of a pod is vaporized, and the vapor pressure is such as to disrupt
the wax above to allow the vapor to escape. It is desirable to have
a "shield"--a physical obstruction that prevents direct passage of
heated tobacco wax composition material from the pod or cup to the
mouthpiece. Generally the shield is attached to the mouthpiece (but
it may equally attach to other parts of the vaporizer). The shield
may also employ features intended to increase airflow turbulence,
without adversely effecting the user's "draw" on the vaporizer.
[0097] The Pod may similarly be designed to minimize the
possibility of wax explosions. For example (and without
limitation), a rim or brim on the pod may act in the same manner as
the shield to obstruct wax explosions from traversing the mouth
piece.
[0098] The pod-receiving chamber may have a rail, slot or
comparable alignment interface to ensure the pod is appropriately
aligned in the receiving chamber, including for other reasons, so
that the airholes from the receiving chamber align or substantially
align with the pod airholes. In this embodiment, the pod has
complimentary features to mate with the alignment interface. Such
alignment may also be used for other purposes, i.e. to facilitate
other connections between pod and receiving chamber (e.g. data
link, ejector system, etc).
[0099] The vaporization device may have an ejection system to
facilitate ejection of the pod from the receiving chamber (as
opposed to relying upon shaking or use of inertia to evacuate the
pod). Such system may comprise, without limitation, a physical
ejector to lift the pod out of the receiving chamber.
[0100] A mouthpiece sits above the pod-receiving chamber assembly.
The mouthpiece employs a combination of distance and relatively low
heat transfer properties to ensure the mouthpiece is not
uncomfortably warm for the user. The mouthpiece may be integrated
with a shield and/or a device to increase turbulent airflow.
[0101] Distinct from the concept of the shield described herein,
certain embodiments will have a sleeve designed to ease cleaning of
the mouthpiece. Wax may form on the inside mouthpiece during use of
the material, either from explosion of wax or from condensation of
materials. Such remainder wax may be unsightly and require manual
cleaning. In certain embodiments, a sleeve may be shaped such that
it adheres or substantially adheres to the mouthpiece. The sleeve
may be disposable, allowing a user to simply dispose of the sleeve
(rather than cleaning the mouthpiece), akin to a disposable coffee
filter. The sleeve may comprise any suitable material, including
without limitation, a paper, pressed paper, cardboard, a
cellulosic, or other suitable material. The selected material for
the sleeve should resist formation from air vortices, or from
trapped wax or condensate. The sleeve material may be coated.
Coatings may be designed (and sleeve materials selected) to resist
adhesion of wax (to encourage the adhered material to drop back to
the heating chamber), or to encourage adhesion. Encouraging
adhesion may useful to avoid contact of the user with condensate
when removing the sleeve. The sleeve may be absorbent to better
catch the wax or condensate.
[0102] A reusable sleeve may also be employed in certain
embodiments. In such embodiments, the sleeve may be removed,
cleaned, and replaced. For such reusable embodiments, any suitable
material may be employed that can be readily re-used.
[0103] For embodiments for which the mouthpiece can be used with a
sleeve, the mouthpiece must be capable of being easily placed into
the mouthpiece, as well as capable of being readily released by the
user for disposal or cleaning. A latch or locking mechanism may be
employed. In some embodiments, the sleeve is held in place by
simple screwing the mouthpiece onto the heating chamber.
Preferably, the sleeve can be released in less than 5 seconds by
the user, preferably in less than 2 seconds, most preferably in
less than one second.
[0104] The sleeve may be any suitable color. In certain
embodiments, a shade of brown may be used to better mask the
appearance of the adhered or trapped wax. In general, but without
limitation, dark colors are preferred.
[0105] In certain embodiments, the pod itself may be fashioned from
a material that heats, e.g. a PTC ceramic. Other materials may also
be used that heat when electric current is supplied. In this
embodiment, the receiving chamber acts as a physical receiving
area, may provide airflow (airholes) and may integrate power to the
pod. The pod may further comprise a thermistor to measure
temperature, either of the pod itself or wax contained therein.
[0106] Empty pods may also be offered to allow the user to treat
the device as an open system (meaning they can use their own
vaporizable materials).
[0107] The pod may be made from any suitable material. Special care
must be given that the pod material does not emit undesirable
elements when heated. The material will generally be a solid
material, but flexible materials may also be employed.
[0108] While a pod with a flat or substantially flat bottom surface
is desirable for handling by the consumer, other shapes may be
used. Specifically, a shape whereby the cup is half a circle will
mean reduce mean geographic distance from the receiving chamber
walls. Other shapes can be selected with this same purposes, i.e.
to reduce geographic distance. Corners may, ceteris paribus, create
higher heat areas within the tobacco wax contained in the pod.
[0109] In certain embodiments, the pod may be integrated with the
sleeve function. For example, the pod may be in the shape of a
circular cauldron--which is heated--connected to an upper conical
shape that prevents the mouthpiece from getting wax or wax
condensate adhered. In such embodiments, the pod may be comprised
of multiple materials--the lower portion designed for heating, and
a separate upper material that is designed to function as a sleeve.
In some embodiment, it may be desirable to have a separating
material between the heatable portion of the pod and the sleeve
portion. It in cases where adequate power is available, the design
may allow the sleeve to heat. Such heat may be useful to reduce
adhered wax composition.
[0110] In certain embodiments, the top of the pod is covered with a
porous layer which remains on top of the pod during use. This
porous layer is sufficiently porous to allow for transmission of
sufficient vapor for the user. The porous layer is similarly
sufficiently porous not to interfere or prevent a desired pressure
drop.
[0111] In certain embodiments, the pressure drop of the device used
to vaporize the pod will have a pressure drop of 20 (mm H20) to 175
(mm H20), preferably 75 (mm H20) to 130 mm (H20), most preferably
90 (mm H20) to 110 (mm H20).
[0112] The porous layer is sufficiently non-porous to prevent (or
substantially prevent or partly prevent) parts of the wax
composition from exploding upwards and escaping from the heating
chamber to whence they may adhered to the mouthpiece.
[0113] The porous layer may be made from any suitable material. In
certain embodiments, a thermo-conductive material is used, such
that the permeable layer. Thermo-conduction may be used to
encourage parts of the wax composition that are caught or trapped
on the permeable layer to drip off and re-join the wax composition
in the heating chamber (and/or themselves be vaporizer).
[0114] In certain embodiments, the porous layer may be selected or
coated so as to resist adhesion of wax composition components to
the layer.
[0115] In certain embodiments, the porous layer includes heating
element(s).
[0116] In certain embodiments, the top of the pod is covered with
two layers. The outer layer is an impermeable or semi-impermeable
layer for barrier purposes (i.e. product stability and freshness)
(a "barrier layer"). Underneath the outer layer is the porous layer
which remains on during use.
[0117] In certain embodiments, porous materials--akin to those
described for the porous top layer, may be used to cover sideholes
or other airholes.
[0118] The top of the pod may be configured to allow for easy
access by a consumer. This allows a consumer to add other waxes or
extracts to the Pod. Conversely, the system may be configured to
make it difficult for a consumer to add their own materials to the
pod.
[0119] A temperature meter can be built into the pod, the receiving
chamber, or both. The pod and receiving chamber are used as part of
a vaporizing system, further comprising a power source (typically
electric, but it may also be a carbon-based source, or butane based
source or other source of heat), and a control module that allows
the user to select heat settings, turn the device on or off, as
well as other features. The device may be able to store and
communicate use data.
[0120] The Pod may be able to communicate to the device (or the
device determine from the Pod) the type of Pod (flavor, quantity of
wax composition, nicotine strength, etc).
[0121] It will be appreciated that the use of a Pod will give
additional flexibility to the wax composition formulation, because
non-vaporizable ingredients may be used in the composition without
leaving the non-vaporizable ingredients as residue that require
cleaning by a user. Film formers or molassess (and other sugars and
sweeteners) are non-limitative examples of non-vaporizable
ingredients that may be employed.
[0122] The use of the pod is not limited to tobacco wax
compositions but may also be employed with other botanical or plant
wax compositions, as well as e-liquids. Such materials may be used
in combination with tobacco wax. References herein to tobacco wax
compositions can also refer to these products and compositions
comprising them.
[0123] Some distinctions in heat transfer are important to
understand in connection with various embodiments of the present
invention. In IQOS and BATs GLO, the tobacco stick (comprising
reconstituted tobacco) requires airspaces in the reconstituted
tobacco stick to allow for the aerosolized components to travel
from the reconstituted sheet and out through the mouthpiece. Were
such air spaces absent, and the tobacco stick comprised of a solid
reconstituted plug, it would be extremely difficult (and require
substantial heat) to force the aerosol through the solid plug. As a
practical matter, only components on edge of a solid plug would
successfully vaporize.
[0124] The IQOS device has an operational temperature of 350 C; in
contrast the GLO uses has a lower operating temperature of 240 C.
This difference in operating heating temperatures can likely be
explained by the different heating configurations of the two
devices. IQOS employs a flat, thin, heated blade or knife upon
which the tobacco stick is impaled. The knife does not reach the
outer edges of the heat stick (tobacco stick) (otherwise it would
destroy the tipping paper on the outside of the tobacco stick).
Approximately, it can be thought of as having the width of 0.8 of
the tobacco stick. In contrast, GLO reportedly heats from the
circumference surrounding the tobacco stick. Assuming a heating
element of the same length, the circumference approach has greater
surface area (circumference*length). Assuming a diameter of 1, and
identical length, the GLO approach offers a surface heating area of
1*3.14, as opposed to two sides of the flat blade (0.8*2=1.6). This
greater surface heating area (again assuming identical lengths)
likely explains in part the lower operating temperature of the GLO
system.
[0125] However, in both GLO and IQOS, heat is required to travel
through airspaces. Air must be drawn in by convection current to be
heated, and air is understood to be a very poor heat conductor.
Heat transfer by air convection is an essential component of both
IQOS and GLO. The use of air convection, together with the relative
difficulty of aerosolizing components from a solid matrix, helps to
explain the relatively long warm up period for these products (20
seconds) and relatively high operating temperatures.
[0126] In contrast, the tobacco wax of the composition has no or
substantially air spaces. In various embodiments, it is a solid,
semi-solid or viscous liquid. All of these embodiments
substantially lack air spaces. The result is that the tobacco wax
composition has efficient heat transfer attributes. Glycerin and
propylene glycol both have excellent heat transfer properties
(sufficiently good for use in anti-freeze systems), as does the
tobacco wax itself. The tobacco wax composition is heated in
preferred embodiments with the absence or substantial absence of
air convection to heat the tobacco wax composition.
[0127] In certain embodiments, the tobacco wax composition of the
present invention has a thermal conductivity at 300 k (80.3 F) of
greater than 0.1, preferably greater than 0.2, more preferably
greater than 0.25 (W/m K).
[0128] The substantial absence of air in the tobacco wax
composition may also serve to prevent or reduce oxidation when the
tobacco wax composition is heated.
[0129] Certain embodiments of the invention are described herein
with reference to FIGS. 1-9, which schematically show examples of
the method and system of the present invention. However,
applicants' invention is not limited to the particular
embodiments/examples shown in the figures.
[0130] FIG. 1 is a perspective view showing a 11 heating chamber
containing a 10 tobacco wax composition. The outside of the heating
chamber assembly is 12. In certain preferred embodiments, the
tobacco wax composition is in a pod.
[0131] FIG. 2 is an exploded perspective of the heating chamber sub
assembly, including a ceramic heating chamber 11, which may contain
a pod or may comprise itself a pod. The 13 heating element may be
printed or coated onto the heating chamber, which in preferred
embodiments in ceramic. 12 is the wall of the heating chamber
casing. 14 is an air flow slot for the heating chamber or pod
receiver. 15 is an airhole in the heat chamber or pod receiver
(other airhole figurations may be employed in different
embodiments). 16 is an electrode insulator. 17 is the electrode. 18
is the mouthpiece screw thread.
[0132] FIG. 3 is a cross-sectional view of the heating chamber
containing a tobacco wax composition. 10 is the tobacco wax
composition; other numbers are as above.
[0133] FIG. 4 is a cross section of the wall of the 12 heating
chamber casing.
[0134] FIG. 5 is a cross section of the receiver for the heating
chamber or pod, including the battery connection section. 19 is the
battery screw thread.
[0135] FIG. 6 is a cross section of the 17 electrode.
[0136] FIG. 7 is a cress section of the 16 electrode insulator.
[0137] FIG. 8 is a perspective view of a pod (or heating chamber)
showing a 13 printed or coated heating element and 20 positive and
21 negative electrical contacts.
[0138] FIG. 9 is an exploded perspective view of a 11 pod, a 23
porous layer, and a 22 barrier layer.
Example A
[0139] Tobacco wax was removed from tobacco leaf using
supercritical CO2 extraction. Tobacco oil was mixed in with the
wax, while retaining a wax consistency. The material was fragrant
and dark brown in color. A nicotine assay indicated a nicotine
strength for the tobacco wax of 4%. The wax was placed in a dry
herb vaporizer and vaped by a healthy adult male. The tobacco wax
vaporized creating a nice vapor volume. The nicotine delivery was
strong and the product was fragrant with tobacco fragrance. The
tobacco wax substantially vaporized leaving minimal residue on the
heating coil.
Example B
[0140] The tobacco wax of Example A was taken and 10% of vegetable
glycerin and 5% of propylene glycol (measuring by weight of the
final composition) was added. The tobacco wax accepted the addition
of these vapor agents. The resulting composition was placed in a
dry herb vaporizer and used by a healthy adult male. The flavor was
excellent and the vapor production was increased from Example
A.
Example C
[0141] The tobacco wax of Example A was taken and grape flavor from
Tobacco Technology, Maryland was added, at 3.5% of the composition.
The resulting tobacco wax composition was placed in a dry herb
vaporizer and used by a healthy adult male. The grape taste was
enjoyed by the user.
Example D
[0142] Tobacco wax was extracted from a different of blend tobacco
leaf using supercritical CO2 extraction. The tobacco wax was dark
with a slightly green tinge. The nicotine content of the tobacco
wax was approximately 1.5%. Nicotine glycerin solution (10%) was
added to 10% of the final composition weight. The product vaped
well but the flavor notes where not as attractive as the tobacco
wax of Example A. It was observed that additional flavors could
improve the product.
Example E
[0143] Oil from the extraction of tobacco described in Example D
was added to the tobacco wax of Example D, and the composition was
mixed using strong shear forces. The resulting product vaped well
and left very little residue.
Example F
[0144] Tobacco wax from Example A was placed in a vaporizer. A
small amount of zero nicotine flavored e-liquid was added to the
vaporizer. The two were not otherwise mixed other than to insert
them together. The wax and the zero were vaporized together. A fair
amount of residue was left by this mix in the vaporizer. The
exercise was repeated with a yet smaller amount of e-liquid with
improve results including much less residue.
Example G
[0145] Tobacco wax from Example A was compounded with a small
amount of sodium carbonate as a buffer agent to effect a more basic
pH.
Example H
[0146] Tobacco wax was extracted from flue cured tobacco with low
TSNA levels. The extraction was performed using supercritical CO2
extraction. The wax partition was approximately 4% of the mass of
the starting tobacco. Tobacco wax was also extracted from burley
tobacco with low TSNA levels, again using supercritical CO2
extraction, and again with a yield of approximately 4%.
Example I
[0147] The tobacco wax partitions of Example H were blended, at a
ratio of 70% flue cured to 30% burley. The combined wax partition
was then mixed with vegetable glycerin, for a final composition of
50% tobacco wax, and 50% vegetable glycerin.
Example J
[0148] The final composition of example I was sent to a third party
laboratory for nicotine testing. The composition was measured to
contain 3.3% nicotine, implying that the blended wax partition had
a starting nicotine level of 6.6% (prior to dilution with vegetable
glycerin). LOQ for the testing was 0.16%.
Example K
[0149] The final composition of Example I was sent to a third party
laboratory for emissions testing. Results were as follows.
TABLE-US-00001 Aerosol Propylene Ethylene Diethylene Mass Device
Puff Glycol Glycol Menthol Nicotine Glycol Glycerol Collected Loss
Mass Intervals mg/puff mg/puff mg/puff mg/puff mg/puff mg/puff mg
mg 1-50 BQL BQL BQL 0.051 BQL 0.510 34.9 52.2 LOQ 0.020 0.002 0.004
0.008 0.002 0.020 NA NA
[0150] Carbonyls testing results were as follows.
TABLE-US-00002 Acetyl Device Puff Acetaldehyde Acetoin Propionyl
Crontonaldehyde Diacetyl Formaldehyde Loss Mass Intervals
.mu.L/puff .mu.L/puff .mu.L/puff .mu.L/puff .mu.L/puff .mu.L/puff
mg 1-50 0.06 BQL BQL BQL BQL BQL 31.1 LOQ 0.02 0.02 0.02 0.02 0.02
0.02 NA
[0151] TNSA results were as follows.
TABLE-US-00003 Aerosol Mass Device Puff NNN NNK Collected Loss Mass
Interval ng/puff ng/puff mg mg 1-50 BQL BQL 45.0 51.6 LOQ 0.20 0.20
NA NA NAT NAB ng/g ng/g FC/BU Blend BQL BQL LOQ 15 15
[0152] The smoke regime for the above testing was: 55 mL puff/30
sec interval/3 sec duration. The composition was vaporized in a
vaporization pen, on high heat.
[0153] Inventors compared the above results with those publicly
available for Philip Morris International's IQOS system (see papers
linked from www.pmiscience.com, including inter alia, Zenzen at al.
"Reduced exposure evaluation of an Electrically Heated Cigarette
Smoking System. Part 2: Smoke chemistry and in vitro toxicological
evaluation using smoking regimens reflecting human puffing
behavior" Regulatory Toxicology and Pharmacology, Volume 71, Issue
2, March 2015). The inventors concluded that the tobacco wax
composition of the present invention provides superior toxicant
profile (i.e. substantially lower levels of the measured toxicants)
as compared with IQOS. This was particularly notable in the case of
formaldehyde, which is considered to be a lower temperature
degradant product, and hence one that is difficult to substantially
reduce in heat not burn tobacco products (as compared with
combustibles). For an excellent discussion of combustion and
tobacco, see Thomas McGrath's presentation entitled "What is
combustion and why is the absence of combustion important for heat
not burn prodicts" (Jun. 16, 2017 presentation at the Global Forum
on Nicotine 2017) (available here:
https:///gfn.net.co/downloads/Presentations
2017/Dr%20Thomas%20Mc%20Grath.pdtf. All of the above references are
hereby incorporated by reference as if fully stated herein.
[0154] Whereas McGrath describes reduced toxicant formation (as
compared with combustibles) of >90 to >95% (and such results
with a less rigorous 2 second puff testing, 55 ml, 30 second
intervals), Applicants achieved superior reductions with the above
results, i.e. >98% reduction and in many cases below
quantifiable limits. Applicants noted that achieving superior
toxicant reductions is particularly surprising in view of the
multi-billion dollar R&D effort (publicly disclosed) associated
with the development of IQOS.
[0155] Applicants postulated that the basis for this surprising
result may reflect in part reduced energy requirements to
volatilize the tobacco wax compositions of the present invention,
as compared to the energy requirements needed aerosolize the
components contained in the solid matrix which is the reconstituted
tobacco comprising the Heat Stick used in IQOS.
[0156] Applicants noted that below quantifiable limits indicates
that no amount of the analyte exists above the limit of
quantification. Thus, in the case of each analyte measuring below
quantifiable limits, the analyte is understood to exist at a level
ranging from zero to less than the quantifiable limit.
Example L
[0157] Polysorbate (Tween 20) was added to the composition of
Example I, and the resulting composition was placed in 5 ml tubes,
alongside of 5 ml tubes filled with the composition of I. It was
noted that the addition of polysorbate substantially reduced
separation of the vegetable glycerin from the tobacco wax.
Example M
[0158] A healthy male volunteer vaped the tobacco extracts
described in Example H separately, i.e. as flue cured and burley
(each with glycerin), and a 70-30 blend (each with glycerin). The
blend was particularly pleasant, offered excellent tobacco flavor
and rich tobacco satisfaction.
Example N
[0159] A healthy male volunteer took a Ploom Model 2 device, and
removed the tobacco from the product's pod, and replaced this
tobacco with the tobacco wax composition of L. The Model 2 was then
started in accordance with its directions. The Model 2 has a thirty
second warm up period, and reaches an operating temperature of 175
C/347 F. The tobacco wax composition violently vaporized during the
warm up phase (the indicating light blinks during said phase), and
bubbled out of the mouthpiece. This demonstrated that the tobacco
wax composition, in certain embodiments of the present invention,
readily vaporizes under 347 F. The inventors attributed the ability
of the tobacco wax vaporization to be readily vaporized--using
on-off heating (as opposed to a prolonged warm up stage--meaning a
warm up stage taking over 3, 4 or 5 seconds).
* * * * *
References