Note: Descriptions are shown in the official language in which they were submitted.
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A TOBACCO OR NON-TOBACCO PRODUCT COMPRISING MAGNESIUM CARBONATE
TECHNICAL FIELD
The invention relates to an oral smokeless tobacco or nicotine-containing non-
tobacco product,
in particular to such product comprising a magnesium carbonate.
BACKGROUND
Smokeless tobacco products for oral use are made from tobacco leaves, such as
lamina and
stem of the tobacco leaf. The material from roots and stalks are normally not
utilized for
production of smokeless tobacco compositions for oral use.
There are two types of moist snuff, the American type and the Scandinavian
type which is also
called snus. American-type moist snuff is commonly produced through a
fermentation process
of moisturized ground or cut tobacco. Scandinavian-type moist snuff (snus) is
commonly
produced by using a heat-treatment process (pasteurization) instead of
fermentation. The
heat-treatment is carried out in order to degrade, destroy or denature at
least a portion of the
microorganisms within the tobacco preparation.
Both the American-type and the Scandinavian-type of moist snuff for oral use
are available in
loose form or portion-packed in a saliva-permeable, porous wrapper material
forming a pouch.
Pouched moist snuff, including snus, is typically used by the consumer by
placing the pouch
between the upper or lower gum and the lip and retaining it there for a
limited period of time.
The pouch material holds the tobacco in place while allowing saliva to pass
into the tobacco
and allowing flavours and nicotine to diffuse from the tobacco material into
the consumer's
mouth.
The pouch material is typically a nonwoven fleece (soft fabric) material, such
as viscose
(regenerated cellulose; viscose fibers are often referred to as viscose rayon
or rayon),
including an acrylic polymer that acts as binder in the nonwoven material and
provides for
heat-sealing of the pouches during manufacturing thereof. The viscose nonwoven
material
normally used for pouched smokeless tobacco products is similar to the fabric
used in tea
bags. Nonwovens are fabrics that are neither woven nor knitted. Methods for
the
manufacturing of nonwoven materials are commonly known in the art.
Pouched smokeless tobacco products for oral use may be post-moisturized after
pouch
formation or not post-moisturized after pouch formation, which herein is
referred to as non-
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post-moisturized. Post-moisturized pouched products may be produced by
spraying water on
the pouched smokeless tobacco product before packaging the pouched products in
cans.
Post-moisturized pouches are sometimes referred to as "original snus". Non-
post-moisturized
pouched products are sometimes referred to as "white snus" and are by some
consumers
considered to have a more appealing appearance.
Pouched smokeless tobacco products may be produced by measuring portions of
the
smokeless tobacco composition and inserting the portions into a nonwoven tube.
Pouched
smokeless tobacco products may alternatively be produced by placing portions
of moist snuff
on a nonwoven web using a pouch packer machine in accordance with the device
disclosed in
US 6,135,120.
Oral pouched smokeless tobacco products are normally sized and configured to
fit comfortably
and discreetly in a user's mouth between the upper or lower gum and the lip.
There are also nicotine-containing non-tobacco snuff products and nicotine-
free non-tobacco
snuff products available which may be offered as alternatives to smokeless
tobacco products.
An example of a nicotine-containing non-tobacco snuff product is provided in
WO 2012/134380. This type of non-tobacco snuff product for oral use may be
portion-packed
in a saliva-permeable, porous wrapper material forming a pouch.
Alkaline pH adjusting agents (pH adjusters) are traditionally used in the
composition of most
oral smokeless tobacco or nicotine-containing non-tobacco products, including
snus, to
maintain a basic pH. pH adjusters, such as sodium carbonate or sodium
bicarbonate, brings
the pH value to the slightly alkaline side, such as about pH 7.5 to 9. Sodium
carbonate may
also be used to give the products their characteristic aroma profile.
Typically, the amount of pH
adjuster in the smokeless tobacco or nicotine-containing non-tobacco
composition is less than
about 7% w/w, such as within the range of from about 3 to about 5% w/w, based
on dry weight
of the tobacco composition. Further, in WO 2009/082331, magnesium carbonate
was used as
a pH stabilizer to attain a stabilized basic pH in the tobacco composition of
an oral smokeless
tobacco product, to improve the product's storage stability.
pH is also known to be one of several factors regulating the uptake of
nicotine during use of an
oral smokeless tobacco product.
Whereas a basic pH improves the product's microbiological stability, it
reduces nicotine
mobility within the product (nicotine extraction) and may detrimentally affect
the product's
taste.
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On the other hand, an acidic pH of an oral smokeless tobacco product improves
nicotine
extraction, but will seriously diminish the nicotine uptake in the oral
cavity. Furthermore, an
acidic pH may have detrimental effects on oral health (e.g. dental health).
Hence, there is a
need for improved oral smokeless tobacco or nicotine-containing non-tobacco
products
balancing nicotine uptake, nicotine extraction and oral health.
The object of the present invention is to overcome or at least mitigate some
of the problems
associated with the prior art.
SUMMARY
The present document relates to an oral smokeless tobacco or a nicotine-
containing non-
tobacco product comprising a composition enclosed by a wrapping material,
wherein the
wrapping material comprises a magnesium carbonate. The present document also
relates to
an oral smokeless tobacco or nicotine-containing non-tobacco product
comprising a
composition enclosed by a wrapping material, and comprising a liner adjacent
to the wrapping
material, wherein the liner comprises magnesium carbonate in an amount of 0.1
to 10 %, by
total weight of the oral smokeless product. The present document is also
directed to the use of
magnesium carbonate in a wrapping material and/or liner of an oral smokeless
tobacco or a
nicotine-containing non-tobacco product for stabilizing the oral pH during use
of said product.
The present document is therefore directed to an oral smokeless tobacco or
nicotine-
containing non-tobacco product comprising a composition enclosed by a wrapping
material
forming a pouch and optionally a liner adjacent to the wrapping material
inside the pouch,
wherein the wrapping material and/or liner comprises magnesium carbonate in an
amount of at
least 0.1% by total weight of the oral product, such as 0.1-10%, 0.5-4%, or 1-
3% by total
weight of the oral product. The magnesium carbonate may be applied on the
outer or inner
surface of the wrapping material and/or liner.
The composition enclosed by the wrapping material may be a smokeless tobacco
composition
or nicotine-containing non-tobacco composition.
The pH of the tobacco or nicotine-containing non-tobacco composition of the
oral smokeless
tobacco or nicotine-containing non-tobacco product may be about 8-9. The pH of
the tobacco
or nicotine-containing non-tobacco composition of the oral smokeless tobacco
or nicotine-
containing non-tobacco product may alternatively be about 6-8, such as about
7.5-8 or about
7.7-7.9. The pH may be regulated by the addition of one or more pH
adjuster(s). The tobacco
or nicotine-containing non-tobacco composition as such may also be devoid of
any added pH
adjuster(s), such as magnesium carbonate.
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The tobacco or nicotine-containing non-tobacco composition of the oral
smokeless tobacco or
nicotine-containing non-tobacco product may comprise magnesium carbonate in an
amount
from 0.1-1%, such as 1-5%, by weight of the composition (in addition to the
magnesium
carbonate present in the wrapping material and/or liner).
The oral smokeless tobacco or nicotine-containing non-tobacco product may be
in the form of
snuff, snus or chewing tobacco, or is in a form resembling snuff, snus or
chewing tobacco.
The liner of the oral smokeless tobacco or nicotine-containing non-tobacco
product may be
water-soluble or not water-soluble.
The wrapping material of the oral smokeless tobacco or nicotine-containing non-
tobacco
product may comprise magnesium carbonate and a water-soluble polymer, such as
one or
more of PVA, PVP, HPC, HPMC, CMC.
The oral smokeless tobacco or nicotine-containing non-tobacco product may be
non-post-
moisturized. The oral smokeless tobacco or nicotine-containing non-tobacco
product may be
contained in a box, can or canister.
The present document is also directed to the use of magnesium carbonate in a
wrapping
material and/or liner of an oral smokeless tobacco or a nicotine-containing
non-tobacco
product for stabilizing the oral pH during use of said product.
The present document is also directed to a method for the in situ formation of
magnesium
carbonate in a wrapping material and/or an optional liner of an oral smokeless
tobacco or
nicotine-containing non-tobacco product comprising a composition enclosed by
said wrapping
material thereby forming a pouch, said method comprising providing an aqueous
polymer-
containing solution comprising magnesium carbonate to said wrapping material
and/or optional
liner.
BRIEF DESCRIPTION OF DRAWINGS
Figure 1 shows oral pH during use of oral smokeless tobacco products in the
form of tobacco-
filled pouches without added magnesium carbonate, tobacco-filled pouches
comprising
magnesium carbonate in the tobacco composition (bulk) only (10% by total
weight of the oral
smokeless product), and tobacco-filled pouches with magnesium carbonate added
to the
wrapping material only (2% by total weight of the oral smokeless product
according to Example
A), respectively.
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Figure 2 shows that the mobility of nicotine in snus decreases with rising pH
of the tobacco
composition. Loose snus (i.e. without wrapping material) with various pH
values were loaded
into columns and extracted with water solutions (ion strength = 1 M, pH = same
as the
respective snus). At pH 6.66, 120% were extracted, as compared to a reference
with pH 7.84
5 (reference = 100%). The figure shows that the mobility is higher for
protonized nicotine in snus
than for unprotonized nicotine.
Figure 3 shows oral pH during 30 minutes' use of an oral smokeless tobacco
product with
magnesium carbonate added only to the wrapping material, compared with an oral
smokeless
tobacco product devoid of any added magnesium carbonate (Example B).
Figure 4 shows comparative oral pH values during 30 minutes use of oral
smokeless tobacco
products with 2% magnesium carbonate added to the wrapping material only
(Example A), and
1% magnesium carbonate in the tobacco composition (bulk) of the oral smokeless
tobacco
product only, respectively, by total weight of the oral smokeless tobacco
product.
DEFINITIONS
By "tobacco" is meant any part, e.g., leaves, stems, and stalks, of any member
of the genus
Nicotiana. The tobacco may be whole, shredded, threshed, cut, ground, cured,
aged,
fermented, or treated in any other way, e.g., granulated or encapsulated.
By "non-tobacco material" is herein meant non-tobacco material, typically
constituted of non-
tobacco plant material and/or a particulate non-tobacco material comprising
one more fillers,
such as polysaccharides (e.g. maltitol or mannitol) and/or microcrystalline
cellulose. The
nicotine-containing non-tobacco composition as disclosed herein in addition to
non-tobacco
material further comprises nicotine or a salt thereof (such as nicotine
bitartrate). Suitable non-
tobacco plant materials are non-tobacco plant fibres, in particular dietary
plant fibers, such as
maize fibers, oat fibres, tomato fibers, barley fibers, rye fibers, apple
fibres, sugar beet fibres,
potato fibres, corn fibres, buckwheat fibres, cocoa fibres, bamboo fibers,
citrus fibers and any
combinations thereof.
"Oral" and "oral use" is in all contexts used herein as a description for use
in the oral cavity,
such as buccal placement.
As used herein "pouched product" or "oral pouched product" and the like refers
to a portion of
e.g. smokeless tobacco composition or nicotine-containing non-tobacco
composition packed in
a saliva-permeable pouch material intended for buccal placement in the oral
cavity. The oral
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pouched product may alternatively be referred to as a portion-packed (pouched)
product for
oral use.
As used herein, the term "water content" refers to the total amount of water
in the preparation,
composition or product referred to. The water content is given herein as
percent by weight
(wt%) of the total weight of the preparation, composition or product referred
to. Water content
may be measured by using a standardized method for water analysis, such as,
Karl Fischer
titration or gas chromatography (GO).
As used herein, the term "moisture content" refers to the total amount of
volatile ingredients,
such as water and other oven volatiles (e.g. propylene glycol and ethanol) in
the composition
or product referred to. The moisture content is given herein as percent by
weight (wt%).
The moisture content of a tobacco material or non-tobacco plant fibers, if
present, may be
determined by using a method based on literature references Federal Register/
vol.74, no.
4/712-719/Wednesday, January 7, 2009/Notices, "Total moisture determination"
and AOAC
(Association of Official Analytical Chemics), Official Methods of Analysis
966.02: "Moisture in
Tobacco" (1990), Fifth Edition, K. Helrich (ed). In this method, the oven
volatile (OV) content of
the tobacco material and the non-tobacco plant fibers, if present, is
determined gravimetrically
by taking 2.5 0.25 g sample and weighing the sample before evaporation of
moisture and after
evaporation of moisture. Mettler Toledo's Moisture Analyzer HB43, a balance
with halogen
heating technology, may be used (instead of an oven and a balance as in the
mentioned
literature references). The sample can be heated to 105 C (instead of 99.5 0.5
C as in the
mentioned literature references). The measurement is stopped when the weight
change is less
than 1 mg during a 90 seconds time period. The moisture content (i.e. oven
volatile content) as
weight percent of the original weight of the sample is then calculated
automatically by the
Moisture Analyzer HB43.
The term "additive" or "additional ingredient" as used herein denotes
substances other than
tobacco material or non-tobacco material, salt (e.g. sodium chloride,
potassium chloride,
magnesium chloride, calcium chloride and any combinations thereof), pH
adjuster (e.g. sodium
hydroxide, potassium hydroxide, potassium carbonate, sodium carbonate or
sodium
bicarbonate) and water. Examples of additives or additional ingredients that
may be present in
a product of the present document include, but are not limited to, flavouring
agents, cooling
agents, heating agents, sweetening agents, colorants, humectants (e.g.
propylene glycol or
glycerol), antioxidants, preservatives (e.g. potassium sorbate), binders,
fillers, non-tobacco
plant fibers and disintegration aids. Such additives may or may not be added
to any oral
smokeless tobacco or nicotine-containing non-tobacco product disclosed herein.
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"Flavour" or "flavouring agent" is used herein for a substance used to
influence the aroma
and/or taste of the smokeless tobacco product, including, but not limited to,
essential oils,
single flavour compounds, compounded flavourings, and extracts.
As used herein, reference to "dry weight percent" refers to weight percent of
the ingredient
referred to on the basis of the total weight of dry ingredients, i.e. all
ingredients of the
preparation, composition or product referred to excluding moisture content.
As used herein "`"/0 w/w" or "wt%" or "weight %" means weight percent of the
component
referred to based on the weight of the total composition or product referred
to unless otherwise
explicitly stated.
As used herein, the term "wrapper" or wrapping material" refers to a saliva-
permeable (and
preferably non-dissolvable) material enclosing a tobacco or nicotine-
containing non-tobacco
composition thereby forming a pouch, thereby providing a pouched product. The
wrapping
material may be made of any suitable saliva-permeable pouch material, such as
non-woven,
woven or knitted materials made from e.g. fibers of cellulose (e.g. cotton),
derivatives of
cellulose, regenerated cellulose (e.g. viscose), binders, synthetic fibers or
synthetic polymers
or combinations thereof. The terms "wrapper" and "wrapping material" may be
used
interchangeably in this document.
By "liner" is in the context of the present document meant a material separate
from the
wrapping material and typically not attached thereto. The liner is typically
placed inside the
pouch formed by the wrapping material and adjacent thereto (i.e. in close
vicinity to the
wrapping material) in order for the magnesium carbonate to be close to the
surface of the
product for it to effect its pH stabilizing effect on oral pH. The liner may
consist of or comprise a
water-soluble composition, e.g. CMC and PVP. Alternatively, the liner is made
of a material
which is not water-soluble, i.e. which does not dissolve upon oral use of the
oral smokeless
tobacco or nicotine-containing non-tobacco product. The liner may be in the
form of a dyestuff
or varnish. The liner may also comprise or consist of cellulose, derivative(s)
of cellulose,
synthetic fibers, binders or combinations thereof. The liner may be present as
a strip or patch.
The liner may partially or fully enclose the composition.
By "outer surface" is in the context of the present document meant a surface
of a product or
part thereof facing a user during use of the product. By "inner surface" is
meant a surface of a
product or part thereof not facing a user during use of the product.
By "stabilization of oral pH" and the like is in the context of the present
document meant a local
stabilization of the pH in the contact volume between an oral smokeless
tobacco or nicotine-
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containing non-tobacco product and the oral mucosa, i.e. what is intended is
not a stabilization
of the pH in the oral cavity as a whole but only a stabilization of the local
pH in the space
between the product and the oral mucosa. Similarly, by the term "oral pH" is
meant the pH in
the contact volume between a tobacco or nicotine-containing non-tobacco
product and the oral
mucosa and not the pH in the oral cavity as a whole.
DETAILED DESCRIPTION
It is known that the pH of an oral smokeless tobacco product drops during
storage thereof.
However, it has now surprisingly been found that the oral pH drops also during
the oral use of
an oral smokeless tobacco product or nicotine-containing non-tobacco product
(see Figure 1,
continuous line). Nicotine permeability through the mucous membrane depends on
pH, with
the uptake improving with higher pH (see e.g. Chen et al., International
Journal of
Pharmaceutics, 184 (1999) 63-72). A drop in pH during use of the product will
thus impair the
nicotine uptake from the surface of the oral smokeless tobacco product. Also,
a lower pH may
have negative effects on the teeth.
As a consequence, there is a need to stabilize the pH at the surface of an
oral smokeless
tobacco or nicotine-containing non-tobacco product during oral use thereof. A
mentioned
above, it is known from WO 2009/082331 that magnesium carbonate can be
incorporated into
the smokeless tobacco or non-tobacco composition itself to stabilize the pH of
the composition
in order to effect a longer storage capability. However, a higher pH in a
nicotine-containing
composition does not favour nicotine release therefrom. Thus, incorporating
magnesium
carbonate in the composition itself may negatively affect nicotine release
therefrom, in
particular at the concentrations of magnesium carbonate that would be
necessary to obtain a
sufficient pH stabilizing effect on oral pH during an extended period of oral
use. As is
demonstrated in the experimental section, a magnesium carbonate concentration
in the
composition in the region of 10% of the total weight of the oral smokeless
tobacco or nicotine-
containing non-tobacco product would be needed to obtain suitable pH
stabilization during an
extended period of oral use (see Figure 1). However, such concentration would
reduce
nicotine mobility within the oral smokeless tobacco or nicotine-containing non-
tobacco product,
and impair the production process regarding product composition and pouch
filling capability
(due to product rheology changes). Moreover, the tobacco product's sensory
characteristics
(e.g. taste) would be impaired.
It has now surprisingly been found that it is possible to provide magnesium
carbonate to the
wrapping material and/or liner in order to stabilize the oral pH during use of
an oral smokeless
tobacco or nicotine-containing non-tobacco product. A magnesium carbonate
concentration in
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the region of 2% in or on a wrapper or liner would give better or equal effect
on oral pH
stabilization as 10% magnesium carbonate in the tobacco composition, counted
on the total
weight of the oral smokeless tobacco or nicotine-containing non-tobacco
product, without the
negative effects on e.g. manufacturing and taste (see comparison in Figure 1).
This despite the
fact known by the skilled person that magnesium carbonate has a low solubility
(in aqueous
solvents such as water and saliva) in comparison to the pH adjusters commonly
used in
smokeless tobacco or non-tobacco products, such as sodium carbonate and sodium
bicarbonate, and thus would not be expected to provide such a high pH
stabilizing effect in the
oral cavity.
The magnesium carbonate in the wrapping material and/or liner as disclosed
herein stabilizes
the oral pH during oral use of the product so that the pH in close proximity
to the mucous
membrane (i.e. the oral pH) does not drop significantly during use of the
product. The drop in
pH during use of a smokeless tobacco or non-tobacco product is most pronounced
in the
immediate vicinity of the product where the product is in contact with the
tissue in the oral
cavity. Magnesium carbonate present in the wrapping material and/or liner as
disclosed herein
prevents this drop in pH and stabilizes the pH at a level which facilitates
nicotine uptake, as a
drop in pH otherwise would lower nicotine uptake.
Hence, there is provided an oral smokeless tobacco product comprising a
tobacco composition
enclosed by a wrapping material said product optionally containing a liner
adjacent to the
wrapping material inside the pouch, wherein the wrapping material and/or liner
comprises a
magnesium carbonate. In line with the reasoning above, there is also provided
an oral
smokeless nicotine-containing non-tobacco product comprising a composition
enclosed by a
wrapping material said product optionally containing a liner adjacent to the
wrapping material
inside the pouch, wherein the wrapping material and/or liner comprises a
magnesium
carbonate.
The composition of a nicotine-containing non-tobacco product may consist of or
comprise non-
tobacco plant fibers, microcrystalline cellulose and/or other filler
materials, and nicotine or
derivatives of nicotine, and water.
When higher amounts of magnesium carbonate are added to the wrapping material
or liner,
the magnesium carbonate is preferably granulated. The person skilled in the
art is well
equipped to understand how to granulate magnesium carbonate.
Oral smokeless tobacco or nicotine-containing non-tobacco products according
to the
invention provide efficient nicotine delivery over time due to the magnesium
carbonate present
in the wrapping material and/or liner, whereby time of use in the oral cavity
may be extended.
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This may be a considerable advantage, in view of change of consumer use
preferences.
Extended times of exposure of the oral smokeless tobacco or nicotine-
containing non-tobacco
product also enhances the importance of the basic surface pH, in view of oral
and/or dental
health.
5 An advantage with using magnesium carbonate to stabilize the oral pH
during use of a
smokeless oral tobacco or nicotine-containing non-tobacco product is that the
risk of burns
caused by the pH increasing agent is reduced as compared to if more easily
dissolvable basic
salts, such as sodium carbonate or sodium bicarbonate, would be used instead.
Without
wishing to be bound by theory, this can be due to that the magnesium carbonate
does not
10 cause such a rapid increase in pH during dissolution as other more
easily dissolvable basic
salts do. As mentioned elsewhere herein, such basic salts are commonly used in
oral
smokeless tobacco compositions to adjust the pH therein. Also, the use of
magnesium
carbonate instead of more easily dissolvable basic salts decreases the risk
for discoloring of
the wrapping material (the pouch material) as the more easily dissolvable
basic salts, such as
sodium carbonate and sodium bicarbonate, are hygroscopic and tend to draw
moisture from
the tobacco or non-tobacco composition which may lead to the pouch material
becoming
discolored and sticky. This is in particular a problem with so called white
pouched tobacco or
non-tobacco products. Further, as magnesium carbonate is a carbonate which is
difficult to
dissolve, it will be consumed much more slowly during storage than a more
easily dissolvable
basic salt, thus providing a more prolonged effect on pH stabilization. In
addition, during oral
use of an oral smokeless tobacco or nicotine-containing non-tobacco product,
saliva will move
into the tobacco or non-tobacco material as this has a higher salt
concentration than the saliva.
If more easily dissolvable carbonates would be use in the wrapping or liner
material, these
would then move together with the saliva into the tobacco or non-tobacco
material. This would
abolish the pH stabilizing effect at the surface of the product where it is in
contact with the oral
mucosa and thus not lead to the beneficial effects on nicotine uptake. As
magnesium
carbonate dissolves more slowly in saliva it will on the other hand stay at
the surface of the
product and beneficially stabilize the oral pH and thus favour the nicotine
uptake in the oral
cavity. More easily dissolvable carbonates, such as sodium carbonate or sodium
bicarbonate
would therefore not be suitable for stabilizing the oral pH of a user of an
oral smokeless
tobacco or non-tobacco product.
A lower pH of the smokeless tobacco or nicotine-containing non-tobacco
composition means
that nicotine can move more freely in the oral smokeless tobacco or nicotine-
containing non-
tobacco product (see Figure 2). Although Figure 2 relates to snus, the results
would be
analogous for snuff products in general (such as American snuff), and chewing
tobacco, as
well as for oral nicotine-containing non-tobacco products.
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In most oral smokeless tobacco or nicotine-containing non-tobacco products the
prevailing
procedure is to add a pH-modifying substance to the composition in order to
increase its pH
and thus nicotine uptake by the mucous membrane. By having a lower pH in the
composition
and apply magnesium carbonate in or on the wrapper or liner, nicotine may more
freely move
to the site of uptake, at which site magnesium carbonate raises the pH to
improve the nicotine
permeability through the mucous membrane. As regards oral smokeless tobacco
products, an
increased permeability for nicotine through the mucous membrane means that the
amount of
tobacco in the tobacco composition may be reduced. As a result of such
reduction, there would
follow a reduction of harmful constituents and by-products. It may moreover
lead to cost
savings.
A further advantage provided of not incorporating magnesium carbonate in the
composition of
an oral smokeless tobacco or nicotine-containing non-tobacco product, or
reducing the amount
of magnesium carbonate therein, is that a lower pH reduces nicotine oxidation
and
evaporation. In addition, a lower pH will also provide improved flavor
stability. The
aforementioned shall however not be understood as meaning that it is always
advantageous to
dispense with magnesium carbonate in the composition. On the contrary, the
present invention
may well be combined with a composition comprising magnesium carbonate.
If it is determined from e.g. a production standpoint to incorporate a
suboptimal magnesium
carbonate concentration in or on the wrapping material or liner, this may be
compensated for
by magnesium carbonate addition to the composition. This is possible, in
accordance with the
invention, since magnesium carbonate acts mainly as a pH stabilizer and only
has a minor
effect on the pH, due to its low solubility.
The wrapping material may comprise magnesium carbonate in an amount of at
least 0.1%,
such as 0.1% to 10%, by total weight of the oral smokeless product. Figure 1
shows that an
oral smokeless tobacco product with a wrapping material comprising magnesium
carbonate is
5-10 times more effective compared to an oral smokeless tobacco product with
magnesium
carbonate added to the tobacco composition, as regards oral pH stabilization.
Experiments
have shown that the pH-modifying effect of a magnesium carbonate starts at a
concentration
of 2%, when the magnesium carbonate is mixed with the tobacco composition.
Hence, an
amount lower than 0.1% (by total weight of the oral smokeless tobacco product)
in or on the
wrapper is not likely to be used. The upper addition level is limited by the
manufacturing
method and probably also by a saturation effect, whereby the magnesium
carbonate will not
dissolve further. At high amounts of magnesium carbonate, the magnesium
carbonate is
preferably granulated. The person skilled in the art is well equipped to
understand how to
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granulate magnesium carbonate. The above reasoning also holds true for oral
nicotine-
containing non-tobacco products in accordance with the invention.
As an alternative solution to the above pH stabilization problem during use,
an oral smokeless
tobacco or nicotine-containing non-tobacco product comprising a composition
enclosed by a
wrapping material is provided, said product comprising a liner adjacent to the
wrapping
material, wherein the liner comprises magnesium carbonate in an amount of at
least 0.1%,
such as 0.1% to 10%, by total weight of the oral smokeless product. Said
composition may be
a tobacco composition or a nicotine-containing non-tobacco composition.
As described herein, the statement "the wrapping material and/or liner
comprising magnesium
carbonate" should be understood as magnesium carbonate being present in or on
(the inside
and/or outside) the wrapping material and/or liner.
The amount of magnesium carbonate may be present in or on a wrapping material
or liner in
the interval from about 0.3 to 8, 0.5 to 7, 0.7 to 6, 0.5 to 4, 1.5 to 2.5%,
or 1 to 3% by total
weight of the oral smokeless tobacco or nicotine-containing non-tobacco
product. The amount
of magnesium carbonate in or on the wrapping material or liner may be created
from low and
high endpoints chosen from the following: 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9,
10% by total weight
of the oral smokeless product. An amount of magnesium carbonate below 0.1% by
total weight
of the product would not give adequate effect on nicotine extraction, whereas
an amount
exceeding 10% by total weight of the product would not further improve the
nicotine extraction,
if the magnesium carbonate is not granulated. If the magnesium carbonate is
present in both
the wrapping material and the liner, the amount of magnesium carbonate in the
wrapping
material and liner, may be decreased so that the total amount of magnesium
carbonate in the
product (i.e. the total amount in the wrapping material and the liner) is in
the range of the
amounts according to the above.
The above amounts of magnesium carbonate in or on a wrapper or liner are based
on in vivo
nicotine extraction data. Herein, an approximation of nicotine uptake has been
obtained by
analyzing nicotine extraction from used pouches (see "Measurement of in vivo
nicotine
extraction", below).
In all instances when % by weight of the oral smokeless product, e.g. the oral
smokeless
tobacco product, is referred to herein, reference is made to moist products,
as provided on the
market (unless defined otherwise). The water content of the oral smokeless
tobacco product
may be 2-55% by total weight of the oral smokeless product. This corresponds
to a moisture
content of approximately 2-60% by total weight of the oral smokeless tobacco
product. The
moisture content of the smokeless tobacco composition may further be within
the range of
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from 10 to 60% w/w, such as within the range of from 15 to 60% w/w, 20 to 60%
w/w, 20 to
58% w/w, 30 to 56% w/w or 40 to 54% w/w. The difference between water and
moisture
content is that the latter also includes other oven volatile compounds, such
as propylene glycol
and/or glycerol.
The tobacco or nicotine-containing non-tobacco composition of the oral
smokeless tobacco
product may be devoid of any added magnesium carbonate This commonly
translates to an
amount of magnesium carbonate in the tobacco composition of the oral smokeless
tobacco
product of 0.1-1% by weight of the tobacco composition, by way of endogenously
produced
magnesium carbonate from the constituent parts of the tobacco and additives
provided.
There is also provided an oral smokeless tobacco or nicotine-containing non-
tobacco product
comprising magnesium carbonate in its wrapping material and/or liner, wherein
the
composition comprises magnesium carbonate in an amount from 1-5% by weight of
the
composition.
In view of the above, the magnesium carbonate present in a tobacco
composition, as
elaborated on in W02009/082331, may be combined with the present invention. By
way of
example, magnesium carbonate in the tobacco composition or the nicotine-
containing non-
tobacco composition may support the nicotine uptake regulation provided by
magnesium
carbonate in the wrapping material and/or liner. It should be remembered,
however, that
magnesium carbonate present in the wrapper and/or liner still provides
controlled nicotine
uptake through the mucous membrane, and reduces production related problems,
irrespective
of magnesium carbonate present in the tobacco composition, as applicable. The
key is the
improved regulation of nicotine uptake, at reduced amounts of magnesium
carbonate in the
tobacco composition, as compared with tobacco compositions disclosed in e.g.
W02009/082331. The same reasoning holds true for nicotine-containing tobacco-
free
products.
The wrapping material and/or liner of the oral smokeless product according to
the present
invention may comprise or consist of cellulose, derivative(s) of cellulose,
synthetic fibers,
binders or combinations thereof.
The liner may be made of material which does not dissolve upon oral use of the
oral
smokeless tobacco or non-tobacco product, i.e. a material which is not water-
soluble.
Alternatively, the liner may be made of a material which is water-soluble so
that the liner is
dissolved upon oral use of the product. The liner, when present, is preferably
provided
separately from the wrapping material so that the wrapping material does not
comprise a liner
comprising magnesium carbonate, i.e. the liner does not form part of the
wrapping material.
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The liner may be small and only cover a small part of the space (area) between
the wrapping
material and the tobacco or nicotine-containing non-tobacco composition or it
may cover a
larger part of this space, such as 1-100%, 1-50%, 10-50%, or 10-20%.
Magnesium carbonate may be provided in or on the wrapper or liner by way of
spraying,
dipping, dusting, coating or chemical incorporation. The magnesium carbonate
may be
provided to the wrapping material and/or liner by using a binder as disclosed
elsewhere herein.
The liner may consist of or comprise a water soluble composition. Moreover,
the liner may be
in the form of a dyestuff or varnish. Application may be effected during
manufacturing of
wrapping/liner material, or application may be on the finished wrapping/liner
material or in
connection to product manufacturing. For example, the magnesium carbonate may
be
chemically bound to a wrapping material or liner by dipping the wrapping
material or liner in a
mixture of water and magnesium hydroxide, and by applying an air flow,
magnesium carbonate
can be formed through a reaction with carbon dioxide. The wrapping material
may also be first
dipped in a concentrated solution of magnesium chloride followed by dipping in
a concentrated
solution of sodium carbonate in order to provide the magnesium carbonate to a
wrapping
material or liner.
In order to facilitate the production, it may be preferred to add the
magnesium carbonate to the
wrapping material.
The magnesium carbonate may be applied on the outer surface of the wrapping
material
and/or liner, for the magnesium carbonate to be located as closely as possible
to the mucous
membrane during use. The magnesium carbonate may additionally or alternatively
be provided
on the inside of the wrapping material and/or liner and/or incorporated
(embedded) in the
wrapping material and/or liner.
Magnesium carbonate may be provided in or on the wrapper or liner by use of a
binder. The
purpose of the binder is to lightly adhere the magnesium carbonate to the
wrapper or liner, but
still provide a quick release at contact with the mucous membrane. Thus, the
concentration of
the binder should be as low as possible, while still ensuring magnesium
carbonate dry loss at
manufacturing, transport and storage.
The binder may be a water-soluble polymer, such as one or more of PVA, PVP,
HPC, HPMC,
CMC, acacia gum or other easily water dissolvable substances. For preparation
of a
magnesium carbonate-binder mixture, the binder may be dissolved in water or
ethanol or a
combination thereof. The wrapping material and/or liner may thus comprise
magnesium
carbonate and a water-soluble polymer, such as one or more of PVA, PVP, HPC,
HPMC, and
CMC.
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The optimum concentration of the binder in the mixture may vary according to
type of binder,
solvent, way of application and amount of magnesium carbonate applied. For PVA
the
preferred concentration of binder in water solution is approximately 8-12% (by
weight).
The magnesium carbonate in or on the wrapping material or liner may be in the
form of
5 hydroxide(s), oxide(s), and/or water of crystallization. The magnesium
carbonates may be
divided into two classes: magnesium carbonate, MgCO3XH20 and magnesium
hydroxyl
carbonate (Mg(CO3)y(OH)z.XH20. In both of these classes there are also
compounds without
crystal water (X=0) and compounds with the same formula but different crystal
structure. Y and
Z are known to the person skilled in the art to be variable. Neither X nor Y
need to be an
10 integer. Y may moreover be 0 for an additive to the composition for in
situ generation of
magnesium carbonate. Some of the compounds are naturally occurring minerals,
whereas
others have to be manufactured. The group consists of more than 35 different
compounds, all
with the own individual CAS-number. All of these compounds may be useful in
the products
disclosed herein.
15 In some embodiments of the present document, the magnesium carbonate may
not be used
with an acid in an acid/base pair.
The oral smokeless tobacco product may be oral snuff or chewing tobacco, and
the oral
smokeless nicotine-containing non-tobacco product may be in a form resembling
any of the
aforementioned products. The product may contain gum, e.g. gum arabicum, and
hence be
similar to a chewing gum in consistency. The snuff product may be snus
(commonly called
Swedish type snuff), or in a form resembling snus. The product may be moist
snuff. The
product may be contained in a box, can or canister. The oral smokeless tobacco
or nicotine-
containing non-tobacco composition, as enclosed by the wrapper, may be in
particular form or
pre-formed.
The oral smokeless tobacco product comprises tobacco material comprising
tobacco leaves or
parts of leaves, such as lamina and stem. The leaves and parts of leaves may
be whole and/or
finely divided (disintegrated), such as ground, cut, shredded, and/or
threshed. The tobacco
may further be cured, aged, fermented or treated in any other way, such as
granulated or
encapsulated, and the parts of leaves may be blended in defined proportions in
the tobacco
material.
The oral smokeless nicotine-containing non-tobacco product as disclosed herein
comprises a
nicotine-containing non-tobacco composition comprising a particulate non-
tobacco material
comprising nicotine or a salt thereof (e.g. nicotine bitartrate) and one more
fillers, such as
polysaccharides (e.g. maltitol or mannitol) and/or microcrystalline cellulose.
Alternatively, or in
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addition, the nicotine-containing non-tobacco composition may comprise non-
tobacco plant
material such as non-tobacco plant fibres, in particular dietary plant fibers,
such as maize
fibers, oat fibres, tomato fibers, barley fibers, rye fibers, apple fibres,
sugar beet fibres, potato
fibres, corn fibres, buckwheat fibres, cocoa fibres, bamboo fibers, citrus
fibers and any
combinations thereof and added nicotine or a salt thereof (such as nicotine
bitartrate). Such
substances used for the nicotine-containing non-tobacco composition may also
be added to a
smokeless tobacco composition in addition to tobacco.
The oral smokeless tobacco composition or oral smokeless nicotine-containing
non-tobacco
composition as disclosed herein may, in addition to the tobacco material, such
as divided
tobacco material, and non-tobacco material, respectively, comprise water, salt
(e.g. one or
more of sodium chloride, potassium chloride, magnesium chloride, calcium
chloride and any
combinations thereof), pH adjuster (e.g. one or more of sodium hydroxide,
potassium
hydroxide, potassium carbonate, sodium carbonate, sodium bicarbonate or
magnesium
carbonate), and optionally one or more additional ingredients, such as
flavouring agents,
cooling agents, heating agents, sweetening agents, colorants, humectants (e.g.
propylene
glycol or glycerol), antioxidants, preservatives (e.g. potassium sorbate),
binders, fillers, non-
tobacco plant fibers and disintegration aids.
Salt, such as sodium chloride, potassium chloride, magnesium chloride, calcium
chloride and
any combinations thereof, may be added to a smokeless tobacco or nicotine-
containing non-
tobacco composition mainly for its taste enhancing properties, but it also has
a preservative
effect which contributes to improved shelf life of the product. Salt, such as
sodium chloride
lowers the water activity of the products, thus preventing micro-organisms
from growing.
Normally, the amount of added salt in the smokeless tobacco or nicotine-
containing non-
tobacco composition is within the range of from about 0.5 to about 10% w/w
based on dry
weight of the smokeless tobacco nicotine-containing non-tobacco composition.
pH adjusters, such as sodium carbonate or sodium bicarbonate, brings the pH
value to the
slightly alkaline side, such as about pH 8 to 9, and may be added to the
tobacco or nicotine-
containing non-tobacco composition. Sodium carbonate may also be used to give
the products
their characteristic aroma profile. Typically, the amount of pH adjuster in
the smokeless
tobacco composition is less than about 7% w/w, such as within the range of
from about 3 to
about 5% w/w, based on dry weight of the tobacco or nicotine-containing non-
tobacco
composition. The products may also be devoid of any added pH adjusters in the
tobacco or
nicotine-containing non-tobacco composition.
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The pH tobacco or nicotine-containing non-tobacco composition of the oral
smokeless tobacco
or nicotine-containing non-tobacco product may be about 6-9. A pH of about 8-9
is particularly
advantageous for Swedish snus. The pH tobacco or nicotine-containing non-
tobacco
composition of the oral smokeless tobacco or nicotine-containing non-tobacco
product may
alternatively be about 6-8, such as about 7.5-8 or about 7.7-7.9. Such a pH is
particularly
advantageous for American snuff.
Humectants, such as propylene glycol or glycerol, may also be added to protect
the product
from drying out and may also have a preservative effect since the water
activity of the product
will be lowered, thereby preventing microorganisms from growing. Normally, the
amount of
humectant in the smokeless tobacco composition is within the range of from
about 5 to about
15% w/w based on dry weight of the smokeless tobacco or nicotine-containing
non-tobacco
composition.
Flavours used are generally natural or nature identical compounds that comply
with food
regulations. Flavours are usually dissolved in a solvent, such as ethanol,
when added.
Typically, the amount of tobacco in the smokeless tobacco composition is
within the range of
from about 40 to 80% w/w based on dry weight of the smokeless tobacco.
The present document is also directed to the use of magnesium carbonate in a
wrapping
material and/or liner of an oral smokeless tobacco or a nicotine-containing
non-tobacco
product for stabilizing the oral pH during use of said product.
The present document is also directed to a method for the in situ formation of
magnesium
carbonate in a wrapping material and/or an optional liner of an oral smokeless
tobacco or
nicotine-containing non-tobacco product comprising a composition enclosed by
said wrapping
material thereby forming a pouch, said method comprising providing an aqueous
polymer-
containing solution comprising magnesium carbonate to said wrapping material
and/or optional
liner.
The invention shall now be described more in detail with reference to the
below examples and
figures, which shall however not be seen as limiting the scope of the
invention in any way
whatsoever.
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EXPERIMENTAL SECTION
MEASUREMENTS
Measurement of pH in the oral cavity
Instrumentation.
The instrumentation consisted of an IngoId Glass pH Catheter M3 from SynMed
U.K. (sub-
manufactured by Mettler-Toledo), connected to an Orion 5 star pH-instrument
from Thermo
Scientific. The measurements were captured directly to Microsoft Excel using
WinWedge data
collection software.
Calibration.
Before the measurements started the pH-electrode was calibrated at ambient
temperature with
three certified buffer solutions (4.01; 7.01 and 10) from Thermo Scientific.
The measurement
temperature was then adjusted to 35 C to emulate the temperature in the oral
cavity.
Sample preparation.
The pH-electrode was fastened to the outside of the snus-pouch while ensuring
that both the
measurement cell and the reference cell were confined within the pouch area.
Measurements.
Oral pH 1: The subjects of the experiments had abstained from any form of
tobacco-use for at
least 30 minutes prior to the experiments. The pH-instrument was switched from
continuous to
timed sampling with a frequency of one measurement per minute. The pouch was
placed in
the mouth between the upper lip and the gum. Particular care was taken to
ensure that the pH-
electrode remained stationary during the measurements and the subjects were
instructed to
remain as immobile as possible. The experiments typically lasted for 30
minutes.
Oral pH 2: An alternative procedure to measure the oral pH was also carried
out; the pH-
electrode was placed on the tongue and pH measured with one second intervals
until a stable
reading was obtained. A snus pouch was then placed on the tongue (time = 0)
and the pH-
measurements continued for 200 seconds.
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Measurement of in vivo nicotine extraction
Procedure
The subjects of the experiments had abstained from any form of tobacco-use for
at least 30
minutes prior to the experiments. The pouches were used randomly under
standardized
conditions as follows: One portion was placed and kept in the same place in
the oral cavity
between the upper lip and the gum for 30 minutes. The subjects were instructed
to keep the
pouch as still as possible. After completion, the pouches were stored in a
freezer prior to
analysis. For each trial five unused pouches were used as reference.
Analysis
All pouches were analyzed for nicotine using a CORESTA GC-method (CORESTA
Recommended Methods No 62. Determination of Nicotine in Tobacco and Tobacco
Products
by Gas Chromatographic Analysis; Determination of Nicotine in Tobacco
(Beitrage zur
Tabakforschung 2001, 19, 251-265); Analysis of Minor Alkaloids in Tobacco
(Beitrage zur
Tabakforschung International 2005, 21, 369-379)).
Calculation
The extraction rate was calculated by comparing the remaining amount of
nicotine in used
pouches with unused pouches.
Oral pH in commercially available snus products.
The oral pH in five commercially available snus products was measured with the
method
denoted as Oral pH 1.
Application of magnesium carbonate
Experiments in which magnesium carbonate was chemically bound to wrapping
material were
performed. In the first test, wrapping material (pouch paper) was dipped in a
mixture of water
and magnesium hydroxide, and by applying an air flow magnesium carbonate was
formed
through a reaction with carbon dioxide. The formed amount of magnesium
carbonate
corresponded to about 30 mg per 0.9 g pouch. Pouches were made and filled with
commercially available snus. Measurement with the Oral pH 1 method on two
subjects showed
that pH was stabilized over 7 compared to 6.5 for the reference sample. In a
second test,
wrapping material (pouch paper) was first dipped in a concentrated solution of
magnesium
chloride followed by dipping in a concentrated solution of sodium carbonate.
After careful
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washing and drying, the material was weighted and the amount of magnesium
carbonate was
calculated. The formed amount of magnesium carbonate corresponded to
approximately 10
mg per 0.9 g pouch.
Example A.
5 Example A comprises a snus pouch where the pouch paper material (wrapping
material) has
been applied with magnesium carbonate. Commercially available snus with a
moisture content
of approximately 55 % and with a pH value of 7.95, as measured with the FDA
recommended
method (Federal Register, Vol. 74, No 4, s.712-719 Wednesday, January 7,
2009), was used
in the example. Sodium carbonate at a level of 2.5 % (w/w) was used as pH
adjuster. The
10 magnesium carbonate mixture was prepared as follows; a solution of 500
ml water and 6 g of
the binder PVA (Poly vinyl alcohol, 363073, Aldrich) was mixed thoroughly,
followed by
blending 200 ml of the solution with 20 g of magnesium carbonate (Magnesium
carbonate
basic, Ph Eur, Fluke Chemika).
Pouches were prepared by dipping empty wrapping material (pouch paper) in the
carbonate
15 mixture. After drying, pouches containing approximately 15 mg magnesium
carbonate per
pouch were selected, said amount corresponding to approximately 2 % magnesium
carbonate
by weight per pouch (total wet weight of end product). The pouches were filled
with 0.65 g of
snus and heat sealed. The reference material consisted of snus from the same
batch, filled in
pouches without magnesium carbonate.
20 Two test subjects used four tobacco-filled pouches each (two samples and
two references)
and the oral pH was measured with the method described above (Oral pH 1) and
the average
pH-values were calculated. The experiment shows (Figure 1 and 4) that the oral
pH is
significantly higher for an oral smokeless tobacco product with a wrapping
material applied
with magnesium carbonate, compared with tobacco-filled pouches devoid of added
magnesium carbonate.
The oral pH was also measured according to Oral pH 2. The average pH-values
from 4
products with wrapping material comprising magnesium carbonate (sample) and 4
reference
tobacco-filled pouches were calculated. The result clearly shows that the pH
in the sample
stabilizes at a higher level compared with the reference and that the
difference in pH using this
method is approximately 0.4 pH-units.
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Example B.
The procedure was exactly the same as in example A, except that the snus had a
pH-value of
8.65 as measured with the FDA recommended method (Federal Register, Vol. 74,
No 4, s.712-
719 Wednesday, January 7, 2009). Sodium carbonate at a level of 2.5 % (w/w)
was used as
pH adjuster. Figure 3 shows that the oral pH 1 is significantly higher for
oral smokeless
tobacco products with wrapping material applied with magnesium carbonate,
compared to
tobacco-filled pouches without any added magnesium carbonate. This is the same
result as in
example A.
In another embodiment the in vivo extraction of nicotine was measured. Five
subjects used five
oral smokeless tobacco products of each type (with magnesium carbonate added
to the
wrapping material and devoid of added magnesium carbonate, respectively). The
procedure
described in "Measurement of in vivo nicotine extraction" above was followed.
After
completion, the oral products were analyzed for nicotine and the extraction
rate was
calculated.
Based on the average extracted amount of nicotine, it was concluded that the
extraction rate
increased from 22 % to 29 %, for oral smokeless tobacco products with
magnesium carbonate
added to the wrapping material. This corresponds to an extraction increase of
approximately
33%.
Example C
Example C constitutes a filled snus pouch comprising a rectangular piece of
wrapping material
functioning as liner, the liner being applied with magnesium carbonate and
placed on the
inside of the wrapping material, hence covering the snus.
In the experiment, snus with a moisture content of approximately 30 % and a pH
of 8.7 was
used. Sodium carbonate at a level of 2.3 % (w/w) was used as pH adjuster.
The liner was prepared by dipping a 58x15 mm pouch paper (wrapping material)
piece in a
slurry consisting of 100 ml water and 15 g of magnesium carbonate (Magnesium
carbonate
basic, Ph Eur, Fluke Chemika). The liners were dried on a metal grid followed
by weight
selection to obtain liners with approximately 20 mg magnesium carbonate per
liner,
corresponding to approximately 2 % magnesium carbonate by total wet weight of
the oral
smokeless tobacco product. The tobacco-filled pouches were hand made by
insertion of the
liner under the wrapping material and addition of 0.9 g snus. As references,
tobacco-filled
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pouches with and without liners, respectively, neither liners nor wrappers
comprising any
magnesium carbonate, were used.
In the in vivo extraction trial, two subjects used five tobacco-filled pouches
of each type. The
procedure described in "Measurement of in vivo nicotine extraction" above was
followed. The
results show that the extraction rate for the tobacco-filled pouches
containing a liner without
magnesium carbonate decreased by 5 % compared to a reference pouch without a
liner. It was
concluded that the liner itself prevents nicotine extraction. However, the
results also showed
that the extraction rate increased by 15 % for oral smokeless tobacco products
comprising
liners applied with magnesium carbonate, as compared with tobacco-filled
pouches with liners
devoid of added magnesium carbonate.
It is to be understood that while the invention has been described in
conjunction with the
detailed description thereof, the foregoing description is intended to
illustrate and not limit the
scope of the invention, which is defined by the scope of the appended claims.
Other aspects,
advantages, and modifications are within the scope of the following claims.
Unless expressly described to the contrary, each of the preferred features
described herein
can be used in combination with any and all of the other herein described
preferred features.
