U.S. patent application number 11/571477 was filed with the patent office on 2008-08-21 for smokeless tobacco product.
This patent application is currently assigned to RADI MEDICAL SYSTEMS AB. Invention is credited to Thomas Engstrom, Torbjorn Mathisen.
Application Number | 20080196730 11/571477 |
Document ID | / |
Family ID | 35783173 |
Filed Date | 2008-08-21 |
United States Patent
Application |
20080196730 |
Kind Code |
A1 |
Engstrom; Thomas ; et
al. |
August 21, 2008 |
Smokeless Tobacco Product
Abstract
The present invention relates generally to a smokeless tobacco
product in the form of a completely dissolvable vehicle (1; 11)
comprising concentrated tobacco extract contained in a dissolvable
matrix. In one embodiment, the vehicle (11) is a multilayer
three-dimensional vehicle whose several layers (12, 13, 14)
dissolve layer by layer in the mouth of a user.
Inventors: |
Engstrom; Thomas; (Uppsala,
SE) ; Mathisen; Torbjorn; (Alvsjo, SE) |
Correspondence
Address: |
FOLEY AND LARDNER LLP;SUITE 500
3000 K STREET NW
WASHINGTON
DC
20007
US
|
Assignee: |
RADI MEDICAL SYSTEMS AB
|
Family ID: |
35783173 |
Appl. No.: |
11/571477 |
Filed: |
June 8, 2005 |
PCT Filed: |
June 8, 2005 |
PCT NO: |
PCT/SE2005/000864 |
371 Date: |
January 24, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60584494 |
Jul 2, 2004 |
|
|
|
Current U.S.
Class: |
131/352 |
Current CPC
Class: |
A24B 15/16 20130101;
A61K 9/006 20130101; A61K 31/465 20130101; A24B 15/24 20130101;
A61K 9/0056 20130101 |
Class at
Publication: |
131/352 |
International
Class: |
A24B 15/00 20060101
A24B015/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 2, 2004 |
SE |
0401721-674 |
Claims
1. Smokeless tobacco product in the form of a dissolvable vehicle
(1; 11) for oral administration, said vehicle being characterized
in that the vehicle comprises a dissolvable polymeric matrix in
which tobacco extract, or a synthetic equivalent thereof, is
included.
2. Smokeless tobacco product according to claim 1, characterized in
that the dissolvable vehicle is a multilayer vehicle (11) and that
said dissolvable polymeric matrix constitutes at least one of the
several layers (12, 13, 14).
3. Smokeless tobacco product according to claim 1, characterized in
that the tobacco extract is dried tobacco extract.
4. Smokeless tobacco product according to claim 2, characterized in
that the outermost layer comprises a mucoadhesive substance.
5. Smokeless tobacco product according to claim 2, characterized in
that at least one layer comprises a substance that swells upon
contact with saliva.
6. Smokeless tobacco product according to claim 2, characterized in
that the multilayer vehicle essentially dissolves layer by layer in
a user's mouth.
7. Smokeless tobacco product according to claim 1, characterized in
that the vehicle has an essentially two-dimensional shape.
8. Smokeless tobacco product according to claim 1, characterized in
the vehicle is, or when placed in a user's mouth swells to, a three
dimensional vehicle, which has a first dimension A, a second
dimension B and a third dimension C, with A.gtoreq.B.gtoreq.C and
C/A.gtoreq. 1/10.
9. Smokeless tobacco product according to claim 8, characterized in
that 1/8.ltoreq.C/A.ltoreq. 2/3.
10. Smokeless tobacco product according to claim 8, characterized
in that 1/7.ltoreq.C/A.ltoreq.1/2.
11. Smokeless tobacco product according to claim 1, characterized
in that said vehicle has a compression modulus less than 0.1
MPa.
12. Smokeless tobacco product according to claim 1, characterized
in that said vehicle has a dissolution time in the interval of 5 to
60 minutes, preferably in the interval of 10 to 30 minutes.
13. Smokeless tobacco product according to claim 1 characterized in
that said extract is free from nicotine.
14. Smokeless tobacco product according to claim 1, characterized
in that said extract is nicotine or synthetically prepared
nicotine.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to a smokeless
tobacco product in the form of a completely dissolvable vehicle
comprising concentrated tobacco extract contained in a dissolvable
matrix.
BACKGROUND OF THE INVENTION
[0002] Smokeless tobacco, e.g. so called "snuff", is widely used as
substitute for cigarettes, cigars and other forms of
smoking-tobacco as it poses comparatively less health risks to the
user. Many people do also use a smokeless alternative during a
transition period to reduce the acute abstinence from nicotine that
may results from a sudden refraining from cigarettes.
[0003] To make such tobacco more user-friendly, it is known to
confine the tobacco in a small non-dissolvable, permeable pouch,
which is kept in the mouth until the tobacco flavours have been
extracted from the tobacco and which is then removed. It is,
however, also well-known that many people find the use of such
tobacco pouches little appealing or even repulsive, mainly because
of the necessity to remove the saliva soaked and soggy tobacco
pouch from the mouth and then dispose the same. The discomfort is,
of course, even more pronounced if the smokeless tobacco is used in
a public environment, such as meeting rooms, restaurants or other
restricted areas, where it can be difficult or even impossible to
dispose the used tobacco pouch in a discreet and hygienic way.
Needless to say, these people are even less appealed by smokeless
tobacco that is not contained in such a pouch.
[0004] For the mucosal administration of drugs such as nicotine,
drug delivering vehicles in the forms of membranes or patches are
known. When such membranes or patches are used for the oral
administration of drugs, they do not, however, create a
three-dimensional sensation in the user's mouth. It is the present
inventors' belief that such a three-dimensional sensation is
crucial for some people's acceptance of smokeless tobacco
products.
[0005] A more appealing smokeless tobacco product is therefore
needed.
SUMMARY OF THE INVENTION
[0006] Today smokeless tobacco is sold in the form of
non-dissolvable tobacco-filled permeable pouches, which a user
keeps in his or her mouth until the flavours have been extracted
from the tobacco and which the user then removes with his/her
fingers, something that many people find unappealing.
[0007] The general object of the present invention is to provide a
more appealing administration form for smokeless tobacco.
[0008] Another object of the invention is to provide a vehicle
that, in the mouth of a user, releases flavours coming from tobacco
extracts as well as other substances, which vehicle provides for a
controlled release and thereby intake of these flavours and
substances.
[0009] A further object is to provide a three-dimensional vehicle
which in the mouth of a user creates a three-dimensional
sensation.
[0010] These objects are achieved with a dissolvable vehicle
comprising a water-soluble polymer matrix in which tobacco extract
has been incorporated. The tobacco extract has been freed from any
type of insoluble residue, and the whole vehicle will therefore
dissolve within the mouth of a user. The necessity of an unpleasant
and discomfortable removal of a saliva-soaked tobacco pouch is
thereby eliminated. In one embodiment of the invention, the
dissolvable vehicle is a three-dimensional vehicle, which in the
mouth of a user creates a three-dimensional sensation.
[0011] According to a preferred embodiment of the present
invention, the dissolvable three-dimensional vehicle has a
multilayer structure, with at least one layer comprising a
water-soluble polymer matrix in which concentrated tobacco extract
has been incorporated. Another layer of the three-dimensional
vehicle may comprise different kinds of flavours, additives, and
other drugs such as nicotine. In one embodiment of the invention, a
multilayered three-dimensional vehicle is adapted to dissolve layer
by layer, thereby providing for a controlled release and subsequent
intake of the drugs and flavours contained in the respective
layers.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a schematic illustration of a first embodiment of
the present invention.
[0013] FIG. 2 is a schematic illustration of a second embodiment of
the present invention.
[0014] FIG. 3 illustrates schematically the dimensions of a vehicle
according to one embodiment of the present invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0015] The present invention relates to a smokeless tobacco product
in the form of a dissolvable vehicle comprising a water-soluble
polymer matrix containing concentrated tobacco extract. The polymer
matrix is made from any type of water-soluble polymer, including
both synthetic and naturally occurring polymeric substances. The
matrix is formulated to optimize the leaching process of the
various flavour substances found in tobacco extracts. In one
embodiment of the invention, the dissolvable vehicle is a body with
significant extensions in all three dimensions, such that the
dissolvable vehicle at the start of the dissolution process creates
a three-dimensional feeling in a user's mouth.
[0016] Examples of suitable water-soluble polymers are various
proteins such as collagen or fibrin, and various carbohydrates like
alginates, guar gum, agarose, as well as various types of
glucosamino-glucanes and cellulose. It can be noted that most of
these carbohydrates can be chemically substituted to significantly
alter their properties. Various types of polymeric alcohols, such
as polyethylene glycols, polypropylene glycols, and polyvinyl
alcohols, can be used to formulate the water-soluble matrix as well
as polypyrollidone, and various polymeric acrylic acids and
ionomers. Several of the alternatives listed above can be
cross-linked in various degrees to achieve alterations in their
dissolution properties. It is further possible to incorporate
various types of non-ionic, cationic and/or anionic substituents in
the polymer matrix to yield satisfying dissolution properties, and
also to accelerate or retard the leaching process of a specific
tobacco flavour.
[0017] As already indicated above, the dissolvable vehicle may be a
multilayer vehicle. In that case, one of the layers, preferably the
outermost layer, can comprise a component with a certain degree of
mucoadhesive properties. An example of such a mucoadhesive
substance is chitosan. A mucoadhesive layer would adhere to the
mucosa in the mouth of a user, and thereby act as a fixation for
the vehicle. Such a mucoadhesive substance could also promote the
penetration of tobacco flavours into the mucosa.
[0018] As used herein, the terms "soluble" or "dissolvable" are
meant to encompass all types of disintegrating, dissolving,
resorbing, absorbing and eroding processes that can occur in a
vehicle that in a user's mouth dissolves in such a way that a
removal from the mouth and a subsequent disposal of a vehicle rest
by hand are not necessary after the tobacco flavours have been
extracted. The different substances mentioned above are therefore
merely illustrative examples of various ingredients that could be
used to formulate a self-disintegrating matrix that constitute a
base for a dissolvable vehicle for a smokeless tobacco product.
[0019] The smokeless tobacco product of the present invention is
based on concentrated tobacco extract, which can be extracted by
several methods well-known in the art. Tobacco extract is perhaps
most easily prepared by treating tobacco with water, or water
containing a small amount of an organic solvent. The preferred
temperature for extraction is room temperature, but any temperature
in the range of 10.degree. C. to 60.degree. C. will work. Also the
pH-value and ionic strength can be adjusted to depress or promote
extraction of certain tobacco substances. Supercritical carbon
dioxide has, for example, been successfully employed to produce
tobacco extracts that are diminished in nicotine.
[0020] The tobacco extract may include extracts from all original
substances of the tobacco plant or a subset thereof, including one
or many original substance(s). In addition, and within the scope of
the present invention as it is defined by the claims, the tobacco
extract may be a synthetically prepared substance having
essentially equivalent characteristics as the corresponding extract
from the tobacco plant. Naturally, the extract may include both one
or many original (natural) substance(s) and one or many synthetic
substance(s).
[0021] According to a preferred embodiment the tobacco extract is
nicotine or synthetically prepared nicotine, being the only
substance or used in combination with other substances.
[0022] Below exemplifying embodiments of a vehicle for a smokeless
tobacco product are described with reference to the accompanying
drawings.
[0023] FIG. 1 illustrates a first and basic embodiment of a
smokeless tobacco product according to the present invention. The
tobacco product comprises a vehicle 1, which is made from a
water-soluble polymeric matrix in which tobacco extract has been
included. The polymeric matrix can be made from any of the polymers
listed above. One way to formulate such a tobacco-containing
polymeric matrix would be to dissolve one or several suitable
polymers in a water-solution of tobacco extracts. The solution is
then dried to a suitable matrix form. During the drying process the
polymers can optionally be cross-linked to alter their dissolution
properties. A polymer material to be used in the present invention
should preferably be soft; it could, for example, have a
compression modulus less than 0.1 MPa. The polymer material can
have a dissolution time ranging from about 5 minutes to about 60
minutes, and preferably from approximately 10 minutes to
approximately 30 minutes. In FIG. 2, a second embodiment of a
vehicle 11 for a smokeless tobacco product is shown. In this
embodiment, the vehicle 11 is a multi-layer vehicle that comprises
an inner layer 12, an intermediate layer 13, and an outer layer 14.
Here, the inner layer 12 comprises a water-soluble polymeric matrix
in which tobacco extract has been included. The matrix can be
formulated in the same way as suggested in conjunction with FIG. 1,
or the polymeric matrix can be in the form of a porous or fibrous
matrix in which dry tobacco extract or water-dissolved tobacco
extract is incorporated. The intermediate layer 13 can then serve
as a cover or seal that encapsulates the tobacco extract inside the
polymeric matrix. The intermediate layer 13 can further comprise a
swelling substance that absorbs saliva and thereby increases the
volume of the vehicle 11. Any type of cross-linked carbohydrates
could be used as a swelling substance. The outer layer 14 can
comprise an adhesive, such as chitosan, which adhere to the mucosa
in a user's mouth, and thereby fixates the vehicle 11 inside the
user's mouth. The outer layer 14 can also comprise a substance that
facilitates the penetration of the flavours and other drugs and
substances into the mucosa. The structure of the vehicle 11 is only
exemplifying, and it should in particular be recognized that more
layers could be added, and that the contents of each layer could be
altered such that, for example, the swelling substance is in the
innermost layer, while the tobacco extract is contained in an
intermediate layer.
[0024] When the vehicle is a multilayer vehicle, the different
layers can be based on the same polymer matrix, the only difference
being that different additives, such as drugs and flavours, are
included in the different layers, with at least one layer
containing the tobacco extract. Another possibility is to prepare a
special polymeric matrix for each layer to thereby make it easy to
control the dissolution of the layer and the release of substances
therefrom. It is also conceivable to apply one layer, e.g. the
outermost layer, in the form of a dragee, which further can
comprise a substance which renders this layer a special effect on
the user.
[0025] An advantage of having a multilayer vehicle is that the
separate layers can be adapted to dissolve sequentially in a user's
mouth. In other words, on outer layer is essentially disintegrated
before an inner layer starts to dissolve. It is thereby easy to
control the effect that the present vehicle has on a user. As an
example, the outermost layer could include a high concentration of
nicotine, as the desire for nicotine presumably is at the highest
just after the user has put the vehicle in his or her mouth, while
a more interior layer could include a lower concentration of
nicotine, when the user's urge for nicotine has been almost
satisfied. The total intake of nicotine could thereby be
reduced.
[0026] The present invention is not restricted to any particular
dimensions of a vehicle for a smokeless tobacco product. The
vehicle can, for example, be in the form of an essentially
two-dimensional structure such as a thin sheet or patch. It is,
however, the present inventors' belief that for some people it is
important that a smokeless tobacco product for oral administration
is capable of creating a three-dimensional sensation in the mouth
of a user. As used herein, the term "three-dimensional" is defined
as a dimensional relationship that creates a three-dimensional
sensation in a user's mouth.
[0027] As an example, most of the plasters and patches known in the
prior art do not fulfil this criterion. In one embodiment of the
present invention, the vehicle for the tobacco extract has
therefore a first dimension (e.g. a length), a second dimension
(e.g. a width) and a third dimensions (e.g. a height), and is
characterized in that none of the three dimensions is negligible in
comparison with one of the other two dimensions. When such a
vehicle is placed in a user's mouth, the user will experience a
sensation that the vehicle occupies space in all three dimensions.
When, for example, placed between a lip and teeth or gums, the
vehicle would slightly stretch the user's lip to provide
essentially the same sensation that is created by a conventional
tobacco pouch.
[0028] If a vehicle for the mucosal administration of tobacco
extracts has a length denoted by A, a width denoted by B, and a
height denoted by C, and if A is larger than (or equal to) B, then
C should be at least one tenth of A (i.e. C/A.gtoreq. 1/10),
preferably C/A.gtoreq. 1/7. A suitable interval for C/A could be
1/8.ltoreq.C/A.ltoreq.1/2. FIG. 3 shows a schematic view of the
vehicle according to the present invention.
[0029] In one embodiment A is about 30 mm, B is about 15 mm, and C
is about 5 mm, such that C/A.apprxeq.1/6. Preferably, a vehicle
according to the present invention is pillowshaped, and provided
with rounded corners and/or edges, as can be seen in FIG. 1 or FIG.
2.
[0030] Here it can be noted that the three-dimensional sensation
referred to above relates to a three-dimensional sensation created
when the vehicle has been placed in the mouth of a user. In other
words, the vehicle can be essentially two-dimensional before it is
placed in the user's mouth. This would in particular apply to a
vehicle comprising a swelling substance. Such a vehicle would then
perhaps not fulfil the above criteria for A, B and C before it has
been placed in the mouth, but would fulfil these criteria shortly
after it has come into contact with salvia. Also such vehicles are
considered to be three-dimensional vehicles.
[0031] Although the present invention has been described with
reference to specific embodiments, also shown in the appended
drawings, it will be apparent for those skilled in the art that
many variations and modifications can be done within the scope of
the invention as described in the specification and defined with
reference to the claims below. It should in particular be
recognized that a vehicle containing tobacco extract can comprise a
large variety of different drugs. One example of such a drug is
nicotine, which can be included in different, selectable
concentrations in different versions of the smokeless tobacco
product of the present invention. The nicotine concentration could,
for example, range from a high concentration to zero, such that
people, e.g. inveterate smokers, gradually can reduce their daily
intake and finally get rid of their nicotine addiction. The
smokeless tobacco product could also be flavoured with extra
flavours, such as liquorice, menthol, spearmint or peppermint. It
is also possible to add vitamins and minerals to create a healthier
product. More dedicated drugs could also be added. Examples of such
drugs would be flour or a suitable teeth-whitening substance, or a
substance that cures halitosis, or some other type of nature-cure
drug.
* * * * *