Title of Invention

CHEWING GUM FOR RELEASE OF TOBACCO ALKALOID

Abstract The invention discloses a chewing gum for release of tobacco alkaloid such as herein described,wherein said chewing gum comprises a polymer system in an amount of from 2 to 99% by weight, flavour in an amount of 0,001 to 30% by weight and sweeteners in an amount of 2% to 80% by weight, wherein said polymer system comprises elastomers in an amount of 0.1 to 10 % by weight of the chewing gum, wherein said polymer system comprises elastomer plasticizers in an amount of 2 to 30 % by weight of the chewing gum, and wherein at least 2% of the tobacco alkaloid comprised in said chewing gum prior to chewing will be released within every 30 seconds in the period from ½ minutes to 2½ minutes from initiation of a chewing process in vitro on a chewing machine with a phosphate buffer with a pH of 7.4.
Full Text Background of the invention
Craving or addiction:
Medical and scientific communities in the US agree that nicotine is addictive.
Nicotine meets both the psychological and physiological measures of addiction:
Psychological - people who are addicted to something will use it compulsively,
without regard for its negative effects on their health or life. A good example would
be someone who continues to smoke, even as they use an oxygen tank to breathe
because of the damage smoking has done to their lungs.
Physiological - neuroscientists call anything that turns on the reward pathway in the
brain addictive. Because stimulating this neural circuitry makes you so good, you
will continue to do it again and again to get those feelings back.
When smokers abruptly stop smoking - the body cannot function the same way in
the absence of the drug as it did before, the physiological effects for nicotine remain,
at least in the short term. They will experience: Irritability, anxiety, depression and
craving for nicotine.
Over a period these symptoms and physiological changes subside. It is in this period
alternative methods of nicotine delivery is essential in order to succeed quitting
smoking.
Nicotine:

Nicotine normally makes up about 5% of a tobacco plant, by weight. Cigarettes
contain 8 - 20 mg of nicotine depending on the brand, but only approximately 1 mg
is actually absorbed by your body when you smoke a cigarette.
Nicotine's effects are short-lived, lasting only 40 minutes to a couple of hours. This
leads people to smoke tobacco periodically throughout the day to dose themselves
with nicotine. Within 10-15 seconds of inhaling, most smokers are in the throes of
nicotine's effects.
Different approaches may be made in order to counteract craving related to absence
of nicotine in the blood.
Many pharmacotherapies have been developed or explored for aiding smokers to
cease smoking. The predominant one is nicotine replacement therapies. Nicotine
replacement therapies involve the administration of nicotine through suitable
delivery systems. Nicotine replacement products available on the market include
nicotine transdermal patches, inhalators, nicotine nasal spray or nicotine chewing
gum. These types of products, like cigarettes, deliver nicotine to the blood via
diffusion of nicotine through the skin or the mucous membrane.
Nicotine transdermal patches release nicotine into the bloodstream through the skin.
A patch is applied each day to a different area of dry, clean, non-hairy skin and left
as long as recommended on the product labelling - typically the non-sleeping hours
of a day. Using the product generates a constant low concentration of nicotine to the
blood over the period applied.
Nicotine nasal spray is inhaled into the person's nose from a pump bottle and
absorbed through the nasal lining into the bloodstream. This form of nicotine
delivery system generates a fast increase of nicotine concentration in the blood -
almost as fast as the cigarette.

Nicotine inhalator enters the user's mouth through a mouthpiece attached to a plastic
cartridge. Although the product is called an "inhaler", it does not deliver nicotine to
the lungs the way a cigarette does. Almost all of the nicotine travels only as far as the
mouth and throat, where it is absorbed through the mucous membrane.
Nicotine chewing gum releases nicotine into the bloodstream through the lining of
the mouth, i.e. the mucous membrane. Unlike gum chewed for pleasure, nicotine
gum requires a measured routine - it is chewed slowly until a slight tingling occurs
or a peppery taste comes out, then it is placed between the check and gum until the
taste or tingling is almost gone. The cycle is typically repeated for about 30 minutes
per gum. Products available slowly build up the nicotine blood concentration over
the first 10-15 minutes of chewing.
The present invention relates to counteracting of craving by means of nicotine
holding chewing gum.
Counteracting of craving by means of nicotine holding chewing gum as such is well-
known within the art.
Basically two different paths have been followed in the prior art, alone or in
combination.
The original approach was to incorporate nicotine in chewing gum and then match
the release of chewing gum with the overall total desired release of nicotine over the
entire chewing period. Typically, such an approach involves considerations with
respect to the release of nicotine over a day compared to one or several different
smoking patterns.

A further attempt to improve the counteracting of craving by means of chewing gum
is to incorporate nicotine in e.g. the coat of a coated chewing gum. Such an approach
may be referred to as biphasic within the art, i.e. the approach of providing an initial
significant dose of nicotine immediately after chewing of a chewing gum has been
initiated and then subsequently, providing a second long term dose subsequently.
Such subsequent dose is also referred to as maintenance dose may e.g. last from
about 10 minutes to 30 minutes of the chewing process.
A problem related to the prior art is however that some users of the chewing gum
may dislike especially the initial dose and mat the subsequent dose typically
mismatches the expectations of the user with respect to relieving of nicotine related
craving.
It is the object of the invention to obtain a chewing gum, which may be applied for
an effective and user-acceptable counteracting of craving not only after use but also
during use.
Summary
The invention relates to a method of relieving nicotine craving comprising the steps
of
providing at least one chewing gum comprising tobacco alkaloid to a user,
providing relief of nicotine craving to said user by transferring of tobacco alkaloid
from the chewing gum to the human body of said user by chewing of said chewing
gum,
said chewing of said chewing gum comprising a chewing process involving a
transfer of tobacco alkaloid from said chewing gum above a threshold transfer rate in

the period of about 54 minute to about 2½ minutes from initiation of said chewing
process.
According to the invention a transfer of nicotine or generally a tobacco alkaloid is
maintained at a threshold transfer rate in an intermediate phase of the chewing
process thereby facilitating an advantageous and effective fast relief due to the fact
that transfer in this particular period affects the perception of nicotine and the
resulting relief significantly e.g. compared to transfer of nicotine late in the chewing
process. It is especially noted that a desired "relief kick" according to the invention
involves that a typically overlooked period of the chewing process, also referred to as
the intermediate phase, provide a very significant part of the desirable nicotine dose
to the human body as this particular period is within the typical time allocated to the
smoking of a cigarette.
According to the invention threshold transfer rate is understood as a minimum rate of
nicotine transfer in a given time interval. In other words, transfer rates above this
minimum rate may be applied within the scope of the invention. 254 minutes
corresponds to 150 seconds.
According to the invention it has been realised that one of the problems related to the
prior art is that a relief to the user of the chewing gum is hardly obtained or at least
slowly when compared to the smoking of a cigarette. It has also been realised that the
provisions of the prior art related to this problem is typically concerned with the
amount of released nicotine from the chewing gum and basically not giving much
thought of how the actual transfer of nicotine is performed. This is both the fact with
respect to conventional long term release based on a chewing time over
approximately 30 minutes and the fast release of nicotine in e.g. coating. Thus, it has
been realised that a very fast release of nicotine, e.g. from the coating, over the first
few seconds appears to have too little influence on the first five to ten minutes of

chewing due to the fact that a large part of this nicotine is swallowed and transferred
to the blood merely metabolically.
According to the invention a transfer rate should be understood as a transfer rate of
nicotine or tobacco alkaloid from the chewing gum to the exterior, i.e. a release rate
although the basic desired performance of the chewing gum also includes a transfer
from the chewing gum to the blood of the relevant human body. Such a release rate
may e.g. be measured in sub-periods of 30 seconds.
In the present invention the term "tobacco alkaloid" mean nicotine or nicotine-like
alkaloid such as nor-nicotine, lobeline, and the like, in the free base or
pharmacologically acceptable acid addition salt form. Plant alkaloids of this type are
obtainable from species of Nicotiana which is a source for nicotine and nor-nicotine,
as well as species of Lobelia and Lobeliaceae (Indian tobacco) which are a source for
lobeline.
Moreover, it is generally noted that specific examples and explanation specifically
referring to nicotine as active agent against craving in no way restricts the scope of
the invention with respect to use of other tobacco alkaloids for the same specific
purpose. A specific mentioning of nicotine at any place in this application is only
used for the purpose of exemplifying the invention in a tangible way and not for the
purpose of excluding alternative functionally equivalents.
It should generally be noted that nicotine is a preferred tobacco alkaloid.
In the present invention, the term nicotine encompasses nicotine or a nicotine
derivative in any form such as, e.g. physical forms like amorphous, crystalline,
polymerphous etc. or chemical form like isomers and enantiomers etc. as well as any
pharmaceutically acceptable salts, complex or solvate thereof. Nicotine may be
selected from nicotine base, nicotine hydrochloride, nicotine dihydrochloride,
nicotine monotartrate, nicotine bitartrate, nicotine sulfate, nicotine zinc chloride such
as zinc chloride monohydrate and nicotine salicylate.

In an embodiment of the invention said tobacco alkaloid comprises nicotine.
In an embodiment of the invention said transfer rate refer to a transfer of nicotine
from the chewing gum to the exterior of the chewing gum.
According to an advantageous embodiment of the invention, the chewing time may
be shortened significantly for at least two different reasons, first of all: a relief is
obtained by the user relatively fast due to the provisions of the invention and
secondly: a mere maintenance of nicotine in the blood appears to be a dynamic more
than a stationary process thereby rendering a mere continuous maintenance of
nicotine less desirable to a user compared to a fast relied of initiated craving. In other
words, relief of craving appears to be a dynamic process.
In an embodiment of the invention said threshold transfer rate is evaluated in sub
periods of the period of about 54 minute to about 254 minutes from initiation of said
chewing process.
According to an embodiment of the invention, a sub period of 30 seconds may be
advantageous for the purpose of establishing whether the transfer rate is maintained.
A transfer rate measured in 30 seconds has thus proved sufficient for the purpose of
obtaining a fast relief. Thus, when applying a sub period of 30 seconds, a transfer
should comply with requirements defined in four sub periods, namely the sub periods
½-1 minute, 1-1½ minute, 1½-2 minutes and 2-2½ minutes.
Evidently even transfer rates may be measured in shorter sub periods of time, e.g. 15
seconds may be applied. Longer sub periods may also be applied or sub periods of
different length, although the period should be chosen carefully for the purpose of
avoiding lowering or dropouts of the nicotine or tobacco alkaloid transfer during the
intermediate release. In particular, according to the invention, a dropout should be
avoided in the intermediate transfer, i.e. from about 54 to 254 minutes as such a

dropout inevitably would result in a lowered transfer in spite of the fact that a
complete release of nicotine is high.
In an embodiment of the invention said chewing of said chewing gum comprising a
chewing process involving a transfer of tobacco alkaloid from said chewing gum
above a further threshold transfer rate in the period of about 2½ minutes to about 10
minutes from initiation of said chewing process, preferably in the period of about 2½
minutes to about 5 minutes from initiation of said chewing process.
According to a further embodiment of the invention a further threshold value may be
applied for the chewing process after the initial 214 minutes of chewing. Thus,
according to an advantageous embodiment of the invention such threshold value
should preferably ensure that a relatively high tobacco alkaloid transfer is obtained in
the period from 2½ minutes up to 10 or preferably at least 5 minutes.
In this way, maintenance of the initially obtained relief may be obtained.
In an embodiment of the invention said threshold transfer rate results in a release of
at least 2%, preferably at least 2.5% of the tobacco alkaloid comprised in said
chewing gum prior to chewing, every 30 seconds in the period from ½ minutes to
about 2½ minutes from initiation of said chewing process.
According to an embodiment of the invention, the tobacco alkaloid release of the
chewing is at least 2%, preferably at least 2.5%, every thirty seconds thereby
maintaining a high osmotic pressure on the mucosa membrane when chewing. This
initial focussing on keeping tobacco alkaloid constantly available in the mouth is in
particular important in the early phase of the chewing process due to the fact that a
fast relief to a user should preferably be obtained quite fast compared to conventional
tobacco alkaloid containing chewing gum and that such desired fast relief requires
not only just sporadic or late release phases but a maintained constantly high

availability of tobacco alkaloid in the mouth over at least a part of the period usually
required for smoking a cigarette.
In an embodiment of the invention said threshold transfer rate results in a release of
at least 3%, preferably at least about 4 % of the tobacco alkaloid comprised in said
chewing gum prior to chewing, every 30 seconds in the period from about ½ minute
to about 2½ minutes from initiation of said chewing process.
According to an embodiment of the invention, the tobacco alkaloid release of the
chewing is at least 3%, preferably at least 4%, every thirty seconds thereby
maintaining a high osmotic pressure on the mucosa membrane when chewing. This
initial focussing on keeping tobacco alkaloid constantly available in the mouth is in
particular important in the early phase of the chewing process due to the fact that a
fast relief to a user should preferably be obtained quite fast compared to conventional
tobacco alkaloid containing chewing gum and that such desired fast relief requires
not only just sporadic or late release phases but a maintained constantly high
availability of tobacco alkaloid in the mouth over at least a part of the period usually
required for smoking a cigarette.
In an embodiment of the invention said threshold transfer rate results in a release of
at least 5%, preferably at least about 6% of the tobacco alkaloid comprised in said
chewing gum prior to chewing, every 30 seconds in the period from about ½ minute
to about 2½ minutes from initiation of said chewing process.
According to a further advantageous embodiment of the invention a transfer rate may
be established and maintained at a high level thereby featuring an improved fast
relief of the user.
In an embodiment of the invention said threshold transfer rate results in a release of
at least 2%, preferably at least 3% of the tobacco alkaloid comprised in said chewing

gum prior to chewing, every 30 seconds in the period of about 254 minutes to about 5
minutes from initiation of said chewing process.
According to a further advantageous embodiment of the invention, tobacco alkaloid
should also be kept available at high rate in the period of about 214 to 5 minutes after
initiation of the chewing process. Again, it should be noted that such threshold rate
should be complied with at virtually anytime within the interval of 2.5 to 5 minutes
from initiation of the chewing process.
In an embodiment of the invention said threshold transfer rate results in a release of
at least 3%, preferably at least 3.5% of the tobacco alkaloid comprised in said
chewing gum prior to chewing, every 30 seconds in the period of about 254 minutes
to about 5 minutes from initiation of said chewing process.
According to a further advantageous embodiment of the invention, tobacco alkaloid
should also be kept available at high rate in the period of about 254 to 5 minutes after
initiation of the chewing process. Again, it should be noted that such threshold rate
should be complied with at virtually time within the interval of 2.5 to 5 minutes from
initiation of the chewing process.
In an embodiment of the invention wherein said threshold transfer rate results in a
release of at least 4%, preferably at least 5% of the tobacco alkaloid comprised in
said chewing gum prior to chewing, every 30 seconds in the period of about 5
minutes to about 10 minutes from initiation of said chewing process.
In an embodiment of the invention said threshold transfer rate results in a release of
at least 2 to 10 %, preferably at least 5% of the tobacco alkaloid comprised in said
chewing gum prior to chewing in the period of about 0 seconds to about 30 seconds
from initiation of said chewing process.

In an embodiment of the invention said threshold transfer rate results in a release of
less than 14 %, preferably less than 12% of the tobacco alkaloid comprised in said
chewing gum prior to chewing in the period of about 0 seconds to about 2½ minutes
from initiation of said chewing process.
According to an embodiment of the invention, the initial transfer of tobacco alkaloid
from the chewing gum should be kept below 12 to 14 % of the tobacco alkaloid
comprised in the chewing gum prior to chewing in order to avoid socalled burning or
tingling. Moreover, too much releasing of e.g. nicotine would on the other hand
result in that a part of the released nicotine is swallowed and therefore only effective
by a metabolic transfer.
In an embodiment of the invention said threshold transfer rate results in a release of
at most 18 %, preferably at most 15% of the tobacco alkaloid comprised in said
chewing gum prior to chewing in the period of about 10 to about 30 minutes from
initiation of said chewing process.
In an embodiment of the invention said threshold transfer rate results in a release of
at least 0.03 mg, preferably at least 0.04 mg of the tobacco alkaloid comprised in said
chewing gum prior to chewing, every 30 seconds in the period from about 54 minute
to about 2% minutes from initiation of said chewing process.
According to the invention a build-up of nicotine or tobacco alkaloid in the blood
should preferably be obtained by a maintained osmotic pressure on the mucous
membrane of the mouth in the intermediate period of the chewing process, e.g. in the
first ten minutes of the chewing process.
In an embodiment of the invention said threshold transfer rate results in a release of
at least 0.05 mg, preferably at least 0.06 mg of the tobacco alkaloid comprised in said

chewing gum prior to chewing, every 30 seconds in the period from about ½ minute
to about 2½ minutes from initiation of said chewing process.
In an embodiment of the invention said threshold transfer rate results in a release of
at least 0.08 mg, preferably at least 0.1 mg of the tobacco alkaloid comprised in said
chewing gum prior to chewing, every 30 seconds in the period from about ½ minute
to about 2½ minutes from initiation of said chewing process.
In an embodiment of the invention said threshold transfer rate results in a release of
at least 0.03 mg, preferably at least 0.04 mg of the tobacco alkaloid comprised in said
chewing gum prior to chewing, every 30 seconds in the period of about 2½ to about
5 minutes from initiation of said chewing process.
In an embodiment of the invention said threshold transfer rate results in a release of
at least 0.05 mg, preferably at least 0.06 mg of the tobacco alkaloid comprised in said
chewing gum prior to chewing, every 30 seconds in the period of about 2½ minutes
to about 5 minutes from initiation of said chewing process.
In an embodiment of the invention wherein said threshold transfer rate results in a
release of at least 0.08 mg, preferably at least 0.1 mg of the tobacco alkaloid
comprised in said chewing gum prior to chewing, every 30 seconds in the period of
about 2½ minutes to about 5 minutes from initiation of said chewing process.
In an embodiment of the invention at least 0.5 mg of tobacco alkaloid is released
within the initial 10 minutes of the chewing process or preferably within the initial 5
to 8 minutes of the chewing process.
According to an embodiment of the invention even higher release should be obtained
such as at least 0.8 mg of tobacco alkaloid is released within the initial 10 minutes of

the chewing process or preferably within the initial 5 to 8 minutes of the chewing
process.
In an embodiment of the invention wherein different parts of the chewing gum is
targeted tobacco alkaloid transfer at different times or in different periods of the
chewing process.
According to an embodiment of the invention different parts of the chewing gum
may be targeted tobacco alkaloid transfer at different times or in different periods of
the chewing process, thereby facilitating the obtaining of the desired constant
transfers or at least the desired minimum transfer of the relevant period of the
chewing process, i.e. typically during the first three to five minutes of the chewing
process. Thus, e.g. the very initial transfer of tobacco alkaloid, i.e. the first seconds
of the chewing process, may be increased by means of e.g. nicotine containing
coating. Alternatively, nicotine may be comprised in beads or other release-delaying
means. Again, further means may include mixture of different polymers having
different release properties. Further means may include different types of buffering.
Thus the threshold transfer rate is obtained by a combination of different parts of the
chewing having different release profiles.
In an embodiment of the invention wherein said chewing gum comprising a coating
and wherein said coating comprises tobacco alkaloid.
According to an embodiment of the invention, tobacco alkaloid is comprised in the
coating and may therefore be released quite fast in the very early stage of the
chewing process.
In an embodiment of the invention said chewing gum comprises substantially
hydrophilic polymers.

In an embodiment of the invention the variation of transfer rate is minimized.
According to an embodiment of the invention, the significant variations of tobacco
alkaloid over time should be avoided in order to obtain an advantageous taste
masking. A sudden tobacco alkaloid peak would thus be difficult to taste mask,
especially when dealing with peaks occurring subsequently to the very initial
chewing process. I1 and I3 as described below are examples of such smoothed
release.
In an embodiment of the invention wherein said tobacco alkaloid is comprised in a
ion exchange resin.
According to an embodiment tobacco alkaloid is nicotine polacrilex.
In an embodiment of the invention wherein said tobacco alkaloid comprises salts of
nicotine.
In an embodiment of the invention said tobacco alkaloid comprises nicotine in its
free from.
In an embodiment of the invention the tobacco alkaloid is buffered.
In an embodiment of the invention the chewing process is less than 30 minutes,
preferably less than 20 minutes.
According to an embodiment the chewing process should be kept short in order to
comply with the basic principles of fast relief as obtained by the desired emulation of
the smoking process.

In an embodiment of the invention the chewing process is matching the smoking
time of a cigarette.
In an embodiment of the invention said chewing gum comprises a polymer system in
an amount of from about 2 to about 99% by weight, flavour in an amount of about
0,001 to about 30% by weight and sweeteners in an amount of about 2% to about
80% by weight.
In an embodiment of the invention said chewing gum comprises fillers in an amount
of from about 0 to about 60% by weight, flavour in an amount of about 0,001 to
about 30% by weight and
sweeteners in an amount of about 2 to about 80% by weight.
In an embodiment of the invention said chewing gum comprises high intensity
sweeteners in an amount of from about 0.001 to about 3% by weight and flavour in
an amount of about 0,001 to about 30% by weight.
In an embodiment of the invention said polymer system comprises elastomers in an
amount of about 0.1 to about 40 % by weight of the chewing gum, preferably in an
amount of about 2 to about 10 % by weight of the chewing gum.
In an embodiment of the invention said polymer system comprises elastomer
plasticizers in an amount of about 2 to about 60 % by weight of the chewing gum,
preferably in an amount of about 5 to about 30 % by weight of the chewing gum.
In an embodiment of the invention said polymer system comprises wax in an amount
of about 0 to about 30% by weight of the chewing gum, preferably in an amount of
about 0 to about 15% by weight of the chewing gum.

In an embodiment of the invention said polymer system comprises softeners in an
amount of about 2 to about 30% by weight of the chewing gum, preferably in an
amount of about 5 to about 20% by weight of the chewing gum.
In an embodiment of the invention said polymer system comprises fillers in an
amount of about 0 to about 50% by weight of the chewing gum, preferably in an
amount of about 0 to about 30% by weight of the chewing gum.
In an embodiment of the invention said polymer system comprises antioxidants in an
amount of about 0 to about 5% by weight of the chewing gum, preferably in an
amount of about 0 to about 2% by weight of the chewing gum.
In an embodiment of the invention at least one piece of said chewing gum is chewed
at a time.
In an embodiment of the invention at least two pieces of said chewing gum are
chewed at a time.
In an embodiment of the invention at least one piece of said chewing gum is chewed
a day.
In an embodiment of the invention at least one piece of said chewing gum is chewed
when the person craves for nicotine.
According to an advantageous embodiment of the invention a tobacco alkaloid
holding chewing may even be applied solely as a reaction on craving of a user. In
other words, mere maintenance of a high nicotine level in the blood may be avoided.
In an embodiment of the invention at least one piece of said chewing is chewed when
the person needs treatment including tobacco alkaloid or nicotine.

The figures
The invention will now be described with reference to the drawings of which
fig.1 shows the release profile of prior art nicotine chewing gums,
fig.2 shows a break-up of the release in 30-second intervals of the intermediate
release of prior art nicotine chewing gums,
fig.3 shows a break-up of the release in 30 second intervals of the intermediate
release of nicotine chewing gums applied according to the invention, and
fig.4 shows a release profile of a combination of prior art chewing gums and chewing
gums according to the invention.

Detailed description of the invention
In general, a chewing gum composition typically comprises a water-soluble bulk
portion, a water-insoluble chewable gum base portion and flavouring agents. The
water-soluble portion dissipates with a portion of the flavouring agent over a period
of time during chewing. The gum base portion is retained in the mouth throughout
the chew. The term chewing gum refers to both a chewing and bubble type gum in its
general sense.
The gum base is the masticatory substance of the chewing gum, which imparts the
chew characteristics to the final product. The gum base typically defines the release
profile of flavours and sweeteners and plays a significant role in the gum product.
The insoluble portion of the gum typically may contain any combination of
elastomers, vinyl polymers, elastomer plasticizers, waxes, softeners, fillers and other
optional ingredients such as colourants and antioxidants.
The composition of gum base formulations can vary substantially depending on the
particular product to be prepared and on the desired masticatory and other sensory
characteristics of the final product. However, typical ranges (% by weight) of the
above gum base components are: 5 to 50% by weight elastomeric compounds, 5 to
55% by weight elastomer plasticizers, 0 to 40% by weight of waxes, 5 to 35% by
weight softener, 0 to 50% by weight filler, and 0 to 5% by weight of miscellaneous
ingredients such as antioxidants, colourants, etc.
Function of elastomers
Elastomers provide the rubbery, cohesive nature to the gum, which varies depending
on this ingredient's chemical structure and how it may be compounded with other

ingredients. Elastomers suitable for use in the gum base and gum of the present
invention may include natural or synthetic types.
Elastomers
The elastomer may be any water-insoluble polymer known in the art, and includes
those gum polymers utilized for chewing gum and bubble gum listed in Food and
Drug Administration, CFR, Title 21, Section 172,615, as "Masticatory Substances of
Natural Vegetable Origin" and "Masticatory Substances, Synthetic"
Useful natural elastomers include natural rubber such as smoked or liquid latex and
guayule, natural gums such as jelutong, lechi caspi, perillo, sorva, massaranduba
balata, massaranduba chocolate, nispero, rosidinha, chicle, gutta percha, gutta kataiu,
niger gutta, tunu, chilte, chiquibul, gutta hang kang.
Useful synthetic elastomers include high molecular weight elastomers such as
butadiene-styrene copolymers, polyisobutadiene and isobutylene-isoprene
copolymers, low molecular weight elastomers such as polybutene, polybutadiene and
polyisobutylene, vinyl polymeric elastomers such as polyvinyl acetate, polyethylene,
vinyl copolymeric elastomers such as vinyl acetate/vinyl laurate, vinyl acetate/vinyl
stearate, ethylene/vinyl acetate, polyvinyl alcohol or mixtures thereof.
Butadiene-styrene type elastomers, or SBR as they may be called, typically are
copolymers of from about 20:80 to 60:40 styrenes:butadiene monomers. The ratio of
these monomers affects the elasticity of the SBR as evaluated by mooney viscosity.
As the styrene:butadiene ratio decreases, the mooney viscosity decreases.
The structure of SBR typically consists of straight chain 1,3-butadiene
copolymerized with phenylethylene (styrene) and provides the non-linear molecular
nature of these elastomers. The average molecular weight of SBR is g/mole.

Isobutylene-isoprene type elastomers, or butyl as they may be called, have molar
percent levels of isoprene ranging from 0.2 to 4.0. Similar to SBR, as the
isoprene:isobutylene ratio decreases, so does the elasticity, measured by mooney
viscosity.
The structure of butyl rubber typically consists of branched 2-methyl-l,3-butadiene
(isoprene) copolymerized with branched 2-methylpropene (isobutylene), and, as with
SBR, this type of structure is non-linear in nature. The average molecular weight of
SBR is in the range from 150.000 g/mole to 1.000.000 g/mole.
Polyisobutylene, or PIB as they may be called, type elastomers are polymers of 2-
methylpropene and, as with SBR and butyl, are non-linear in nature. The low
molecular weight elastomers provide soft chew characteristics to the gum base and
still provide the elastic qualities as do the other elastomers. Average molecular
weights may range from about 30,000 to 120,000 g/mole and the penetration may
range from about 4 millimetres to 20 millimetres. The higher the penetration, the
softer the PIB. Similar to the SBR and butyl, the high molecular weight elastomers
provide elasticity the gum. Average molecular weight may range from 120.000 to
1.000.000 g/mole.
Polybutenes range in average molecular weight from about 5.000 g/mole to about
30.000 g/mole.
Function of vinyl polymers
½nyl polymeric and copolymeric type elastomers provide tack resistance, vary the
chew characteristics of gums made from these bases having vinyl polymers and offer
hydrophilic properties beneficial to sensory perception of the final gums.
½nyl polymers
For vinyl copolymeric types, the amount of vinyl laurate, vinyl stearate, or ethylene
present in the vinyl laurate/vinyl acetate (VL/VA), vinyl stearate/vinyl acetate

(VS/VA), or ethylene/vinyl acetate (EVA) copolymers respectively typically ranges
from about 10 to about 60% by weight of the copolymer. Average molecular weights
of these polymers may range from about 2.000 g/mole to about 100.000 g/mole.
The vinyl polymers such as polyvinyl alcohol and polyvinyl acetate have an average
molecular weight from about 8.000 g/mole to about 65.000 g/mole.
Polymers of vinyl acetate (PVAc) are branched in nature. The degree of branching is
increased when vinyl acetate monomers are copolymerized with vinyl laurate, vinyl
stearate, ethylene and the like. The higher the degree of branching, the higher the
compatibility when blended or compounded with normal-alkanic and iso-alkanic
type waxes.
It is e.g. common in the industry to combine in a gum base a synthetic elastomer
having a high molecular weight and a low-molecular-weight elastomer. Presently
preferred combinations of synthetic elastomers include, but are not limited to,
polyisobutylene and styrene-butadiene, polyisobutylene and polyisoprene,
polyisobutylene and isobutylene-iso
prene copolymer (butyl rubber) and a combination of polyisobutylene, styrene-
butadiene copolymer and isobutylene isoprene copolymer, and all of the above
individual synthetic polymers in admixture with polyvinyl acetate, vinyl acetate-
vinyl laurate copolymers, respectively and mixtures thereof.
Function of elastomer plasticizers
Elastomer plasticizers vary the firmness of the gum base. Their specificity on
elastomer inter-molecular chain breaking (plasticizing) along with their varying
softening points cause varying degrees of finished gum firmness and compatibility
when used in base. This may be important when one wants to provide more
elastomeric chain exposure to the alkanic chains of the waxes.
Elastomer plasticizers

Elastomer plasticizers suitable for use in the present invention include natural rosin
esters often referred to as ester gums. Such elastomer plasticizers known in the art
are methyl, glycerol and pentaerythritol esters of rosins and modified rosins, such as
hydrogenated, dimerized and polymerized rosins. Examples are glycerol ester of
wood and gum rosin, glycerol ester of partially hydrogenated wood and gum rosin,
glycerol ester of polymerized wood and gum rosin, glycerol ester of partially
dimerized wood and gum rosin, glycerol ester of tall oil rosin, pentaerythritol ester of
wood and gum rosin, pentaerythritol esters of partially and fully hydrogenated wood
and gum rosin, methyl esters of wood and gum rosins and partially and fully
hydrogenated methyl esters of wood and gum rosin.
The synthetic elastomer plasticizers include terpene resins derived from alpha-
pinene, beta-pinene and/or d-limonene.
The elastomer plasticizers used may be of one type or of combinations of more than
one type. Typically, the ratios of one to the other are dependent on each respective
softening point, the effect on flavour release, and the respective degree of tack they
case to the gum. Ball and ring softening points of the rosin ester types described
above may range from about 45.degree. C. to about 120.degree. C. Softening points
of the terpene resins may range from about 60.degree. C. to about BO.degree. C.
Function of waxes
Petroleum waxes aid in the curing of the finished gum made from the gum base as
well as improve shelf life and texture. Wax crystal size influences the release of
flavour. Those waxes high in iso-alkanes have a smaller crystal size than those waxes
high in normal-alkanes, especially those with normal-alkanes of carbon numbers less
than 30. The smaller crystal size allows slower release of flavour since there is more
hindrance of the flavour's escape from this wax versus a wax having larger crystal
sizes. The compatibility of gum bases made using normal-alkanic waxes is less when
compared to gum bases made with iso-alkanic waxes.

Waxes
Petroleum wax (refined paraffin and microcrystalline wax) and paraffin wax are
composed of mainly straight-chained normal-alkanes and branched iso-alkanes. The
ratio of normal-alkanes to iso-alkanes varies.
The normal-alkanic waxes typically have carbon chain lengths >C-18 but the lengths
are not predominantly longer than C-30. The branched and ring structures are located
near the end of the chain for those waxes that are predominantly normal-alkanic. The
viscosity of normal-alkanic waxes is number average molecular weight is The iso-alkanic waxes typically have carbon lengths that are predominantly greater
than C-30. The branched chains and ring structures are located randomly along the
carbon chain in those waxes that are predominantly iso-alkanic. The viscosity of iso-
alkanic waxes is greater than 10 mm2/s (at 100 °C) and the combined number
average molecular weight is >600 g/mole.
Synthetic waxes are produced by means that are atypical for petroleum wax
production and are thus not considered petroleum wax. The synthetic waxes may
include waxes containing branched alkanes and copolymerized with monomers such
as, but not limited to propylene, polyethylene, and Fischer Tropsch type waxes.
Polyethylene wax is a synthetic wax containing alkane units of varying lengths
having attached thereto ethylene monomers.
The natural waxes may include rice bran wax, bees' wax, carnauba wax or candelilla
wax.
The waxes may be used alone or in any combination.

Function of softeners
The selection of softeners has an influence on the softness of the base. Softeners
modify the texture, cause the hydrophobic and hydrophilic components of the base to
be miscible, and may further plasticize the synthetic elastomers of the gum base. The
emulsifiers, which belongs to the group of softeners, provide the gum base with
water-binding properties, which confer to the gum base a pleasant smooth surface
and reduce its adhesive properties.
Softeners
Softeners suitable for use in the gum base include triglycerides of non-hydrogenated,
partially hydrogenated and fully hydrogenated vegetable oils and tallow, cocoa butter
and degreased cocoa powder and in addition to these the emulsifiers.
The group of triglycerides include cottonseed, palm, palm kernel, coconut, safflower,
rapeseed, sunflower, tallow, soybean, cocoa butter, medium-chained triglycerides
and the like.
The caproic, caprylic, capric, myristic, lauric and palmitic fatty acids of the
triglycerides tend to plasticize the synthetic elastomers more than triglycerides
containing predominantly stearic fatty acid
To the group of emulsifiers belong the monoglycerides, diglycerides, acetylated
mono and diglycerides, distilled mono- and diglycerides, glycerol monostearate,
propylene glycol monostearate, Na-, K-, Mg- and Ca-stearates, glycerol triacetate,
fatty acid monoglycerides (e.g. stearic, palmitic, oleic and linoleic acids), lactic acid
esters and acetic acid esters of mono- and diglycerides, sugar esters of edible fatty
acids also referred to as sucrose polyesters including those disclosed in WO
00/25598, lecithin and hydroxylated lecithin, most of these may contain triglyceride
levels less than 2% by weight from their manufacturing processing,

The softeners including the emulsifiers may be used alone or at least two or more in
combination.
Function of fillers
Fillers used in gum base modify the texture of the gum base and aid in processing.
Particle size has an effect on cohesiveness, density and processing characteristics of
the gum base and its compounding. The smaller the particle size, the more dense and
cohesive the final gum base. Also, by selecting fillers based on their particle size
distribution, initial mass compounding may be varied, thus allowing alteration of the
compounding characteristics of the initial mass during gum base processing and
ultimately the final chew characteristics of gums made from these gum bases.
Fillers
Fillers suitable for use in the gum base include magnesium and calcium carbonate,
ground limestone and silicate types such as magnesium and aluminum silicate, kaolin
and clay, aluminium oxide, silicium oxide, talc, as well as titanium oxide, mono-, di-
and tricalcium phosphate, sodium sulphate, cellulose polymers such as ethyl, methyl
and wood or mixtures thereof.
Talc filler may be used in the gum base and gum of the present invention that may
come in contact with or employ acid flavours or provide an acidic environment
needed to prevent degradation of an artificial sweetener by reacting with calcium
carbonate type fillers. Mean particle size for calcium carbonate and talc fillers
typically range from about 0.1 micron to about 15 microns.
The fillers may also include natural organic fibres such as fruit vegetable fibres,
grain, rice, cellulose and combinations thereof.
Function and list of other optional ingredients such as antioxidants, colourants and
flavourants:

Antioxidants prolong shelf life and storage of gum base, finished gum or their
respective components including fats and flavour oils.
Antioxidants suitable for use in gum base include butylated hydroxyanisole (BHA),
butylated hydroxytoluene (BHT), betacarotenes, tocopherols, acidulants such as
½tamin C, propyl gallate, other synthetic and natural types or mixtures thereof.
Flavourants and colourants impart characteristics or remove or mask undesired
characteristics. Colourants may typically include FD&C type lakes, plant extracts,
fruit and vegetable extracts and titanium dioxide flavourants may typically include
cocoa powder, heat-modified amino acids and other vegetable extracts.
Preparation of gum bases
Gum bases are typically prepared by adding an amount of the elastomer, elastomer
plasticizer and filler, and on occasion a vinyl polymer, to a heated (10°C - 120°C)
sigma blade mixer with a front to rear speed ratio of from about 1.2:1 to about 2:1,
the higher ratio typically being used for gum base which requires more rigorous
compounding of its elastomers.
The initial amounts of ingredients comprising the initial mass may be determined by
the working capacity of the mixing kettle in order to attain a proper consistency and
by the degree of compounding desired to break down the elastomer and increase
chain branching. The higher the level of filler at the start or selection of a filler
having a certain particle size distribution, the higher the degree of compounding and
thus more of the elastomeric chain crosslinking are broken, causing more branching
of the elastomer thus lower viscosity gum bases and thus softer final gum base and
gum made from such a gum base. The longer the time of compounding, the use of
lower molecular weight or softening point gum base ingredients, the lower the
viscosity and firmness of the final gum base.
Compounding typically begins to be effective once the ingredients have massed

together. Anywhere from 15 minutes to 90 minutes may be the length of
compounding time.
Preferably, the time of compounding is from 20 minutes to about 60 minutes. The
amount of added elastomer plasticizer depends on the level of elastomer and filler
present. If too much elastomer plasticizer is added, the initial mass becomes over
plasticized and not homogeneous.
After the initial ingredients have massed homogeneously and compounded for the
time desired, the balance of the gum base ingredients are added in a sequential
manner until a completely homogeneous molten mass is attained. Typically, any
remainder of elastomer, elastomer plasticizer, vinyl polymer and filler, are added
within 60 minutes after the initial compounding time. The filler and the elastomer
plasticizer would typically be individually weighed and added in portions during this
time. The optional waxes and the softeners are typically added after the elastomer
and elastomer plasticizers and during the next 60 minutes. Then the mass is allowed
to become homogeneous before dumping.
Typical gum base processing times may vary from about one to about three hours,
preferably from about 1 1/2 to 2 1/2 hours, depending on the formulation. The final
mass temperature when dumped may be between 70°C. and 130°C. and preferably
between 100°C. and 120°C. The completed molten mass is emptied from the mixing
kettle into coated or lined pans, extruded or cast into any desirable shape and allowed
to cool and solidify. Those skilled in the art will recognize that many variations of
the above described procedure may be followed.
The water-soluble portion of chewing gum.
The water-soluble portion of the chewing gum may comprise softeners, sweeteners,
high intensity sweeteners, flavoring agents, acidulants, fillers, antioxidants, and other

components that provide desired attributes. Softeners typically constitute from about
0.5 percent to about 25.0 percent by weight of the chewing gum. The bulking agents
generally comprise from about 5 percent to about 90 percent, preferably from about
20 percent to about 80 percent of the chewing gum. High-intensity sweeteners in
gum typically may range from about 0.01 to 0.50 weight percent. A flavoring agent
may be present in the chewing gum in an amount within the range of from about 0.1
to about 30.0 weight percent of the gum.
Softeners
Softeners are added to the chewing gum in order to optimize the chewability and
mouth feel of the gum.
Softeners contemplated for use in the gum include glycerin, modified lecithin and
combinations thereof. Further aqueous sweetener solutions such as those containing
sorbitol, hydrogenated starch hydrolysates, corn syrup and combinations thereof may
be used as softeners.
Sweeteners
Bulk sweeteners include both sugar and sugarless components. Bulk sweeteners may
typically constitute 5 to about 95% by weight of the chewing gum, more typically
constitute 20 to about 80% by weight, and more commonly, 30 to 60% by weight of
the gum.
The sweeteners often fill the role of bulking agents in the gum. The sweeteners are
improving juiciness of the gum and are supporting the flavourprofile of the gum.
Sugar sweeteners generally include, but are not limited to saccharide-containing
components commonly known in the chewing gum art, such as sucrose, dextrose,
maltose, saccharose, lactose, sorbose, dextrin, trehalose, D-tagatose, dried invert
sugar, fructose, levulose, galactose, corn syrup solids, glucose syrup, hydrogenated
glucose syrup, and the like, alone or in combination.
The sweetener can be used in combination with sugarless sweeteners.

Generally, sugarless sweeteners include components with sweetening characteristics
but which are devoid of the commonly known sugars and comprise, but are not
limited to, sugar alcohols such as sorbitol, mannitol, xylitol, hydrogenated starch
hydrolyzates, maltitol, isomalt, erythritol, lactitol and the like, alone or in
combination.
Depending on the particular sweetness release profile and shelf-life stability needed,
bulk sweeteners can also be used in combination high-intensity sweeteners.
Preferred high intensity sweeteners include, but are not limited to sucralose, aspar-
tame, salts of acesulfame, alitame, saccharin and its salts, cyclamic acid and its salts,
cyclamate, glycyrrhizin, dihydrochalcones, thaumatin, monellin, sterioside and the
like, alone or in combination. In order to provide longer lasting sweetness and
flavour perception, it may be desirable to encapsulate or otherwise control the release
of at least a portion of the artificial sweetener. Such techniques as wet granulation,
wax granulation, spray drying, spray chilling, fluid bed coating, coascervation,
encapsulation in yeast cells and fibre extrusion may be used to achieve the desired
release characteristics. The encapsulation can also be performed in another material
such as resin.
Usage level of the artificial sweetener will vary greatly and will depend on such
factors as potency of the sweetener, rate of release, desired sweetness of the product,
level and type of flavour used and cost considerations. Thus, the active level of
artificial sweetener may vary from 0.02 to about 8%. When carriers used for
encapsulation are included, the usage level of the encapsulated sweetener will be
proportionally higher.
Combinations of sugar and/or sugarless sweeteners may be used in chewing gum.
Additionally, the softener may also provide additional sweetness, if such softeners as
aqueous sugar or alditol are used.

If a low calorie gum is desired, a low caloric bulking agent can be used. Examples of
low caloric bulking agents include polydextrose; Raftilose, Raftilin; Fructooligo-
saccharides (NutraFlora@); Palatinose oligosaccharide; Guar Gum Hydrolysate
(SunFiber@); or indigestible dextrin (Fibersol). However, other low calorie-bulking
agents can be used.
Flavour
The chewing gum centres provided herein may contain aroma agents and flavouring
agents including natural and synthetic flavourings e.g. in the form of natural
vegetable components, essential oils, essences, extracts, powders, including acids
and other substances capable of affecting the taste profile. Examples of liquid and
powdered flavourings include coconut, coffee, chocolate, vanilla, grape fruit,
orange, lime, menthol, liquorice, caramel aroma, honey aroma, peanut, walnut,
cashew, hazelnut, almonds, pineapple, strawberry, raspberry, tropical fruits, cherries,
cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, fruit essence
such as from apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple,
and plum essence. The essential oils include peppermint, spearmint, menthol,
eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the
fruits (e.g. lemon, bergamot and orange) as mentioned above.
The chewing gum flavour may be a natural flavouring agent, which is freeze-dried,
preferably in the form of a powder, slices or pieces of combinations thereof. The
particle size may be less than 3 mm, preferably less than 2 mm, more preferably less
than 1 mm, calculated as the longest dimension of the particle. The natural flavouring
agent may be in a form where the particle size is from about 3 µm to 2 mm, such as
from 4 µm to 1 mm. Preferred natural flavouring agents include seeds from a fruit
e.g. from strawberry, blackberry and raspberry.
Various synthetic flavours, such as mixed fruit flavours may also be used in the
present chewing gum centres. The aroma agent may be used in quantities smaller
than those conventionally used. The aroma agents and/or flavours may be used in an

amount of from 0.01 to about 30% by weight (preferably from 0.01 to about 15% by
weight) of the final product depending on the desired intensity of the aroma and/or
flavour used. Preferably, the content of aroma/flavour is in the range of from 0.2 to
3% by weight of the total composition.
Acidulants
Also various acids are used typically in combination with fruit flavours, such as
adipinic acid, succinic acid, fumaric acid, citric acid, tartaric acid, malic acid, acetic
acid, lactic acid, phosphoric acid and glutaric acid or salts thereof. They are typically
added in amounts of 0.01 to 10%.
Fillers
Fillers suitable for use in the chewing gum include magnesium and calcium
carbonate, ground limestone and silicate types such as magnesium and aluminum
silicate, kaolin and clay, aluminium oxide, silicium oxide, talc, as well as titanium
oxide, mono-, di- and tricalcium phosphate, sodium sulphate, cellulose polymers
such as ethyl, methyl and wood or mixtures thereof.
Talc filler may be used in the chewing gum of the present invention that may come
in contact with or employ acid flavours or provide an acidic environment needed to
prevent degradation of an artificial sweetener by reacting with calcium carbonate
type fillers. Mean particle size for calcium carbonate and talc fillers typically range
from about 0.1 micron to about 15 microns.
The fillers may also include natural organic fibres such as fruit vegetable fibres,
grain, rice, cellulose and combinations thereof.
Function and list of other optional ingredients such as antioxidants, colourants and
taste masking agents:
Antioxidants prolong shelf life and storage of gum base, finished gum or their
respective components including fats and flavour oils.

Antioxidants
Antioxidants suitable for use in gum base include butylated hydroxyanisole (BHA),
butylated hydroxytoluene (BHT), betacarotenes, tocopherols, acidulants such as
½tamin C, propyl gallate, other synthetic and natural types or mixtures thereof.
Colourants
Colourants and whiteners may include FD & C-type dyes and lakes, fruit and
vegetable extracts, titanium dioxide, and combinations thereof.
Taste masking agents
The taste masking agent improves the organoleptic properties of the product.
The masking agent include sucralose, zinc gluconate, ethyl maltol, glycine,
acesulfame-K, aspartame, saccharin, fructose, xylitol, spray dried licorice root,
glycerrhizine, dextrose, sodium gluconate, glucono delta-lactone, ethyl vanillin,
vanillin, normal and high-potency sweeteners, and a variety of appropriate flavors.
Active agents
The chewing gum according to the present invention may also comprise active
agents other than nicotine. Active agents to be used in connection with the present
invention may be any substance desired to be released from the chewing gum. If an
accelerated rate of release is desired, corresponding to the effect obtained for the
flavour, the primary substances are those with limited water solubility, typically
below 10 g/100 ml including substances, which are entirely water insoluble.
Examples are medicines, dietary supplements, oral compositions, anti-smoking
agents, highly potent sweeteners, pH adjusting agents, etc.
Further examples of active ingedients include paracetamol, benzocaine, cinnarizine,

menthol, carvone, coffeine, chlorhexidine-di-acetate, cyclizine hydrochloride, 1,8-
cineol, nandrolone, miconazole, mystatine, aspartame, sodium fluoride, nicotine,
saccharin, cetylpyridinium chloride, other quaternary ammoniumcompounds, vitamin
E, vitamin A, vitamin D, glibenclamide or derivatives thereof, progesterone, ace-
tylsalicylic acid, dimenhydrinate, cyclizine, metronidazole, sodium hydrogencarbo-
nate, the active components from ginkgo, the active components from propolis, the
active components from ginseng, methadone, oil of peppermint, salicylamide,
hydrocortisone or astemizole.
Examples of active agents in the form of dietary supplements are for instance salts
and compounds having the nutritive effect of vitamin B2 (riboflavin), B12, folinic
acid, niacine, biotine, poorly soluble glycerophosphates, amino acids, the vitamins A,
D, E and K, minerals in the form of salts, complexes and compounds containing
calcium, phosphorus, magnesium, iron, zinc, copper, iodine, manganese, chromium,
selenium, molybdenum, potassium, sodium or cobalt.
Furthermore, reference is made to lists of nutritients acccepted by the authorities in
different countries such as for instance US code of Federal Regulations, Title 21,
Section 182.5013.182 5997 and 182.8013-182.8997.
Examples of active agents in the form of compounds for the care or treatment of the
oral cavity and the teeth, are for instance bound hydrogen peroxide and compounds
capable of releasing urea during chewing.
Examples of active agents in the form of antiseptics are for instance salts and
compounds of guanidine and biguanidine (for instance chlorhexidine diacetate) and
the following types of substances with limited water-solubility: quaternary
ammonium compounds (for instance ceramine, chloroxylenol, crystal violet,
chloramine), aldehydes (for instance paraformaldehyde), compounds of dequaline,

polynoxyline, phenols (for instance thymol, para chlorophenol, cresol)
hexachlorophene, salicylic anilide compounds, triclosan, halogenes (iodine,
iodophores, chloroamine, dichlorocyanuric acid salts), alcools (3,4 dichlorobenzyl
alcohol, benzyl alcohol, phenoxyethanol, phenylethanol), cf. furthermore Martindale,
The Extra Pharmacopoeia, 28th edition, page 547-578; metal salts, complexes and
compounds with limited water-solubility, such as aluminium salts, (for instance
aluminium potassium sulfate AIK (S04) 2,12H20) and furthermore salts, complexes
and compounds of boron, barium, strontium, iron, calcium, zinc, (zinc acetate, zinc
chloride, zinc gluconate), copper (copper chloride, copper sulfate), lead, silver,
magnesium, sodium, potassium, lithium, molybdenum, vanadium should be
included; other compositions for the care of mouth and teeth: for instance; salts,
complexes and compounds containing fluorine (such as sodium fluoride,
sodiummonofluorophosphate, aminofluorides, stannous fluoride), phosphates,
carbonates and selenium.
Cf. furthermore J. Dent. Res. Vol. 28 No. 2, page 160-171,1949, wherein a wide
range of tested compounds are mentioned.
Examples of active agents in the form of agents adjusting the pH in the oral cavity
include for instance: acceptable acids, such as adipinic acid, succinic acid, fumaric
acid, or salts thereof or salts of citric acid, tartaric acid, malic acid, acetic acid, lactic
acid, phosphoric acid and glutaric acid and acceptable bases, such as carbonates,
hydrogen carbonates, phosphates, sulfates or oxides of sodium, potassium,
ammonium, magnesium or calcium, especially magnesium and calcium.
Examples of active agents in the form of anti-smoking agents include for instance:
nicotine, tobacco powder or silver salts, for instance silver acetate, silver carbonate
and silver nitrate.

Further examples of active agents are medicines of any type.
Examples of active agents in the form of medicines include coffeine, salicylic acid,
salicyl amide and related substances (acetylsalicylic acid, choline salicylate,
magnesium salicylate, sodium salicylate), paracetamol, salts of pentazocine
(pentazocine hydrochloride and pentazocinelactate), buprenorphine hydrochloride,
codeine hydrochloride and codeine phosphate, morphine and morphine salts
(hydrochloride, sulfate, tartrate), methadone hydrochloride, ketobemidone and salts
of ketobemidone (hydrochloride), beta-blockers, (propranolol), calcium antagonists,
verapamil hydrochloride, nifedinpine as well as suitable substances and salts thereof
mentioned in Pharm. Int., Nov. 85, pages 267-271, Barney H. Hunter and Robert L.
Talbert, nitroglycerine, erythrityl tetranitrate, strychnine and salts thereof, lidocaine,
tetracaine hydrochloride, etorphine hydrochloride, atropine, insulin, enzymes (for
instance papain, trypsin, amyloglucosidase. glucoseoxidase, streptokinase,
streptodornase, dextranase, alpha amylase), polypeptides (oxytocin, gonadorelin,
(LH. RH), desmopressin acetate (DDAVP), isoxsuprine hydrochloride, ergotamine
compounds, chloroquine (phosphate, sulfate), isosorbide, demoxytocin, heparin.
Other active ingredients include beta-lupeol, Letigen, Sildenafil citrate and
derivatives thereof.
Dental products include Carbami, CPP Caseine Phospho Peptide; Chlorhexidine,
Chlorhexidine di acetate, Chlorhexidine Chloride, Chlorhexidine di gluconate,
Hexetedine, Strontium chloride, Potassium Chloride, Sodium bicarbonate, Sodium
carbonate, Fluor containing ingredients, Fluorides, Sodium fluoride, Aluminium
fluoride, Ammonium fluoride, Calcium fluoride, Stannous fluoride, Other fluor
containing ingredients Ammonium fluorosilicate, Potasium fluorosilicate, Sodium
fluorosilicate, Ammonium monofiuorphosphate, Calcium monofluorphosphate,
Potassium monofluorphosphate, Sodium monofluorphosphate, Octadecentyl
Ammonium fluoride, Stearyl Trihydroxyethyl Propylenediamine Dihydrofluoride,

Vitamins include A, B1, B2, B6, B12, Folin acid, niacin, Pantothensyre, biotine, C,
D, E, K.
Minerals include Calcium, phosphor, magnesium, iron, Zink, Cupper, lod, Mangan,
Crom, Selene, Molybden. Other active ingredients include:Q10@, enzymes. Natural
drugs including Ginkgo Biloba, ginger, and fish oil. The invention also relates to use
of migraine drugs such as Serotonin antagonists: Sumatriptan, Zolmitriptan,
Naratriptan, Rizatriptan, Eletriptan; nausea drugs such as Cyclizin, Cinnarizin,
Dimenhydramin, Difenhydrinat; hay fever drugs such as Cetrizin, Loratidin, pain
relief drugs such as Buprenorfin, Tramadol, oral disease drugs such as Miconazol,
Amphotericin B, Triamcinolonaceton; and the drugs Cisaprid, Domperidon,
Metoclopramid.
Preparation of chewing gum
In general, chewing gum may be manufactured by sequentially adding the various
chewing gum ingredients to a commercially available mixer known in the art. After
the initial ingredients have been thoroughly mixed, the gum mass is discharged from
the mixer and shaped into the desired form such as by rolling into sheets and cutting
into sticks, extruded into chunks or casting into pellets.
Generally, the ingredients may be mixed by first melting the gum base and adding it
to the running mixer. Colors, active agents and/or emulsifiers may also be added at
this time. A softener such as glycerin may also be added at this time, along with
syrup and a portion of the bulking agent/sweetener. Further portions of the bulking
agent/sweetener may then be added to the mixer. A flavoring agent is typically added
with the final portion of the bulking agent/sweetener. A high-intensity sweetener is
preferably added after the final portion of bulking agent and flavor have been added.
The entire mixing procedure typically takes from five to fifteen minutes, but longer
mixing times may sometimes be required. Those skilled in the art will recognize that

many variations of the above described procedure may be followed. Including the
one-step method described in US patent application 2004/0115305 hereby
incorporated as reference.
Structure of the chewing gum
According to the invention, the form and shape of the nicotine chewing gum may be
any suitable and user friendly structure. Accordingly, the gum centre or gum may be
e.g. in a form selected from a pellet, a cushion-shaped pellet, a stick, a tablet, a
chunk, a pastille, a pill, a ball and a sphere. Chewing gums are formed by extrusion,
compression, rolling and may be centre filled with liquids and/or solids in any form.
Coating
In accordance with the invention, the chewing gum element may comprise about 0.1
to about 75% by weight of an outer coating applied onto the chewing gum centre.
Thus, suitable coating types include hard coatings, film coatings and soft coatings of
any composition including those currently used in coating of chewing gum,
pharmaceutical products and confectioneries and any combination thereof.
One presently preferred outer coating type is a hard coating, which term is used in
the conventional meaning of that term including sugar coatings and sugar-free (or
sugarless) coatings and combinations thereof. The object of hard coating is to obtain
a sweet, crunchy layer, which is appreciated by the consumer and it may moreover
protect the gum centres for various reasons. In a typical process of providing the
chewing gum centres with a protective sugar coating, the gum centres are
successively treated in suitable coating equipment with aqueous solutions of
crystallisable sugar such as sucrose or dextrose, which, depending on the stage of
coating reached, may contain other functional ingredients, e.g. fillers, binding agents,
colours, etc. In the present context, the sugar coating may contain further functional

or active compounds including flavour compounds and/or pharmaceutically active
compounds.
In the production of chewing gum it may, however, be preferred to replace the
cariogenic sugar compounds in the coating by other, preferably crystallisable,
sweetening compounds that do not have a cariogenic effect. In the art such coating
are generally referred to as sugarless or sugar-free coatings. Presently preferred non-
cariogenic hard coating substances include polyols, e.g. sorbitol, maltitol, mannitol,
xylitol, erythritol, lactitol, isomalt and tagatose which are obtained by industrial
methods by hydrogenation of D-glucose, maltose, fructose or levulose, xylose,
erythrose, lactose, isomaltulose and D-galactose, respectively and trehalose, which is
a non-cariogene mono- di-saccharide.
In a typical hard coating process as it will be described in details in the following, a
suspension containing crystallisable sugar and/or polyol is applied onto the gum
centres and the water it contains is evaporated off by blowing with air. This cycle
must be repeated several times, typically 3 to 80 times, in order to reach the swelling
required. The term "swelling" refers to the increase in weight or thickness of the
products, as considered at the end of the coating operation by comparison with the
beginning, and in relation to the final weight or thickness of the coated products. In
accordance with the present invention, the coating layer constitutes about 0,1 to
about 75% by weight of the finished chewing gum element, such as about 10 to
about 60% by weight, including about 15 to about 50% by weight.
In further useful embodiments the outer coating of the chewing gum element of the
invention is an element that is subjected to a film coating process and which
therefore comprises one or more film-forming polymeric agents and optionally one
or more auxiliary compounds, e.g. plasticizers, pigments and opacifiers. A film
coating is a thin polymer-based coating applied to a chewing gum centre of any of
the above forms. The thickness of such a coating is usually between 20 and 100 µm.

Generally, the film coating is obtained by passing the chewing gum centres through a
spray zone with atomised droplets of the coating materials in a suitable aqueous or
organic solvent vehicle, after which the material adhering to the gum centres is dried
before the next portion of coating is received. This cycle is repeated until the coating
is complete.
In the present context, suitable film-coating polymers include edible cellulose
derivatives such as cellulose ethers including methylcellulose (MC), hydroxyethyl
cellulose (HEC), hydroxypropyl cellulose (HPC) and hydroxypropyl methylcellulose
(HPMC). Other useful film-coating agents are acrylic polymers and copolymers, e.g.
methylacrylate aminoester copolymer or mixtures of cellulose derivatives and acrylic
polymers. A particular group of film-coating polymers, also referred to as functional
polymers are polymers that, in addition to its film-forming characteristics, confer a
modified release performance with respect to active components of the chewing gum
formulation. Such release modifying polymers include methylacrylate ester
copolymers, ethylcellulose (EC) and enteric polymers designed to resist the acidic
stomach environment, yet dissolve readily in the duodenum. The latter group of
polymers include: cellulose acetate phtalate (CAP), polyvinyl acetate phtalate
(PVAP), shellac, metacrylic acid copolymers, cellulose acetate trimellitate (CAT)
and HPMC. It will be appreciated that the outer film coating according to the present
invention may comprise any combination of the above film-coating polymers.
In other embodiments, the film coating layer of the chewing gum elements according
to the invention comprises a plasticizing agent having the capacity to alter the
physical properties of a polymer to render it more useful in performing its function as
a film-forming material. In general, the effect of plasticizers will be to make the
polymer softer and more pliable as the plasticizer molecules interpose themselves
between the individual polymer strands thus breaking down polymer-polymer
interactions. Most plasticizers used in film coating are either amorphous or have very
little crystallinity. In the present context, suitable plasticizers include polyols such as

glycerol, propylene glycol, polyethylene glycol, e.g. the 200-6000 grades hereof,
organic esters such as phtalate esters, dibutyl sebacate, citrate esters and thiacetin,
oils/glycerides including castor oil, acetylated monoglycerides and fractionated
coconut oil.
The choice of film-forming polymer(s) and plasticizing agent(s) for the outer coating
of the present chewing gum element is made with due consideration for achieving the
best possible barrier properties of the coating in respect of dissolution and diffusion
across the film of moisture and gasses.
The film coating of the chewing gum elements may also contain one or more colou-
rants or opacifiers. In addition to providing a desired colour hue, such agents may re-
flect light or form a barrier against moisture and gasses. Suitable colourants/pacifiers
include organic dyes and their lakes, inorganic colouring agents, e.g. titanium oxide
and natural colours such as e.g. P-carotene or chlorophyll.
Additionally, film coatings may contain one or several auxiliary substances such as
flavours and waxes or saccharide compounds such as polydextrose, dextrins
including maltodextrin, lactose, modified starch, a protein such as gelatine or zein, a
vegetable gum and any combination thereof.
In one specific embodiment the chewing gum centre is in the form of a stick which is
provided on at least one side with an edible film comprising layer of a coating of a
film forming agent, e.g. a cellulose derivative, a modified starch, shallac, gum arabic,
a dextrin, gelatine, zein, a vegetable gum, a synthetic polymer and any combination
thereof, and a wax such as beeswax, carnauba wax, microcrystalline wax, paraffin
wax and combinations thereof.
The following examples are given for illustration, but not limitation of the invention.


Example 1
Preparation of gum base.
Gum bases are prepared, which comprises the following ingredients:
Elastomers
Elastomer plasticizers
"Waxes
Softeners

Fillers
Antioxidants
The detailed formulations are given in table 1. It should be emphasized that several
other gum base compositions may be applied within the scope of the invention.
The elastomers and fillers are added to the mixing kettle provided with mixing means
like e.g. horizontally placed Z-shaped arms. The kettle had been preheated for 15
minutes to a temperature of about 120 deg. C. The rubber is broken into small pieces
and softened with mechanical action in the kettle.
The elastomer plasticizer is slowly added to the elastomer until the mixture becomes
homogeneous. The remaining elastomer plasticizer is then added to the kettle and
mixed for 10-20 minutes. The softening ingredients are added and mixed for 20-40
minutes until the whole mixture becomes homogeneous.
The mixture is then discharged into a pan and allowed to cool to room temperature
from the discharge temperature of 120 deg. C.
Example 2
Chewing gum is prepared by use of the gum base in example 1 formulated according
to table 1. A conventional mechanical mixing procedure is used with the use of only
moderate heating.
Gum base and filler is mixed in a mixing kettle provided with mixing means like e.g.
horizontally placed Z-shaped arms. The kettle had been preheated to a temperature of
up to approximately 50 deg. C.
When the content is homogeneous the other ingredients are added according to a
specified time schedule. Nicotine is added in the first half of the mixing process.

The pieces may be formulated with 0.1-8 mg of nicotine per piece preferably 2-4
mg. The pieces evaluated comprise 2 mg nicotine per piece.
The chewing gum was coated by means of hard coating. The coating may e.g. be
applied according to the methods disclosed in the US patent 6,627,234, hereby
included by reference.
Example 3'
Chewing gum is prepared by use of the gum base in example 1 formulated according
to table 1. A conventional mechanical mixing procedure is used with the use of only
moderate heating.
Gum base and filler is mixed in a mixing kettle provided with mixing means like e.g.
horizontally placed Z-shaped arms. The kettle had been preheated to a temperature of
up to approximately 50 deg. C.
When the content is homogeneous the other ingredients are added according to a
specified time schedule. Nicotine is added in the first half of the mixing process.
The pieces may be formulated with 0.1-8 mg of nicotine per piece preferably 2-4
mg. The pieces evaluated comprise 2 mg nicotine per piece.
The chewing gum was coated by means of hard coating. The coating may e.g. be
applied according to the methods disclosed in the US patent 6,627,234, hereby
included by reference.

Chewing gum is prepared by use of the gum base in example 1 formulated according
to table 1. A conventional mechanical mixing procedure is used with the use of only
moderate heating.
Gum base and filler are mixed in a mixing kettle provided with mixing means like
e.g. horizontally placed Z-shaped arms. The kettle had been preheated to a
temperature of up to approximately 50 deg. C.
When the content is homogeneous the other ingredients are added according to a
specified time schdule. Nicotine is added in the first half of the mixing process.
The pieces may be formulated with 0.1-8 mg of nicotine per piece preferably 2-4
mg. The pieces evaluated comprise 2 mg nicotine per piece.
The chewing gum was coated by means of hard coating. The coating may e.g. be
applied according to the methods disclosed in the US patent 6,627,234, hereby
included by reference.
Example 5
The release of the active agent in Example 2-4 and two commercial products are
determined in vitro. The test in vitro is carried out on a chewing machine (European
Pharmacopeia 4 th. ed. 2.9.25 Chewing gum medicated, drug release from) by
chewing one piece of chewing gum at specified time intervals 0,1,2, 3,5,7.5,10,20
and 30 minutes in a phosphate buffer with a pH of 7.4.
The results are illustrated and explained below
Fig. 1 illustrates a release profile of two prior art nicotine chewing gums as a
function of time.

It is noted that the very initial and the intermediate release, is relatively low over the
period corresponding to a typical smoking time i.e. 5-8 minutes. The release rate
from 0-1 minutes is even lower than the remaining intermediate release.
The two prior art nicotine chewing gums PA1 and PA2 are both intended for use by
means of a chew process over approximately thirty minutes. In other words, the
intended build-up of nicotine in the blood of the user is a process running over quite
a long while.
It is noted that both nicotine chewing gums appear to be releasing relatively linear.
Fig. 2 illustrates the release of fig. 1 in specific intervals of the above-mentioned
chewing gums PA1 and PA2 over the initial chewing period of 0 to 5 minutes in
intervals of 30 seconds. In other words a sort of differential illustration of the release
focusing on the release in the individual sub-periods of the illustrated release time.
As illustrated, the evaluated sub-periods are 0-½ minute, ½-1 minute, 1 minute -1½
minute, 1½ minute -2 minute, 2minute - 2½minute, 2½minute - 3minute, 3 minute -
3½ minute, 3½ -4 minutes, 4-4½ minutes and 4½ - 5 minutes.
It is noted that the very initial release and intermediate release, is increasing
relatively slow over a relatively long period compared to a typical smoking time in
spite of the fact that the release showed in fig. 1 appeared to be relatively constant.
Fig. 3 illustrates the initial and intermediate release of three chewing gums Il, 12 and
I3 applicable according to the invention. The release, or transfer from the chewing
gum to the exterior of the chewing gum, is illustrated in the same way as the prior art
chewing gums of fig. 2.
The illustrated chewing gums benefit of an initial advantageous release over the
complete critical period of the first five to eight minutes of smoking. It is thus noted

that the release is never below 2% per sub period, i.e. 30 seconds. In other words,
when the chewing gum is applied according to the invention, a constant amount of
nicotine may be available for transfer into the blood via the mucosa membrane.
It is also noted that the chewing I3 features a very significant release in the first few
minutes of the chewing process, thereby facilitating a fast relief due to the fact that a
high osmotic pressure on the mucosa membrane may be maintained from the very
beginning.
It is further noted that the chewing gum I1 and 12 features a very constant release
over the first 5 minutes of chewing. This may be regarded very advantageous when
complying with e.g. the taste problem related to nicotine in the mouth.
Fig. 3 illustrates the resulting release obtained when a nicotine chewing gum is
chewed in a chewing machine.
According to the invention, a nicotine chewing gum having the properties as
illustrated in fig. 3 may be applied according to the following process steps.
A nicotine chewing gum, e.g. I1, I2 or I3 is provided to a user having a human body.
The human user may then chew the chosen nicotine chewing gum and a fast relief
with respect to craving may be obtained by the transfer of nicotine from the nicotine
chewing gum to the blood of the user via the mucosa membrane.
As the applied nicotine chewing gum features a transfer of nicotine from the chewing
gum above a chosen threshold transfer rate in the period of about ½ minute to about
2½ minutes from initiation of said chewing process a constant osmotic pressure may
be maintained on the mucosa membrane during a relatively long intermediate period
of the chewing process. In this way, a fast relief has been according to an
embodiment of the invention.

It is noted that none of the chewing gums applied according to the invention features
a transfers of nicotine from the chewing gum below 2mg of nicotine per 30 second. It
is also noted that e.g. 12 features a maintained dose of never below 4mg per 30
second.
Fig. 4 illustrates the initial and intermediate release from the above discussed
chewing gums PA1, PA2, I1, 12 and 13 over the initial approximately 8 minutes of
the chewing process. It is noted that the quickest releaser tends to flatten out after
about 4- 5 minutes of chewing.

We claim:
1. Chewing gum for release of tobacco alkaloid, such as herein described,
wherein said chewing gum comprises a polymer system in an amount of from 2 to
99% by weight, flavour in an amount of 0,001 to 30% by weight and sweeteners in
an amount of 2% to 80% by weight,
wherein said polymer system comprises elastomers in an amount of 0.1 to 10 % by
weight of the chewing gum,
wherein said polymer system comprises elastomer plasticizers in an amount of 2 to
30 % by weight of the chewing gum, and
wherein at least 2% of the tobacco alkaloid comprised in said chewing gum prior to
chewing will be released within every 30 seconds in the period from ½ minutes to
2½ minutes from initiation of a chewing process in vitro on a chewing machine with
a phosphate buffer with a pH of 7.4.
2. Chewing gum as claimed in claim 1, wherein said tobacco alkaloid comprises
nicotine.
3. Chewing gum as claimed in claim 1 or 2, wherein said chewing gum is a
compressed chewing gum.
4. Chewing gum as claimed in any of the claims 1-3, wherein at least 2.5% of the
tobacco alkaloid comprised in said chewing gum prior to chewing will be released
within every 30 seconds in the period from ½ minutes to 2½ minutes from initiation
of said chewing process.
5. Chewing gum as claimed in any of the claims 1-4, wherein at least 3%, preferably
at least 4 % of the tobacco alkaloid comprised in said chewing gum prior to chewing
will be released within every 30 seconds in the period from ½ minute to 2½ minutes
from initiation of said chewing process.
6. Chewing gum as claimed in any of the claims 1-5, wherein at least 5%, preferably
at least 6% of the tobacco alkaloid comprised in said chewing gum prior to chewing

will be released within every 30 seconds in the period from ½ minute to 2½ minutes
from initiation of said chewing process.
7. Chewing gum as claimed in any of the claims 1-6, wherein at least 2%, preferably
at least 3% of the tobacco alkaloid comprised in said chewing gum prior to chewing
will be released within every 30 seconds in the period of 2½ minutes to 5 minutes
from initiation of said chewing process.
8. Chewing gum as claimed in any of the claims 1-7, wherein at least 3%, preferably
at least 3.5% of the tobacco alkaloid comprised in said chewing gum prior to
chewing will be released within every 30 seconds in the period of 2½ minutes to 5
minutes from initiation of said chewing process.
9. Chewing gum as claimed in any of the claims 1-8, wherein at least 4%, preferably
at least 5% of the tobacco alkaloid comprised in said chewing gum prior to chewing
will be released within every 30 seconds in the period of 5 minutes to 10 minutes
from initiation of said chewing process.

10. Chewing gum as claimed in any of the claims 1-9, wherein at least 2 to 10 %,
preferably at least 5% of the tobacco alkaloid comprised in said chewing gum prior
to chewing will be released within the period of 0 seconds to 30 seconds from
initiation of said chewing process.
11. Chewing gum as claimed in any of the claims 1-10, wherein less than 14 %,
preferably less than 12% of the tobacco alkaloid comprised in said chewing gum
prior to chewing will be released within the period of 0 seconds to 2½ minutes from
initiation of said chewing process.
12. Chewing gum as claimed in any of the claims 1-11, wherein at most 18 %,
preferably at most 15% of the tobacco alkaloid comprised in said chewing gum prior
to chewing will be released within the period of 10 to 30 minutes from initiation of
said chewing process.

13. Chewing gum as claimed in any of the claims 1-12, wherein at least 0.03 mg,
preferably at least 0.04 mg of the tobacco alkaloid comprised in said chewing gum
prior to chewing will be released within every 30 seconds in the period from ½
minute to 2½ minutes from initiation of said chewing process.
14. Chewing gum as claimed in any of the claims 1-13, wherein at least 0.05 mg,
preferably at least 0.06 mg of the tobacco alkaloid comprised in said chewing gum
prior to chewing will be released within every 30 seconds in the period from ½
minute to 2½ minutes from initiation of said chewing process.
15. Chewing gum as claimed in any of the claims 1-14, wherein at least 0.08 mg,
preferably at least 0.1 mg of the tobacco alkaloid comprised in said chewing gum
prior to chewing will be released within every 30 seconds in the period from ½
minute to 2½ minutes from initiation of said chewing process.
16. Chewing gum as claimed in any of the claims 1-15, wherein at least 0.03 mg,
preferably at least 0.04 mg of the tobacco alkaloid comprised in said chewing gum
prior to chewing will be released within every 30 seconds in the period of 2/4 to 5
minutes from initiation of said chewing process.
17. Chewing gum as claimed in any of the claims 1-16, wherein at least 0.05 mg,
preferably at least 0.06 mg of the tobacco alkaloid comprised in said chewing gum
prior to chewing will be released within every 30 seconds in the period of 2½
minutes to 5 minutes from initiation of said chewing process.
18. Chewing gum as claimed in any of the claims 1-17, wherein at least 0.08 mg,
preferably at least 0.1 mg of the tobacco alkaloid comprised in said chewing gum
prior to chewing will be released within every 30 seconds in the period of 2½
minutes to 5 minutes from initiation of said chewing process.
19. Chewing gum as claimed in any of the claims 1-18, wherein at least 0.5 mg of
tobacco alkaloid is released within the initial 10 minutes of the chewing process or
preferably within the initial 5 to 8 minutes of the chewing process.

20. Chewing gum as claimed in any of the claims 1-19, wherein different parts of the
chewing gum is targeted tobacco alkaloid transfer at different times or in different
periods of the chewing process.
21. Chewing gum as claimed in any of the claims 1-20, wherein said chewing gum
comprising a coating and wherein said coating comprises tobacco alkaloid.
22. Chewing gum as claimed in any of the claims 1-21, wherein said chewing gum
comprises substantially hydrophilic polymers.

23. Chewing gum as claimed in any of the claims 1-22, wherein said tobacco
alkaloid is comprised in a ion exchange resin.
24. Chewing gum as claimed in any of the claims 1-23, wherein said tobacco
alkaloid comprises salts of nicotine.
25. Chewing gum as claimed in any of the claims 1-24, wherein said tobacco
alkaloid comprises nicotine in its free from.

26. Chewing gum as claimed in any of the claims 1-25, wherein the tobacco alkaloid
is buffered.
27. Chewing gum as claimed in any of the claims 1-26, wherein the chewing process
is less than 30 minutes, preferably less than 20 minutes.
28. Chewing gum as claimed in any of the claims 1-27, wherein said chewing gum
comprises fillers in an amount of from 0 to 60% by weight, flavour in an amount of
0,001 to 30% by weight and sweeteners in an amount of 2 to 80% by weight.
29. Chewing gum as claimed in any of the claims 1-28, wherein said chewing gum
comprises high intensity sweeteners in an amount of from 0.001 to 3% by weight and
flavour in an amount of 0,001 to 30% by weight.

30. Chewing gum as claimed in any of the claims 1-29, wherein said polymer system
comprises elastomers in an amount of as claimed in 2 to 10 % by weight of the
chewing gum.
31. Chewing gum as claimed in any of the claims 1-30, wherein said polymer system
comprises elastomer plasticizers in an amount of 5 to 30 % by weight of the chewing
gum.
32. Chewing gum as claimed in any of the claims 1-31, wherein said polymer system
comprises wax in an amount of 0 to 30% by weight of the chewing gum, preferably
in an amount of 0 to 15% by weight of the chewing gum.
33. Chewing gum as claimed in any of the claims 1-32, wherein said polymer system
comprises softeners in an amount of 2 to 30% by weight of the chewing gum,
preferably in an amount of 5 to 20% by weight of the chewing gum.
34. Chewing gum as claimed in any of the claims 1-33, wherein said polymer system
comprises fillers in an amount of 0 to 50% by weight of the chewing gum, preferably
in an amount of 0 to 30% by weight of the chewing gum.
35. Chewing gum as claimed in any of the claims 1-34, wherein said polymer system
comprises antioxidants in an amount of 0 to 5% by weight of the chewing gum,
preferably in an amount of 0 to 2% by weight of the chewing gum.


ABSTRACT

CHEWING GUM FOR RELEASE OF TOBACCO ALKALOID
The invention discloses a chewing gum for release of tobacco alkaloid such as herein
described,wherein said chewing gum comprises a polymer system in an amount of
from 2 to 99% by weight, flavour in an amount of 0,001 to 30% by weight and
sweeteners in an amount of 2% to 80% by weight, wherein said polymer system
comprises elastomers in an amount of 0.1 to 10 % by weight of the chewing gum,
wherein said polymer system comprises elastomer plasticizers in an amount of 2 to
30 % by weight of the chewing gum, and wherein at least 2% of the tobacco alkaloid
comprised in said chewing gum prior to chewing will be released within every 30
seconds in the period from ½ minutes to 2½ minutes from initiation of a chewing
process in vitro on a chewing machine with a phosphate buffer with a pH of 7.4.

Documents:

02281-kolnp-2007-abstract.pdf

02281-kolnp-2007-assignment.pdf

02281-kolnp-2007-claims.pdf

02281-kolnp-2007-correspondence others 1.2.pdf

02281-kolnp-2007-correspondence others-1.3.pdf

02281-kolnp-2007-correspondence others.pdf

02281-kolnp-2007-description complete.pdf

02281-kolnp-2007-drawings.pdf

02281-kolnp-2007-form 1.pdf

02281-kolnp-2007-form 3-1.1.pdf

02281-kolnp-2007-form 3.pdf

02281-kolnp-2007-form 5.pdf

02281-kolnp-2007-international publication.pdf

02281-kolnp-2007-international search report.pdf

02281-kolnp-2007-pct request form.pdf

2281-KOLNP-2007-(07-03-2012)-CORRESPONDENCE.pdf

2281-KOLNP-2007-(07-03-2012)-FORM-3.pdf

2281-KOLNP-2007-(07-03-2012)-OTHERS.pdf

2281-KOLNP-2007-(07-03-2012)-PETITION UNDER RULE 137.pdf

2281-KOLNP-2007-(11-10-2011)-ABSTRACT.pdf

2281-KOLNP-2007-(11-10-2011)-AMANDED CLAIMS.pdf

2281-KOLNP-2007-(11-10-2011)-DESCRIPTION (COMPLETE).pdf

2281-KOLNP-2007-(11-10-2011)-DRAWINGS.pdf

2281-KOLNP-2007-(11-10-2011)-EXAMINATION REPORT REPLY RECIEVED.pdf

2281-KOLNP-2007-(11-10-2011)-FORM 1.pdf

2281-KOLNP-2007-(11-10-2011)-FORM 13.pdf

2281-KOLNP-2007-(11-10-2011)-FORM 2.pdf

2281-KOLNP-2007-(11-10-2011)-OTHERS.pdf

2281-KOLNP-2007-(11-10-2011)-PETION UNDER RULE 137.pdf

2281-KOLNP-2007-ASSIGNMENT.pdf

2281-KOLNP-2007-CORRESPONDENCE-1.4.pdf

2281-KOLNP-2007-CORRESPONDENCE.pdf

2281-KOLNP-2007-EXAMINATION REPORT.pdf

2281-KOLNP-2007-FORM 13.pdf

2281-kolnp-2007-form 18.pdf

2281-KOLNP-2007-FORM 3.pdf

2281-KOLNP-2007-FORM 5.pdf

2281-KOLNP-2007-FORM-13.pdf

2281-KOLNP-2007-GRANTED-ABSTRACT.pdf

2281-KOLNP-2007-GRANTED-CLAIMS.pdf

2281-KOLNP-2007-GRANTED-DESCRIPTION (COMPLETE).pdf

2281-KOLNP-2007-GRANTED-DRAWINGS.pdf

2281-KOLNP-2007-GRANTED-FORM 1.pdf

2281-KOLNP-2007-GRANTED-FORM 2.pdf

2281-KOLNP-2007-GRANTED-SPECIFICATION.pdf

2281-KOLNP-2007-OTHERS.pdf

2281-KOLNP-2007-PA.pdf

2281-KOLNP-2007-REPLY TO EXAMINATION REPORT.pdf


Patent Number 255433
Indian Patent Application Number 2281/KOLNP/2007
PG Journal Number 08/2013
Publication Date 22-Feb-2013
Grant Date 21-Feb-2013
Date of Filing 20-Jun-2007
Name of Patentee FERTIN PHARMA A/S
Applicant Address DANDYVEJ 19, DK-7100, VEJLE
Inventors:
# Inventor's Name Inventor's Address
1 ANDERSEN, CARSTEN PEDERSHOLMS ALLE 61, DK-7100, VEJLE
PCT International Classification Number A61K 9/68,A61P 25/34
PCT International Application Number PCT/DK2004/000833
PCT International Filing date 2004-11-30
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA