U.S. patent application number 11/525638 was filed with the patent office on 2007-06-28 for oral composition and method for stress reduction associated with smoking cessation.
Invention is credited to Kevin B. Broderick, David J. Cai, Michael J. Greenberg.
Application Number | 20070144544 11/525638 |
Document ID | / |
Family ID | 37865648 |
Filed Date | 2007-06-28 |
United States Patent
Application |
20070144544 |
Kind Code |
A1 |
Cai; David J. ; et
al. |
June 28, 2007 |
Oral composition and method for stress reduction associated with
smoking cessation
Abstract
A confectionary composition is used in a method of reducing
stress and the urge to smoke in abstaining tobacco users. The
confectionary composition includes at least one of a sugar or a
sugar alcohol and an effective amount of stress-reducing flavoring
agent. Where the confectionary composition is a chewing gum, the
composition includes a water soluble bulk portion and a water
insoluble base portion. The stress-reducing flavoring agent can be
one or more of peppermint flavor, vanilla flavor, or peach flavor.
The stress-reducing flavoring agent reduces an abstaining tobacco
user's urge to smoke and can reduce the level of salivary Cortisol
in the abstaining tobacco user. The method reduces stress in
tobacco users who must temporarily abstain from tobacco use and can
reduce consumption of tobacco by tobacco users by increasing the
interval between consumption events.
Inventors: |
Cai; David J.; (Elmhurst,
IL) ; Greenberg; Michael J.; (Northbrook, IL)
; Broderick; Kevin B.; (Berwyn, IL) |
Correspondence
Address: |
BRINKS HOFER GILSON & LIONE
P.O. BOX 10395
CHICAGO
IL
60610
US
|
Family ID: |
37865648 |
Appl. No.: |
11/525638 |
Filed: |
September 22, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60722307 |
Sep 30, 2005 |
|
|
|
Current U.S.
Class: |
131/271 ;
131/273 |
Current CPC
Class: |
A61P 25/30 20180101;
A23G 4/068 20130101; A23G 4/06 20130101; A23G 3/36 20130101; A24F
47/00 20130101 |
Class at
Publication: |
131/271 ;
131/273 |
International
Class: |
A24F 47/00 20060101
A24F047/00 |
Claims
1. A confectionary composition, formulated to reduce stress and the
urge to smoke in abstaining tobacco users, the composition
comprising: (a) at least one of a sugar or a sugar alcohol; and (b)
an effective amount of a stress-reducing flavoring agent sufficient
to substantially reduce the urge to consume tobacco products.
2. The composition of claim 1 wherein the stress-reducing flavoring
agent comprises peppermint flavor.
3. The composition of claim 1 wherein the stress-reducing flavoring
agent comprises vanilla flavor.
4. The composition of claim 1 wherein the stress-reducing flavoring
agent comprises a combination of peppermint flavor and vanilla
flavor.
5. The composition of claim 1 wherein the stress-reducing flavoring
agent comprises peach flavor.
6. The composition of claim 1 wherein the composition comprises a
chewing gum.
7. The composition of claim 1 wherein the composition comprises a
hard candy.
8. The composition of claim 1 wherein the composition comprises a
soft candy.
9. The composition of claim 1 wherein the composition further
comprises an artificial sweetener.
10. The composition of claim 1 wherein the stress-reducing
flavoring agent reduces the level of salivary Cortisol in the
abstaining tobacco users.
11. A chewing gum composition formulated to reduce stress and the
urge to smoke in abstaining tobacco users, the composition
comprising: (a) a water soluble bulk portion; (b) a water insoluble
base portion; and (c) an effective amount of at least one
stress-reducing flavoring agent sufficient to substantially reduce
the urge to smoke.
12. The chewing gum composition of claim 11 wherein the water
soluble bulk portion comprises one or more sweeteners, high
intensity sweeteners, flavoring agents, softeners, emulsifiers,
colors, acidulants, fillers, and antioxidants.
13. The chewing gum composition of claim 11 wherein the water
insoluble base portion comprises one or more of elastomers, resins,
fats and oils, softeners, and inorganic fillers.
14. The chewing gum of claim 11 wherein the stress-reducing
flavoring agent comprises peppermint flavor.
15. The chewing gum of claim 14 wherein the peppermint flavor
comprises spray dried peppermint flavor.
16. The chewing gum of claim 11 wherein the stress-reducing
flavoring agent comprises vanilla flavor.
17. The chewing gum of claim 11 wherein the stress-reducing
flavoring agent comprises a combination of peppermint flavor and
vanilla flavor.
18. The chewing gum of claim 11 wherein the stress-reducing
flavoring agent comprises peach flavor.
19. The chewing gum of claim 11 wherein the water soluble bulk
portion comprises a water soluble polyhydric alcohol and artificial
sweeteners.
20. A coated chewing gum product comprising the composition of
claim 11.
21. A method of reducing the urge to smoke in abstaining tobacco
users comprising orally administering a confectionary composition
having an amount of stress-reducing flavoring agent effective to
substantially reduce the urge to smoke during periods of smoking
abstinence.
22. The method of claim 21 wherein the oral administration of the
confectionary composition reduces psychological anxiety during
periods of smoking abstinence.
23. The method of claim 21 wherein the oral administration of the
confectionary composition increases the time period between tobacco
use sessions in a habitual tobacco user.
24. A method of reducing stress in tobacco users who must
temporarily abstain from tobacco use comprising orally
administering a confectionary composition having an amount of
stress-reducing flavoring agent effective to substantially reduce
the urge to smoke during periods of smoking abstinence.
25. A method of reducing consumption of tobacco by a tobacco user
by increasing the interval between consumption events comprising
orally administering a confectionary composition having an amount
of stress-reducing flavoring agent effective to substantially
reduce the urge to smoke during periods of smoking abstinence.
Description
RELATED APPLICATION DATA
[0001] This application claims priority to U.S. Provisional Patent
Application having Ser. No. 60/722,307, filed Sep. 30, 2005.
TECHNICAL FIELD
[0002] The invention relates generally to aids for treating tobacco
or nicotine habits and, more particularly, to oral compositions,
such as chewing gum and confectionary compounds, formulated to
relieve psychological and physiological stress associated with
smoking cessation.
BACKGROUND
[0003] There are about 1.1 billion tobacco smokers worldwide. In
the U.S., about 30% of the population smokes cigarettes, of these,
about 36-40% are 18-25 years old. Direct and passive exposure to
smoking, and particularly cigarette smoking, is recognized as a
substantial health factor, and a major risk factor in a variety of
diseases, including coronary artery disease and a wide range of
cancers. It is also recognized that nicotine, a constituent of
tobacco, is highly addictive, making decreasing or ceasing to smoke
tobacco-related products very difficult for a significant
percentage of tobacco users. As governments worldwide increase
restrictions on tobacco use in public, there is a need for methods
to assist smokers, and especially young adults, with the stress of
smoking cessation. Many products now in use to reduce the urge to
smoke may also directly or indirectly lower stress levels
associated with smoking cessation.
[0004] At present there are several consumer products that attempt
to help people overcome their addiction to nicotine found in all
tobacco related products. One type of product includes a
transdermal patch, which allows the person's body to slowly absorb
a prescribed amount of nicotine over a given period. Little by
little the dosage of nicotine in the patches is decreased until the
person is no longer addicted. Once the physical addiction to
nicotine is overcome, the person can more easily fight the
psychological stress associated with smoking cessation.
[0005] Another type of product is sold in the form of a chewing gum
containing nicotine. Thus, whenever a smoker has the urge to smoke,
the smoker will chew the gum instead. However, the smoker still has
to restrict the use of the gum in a manner that will eventually
overcome the addiction.
[0006] There are substantial limitations and drawbacks to the
various methods of nicotine-replacement therapy in current use.
Orally ingested materials containing nicotine have a bad taste, may
lead to mouth ulcers, heartburn and other adverse consequences, and
are highly dependent of the user following a specific regime. Other
forms of oral administration can result in nausea, unpredictable
nicotine blood levels and the like. Patches, including transdermal
patches, and other topical applications of nicotine can cause skin
irritation, and patches containing nicotine are known to cause
pruritus.
[0007] Devices and methods involving nicotine therapy all
necessarily depend on the use of nicotine, the substance causing
addiction, to control nicotine craving or desire. This approach is
thus susceptible to abuse, and users are known to become addicted
to the use of gum, patches or the like, and not to decrease
nicotine intake as instructed. In addition, users are known to
concurrently use both tobaccos, as in cigarettes, and nicotine
therapy aids, such as gum or patches, thereby increasing the total
intake of nicotine. Further, in such instances acute adverse
medical consequences may result, including increased heart rate,
increased blood pressure and other conditions associated with
nicotine administration. Accordingly, the use of nicotine therapy
may actually increase the stress associated with smoking
cessation.
[0008] There are certain herbal preparations that are known to have
been used as smoking materials, including use in non-tobacco
cigarettes. For example, nicotine-free herbal compositions, have
been used either as a substitute for or in combination with
tobacco. This smoking composition may include Laurus nobilis and
Nelumbo garetin. Also, herbs such as Plantago major, Piper
methysticum, and Hypericum perforatum have been used in herbal
preparations for aid in cessation of tobacco.
[0009] Several non-nicotine chewing gum and confectionary smoking
cessation aids have been developed. For example, citrus leaf
powder, oat extract, and tea extracts have been used in an
anti-smoking chewing gum. Other non-nicotine confections have been
formulated containing sugar substitutes. For example, sugar
alcohols, maltitol and lactitol, and menthol or mint flavor have
been used in smoking control confections.
BRIEF SUMMARY
[0010] In one aspect of the invention, a confectionary composition
is formulated to reduce stress and the urge to smoke in abstaining
tobacco users. The composition includes at least one of a sugar or
a sugar alcohol and an effective amount of a stress-reducing
flavoring agent sufficient to substantially reduce the urge to
consume tobacco products.
[0011] In another aspect of the invention, a chewing gum
composition is formulated to reduce stress and the urge to smoke in
abstaining tobacco users. The composition includes a water soluble
bulk portion, a water insoluble base portion, and at least one
stress-reducing flavoring agent sufficient to substantially reduce
the urge to smoke.
[0012] In yet another aspect of the invention, a method of reducing
the urge to smoke in abstaining tobacco users includes orally
administering a confectionary composition having an amount of
stress-reducing flavoring agent effective to substantially reduce
the urge to smoke during periods of smoking abstinence.
[0013] In a further aspect of the invention, a method of reducing
stress in tobacco users who must temporarily abstain from tobacco
use includes orally administering a confectionary composition
having an amount of stress-reducing flavoring agent effective to
substantially reduce the urge to smoke during periods of smoking
abstinence.
[0014] In a still further aspect of the invention, a method of
reducing consumption of tobacco by a tobacco user by increasing the
interval between consumption events comprising orally administering
a confectionary composition having an amount of stress-reducing
flavoring agent effective to substantially reduce the urge to smoke
during periods of smoking abstinence.
[0015] The stress-reducing flavoring agent can be one or more of
peppermint flavor, vanilla flavor, or fruit flavors, such as peach
flavor.
DETAILED DESCRIPTION
[0016] The present invention will now be further described. In the
following passages, different aspects of the invention are defined
in more detail. Each aspect so defined may be combined with any
other aspect or aspects unless clearly indicated to the contrary.
In particular, any feature indicated as being preferred or
advantageous may be combined with any other feature or features
indicated as being preferred or advantageous.
[0017] Confectionary compositions can be used as vehicles for
delivering components to the oral cavity which provide benefits
such as breath freshening and antibactericidal properties. Such
systems have the advantage of providing a consumer with a
convenient and inexpensive method for maintaining oral health and
fresh breath throughout the course of the day. Chewing gums and
confections such as hard and soft candies also provide the user
with certain psychological benefits. The action of chewing a gum or
sucking on a candy can provide a form of relaxation and provide
relief of stress and tension in the body.
[0018] The cessation of smoking or other forms of tobacco use in
tobacco users is usually accompanied by increased stress levels.
The human stress hormone Cortisol is secreted in response to
stressful or threatening situations, such as during periods when a
person has the urge to smoke, but cannot because of either
environmental restrictions or attempting to break the smoking
habit. Saliva Cortisol is released in the oral cavity during times
of mental stress or increased body tension. (J. Smyth, et al.
"Stressors And Mood Measured On A Momentary Basis Are Associated
With Salivary Cortisol Secretion" Psychoneuroendocrinology 1998;
23:353-370).
[0019] In accordance with an embodiment of the invention, an oral
delivery vehicle, preferably a confectionary product such as a
chewing gum or the like, containing an effective amount of a
stress-reducing flavoring agent, is masticated by an abstaining
tobacco user. Suitable confectionary products include tablets,
lozenges, hard and soft candies, pressed mints, and the like. The
term "masticated" as used herein includes operations by which a
chewing gum or candy is partially or wholly consumed while it is
being held in the mouth, such as by chewing, sucking, or
dissolving. Holding the product in the mouth for longer periods of
time is expected to be associated with greater levels of stress
reduction in an abstaining tobacco user.
[0020] The present invention provides a confectionary that reduces
the anxiety in tobacco users when they cannot smoke. For example,
during travel on commercial airlines, while at meetings, while in
non-smoking restaurants, and the like. These are situations in
which tobacco users must temporarily abstain from tobacco use.
Accordingly, the present invention contemplates a method in which a
confection containing a stress-reducing flavoring agent is used to
relieve stress in tobacco users who must temporarily abstain from
tobacco use.
[0021] The present invention also provides a confectionary that,
when used, effectively increases the time period between tobacco
use episodes by reducing the urge to smoke or otherwise use or
consume tobacco products. By relieving the stress associated with
abstaining from tobacco use, the overall consumption of tobacco
products can be reduced in individuals desiring to permanently
abstain from tobacco use. In this aspect, the invention provides a
method of assisting tobacco users in overcoming a tobacco use
habit.
[0022] The present invention incorporates flavoring agents in a
confectionary composition that have been discovered to reduce
stress generally, and stress related to tobacco abstinence as well
as the urge to smoke. In accordance with one embodiment of the
invention, an oral composition includes an effective amount of a
flavoring agent such as peppermint or vanilla or both. In other
embodiments, an oral composition includes an effective amount of a
fruit flavoring agent, such as peach. These flavoring agents have
been found effective in reducing the urge to smoke in both men and
women over an extended period after smoking cessation. In
particular, chewing gums containing peppermint or vanilla flavors
were found to reduce saliva Cortisol levels in test subjects in a
three-day trial following cessation of cigarette smoking.
[0023] Studies conducted to determine the effects of peppermint and
vanilla flavored chewing gums have shown an alleviation of
withdrawal symptoms and a reduction in the urge to smoke in
cigarette smokers. In a double-blind, randomized cross-over study,
the withdrawal symptoms, urge to smoke, and salivary Cortisol
levers were measured in 10 subjects over a three-day trial
following cessation of smoking. In the study, the salivary corisol
levels in 5 women and 5 men were measured at several intervals on
the third day of the abstinence test period. Both the urge to smoke
and the overall withdrawal symptoms were measured on the third day
of the abstinence.
[0024] In the study, the subjects had their last cigarette before
going to bed on Sunday. They did not smoke on Monday, the first day
of abstinence, but answered questions relating to symptoms and urge
to smoke at about 10 am. This was designated as zero hour. The "48
hour" tests were run at about 10:00 am on Wednesday, the third day
of abstinence. Saliva samples were taken throughout Wednesday.
Thus, by the time the last saliva sample was taken on Wednesday
night, the subjects had gone 72 hours since their last cigarette.
Abstinence was enforced by testing for carbon monoxide in the
breath--a clear indicator of cigarette smoking.
[0025] Table 1 below shows scale values relating to the urge to
smoke for the overall study as a group, and for the women and the
men within the group. TABLE-US-00001 TABLE 1 Urge To Smoke At A 48
Hour Interval After Cessation Of Smoking (self-reported scale
values) Total Women Men Peppermint Gum 73.9 83.6 64.2 Vanilla Gum
64.3 61.2 67.4 No Gum 85.1 88.8 81.4
[0026] The values shown in Table 1 are Visual Analog Scale Values
in which the subjects indicated on a 100 mm line scale the degree
of their subjective urge to smoke. The scale values ranged from 0
(no urge to smoke) to 100 (maximum urge to smoke).
[0027] Overall, both peppermint and vanilla flavored chewing gums
substantially reduced the urge to smoke in comparison with no
chewing gum. Further, the study showed that, overall, vanilla
flavored chewing gum had a more pronounced effect on the urge to
smoke than peppermint flavored chewing gum. The vanilla flavored
chewing gum reduced the urge to smoke by about 24% compared with no
chewing gum.
[0028] Within the group, vanilla flavored chewing gum reduced the
urge to smoke in the female subjects by about 31%, while the
peppermint chewing gum had a much less pronounced reduction. In
men, the peppermint flavored chewing gum reduced the urge to smoke
by about 21%, while the vanilla flavored chewing gum had a slightly
less effect on the urge to smoke.
[0029] The total withdrawal systems in the test subjects are shown
in Table 2 below. TABLE-US-00002 TABLE 2 Total Withdrawal Symptoms
At A 48 Hour Interval After Cessation Of Smoking (average scale
values of self-reported symptom severity) Total Women Men
Peppermint Gum 11.6 12.8 10.4 Vanilla Gum 13.5 14.2 12.8 No Gum
16.5 18.6 14.4
[0030] The values listed in Table 2 are the average of the
subject's self-reported severity of eleven smoking
cessation-related symptoms. The values for each symptom are
provided on a four-point scale. The values for each symptom range
from 0 (not present) to 3 (severe). Thus, in the averages listed
above in Table 2, the maximum possible score when all eleven
symptoms are at their highest level for any one subject is 33.
[0031] In the overall study group, both peppermint flavored chewing
gum and vanilla flavored chewing gum substantially reduced the
total withdrawal symptoms. The peppermint and vanilla flavored
chewing gums reduced the total withdrawal symptoms by 30% and 18%,
respectively. In the female subjects, peppermint flavored chewing
gum reduced the total withdrawal symptoms by about 30%, while the
vanilla flavored chewing gum reduced the total withdrawal symptoms
by about 24%. In the male subjects, the peppermint flavored chewing
gum reduced the total withdrawal symptoms by about 28%, while the
vanilla flavored chewing gum showed much less effect.
[0032] During the third day of abstinence, the saliva samples were
taken at six intervals throughout the day: upon wakening (A), 45
minutes later (A+45), at noon (12), at 6:00 pm (6), between 8:00
and 9:00 pm (8-9), and at bed time (B). Cortisol levels are known
to peak shortly after rising in the morning and then decline
throughout the day. Using the peak Cortisol level as a baseline,
the reduction in saliva Cortisol levels was determined for the
control and experimental treatments.
[0033] Table 3 shows the relative saliva Cortisol levels taken from
the test subjects at the various time intervals on the third day
following cessation of smoking. The values shown in the table are
nanomoles of Cortisol per milliliter of saliva. TABLE-US-00003
TABLE 3 Saliva Cortisol Levels On The Third Day After Cessation Of
Smoking (nanomoles/ml) A A + 45 12 6 8-9 B Peppermint Gum 0.53 0.50
0.32 0.12 0.18 0.20 Vanilla Gum 0.40 0.59 0.25 0.10 0.09 0.12 No
Gum 0.34 0.42 0.29 0.22 0.20 0.11
[0034] The results are shown for subjects that were allowed to chew
peppermint flavored chewing gum, vanilla flavored chewing gum, and
no chewing gum. As shown above in Table 3, peak salivary Cortisol
levels were measured in the test subjects at the time of awakening
(A) and shortly after arising (A+45), then declined over the
remainder of the day. The subjects chewing either the peppermint
flavored chewing gum or the vanilla flavored chewing gum showed
greater reductions from peak levels than did the subjects who
chewed no gum. This indicates that the experimental gums were
effective in substantially reducing stress in smokers on the third
day of abstinence.
[0035] As illustrated in the foregoing description, the stress
associated with abstaining from the use of tobacco products can be
substantially reduced by consuming a confectionary composition
having a stress-reducing flavoring agent.
[0036] The following examples illustrate various embodiments of the
invention for oral compositions including stress-reducing flavoring
agents.
Chewing Gum
[0037] Pursuant to the present invention, a flavor such as
peppermint, vanilla, peach flavor or other stress-reducing
flavoring agents can be used to formulate a chewing gum. In this
regard, the present invention also provides a chewing gum
comprising a water insoluble base portion, a water soluble base
portion, and a stress-relieving flavoring agent. The water soluble
portion dissipates with a portion of the flavor over a period of
time during chewing. The gum base portion is retained in the mouth
throughout the chew. The chewing gum may be any of a variety of
different chewing gums, including low or high moisture, sugar or
sugarless, wax-containing or wax-free, low calorie and/or a chewing
gum that includes dental health agents.
[0038] The insoluble gum base generally comprises elastomers,
resins, fats and oils, softeners, and inorganic fillers. The gum
base may or may not include wax. The insoluble gum base can
constitute about 5 to about 95 percent, by weight, of the chewing
gum, more commonly, the gum base comprises about 10 to about 50
percent of the gum, and in some preferred embodiments, about 20 to
about 35 percent, by weight, of the chewing gum.
[0039] In one formulation, the chewing gum base contains about 20
to about 60 weight percent synthetic elastomer, about 0 to about 30
weight percent natural elastomer, about 5 to about 55 weight
percent elastomer plasticizer, about 4 to about 35 weight percent
filler, about 5 to about 35 weight percent softener, and optional
minor amounts (about one percent or less) of miscellaneous
ingredients such as colorants, antioxidants, and the like.
[0040] Synthetic elastomers may include, but are not limited to,
polyisobutylene with a GPC weight average molecular weight of about
10,000 to about 95,000, isobutylene-isoprene copolymer (butyl
elastomer), styrene-butadiene copolymers having styrene-butadiene
ratios of about 1:3 to about 3:1, polyvinyl acetate having a GPC
weight average molecular weight of about 2,000 to about 90,000,
polyisoprene, polyethylene, vinyl acetate-vinyl laurate copolymer
having vinyl laurate content of about 5 to about 50 percent by
weight of the copolymer, and combinations thereof.
[0041] Preferred ranges are, for polyisobutylene, about 50,000 to
about 80,000 GPC weight average molecular weight, for
styrene-butadiene, 1:1 to 1:3 bound styrene-butadiene, for
polyvinyl acetate, 10,000 to 65,000 GPC weight average molecular
weight with the higher molecular weight polyvinyl acetates
typically used in bubble gum base, and for vinyl acetate-vinyl
laurate, vinyl laurate content of about 10 to about 45 percent.
[0042] Natural elastomers may include natural rubber such as smoked
or liquid latex and guayule as well as natural gums such as
jelutong, lechi caspi, perillo, sorva, massaranduba balata,
massaranduba chocolate, nispero, rosindinha, chicle, gutta hang
kang, and combinations thereof. The preferred synthetic elastomer
and natural elastomer concentrations vary depending on whether the
chewing gum in which the base is used is adhesive or conventional,
bubble gum or regular gum, as discussed below. Preferred natural
elastomers include jelutong, chicle, sorva and massaranduba
balata.
[0043] Elastomer plasticizers may include, but are not limited to,
natural rosin esters such as glycerol esters of partially
hydrogenated rosin, glycerol esters polymerized rosin, glycerol
esters of partially dimerized rosin, glycerol esters of rosin,
pentaerythritol esters of partially hydrogenated rosin, methyl and
partially hydrogenated methyl esters of rosin, pentaerythritol
esters of rosin; synthetics, such as terpene resins derived from
alpha-pinene, beta-pinene, and/or d-limonene; and any suitable
combinations of the foregoing, the preferred elastomer plasticizers
will also vary depending on the specific application, and on the
type of elastomer which is used.
[0044] Fillers/texturizers may include magnesium and calcium
carbonate, ground limestone, silicate types such as magnesium and
aluminum silicate, clay, alumina, talc, titanium oxide, mono-, di-
and tri-calcium phosphate, cellulose polymers, such as wood, and
combinations thereof.
[0045] Water insoluble softeners and emulsifiers are typically
incorporated into the gum base at levels between 5 and 50%. These
may include fats such as tallow, hydrogenated tallow, hydrogenated
and partially hydrogenated vegetable oils, cocoa butter; fatty
ingredients such as glycerol monostearate and other mono- and
diglycerides, glycerol triacetate, lecithin, acetylated mono- and
diglycerides, fatty acids (e.g. stearic, palmitic, oleic and
linoleic acids), waxes such as paraffin and microcrystalline waxes
and combinations thereof.
[0046] Colorants and whiteners may include FD&C-type dyes and
lakes, fruit and vegetable extracts, titanium dioxide, and
combinations thereof.
[0047] The gum base may or may not include wax. An example of a
wax-free gum base is disclosed in U.S. Pat. No. 5,286,500, the
disclosure of which is incorporated herein by reference.
[0048] In addition to a water insoluble gum base portion, a typical
chewing gum composition includes a water soluble bulk portion and
one or more flavoring agents. The water soluble portion can include
bulk sweeteners, high intensity sweeteners, flavoring agents,
softeners, emulsifiers, colors, acidulants, fillers, antioxidants,
and other components that provide desired attributes.
[0049] Bulk sweeteners include both sugar and sugarless components.
Bulk sweeteners typically constitute about 5 to about 95% by weight
of the chewing gum, more typically, about 20 to about 80% by
weight, and more commonly, about 30 to about 60% by weight of the
gum.
[0050] Sugar sweeteners generally include saccharide-containing
components commonly known in the chewing gum art, including, but
not limited to, sucrose, dextrose, maltose, dextrin, dried invert
sugar, fructose, levulose, galactose, corn syrup solids, and the
like, alone or in combination.
[0051] Sugarless sweeteners include, but are not limited to, sugar
alcohols such as sorbitol, mannitol, xylitol, hydrogenated starch
hydrolysates, maltitol, and the like, alone or in combination, and
polymeric sucrose replacers including maltodextrins, polydextrose,
and hydrogenated starch hydrolysate (HSH).
[0052] High intensity artificial sweeteners can also be used, alone
or in combination with the above. Preferred sweeteners include, but
are not limited to sucralose, aspartame, Neotame, salts of
acesulfame, such as the synthetic sweetener
3,6-dihydro-6-methyl-1-1,2,3-oxathiazin-4-one-2,2-dioxide,
particularly the potassium substituted sweetener (Acesulfame-K),
alitame, saccharin and its salts, cyclamic acid and its salts,
glycyrrhizin, dihydrochalcones, thaumatin, monellin, and the like,
alone or in combination. In order to provide longer lasting
sweetness and flavor 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,
coacervation, and fiber extension may be used to achieve the
desired release characteristics.
[0053] 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
flavor used and cost considerations. Thus, the active level of
artificial sweetener may vary from about 0.02 to about 8%. When
carriers used for encapsulation are included, the usage level of
the encapsulated sweetener will be proportionately higher.
[0054] Encapsulated sweeteners can also be incorporated into the
gum formulation. The encapsulation techniques that can be used can
give varying degrees of coating from partial to full coating
depending on the coating composition used in the process. Also the
coating compositions may be susceptible to water permeating to
various degrees. Generally, compositions that have high organic
solubility, good film forming properties, and low water solubility,
provide a better encapsulation of aspartame. Such compositions
include acrylic polymers and copolymers, carboxyvinyl polymers,
polyamides, polystyrene, polyvinyl acetate, polyvinyl acetate
phthalate, polyvinyl pyrrolidone, and waxes.
[0055] Although all of the above materials are possible for the
encapsulation of aspartame, only food grade materials should be
used. Two standard food grade coating materials that are good
formers, but not water soluble, are shellac and Zein. Others which
are more water soluble, but also good film formers, are materials
such as agar, alginates, a wide range of cellulose derivative like
ethyl cellulose and hydroxpropylmethyl cellulose, dextrin, gelatin
and modified starches. Other encapsulants like acacia or
maltodextrin can also be used to encapsulate the aspartame.
[0056] Generally, the higher the level of coating and the lower the
amount of aspartame, the higher the stability of aspartame. To
obtain the desired encapsulation, the encapsulant should be
preferably at least about 20% of the coated product. More
preferably, the encapsulant should be at least about 30% of the
coated product, and most preferably should be at least about 40% of
the coated product. Depending on the coating material, a higher or
lower amount of coating material may be needed to provide the
desired encapsulation.
[0057] Another method of partial encapsulation is agglomeration
with an agglomerating agent, which partially coats aspartame. This
method includes the step of mixing the aspartame and agglomerating
agent with a small amount of water or solvent. The mixture is
prepared in such a way as to have individual wet particles in
contact with each other so a partial coating can be applied. After
the water or solvent is removed, the mixture is ground and used as
a powdered coated encapsulated aspartame.
[0058] Materials that can be used as the agglomerating agent are
the same as those used in the encapsulation previously mentioned.
However, since the coating is only a partial encapsulation, some
agglomeration agents are more effective than others. Some of the
better agglomerating agents are organic polymers such as acrylic
polymer and copolymers, polyvinyl acetate, polyvinyl pyrrolidone,
waxes, shellac and Zein. Other agglomerating agents may not be as
effective as are the polymers, waxes, shellac and Zein. These other
agglomerating agents include, but are not limited to, agar,
alginates, a wide range of cellulose derivatives, dextrin, gelatin,
modified starches, and vegetable gums such as guar gums, locust
bean gum, and carrageenan.
[0059] Even though the agglomerated aspartame is only partially
coated, when the quantity of coating is increased compared to the
quantity of aspartame, improved aspartame stability is obtained.
The level of coating used in the agglomerated product should be at
about 5%. Preferably the coating level should be at least about
15%, and more preferably about 20%.
[0060] Aspartame may be coated in a two-step process or multiple
step process. Aspartame may be encapsulated with any of the
materials previously described and then the encapsulated material
can be agglomerated as previously described to obtain an
encapsulated/agglomerated product that could be used in chewing gum
to improve stability.
[0061] Combinations of sugar and/or sugarless sweeteners may be
used in chewing gum. Additionally, the softener may also provide
additional sweetness such as with aqueous sugar or alditol
solutions.
[0062] 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; Fructooligosaccharides
(NutraFlora); Palatinose oligosaccharide; Guar Gum Hydrolysate (Sun
Fiber); or indigestible dextrin (Fibersol). However, other low
calorie bulking agents can be used.
[0063] Softeners are added to the chewing gum in order to optimize
the chewability and mouth feel of the gum. Softeners, also known in
the art as plasticizers or plasticizing agents, generally
constitute between about 0.5% to about 15% of the chewing gum.
These include glycerin, propylene glycol and aqueous sweetener
solutions such as those containing sorbitol. Hydrogenated starch
hydrolysate and corn or other starch hydrolysate syrups (sometimes
called glucose syrups) and combinations thereof are particularly
preferred as they also function as binders to improve the
flexibility and other physical properties of the gum.
[0064] In addition to the stress-reducing flavoring agents
described above, a variety of additional flavoring agents can be
used. The flavor can be used in amounts of approximately about 0.1
to about 10 weight percent of the gum, and preferably, about 0.3 to
2%. Flavoring agents may include essential oils, synthetic flavors
or mixtures thereof including, but not limited to, oils derived
from plants and fruits. In addition to peppermint oil, vanilla, and
peach, other mint oils including spearmint oil, can be added.
Artificial flavoring agents and components may also be used.
Natural and artificial flavoring agents may be combined in any
sensorially acceptable fashion.
[0065] The stress-reducing flavoring agent can be in the form of a
spray-dried flavor. Spray-drying of the flavor oils, such as
peppermint oil, can be accomplished by conventional spray-drying
techniques whereby a carrier solution or mixture containing the
flavor oil is fed through a pressure nozzle and atomized.
Generally, the spray-dried flavor is present in the carrier mixture
in amounts of about 15 to about 20% by weight of the total carrier
and flavor. In the case of spray-dried mint flavors which are to be
used in sugar-containing chewing gum compositions, the carrier
solution can be a sucrose solution. In sugarless formulations, the
carrier solution can be an aqueous gum arabic solution.
[0066] The oral composition of the invention can also contain
cooling agents and cooling flavors, such as those disclosed in U.S.
Pat. No. 6,627,233, the disclosure of which is incorporated by
reference herein. Cooling agents and flavors are used in chewing
gum to improve the "cool" sensation perceived upon chewing the gum
and to extend the duration of the "cool" sensation. In chewing
gums, adding a cooling agent provides the chewing gum with an
unexpected, high-flavor impact. This is particularly valuable for
sugarless chewing gum where the harsh notes of an added flavor are
not masked by sugar. Several different known cooling agents can be
used including menthyl succinate; acyclic carboxamide; menthyl
lactate; 3-1-menthoxypropane-1,2-diol; N-substituted p-menthane
carboxamide; menthone glycerol ketals and mixtures thereof.
[0067] In an additional aspect, a cooling agent or combinations of
cooling agents can be treated to have a modified-release. The
controlled release combination of physiological cooling agents is
obtained by modifying the cooling agents by encapsulation, partial
encapsulation or partial coating, entrapment or absorption with
water-soluble materials or water-insoluble materials. The
procedures for modifying the physiological cooling agents include
spray drying, spray chilling, fluid-bed coating, coacervation,
extrusion, and other agglomerating and standard encapsulating
techniques. The cooling agents may also be absorbed onto an inert
or water-insoluble material. The cooling agents may be modified in
a multiple step process comprising any of the processes noted.
[0068] In general, the chewing gum is manufactured by sequentially
adding the various chewing gum ingredients to a commercially
available mixer known in the art. After the ingredients have been
thoroughly mixed, the gum mass is discharged from the mixer and
shaped into the desired form, such as rolling into sheets and
cutting into sticks or tabs, extruding into chunks or casting into
pellets, which are then coated or panned.
[0069] Generally, the ingredients are mixed by first melting the
gum base and adding it to the running mixer. The base may also be
melted in the mixer itself. Color or emulsifiers may also be added
at this time. The softener may also be added at this time, along
with syrup and a portion of the bulking agent. Further parts of the
bulking agent are added to the mixer. Flavoring agents, such as the
stress-reducing flavoring agent described above are added with the
final portion of the bulking agent. Other optional ingredients are
added to the batch in a typical fashion, well known to those of
ordinary skill in the art.
[0070] 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.
[0071] After the ingredients are mixed, the gum mass is either
sheeted or formed into pellets or balls. Pellet or ball gum is
prepared as conventional chewing gum but formed into pellets that
are pillow shaped, or into balls.
[0072] If a coated chewing gum is desired, the pellets/balls can be
used as cores for a coated chewing gum product having a core. The
cores can be sugar or polyol coated or panned by conventional
panning techniques to make a coated pellet gum. The weight of the
coating may be about 20% to about 50% of the weight of the finished
product, but may be as much as 75% of the total gum product.
[0073] Conventional panning procedures generally coat with sucrose,
but recent advances in panning have allowed use of other
carbohydrate materials to be used in place of sucrose. Some of
these coating materials include, but are not limited to, sugars
such as dextrose, maltose, isomaltulose, and tagatose, or sugarless
bulk sweeteners such as xylitol, sorbitol, lactitol, hydrogenated
isomaltulose, erythritol, maltitol, and other new polyols (also
referred to as alditols) or combinations thereof. A preferred
coating comprises about 30% to about 75% maltitol. These materials
may be blended with panning modifiers including, but not limited
to, gum arabic, gum talha, maltodextrins, corn syrup, gelatin,
cellulose type materials like carboxymethyl cellulose or
hydroxymethyl cellulose, starch and modified starches, vegetables
gums like alginates, locust bean gum, guar gum, and gum tragacanth.
Antistick agents may also be added as panning modifiers, which
allow the use of a variety of carbohydrates and sugar alcohols.
Flavors, such as the stress-reducing flavoring agents described
above, may also be added with the sugar or sugarless coating to
yield unique product characteristics.
[0074] Table 4 below provides two exemplary chewing gum
formulations in accordance with aspects of the invention.
TABLE-US-00004 TABLE 4 Chewing Gum Composition Vanilla Flavored
Peppermint Flavored Ingredient Gum Gum Gum Base 25.90 25.90
Alditol/Glycerin Syrup 37.90 37.90 Sorbitol 33.54 31.91
Encapsulated Acesulfame K 0.75 0.75 Encapsulated Aspartame 0.11
0.11 Acesulfame K 0.05 0.05 Lecithin 0.10 0.10 Salt Solution (10%)
0.05 0.05 Water 0.10 0.10 Vanilla Flavor 1.50 -- Peppermint Flavor
-- 1.95 Spray Dried Peppermint -- 0.10 Spray Dried Cooling Agent --
0.08 Cocoa Glycerin Dispersion -- 1.00 Total 100.00 100.00
[0075] The Alditol/Glycerin Syrup listed above is a blend of
sorbitol solution, hydrogenated starch hydrolysate syrup, and
glycerin co-evaporated to about 3% moisture. The composition of the
Alditol/Glycerin Syrup composition is given below in Table 5.
TABLE-US-00005 TABLE 5 Alditol/Glycerin Syrup Composition Glycerin
39.00 Mannitol 1.50 HSH solids 5.50 Sorbitol 51.00 Water 3.00 Total
100.00
Candy
[0076] In another aspect of the invention, confectionery
compositions or products containing stress-reducing flavoring
agents can include, for example, hard candies, chewy candies,
coated chewy center candies, and tabletted candies. By way of
example, the hard candy is primarily comprised of corn syrup and
sugar, and derives its name from the fact that it contains only 1%
and 4% moisture. In appearance, these types of candies are solid,
but they are actually supercooled liquids, which are far below
their melting points. There are different types of hard candies.
Glass types are usually clear or made opaque with dyes. Grained
types of hard candies are always opaque.
[0077] Another aspect of the present invention contemplates the
incorporation of the stress reducing flavoring agents into solid
oral carriers such as slow dissolving tablets or lozenges
manufactured by conventional techniques. The solid carrier is sugar
or a water soluble polyhydric alcohol (polyol) such as mannitol,
xylitol, sorbitol, maltitol, a hydrogenated starch hydrolysate
("Lycasin"), hydrogenated glucose, hydrogenated disaccharides,
and/or hydrogenated polysaccharides, as the major ingredient, in an
amount of about 85-98% by weight of the total carrier. Solid salts
such as sodium bicarbonate, sodium chloride, potassium bicarbonate
or potassium chloride may totally or partially replace the polyol
carrier.
[0078] Tableting lubricants, in minor amounts of about 0.1 to 5% by
weight, may be incorporated into the tablet or lozenge formulation
to facilitate the preparation of both the tablets and the lozenges.
Suitable lubricants include vegetable oil such as coconut oil,
magnesium stearate, aluminum stearate, talc, starch and
Carbowax.
[0079] Lozenge formulations may contain about 2% hydrocolloid as a
barrier agent to provide a shiny surface as opposed to a tablet
which has a smooth finish. The lozenge or tablet may optionally be
coated with a coating material such as waxes, shellacs,
carboxymethyl cellulose, polyethylene/maleic anhydride copolymer or
Kappa-carrageenan, to further increase the time it takes the tablet
or lozenge to dissolve in the mouth. The coated tablet or lozenge
should be slowly dissolving, providing a sustained release rate of
the active ingredients over the period of about 3 to about 15
minutes.
[0080] The stress-reducing flavoring agents of the present
invention are incorporated into a lozenge or tablet by conventional
mixing and tableting techniques known in this field.
[0081] The present embodiment of the invention further contemplates
the optional inclusion of a sweetener, flavorant, or colorant
component into the tablets or lozenges containing stress-reducing
flavoring agents.
[0082] The sweetener component comprises any one or more sweeteners
known in the art, including both natural and artificial sweeteners.
The sweetener may be chosen from a wide range of materials,
including water-soluble sweeteners, water-soluble artificial
sweeteners, dipeptide based sweeteners, and mixtures thereof. Thus,
sweeteners may be chosen from the following non-limiting list,
which includes sugars such as sucrose, glucose, corn syrup,
dextrose, invert sugar, fructose and mixtures thereof; saccharine
and its various salts such as the sodium or calcium salt; cyclamic
acid and its various salts such as the sodium salt; free aspartame;
dihydrochalcone sweetening compounds; glycyrrhizin; stevioside;
monellin; thaumatin; sucralose; isomaltitol; neosugar; lactitol;
polydextrose; tagatose; maltitol; and sugar alcohols such as
sorbitol, sorbitol syrup, mannitol, xylitol, and the like. Also
contemplated as a sweetener is the nonfermentable sugar substitute
hydrogenated starch hydrolysate (also known as Lycasin). Also
contemplated is the synthetic sweetener
3,6-dihydro-6-methyl-1-1,2,3-oxathiazin-4-one-2,2-dioxide,
particularly potassium (Acesulfame-K), sodium and calcium salts
thereof. Sorbitol is the preferred sweetening and bulking agent.
The amount of sweetener included is an amount effective to provide
the desired degree of sweetness and bulk, generally 0.001 to 70
weight % of the tablet or lozenge.
[0083] High intensity artificial sweeteners can also be used, alone
or in combination, with the above. Preferred sweeteners include,
but are not limited to, sucralose, aspartame, APM derivatives such
as neotame, salts of acesulfame, altitame, saccharin and its salts,
cyclamic acid and its salts, glycyrrhizinate, dihydrochalcones,
thaumatin, monellin, and the like, alone or in combination. In
order to provide longer lasting sweetness and flavor 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, coacervation, and fiber extension may be used to
achieve the desired release characteristics.
[0084] In addition to the stress-reducing flavoring agents,
additional flavorants may be included. Suitable additional
flavorants include natural and artificial flavors, such as menthol,
oil of spearmint, oil of cinnamon, oil of wintergreen (methyl
salicylate), and various fruit flavors, including but not limited
to lemon oil, orange oil, grape flavor, lime oil, grapefruit oil,
apple, apricot essence, and combinations thereof. As described
above, particularly preferred flavors are stress-reducing flavoring
agents, such as peppermint, vanilla, and peach. The flavorings are
generally utilized in amounts that will vary depending upon the
individual flavor, and may, for example, range in amounts of about
0.5% to about 3% by weight of the tablet or lozenge.
[0085] Colorants can be present in the tablets or lozenges of the
present invention. Examples include pigments such as titanium
dioxide, natural food colorants such as beta carotenes, betanin,
turmeric, and other dyes suitable for food, drug and cosmetic
applications known as F.D. & C. dyes, and the like. The
materials may be incorporated in amounts of up to about 1% by
weight, preferably up to about 6% by weight of the tablet or
lozenge.
[0086] The stress-reducing flavoring agents may be incorporated
into an otherwise conventional pressed tablet formulation. The
pressed tablet into which the stress-reducing flavoring agents are
incorporated may be prepared by wet granulation, dry granulation,
and direct compression methods. These methods involve conventional
procedures well known to the ordinary skilled artisan. In general,
wet granulation involves mixing milled powders, preparing a wet
mass by blending the milled powders with a binder solution, coarse
screening the wet mass and drying the moist granules, screening the
granules through a 14 to 20 mesh screen, mixing the screened
granules with lubricants and disintegrate agents and finally tablet
compressing the mass. In contrast, dry granulation generally
involves milling of powders, compression into large hard tablets to
make slugs, screening of slugs, mixing with lubricants and
disintegrating agents and finally tablet compression. In the direct
compression method, the milled ingredients are mixed and then
merely tabletted by compression.
[0087] The pressed tablet ingredients used in the invention are
selected from those materials routinely used. Such ingredients
primarily include sweeteners, lubricants, and optional coloring
agents, binders and fillers.
[0088] Sweetening agents may be selected from a wide range of
materials such as water-soluble sweetening agents, water-soluble
artificial sweeteners, and dipeptide based sweeteners, including
mixtures thereof. Without being limited to particular sweeteners,
representative illustrations encompass: 1) Water-soluble sweetening
agents such as monosaccharides, disaccharides and polysaccharides
such as xylose, ribose, glucose, mannose, galactose, lactose,
fructose, dextrose, sucrose, sugar, maltose, partially hydrolyzed
starch, or corn syrup solids and sugar alcohols such as sorbitol,
xylitol, mannitol and mixtures thereof; 2) Water-soluble artificial
sweeteners such as the soluble saccharin salts, i.e. sodium or
calcium saccharin salts, cyclamate salts and the like, and the free
acid form of saccharin; 3) Dipeptide based sweeteners include
L-aspartyl-L-phenylalanine methyl ester and related compounds.
[0089] In general, the amount of sweetener will vary with the
desired amount of sweetener selected. This amount will normally be
about 0.001% to about 98% by weight when using an easily
extractable sweetener. The water-soluble sweeteners are preferably
used in amounts of about 75% to about 98% by weight, and most
preferably about 80% to about 95% by weight of the final tablet
composition. In contrast, the artificial sweeteners are used in
amounts of about 0.01% to about 5.0% and most preferably about
0.05% to about 0.25% by weight of the final tablet composition.
These amounts are necessary to achieve a desired level of sweetness
independent from the flavor level achieved from the flavor oil.
[0090] Lubricants are used in the tablet formulations in order to
ease the ejection of the tablet from the die, to prevent sticking
of the tablets to the punches and to limit wear on dies and
punches. Tableting lubricants may be selected from a wide range of
materials such as magnesium stearate, calcium stearate, zinc
stearate, hydrogenated vegetable oils, talc, light mineral oil,
sodium benzoate, sodium lauryl sulfate, magnesium lauryl sulfate
and mixtures thereof. Magnesium stearate is the preferred lubricant
in view of its ready availability and efficient lubrication
properties.
[0091] The lubricants should be in as fine a state of subdivision
as possible since the smaller the particle size the greater the
efficiency in the granulation. Preferred sizes are those that pass
through an 80 or 100 mesh screen and most preferred through a 200
mesh screen before use. The amount of lubricant will vary broadly
and is preferably from about 0.1% to about 5% by weight of the
total composition.
[0092] Colorants should be selected from materials that are
unaffected by higher temperatures and are considered optional
ingredients in the tablet formulations. Such materials when used
are employed in amounts of 0 to about 0.03% by weight of the total
formulation.
[0093] Binders that are used when a wet granulation process is
employed include starch, pregelatinized starch, gelatin, free
polyvinylpyrrolidone, methylcellulose, sodium
carboxymethylcellulose, polyvinylalcohols and so forth. Binders
when used can be employed in amounts up to about 25% and preferably
about 5 to about 15% by weight. Conventional fillers may also be
present such as calcium sulfate, dicalcium phosphate, tricalcium
phosphate, starch, microcrystalline cellulose and so forth in
amounts up to about 50% by weight with preferred amounts from about
5 to 20% by weight of the final formulation.
[0094] The pressed tablet formulations can be prepared by
conventional means using standard techniques and equipment known to
those skilled in the art. In one method, stress-reducing flavoring
agents are blended with the tablet formulation ingredients. Once
incorporated, mixing is continued until a uniform mixture is
obtained and thereafter the mixture is formed into suitable shapes
by subjecting the formulation to a tableting operation. Compression
pressures on the order up to 65 megapascals (approximately 12 tons
per square inch) are normally employed.
[0095] In the event that the oral composition is in the form of a
lozenge or a pressed tablet, a barrier agent is usually present,
preferably in a concentration of up to about 2 weight %. The
barrier agent provides a shiny surface as opposed to a tablet
which, although having a smooth finish, is usually not shiny. In a
preferred embodiment, the barrier agent is a hydrocolloid.
[0096] Where the oral composition is a lozenge, a tablet, or a
pressed tablet, these products may be coated with a coating
material. Among the coating materials suitable for use in this
application are waxes, shellacs, carboxymethyl cellulose,
ethylene-maleic anhydride copolymers and carragennan. A coating
material is used to increase the time it takes for the tablet or
lozenge to dissolve in the mouth. A coated tablet or lozenge is
slow dissolving, providing sustained release of the active
ingredients over a longer period of time, for example 3 to 15
minutes, or sometimes even longer.
[0097] It should be understood that various changes and
modifications to the presently preferred embodiments described
herein will be apparent to those skilled in the art. For example,
other comestibles which may be formed from the components discussed
above are within the contemplation of the present invention. Such
changes and modifications can be made without departing from the
spirit and scope of the present invention and without diminishing
its intended advantages. It is therefore intended that such changes
and modifications are within the scope of the appended claims and
equivalents thereof.
* * * * *