U.S. patent application number 09/749983 was filed with the patent office on 2002-03-28 for chewing gum product including a hydrophilic gum base and method of producing.
This patent application is currently assigned to Wm. Wrigley Jr. Company.. Invention is credited to Barkalow, David G., Bunczek, Michael T., Greenberg, Michael J., Mazzone, Philip, Monen, George W., Urnezis, Philip W..
Application Number | 20020037340 09/749983 |
Document ID | / |
Family ID | 26869483 |
Filed Date | 2002-03-28 |
United States Patent
Application |
20020037340 |
Kind Code |
A1 |
Urnezis, Philip W. ; et
al. |
March 28, 2002 |
CHEWING GUM PRODUCT INCLUDING A HYDROPHILIC GUM BASE AND METHOD OF
PRODUCING
Abstract
A method for producing a chewing gum with an improved release of
a lipophilic active agent, as well as the chewing gum so produced,
is obtained by using a hydrophilic gum base. The preferred and
novel gum base includes hydrophilic polymers, hydrophilic
softeners/emulsifiers and fillers, but is essentially free of
hydrophobic elastomers and hydrophobic softeners, as well as waxes
and elastomer solvents. The lipophilic active agent is preferably
added to a coating on a chewing gum pellet made using a hydrophilic
gum base, such as by being mixed into a coating solution. The
coating solution may contain a high-intensity sweetener. An active
agent may also be used in the gum core.
Inventors: |
Urnezis, Philip W.;
(Lombard, IL) ; Mazzone, Philip; (Griffith,
IN) ; Greenberg, Michael J.; (Northbrook, IL)
; Bunczek, Michael T.; (Lisle, IL) ; Barkalow,
David G.; (Deerfield, IL) ; Monen, George W.;
(Woodridge, IL) |
Correspondence
Address: |
BRINKS HOFER GILSON & LIONE
P.O. BOX 10395
CHICAGO
IL
60610
US
|
Assignee: |
Wm. Wrigley Jr. Company.
|
Family ID: |
26869483 |
Appl. No.: |
09/749983 |
Filed: |
December 27, 2000 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60173736 |
Dec 30, 1999 |
|
|
|
Current U.S.
Class: |
426/5 ;
424/48 |
Current CPC
Class: |
A23G 4/20 20130101; A23G
4/066 20130101; A23G 4/10 20130101; A23G 4/02 20130101; A23G 4/08
20130101; A23G 4/06 20130101; A23G 4/126 20130101; A61K 9/0058
20130101 |
Class at
Publication: |
426/5 ;
424/48 |
International
Class: |
A23G 003/30 |
Claims
1. A hydrophilic gum base comprising: a) about 20% to about 90%
hydrophilic polymers; b) about 5% to about 35% hydrophilic
softeners/emulsifiers; and c) about 4% to about 50% filler; d) the
chewing gum base being essentially free of hydrophobic polymers,
elastomer solvents, waxes and hydrophobic softeners.
2. The hydrophilic gum base of claim 1 wherein the hydrophilic
polymers are selected from the group consisting of polyvinyl
acetate, short and medium chain polyesters, short and medium chain
polyamides, and short and medium side chain poly(vinyl esters) and
combinations thereof.
3. The hydrophilic gum base of claim 1 wherein the hydrophilic
polymers are selected from the group consisting of high molecular
weight polyvinyl acetate, low molecular weight polyvinyl acetate,
polyvinyl butyrates, polyvinyl propionates and combinations
thereof.
4. The hydrophilic gum base of claim 1 wherein the hydrophilic
softeners/emulsifiers are selected from the group consisting of
glycerol monostearate, glycerol triacetate, lecithin, mono-, and
diglycerides, short and medium chain triglycerides, acetylated
monoglycerides, and combinations thereof.
5. The hydrophilic gum base of claim 1 wherein the filler is
selected from the group consisting of magnesium carbonate, calcium
carbonate, ground limestone, magnesium silicate, aluminum silicate,
clay, alumina, talc, titanium oxide, mono-, di- and tri-calcium
phosphate, cellulose polymers and combinations thereof.
6. The hydrophilic gum base of claim 1 wherein the base is free of
butyl elastomers, polyisobutylene and styrene butadiene rubber.
7. The hydrophilic gum base of claim 1 wherein the base is free of
trypene resins, rosen esters and ester gums.
8. The hydrophilic gum base of claim 1 wherein the gum base, when
admixed into a non-coated chewing gum product including lipophilic
active agents, releases at least 10% of the lipophilic active agent
from the chewing gum product within 30 minutes of chewing.
9. A chewing gum product made using the gum base of any one of
claims 1-8.
10. A coated chewing gum product comprising: a) a chewing gum core
made from a hydrophilic gum base; and b) a coating on the core, the
coating including a lipophilic active agent.
11. The coated chewing gum product of claim 10 wherein the
lipophilic active agent is selected from the group consisting of
vitamins, cancer chemotherapeutics, antimycotics, oral
contraceptives, analgesics, antacids, muscle relaxants,
antihistamines, decongestants, anesthetics, antitussives,
diuretics, anti-inflammatories, antibiotics, antivirals,
psychotherapeutic agents, anti-diabetic agents, cardiovascular
agents, bioengineered pharmaceuticals, nutraceuticals and
nutritional supplements.
12. A method of producing coated chewing gum products containing at
least one lipophilic active agent in the coating comprising the
steps of: a) providing chewing gum product cores wherein the
chewing gum is made from a hydrophilic gum base: b) providing a
coating solution; c) coating the chewing gum product cores with the
coating solution to provide coated chewing gum products, the
coating including a lipophilic active agent at a level of from
about 12 micrograms to about 250 milligrams per gram of coated
chewing gum product.
13. The method of claim 12 wherein the active agent is mixed in the
coating solution prior to coating the cores.
14. The method of claim 13 wherein the active agent is also mixed
with a solvent before adding to the coating solution and the
resulting mixture is added to the chewing gum coating.
15. The method of claim 14 wherein the solvent is water, alcohol or
flavor.
16. The method in claim 12 wherein a high-potency sweetener
selected from the group consisting of aspartame, alitame, salts of
acesulfame, cyclamate and its salts, saccharine and its salts,
neotame, thaumatin, monellin, dihydrochalcones, sucralose and
combinations thereof is mixed in the coating solution.
17. The method of claim 12 wherein said lipophilic active agent is
selected from the group consisting of vitamins, analgesics,
antacids, antihistamines, antitussives, antibacterial agents,
decongestants and anesthetics.
18. The method of claim 12 wherein the active agent is a
nutraceutical.
19. The method of claim 12 wherein said active agent is vitamin
E.
20. The method of claim 12 wherein the coating operation includes
the application of multiple coats of coating solution and
application of powder material between coats of coating
solution.
21. The method of claim 20 wherein the active agent is included in
the powder material.
22. The method of claim 20 wherein active agent is included in both
the coating solution and the powder material.
23. The method of claim 12 wherein a lipophilic active agent is
also included in the chewing gum cores.
24. The method of claim 23 wherein the active agents in the gum
cores and coating are the same.
25. The method of claim 23 wherein the active agent in the cores is
different than the active agent in the coating.
26. The method of claim 12 wherein at least two different coating
solutions are used to make the coating.
27. The method of claim 26 wherein the active agent is mixed with
the first of the at least two different coating solutions and
applied to form a film, and a second coating solution without an
active agent is applied over the film coated cores.
28. The method of claim 12 wherein the active agent is present in
the coating at a level of from about 10 ppm to about 30% of the
coating.
29. A method of delivering a lipophilic active agent comprising the
steps of: a) providing a chewing gum product having i) a chewing
gum core made using a hydrophilic gum base and ii) a coating
including a lipophilic active agent in the coating; and b) chewing
the chewing gum product for at least 10 minutes in a oral cavity of
an individual chewing the chewing gum product.
30. The method of claim 29 wherein the active agent is chosen from
the group consisting of: vitamins; analgesics; muscle relaxants;
antibiotics; antivirals; antihistamines; decongestants;
anti-inflammatories; antacids; psychotherapeutic agents; and
cardiovascular agents.
Description
REFERENCE TO EARLIER FILED APPLICATION
[0001] The present application claims the benefit of the filing
date under 35 U.S.C. .sctn. 119(e) of provisional U.S. Patent
Application, Serial No. 60/173,736, filed Dec. 30, 1999, which is
hereby incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to methods for producing
chewing gum. More particularly, the invention relates to producing
chewing gum containing an effective amount of an active medicament.
Preferably, the active medicament is added to the chewing gum
coating to improve its rate of release from chewing gum and improve
its release by using a hydrophilic base composition.
[0003] In recent years, efforts have been devoted to controlling
release characteristics of various ingredients in chewing gum. Most
notably, attempts have been made to delay the release of sweeteners
and flavors in various chewing gum formulations to thereby lengthen
the satisfactory chewing time of the gum. Delaying the release of
sweeteners and flavors can also avoid an undesirable overpowering
burst of sweetness or flavor during the initial chewing period. On
the other hand, some ingredients have been treated so as to
increase their rate of release in chewing gum.
[0004] Besides sweeteners, other ingredients may require a
controlled release from chewing gum. In certain embodiments, it is
contemplated that a lipophilic active medicament that is added to
the gum coating is generally released very readily. An active may
be added to the gum coating, which is a water soluble matrix, such
that, during the chewing period, the active agent may be released
quickly, resulting in a fast release. This would allow a chewing
gum coating to be a carrier for an active medicament with these
fast release characteristics. However, during chewing the
lipophilic active agent may become bound to the chewing gum base
composition, and not released in sufficient quantity for
effectiveness.
[0005] It is of course known to provide active medicaments to
individuals for various purposes. These medicaments can be used to
treat diseases and as such are typically referred to as drugs or
medicaments. Likewise, the drugs or medicaments can be used for
preventive purposes. Still, it is known to provide medicaments to
an individual for a variety of non-medical purposes including
enhancing performance or maintaining health.
[0006] There are a great variety of such medicaments. These
medicaments run the gamut from stimulants such as caffeine to drugs
such as analgesics, tranquilizers, cardiovascular products, as well
as vitamins, and supplements. Some such medicaments are taken on an
"as-needed" basis while other medicaments must be taken at regular
intervals by the individual.
[0007] There is therefore a need for an improved method of
delivering lipophilic active agents to an individual.
SUMMARY OF THE INVENTION
[0008] The present invention provides improved methods for
delivering a medicament or active agent to an individual. To this
end, coated chewing gum products are provided including a
medicament or active agent. The medicament or active agent is
present within the coating of a chewing gum composition. It has
been found that by adding the active agent to a gum coating, the
medicament or active agent is quickly released from the chewing gum
into saliva. Continuing to chew the chewing gum may create a
pressure within the buccal cavity and may force the medicament or
active agent or medicament directly into the systemic system of the
individual through the oral mucosa contained in the oral cavity.
However, the lipophilic active agent may become partially bound in
the chewing gum base and gum matrix and not be completely
released.
[0009] In one aspect, the present invention is a hydrophilic gum
base comprising:
[0010] a) about 20% to about 90% hydrophilic polymers;
[0011] b) about 5% to about 35% hydrophilic softeners/emulsifiers;
and
[0012] c) about 4% to about 50% filler;
[0013] d) the chewing gum base being essentially free of
hydrophobic polymers, elastomer solvents, waxes and hydrophobic
softeners.
[0014] Improved chewing gum products including medicaments and
active agents in a gum coating and a hydrophilic base composition
are also provided by the present invention.
[0015] To this end, the present invention provides a method of drug
delivery comprising the steps of: providing a hydrophilic chewing
gum core and a chewing gum coating that includes a medicament in
the chewing gum coating; and chewing the chewing gum to cause the
medicament to be released from the chewing gum coating into the
oral cavity of the chewer.
[0016] The active medicament may be any agent that is lipophilic
and is traditionally used as a medicament and lends itself to being
administered through the oral cavity. Such active agents may be
vitamins, cancer chemotherapeutics; antimycotics; oral
contraceptives, analgesics, antacids, muscle relaxants,
antihistamines, decongestants, antibacterial agents, anesthetics,
antitussives, diuretics, anti-inflammatories, antibiotics, AIDS
medication, neurological drugs, antivirals, psychotherapeutic
agents, anti-diabetic agents, cardiovascular agents, nutraceuticals
and nutritional supplements.
[0017] Accordingly, an advantage of an embodiment of the present
invention is to provide new methods for delivering lipophilic
medicaments or active agents to an individual.
[0018] Further, an advantage of an embodiment of the present
invention is to provide a method of administering a lipophilic
medicament or agent to an individual at a lower level than is
typically administered orally while still achieving the same
effect.
[0019] Additionally, an advantage of an embodiment of the present
invention is to provide a method of administering lipophilic drugs
that is more palatable than current methods.
[0020] Moreover, an advantage of an embodiment of the present
invention is to provide an improved method for drug delivery.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0021] The present invention provides improved methods for
delivering medicaments and other active agents to an individual, as
well as improved gum base and chewing gum formulations. As used
herein, the term chewing gum also includes bubble gum and the like.
Pursuant to the present invention, a medicament or active agent is
contained in the coating of a chewing gum formulation, in contrast
to some prior such formulations where the medicament or active
agent is contained directly in the chewing gum composition.
[0022] Accordingly, as the chewing gum is chewed, the active agent
is released into the saliva more quickly. During continual chewing,
the medicament or active in the saliva may be then forced due to
the pressure created by the chewing gum through the oral mucosa in
the oral cavity.
[0023] When an active such as vitamin E is added to a gum coating,
the active agent will have an increased water dispersability, and
release quickly into the mouth from the gum coating. Depending on
the active agent, which will generally be non-water soluble but oil
soluble or lipophilic, adding the active agent to a gum coating
will increase the release of the active agent from chewing gum.
[0024] Other agents or medicaments may be included in the present
invention. By the term "active agent" the present invention refers
to a compound that has a desired therapeutic or physiological
effect once ingested and/or metabolized. The therapeutic effect may
be one which decreases the growth of a xenobiotic or other gut
flora or fauna, provides the physical relief from a malady (e.g.,
diminishes pain, acid reflux or other discomfort), has an effect on
the brain chemistry or molecules that determine mood and behavior,
or has improved nutritional benefits. Of course these are just
examples of what is intended by therapeutic effect. Those of skill
in the art will readily recognize that a particular agent has or is
associated with a given therapeutic effect.
[0025] The active agent may be any agent that is traditionally used
as a medicament and lends itself to being administered through the
oral cavity. Such active agents may be vitamins, cancer
chemotherapeutics, antimycotics, oral contraceptives, analgesics,
antacids, muscle relaxants, antihistamines, decongestants,
anesthetics, antitussives, diuretics, anti-inflammatories,
antibiotics, antivirals, psychotherapeutic agents, anti-diabetic
agents, cardiovascular agents, bioengineered pharmaceuticals,
nutraceuticals and nutritional supplements. Vitamins particularly
that may be delivered using this invention include, and are mostly
limited to, fat soluble vitamins such as thiamin, riboflavin,
pyridoxine, pantothenic acid, choline, carnitine, vitamin D and its
analogs, vitamin A and the carotenoids, retinoic acid, vitamin E
and vitamin K.
[0026] Compositions that may be formulated into a suitable chewing
gum formulation are described in, for examples, U.S. Pat. No.
5,858,423; U.S. Pat. No. 5,858,413; U.S. Pat. No. 5,858,412 and
U.S. Pat. No. 5,858,383. Additionally, Goodman and Gilman's "The
Pharmaceutical Basis of Therapeutics" (Eds. Hardman et al., Publ.
McGraw Hill, NY) provides comprehensive guidance of useful drugs
and their mechanisms of action. Medicated chewing gums have been
particularly effective in the delivery of agents such as nicotine
as described in, for example, U.S. Pat. No. 5,866,179; and U.S.
Pat. No. 5,889,028. U.S. Pat. No. 5,846,557 describes general
chewing gum compositions containing cough suppressing agents. These
patents are incorporated herein by reference as providing a
teaching of the incorporation of medicinal agents into oral
chewable formulations. It should be understood that the present
chewing gum formulation(s) and coatings are not limited to the
agents listed herein above, indeed any lipophilic medicinal or
other active agent that lends itself to ingestion may be formulated
into the chewing gum coatings and used in the present
invention.
[0027] Nutraceuticals and nutritional supplements may also be added
to chewing gums as well as the gum coatings as active agents. Among
these are lipophilic herbs and botanicals that include, but are not
limited to capsicum, chamomile, cat's claw, echinacea, garlic,
ginger, ginko, various ginseng, green tea, golden seal, kava kava,
nettle, passion flower, saw palmetto, St. John's wort, and
valerian. Other nutraceuticals that also can be added to chewing
gum coating as active agents are benzoin, glucosamine, grapeseed
extract, guarana, phosphotidylserine, phytosterols, phytochemicals,
isoflavones, lecithin, lycopene and polyphenol as well as weight
loss agents such as phenylpropanolamine.
[0028] The level of medicament or agent in the chewing gum
formulation and in the coating is selected so as to create, when
the gum is chewed, a sufficiently high concentration of the
medicament or agent in the saliva.
[0029] Pursuant to the present invention, depending on the agent or
medicament, the dosing regiment will change. For example, if the
medicament is an analgesic, the chewing gum product would be taken
on an "as-needed" basis. Of course, similar to the oral
administration of an analgesic, there would be restrictions on the
number of pieces of chewing gum product chewed, for example, not
more often than one pellet every four hours and not more often than
four to five times a day. If the agent is a vitamin such as vitamin
E to be used to enhance performance or other nutritional benefit,
then the chewing gum product would be chewed as needed.
[0030] Referring now to the chewing gum, pursuant to the present
invention the chewing gum may be based on a variety of different
chewing gums that are known. For example, the chewing gums can be
low or high moisture, sugar or sugarless, low calorie (via high
base or low calorie bulking agents), and/or may contain dental
agents.
[0031] Lipophilic active agents may be added to the gum coating
along with sweeteners, more specifically high-intensity sweeteners
such as thaumatin, dihydrochalcones, acesulfame K, aspartame,
N-substituted APM derivatives such as neotame, sucralose, alitame,
saccharin and cyclamates. These can also have the effect of
reducing unpleasant tastes such as bitterness. Additional
bitterness inhibitors or taste maskers can also be combined with
active agents and sweeteners to give a reduced unpleasant
taste.
[0032] Lipophilic active agents may also be combined in a coated
chewing gum product. Multiple actives, such as vitamins, may be
added to a gum coating for fast release but not added to the gum
center unless encapsulated for later release. If the active agent
has an affinity for the gum base, it may naturally give a slow
release without encapsulation. If the active agent normally has a
fast release, it would have to be encapsulated or entrapped for the
desired time release.
[0033] In many instances, active medicaments may have a low quality
off-taste or bitterness if added to a chewing gum coating. In most
cases, this off taste may be masked with high intensity sweeteners,
but in other instances, a bitterness inhibitor may be needed to
reduce a bitter taste of a medicament.
[0034] There are a wide variety of bitterness inhibitors that can
be used in food products as well as with active agents. Some of the
preferred bitterness inhibitors are the sodium salts which are
discussed in the article Suppression of Bitterness by Sodium:
Variations Among Bitter Taste Stimuli, by R. A. S. Breslin and G.
K. Beceuchenp from Monell Chemical Senses Center, Philadelphia, Pa.
Sodium salts discussed are sodium acetate and sodium gluconate.
Other sodium salts that may also be effective are sodium glycinate,
sodium ascorbate and sodium glycerolphosphate. Among these, the
most preferred is sodium gluconate and sodium glycinate, since they
have a low salty taste and are most effective to reduce bitterness
of most active medicaments.
[0035] Most of the sodium salts are very water soluble and are
readily released from chewing gum coating to function as bitterness
inhibitors. In most instances, the sodium salts which release
readily from a chewing gum center may be modified by encapsulation
to give an even faster release from chewing gum. However, in some
instances the sodium salts would be encapsulated or entrapped to
give a delayed release from gum. Generally, the bitterness
inhibitor should release with the active medicament for maximum
effectiveness.
[0036] Release of the medicament from gum coating may also be
effected by particle size of the medicament. Small particles
release more quickly whereas large particles release more slowly.
Fast release can also be accomplished by dissolving the medicament
in a liquid used to make a gum coating.
[0037] In general, a chewing gum composition typically comprises a
water-soluble bulk portion, a water-insoluble chewable gum base
portion and typically water-insoluble flavoring agents. The
water-soluble portion dissipates with a portion of the flavoring
agent over a period of time during chewing. The gum base portion is
retained in the mouth throughout the chew.
[0038] The unique insoluble gum base of the present invention will
comprise hydrophilic polymers (also referred to as polar polymers),
including various molecular weights of polyvinyl acetate, short and
medium chain polyesters or polyamides, and short and medium side
chain poly (vinyl esters) (e.g. polyvinyl butyrates, polyvinyl
propionates). The insoluble gum base will be essentially free of
hydrophopic polymers such as natural and synthetic rubber
elastomers, particularly butyl elastomers, polyisobutylene and
styrene butadiene rubber elastomers. The insoluble gum base will
also be essentially free of elastomer solvents, such as terpene
resins, ester gums and rosin esters. The insoluble gum base will
contain hydrophilic softeners/emulsifiers, but will be essentially
free of hydrophobic softeners. The insoluble gum base can
constitute about 5% to about 95% by weight of the chewing gum, more
commonly about 10% to about 50% of the gum or about 25% to 35% by
weight of the gum.
[0039] In a particular embodiment, the chewing gum base of the
present invention contains about 20% to about 90% by weight
hydrophilic polymers, about 4% to about 50% by weight filler, about
5% to about 35% by weight hydrophilic softeners/emulsifiers, and
optional minor amounts (about 1% or less by weight) of
miscellaneous ingredients such as colorants, antioxidants, etc.
[0040] 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 oat fiber,
and combinations thereof.
[0041] Hydrophilic softeners/emulsifiers may include glycerol
monostearate, glycerol triacetate, lecithin, mono-, and
diglycerides, and short and medium chain triglycerides, acetylated
monoglycerides, and combinations thereof.
[0042] Colorants and whiteners may include FD&C-type dyes and
lakes, fruit and vegetable extracts, titanium dioxide, and
combinations thereof.
[0043] 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.
[0044] Softeners are added to the chewing gum in order to optimize
the chewability and mouth feel of the gum. The softeners, which are
also known as plasticizers and plasticizing agents, generally
constitute between approximately 0.5% to about 15% by weight of the
chewing gum. The softeners may include glycerin, lecithin, and
combinations thereof. Aqueous sweetener solutions such as those
containing sorbitol, hydrogenated starch hydrolysates, corn syrup
and combinations thereof, may also be used as softeners and binding
agents in chewing gum.
[0045] 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. 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, glactose, corn syrup solids, and the
like, alone or in combination. 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.
[0046] 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, N-substituted APM
derivatives such as neotame, salts of acesulfame, alitame,
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 extrusion may be used to achieve the
desired release characteristics.
[0047] 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.
[0048] 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.
[0049] A variety of flavoring agents can also be used, if desired.
The flavor can be used in amounts of about 0.1 to about 15 weight
percent of the gum, and preferably, about 0.2% to about 5% by
weight. Flavoring agents may include essential oils, synthetic
flavors or mixtures thereof including, but not limited to, oils
derived from plants and fruits such as citrus oils, fruit essences,
peppermint oil, spearmint oil, other mint oils, clove oil, oil of
wintergreen, anise and the like. Artificial flavoring agents and
components may also be used. Natural and artificial flavoring
agents may be combined in any sensorially acceptable fashion.
[0050] In general, 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, extruding into chunks or casting into pellets,
which are then coated or panned.
[0051] 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. A softener such as glycerin 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
are typically 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.
[0052] 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.
[0053] In this invention, lipophilic medicaments or actives are
used in the coating/panning of a pellet chewing gum. Pellet or ball
gum is prepared as conventional chewing gum but formed into pellets
that are pillow shaped, or into balls. The pellets/balls can then
be sugar coated or panned by conventional panning techniques to
make a unique coated pellet gum. The lipophilic active agent will
be soluble in flavor or can be blended with other powders often
used in some types of conventional panning procedures. Lipophilic
active agents are isolated from other gum ingredients, which
modifies their release rate from chewing gum. Levels of actives may
be about 10 ppm to 30% by weight of chewing gum coating. 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. The active agent will generally be used at a level of
about 12 micrograms to about 250 milligrams per gram of coated
chewing gum product. The active level will generally be based on
the dosage for one or two pellets.
[0054] Conventional panning procedures generally coat with sucrose,
but recent advances in panning have allowed other carbohydrate
materials to be used in place of sucrose. Some of these components
include, but are not limited to, dextrose, maltose, palatinose,
xylitol, lactitol, hydrogenated isomaltulose, erythritol, maltitol,
and other new alditols or combinations thereof. These materials may
be blended with panning modifiers including, but not limited to,
gum arabic, 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, insoluble carbonates
like calcium carbonate or magnesium carbonate and talc. Antitack
agents may also be added as panning modifiers, which allow the use
of a variety of carbohydrates and sugar alcohols to be used in the
development of new panned or coated gum products. Flavors may also
be added with the sugar or sugarless coating and with the active to
yield unique product characteristics.
[0055] Another type of pan coating could also isolate the
lipophilic active agent from the chewing gum ingredients. This
technique is referred to as a film coating and is more common for
pharmaceuticals than in chewing gum, but procedures are similar. A
film like shellac, zein, or cellulose type material is applied onto
a pellet-type product forming a thin film on the surface of the
product. The film is applied by mixing the polymer, plasticizer and
a solvent (pigments are optional) and spraying the mixture onto the
pellet surface. This is done in conventional type panning
equipment, or in more advanced side-vended coating pans. Since
lipophilic active agents will be alcohol soluble, they may be
readily added with this type of film. When a solvent like an
alcohol is used, extra precautions are needed to prevent fires and
explosions, and specialized equipment must be used.
[0056] Some film polymers can use water as the solvent in film
coating. Recent advances in polymer research and in film coating
technology eliminates the problem associated with the use of
solvents in coating. These advances make it possible to apply
aqueous films to a pellet or chewing gum product. Some lipophilic
active agents can be suspended in this aqueous film or even an
alcohol solvent film, in which an active agent is highly soluble.
This film may also contain a flavor along with a polymer and
plasticizer. The active agent can also be suspended in the aqueous
or non-aqueous solvent and coated on the surface with the aqueous
film. In some instances a combination of film and sugar or polyol
coating may be useful, especially if the active agent is added with
the film coating material. Also the film coating may be applied
early, middle, or late in the coating process. This will give a
unique release of active agent from a film-coated product.
[0057] After a coating film with a lipophilic active medicament is
applied to a chewing gum product, a hard shell sugar or polyol
coating may then be applied over the film coated product. In some
instances a soft shell sugar or polyol coating may also be used
over the film coated product. The level of film coating applied to
a pellet gum may be generally from about 0.5% to about 3% of the
gum product. The level of overcoating of the hard or soft shell may
be about 20% to about 75%. When the active agent is added with the
film coating and not with the sugar/polyol coating, better control
of the amount of active agent in the product may be obtained. In
addition, the sugar/polyol overcoating may give an improved
stability to the active agent in the product.
[0058] As noted above, the coating may contain ingredients such as
flavoring agents, as well as artificial sweeteners and dispersing
agents, coloring agents, film formers and binding agents. Flavoring
agents contemplated by the present invention include those commonly
known in the art such as essential oils, synthetic flavors or
mixtures thereof, including but not limited to oils derived from
plants and fruits such as citrus oils, fruit essences, peppermint
oil, spearmint oil, other mint oils, clove oil, oil of wintergreen,
anise and the like. The flavoring agents may be used in an amount
such that the coating will contain from about 0.2% to about 3%
flavoring agent, and preferably from about 0.7% to about 2.0%
flavoring agent. Active agents may be preblended with the flavor
used in the coating.
[0059] Artificial sweeteners contemplated for use in the coating
include but are not limited to synthetic substances, saccharin,
thaumatin, alitame, saccharin salts, aspartame, N-substituted APM
derivatives such as neotame, sucralose and acesulfame-K. The
artificial sweetener may be added to the coating syrup in an amount
such that the coating will contain from about 0.01% to about 0.5%,
and preferably from about 0.1% to about 0.3% artificial
sweetener.
[0060] Dispersing agents are often added to syrup coatings for the
purpose of whitening and tack reduction. Dispersing agents
contemplated by the present invention to be employed in the coating
syrup include titanium dioxide, talc, or any other antistick
compound. Titanium dioxide is a presently preferred dispersing
agent of the present invention. The dispersing agent may be added
to the coating syrup in amounts such that the coating will contain
from about 0.1% to about 1%, and preferably from about 0.3% to
about 0.6% of the agent.
[0061] Coloring agents are preferably added directly to the syrup
in a dye or lake form. Coloring agents contemplated by the present
invention include food quality dyes. Film formers preferably added
to the syrup include methyl cellulose, gelatins, hydroxypropyl
cellulose, ethyl cellulose, hydroxyethyl cellulose, carboxymethyl
cellulose and the like and combinations thereof. Binding agents may
be added either as an initial coating on the chewing gum center or
may be added directly into the syrup. Binding agents contemplated
by the present invention include gum arabic, gum talha (another
type of acacia), alginate, cellulosics, vegetable gums and the
like.
[0062] The coating is initially present as a liquid syrup which
contains from about 30% to about 80% or 85% of the coating
ingredients previously described herein, and from about 15% or 20%
to about 70% of a solvent such as water. In general, the coating
process is carried out in a rotating pan. Sugar or sugarless gum
center tablets to be coated are placed into the rotating pan to
form a moving mass.
[0063] The material or syrup which will eventually form the coating
is applied or distributed over the gum center tablets. Flavoring
agents may be added before, during and after applying the syrup to
the gum centers. Once the coating has dried to form a hard surface,
additional syrup additions can be made to produce a plurality of
coatings or multiple layers of hard coating.
[0064] In a hard coating panning procedure, syrup is added to the
gum center tablets at a temperature range of from about 100.degree.
F. to about 240.degree. F. Mostly, the syrup temperature is from
about 130.degree. F. to about 200.degree. F. throughout the process
in order to prevent the polyol or sugar in the syrup from
crystallizing. The syrup may be mixed with, sprayed upon, poured
over, or added to the gum center tablets in any way known to those
skilled in the art.
[0065] In general, a plurality of layers is obtained by applying
single coats, allowing the layers to dry, and then repeating the
process. The amount of solids added by each coating step depends
chiefly on the concentration of the coating syrup. Any number of
coats may be applied to the gum center tablet. Generally, no more
than about 75-100 coats are applied to the gum center tablets. The
present invention contemplates applying an amount of syrup
sufficient to yield a coated comestible containing about 10% to
about 75% coating. Where higher dosage of an active agent is
needed, the final product may be higher than 75% coating.
[0066] Those skilled in the art will recognize that in order to
obtain a plurality of coated layers, a plurality of premeasured
aliquots of coating syrup may be applied to the gum center tablets.
It is contemplated, however, that the volume of aliquots of syrup
applied to the gum center tablets may vary throughout the coating
procedure.
[0067] Once a coating of syrup is applied to the gum center
tablets, the present invention contemplates drying the wet syrup in
an inert medium. A preferred drying medium comprises air. Forced
drying air contacts the wet syrup coating in a temperature range of
from about 70.degree. to about 115.degree. F. Generally, the drying
air is in the temperature range of from about 80.degree. to about
100.degree. F. The invention also contemplates that the drying air
possess a relative humidity of less than about 15 percent.
Preferably, the relative humidity of the drying air is less than
about 8 percent.
[0068] The drying air may be passed over and admixed with the syrup
coated gum centers in any way commonly known in the art. Generally,
the drying air is blown over and around or through the bed of the
syrup coated gum centers at a flow rate, for large scale
operations, of about 2800 cubic feet per minute. If lower
quantities of material are being processed, or if smaller equipment
is used, lower flow rates would be used.
[0069] For many years, flavors have been added to a sugar coating
of pellet gum to enhance the overall flavor of the gum. These
flavors include spearmint flavor, peppermint flavor, wintergreen
flavor, and fruit flavors. These flavors are generally preblended
with the coating syrup just prior to applying it to the core, or
added together with the syrup in one or more coating applications
in a revolving pan containing the cores. Generally, the coating
syrup is very hot, about 130.degree. to 200.degree. F., and the
flavor may volatilize if preblended with the coating syrup too
early.
[0070] The concentrated coating syrup is applied to the gum cores
as a hot liquid, the sugar or polyol allowed to crystallize, and
the coating then dried with warm, dry air. This is repeated in
about 30 to 100 applications to obtain a hard shell coated product
having an increased weight gain of about 40% to 75%. A flavor is
applied with one, two, three or even four or more of these coating
applications. Each time flavor is added, several non-flavored
coatings are applied to cover the flavor before the next flavor
coat is applied. This reduces volatilization of the flavor during
the coating process.
[0071] For mint flavors such spearmint, peppermint and wintergreen,
some of the flavor components are volatilized, but sufficient
flavor remains to give a product having a strong, high impact
flavor. Fruit flavors, that may contain esters, are more easily
volatilized and may be flammable and/or explosive and therefore,
generally these type of fruit flavors may be pretreated in order to
be able to add them to a gum coating.
[0072] In an embodiment of this invention, a lipophilic active
agent is preblended with a gum arabic solution to become a paste
and then applied to the cores. To reduce stickiness, the preblend
may be mixed with a small amount of coating syrup before being
applied. Forced air drying is then continued as the gum arabic
binds the active agent to the cores. Then additional coatings are
applied to cover the active agent and imbed the active agent in the
coatings.
GUM FORMULATION EXAMPLES
[0073] The following examples of the invention and comparative
examples are provided by way of explanation and illustration.
[0074] As noted earlier, the gum formulas can be prepared as sugar
or sugarless type formulations. These formulas are made in a pellet
or pillow shape pellet or a round ball or any other shape of
product for coating/panning. However, gum formulas for pellet
centers are generally adjusted to a higher level of gum base than
stick gum to give a more consumer acceptable size of gum bolus.
[0075] Keeping this in mind, if a coating of about 25% of the total
product is added to a pellet core as sugar or polyols, the gum base
in the pellet core should also be increased by 25%. Likewise, if a
33% coating is applied, the base levels should also be increased by
33%. As a result, gum centers are usually formulated with about 25%
to about 40% gum base with a corresponding decrease in the other
ingredients except flavor. Even higher levels of base may be used
when an active agent is added to a pellet coating. Generally
flavors increase with the level of gum base as the base tends to
bind flavors into the gum and more flavor is needed to give a good
flavorful product. However flavors can also be added to the coating
to give increased flavor impact and more flavor perception.
EXAMPLES
[0076] Conventional coated gum compositions may contain a
lipophilic active agent in the gum coating. When this composition
is chewed for 30 minutes about 50% of the lipophilic active
releases from the chewed gum as determined by gum bolus analysis.
It was believed that the lipophilic active agent was being bound
into the lipophilic gum base composition and not being released. As
a result, tests were made comparing conventional gum bases and
their release of a lipophilic active agent from conventional
non-coated gum formulations.
[0077] The following tests of gum bases were made with the
following gum formula:
1 % Base 19.65 Sugar 53.68 39 DE, 43 Be syrup 13.33 Dextrose,
Monohydrate 9.90 Glycerin 1.29 Peppermint flavor 0.90 Lecithin 0.25
Vitamin E acetate 1.00 100,00
[0078] Several conventional and non-conventional bases formulations
were first tested.
2 Comparative Comparative Comparative Example A Example B* Example
C Glycerol Ester of Hyd. Rosin 20.4% -- -- Butyl Rubber -- 2.0% --
Terpene Resins -- -- 25.9% Isobutylene/isoprene/ -- -- 10.3%
copolymer High MW PVAc 36.9% 31.5% -- Low MW PVAc -- 43.75% 27.3%
Polyisobutylene 11.9% 6.0% 2.3% Glycerol Triacetate 5.7% 6.75% --
Glycerol Monostearate 4.5% -- 4.7% Acetylated Monoglycerides 3.9%
-- -- Hydrogenated Vegetable Oil -- -- 3.2% Wax -- -- 12.4%
Lecithin -- -- 1.4% Talc 16.7% -- -- Color -- -- 0.6% Calcium
Carbonate -- 10.0% 11.9% 100.0% 100.0% 100.0% Vitamin E released**
0.21% 2.88% 0.52% *Example 1 base formulation from U.S. Pat. No.
5,601,858. **Vitamin E acetate released from gum bolus after 30
minutes chewing.
[0079] In order to increase the release of vitamin E acetate from
the gum bolus during chewing, the following hydrophilic gum bases
were made:
3 Example Example Example Example 1 2 3 4 % % % % High MW PVAc
31.000 28.630 27.600 27.280 Low MW PVAc 43.00 39.795 38.400 37.840
Oat Fiber 12.00 11.100 10.000 22.560 Glycerol Triacetate 7.000
6.475 10.000 6.160 MCTs*** 7.000 14.000 14.000 6.160 100 100 100
100 Vitamin E released** 34.2 59.0 57.0 43.1 ***Medium chain
triglycerides
[0080] Chewing gum formulations were made from these base
compositions using the gum formula noted previously and the gum
bolus was analyzed for vitamin E acetate after 30 minutes of
chewing. These results, which show the amount of vitamin E acetate
released, indicate that the hydrophilic base compositions above
gave an improved release of vitamin E acetate, a lipophilic active
agent. A hydrophilic base should release at least 10% of a
lipophilic active agent, and more preferably at least 30% within 30
minutes of chewing. If this type of base can be used to give an
improved release from the gum, then using it as part of a gum core
and adding the lipophilic active agent to the gum coating, the
release should be even greater still.
[0081] The following gum base and gum formula was made into pellets
for coating:
4 Example 5 Base Formula % High MW PVAc 26.35 Low MW PVAc 36.65
Calcium Carbonate 10.00 Glycerol Triacetate 13.00 MCTs 14.00
100.00
[0082]
5 Example 5 Gum Formula % Base 33.00 Calcium Carbonate 13.00
Sorbitol Powder 39.70 Glycerin 12.00 Peppermint Flavor 0.96
Encapsulated Sweeteners 1.34 100.00
[0083] These centers were then precoated with a mannitol Quick Coat
material from Wolf & Olsen. Precoat was done by making a 40%
solution of Quick Coat and applying to the gum centers to wet the
centers and then applying a dry charge of the powder Quick Coat
material. This was done twice as a precoat. Then a hard shell
coating of xylitol with Vitamin E acetate was applied to 1 Kg of
centers to the following formula:
6 Example 5 Coating Formula, grams Syrup 1 Syrup 2 Xylitol 509 509
Water 90 90 40% Gum Talha Solution 168.5 168.5 Titanium Dioxide 3 3
Peppermint Flavor* 4 -- Vitamin E Acetate** 16 -- *Flavor added
with two applications (about 10th and 20th coat) **Liquid vitamin E
acetate added in 4 application between flavor applications.
[0084] The gum center weight was 1.25 grams per piece and was
coated to a 1.91 grams per piece weight to give a 34.5% coating.
Although nearly all of the acetate is released in 10 minutes,
coated gum product was chewed for 30 minutes and the gum bolus was
analyzed for vitamin E acetate and gave an 80.8% release. This is
much higher than previous amounts of lipophilic actives being
released from conventional coated gum formulations.
[0085] It should be appreciated that the compositions and methods
of the present invention are capable of being incorporated in the
form of a variety of embodiments, only a few of which have been
illustrated and described above. The invention may be embodied in
other forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative and not restrictive, and the
scope of the invention, therefore, indicated by the appended claims
rather than by the foregoing description. All changes which come
within the meaning and range of equivalency of the claims are to be
embraced within their scope.
* * * * *