U.S. patent application number 10/436536 was filed with the patent office on 2003-11-06 for chewing gum containing a nutritional supplemental.
This patent application is currently assigned to Deseret Laboratories, Inc.. Invention is credited to Gubler, Scott A..
Application Number | 20030206993 10/436536 |
Document ID | / |
Family ID | 25541590 |
Filed Date | 2003-11-06 |
United States Patent
Application |
20030206993 |
Kind Code |
A1 |
Gubler, Scott A. |
November 6, 2003 |
Chewing gum containing a nutritional supplemental
Abstract
A chewing gum tablet is prepared by cooling a chewing gum
composition to a temperature at which the gum composition is
brittle, and grinding the cooled, brittle gum composition to form a
chewing gum powder. The gum composition can be cooled by mixing it
with a coolant, such as solid carbon dioxide, prior to grinding.
The chewing gum powder is mixed with an active composition
comprising a nutritional supplement, such as one or more vitamins,
minerals, or herbs, to form a nutritional supplement-containing
powder. The mixture of gum powder and the nutritional supplement,
along with other optional additives, is then granulated to form
nutritional supplement-containing granules. These granules are then
compressed to form chewing gum tablets.
Inventors: |
Gubler, Scott A.; (St.
George, UT) |
Correspondence
Address: |
David O. Seeley
WORKMAN, NYDEGGER & SEELEY
P.O. Box 45862
SALT LAKE CITY
UT
84145
US
|
Assignee: |
Deseret Laboratories, Inc.
|
Family ID: |
25541590 |
Appl. No.: |
10/436536 |
Filed: |
May 13, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10436536 |
May 13, 2003 |
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09995260 |
Nov 27, 2001 |
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6582738 |
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09995260 |
Nov 27, 2001 |
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09394217 |
Sep 13, 1999 |
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6322828 |
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Current U.S.
Class: |
426/5 |
Current CPC
Class: |
A23G 4/04 20130101; A23G
4/18 20130101; A23G 4/126 20130101; A61K 9/0058 20130101; A23G 4/02
20130101; A23G 7/02 20130101; A23G 4/064 20130101; A23G 4/068
20130101; A61K 9/2095 20130101; A23G 4/00 20130101; A23G 4/06
20130101 |
Class at
Publication: |
426/5 |
International
Class: |
A23G 003/30 |
Claims
What is claimed and desired to be secured by United States Letters
Patent is:
1. A process for preparing a chewing gum tablet, the process
comprising: cooling a chewing gum composition to a temperature at
which the gum composition is brittle; grinding the cooled chewing
gum composition to form a chewing gum powder; mixing the chewing
gum powder with an active composition comprising a nutritional
supplement to form a nutritional supplement-containing powder;
granulating the nutritional supplement-containing powder to form a
plurality of nutritional supplement-containing granules; and
forming the nutritional supplement-containing granules into one or
more chewing gum tablets.
2. The process of claim 1, wherein the cooling of the chewing gum
composition comprises contacting the chewing gum composition with a
coolant comprising a non-reactive substance capable of cooling the
chewing gum composition to the brittle temperature.
3. The process of claim 2, wherein the coolant comprises solid
carbon dioxide.
4. The process of claim 1, wherein the grinding of the cooled
chewing gum composition is carried out in the presence of a coolant
in contact with the chewing gum composition, the coolant comprising
a non-reactive substance.
5. The process of claim 4, wherein the coolant comprises solid
carbon dioxide.
6. The process of claim 1, wherein the cooling and grinding are
carried out by mixing the chewing gum composition with solid carbon
dioxide and grinding the chewing gum and solid carbon dioxide
mixture.
7. The process of claim 6, wherein the chewing gum composition is
mixed with solid carbon dioxide and an anti-caking agent.
8. The process of claim 1, wherein the cooling and grinding are
carried out by: providing a mixture of the chewing gum composition,
solid carbon dioxide, and an anti-caking agent; grinding the
mixture in a first grinding step; adding additional amounts of
solid carbon dioxide and anti-caking agent to the ground mixture;
and further grinding the mixture in a second grinding step.
9. The process of claim 8, wherein the anti-caking agent comprises
precipitated silicon dioxide.
10. The process of claim 1, wherein the chewing gum composition is
cooled to a temperature below about -30.degree. C.
11. The process of claim 1, wherein the granulating is carried out
in a fluid bed granulator.
12. The process of claim 11, further comprising coating the
nutritional supplement-containing powder in the fluid bed
granulator with a coating agent.
13. The process of claim 1, wherein the chewing gum powder is mixed
with one or more additives prior to granulating, the additives
selected from the group consisting of coating agents, binders,
lubricants, and sweeteners.
14. The process of claim 1, wherein the nutritional supplement
comprises one or more vitamins.
15. The process of claim 14, wherein the one or more vitamins are
selected from the group consisting of vitamin A, vitamin C, vitamin
D, vitamin E, vitamin K, vitamin B.sub.6, vitamin B.sub.12,
thiamine, riboflavin, biotin, folic acid, niacin, pantothenic acid,
and mixtures thereof.
16. The process of claim 1, wherein the nutritional supplement
comprises one or more mineral nutrients.
17. The process of claim 16, wherein the one or more mineral
nutrients comprise one or more elements selected from the group
consisting of sodium, potassium, calcium, magnesium, phosphorus,
sulfur, chorine, iron, copper, iodine, zinc, selenium, manganese,
chromium, molybdenum, fluorine, cobalt, and combinations
thereof.
18. The process of claim 1, wherein the nutritional supplement
comprises one or more vitamins and one or more mineral
nutrients.
19. The process of claim 1, wherein the nutritional supplement
comprises one or more herbs.
20. The process of claim 19, wherein the nutritional supplement
comprises a mixture of different herbs.
21. The process of claim 1, wherein the nutritional
supplement-containing granules have an average size of about 15
mesh to about 30 mesh.
22. A process for preparing a chewing gum tablet, the process
comprising: providing a mixture comprising a chewing gum
composition and solid carbon dioxide; grinding the mixture to form
a chewing gum powder; removing the solid carbon dioxide from the
chewing gum powder; mixing the chewing gum powder with a an active
composition comprising a nutritional supplement to form a
nutritional supplement-containing powder; granulating the
nutritional supplement-containing powder to form a plurality of
nutritional supplement-containing granules; and compressing the
nutritional supplement-containing granules into one or more chewing
gum tablets.
23. The process of claim 22, wherein the mixture further comprises
an anticaking agent.
24. The process of claim 23, wherein the anti-caking agent
comprises precipitated silicon dioxide.
25. The process of claim 23, wherein the grinding step comprises:
grinding the mixture in a first grinding step; adding additional
amounts of solid carbon dioxide and anti-caking agent to the ground
mixture; and further grinding the ground mixture in a second
grinding step to form the chewing gum powder.
26. The process of claim 22, wherein the removing of the solid
carbon dioxide from the chewing gum powder comprises storing the
chewing gum powder for a sufficient time such that substantially
all of the solid carbon dioxide sublimes.
27. The process of claim 22, wherein the removing of the solid
carbon dioxide from the chewing gum powder comprises processing the
chewing gum powder and the solid carbon dioxide in a fluid bed
granulator.
28. The process of claim 22, wherein the chewing gum powder is
mixed with one or more additives prior to granulating, the
additives selected from the group consisting of coating agents,
binders, lubricants, and sweeteners.
29. The process of claim 22, wherein the nutritional supplement
comprises one or more vitamins.
30. The process of claim 29, wherein the one or more vitamins are
selected from the group consisting of vitamin A, vitamin C, vitamin
D, vitamin E, vitamin K, vitamin B.sub.6, vitamin B.sub.12,
thiamine, riboflavin, biotin, folic acid, niacin, pantothenic acid,
and mixtures thereof.
31. The process of claim 22, wherein the nutritional supplement
comprises one or more mineral nutrients.
32. The process of claim 31, wherein the one or more mineral
nutrients comprise one or more elements selected from the group
consisting of sodium, potassium, calcium, magnesium, phosphorus,
sulfur, chorine, iron, copper, iodine, zinc, selenium, manganese,
chromium, molybdenum, fluorine, cobalt, and combinations
thereof.
33. The process of claim 22, wherein the nutritional supplement
comprises one or more vitamins and one or more mineral
nutrients.
34. The process of claim 22, wherein the nutritional supplement
comprises one or more herbs.
35. A chewing gum tablet produced by the process of claim 22.
36. A chewing gum tablet produced by a process comprising: cooling
a chewing gum composition to a temperature at which the gum
composition is brittle; grinding the cooled chewing gum composition
to form a chewing gum powder; mixing the chewing gum powder with an
active composition comprising a nutritional supplement to form a
nutritional supplement-containing powder; granulating the
nutritional supplement-containing powder to form a plurality of
nutritional supplement-containing granules; and forming the
nutritional supplement-containing granules into a tablet.
37. The chewing gum tablet of claim 36, wherein the nutritional
supplement comprises one or more vitamins.
38. The chewing gum tablet of claim 36, wherein the nutritional
supplement comprises one or more mineral nutrients.
39. The chewing gum tablet of claim 36, wherein the nutritional
supplement comprises one or more vitamins and one or more mineral
nutrients.
40. The chewing gum tablet of claim 36, wherein the nutritional
supplement comprises one or more herbs.
41. A chewing gum tablet, comprising: a plurality of granulated
particles compressed to form a tablet, the granulated particles
comprising: a chewing gum composition; and a nutritional supplement
comprising one or more herbs.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of application Ser. No.
09/995,260, filed on Nov. 27, 2001, which is a continuation-in-part
of U.S. application Ser. No. 09/394,217, filed on Sep. 13, 1999,
now U.S. Pat. No. 6,322,828 B1, both of which are incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to processes for producing
chewing gums containing active ingredients. In particular, the
present invention relates to a process for preparing a chewing gum
tablet containing one or more nutritional supplements.
[0004] 2. Background Technology
[0005] Conventional chewing gum processing technology involves
melting a gum base in, for example, a sigma blender, and adding
components such as sweeteners and flavorants to the melt. The
melted mass is then extruded, rolled into sheets, and cut to the
desired shape on the rollers. This conventional technology,
however, suffers from several disadvantages when applied to the
preparation of chewing gums containing active ingredients. For
example, the elevated temperatures used in forming the melt can
adversely affect the chemical stability of any active ingredients
contained therein. In addition, the melting and mixing process for
the highly viscous gum mass makes controlling the accuracy and
uniformity of the amount of active ingredient difficult, and this
difficulty is further exacerbated by the lack of a precise form,
shape or weight of the gum product. In addition, conventional gum
processing technology is generally poorly suited for high-speed,
low cost production of gum products having active ingredients.
[0006] Several patents are directed to methods of processing
chewing gums which attempt to overcome some of the disadvantages
described above. For example, U.S. Pat. No. 4,000,321 to Mochizuki
et al. is directed to a process for preparing chewing gum, in which
a chewing gum composition is cooled to -15.degree. C. to facilitate
fragmentation, and the cooled composition is pulverized with a
crusher, hammer mill, pelletizer or turbomill. The pulverized
product is then melted to cause the pulverized pieces to co-adhere,
forming a chewing gum reportedly having low specific gravity and a
soft chewing texture. The process, however, suffers from all of the
disadvantages associated with heating, process speed, poorly
defined forms and weights described above, and is not well-suited
for making a chewing gum dosage form containing an active
ingredient.
[0007] U.S. Pat. No. 5,711,961 to Reiner et al. discloses a
pharmaceutical chewing gum composition in tablet form made by
freezing chewing gum, grinding the gum in a mill, and granulating
the ground gum in a fluid bed. Thereafter, a medicinal active agent
is mixed with the granulate, and the granulates are compressed into
tablets.
[0008] In U.S. Pat. No. 4,975,270 to Kehoe, a medicament-active
chewing gum is disclosed which is made by freezing and grinding
into a particle mass an elastomer, an active agent, and silica in
the presence of liquefied carbon dioxide. The particles are then
shaped into a chewing gum product. In the process of Kehoe, the gum
and the active ingredient are mixed together while heating, and
then the mixture is frozen and ground into particles.
[0009] In U.S. Pat. No. 4,753,805 to Cherukuri et al. a chewing gum
composition in the form of a tablet having a low moisture content
is disclosed. The tablet is produced by grinding a chewing gum
composition, granulating the ground composition, blending the
granulated composition with an active agent and a compression aid,
and compressing the granulated product to form a tablet. Grinding
of the chewing gum composition, typically a difficult process
because of the tendency for the gum to stick to the grinding
apparatus, is accomplished by the use of a grinding aid such as an
alkaline metal phosphate, an alkaline earth metal phosphate, or a
maltodextrin. The use of such grinding aids, however, is
disadvantageous. The metal phosphate salts are highly alkaline, and
such alkalinity may be incompatible with certain active
ingredients. In addition, the grinding aid remains in the
composition and ultimately in the chewing gum tablet, and the
presence of a large amount of metal phosphate is potentially
problematic from therapeutic and safety perspectives.
[0010] Thus, there is a need for processes to produce
active-containing chewing gums that do not suffer from the
disadvantages of conventional active-containing chewing gum
formulations.
SUMMARY OF THE INVENTION
[0011] The present invention relates to a process for preparing a
chewing gum tablet containing a nutritional supplement and the
resulting chewing gum tablet product. The process of the invention
includes cooling a chewing gum composition to a temperature at
which the gum composition is brittle, and grinding the cooled,
brittle gum composition to form a chewing gum powder. The
composition can be cooled by mixing it with a coolant, such as
solid carbon dioxide, prior to grinding. The chewing gum powder is
mixed with an active composition comprising a nutritional
supplement, such as one or more vitamins, minerals, or herbs, to
form a nutritional supplement-containing powder. The mixture of
powder and nutritional supplement, along with other optional
additives, is then granulated to form nutritional
supplement-containing granules. These granules are then compressed
to form chewing gum tablets.
[0012] In another aspect, the present invention is directed to a
chewing gum tablet comprising a plurality of granulated particles
compressed to form the tablet. The granulated particles comprise a
chewing gum composition and a nutritional supplement, along with
any other ingredients added during processing to form the tablet.
The granules forming the tablet can be of a size suitable for
tabletization methods.
[0013] These and other features of the present invention will
become more fully apparent from the following description and
appended claims, or may be learned by the practice of the invention
as set forth hereinafter.
DETAILED DESCRIPTION OF THE INVENTION
[0014] The present invention is directed to a process for preparing
a chewing gum tablet containing a nutritional supplement and the
resulting chewing gum tablet product. The process of the invention
generally includes cooling a chewing gum composition to a
temperature at which the composition is brittle, and grinding the
cooled, brittle chewing gum composition to form a chewing gum
powder. The chewing gum powder is mixed with a nutritional
supplement, such as one or more vitamins, minerals, or herbs, to
form a nutritional supplement-containing powder. The mixture of
chewing gum powder and nutritional supplement, along with other
optional additives, is then granulated to form nutritional
supplement-containing granules. These granules are then compressed
to form chewing gum tablets. Each of these process steps will be
discussed in further detail as follows.
[0015] In an initial step of the process of the invention, a
chewing gum composition is cooled to a temperature at which the
composition is brittle. The chewing gum composition can be any
chewing gum formulation, such as conventional gum compositions
known in the art. In general, such gum compositions include a
chewing gum base, to which may be added conventional flavorants,
sweeteners, colorants, and other ingredients known in the art. The
chewing gum base is typically a natural or synthetic elastomer,
such as rubber, chicle, lechi caspi, jelutong, polyisobutylene, an
isobutylene-isoprene copolymer, a styrene-butadiene copolymer, or
other suitable gum bases known in the art. In order to facilitate
the subsequent grinding step, the chewing gum composition is
preferably in the form of chips, pellets, or other relatively small
particles.
[0016] In cooling the chewing gum composition to a temperature at
which the composition is brittle, it should be appreciated that
even a mildly cooled chewing gum composition will possess some
degree of brittleness. However, to be suitable for the process of
the present invention, the composition is cooled to a temperature
at which the composition is sufficiently brittle such that the
brittleness is maintained during the subsequent grinding step
without adhesion to the grinding apparatus. The appropriate
temperature is determined in part by the specific composition of
the chewing gum, and is easily determined empirically by observing
the properties of the cooled chewing gum composition. Thus, a
chewing gum composition cooled to a temperature sufficiently low
can be ground in, for example, a mill grinder, without the
composition sticking to the grinder parts. The chewing gum
composition can be cooled to a temperature of less than about
-15.degree. C., preferably less than about -30.degree. C., and more
preferably less than about -40.degree. C.
[0017] The cooling of the gum composition can be carried out by any
of a variety of cooling processes. The chewing gum composition can
be frozen in a conventional freezer apparatus capable of reaching
the very low temperatures needed to achieve the requisite
brittleness. Preferably, however, the chewing gum composition is
cooled by contacting it with a coolant. The coolant can be any
substance capable of cooling the chewing gum composition to the
desired temperature and can be, for example, a cryogenic liquid
such as liquid nitrogen, a cold solid such as solid carbon dioxide,
or a cold gas such as the gaseous boil-off from a cryogenic liquid.
The coolant should be chosen so that the coolant does not interact
adversely with the chewing gum composition or with the mixing or
grinding apparatus used in the present process. In addition, the
coolant should not produce a substance that upon warming produces
such adverse interactions, or that leaves a residue that adversely
affects subsequent processing or presents potential safety hazards
when the chewing gum tablet is chewed. For example, a coolant such
as water ice, even if cooled to a sufficiently low temperature,
would not be preferred, as any water ice that melts will form
liquid water, which is absorbed by the chewing gum composition.
Likewise, a coolant such as a hydrocarbon slush would not be
preferred, since any hydrocarbon residue remaining in the chewing
gum composition would present potential safety hazards when the
chewing gum tablet is consumed.
[0018] In accordance with the present invention, and in a
particularly preferred aspect, it has been surprisingly found that
by mixing a chewing gum composition with solid carbon dioxide (dry
ice), the chewing gum composition can be cooled to a brittle
temperature without the undesirable effects discussed above. At the
sublimation temperature, -78.5.degree. C., solid carbon dioxide is
sufficiently cold to ensure that the chewing gum composition is
suitably brittle. Of course, the solid carbon dioxide can be cooled
to an even lower temperature, if desired. Upon warming, the solid
carbon dioxide sublimes to form carbon dioxide gas, which does not
react with the chewing gum composition, is not absorbed by the
composition, and does not interact adversely with processing
apparatuses. Further, the gaseous, non-reactive nature of the
sublimation product ensures that no undesirable and potentially
hazardous residue of the coolant remains in the chewing gum tablet
product. Preferably, the solid carbon dioxide coolant is provided
in pelletized form to facilitate further processing steps.
[0019] Alternatively, the steps of cooling the chewing gum
composition and grinding the composition can be combined into a
single step by, for example, cooling the grinding apparatus itself,
such as by contacting the grinding apparatus with a coolant. For
example, in this alternative aspect, the grinding apparatus can be
placed in a cooling jacket of liquid nitrogen or other cold liquid.
For more efficient cooling, in this embodiment, the chewing gum
composition is preferably pre-cooled, although the pre-cooling need
not be to a temperature as low as the brittle temperature. It
should be appreciated that even in the embodiment where the chewing
gum composition is cooled my mixing it with a coolant, it may also
be advantageous to cool the grinding apparatus as well.
[0020] If desired, the chewing gum composition can be mixed with an
anti-caking agent prior to the grinding step. Such anti-caking
agents are known in the art. A preferred anticaking agent is
precipitated silicon dioxide (silica). When the chewing gum
composition is mixed with solid carbon dioxide and an anti-caking
agent prior to grinding, the anticaking agent helps to prevent
agglomeration of the subsequently ground chewing gum particles,
upon sublimation of the solid carbon dioxide.
[0021] If a coolant, such as solid carbon dioxide, and other
components, such as an anticaking agent are used, the chewing gum
composition and other substances can be combined using a
conventional mixing apparatus, such as a vented V-blender.
[0022] The mixture of the chewing gum composition, and other
components such as coolant and anti-caking agent, is then ground to
form a fine chewing gum powder. The grinding can be carried out
using any conventional grinding apparatus, such as a mill grinder.
In one embodiment, a mixture of a chewing gum composition, solid
carbon dioxide, and precipitated silica is provided, and the
mixture is introduced into a mill grinder. The mixture is ground to
a fine powder, and the solid carbon dioxide remains present during
the grinding process. It has been surprisingly found that by
co-grinding the chewing gum composition and solid carbon dioxide,
the chewing gum composition can be ground into a fine powder,
without any adverse adhesion to the grinding apparatus.
[0023] The desired properties of the ground chewing gum composition
are better achieved when the composition is kept at a very low
temperature throughout the grinding process. Thus, in a
particularly preferred process, a mixture of chewing gum
composition, solid carbon dioxide and precipitated silica is ground
in a mill grinder in a first grinding step, additional solid carbon
dioxide and precipitated silica are added to the ground mixture,
and the mixture is further ground in a second grinding step. This
two-step grinding process advantageously keeps the chewing gum
composition at a very low temperature. Although not wishing to be
bound by theory, it is further believed that the presence of the
solid carbon dioxide particles, in addition to providing the
necessary cooling, also serves to enhance the efficiency of the
grinding process. It should be appreciated that although a two-step
grinding process is described herein, the number of steps is not
particularly limited. Thus, a process in which additional solid
carbon dioxide and/or precipitated silica are added in multiple
steps, or even in a slow, continuous stream, may also be used if
desired.
[0024] After the mixture is ground to a powder, the coolant can be
removed by, for example, allowing the coolant to evaporate. When
using solid carbon dioxide, the coolant is removed simply by
allowing the solid carbon dioxide to sublime, releasing harmless
carbon dioxide gas and leaving no undesirable contaminants. The
ground composition can be stored such that the carbon dioxide gas
can escape, as for example in loosely closed plastic bags.
Alternatively, the carbon dioxide can be removed more rapidly by
processing the ground composition in a fluidized bed reactor.
[0025] Once the coolant has been removed from the chewing gum
powder, the powder is mixed with an active composition comprising a
nutritional supplement to form a nutritional supplement-containing
powder. The nutritional supplement can include one or more active
ingredients such as vitamins, mineral nutrients, herbs, other
natural products having nutritional value, such as essential amino
acids, as well as various mixtures or combinations thereof.
[0026] Examples of suitable vitamins for the nutritional supplement
include vitamin A, vitamin C, vitamin D, vitamin E, vitamin K,
vitamin B.sub.6, vitamin B.sub.12, thiamine, riboflavin, biotin,
folic acid, niacin, pantothenic acid, and mixtures thereof.
Examples of suitable mineral nutrients include those having one or
more elements selected from sodium, potassium, calcium, magnesium,
phosphorus, sulfur, chorine, iron, copper, iodine, zinc, selenium,
manganese, chromium, molybdenum, fluorine, cobalt, and combinations
thereof.
[0027] Various herbs can be utilized in the nutritional supplement.
The herbs are generally selected from those which have various
medicinal or dietary supplement properties. Herbs are generally
aromatic plants or plant parts that can be used medicinally or for
flavoring. Suitable herbs can be used singly or in various mixtures
in the chewing gum composition of the invention.
[0028] The chewing gum powder can also be mixed with other
ingredients as desired, before forming the powder into a tablet.
Such ingredients can be any ingredient known to be incorporated
into chewing gum and not incompatible with tablet formation, such
as coating agents, binders, lubricants, sweeteners, as well as
other active ingredients, and the like.
[0029] The foregoing ingredients can be combined with the chewing
gum powder by blending, such as in a sigma mill, or a high shear
mixer. If a conventional blending apparatus is used, the powder
mixture can include sufficient amounts of binder to enable
effective processing of the mixture. Such binders, well-known in
the art, are typically aqueous, and the large amounts of aqueous
binder necessary to enable tabletization from a blended mixture are
not preferred, as the mixture tends to swell and to develop a
disadvantageous stickiness that makes tabletization less efficient.
However, although not preferred, such blending processes can still
be used in the process of the present invention.
[0030] In a preferred process, it has been surprisingly found that
the powdered chewing gum produced by the process described above
can be combined with other ingredients, such as nutritional
supplements and other additives, in a fluidized bed reactor. The
use of a fluidized bed reactor is particularly advantageous, as the
process in the reactor partially rebuilds the powder into granules,
as well as coats the powder particles and/or granules with a
coating agent if used, thereby minimizing undesired particle
agglomeration. In this embodiment, the temperature of the process
should be controlled. If the temperature is too low, the mixture
(the "blend") will stick because of a low evaporation rate as the
binding solution is sprayed on the blend. The granules that develop
are then too large for subsequent tabletization. If the temperature
is too high, the blend can soften, with the same disadvantageous
results. With these considerations in mind, one skilled in the art
can readily determine the appropriate process temperature by
observing and optimizing the properties of the granules produced.
To reduce the processing time, the fluid bed granulator can be
pre-heated to the chosen processing temperature prior to adding the
powder mixture. After granulation, the granulate can be discharged
onto screens, and any granules that are too large can be
removed.
[0031] In a preferred process, the powder mixture, containing the
powdered chewing gum composition, nutritional supplement, and other
additives, is weighed into individual "charges" for the fluid bed
granulator. After processing as described above, and screening, the
individual charges are then preferably recombined and mixed in a
V-blender, and the resultant "cross-blend" is then discharged
across a screen to again remove any granules that are too large. It
is particularly advantageous to sample the cross-blend discharge by
taking multiple samples from the discharge stream, for analysis of
the nutritional supplement. Thus, the discharge mixture can be
stored while the multiple samples are analyzed, to ensure that the
desired level and uniformity of level of the nutritional supplement
are present. If necessary, additional amounts of the nutritional
supplement can then be added to the mixture.
[0032] The discharge mixture is again placed in a V-blender, and
any additional nutritional supplement is added. In addition, an
anti-adherent is preferably added at this time, along with any
other desired excipients or inactive ingredients. A preferred
anti-adherent is talc. The mixture can then be discharged, again
screened, and staged for compression.
[0033] The compression of the granules to form tablets can be
carried out by any conventional process, such as a punching
process. Of course, the punching process should be monitored for
signs of sticking to the punches, and the apparatus cleaned, and/or
coated with additional anti-adherent as needed.
[0034] By granulating the gum powder after mixing it with the
nutritional supplement, the gum powder and the nutritional
supplement are bound together in the granules, which prevents
separation of the nutritional supplement from the gum powder during
the tablet forming process. Thus, a more even mix of gum particles
and nutritional supplement are present in the formed gum
tablets.
[0035] The process of the present invention results in chewing gum
tablets that are precisely and uniformly formed in a well-defined
shape and weight. The process for preparing the chewing gum tablets
is also capable of being carried out in high-speed and efficient
manufacturing facilities.
[0036] In another aspect, the present invention is directed to a
chewing gum tablet comprising a plurality of granulated particles
compressed to form the tablet. The granulated particles comprise a
chewing gum composition and a nutritional supplement, along with
any other ingredients added during processing to form the tablet.
The granules forming the tablet can be of a size suitable for
tabletization, typically from about 15 mesh to about 30 mesh, and
preferably from about 20 mesh to about 25 mesh. The chewing gum
tablets of the invention can be produced by any of the methods
described above. Advantageously, the tablets do not contain any
residue of a grinding aid, such as an alkaline phosphate used in
conventional methods.
[0037] The present invention may be embodied in other specific
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. The scope of
the invention is, 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.
* * * * *