U.S. patent application number 09/893019 was filed with the patent office on 2001-11-29 for remineralizing-mineralizing oral products containing discrete cationic and anionic agglomerate components and method of use.
Invention is credited to Barth, Jordan, Usen, Norman, Winston, Anthony E..
Application Number | 20010046475 09/893019 |
Document ID | / |
Family ID | 23257016 |
Filed Date | 2001-11-29 |
United States Patent
Application |
20010046475 |
Kind Code |
A1 |
Barth, Jordan ; et
al. |
November 29, 2001 |
Remineralizing-mineralizing oral products containing discrete
cationic and anionic agglomerate components and method of use
Abstract
A solid oral product, e.g., chewing gum, lozenge, an edible
foodstuff, and the like, which is useful for remineralizing
subsurface dental lesions and/or mineralizing exposed dentinal
tubules, contains (A) a discrete cationic agglomerate component
composed of at least one water-soluble or partially water-soluble
calcium salt and a first inert solid carrier, and (B) a discrete
anionic agglomerate component composed of at least one
water-soluble orthophosphate salt and a second inert solid carrier.
The agglomerate nature of the cationic and anionic components keeps
these components separate from one another during storage of the
product but allows the cationic and anionic salts to be
simultaneously released from the product upon mixing of the product
with water and/or saliva to form a mixed aqueous solution such that
the solution contains both calcium cations released from the
calcium salt and orthophosphate anions released by the
orthophosphate salt.
Inventors: |
Barth, Jordan; (East
Brunswick, NJ) ; Winston, Anthony E.; (East
Brunswick, NJ) ; Usen, Norman; (Marlboro,
NJ) |
Correspondence
Address: |
Stuart D. Frenkel, Esquire
Liniak, Berenato, Longacre & White
Ste. 240
6550 Rock Spring Drive
Bethesda
MD
20817
US
|
Family ID: |
23257016 |
Appl. No.: |
09/893019 |
Filed: |
June 26, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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09893019 |
Jun 26, 2001 |
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09322918 |
Jun 1, 1999 |
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Current U.S.
Class: |
424/49 |
Current CPC
Class: |
A61Q 11/00 20130101;
A61K 2800/88 20130101; A61K 8/19 20130101; A61K 8/24 20130101 |
Class at
Publication: |
424/49 |
International
Class: |
A61K 007/16 |
Claims
What is claimed is:
1. A solid oral product capable of effecting remineralization of
subsurface dental lesions and/or mineralization of exposed dentinal
tubules, comprising: (A) a discrete cationic agglomerate component
comprising at least one water-soluble or partially water-soluble
calcium salt and a first inert solid carrier, and (B) a discrete
anionic agglomerate component comprising at least one water-soluble
orthophosphate salt and a second inert solid carrier; wherein
components (A) and (B) have a pH in water such that a mixed aqueous
solution formed by mixing components (A) and (B) with water and/or
saliva has a pH of from about 4.5 to about 10.0; further wherein
the cationic and anionic agglomerate components are simultaneously
releasable from the product upon mixing of the product with water
and/or saliva to form the mixed aqueous solution such that the
mixed aqueous solution comprises calcium cations released from the
calcium salt and orthophosphate anions released by the
orthophosphate salt.
2. A product according to claim 1, wherein one or both of the first
and second solid inert carriers is selected from the group
consisting of sorbitol, mannitol, and xylitol.
3. A product according to claim 1, wherein one or both of the first
and second solid inert carriers is an insoluble silica or an
insoluble calcium phosphate.
4. A product according to claim 3, wherein the insoluble calcium
phosphate is selected from the group consisting of dicalcium
phosphate dihydrate, anhydrous dicalcium phosphate, tricalcium
phosphate and calcium hydroxyapatite.
5. A product according to claim 1, wherein one or both of the
cationic and anionic agglomerate components further comprises a
binder.
6. A product according to claim 5, wherein said binder is a polymer
selected from the group consisting of polyvinyl acetate, PVP and
carboxymethyl cellulose.
7. A product according to claim 1, wherein the cationic and anionic
agglomerate components each have an average particle size ranging
from about 20 to about 500 microns.
8. A product according to claim 1, wherein the cationic and anionic
agglomerate components each have an average particle size ranging
from about 30 to about 100 microns.
9. A product according to claim 1, wherein the product has a smooth
consistency and the cationic and anionic agglomerate components
each have an average particle size of from about 30 to about 50
microns.
10. A product according to claim 1, wherein the product has a
crunchy consistency and the cationic and anionic agglomerate
components each have an average particle size of from about 50 to
about 80 microns.
11. A product according to claim 1, wherein components (A) and (B)
have a pH in water such that the mixed aqueous solution has a pH of
from about 5.0 to about 8.0.
12. A product according to claim 1, wherein components (A) and (B)
have a pH in water such that the mixed aqueous solution has a pH of
from about 5.5 to about 7.0.
13. A product according to claim 1, wherein the calcium salt is a
water-soluble calcium salt selected from the group consisting of
calcium chloride, calcium nitrate, calcium acetate, calcium
lactate, calcium gluconate, and mixtures thereof.
14. A product according to claim 1, wherein the calcium salt is
calcium nitrate.
15. A product according to claim 1, wherein the calcium salt is a
partially water-soluble calcium salt selected from the group
consisting of calcium sulfate, anhydrous calcium sulfate, calcium
sulfate hemihydrate, calcium sulfate dihydrate, calcium malate,
calcium tartrate, calcium malonate and calcium succinate.
16. A product according to claim 1, wherein the calcium salt is
calcium sulfate.
17. A product according to claim 1, wherein the orthophosphate salt
is selected from the group consisting of alkali metal salts of
orthophosphoric acid and ammonium salts of orthophosphoric
acid.
18. A product according to claim 1, wherein the orthophosphate salt
is selected from the group consisting of potassium orthophosphate,
sodium orthophosphate, ammonium orthophosphate, monopotassium
orthophosphate, dipotassium orthophosphate, tripotassium
orthophosphate, monosodium orthophosphate, disodium orthophosphate
and trisodium orthophosphate.
19. A product according to claim 1, wherein the cationic
agglomerate component further comprises at least one non-toxic
divalent metal salt other than a calcium salt.
20. A product according to claim 1, wherein the anionic agglomerate
component further comprises at least one water-soluble fluoride
salt.
21. A product according to claim 1, wherein the oral product is
selected from the group consisting of chewing gums, lozenges,
tablets, edible food products, candy, dragees, and pastilles.
22. A product according to claim 1, wherein the solid product is a
chewing gum and the product further comprises (C) a gum base.
23. A method for remineralizing at least one subsurface lesion in
at least one tooth and/or mineralizing at least one exposed
dentinal tubule in the at least one tooth, comprising the steps of:
(1) providing a solid oral product comprising: (A) a discrete
cationic agglomerate component comprising at least one
water-soluble or partially water-soluble calcium salt and a first
inert solid carrier, and (B) a discrete anionic agglomerate
component comprising at least one water-soluble orthophosphate salt
and a second inert solid carrier; wherein components (A) and (B)
have a pH in water such that a mixed aqueous solution formed by
mixing components (A) and (B) with water and/or saliva has a pH of
from about 4.5 to about 10.0; further wherein the cationic and
anionic agglomerate components are simultaneously releasable from
the product upon mixing of the product with water and/or saliva to
form the mixed aqueous solution such that the mixed aqueous
solution comprises calcium cations released from the calcium salt
and orthophosphate anions released by the orthophosphate salt; (2)
contacting the product with water and/or saliva so as to form a
mixed aqueous solution having a pH of from about 4.5 to about 10.0
and comprising calcium cations released by the calcium salt and
orthophosphate ions released by the orthophosphate salt; and (3)
contacting the at least one tooth with the mixed aqueous solution
for a period of time sufficient to allow a
remineralizing/mineralizing amount of the calcium anions and a
remineralizing/mineralizing amount of the orthophosphate anions to
diffuse through the tooth to a subsurface thereof, wherein the
diffused calcium cations and the diffused orthophosphate anions
react together to form calcium hydroxyapatite onto the subsurface
lesion and/or onto the exposed dentinal tubule, thereby
remineralizing said lesion and/or mineralizing said exposed
dentinal tubule.
24. A method according to claim 23, wherein the product provided in
step (1) is a chewing gum, and step (2) is effected by chewing the
product.
25. A method according to claim 23, wherein the product provided in
step (1) is a candy or a lozenge, and step (2) is effected by
sucking the product.
26. A method according to claim 23, wherein the product provided in
step (1) is a toothpowder or a foodstuff, and step (2) is effected
by eating the product.
Description
BACKGROUND OF THE INVENTION
[0001] Cross-reference is made to the following, commonly assigned
U.S. patent applications:
[0002] Ser. No. 08/891,077 (filed Jul. 10, 1997)
[0003] Ser. No. 08/722,457 (filed Sep. 27, 1996)
[0004] Ser. No. 08/722,458 (filed Sep. 27, 1996)
[0005] Ser. No. 08/832,827 (filed Apr. 3, 1997)
[0006] Ser. No. 08/888,623 (filed Jul. 7, 1997)
[0007] Ser. No. 09/005,045 (filed Jan. 9, 1998)
[0008] Cross-reference is also made to the following commonly
assigned U.S. patents:
[0009] U.S. Pat. No. 5,571,502
[0010] U.S. Pat. No. 5,603,922
[0011] U.S. Pat. No. 5,605,675
[0012] U.S. Pat. No. 5,614,175
[0013] U.S. Pat. No. 5,645,853
[0014] U.S. Pat. No. 5,817,296
[0015] U.S. Pat. No. 5,833,957
[0016] U.S. Pat. No. 5,858,333
[0017] U.S. Pat. No. 5,866,102
[0018] U.S. Pat. No. 5,895,641
[0019] This invention is related to oral products capable of
remineralizing subsurface dental lesions and/or mineralizing
exposed dentinal tubules. More particularly, this invention is
related to oral products capable of remineralizing subsurface
dental lesions and/or mineralizing exposed dentinal tubules,
wherein the oral products contain discrete cationic and anionic
phases which do not react with one another prior to use of the
product. This invention is further related to methods of using the
oral products of this invention to remineralize subsurface dental
lesions and/or mineralize exposed dentinal tubules.
[0020] The primary component of the enamel and dentin in teeth is
calcium phosphate in the form of calcium hydroxyapatite. This
material is highly insoluble at normal oral pHs but tends to
dissolve in acidic media. Thus, when teeth are exposed to acids,
e.g., acids generated during the bacteria-induced glycolysis of
sugar in the oral cavity, lesions (i.e., demineralized areas) can
form below the surface of intact enamel. Dental caries, the leading
cause of tooth damage in humans, usually begins with these
subsurface lesions, which are formed before a cavity is even
detectable. If unchecked, the surface enamel above a subsurface
lesion will eventually collapse, leading to cavitation and
subsequent loss of tooth structure.
[0021] Subsurface remineralization can arrest and repair the
carious lesions before any permanent structural damage to the tooth
occurs. Unlike surface remineralization processes, which deposit
calcium phosphate onto the tooth surface, subsurface
remineralization processes precipitate calcium phosphate in the
subsurface enamel where demineralization initially occurs.
[0022] Saliva is supersaturated with calcium and orthophosphate
ions and, therefore, can help protect teeth against
demineralization and remineralize teeth which have become
demineralized. However, because saliva contains only modest levels
of these ions, saliva-promoted remineralization tends to be
slow.
[0023] The remineralization process can be speeded up by increasing
the concentrations of dissolved calcium and orthophosphate ions in
the oral cavity. However, this is not easy to do because, at the pH
levels in the oral cavity, calcium and orthophosphate ions have a
strong affinity for one another and tend to rapidly precipitate
calcium phosphate. If such precipitation occurs too soon,
subsurface remineralization, which requires that the calcium and
orthophosphate ions remain soluble for a period of time sufficient
to permit their diffusion into the demineralized subsurface of the
dental enamel, will be reduced or prevented.
[0024] Thus, to achieve subsurface remineralization, precipitation
of the calcium phosphate must be delayed until sufficient levels of
the calcium and orthophosphate ions have reached the subsurface of
the tooth.
[0025] A number of remineralizing products and methods have been
developed which are designed at least in part to prevent premature
reaction between calcium and orthophosphate ions used in such
product or method. Reference is made, for example, to U.S. Pat.
Nos. 4,083,955; 4,080,440; 4,606,912; 4,610,873; 4,397,837;
4,348,381; 4,177,258; 4,183,915; 4,460,565; 5,037,639; 5,268,167;
5,427,768; 5,437,857; and 5,460,803. Reference is also made to
commonly assigned U.S. Pat. Nos. 5,571,502; 5,603,922; 5,605,675;
5,614,175; 5,645,853; 5,817,296; 5,833,957; 5,858,333; 5,866,102;
and 5,895,641.
[0026] U.S. Pat. No. 4,083,955 (Grabenstetter et al.) discloses a
method for remineralizing subsurface dental enamel, wherein a
calcium salt solution and a phosphate salt solution are
sequentially applied to dental enamel to effect subsurface
remineralization thereof. The delivery system for the calcium and
phosphate salt solutions can be in the form of two separate
delivery vehicles, each containing one component, or in the form of
a single delivery vehicle which contains both components but
releases them sequentially. Examples of two-vehicle systems include
mouthwash-mouthwash, toothpaste-toothpaste, candy drop-candy drop,
nutritional substance-nutritional substance, and
toothpowder-toothpowder. Examples of one-vehicle systems include a
toothpaste wherein one ingredient is encapsulated for delayed
release, a two-compartment bottle, a lozenge with a laminated
structure so that first one ionic ingredient is released and then
the other, a chewing gum made so that one ingredient is released
before the other, and a nutritional substance in which one
ingredient is released before the other.
[0027] U.S. Pat. No. 4,080,440 (DiGiulio et al.) discloses a method
and a two-part product for remineralizing subsurface lesions in
dental enamel, wherein the product contains a cationic part
composed of a water-soluble calcium salt and an anionic part
composed of a water-soluble phosphate salt. Remineralization is
carried out by mixing a solution containing the cationic part with
a solution containing the anionic part to form a metastable
solution which is then promptly applied to the teeth. DiGiulio et
al. teaches that the cationic and anionic parts are stored
separately in the product to avoid premature precipitation of
calcium phosphate. The product, examples of which include two-part
mouthwashes and two-part toothpastes, may be in the form of a kit
composed of separately packaged solutions of the respective cations
and anions. As a two-part toothpaste, the product may be packaged
in a codispensing toothpaste tube.
[0028] U.S. Pat. Nos. 4,606,912 and 4,610,873 (both to Rudy et al.)
are each directed to an aqueous mouthwash solution which is
maintainable as a one-bottle solution and capable of remineralizing
caries lesions in teeth. The solution is made by forming an aqueous
solution containing a source of calcium ions and a chelating agent
for calcium ions, causing the chelation of at least 50% of the
calcium ions, and subsequently adding a source of phosphate ions to
the aqueous solution. The Rudy et al. patents teach that by
bringing about the chelation of at least 50% of the calcium ions,
the precipitation of calcium phosphate from the solution is
avoided.
[0029] U.S. Pat. Nos. 4,177,258, 4,183,915 and 4,348,381 (all to
Gaffar et al.) are each directed to stable, one-part aqueous
compositions capable of remineralizing carious lesions in dental
enamel and composed of a solution of water having dissolved therein
a source of calcium ions and a source of phosphate ions, a fluoride
compound and an antinucleating agent. The Gaffar et al. patents
teach that the antinucleating agent prevents spontaneous
precipitation of calcium phosphate on the enamel surfaces and
thereby permits diffusion of the remineralizing components to the
subsurface lesions. The Gaffar et al. patents further teach that
the aqueous remineralizing composition is suitably prepared as a
dental mouthrinse and also can be incorporated into other
dentifrice compositions such as a dental cream or gel, mouth spray,
troche, chewable tablet, lozenge and the like.
[0030] U.S. Pat. No. 4,460,565 (Weststrate et al.) discloses an
anticariogenic remineralizing dentifrice containing two or more
fluorine compounds, at least one water-soluble phosphate salt and
at least one compound providing calcium ions. Examples of such
dentifrices include toothpastes, prophylactic pastes, tooth
polishes, mouth waters, application liquids, gels, and specific
chewing gums. Weststrate et al. teaches that the specific calcium
complexes used as the source of calcium ions therein are capable of
retaining the calcium in an active form in dentifrices without
deactivating the phosphate and fluoride ions.
[0031] U.S. Pat. Nos. 5,037,639; 5,268,167; 5,437,857; 5,427,768;
and 5,460,803 (all to Tung) involve the use of amorphous calcium
compounds such as amorphous calcium phosphate (ACP), amorphous
calcium phosphate fluoride (ACPF) and amorphous calcium carbonate
phosphate (ACCP) for use in remineralizing teeth. These amorphous
compounds or solutions which form the amorphous compounds when
applied either onto or into dental tissue prevent and/or repair
dental weaknesses such as dental caries, exposed roots and dentin
sensitivity. Remineralization is accomplished by bringing the
amorphous compound into contact with the dental tissue. This can be
done directly, i.e., putting an amorphous compound directly on the
tooth, or indirectly through a carrier, i.e., incorporating the
amorphous compound in a carrier such as a gel, a chewing gum, or a
toothpaste and applying the carrier to the dental tissue. Once
contact is established with the tooth, the amorphous calcium
phosphate compounds will recrystallize to the less soluble apatite
form in the lesion and reform the tooth. However, under conditions
where amorphous calcium phosphate compounds are stable, the
quantity of calcium and phosphate released is relatively low and,
therefore, remineralization is slower than desirable. The Tung
patents also teach the use of two-part solutions wherein a first
part contains phosphate salt(s) and a second part contains calcium
salt(s), wherein either the first part or the second part further
contains carbonate salt(s). In addition, the Tung patents teach
solutions formed by dissolving in water a solid powder containing
calcium salt(s), phosphate salt(s), and carbonate salt(s). These
solutions are then applied to dental tissue. The Tung patents
further teach the use of non-carbonated solid powders containing
mixtures of calcium salts and phosphate salts which can be applied
directly to the tooth or dispersed in gel, chewing gum, or other
non-aqueous mediums such as toothpaste which is placed in contact
with the tooth.
[0032] U.S. Pat. Nos. 5,603,922, 5,817,296, 5,833,957 and 5,858,333
(all to Winston et al.) each disclose one-part and/or two-part
products and methods of using same to remineralize subsurface
lesions. The one-part and two-part products contain at least one
water-soluble calcium salt, at least one water-soluble divalent
metal salt wherein the divalent metal is other than calcium and at
least one water-soluble phosphate salt. In the two-part products,
the calcium and divalent metal salts are disposed in a first
discrete component, and the phosphate salt(s) is disposed in a
second discrete component.
[0033] U.S. Pat. Nos. 5,605,675 and 5,895,641 to Usen et al.
disclose a two-part product and method of using same for
remineralizing dental enamel, wherein the product contains a first
discrete component containing at least one water-soluble calcium
salt and a second discrete component containing at least one
water-soluble phosphate salt and at least one water-soluble
fluoride salt.
[0034] U.S. Pat. No. 5,645,853 to Winston et al. is directed to a
chewing gum product and method of using same for remineralizing
subsurface lesions in teeth, wherein the product contains a
water-soluble cationic portion composed of at least one
water-soluble calcium salt and at least one water-soluble,
non-toxic divalent metal salt wherein the divalent metal is other
than calcium; a water-soluble anionic portion containing at least
one water-soluble phosphate salt; and a gum base.
[0035] U.S. Pat. Nos. 5,571,502, 5,614,175 and 5,866,102 (all to
Winston et al.) are each directed to one-part, non-aqueous products
and methods of using same for remineralizing subsurface lesions,
wherein the products contain at least one water-soluble calcium
salt; at least one water-soluble phosphate salt; either a
stabilizer or a hydrophilic, non-aqueous, water-soluble vehicle;
and, optionally, at least one water-soluble fluoride salt. When the
components are mixed with water or saliva to form an aqueous mixed
solution, the solution has a pH of from about 4.5 to about
10.0.
[0036] Although the aforementioned patents disclose various ways of
keeping the calcium and phosphate ions separate from one another
during storage of the product, it would be desirable to provide an
easier and less expensive way of keeping the calcium and phosphate
ions separate before use.
[0037] Particularly useful oral products for delivering
remineralizing/mineralizing components to the teeth are chewing gum
products. This is because the inherent nature of chewing gums
allows prolonged contact with the teeth and further because the gum
base can provide sustained release of the
remineralizing/mineralizing components, thereby minimizing the
amount of such components that must be used.
[0038] Several of the aforementioned patents disclose the use of
remineralizing/mineralizing chewing gum products and other solid
oral products. Non-limiting examples of other patents which teach
the use of chewing gums or other solid oral products to deliver
active components to teeth include U.S. Pat. Nos. 4,233,288;
4,828,845; 4,405,600; 5,204,115; 4,153,732; 3,892,843; 4,906,455;
4,902,498; 5,496,558; and 5,380,530.
[0039] Thus, it would be desirable to provide a chewing gum
product, as well as other solid oral products, which contain
remineralizing-mineraliz- ing cationic and anionic salts, wherein
the chewing gum product uses relatively inexpensive and easy means
for keeping the salts separate from another during storage of the
product.
[0040] Accordingly, a primary object of this invention is to
provide an oral product capable of remineralizing subsurface dental
lesions and capable of mineralizing exposed dentinal tubules and
composed of water-soluble calcium and phosphate salts, wherein the
product uses relatively inexpensive and easy means to keep the
salts separate from one another in the product.
[0041] A further object of this invention is to provide an oral
product having the aforementioned characteristics, wherein the
product is a solid oral product such as, e.g., a chewing gum
product, a lozenge, a candy product, an edible foodstuff, a
toothpowder, and the like.
[0042] A still further object of this invention is to provide a
method of remineralizing subsurface dental lesions and/or
mineralizing exposed dentinal tubules, using an oral product having
the aforementioned characteristics.
[0043] These and other objects which are achieved according to the
present invention can be discerned from the following
description.
SUMMARY OF THE INVENTION
[0044] In the present invention, remineralizing-mineralizing
cationic and anionic salts are kept from reacting with one another
prior to use of the oral product by disposing these salts as
separate cationic and anionic agglomerates in the product. The
agglomerated nature of the cationic and anionic salts allows these
salts to be effectively separated from one another during storage
of the product but also allows these salts to be simultaneously
released from the product upon contact with water, such as, e.g.,
by chewing, sucking or eating.
[0045] Thus, in one aspect thereof, the present invention provides
a solid oral product capable of remineralizing subsurface dental
lesions and capable of mineralizing exposed dentinal tubules,
containing:
[0046] (A) a discrete cationic agglomerate component composed of a
remineralizing-mineralizing amount of at least one water-soluble or
partially water-soluble calcium salt and a first inert solid
carrier, and
[0047] (B) a discrete anionic agglomerate component composed of a
remineralizing-mineralizing amount of at least one water-soluble
orthophosphate salt and a second inert solid carrier;
[0048] wherein components (A) and (B) have a pH in water such that
a mixed aqueous solution formed by mixing components (A) and (B)
with water and/or saliva has a pH of from about 4.5 to about
10.0;
[0049] further wherein the cationic and anionic agglomerate
components are simultaneously releasable from the product upon
mixing of the product with water and/or saliva to form the mixed
aqueous solution such that the mixed aqueous solution contains
calcium cations released from the calcium salt and orthophosphate
anions released by the orthophosphate salt.
[0050] The solid oral product of this invention may be in the form
of a chewing gum, a lozenge, a candy, an edible foodstuff, a
tablet, a toothpowder, and the like.
[0051] Another aspect of the present invention is directed to a
method of using the solid oral product of this invention to
remineralize at least one subsurface dental lesion and/or
mineralize at least one exposed dentinal tubule in at least one
tooth. Such method involves the steps of:
[0052] (1) providing the oral product of this invention;
[0053] (2) contacting the product with water and/or saliva so as to
form a mixed aqueous solution having a pH of from about 4.5 to
about 10.0 and containing calcium cations released by the calcium
salt and orthophosphate ions released by the orthophosphate salt;
and
[0054] (3) contacting the at least one tooth with the mixed aqueous
solution for a period of time sufficient to allow a
remineralizing/mineralizing amount of the calcium anions and a
remineralizing/mineralizing amount of the orthophosphate anions to
diffuse through the tooth to a subsurface thereof, wherein the
diffused calcium cations and the diffused orthophosphate anions
react together to form calcium hydroxyapatite onto the subsurface
lesion and/or onto the exposed dentinal tubule, thereby
remineralizing the lesion and/or mineralizing the exposed dentinal
tubule.
[0055] If the product is a chewing gum, step (2) of the method of
this invention involves chewing the product to release the calcium
and orthophosphate salts. If the product is a lozenge, step (2)
involves sucking the product. If the product is an edible
foodstuff, step (2) involves eating the product.
DETAILED DESCRIPTION OF THE INVENTION
[0056] As stated above, the present invention is directed to solid
oral products and methods of using same to remineralize subsurface
dental lesions and/or to mineralize exposed dentinal tubules.
[0057] As used herein, the term "solid oral product" refers to a
product which can be sucked, chewed or eaten. Non-limiting examples
of such products include chewing gums, lozenges, candies, food
products, dragees, bon bons, toothpowders, and the like.
[0058] The oral product of this invention contains a discrete
cationic agglomerate component and a discrete anionic agglomerate
component. The discrete cationic agglomerate component contains a
remineralizing-mineralizing amount of at least one water-soluble or
partially water-soluble calcium salt and may contain one or more
non-toxic, water-soluble salts of a divalent metal other than
calcium. The discrete anionic agglomerate component contains a
remineralizing-mineralizing amount of at least one water-soluble
orthophosphate salt and, optionally, at least one water-soluble
fluoride salt.
[0059] With respect to the amounts of the calcium and
orthophosphate salts, the term "remineralizing-mineralizing amount"
means that amount which is sufficient to effect substantial
remineralization of subsurface lesions in teeth and/or to effect
substantial mineralization of exposed dentinal tubules.
[0060] As used herein with respect to the partially water-soluble
calcium salt(s), the term "partially water-soluble" refers to a
calcium salt having a solubility which is greater than that of
dicalcium phosphate dihydrate in an aqueous solution having a pH of
about 7.0 and a temperature of about 25.degree. C. but which is
less than that solubility which would release more than about 1400
ppm of calcium cations in such aqueous solution. In an aqueous
solution having a pH of about 7.0 at a temperature of about
25.degree. C., dicalcium phosphate dihydrate can release up to
about 40 ppm of calcium cations by weight of the aqueous solution.
Thus, partially water-soluble calcium salts useful in the oral
product of this invention include calcium salts having a solubility
in water such that the salt is capable of releasing more than about
40 ppm but no more than about 1400 ppm, preferably from about 100
ppm to no more than about 1400 ppm, of calcium cations by weight of
an aqueous solution having a pH of about 7.0 at a temperature of
about 25.degree. C. As used herein with respect to the
water-soluble calcium salt(s), water-soluble orthophosphate
salt(s), water-soluble non-calcium divalent metal salt(s) and
water-soluble fluoride salt(s), the term "water-soluble" refers to
a solubility in water such that the salt is capable of releasing at
least about 1400 ppm by weight of ions into an aqueous solution
having a temperature of about 25.degree. C. and a pH of about
7.0.
[0061] As will be discussed in greater detail hereinbelow, the oral
products of this invention are made by forming separate
agglomerates of the calcium and orthophosphate salts in combination
with other dry, inert materials and carriers such as, e.g.,
sorbitol, mannitol, silicas, insoluble calcium phosphates, and the
like. The agglomerate composed of the calcium salt(s) may further
contain the non-calcium divalent metal salt(s), while the
agglomerate containing the orthophosphate salt(s) may also contain
the water-soluble fluoride salt(s). The agglomerate containing the
calcium salt(s) is referred to herein as the "cationic agglomerate"
or the "cationic agglomerate component", while the agglomerate
containing the orthophosphate salt(s) is referred to herein as the
"anionic agglomerate" or the "anionic agglomerate component".
[0062] The cationic and anionic agglomerates are then incorporated
into a basic solid oral product, e.g., chewing gum, lozenge, and
the like, to form the remineralizing/mineralizing final solid oral
product of this invention. As used herein, the term "basic solid
oral product" refers to a solid oral product to which the
agglomerates of this invention have not been added.
[0063] The cationic and anionic agglomerates used in the present
invention may be made by several different methods including, e.g.,
direct compression (i.e., dry agglomeration) methods, wet
granulation methods, and absorption methods (involving absorption
onto inert substances).
[0064] In direct compression methods, the calcium salt is
intimately mixed with a first inert carrier, and the orthophosphate
salt is intimately mixed with a second inert carrier. Each mixture
is then compressed into dry flakes, tablets or agglomerates using,
e.g., a tablet press or a Chilsonator. The resulting solids are
then ground to the desired agglomerate size and added to a basic
solid oral product (which has been formed according to known
methods) to form the final product of this invention.
[0065] The most preferred inert carriers for use in direct
compression processes are sorbitol, mannitol and xylitol.
[0066] In wet granulation processes, the calcium salt and a first
inert carrier are placed in a mixer/agglomerator, and the
orthophosphate salt and a second inert carrier are placed in a
separate mixer/agglomerator. The two sets of materials then undergo
mixing and agglomeration in the presence of water or other liquid.
The powdered materials being agglomerated or the liquid being added
preferably contains a binder to hold the agglomerated material
together after drying. Suitable binders include, for example, PVP,
polyvinyl acetate (PVA) or carboxymethylcellulose (CMC). The
calcium-containing product and the phosphate-containing product are
then dried and ground to the desired particle size. The particles
are then added to a basic solid oral product to form the final
product.
[0067] For wet agglomeration processes, the preferred inert
carriers are insoluble materials such as, e.g., silicas or
insoluble calcium phosphates. Non-limiting examples of suitable
insoluble calcium phosphates include dicalcium phosphate dihydrate,
anhydrous dicalcium phosphate, tricalcium phosphate and calcium
hydroxyapatite.
[0068] Another method for making the agglomerates used in the
present invention involves absorbing the calcium salt (and
non-calcium divalent metal salt, if present) and the orthophosphate
salt (and the fluoride salt, if present) onto separate inert
substances. For example, the calcium and orthophosphate salts can
be dissolved separately in water and the resulting solutions each
added, with mixing, to an absorbent material of an appropriate
particle size. If desired, PVP, CMC or other polymer can be
included in the respective solutions to form a soluble film around
the particles or to promote agglomeration of the absorbing
particles. The materials are then dried and added to a basic solid
oral product to form the final product.
[0069] The agglomerated particles used in the present invention
preferably have a particle size of from about 100 to about 2000
microns. For smooth oral products, the particle sizes preferably
range from about 400 to about 840 microns. For crunchy oral
products, the particle sizes preferably range from about 840 to
about 2000 microns.
[0070] As stated above, the cationic agglomerate component used in
this invention contains at least one water-soluble or partially
water-soluble calcium salt, and the anionic agglomerate component
contains at least one water-soluble orthophosphate salt.
[0071] Non-limiting examples of partially water-soluble calcium
salts suitable for use in this invention include calcium sulfate,
anhydrous calcium sulfate, calcium sulfate hemihydrate, calcium
sulfate dihydrate, calcium malate, calcium tartrate, calcium
malonate, calcium succinate, and mixtures of the foregoing. Calcium
sulfate is preferred.
[0072] Partially water-soluble calcium salts can be prepared in
situ, for example, by preparing mixtures of an acid such as, e.g.,
tartaric acid, and a water-soluble calcium salt such as, e.g.,
calcium nitrate, and adjusting the pH as needed.
[0073] Non-limiting examples of water-soluble calcium salts useful
in the product of this invention include, for example, calcium
chloride, calcium lactate, calcium nitrate, calcium acetate, and
calcium gluconate. Calcium lactate is preferred.
[0074] Mixtures of water-soluble and partially water-soluble
calcium salts may be used in the oral product of this
invention.
[0075] Suitable water-soluble inorganic orthophosphate salts for
use in the present invention include, for example, alkali salts and
ammonium salts of ortho-phosphoric acid, such as, e.g., potassium,
sodium or ammonium orthophosphate; monopotassium orthophosphate;
dipotassium orthophosphate; tripotassium orthophosphate; monosodium
orthophosphate; disodium orthophosphate and trisodium
orthophosphate.
[0076] As stated previously herein, the cationic agglomerate
component may further contain one or more non-toxic, divalent metal
salts other than calcium salt. Such salts release divalent metal
cations which help to stabilize the mixed aqueous solution against
rapid precipitation of the calcium cations and the phosphate and
fluoride anions (if present). The remineralizing cations and anions
can then diffuse through the tooth surface to the demineralized
subsurface lesion(s) and/or the exposed dentin tubule where the
diffused cations and anions then react to form an insoluble
precipitate which is bound to the tooth. As a result, when an
effective amount of the divalent metal cations is used, the
subsurface lesion is more effectively remineralized or desensitized
and/or the exposed dentin tubule is more effectively
mineralized.
[0077] The divalent metal salt(s) which can be used in the products
of the present invention may be any water-soluble, non-toxic
divalent metal compound which will stabilize the calcium, phosphate
and fluoride ions so that these ions do not rapidly or prematurely
precipitate before diffusing into the teeth. In practice, however,
it has been found that at least one member selected from the group
consisting of magnesium, strontium, tin, and zinc, with magnesium
being preferred, is the most effective divalent metal in
stabilizing the system.
[0078] Suitable magnesium compounds include, for example, magnesium
acetate, magnesium ammonium sulfate, magnesium benzoate, magnesium
bromide, magnesium borate, magnesium citrate, magnesium chloride,
magnesium gluconate, magnesium glycerophosphate, magnesium
hydroxide, magnesium iodide, magnesium oxide, magnesium propionate,
magnesium D-lactate, magnesium DL-lactate, magnesium
orthophosphate, magnesium phenolsulfonate, magnesium pyrophosphate,
magnesium sulfate, magnesium nitrate, and magnesium tartrate.
Preferred magnesium compounds are magnesium chloride, magnesium
acetate and magnesium oxide.
[0079] Suitable strontium compounds include, for example, strontium
acetate, strontium ammonium sulfate, strontium benzoate, strontium
bromide, strontium borate, strontium caprylate, strontium
carbonate, strontium citrate, strontium chloride, strontium
gluconate, strontium glycerophosphate, strontium hydroxide,
strontium iodide, strontium oxide, strontium propionate, strontium
D-lactate, strontium DL-lactate, strontium pyrophosphate, strontium
sulfate, strontium nitrate, and strontium tartrate. Preferred
strontium compounds are strontium acetate, strontium chloride,
strontium nitrate.
[0080] Suitable tin compounds include, for example, stannous
acetate, stannous ammonium sulfate, stannous benzoate, stannous
bromide, stannous borate, stannous carbonate, stannous citrate,
stannous chloride, stannous gluconate, stannous glycerophosphate,
stannous hydroxide, stannous iodide, stannous oxide, stannous
propionate, stannous D-lactate, stannous DL-lactate, stannous
orthophosphate, stannous pyrophosphate, stannous sulfate, stannous
nitrate, and stannous tartrate. A preferred tin compound is
stannous chloride.
[0081] Suitable zinc compounds include, for example, zinc acetate,
zinc ammonium sulfate, zinc benzoate, zinc bromide, zinc borate,
zinc citrate, zinc chloride, zinc gluconate, zinc glycerophosphate,
zinc hydroxide, zinc iodide, zinc oxide, zinc propionate, zinc
D-lactate, zinc DL-lactate, zinc pyrophosphate, zinc sulfate, zinc
nitrate, and zinc tartrate. Preferred zinc compounds are zinc
acetate, zinc chloride, zinc sulfate, and zinc nitrate.
[0082] In addition to the water-soluble orthophosphate salt(s), the
anionic agglomerate component used in the present invention may
further contain at least one water-soluble fluoride salt. Suitable
water-soluble fluoride salts for use in the present invention
include the alkali metal or ammonium fluorides such as sodium,
potassium, lithium or ammonium fluoride; tin fluoride; indium
fluoride; zirconium fluoride; copper fluoride; nickel fluoride;
palladium fluoride; fluorozirconates such as sodium, potassium or
ammonium fluorozirconate or tin fluorozirconate; fluorosilicates;
fluoroborates; and fluorostannites. Although not preferred,
fluoro-phosphates, such as sodium fluorophosphate, potassium
fluorophosphate and ammonium fluorophosphate, are also suitable for
use in the present invention. In addition, organic fluorides, such
as the known amine fluorides, can also be used in the oral products
of this invention.
[0083] Sodium fluoride is the preferred fluoride salt for use in
the present invention.
[0084] In preferred embodiments of the present invention, the
respective remineralizing/mineralizing amounts of the cationic and
anionic agglomerate components are such as to provide a mixed
aqueous solution composed of these salts with from about 100 ppm to
about 15,000 ppm of dissolved calcium ions and from about 100 ppm
to about 15,000 ppm of dissolved orthophosphate ions.
[0085] If a non-calcium divalent metal salt is used in the cationic
agglomerate component, the amount of such salt used should be such
as to provide the mixed aqueous solution with at least about 10
ppm, more preferably at least about 100 ppm, and most preferably
from about 100 ppm to about 20,000 ppm of divalent metal
cations.
[0086] To avoid fluorosis and other toxic effects, it is
undesirable to ingest an average of more than about 0.2 mg of
fluoride from all sources all day. Therefore, the concentration of
fluoride provided in products of the invention should be
appropriately limited. The concentration of fluoride ions in a
chewing gum, tablet, or lozenge should be no more than about 100
ppm, preferably no more than 20 ppm, most preferably in the range
of from 0.5 to 10 ppm. In edible foods, the purposeful addition of
fluoride should be avoided.
[0087] The products of this invention preferably contain from about
0.05% to about 15.0% by weight, more preferably from about 0.10% to
about 10.0% by weight, of the calcium salt(s), and from about 0.05%
to about 15.0% by weight, more preferably from about 0.10% to about
10.0% by weight, of the orthophosphate salt(s). The product may
further contain at least 0.0001%, preferably from about 0.001% to
about 2.0%, and more preferably from about 0.01% to about 1.0%, by
weight of the divalent metal salt(s).
[0088] The products of this invention contain a molar ratio of the
calcium salt(s) to the orthophosphate salt(s) of preferably from
about 0.01:1 to about 100:1. Most preferably, the concentration of
the calcium salt(s) and the concentration of the orthophosphate
salt(s) are preferably essentially the same in the products of this
invention. The concentration of the calcium salt(s) may exceed the
solubility of such salt, whereas the concentration of the
orthophosphate salt(s) is usually as high or even higher than the
solubility thereof.
[0089] The cationic and anionic agglomerate components used in the
present invention have a pH in water such that a mixed aqueous
solution formed by mixing these components with water and/or saliva
has a pH of from about 4.5 to about 10.0, preferably from about 5.0
to about 7.0, more preferably from about 5.0 to about 5.75. At a pH
within such range, enough of the calcium ions, orthophosphate ions
and, if present, non-calcium divalent metal ions and fluoride ions
in the mixed aqueous solution remain soluble for the period of time
required to allow sufficient amounts of the ions to diffuse through
the tooth surface so as to substantially remineralize the
subsurface lesions and/or substantially mineralize the exposed
tubules of the dental enamel. If the mixed aqueous solution has a
pH below about 3, demineralization will occur rapidly because the
concentration of calcium and phosphate in saliva is likely to be
significantly below saturation. A pH below about 2.5 is undesirable
from a safety standpoint.
[0090] The pH of the mixed aqueous solution may be adjusted to the
desired pH by methods well known in the art. The pH may be lowered
by the addition of any acid which is safe for use in the oral
cavity and which yields the desired pH at the amount employed.
Examples of suitable acids include acetic acid, phosphoric acid,
citric acid, malic acid, gluconic acid and succinic acid.
Alternatively, acidic phosphate salts can be used to produce an
acidic pH and alkaline phosphate salts can be used to produce an
alkaline pH.
[0091] As stated previously herein, the solid oral products of this
invention are prepared by incorporating the cationic and anionic
agglomerate components into a basic solid oral product, e.g.,
chewing gum, lozenge, and the like. An alternative way of preparing
the product of this invention is to provide for two separate solid
oral products (e.g., chewing gums or lozenges) which are then
broken up into pieces. The pieces are then homogeneously mixed and
compressed together to produce a single solid oral product (e.g., a
single gum or lozenge) composed of separate zones containing the
calcium and phosphate salts. For example, a lozenge can be prepared
from two lozenges wherein one lozenge contains the
calcium-containing composition and the second lozenge contains the
phosphate-containing composition. The lozenges are then grinded
into particles which are then homogeneously mixed and compressed
into a single lozenge containing separate zones of calcium and
orthophosphate salts.
[0092] The present invention further provides a method of
remineralizing subsurface dental lesions and/or mineralizing
exposed dentinal tubules using the oral product of this invention.
The method of this invention involves the steps of:
[0093] (1) providing the oral product of this invention;
[0094] (2) causing the oral product to be mixed with water and/or
saliva in the oral cavity so as to form a mixed aqueous solution
having a pH of from about 4.5 to about 10.0 and containing calcium
ions released by the calcium salt and orthophosphate ions released
by the orthophosphate salt; and
[0095] (3) promptly after formation of the mixed aqueous solution,
applying the solution to the tooth for a period of time sufficient
to allow a remineralizing amount of the calcium ions and a
remineralizing amount of the orthophosphate ions to diffuse through
the tooth to a subsurface area thereof, the diffused calcium ions
and the diffused orthophosphate ions reacting at the subsurface
area to form an insoluble calcium phosphate precipitate which is
bound to the tooth, thereby remineralizing the subsurface lesion
and/or mineralizing the exposed dentinal tubule.
[0096] The length of time in which the tooth is treated with the
mixed aqueous solution is important to the present invention. The
period of treatment needs to be long enough to allow diffusion of
the ions through the tooth surface to the demineralized subsurface
lesion(s) and/or exposed dentin tubule(s). Such period of treatment
is preferably at least about 2 minutes, more preferably at least
about 5 minutes, and most preferably at least about 15 minutes.
[0097] As stated previously herein, the ions which have diffused
through the tooth surface form an insoluble precipitate on the
demineralized subsurface lesion(s) and/or on the exposed dentin
tubule(s). Although many precipitates are within the broad scope of
this invention, it is preferred that the precipitate render the
remineralized subsurface and/or mineralized dentin of the tooth
treated in accordance with this invention more resistant to
demineralization than was the original enamel. Thus, the preferred
precipitate is one which is less soluble than the original enamel.
Tooth enamel primarily contains a slightly carbonated apatite. If
the precipitating species is not carbonated, the precipitate will
be somewhat less soluble than the original enamel. Therefore, when
fluoride anions are not present, it is desirable that conditions be
present which favor the precipitation of unsubstituted
hydroxyapatite. Thus, for example, it is desirable to avoid the
addition of carbonates or bicarbonates to non-fluoride
compositions. On the other hand, if fluoride salts are used in the
products of this invention, the apatite will incorporate fluoride
anions, thus rendering the precipitate more resistant to
demineralization than was the original enamel. However, even when
fluoride anions are not directly added to the
remineralizing/mineralizing mixed aqueous composition used in the
present invention, it has been found that the teeth treated with
such composition will absorb more fluoride when subsequently
treated with a fluoride-containing product (e.g., a fluoride
toothpaste) than teeth which had not been pretreated with such
composition.
[0098] Thus, the precipitate formed in the present invention is
preferably a calcium phosphate or a hydroxyapatite.
[0099] Therefore, use of the products of this invention not only
remineralizes the demineralized enamel and/or mineralize the
exposed dentin tubules but also renders such remineralized enamel
and/or mineralized dentin tubule more resistant to subsequent
demineralization than was the original enamel or tubule.
[0100] The mixed aqueous solution formed from the products of this
invention and the insoluble precipitate formed from the mixed
aqueous solution must both have acceptable levels of toxicity. In
other words, the particular ions, in the amounts used in the
remineralization and/or mineralization process, must be non-toxic.
Furthermore, such solution and precipitate should be otherwise
compatible in the oral environment.
[0101] As mentioned previously herein, the solid product of this
invention may be in the form of a chewing gum, a lozenge, a candy,
an edible food product, a tablet, a toothpowder, and the like. In
preferred embodiments, the solid product of this invention is a
chewing gum or lozenge, more preferably a chewing gum.
[0102] Chewing gums are the preferred vehicles for delivering the
cationic and anionic components of the present invention because
the inherent nature of chewing gums allows prolonged contact with
the teeth and, further, because the gum base can provide sustained
release of the anionic and cationic components of the products of
this invention, thus minimizing the amount of the anionic and
cationic components that must be used.
[0103] Chewing gum products within the scope of this invention may
be any of a variety of different chewing gums, bubble gums,
dragees, and the like, including low or high moisture, sugar or
sugarless, wax-containing or wax-free, low calorie (via high base
or low calorie bulking agents), and/or may contain other dental
health agents.
[0104] Chewing gum generally consists of a water-insoluble gum
base, a water-soluble portion and flavors. 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.
[0105] The insoluble gum base generally contains elastomers,
resins, fats and oils, softeners, and inorganic fillers. The gum
base may or may not include wax. The insoluble gum base can
constitute from about 5% to about 95%, preferably from about 10% to
about 50%, more preferably from about 20% to about 35%, by weight
of the chewing gum.
[0106] In one embodiment, the chewing gum base which can be used in
the present invention contains from about 20% to about 60% by
weight of a synthetic elastomer, from 0% to about 30% by weight of
a natural elastomer, from about 5% to about 55% by weight of an
elastomer plasticizer, from about 4% to about 35% by weight of a
filler, from about 5% to about 35% by weight of a softener, and,
optionally, minor amounts (about 1% by weight or less) of
miscellaneous ingredients such as colorants, antioxidants, and the
like.
[0107] Synthetic elastomers suitable for use herein include but are
not limited to polyisobutylene with GPC weight average molecular
weight of from about 10,000 to about 95,000, preferably from about
50,000 to about 80,000; isobutylene-isoprene copolymer (butyl
elastomer); styrene-butadiene copolymers having styrene-butadiene
ratios of from about 1:3 to about 3:1, preferably from about 1:1 to
about 1:3; polyvinyl acetate having a GPC weight average molecular
weight of from about 2000 to about 90,000, preferably from about
10,000 to about 65,000; polyisoprene; polyethylene; vinyl
acetate-vinyl laurate copolymer having a vinyl lauryl content of
from about 5% to about 50% by weight, preferably from about 10% to
about 45% by weight, of the copolymer, and combinations
thereof.
[0108] Non-limiting examples of suitable natural elastomers 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. Preferred
natural elastomers include jelutong, chicle, sorva, and
massaranduba balata.
[0109] The preferred concentrations of the synthetic elastomer and
the natural elastomer will 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.
[0110] Non-limiting examples of suitable elastomer plasticizers
include 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,
penta-erythritol 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 elastomers will also
vary depending on the specific application, and on the type of
elastomer which is used.
[0111] Non-limiting examples of suitable fillers/texturizers
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.
[0112] Non-limiting examples of suitable softeners/emulsifiers
include tallow; hydrogenated tallow; hydrogenated and partially
hydrogenated vegetable oils; cocoa butter; glycerol monostearate;
glycerol triacetate; lecithin; mono-, di-, and triglycerides;
acetylated monoglycerides; fatty acids such as stearic acid,
palmitic acid, oleic acid and linoleic acid; and combinations
thereof.
[0113] Suitable colorants and whiteners include, e.g.,
FD&C-type dyes and lakes, fruit and vegetable extracts,
titanium dioxide and combinations thereof.
[0114] The base may or may not include wax.
[0115] In addition to a water-insoluble gum base portion, a typical
chewing gum product includes a water-soluble bulk portion and one
or more flavoring agents. The water-soluble portion can include,
e.g., bulk sweeteners, high intensity sweeteners, flavoring agents,
softeners, emulsifiers, colors, acidulants, fillers, antioxidants,
and other components that provide desired attributes.
[0116] Softeners are added to chewing gum products to optimize the
chewability and mouth feel of the gum. The softeners, which are
also known as plasticizers and plasticizing agents, generally
constitute from about 0.5% to about 15% by weight of the chewing
gum. The softeners may include, e.g., 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 products.
[0117] Bulk sweeteners include both sugar and sugarless components.
The bulk sweetener(s) preferably constitutes from about 5% to about
95% by weight, more preferably from about 20% to about 80% by
weight, and most preferably from about 30% to about 60% by weight,
of the chewing gum.
[0118] Sugar sweeteners generally include saccharide-containing
components such as, e.g., sucrose, dextrose, maltose, dextrin,
dried invert sugar, fructose, levulose, galactose, corn syrup
solids, and the like, alone or in combination.
[0119] Sugarless sweeteners include, e.g., sugar alcohols such as
sorbitol, mannitol, xylitol, hydrogenated starch hydrolysates,
maltol, and the like, alone or in combination.
[0120] High intensity artificial sweeteners can also be used, alone
or in combination with the above. Non-limiting examples of such
sweeteners include sucralose, aspartame, salts of acesulfame,
alitame, saccharin and its salts, cyclamic acid and its salts,
glycyrrhizin, dihydrochalccones, thaumatin, monellin, and the like,
alone or in combination. 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.
[0121] The amount of the artificial sweetener used 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 the artificial sweetener may vary from about 0.02% to
about 8.0% by weight. When carriers used for encapsulation are
included, the amount of the encapsulated sweetener used will be
proportionately higher.
[0122] The chewing gum of this invention may be either sugarless or
sugar-containing. Alternatively, the chewing gum may contain
combinations of sugar and/or sugarless sweeteners. While ordinary
sugars, e.g., sucrose, can be used in the invention, it is
preferable to avoid them because of their cariogenic nature.
Non-fermentable sugars such as sorbitol are preferred.
Additionally, a softener may be added which provides additional
sweetness such as with aqueous sugar or alditol solutions.
[0123] If a low calorie gum is desired, a low caloric bulking agent
can be used. Non-limiting examples of such low calorie bulking
agents include polydextrose, raftilose, raftilin,
fructooligosaccharides, palatinose oligosaccharides, guar gum
hydrolysates, or indigestible dextrin.
[0124] Suitable flavoring agents include those which have been
previously described herein.
[0125] The flavoring agent can be used in the chewing gum of this
invention in an amount preferably ranging from about 0.1% to about
15.0% by weight, more preferably from about 0.2% to about 5.0% by
weight.
[0126] The chewing gum may also contain a dental abrasive. Dental
abrasives are particularly valuable in chewing gums because of the
polishing action which occurs during chewing. The term "dental
abrasives" as used herein includes all manner and form of such
materials which are normally used in toothpastes, chewing gums and
the like. The preferred dental abrasive for use in this invention
is dicalcium diphosphate dihydrate, which also serves as an
alkaline buffer. Other non-limiting examples of suitable dental
abrasives include calcium carbonate, sodium metaphosphate, aluminum
hydroxide, magnesium carbonate, calcium sulphate, silicas such as
aerogels and xerogels, and tricalcium phosphate. The dental
abrasive is preferably used in an amount of from about 1.0% to
about 30.0% by weight, more preferably from about 1.5% to about
20.0% by weight.
[0127] The chewing gum of this invention may also contain
glycerine, which serves to soften and maintain the chewability of
the chewing gum for prolonged periods and also adds to the
sweetness of the chewing gum. The glycerine is preferably used in
an amount of from about 0.01% to about 10.0% by weight, more
preferably from about 0.2% to about 5.0% by weight of the chewing
gum.
EXPERIMENTAL
[0128] Examples 1-4 illustrate agglomerated compositions which can
be used in the remineralizing chewing gums of the present
invention.
EXAMPLE 1
[0129] In Example 1, cationic and anionic agglomerate particles are
prepared from the ingredients set forth in Table I below.
1TABLE I Example 1: Agglomerate Particle Ingredients Cationic Part
Anionic Part Ingredient (wt. %) (wt. %) Sorbitol 60.00 60.00
Calcium Acetate 40.00 0 Monosodium Orthophosphate 0 40.00
[0130] The ingredients in the cationic part are initially mixed and
compressed by any means, e.g., passage through a chilsonator
(Fitzpatrick) to form a solid sheet or passage through a tablet
press. The resulting solid materials are then ground to a desirable
particle size of from about 50 to about 500 microns.
[0131] Similarly, the ingredients in the anionic part are mixed and
compressed in the same manner as was done with the ingredients in
the cationic part, the resulting solid materials also being ground
to a desirable particle size of from about 50 to about 500
microns.
[0132] The agglomerated cationic and anionic particles are then
added to a conventional chewing gum base to form a chewing gum
product containing about 2.5% by weight of the cationic particles,
about 2.5% by weight of the anionic particles, and about 95.0% by
weight of the conventional chewing gum ingredients.
EXAMPLE 2
[0133] In Example 2, cationic and anionic agglomerate particles are
prepared from the ingredients set forth in Table II below.
2TABLE II Example 2: Agglomerate Particle Ingredients Cationic Part
Anionic Part Ingredient (wt. %) (wt. %) Sorbitol 40.00 50.00
Xylitol 20.00 0 Malic Acid 0 5.00 Calcium Lactate 40.00 0
Monoammonium Phosphate 0 45.00
[0134] The mixing and compressing steps followed in Example 1 above
are repeated in Example 2. The solid materials formed from the
mixing and compressing of the cationic part ingredients are ground
to a particle size of from about 50 to about 500 microns. Likewise,
the solid materials formed from the mixing and compressing of the
anionic part ingredients are also ground to a particle size of from
about 50 to about 500 microns.
[0135] The agglomerated cationic and anionic particles are then
added to a conventional chewing gum base to form a chewing gum
product containing about 8.0% by weight of the cationic particles,
about 2.0% by weight of the anionic particles, and about 90.0% by
weight of the conventional chewing gum ingredients.
EXAMPLE 3
[0136] In Example 3, cationic and anionic agglomerate particles are
prepared from the ingredients set forth in Table III below.
3TABLE III Example 3: Agglomerate Particle Ingredients Cationic
Part Anionic Part Ingredient (wt. %) (wt. %) Sorbitol 40.00 60.00
Mannitol 20.00 0 Sodium Bicarbonate 0 5.00 Calcium Sulfate 40.00 0
Dipotassium Phosphate 0 35.00
[0137] The mixing and compressing steps followed in Examples 1 and
2 above are repeated in Example 3, with the solid materials formed
from the cationic and anionic part ingredients being ground to a
desirable particle size of between about 50 and about 500
microns.
[0138] The agglomerated cationic and anionic particles are then
added to a conventional chewing gum base to form a chewing gum
product containing about 6.0% by weight of the cationic particles,
about 4.0% by weight of the anionic particles, and about 90.0% by
weight of the conventional chewing gum ingredients.
EXAMPLE 4
[0139] In Example 4, cationic and anionic agglomerate particles are
prepared from the ingredients set forth in Table IV below.
4TABLE IV Example 4: Agglomerate Particle Ingredients Cationic Part
Anionic Part Ingredient (wt. %) (wt. %) Carbowax 8000 25.00 30.00
Xylitol 10.00 0 Calcium Chloride 65.00 0 Monopotassium Phosphate 0
70.00
[0140] The mixing and compressing steps followed in Examples 1, 2
and 3 are repeated in Example 4. The solid particles are ground to
a particle size of between about 50 and about 500 microns.
[0141] The agglomerated cationic and anionic particles are then
added to a conventional chewing gum base to form a chewing gum
product containing about 5.0% by weight of the cationic particles,
about 2.0% by weight of the anionic particles, and about 93.0% by
weight of the conventional chewing gum ingredients.
* * * * *