U.S. patent application number 10/719602 was filed with the patent office on 2004-07-15 for compositions for removing stains from dental surfaces, and methods of making and using the same.
Invention is credited to Holme, Samantha K., Luo, Shiuh John.
Application Number | 20040136928 10/719602 |
Document ID | / |
Family ID | 30443880 |
Filed Date | 2004-07-15 |
United States Patent
Application |
20040136928 |
Kind Code |
A1 |
Holme, Samantha K. ; et
al. |
July 15, 2004 |
Compositions for removing stains from dental surfaces, and methods
of making and using the same
Abstract
A composition for removing stains from dental surfaces
comprising a stain removing effective amount of at least two active
components selected from a peroxide compound, a polyphosphate, and
an anionic surfactant, in combination with an orally acceptable
carrier. The present invention is further directed to methods of
making and using the same.
Inventors: |
Holme, Samantha K.; (Pompton
Plains, NJ) ; Luo, Shiuh John; (Livingston,
NJ) |
Correspondence
Address: |
Linda A. Vag
Pfizer Inc.
201 Tabor Road
Morris Plains
NJ
07950
US
|
Family ID: |
30443880 |
Appl. No.: |
10/719602 |
Filed: |
November 21, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10719602 |
Nov 21, 2003 |
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10285217 |
Oct 31, 2002 |
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6685916 |
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Current U.S.
Class: |
424/53 |
Current CPC
Class: |
A23G 4/064 20130101;
A61K 8/0216 20130101; A61K 8/22 20130101; A23G 3/362 20130101; A61Q
11/00 20130101; A61K 8/24 20130101; A61K 8/42 20130101; A23G 4/06
20130101; A23G 3/36 20130101 |
Class at
Publication: |
424/053 |
International
Class: |
A61K 007/20 |
Claims
What is claimed is:
1. A composition for removing stains from dental surfaces
comprising a stain removing effective amount of at least two active
components selected from a peroxide compound, a polyphosphate, and
an anionic surfactant, said composition further comprising an
orally acceptable carrier.
2. The composition of claim 1 wherein the peroxide compound is
selected from the group consisting of carbamide peroxide, hydrogen
peroxide, calcium peroxide, sodium peroxide, strontium peroxide,
zinc peroxide, magnesium peroxide and mixtures thereof.
3. The composition of claim 1 wherein the polyphosphate is selected
from the group consisting of tripolyphosphates,
tetrapolyphosphates, pyrophosphates, hexametaphosphates and
mixtures thereof.
4. The composition of claim 3 wherein the polyphosphate is selected
from the group consisting of water soluble alkali metal
polyphosphates.
5. The composition of claim 4 wherein the polyphosphate is selected
from the group consisting of sodium tripolyphosphate, potassium
tripolyphosphate, sodium potassium tripolyphosphate, sodium
hexametaphosphate, tetrasodium pyrophosphate, sodium acid
pyrophosphate and mixtures thereof.
6. The composition of claim 1 wherein the polyphosphate is present
in a stain removing effective amount of from about 0.01% to 5% by
weight based on the total weight of the composition.
7. The composition of claim 6 wherein the polyphosphate is present
in a stain removing effective amount of from about 0.1% to 3% by
weight based on the total weight of the composition.
8. The composition of claim 7 wherein the polyphosphate is present
in a stain removing effective amount of from about 1.0% to 3% by
weight based on the total weight of the composition.
9. The composition of claim 1 where the anionic surfactant is
selected from the group consisting of sulfated butyl oleate, medium
and long chain fatty acid esters and salts, sodium and potassium
salts of stearate and palmitate and methyl and ethyl esters
thereof, sodium oleate, salts of fumaric acid, potassium glomate,
organic acid esters of mono- and diglycerides, stearyl
monoglyceridyl citrate, succistearin, dioctyl sodium
sulfosuccinate, glycerol tristearate, lecithin, hydroxylated
lecithin, sodium lauryl sulfate, acetylated monoglycerides,
succinylated monoglycerides, monoglyceride citrate, ethoxylated
mono- and diglycerides, sorbitan monostearate, calcium
stearyl-2-lactylate, sodium stearyl lactylate, lactylated fatty
acid esters of glycerol and propylene glycerol,
glycerol-lactoesters of C.sub.8-C.sub.24 fatty acids, polyglycerol
esters of C.sub.8-C.sub.24 fatty acids, propylene glycol alginate,
sucrose C.sub.8-C.sub.24 fatty acid esters, diacetyl tartaric and
citric acid esters of mono- and diglycerides, triacetin, and
mixtures thereof.
10. The composition of claim 1 where the anionic surfactant is
selected from the group consisting of sulfated butyl oleate, medium
and long chain fatty acid esters and salts, organic acid esters of
mono- and diglycerides, ethoxylated mono- and diglycerides,
lactylated fatty acid esters of glycerol and propylene glycerol,
glycerol-lactoesters of C.sub.8-C.sub.24 fatty acids, polyglycerol
esters of C.sub.8-C.sub.24 fatty acids, sucrose C.sub.8-C.sub.24
fatty acid esters, diacetyl tartaric and citric acid esters of
mono- and diglycerides, and mixtures thereof.
11. The composition of claim 1 wherein the anionic surfactant is
selected from the group consisting of sodium stearate, potassium
stearate, sodium palmitate, potassium palmitate, sodium oleate,
glycerol stearate, glycerol lactate, glycerol stearate lactate,
sucrose monostearate, sucrose distearate, sucrose monolaurate,
sucrose dilaurate, polyglycerol esters of monostearate,
polyglycerol esters of monolaurate, glycerol-lactoesters of
C.sub.14-C.sub.20 fatty acids, polyglycerol esters of
C.sub.14-C.sub.20 fatty acids, sucrose C.sub.14-C.sub.20 fatty acid
esters, and mixtures thereof.
12. The composition of claim 1 where the anionic surfactant is
selected from the group consisting of sodium stearate, sodium
palmitate, citric acid esters of mono- and diglycerides, lactic
acid esters of mono- and diglycerides, and mixtures thereof.
13. The composition of claim 1 in the form of a chewing gum, said
anionic surfactant being present in an amount of from about 0.1% to
2.0% by weight based on the total weight of the composition.
14. The composition of claim 13 wherein the amount of the anionic
surfactant is from about 0.4% to 1.2% by weight based on the total
weight of the composition.
15. The composition of claim 1 in the form of a confectionery, said
anionic surfactant being present in an amount of from about 0.1% to
20% by weight based on the total weight of the composition.
16. The composition of claim 15 wherein the amount of the anionic
surfactant is from about 3% to 15% by weight based on the total
weight of the composition.
17. The composition of claim 1 wherein the composition is selected
from the group consisting of chewing gums, centerfill confections,
nougats, candies, panning goods, gel confections, fondants,
lozenges, hard boiled candies, mints, troches, pastilles,
microcapsules, cakes, wafers, thin films, tablets and compressed
tablets.
18. The composition of claim 1 wherein the composition is selected
from the group consisting of mouthwashes, mouth sprays,
toothpastes, tooth powders, tooth gels, dental creams, dental
flosses, liquids, gels, and oral film forming dentifrices.
19. The composition of claim 1 in the form of a dentifrice, said
anionic surfactant being present in an amount of from about 0.01%
to 20% by weight based on the total weight of the composition.
20. The composition of claim 1 wherein the peroxide compound is
present in a stain removing effective amount of from about 0.01% to
10% by weight based on the total weight of the composition.
21. The composition of claim 20 wherein the peroxide compound is
present in a stain removing effective amount of from about 0.1% to
5% by weight based on the total weight of the composition.
22. The composition of claim 21 wherein the peroxide compound is
present in a stain removing effective amount of from about 0.2% to
3% by weight based on the total weight of the composition.
23. The composition of claim 1 in the form of a chewing gum,
wherein: the peroxide compound is present in the stain removing
effective amount of from about 0.01% to 10% by weight based on the
total weight of the composition; and the polyphosphate is present
in the stain removing effective amount of from about 0.01% to 5% by
weight based on the total weight of the composition.
24. The composition of claim 1 in the form of a chewing gum,
wherein: the peroxide compound is present in the stain removing
effective amount of from about 0.01% to 10% by weight based on the
total weight of the composition; and the anionic surfactant is
present in the stain removing effective amount of from about 0.1%
to 2.0% by weight based on the total weight of the composition.
25. The composition of claim 1 in the form of a chewing gum,
wherein: the polyphosphate is present in the stain removing
effective amount of from about 0.01% to 5% by weight based on the
total weight of the composition; and the anionic surfactant is
present in the stain removing effective amount of from about 0.1%
to 2.0% by weight based on the total weight of the composition.
26. The composition of claim 1 in the form of a confectionery,
wherein: the peroxide compound is present in the stain removing
effective amount of from about 0.01% to 10% by weight based on the
total weight of the composition; and the polyphosphate is present
in the stain removing effective amount of from about 0.01% to 5% by
weight based on the total weight of the composition.
27. The composition of claim 1 in the form of a confectionery,
wherein: the polyphosphate is present in the stain removing
effective amount of from about 0.01% to 5% by weight based on the
total weight of the composition; and the anionic surfactant is
present in the stain removing effective amount of from about 0.1%
to 20.0% by weight based on the total weight of the
composition.
28. The composition of claim 1 in the form of a confectionery,
wherein: the peroxide compound is present in the stain removing
effective amount of from about 0.01% to 10% by weight based on the
total weight of the composition; and the anionic surfactant is
present in the stain removing effective amount of from about 0.1%
to 20.0% by weight based on the total weight of the
composition.
29. The composition of claim 1 further comprising an encapsulating
substance for encapsulating the peroxide compound within the
composition.
30. The composition of claim 29 wherein the encapsulating substance
is selected from the group consisting of natural gums, synthetic
gums, edible oils, polymers, olefin copolymers, resins, waxes,
mineral oils, and mixtures thereof.
31. The composition of claim 1 wherein the orally acceptable
carrier is a solid carrier.
32. The composition of claim 1 wherein the orally acceptable
carrier is a gum or wax base.
33. A method of removing stains from dental surfaces comprising
administering a stain removing effective amount of the composition
of claim 1 to the oral cavity of a warm-blooded animal including
humans for contact with the dental surfaces thereof.
34. A method of making the composition of claim 1 comprising
combining the effective amount of at least two active components
selected from the peroxide compound, the polyphosphate, and the
anionic surfactant, with the orally acceptable carrier.
Description
FIELD OF THE INVENTION
[0001] The present invention is related generally to stain removing
compositions for promoting dental hygiene, more particularly to
dental stain removing compositions containing a novel combination
of stain removing agents and methods of making and using such
compositions.
BACKGROUND OF THE INVENTION
[0002] Unblemished white teeth have long been considered
cosmetically desirable. Unfortunately, in the absence of thorough
dental cleaning, teeth can become discolored or stained from
chromogenic (color-causing) substances present in food, beverages,
tobacco, and the like, and internal sources such as blood,
amalgam-based fillings, and antibiotics (e.g., tetracycline). The
tooth structures that are generally responsible for presenting a
stained appearance are enamel, dentin, and the acquired pellicle.
Tooth enamel is predominantly formed from inorganic material,
mostly in the form of hydroxyapatite crystals, and further contains
approximately 5% organic material primarily in the form of
collagen. In contrast, dentin is composed of about 20% protein
including collagen, the balance consisting of inorganic material,
predominantly hydroxyapatite crystals, similar to that found in
enamel. The acquired pellicle is a proteinaceous layer present on
the surface of tooth enamel which reforms rapidly after an
intensive tooth cleaning.
[0003] Discoloration of teeth can result from extrinsic and/or
intrinsic staining. Extrinsic staining of the acquired pellicle
arises as a result of compounds such as tannins and other
polyphenolic compounds that have become trapped in and tightly
bound to the proteinaceous layer on the surface of teeth.
Discoloration from this type of staining can usually be removed by
mechanical methods of tooth cleaning. In contrast, intrinsic
staining occurs when staining compounds penetrate the enamel and
even the dentin, or alternatively, such staining arises from
sources within the tooth. Discoloration from intrinsic staining is
not readily amenable to mechanical methods of tooth cleaning.
Chemical methods, which utilize substances that can penetrate into
the tooth structure, are usually required to eliminate such
discoloration. Accordingly, intrinsic tooth staining is generally
more intractable and difficult to address than extrinsic tooth
staining.
[0004] Currently, there are a number of basic methods for removing
stains in teeth. These methods are generally based on the use of
abrasives, hydrolytic agents or oxidizing agents to break down the
staining material. The first method involves mechanically abrading
the stain through the use of harsh abrasives or polishing agents
normally employed in toothpaste preparations. Typical preparations
containing abrasives are toothpastes, gels or powder dentifrices,
which require close contact with the teeth. Brushing and similar
scrubbing or polishing action is typically required as a complement
to successful stain removal. In the second method, hydrolytic
agents including proteolytic enzymes can be used to whiten teeth.
These products are usually in the form of pastes or gels, and
function to whiten teeth by removing the plaque and calculus that
have entrapped the stain.
[0005] Oxidizing agents such as urea peroxide, hydrogen peroxide or
calcium peroxide, represent the most common forms of whitening
agents for tooth enamels. It is believed that peroxides whiten
teeth by releasing hydroxyl radicals capable of breaking down the
plaque/stain complex into a form that can be flushed away or
removed by an abrasive. Treatments using oxidizing agents typically
require significant time to achieve good results depending on the
peroxide source and its concentration.
[0006] Other active stain removing components including surface
active agents such as anionic surfactants, and chelators such as
polyphosphates have been incorporated into stain removing
compositions because of their good stain removing properties.
However, such components have a few drawbacks. For example, excess
amounts of surfactants can produce an undesirable soapy taste in
the composition. Chelators also provide good stain removal
activity, however, if added in excess amounts, can also negatively
affect the taste (e.g., salty, bitter, and metallic) of the
composition. Accordingly, although chelators and surfactants are
good stain removing agents, the amounts that can be added to the
composition are limited to avoid or minimize the problems discussed
above.
[0007] It would therefore be a significant advance in the art of
dental whitening to provide a composition capable of removing
stains from dental surfaces, while maintaining desirable
organoleptic and taste properties. It would be a further advance to
provide a composition, which may be administered to a warm-blooded
animal including humans through a convenient vehicle at any time.
It would be a further advance in the art to employ chewing gums and
confectionery compositions as an effective vehicle for delivering
stain removing agents to the teeth because they permit protracted
contact of the stain removing agents to the teeth with minimal
effort on the part of the warm-blooded animal and are convenient
for the warm-blooded animal to use at any time.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The following drawings are illustrative of embodiments of
the present invention and are not intended to limit the invention
as encompassed by the claims forming part of the application.
[0009] FIG. 1 is a graph showing the % stain reduction obtained
from soaking stained hydroxyapatite disks in test solutions in
accordance with the present invention;
[0010] FIG. 2 is a graph showing the % stain reduction obtained
from simulated chewing tests utilizing different combinations of
stain removing agents incorporated into chewing gum in accordance
with the present invention; and
[0011] FIG. 3 is a graph showing the % stain reduction obtained
from stained bovine teeth after 20 minutes of treatment in test
solutions in accordance with the present invention.
SUMMARY OF THE INVENTION
[0012] The present invention is generally directed to a composition
for removing stains from dental surfaces in which a combination of
stain removing agents have been incorporated therein so that an
effective amount is available to produce an improved, synergistic
stain removing or tooth whitening effect. The composition of the
present invention includes a novel combination of stain removing
agents that exhibits improved stain removing efficacy as compared
to the use of individual stain removing agents alone, thereby
enabling reduction in the effective amounts of each component
incorporated. In addition, the compositions of the present
invention are compatible for use in solid oral formulations
including chewing gum and confectioneries, while effectively
maintaining desirable organoleptic and taste properties.
[0013] In a particular aspect of the present invention, there is
provided a composition for removing stains from dental surfaces,
comprising a stain removing effective amount of at least two active
components selected from a peroxide compound, a polyphosphate, and
an anionic surfactant. The composition of the present invention
will also typically contain an orally acceptable carrier.
[0014] In another particular aspect of the present invention, there
is provided a method of removing stains from dental surfaces,
comprising administering a stain removing effective amount of the
composition of the present invention to the oral cavity of a
warm-blooded animal including humans for cleaning and whitening
contact with the dental surfaces thereof.
[0015] In a preferred embodiment of the present invention, the
preferred peroxide compound is selected from the group consisting
of carbamide peroxide, hydrogen peroxide, calcium peroxide and
mixtures thereof, the preferred polyphosphate is selected from the
group consisting of tripolyphosphates, tetrapolyphosphates,
pyrophosphates, hexametaphosphates and mixtures thereof, and the
preferred anionic surfactant is selected from the group consisting
of medium and long chain fatty acid esters and salts, organic acid
esters of monoglycerides and diglycerides, citric acid ester of
mono- and diglycerides, lactic acid esters of mono- and
diglycerides, sodium palmitate, sodium stearate, and mixtures
thereof.
DETAILED DESCRIPTION OF THE INVENTION
[0016] The present invention is directed to compositions with stain
removing properties for producing a whitening effect on dental
surfaces that are treated with the same. Such compositions are
especially suitable for removing stains, which adhere to, or are
entrapped in materials on, the surface of teeth and for preventing
build-up of the stain entrapping material and stains on dental
surfaces. The compositions of the present invention are meant to
include products, which are not intentionally swallowed for
purposes of systemic administration of therapeutic agents, but are
retained in the oral cavity for a sufficient time to contact the
dental surfaces for purposes of providing beneficial dental
effects. The compositions of the present invention may be in a form
selected from, for example, dentifrices including mouthwashes,
toothpastes, tooth powders, dental creams, dental flosses, liquids,
gels, and the like; chewing gums including centerfilled gums, and
the like; and confectioneries including mints, lozenges, and the
like. In a preferred embodiment, the compositions of the present
invention are in the form of chewing gums and confectionery
formulations.
[0017] In accordance with the present invention, a stain removing
effective amount of stain removing agents including a novel
combination of at least two active components selected from
peroxide compounds, polyphosphates and anionic surfactants, is
employed in the compositions of the present invention to provide
effective stain removing activity. Applicants have discovered that
the novel combination of stain removing agents significantly
improves stain removing activity over the activity of the
individual component stain removing agents alone. In addition,
Applicants have also discovered that the novel combination of stain
removing agents enables reduction of the amount of each of the
stain removing agents in the composition. Accordingly, the amount
of anionic surfactants including sodium stearate, can be
effectively reduced to avoid the problems associated prior art gum
compositions including unpleasant mouthfeel, premature breakdown of
gum base, soapy taste and the like. Applicants have further
discovered that this novel combination effectively enables a
reduction in the amount of polyphosphates while maintaining robust
stain removing activity, thereby eliminating or significantly
reducing the unpleasant taste (i.e., salty, bitter, metallic)
typically associated with compositions containing higher levels of
polyphosphates.
[0018] The term "stain removing effective amount" as used herein is
an amount of the combination of stain removing agents disclosed
herein that is sufficient to prevent, eliminate or at least reduce
the presence of stains on dental surfaces in warm-blooded animals
including humans, but low enough to avoid any undesirable side
effects. The stain removing effective amount of the combination of
stain removing agents of the present invention may vary with the
type and extent of the particular stain, the age and physical
condition of the warm-blooded animal including humans being
treated, the duration of treatment, the nature of concurrent
therapy, the specific form (i.e., salt) of the stain removing agent
employed, and the particular carrier from which the stain removing
agent is applied.
[0019] The concentration of the stain removing agents in the
composition of the present invention depends on the type of
composition (e.g., toothpaste, mouthwash and rinse, lozenge,
chewing gum, confectionery, and the like) used to apply the stain
removing agents to the dental surfaces, due to differences in the
efficiency of the compositions contacting the teeth and due also to
the effective amount of the composition generally used. The
concentration may also depend on the level of the stains
present.
[0020] Except as otherwise noted, the amount of the ingredients
incorporated into the compositions according to the present
invention is designated as % by weight based on the total weight of
the composition.
[0021] In accordance with the present invention, suitable peroxide
compounds include any compounds containing an O--O bond, which can
break down to supply at least one active specie. Examples of
preferred peroxide compounds are inorganic peroxides such as
hydrogen peroxide, sodium peroxide, calcium peroxide, strontium
peroxide, zinc peroxide or magnesium peroxide, and organic
peroxides including, but not limited to, carbamide peroxide. The
amount of the peroxide compound incorporated into the present
composition will vary depending upon the particular individual or
combinations of stain removing agents employed, and the type of
other components or ingredients of the composition and their
respective amounts. The peroxide compound of the present invention
may be present in a stain removing effective amount of from about
0.01% to 10%, preferably from about 0.1% to 5%, and more preferably
from about 0.2% to 3% by weight based on the total weight of the
composition.
[0022] In one embodiment of the present invention, the peroxide
compound may be encapsulated to prevent premature degradation and
to control the release rate of the active specie from the
composition of the present invention. Processes for embedding or
encapsulating peroxide compounds such as through microencapsulation
to yield small beads of peroxide compounds, are generally known in
the art. The peroxide compound may be encapsulated in encapsulating
substances including, but not limited to, edible natural or
synthetic gums such as xanthan gum or guar gum; edible oils such as
peanut oil, coconut oil, palm oil, or safflower oil; polymers such
as gelatin, starches, polyamides, polyurethanes, or ethylcellulose;
olefin copolymers such as carbowax; resins; waxes such as paraffin;
mineral oils or other edible inert carriers capable of coating and
preserving the peroxide compound until release such as through
mechanical action (e.g. chewing) between the teeth or by enzymatic
action especially interaction of the peroxide compound and saliva
or water in the mouth for generating nascent oxygen. Further
details on processes for encapsulating active ingredients including
microencapsulation, may be found in U.S. Pat. Nos. 4,867,902,
5,403,578, 5,976,507 and 6,258,343, the contents of which are
incorporated herein by reference.
[0023] In accordance with the present invention, suitable
polyphosphates include any compounds having two or more phosphate
groups arranged primarily in a linear configuration, although some
cyclic derivatives may be present. In a preferred embodiment, the
polyphosphates are those having four or more phosphate groups.
Examples of preferred polyphosphates are inorganic polyphosphate
salts including tripolyphosphates such as, for example, wholly or
partially neutralized water soluble alkali metal salts thereof
including sodium, potassium or ammonium tripolyphosphates;
tetrapolyphosphates; hexametaphosphates such as sodium
hexametaphosphate; pyrophosphates such as tetrasodium pyrophosphate
and sodium acid pyrophosphate; and mixtures thereof. Most preferred
polyphosphates are those having relatively small molecular sizes
such as sodium tripolyphosphate, which typically are more soluble
and exhibit enhanced penetration of plaque or biofilm to provide
greater tooth whitening effect.
[0024] The amount of the polyphosphate incorporated into the
present composition will vary depending upon the particular
individual or combinations of stain removing agents employed, and
the type of other components of the composition and their
respective amounts. The polyphosphate may be present in the
compositions of the present invention in a stain removing effective
amount of from about 0.01% to 5.0% by weight based on the total
weight of the composition. The preferred stain removing effective
amount of the polyphosphate is from about 0.1% to 3.0% by weight,
and the most preferred effective amount ranging from about 1.0% to
3.0% by weight.
[0025] In accordance with the present invention, suitable anionic
surfactants employed in the present invention include sulfated
butyl oleate, medium and long chain fatty acid esters and salts, in
particular the sodium and potassium salts of the stearate and
palmitate and mixtures thereof, and methyl and ethyl esters
thereof, sodium oleate, salts of fumaric acid, potassium glomate,
organic acid esters of mono- and diglycerides such as stearyl
monoglyceridyl citrate, succistearin, dioctyl sodium
sulfosuccinate, glycerol tristearate, lecithin, hydroxylated
lecithin, sodium lauryl sulfate, acetylated monoglycerides,
succinylated monoglycerides, monoglyceride citrate, ethoxylated
mono- and diglycerides, sorbitan monostearate, calcium
stearyl-2-lactylate, sodium stearyl lactylate, lactylated fatty
acid esters of glycerol and propylene glycerol,
glycerol-lactoesters of C.sub.8-C.sub.24 fatty acids, preferably
glycerol-lactoesters of C.sub.14-C.sub.20 fatty acids, polyglycerol
esters of C.sub.8-C.sub.24 fatty acids, preferably polyglycerol
esters of C.sub.14-C.sub.20 fatty acids, propylene glycol alginate,
sucrose C.sub.8-C.sub.24 fatty acid esters, preferably sucrose
C.sub.14-C.sub.20 fatty acid esters, diacetyl tartaric or citric
acid esters of mono- and diglycerides, triacetin and the like and
mixtures thereof.
[0026] In one preferred form of the present invention, the anionic
surfactants are selected from sodium stearate and sodium palmitate
and mixtures thereof, sodium oleate, a mixture of citric acid
esters or lactic acid esters of monoglycerides and diglycerides, as
for example, glycerol stearate lactate, glycerol stearate and
glycerol lactate and mixtures thereof, sucrose monostearate,
sucrose distearate, sucrose monolaurate, sucrose dilaurate,
polyglycerol esters of monostearate, polyglycerol esters of
monolaurate and mixtures thereof.
[0027] Exemplary preferred anionic surfactants for use in the
compositions of the present invention are sodium stearate, usually
available as an approximate 50/50 mixture with sodium palmitate,
and, a mixture of at least one citric acid ester of mono- and/or
diglycerides. A suitable example of a commercial stain removing
agent in the latter class is IMWITOR 370.RTM. available from Condea
Vista Company. Also preferred are surfactants selected from lactic
acid esters of monoglycerides and diglycerides, and mixtures
thereof.
[0028] The amount of the anionic surfactant incorporated into the
compositions of the present invention will vary depending upon the
particular individual or combinations of stain removing agents
employed, and the type of other components of the composition and
their respective amounts. For example, a preferred stain removing
effective amount of sodium stearate is about 0.5% by weight, a
preferred amount of a mixture of lactic acid esters of
monoglycerides and diglycerides is about 0.6% by weight while a
preferred amount of a mixture of citric acid esters of mono- and
diglycerides (e.g., IMWITOR 370.RTM.) is from about 0.6% to 1.0% by
weight.
[0029] The amount of the anionic surfactant for chewing gum
compositions is typically from about 0.1% to 2.0% by weight based
on the total weight of the chewing gum composition. The preferred
amount of the anionic surfactant is from about 0.4% to 1.2% by
weight. The amount of the anionic surfactant will vary depending
upon the particular carrier, and individual or combination of
stain-removing agents of the present invention employed.
[0030] Some of the preferred anionic surfactants for use in the
confectionery compositions of the present invention are sodium
stearate, sodium palmitate and mixtures thereof. As previously
indicated, sodium stearate is usually available as an approximately
evenly divided mixture with sodium palmitate.
[0031] The amount of the anionic surfactants, which may be employed
in the confectionery compositions of the present invention will
vary over a range depending on, for example, the type of
composition and the particular individual or combination of stain
removing agents which are employed. Generally, the amount of stain
removing agent used in the confectionery compositions of the
present invention will exceed the amount of the stain removing
agent employed for the chewing gum composition for a particular
stain removing agent.
[0032] Typically, the anionic surfactant for the confectionery
compositions will be present in an amount of from about 0.1% to 20%
by weight based on the total weight of the composition. The
preferred amount of the anionic surfactant is from about 3% to 15%
by weight.
[0033] Typically, the anionic surfactant for other compositions
including dentifrices will be present in an amount of from about
0.01% to 20% by weight based on the total weight of the
composition. The preferred amount of the anionic surfactant is from
about 3% to 15% by weight.
[0034] In one preferred embodiment of the present invention, the
composition comprises a stain removing effective amount of the
combination of sodium tripolyphosphate, sodium stearate and
optionally carbamide peroxide, and an orally acceptable
carrier.
[0035] The compositions of the present invention further comprise
an orally acceptable carrier, in an amount appropriate to
accommodate the other components of the formulation. The term
"orally acceptable carrier" refers to a vehicle capable of being
mixed with the active components for delivery to the oral cavity
for tooth whitening and cleaning purposes, and which will not cause
harm to warm-blooded animals including humans. The orally
acceptable carriers further include those components of the
composition that are capable of being commingled without
interaction in a manner which would substantially reduce the
composition's stability and/or efficacy for dental stain removal in
the oral cavity in warm-blooded animals including humans, in
accordance with the compositions and methods of the present
invention.
[0036] The orally acceptable carriers of the present compositions
can include one or more compatible solid or liquid filler diluents
or encapasulating substances, which are suitable for oral
administration. The carriers or excipients of the present invention
may be in any form appropriate to the mode of delivery, for
example, solutions, colloidal dispersions, emulsions, suspensions,
rinses, gels, foams, powders, solids, and the like, and can include
conventional components of toothpastes (including gels),
mouthwashes and rinses, mouth sprays, chewing gums, lozenges, and
confectioneries. Carriers suitable for the preparation of
compositions of the present invention are well known in the art.
Their selection will depend on secondary considerations like taste,
cost, shelf stability and the like.
[0037] Types of additives or ingredients, which may also be
included in the present compositions of the present invention,
include, for example, abrasives, fluoride ion releasing compounds,
thickening agents, humectants, flavoring and sweetening agents,
anticalculus agents, alkali metal bicarbonate salts, surfactants,
remineralizers and other miscellaneous additives such as
anti-inflammatory agents, and the like. Suitable remineralizers
include, for example, calcium phosphate salts such as
alpha-tricalcium phosphate, monocalcium phosphate monohydrate,
anhydrous dicalcium phosphate, dicalcium phosphate dihydrate,
octacalcium phosphate or tetracalcium phosphate; and calcium
glycerophosphate, and mixtures thereof.
[0038] The dentifrice compositions of the present invention may
further include mouthwashes, rinses, and mouth sprays. Components
of such mouthwashes, rinses and mouth sprays typically include
water being present in an amount of from about 45% to 95%, and one
or more of ethanol in an amount up to about 70%, a humectant in an
amount up to about 50%, a surfactant in an amount from about 0.01%
to 7%, a flavoring agent in an amount from about 0.04% to 2%, a
sweetening agent in an amount from about 0.1% to 3%, and a coloring
agent in an amount from about 0.001% to 0.5%. Such mouthwashes,
rinses and mouth sprays may also include one or more of an
anticaries agent in an amount from about 0.05% to 0.3% (e.g.,
fluoride ion releasing compound), and an anticalculus agent in an
amount from about 0.1% to 3%.
[0039] Other dentifrice compositions of the present invention may
include dental solutions. Components of such dental solutions
generally include water in an amount from about 90% to 99%, and one
or more of a preservative in an amount from about 0.01% to 0.5%, a
thickening agent in an amount up to about 5%, and a flavoring agent
in an amount from about 0.1% to 3%.
[0040] Other dentifrice compositions of the present invention may
be in the form of toothpastes, tooth gels, and tooth powders.
Components of such toothpastes and tooth gels generally include one
or more of a dental abrasive, generally in an amount of from about
10% to 50%, a surfactant in an amount from about 0.5% to 10%, a
thickening agent in an amount from about 0.1% to 5%, a humectant in
an amount from about 10% to 55%, a flavoring agent in an amount
from about 0.04% to 2%, a sweetening agent in an amount from about
0.1% to 3%, a coloring agent in an amount from 0.01% to 0.5%, and
water in an amount from about 2% to 45%. Such toothpastes or tooth
gels may also include one or more anticaries agents in an amount
from about 0.05% to 0.3% (e.g., fluoride ion releasing compound),
and an anticalculus agent in an amount from about 0.1% to 13%. The
liquids and solids of such compositions are proportioned to form a
creamy or gelled mass, which can be extruded from a pressurized
container or from a collapsible tube. Tooth powders, of course,
contain substantially all non-liquid components.
[0041] Most preferred compositions of the present invention are
chewing gum and confectioneries. Chewing gum compositions typically
include one or more of gum bases, flavoring agent and bulk
sweeteners. The term "confectioneries" as used herein includes, but
is not limited to: nougats, candies, panning goods, gel
confections, fondants, lozenges, hard boiled candies, mints,
troches, pastilles, microcapsules, and fast-dissolving solid forms
including freeze dried forms (cakes, wafers, thin films, and
tablets) and fast dissolving solid forms including compressed
tablets. The term "fast dissolving solid form" as used herein means
that the solid dosage form dissolves in less than about 60 seconds,
preferably less than about 15 seconds, more preferably less than
about 5 seconds, in the oral cavity. Lozenges include discoid
shaped solids comprising a therapeutic agent in a flavored base.
The base may be a hard sugar candy, glycerinated gelatin, or
combination of sugar with sufficient mucilage to give it form.
Lozenge compositions (compressed tablet type) typically include one
or more fillers (compressible sugar), flavoring agents and
lubricants.
[0042] Applicants have determined that effective stain removing
chewing gum and confectionery compositions can be prepared by a
suitable selection of the combination of stain removing agents of
the present invention and the formulation of the gum and
confectionery compositions and the manner in which the combination
of stain removing agents are added to the compositions which
enables the release of the combination of stain removing agents in
an effective amount so that the combination may come into contact
with dental surfaces including tooth surfaces while maintaining or
improving the organoleptic properties commonly associated with such
products.
[0043] The chewing gum compositions of the present invention, may
be coated or uncoated and be in the form or slabs, sticks, pellets,
balls and the like. The composition of the different forms of the
chewing gum compositions will be similar but may vary with regard
to the ratio of the ingredients. For example, coated gum
compositions may contain a lower percentage of softeners. Pellets
and balls have a small chewing gum core, which is then coated with
either a sugar solution or a sugarless solution to create a hard
shell. Slabs and sticks are usually formulated to be softer in
texture than the chewing gum core. For practice of the present
invention however, in order to overcome any detrimental softening
effect the surfactant active may have on the gum base, it is
preferred to formulate a slab or stick gum having a firmer texture
(i.e. with less softener than is typically employed).
[0044] Centerfilled gum is another common gum form. The gum portion
has a similar composition and mode of manufacture to that described
above. However, the centerfill is typically an aqueous solution or
gel, which is injected into the center of the gum during
processing. The combination of stain removing agents could
optionally be incorporated into the centerfill during manufacture
of the fill or into the chewing gum. The centerfill gum may also be
optionally coated and may be prepared in various forms such as in
the form of a lollipop.
[0045] For practice of the present invention it is preferred to use
a coated gum wherein the combination of stain removing agents is in
at least one of the core and the coating. Most preferred for
removing stains is a coated gum wherein the combination of the
stain removing agents is at least in the coating.
[0046] The chewing gum composition of the present invention
includes gum base and most of the other typical chewing gum
composition components such as sweeteners, softeners, flavorants
and the like. The combination of stain removing agents employed in
the present invention, includes a mixture of at least two stain
removing components selected from peroxides, polyphosphates and
anionic surfactants. The chewing gum composition may contain a
reduced amount of softening agents such as lecithin or glycerin or
may eliminate softeners. In addition, the chewing gum composition
may contain a larger amount of sugar alcohols than conventional
chewing gum compositions to facilitate delivery of the combination
of stain removing agents employed in the present invention to the
tooth surfaces.
[0047] In accordance with one aspect of the chewing gum composition
of the present invention, the stain removing agents are added
during the manufacture of the chewing gum composition, that is,
with the sweeteners, flavorants and the like. In another aspect of
the present invention, the stain removing agents are added as one
of the last steps, preferably the last step in the formation of the
chewing gum composition. Applicants have determined that this
process modification incorporates the combination of stain removing
agents into the gum composition without materially binding the
stain removing agents therein such as may occur if the stain
removing agents are mixed directly with the gum base. Thus, the
stain removing agents, while only loosely contained within the gum
composition can be more effectively released therefrom during a
typical chewing operation. Thus, a material portion of the stain
removing agents is free of the gum base.
[0048] In a further aspect of the invention, the gum base generally
comprises elastomers, elastomer plasticizers, waxes, fats, oils,
emulsifiers, fillers, texturizers and may include a desirable
combination of the stain removing agents as hereinafter
described.
[0049] Elastomers constitute from about 5% to 95% by weight of the
base, preferably 10% to 70% by weight and most preferably 15% to
45% by weight. Examples of elastomers include synthetic elastomers
such as polyisobutylene, polybutylene, isobutylene-isoprene
co-polymers, styrene-butadiene co-polymers, polyvinylacetate and
the like. Elastomers may also include natural elastomers such as
natural rubber as well as natural gums such as jelutong, lechi
caspi, perillo, massaranduba balata, chicle, gutta hang kang or
mixtures thereof. Other elastomers are known to those of ordinary
skill in the art.
[0050] Elastomer plasticizers modify the firmness of the finished
gum when used in the gum base. Elastomer plasticizers are typically
present in an amount of up to about 75% by weight of the gum base,
preferably from about 5% to 45% by weight and more preferably from
about 10% to 30% by weight. Examples of elastomer plasticizers
include natural rosin esters such as glycerol ester of partially
hydrogenated rosin, glycerol ester of tall oil rosin,
pentaerythritol esters of partially hydrogenated rosin, methyl and
partially hydrogenated methyl esters of rosin, and the like.
Synthetic elastomer plasticizers such as terpene resins may also be
employed in gum base composition.
[0051] Waxes include synthetic and naturally occurring waxes such
as polyethylene, bees wax, carnauba and the like. Petroleum waxes
such paraffin may also be used. The waxes may be present in the
amount of up to about 30% by weight of the gum base. Waxes aid in
the curing of the finished gum and help improve the release of
flavor and may extend the shelf life of the product.
[0052] Fillers modify the texture of the gum base and aid
processing. Examples of such fillers include magnesium and aluminum
silicates, clay, alumina, talc, titanium oxide, cellulose polymers,
and the like. Fillers are typically present in an amount of from 1%
to 60% by weight.
[0053] Examples of softeners used in the gum base include
hydrogenated and partially hydrogenated vegetable oils, cocoa
butter, glycerol monostearate, glycerol triacetate, di- and
triglycerides, fatty acids such as stearic acid, palmitic acid,
oleic acid, linoleic acid, linolenic acid and the like.
[0054] The gum base constitutes between 5% and 95% by weight of the
chewing gum composition, more typically 10% to 50% by weight, and
most typically from about 25% to 35% by weight of the chewing gum.
A higher amount of gum base is preferred.
[0055] Other ingredients used in chewing gum compositions include
sweeteners, both natural and artificial and both sugar and
sugarless. Sweeteners are typically present in the chewing gum
compositions in amounts of from about 20% to 80% by weight,
preferably from about 30% to 60% by weight. Sugarless sweeteners
include, but are not limited sugar alcohols such as sorbitol,
mannitol, xylitol, hydrogenated starch hydrolysates, maltitol and
the like may also be present. High intensity sweeteners such as
sucralose, aspartame, neotame, salts of acesulfame, and the like
are typically present up to about 1.0% by weight.
[0056] Flavoring agents, which can vary over a wide range, may be
selected in amounts from about 0.1% to 10.0% by weight, preferably
from about 0.5% to 5.0% by weight. Flavoring agents for use in
chewing gum compositions are well known and include citrus oils,
peppermint oil, spearmint oil, oil of wintergreen, menthol and the
like.
[0057] Softeners may be present to modify the texture of the
chewing gum composition. Unlike typical gum compositions, softeners
in the compositions of the present invention are typically present
in reduced amounts of from about 0.5% to 10% by weight based on the
total weight of the chewing gum composition.
[0058] Other materials, which may be present in the gum composition
of the present invention, include antioxidants (e.g. butylated
hydroxyanisole, butylated hydroxytoluene, beta-carotenes,
tocopherols), colorants, flavorants and the like.
[0059] Coating techniques for applying a coating for a chewing gum
composition such as pan and spray coating are well known. Preferred
in the practice of the present invention is coating with solutions
adapted to build a hard candy layer. Both sugar and sugar alcohols
may be used for this purpose together with high intensity
sweeteners, colorants, flavorants, binders and other conventional
additives. When the combination of stain removing agents is
provided in the coating of a chewing gum composition, a solution of
the stain removing agents is preferably, alternately applied with
the flavorant.
[0060] The sweetener may be present in an amount of from about 30%
to 80% by weight of the coating syrup. A binder such as magnesium
stearate may be added to the coating syrup in an amount of from
about 1% to 15% by weight of the coating syrup to enhance or
promote adhesion. Optionally, minor amounts of conventional
additives may also be present. The sweeteners suitable for use in
the coating syrup comprise sugarless sweeteners such as the
polyhydric alcohols, e.g., xylitol, sorbitol, mannitol, and
mixtures, thereof; as well as maltitol, isomaltitol, hydrogenated
starch hydrolysates, and hydrogenated glucose syrups. Mono, di- and
polysaccharide may also be included. For example, sugars such as
sucrose, fructose, glucose, galatose and maltose may also be
employed as a sweetener. Other sweeteners suitable for use in the
coating syrup include, but are not limited to free saccharin acid,
water soluble salts of saccharin, cyclamate salts, palatinit
dihydrochalcones, glycyrrhizin, L-aspartyl-L-phenylalanine methyl
ester, amino acid based sweeteners, talin, steviosides,
dihydrochalcone compounds, acesulfame salts and mixtures
thereof.
[0061] Other ingredients may be added in minor amounts to the
coating syrup and include moisture absorbing compounds,
anti-adherent compounds, dispersing agents and film forming agents.
The moisture absorbing compounds suitable for use in the coating
syrups include mannitol or dicalcium phosphate. Examples of useful
anti-adherent compounds, which may also function as filler, include
talc, magnesium trisilicate and calcium carbonate. These
ingredients may be employed in amounts of about 0.5% to 5% by
weight of the syrup. Examples of dispersing agents, which may be
employed in the coating syrup, include titanium dioxide, talc or
other anti-adherent compounds as set forth above.
[0062] The coating syrup is usually heated and a portion thereof
deposited on the cores. Usually a single deposition of the coating
syrup is not sufficient to provide the desired amount or thickness
of coating and it usually will be necessary to apply second, third
or more coats of the coating syrup in order to build up the weight
and thickness of the coating to desired levels with layers allowed
to dry in-between coats.
[0063] A preferred aspect of the chewing gum composition of the
present invention comprises adding the stain removing agents to the
coating. The stain removing agents are preferably applied
subsequent to the syrup coating. It is preferred to then apply a
coating of high intensity sweetener prior to coating with the
portion containing the stain removing agents. The coating
containing the stain removing agents is preferably applied
alternately to the application of a flavorant solution. In the
practice of the present invention, the coating containing the stain
removing agents may be applied as a solution or may be applied as a
dry charge or, where applicable, melted and applied. For fatty acid
salts, a dry charge may be preferred. In coating a chewing gum
composition, the applications of coating syrup are continued until
the average gum piece weight reaches the required coating weight,
preferably until the coating comprises from about 20% to 30% by
weight of the final pellet weight. Further details regarding the
preparation of chewing gum compositions can be found in Skuse's
Complete Confectioner (13.sup.th Edition) (1957) including pp.
41-71, 133-144, and 255-262; and Sugar Confectionery Manufacture
(2.sup.nd Edition) (1995), E. B. Jackson, Editor, pp. 258-286, the
content of which is incorporated herein by reference.
[0064] The present invention also encompasses confectionery
compositions containing a suitable selection of the present
combination of stain removing agents. Confectionery compositions
include compressed tablets such as mints, hard boiled candies,
nougats, gels, centerfill confections, fondants, panning goods and
other compositions falling within the generally accepted definition
of confectionery compositions.
[0065] Confectionery compositions in the form of pressed tablets
such as mints may generally be made by combining finely sifted
sugar or sugar substitute, flavoring agent (e.g. peppermint
flavor), bulking agent such as gum arabic, and an optional coloring
agent. The flavoring agent and the bulking agent are combined and
then gradually the sugar or sugar substitute are added along with a
coloring agent, if needed.
[0066] The product is then granulated by passing through a sieve of
desired mesh size (e.g. 12 mesh) and then dried at typically
55.degree. C. to 60.degree. C. The resulting powder is fed into a
tableting machine fitted with a large size punch and the resulting
pellets are broken into granules and then pressed.
[0067] High boiled candies typically contain sugar or sugar
substitute, glucose, water, flavoring agent and optional coloring
agent. The sugar is dissolved in the water and glucose is then
added. The mixture is brought to a boil. The resulting liquid to
which may previously have been added a coloring agent is poured
onto an oiled slab and cooled. The flavoring agent is then added
and kneaded into the cooled mass. The resulting mixture is then fed
to a drop roller assembly known in the art to form the final hard
candy shape.
[0068] A nougat composition typically includes two principal
ingredients, a high boiled candy and a frappe. By way of example,
egg albumen or substitute thereof is combined with water and
whisked to form a light foam. Sugar and glucose are added to water
and boiled typically at about 130.degree. C. to 140.degree. C. and
the resulting boiled product is poured into a mixing machine and
beat until creamy. The beaten albumen and flavoring agent are
combined with the creamy product and the combination is thereafter
thoroughly mixed.
[0069] Further details regarding the preparation of confectionery
compositions can be found in Skuse's Complete Confectioner
(13.sup.th Edition) (1957) including pp. 41-71, 133-144, and
255-262; and Sugar Confectionery Manufacture (2.sup.nd Edition)
(1995), E. B. Jackson, Editor, pp. 129-168, 169-188, 189-216,
218-234, and 236-258, the content of which is incorporated herein
by reference.
[0070] In another embodiment of the present invention, there is
provided a method of removing stains from dental surfaces of the
oral cavity in warm-blooded animals including humans, by
administering, applying or contacting a stain removing effective
amount of the compositions of the present invention including
chewing gum and confectionery compositions to the oral cavity. The
stain removing effective amount of the compositions of the present
invention is preferably administered, applied or contacted to the
surface of the teeth, for the treatment or prevention of stains on
dental surfaces, in one or more conventional ways. For example, the
dental surfaces may be rinsed with a solution (e.g., mouthwash,
rinse) containing the composition of the present invention. If a
dentifrice (e.g., toothpaste, tooth gel, or tooth powder) is
employed, the teeth may be bathed in the liquid and/or lather
generated by brushing the teeth; etc., for a sufficient time,
preferably from about 10 seconds to 10 minutes, more preferably
from about 30 seconds to 60 seconds. The method of the present
invention may further involve expectoration of most of the
composition following contact of the present composition to the
dental surfaces.
[0071] The frequency of the application or contact of the
composition to the dental surfaces is preferably from about once a
week to about four times per day, more preferably from about 3
times per week to three times per day, even more preferably at
least once per day. The period of such treatment typically ranges
from about one day to a lifetime. For particular stains the
duration of stain removing treatment depends on the severity of the
stain being treated, the particular delivery form utilized and the
warm-blooded animal's response to treatment.
[0072] Other non-limiting examples include administering, applying
or contacting the compositions of the present invention to the
teeth include rinsing with a mouthwash or rinse solution and
brushing with a dentifrice. Other methods of applying the present
composition to the surfaces of the teeth are apparent to those
skilled in the art. Preferred methods of applying the chewing gum
and confectionery compositions include chewing gum that contains
the composition of the present invention, chewing or sucking on a
breath tablet or lozenge or other confectioneries.
[0073] The forgoing discussion discloses and describes merely
exemplary embodiments of the present invention. One skilled in the
art will readily recognize from such discussion, and from the
accompanying claims, that various changes, modifications, and
variations can be made therein without departing from the spirit
and scope of the invention as defined in the following claims.
EXAMPLE 1
Experimental Results From a Stain Removal Study
[0074] Materials and Methods
[0075] A flow system was prepared to treat hydroxyapatite (HAP)
disks for staining. Tea, coffee and porcine gastric mucin solution
was mixed to yield a staining broth. The staining broth was
circulated through the flow system in contact with the HAP disks at
a rate of 15 ml per minute for about 96 hours at 37.degree. C. The
resulting stained HAP disks were rinsed in a solution of artificial
saliva at a pH of about 7 and allowed to dry for about 2 hours at
room temperature.
[0076] Once the HAP disks were dry, a baseline stain reading was
determined for each HAP disk by measuring its diffuse reflectance
absorbance value using a Minolta spectrometer. The measurement was
made over the entire visible color spectrum in accordance with the
Commission International de L'Eclairage Laboratory (CIELAB) color
scale. The CIELAB color scale quantifies color according to 3
parameters: lightness-darkness scale (L), red-green chroma (RGC),
and yellow-blue chroma (YBC). An average of three absorbance
measurements were made for each HAP disk. The HAP disks were then
divided into seven balanced groups of five HAP disks each.
[0077] Seven test solutions were prepared each containing solutions
selected from 0.05% sodium stearate (SS); 0.05% sodium
hexametaphosphate (SHMP); 0.05% sodium tripolyphosphate (STPP);
0.05% tetrasodium pyrophosphate (TSPP); 0.05% sodium stearate (SS)
and 0.05% sodium hexametaphosphate (SHMP); 0.05% sodium stearate
(SS) and 0.05% sodium tripolyphosphate (STPP); and 0.05% sodium
stearate (SS) and 0.05% tetrasodium pyrophosphate (TSPP).
[0078] Results
[0079] Each group of stained HAP disks was treated with a
corresponding test solution for comparative examination of their
stain removing activity. No control test solution was used in this
study. The HAP disks were placed in the flow system and treated
with the corresponding test solution at a flow rate of about 15
ml/min for about one hour at 37.degree. C. The treated HAP disks
were allowed to air-dry for 2 hours at room temperature. Each of
the treated HAP disk was measured for changes in staining color.
The overall change in stain level (.DELTA.E) was determined for
each of the treated HAP disks. The .DELTA.E value for each test
solution is shown in Table 1 below, with greater values indicating
less stain and greater whitening of the disks.
1TABLE 1 Stain Removal Results Corresponding to Each Test Solution
Test Solution .DELTA.E values Sodium stearate (0.05%) 5.7 Sodium
hexametaphosphate (0.05%) 4.3 Sodium tripolyphosphate (0.05%) 6.8
Tetrasodium pyrophosphate (0.05%) 3.7 Sodium stearate (0.05%)/ 9.2
Sodium hexametaphosphate (0.05%) Sodium stearate (0.05%)/ 10.8
Sodium tripolyphosphate (0.05%) Sodium stearate (0.05%)/ 8.0
Tetrasodium pyrophosphate (0.05%)
[0080] The results shown in Table 1 as indicated by the .DELTA.E
values demonstrate a stain removing effect for all test
solutions.
EXAMPLE 2
In-Vitro Stain Removal Study
[0081] Materials and Methods
[0082] Several hydroxyapatite disks were prepared and pretreated to
form on the surface of the disks a biofilm that was discolored with
a vegetable stain. The color intensity of each disk was then
determined utilizing a Chrom-A-Meter. The disks were suspended in
either water or a test solution containing a solution selected from
1) 0.05% sodium stearate; 2) 0.3% sodium tripolyphosphate, 3) 0.3%
carbamide peroxide; 4) 0.3% carbamide peroxide and 0.05% sodium
stearate; and 5) 0.3% carbamide peroxide and 0.3% sodium
tripolyphosphate, respectively. Water acts as a control to take
into account the differences in the disk composition and the
variation in the stain thickness between batches. The disks were
treated for two ten (10) minute intervals, and characterized by the
Chrom-A-Meter after each treatment interval. The change in color is
expressed by .DELTA.E values relative to the water treatment alone.
The percent stain reduction is then calculated. The results are
presented in FIG. 1.
[0083] As shown in FIG. 1, the combination of carbamide peroxide
and sodium stearate and the combination of carbamide peroxide and
sodium tripolyphosphate enhanced stain removing effect over what
would be expected from the results achieved with the individual
stain removing components alone.
Preparation of the Stain Solution
[0084] The stain solution was comprised of components prepared from
coffee (e.g., Chock Full O'Nuts All Method Grind), tea (e.g.,
Lipton Flo-Thru Tea Bags), blueberry pie filling, and grape juice
(e.g., Welch's) and mixed together. 500 mL of coffee, prepared in a
coffee maker using 31/2 scoops of coffee to 700 mL of water; was
placed in a 4-L Erlenmeyer flask and stirred. 50 mL of blueberry
pie filling was liquefied and added to the 4-L Erlenmeyer flask,
and the contents were stirred. 500 mL of tea, prepared by steeping
4 Lipton Flo-Thru tea bags in 600 mL of pre-boiled water for about
5 minutes in a 800 mL beaker, was added to the 4-L Erlenmeyer
flask. Then, 50 mL of the grape juice was added to the flask, and
the contents were stirred to form the stain solution.
Staining Procedure
[0085] Hydroxyapatite disks were placed with the bottom surface
down on the bottom of a glass dish. The disks were maintained in a
slightly moist state. The stain solution was poured down the sides
of the glass dish avoiding direct flow over the surface of the
disks, until the disks were covered by at least 1/2 inch of the
stain solution. The glass dish was covered, and the disks were
allowed to soak overnight at room temperature. A beaker was filled
with water at 25.degree. C., and each disk was dipped in the water
after removal from the stain solution, and placed in a dish lined
with an absorbent towel with the stain side up. The disks were
allowed to dry overnight at 37.degree. C.
Treatment of Stained Disks
[0086] Test solutions were each prepared in 400 g of distilled
water along with the corresponding amounts of the active components
to achieve the above concentration levels at 37.degree. C. The test
solutions were continuously stirred at about 400 rpm. The negative
control consisted of 400 g of distilled water at 37.degree. C.,
which was also continuously stirred at about 400 rpm. Each of the
stained disks was checked with the Chrom-A-Meter to determine the
CIELAB value. The disks were each picked up with a pair of forceps,
and suspended in the corresponding test solution or water
(control). Each disk was held between the side of the beaker and
the vortex from the stirring midway below the surface of the
solution for about 10 minutes. Each disk was then removed from the
solution and allowed to dry. Each of the disks was checked by the
Chrom-A-Meter to determine the CIELAB value. The above treatment
procedure was repeated for each disk for a total of 20 minutes of
treatment.
[0087] Results
[0088] The test results as shown in FIG. 1, indicate that the test
solutions containing carbamide peroxide in combination with sodium
stearate and sodium tripolyphosphate, respectively, provided a
marked reduction in the occurrence of staining after the test
period over each of the test solutions containing the individual
active ingredients alone and in comparison to treatment with water
alone.
EXAMPLE 3
In-Vitro Stain Removal Study
[0089] Materials and Methods
[0090] Five coated gum samples were tested in a stain removal test
model each an active compositions selected from 1) 0.5% sodium
stearate in a core portion; 2) 0.5% sodium stearate in a coating
portion and 3% carbamide peroxide in a core portion; 3) 0.5% sodium
stearate in a coating portion and 1% sodium tripolyphosphate in a
core portion; 4) 0.5% sodium stearate in a coating portion and 3%
sodium tripolyphosphate/carbamide peroxide in a core portion; and
5) 0.5% sodium stearate in a coating portion and 1% sodium
tripolyphosphate/carbamide peroxide in a core portion. The gum
samples were masticated by a chewing machine, which was outfitted
with stained bovine teeth providing chewing surfaces to simulate
the top and bottom teeth in a human mouth. The samples were chewed
for five minutes. The bovine teeth were checked with a
Chrom-A-Meter before they were outfitted into the machine, and
checked again after simulated chewing over a one week period (28
doses). The color change was then determined by calculating the AE
value. All of the stain was then removed from the bovine tooth
samples and read again with the Chrom-A-Meter. The percent stain
reduction was then calculated. The results are presented in FIG.
2.
[0091] Results
[0092] The test results indicate that the gum samples containing
carbamide peroxide in combination with sodium stearate and sodium
tripolyphosphate provided a marked reduction in stains after the
test period.
EXAMPLE 4
Chewing Gum Compositions
[0093]
2TABLE 2 Composition 1 Composition 2 Composition 3 Ingredient (%
w/w) (% w/w) (% w/w) Gum base 26.25 26.25 26.25 Calcium Carbonate
3.75 3.75 3.75 Sorbitol 28.05 27.55 30.55 Mannitol 7.50 7.50 7.50
Maltitol 21.62 21.62 21.62 Glycerine 1.00 1.00 1.00 Flavorant 3.15
3.15 3.15 Gum Arabic 1.16 1.16 1.16 Titanium dioxide 0.17 0.17 0.17
Wax Candellia 0.03 0.03 0.03 Sodium Stearate* 0.50 -- -- Sodium
3.00 3.00 3.00 Tripolyphosphate Sweetener 0.82 0.82 0.82 IMWITOR
370 .RTM. -- 1.00 1.00 Carbamide Peroxide 3.00 3.00 -- Total 100.00
100.00 100.00 *Sodium stearate/sodium palmitate @ 50/50
[0094] The chewing gum compositions identified in Table 2 were
prepared by conventional methods known in the art. The gum base was
heated to sufficiently soften the base without adversely affecting
the physical and chemical make up of the base. The molten gum base
and the filler were then added to a mixing kettle. The sugar
alcohols, glycerin, flavor, high intensity sweetener and stain
removing agents of the present invention were added with mixing to
obtain a homogenous mixture, with the stain removing agents of the
present invention, added last. The mixture was then discharged from
the mixing kettle and rolled and scored into a desired piece size
by conventional techniques.
EXAMPLE 5
A Stain Removal Test Model
[0095] Materials and Methods
[0096] Using methods similar to those described in Example 2 with
the exception of having the hydroxyapatite disks substituted by
bovine teeth, five test solutions were tested in a stain removal
test model. The bovine teeth were prepared and pretreated to form a
biofilm thereon that was discolored with a vegetable stain. The
color intensity of each bovine tooth was then determined utilizing
a Chrom-A-Meter. The bovine teeth were suspended in either water
(control) or a test solution selected from 1) 0.05% sodium
tripolyphosphate/0.1% sodium stearate; 2) 0.1% sodium
tripolyphosphate/0.05% sodium stearate; 3) 0.1% sodium
tripolyphosphate/0.075% sodium stearate; and 4) 0.1% sodium
tripolyphosphate/0.1% carbamide peroxide. Treatment with water
provided a control to take into account the differences in the
tooth composition and the variation in the stain thickness between
batches.
[0097] The disks were treated for two ten (10) minute intervals,
and characterized by the Chrom-A-Meter after each treatment
interval. The change in color is expressed in the determination of
.DELTA.E values relative to the water treatment. The percent stain
reduction was then calculated from the .DELTA.E values. The results
are presented in FIG. 3.
[0098] Results
[0099] As shown in FIG. 3, the test solutions each comprising a
particular combination of the staining removing agents of the
present invention, exhibited significant stain removing effect as
compared to treatment with water alone.
EXAMPLE 6
Pressed Mint Tablet Composition
[0100]
3 TABLE 3 Composition 1 Composition 2 Ingredient (% w/w) (% w/w)
Sorbitol 90.55 85.55 High Intensity Sweetener 0.15 0.15 Flavorant
1.300 1.300 Sodium Tripolyphosphate 3.00 3.00 Sodium Stearate* 5.0
10.0 Total 100.00 100.00 *Sodium stearate/sodium palmitate @
50/50
[0101] The pressed mint tablet compositions identified in Table 3
were prepared by conventional methods as known in the art. The
sweeteners were finely sifted and combined. The other ingredients
and the stain removing agents were combined and gradually the
sweeteners are added. The resulting mixture was then granulated by
passing through a sieve of desired mesh size (e.g. 12 mesh) and
then dried at typically 55.degree. C. to 60.degree. C. The
resulting mixture was then fed into a tableting machine fitted with
a large size punch and the resulting pellets are broken into
granules and then pressed.
EXAMPLE 7
Clinical Study with Pressed Mints
[0102] A clinical study was implemented to establish the stain
removing activity of the mint compositions of Example 6 over a no
treatment control. 150 subjects were divided into three groups of
50. Two groups of subjects each received a test composition
selected from one of the following: the mint composition 1 of
Example 6 and the mint composition 2 of Example 6. A third group
received no treatment. The test compositions were administered
orally and allowed to dissolve in the subjects' mouths, four times
per day over an 8-week period. The subjects were evaluated for
tooth stain using a modified Lobene Index at baseline on week 4 and
on week 8.
[0103] The Lobene Index is a visual scale used by dental care
professionals to measure tooth staining. The teeth of the subjects
were divided into two regions, the body margin and the gingival
margin. The regions were evaluated for both intensity of the stain
(i.e., darkness) and the extent of the stain (i.e., area) on a
scale of 0 to 3 to determine a total tooth score for each subject.
The level of stain was measured over time by comparing the total
tooth scores, and deriving therefrom a pairwise comparison of
p-values for stain reduction. The results of the study are shown in
Table 4.
4TABLE 4 Pairwise Comparison of p-values for Stain Reduction Mint
Composition 1 Mint Composition 2 Control <0.001 <0.001 (No
Treatment) Mint Composition 1 -- 0.091
[0104] Results
[0105] The subjects administered with either mint compositions 1 or
2 were found to have significantly less extrinsic tooth stain
compared to the stain reduction exhibited by the control group. It
was determined that the stain reduction exhibited by the mint
compositions 1 and 2 over no treatment was statistically
significant at a level corresponding to p.ltoreq.0.05. There was no
significant difference in stain reduction between the mint
composition 1 group and the mint composition 2 group.
* * * * *