U.S. patent application number 15/903564 was filed with the patent office on 2018-06-28 for oral care whitening compositions.
This patent application is currently assigned to Colgate-Palmolive Company. The applicant listed for this patent is Colgate-Palmolive Company. Invention is credited to Thomas Boyd, Suman Chopra, Prakasarao Mandadi, Dennis Ontumi.
Application Number | 20180177709 15/903564 |
Document ID | / |
Family ID | 47501498 |
Filed Date | 2018-06-28 |
United States Patent
Application |
20180177709 |
Kind Code |
A1 |
Boyd; Thomas ; et
al. |
June 28, 2018 |
Oral Care Whitening Compositions
Abstract
Described herein are whitening compositions comprised of a
peroxide component, and an adhesion system, which effectively
provide whitening using a remarkably low level of peroxide. Methods
of making and using these compositions are also described
herein.
Inventors: |
Boyd; Thomas; (Metuchen,
NJ) ; Ontumi; Dennis; (Easton, PA) ; Mandadi;
Prakasarao; (Flemington, NJ) ; Chopra; Suman;
(Monroe, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Colgate-Palmolive Company |
New York |
NY |
US |
|
|
Assignee: |
Colgate-Palmolive Company
New York
NY
|
Family ID: |
47501498 |
Appl. No.: |
15/903564 |
Filed: |
February 23, 2018 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
14366340 |
Jun 18, 2014 |
9931292 |
|
|
PCT/US2011/066087 |
Dec 20, 2011 |
|
|
|
15903564 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61K 8/89 20130101; A61K
8/92 20130101; A61K 2800/48 20130101; A61Q 11/00 20130101; A61C
19/066 20130101; A61K 2800/54 20130101; A61K 8/042 20130101; A61K
2800/40 20130101; A61K 8/8176 20130101; A61K 2800/31 20130101; A61K
2800/872 20130101; A61K 8/891 20130101; A61K 8/22 20130101; A61K
8/49 20130101; A61K 8/892 20130101 |
International
Class: |
A61K 8/81 20060101
A61K008/81; A61Q 11/00 20060101 A61Q011/00; A61K 8/04 20060101
A61K008/04; A61K 8/49 20060101 A61K008/49; A61K 8/92 20060101
A61K008/92; A61K 8/89 20060101 A61K008/89; A61C 19/06 20060101
A61C019/06; A61K 8/22 20060101 A61K008/22; A61K 8/892 20060101
A61K008/892; A61K 8/891 20060101 A61K008/891 |
Claims
1. A non-aqueous oral care composition comprising: a peroxide
component comprising a peroxide source in the amount of 0.05% to
0.15% of the total weight of the composition; and 40% to 80% of an
adhesion system comprising: a hydrophobic component comprising a
silicone adhesive, a silicone fluid and a dental surface adhesion
enhancing agent selected from the group consisting of bees wax,
mineral oil, a blend of mineral oil and polyethylene, petrolatum,
white petrolatum, a blend of liquid paraffin and a
butene/ethylene/styrene hydrogenated copolymer, a polyethylene wax,
polyisobutene, a polyvinyl pyrrolidone/vinyl acetate copolymer; and
a combination of two or more thereof, wherein the composition when
applied to the teeth is sufficiently viscous to form an adherent,
continuous layer on a dental surface and deliver an effective
amount of said peroxide source to a tooth surface.
2. The composition of claim 1 wherein the peroxide source is
selected from the group consisting of hydrogen peroxide; urea
peroxide, sodium percarbonate, sodium perborate; and a combination
of two or more thereof.
3. The composition of claim 1, wherein the peroxide component
further comprises cross-linked polyvinylpyrrolidone, wherein the
peroxide source is complexed with the cross-linked polyvinyl
pyrrolidone.
4. (canceled)
5. The composition of claim 1 wherein the peroxide source is
hydrogen peroxide.
6. The composition of claim 1, wherein the dental surface adhesion
enhancing agent comprises an additional amount of cross-linked
polyvinylpyrrolidone.
7. The composition of claim 6, wherein the additional amount of
cross-linked polyvinylpyrrolidone is not complexed with a peroxide
source.
8. (canceled)
9. The composition of claim 1 wherein the peroxide source is
present in an amount from about 0.08% to about 0.12%, by weight of
the composition.
10. The composition of claim 1, wherein the peroxide source is
present in the amount of about 0.1%, by weight of the
composition.
11. The composition of claim 1, wherein the silicone adhesive is a
pressure sensitive silicone adhesive.
12. The composition of claim 11, wherein the pressure sensitive
silicone adhesive is a copolymer prepared by condensing a silicone
resin with a dihydroxy polydiorganosiloxane.
13. The composition of claim 12, wherein the dihydroxy
polydiorganosiloxane is dihydroxy polydimethylsiloxane.
14. The composition of claim 1, wherein the silicone resin is a
silanol-containing silicone resin.
15. (canceled)
16. The composition of claim 15, wherein the silicone fluid
comprises a siloxane polymer.
17. (canceled)
18. The composition of claim 17, wherein the organic material
comprises mineral oil.
19. The composition of claim 1, wherein the dental surface adhesion
enhancing agent is present in an amount of about 15% to about 25%,
by weight, of the composition.
20. The composition of claim 1, wherein the dental surface adhesion
enhancing agent is present in the amount of about 16% to about 20%,
by weight, of the composition.
21. The composition of claim 1, wherein the dental surface adhesion
enhancing agent is present at a concentration of about 18%, by
weight, of the composition.
22. A method for whitening a tooth comprising applying a
composition of claim 1 to a tooth of a mammal.
23. The method of claim 22, wherein the composition is applied
using a pen.
24. The method of claim 22, wherein the composition is maintained
on the surface of the tooth for a plurality of minutes.
Description
BACKGROUND
[0001] Products that are presently available to whiten teeth
include a variety of different ingredients, but the primary active
ingredient is a peroxide source. These products typically contain
substantial amounts of whitening agents, for example, greater than
5% of a peroxide source. However, in some countries, such as many
European countries, regulatory authorities have prohibited such
levels of peroxide in dental whitening products. Thus, products
providing effective levels of whitening with lower amounts of
peroxide are highly desirable.
SUMMARY
[0002] In some embodiments, the present invention provides a
non-aqueous dental whitening composition comprising: a peroxide
component comprising a peroxide source in the amount of about 0.1%
to about 5% of the total weight of the composition; and an adhesion
system comprising a hydrophobic component comprising a silicone
adhesive and a dental surface adhesion enhancing agent; wherein the
composition when applied to the teeth is sufficiently viscous to
form an adherent, continuous layer of the composition on dental
enamel surfaces and deliver an effective amount of the peroxide
source to a tooth surface.
[0003] In some embodiments, the present invention provides methods
of whitening a tooth comprising applying any of the compositions
described herein to a tooth of a mammal.
[0004] Further areas of applicability of the present invention will
become apparent from the detailed description and examples provided
hereinafter. It should be understood that the detailed description
and specific examples, while providing specific embodiments of the
invention, are intended for illustration only and should in no way
limit the scope of the invention.
DETAILED DESCRIPTION
[0005] In some embodiments, the composition of the present
invention is a viscous liquid, preferably a gel, which maintains
its consistency during storage enabling the product to be painted
on the tooth surface with a soft applicator pen or brush.
[0006] In some embodiments, the composition of the present
invention provides a stable vehicle that prevents the decomposition
of the peroxide whitening agent during storage and before use.
[0007] Once applied on a tooth surface, the saliva on the tooth
enamel surface to which the composition is applied will either
dissolve or disintegrate the peroxide containing matrix resulting
in a rapid decomposition of the peroxide, and thereby provide an
effective concentration of the peroxide source at the tooth
surface, despite its relatively low concentration in the
composition. Surprisingly, this low concentration is capable of
delivering an acceptable level of tooth whitening.
[0008] The whitening composition of the present invention is a
portable viscous liquid or gel tooth whitener that can be applied
to the teeth as a coated layer conveniently painted onto the tooth
enamel surface. Upon application to the teeth, the applied
whitening composition forms an adherent layer of peroxide
containing product that has the capacity to release the peroxide
whitening agent over an extended period of time, e.g., from about 5
minutes to about 12 hours. The applied layer adheres to the tooth
surface whereby the released peroxide source then whitens the teeth
to which the composition is applied.
[0009] In some embodiments, the tooth whitening compositions of the
present invention are substantially anhydrous, that is, no water is
added. The composition may contain trace levels of water from
ingredients or from product manufacture; however, such trace levels
are insubstantial and do not interfere with the hydrophobic
character of the composition.
[0010] The viscosity of a composition of the invention is greater
than about 1,000 centipoise (cPs) and less than about 900,000 cPs,
in a more specific embodiment greater than about 10,000 cP and less
than about 100,000 cPs, in a more specific embodiment greater than
50,000 cPs and less than 900,000 cPs, and in an even more specific
embodiment from between about 200,000 cPs to about 600,000 cPs.
[0011] In some embodiments, the present invention comprises a
hydrophobic component, carrier or base material that comprises a
silicone polymer. The term "hydrophobic" or "water-insoluble" as
applied to polymers and as employed herein refers to an organic
polymer which is substantially non-aqueous having a water
solubility of less than one gram per 100 grams of water at
25.degree. C. Any such silicone polymers that are compatible with
the whitening agents described herein, and which can produce a
tooth whitening composition having a desired viscosity can be
used.
[0012] In some embodiments, the hydrophobic polymers suitable for
use in the present invention are referred to as "siloxane"
polymers, which are also generally known in the art as "silicone"
polymers. In certain embodiments of the present invention, the
hydrophobic polymers that comprise the hydrophobic material are
those in which a whitening agent can be dispersed and are well
known in the art. Many such silicone polymers are commercially
available. In various embodiments, a preferred silicone-based
hydrophobic polymer is a polyorganosiloxane, in particular
polydimethylsiloxane.
[0013] In some embodiments, the siloxane polymers that can function
as part of the hydrophobic component are in the form of a fluid.
Polysiloxane fluids useful herein for the hydrophobic silicone
material component include those with a viscosity, at 25.degree.
C., of about 1 milliPascal-sec (mPa-s) to about 1000 mPa-s, or
about 2 mPa-s to about 500 mPa-s, or about 20 mPa-s to about 400
mPa-s. Polysiloxane fluids for use herein can be linear or cyclic,
and can be substituted with a wide variety of substituents. In
certain embodiments, substituents include methyl, ethyl and phenyl
substituents. Suitable polysiloxane fluids include linear
polysiloxane polymers such as dimethicone and other low viscosity
analogues of the polysiloxane materials, in certain embodiments
having a viscosity, at 25.degree. C., of 200 mPa-s or less and
cyclomethicone, and other cyclic siloxanes having for example a
viscosity, at 25.degree. C., of 200 mPa-s or less. Other fluids
include polysiloxane polyether copolymers and hydroxy terminated
polydimethyl-siloxane fluid (e.g., Dow Corning
ST-DIMETHTCONOL..TM.. 40, Dow Corning SGM 36, SGM3). Commercial
examples of materials that are suitable for use herein include
DC200 series fluids marketed by Dow-Corning Corporation and the AK
Fluid series marketed by Wacker-Chemie GmbH, Munchen, Germany. High
molecular silicone resins with a polysiloxane blend may also be
used including powdered tri methylsiloxysilicate, for example, Dow
Corning 593 fluid, Wacker Belsil TMS 803. Another suitable silicone
fluid from Dow Corning is Q7-9210.
[0014] In some embodiments, at least part of the hydrophobic
component is a silicone pressure sensitive adhesive (PSA). Such
PSAs can be produced by condensing a silicone resin and an
organosiloxane such as a polydiorganosiloxane. Such hydrophobic
polymers are an elastomeric, tacky material, adhesion of which to
dental enamel surfaces can be varied by altering the ratio of
silicone resin to polydiorganosiloxane in the copolymer molecule.
Such polymers are pressure sensitive hydrophobic polymers
specifically designed for pharmaceutical use and are permeable to
many drug compounds and find application for the transdermal
application of various compounds. In some embodiments, the silicone
polymers are the copolymer product of mixing a silanol terminated
polydiorganosiloxane such as polydimethyl siloxane with a
silanol-containing silicone resin whereby the silanol groups of the
polydiorganosiloxane undergo a condensation reaction with the
silanol groups of the silicone resin so that the
polydiorganosiloxane is lightly crosslinked by the silicone resin
(that is, the polydiorganosiloxane chains are bonded together
through the resin molecules to give chain branching and
entanglement and/or a small amount of network character) to form
the silicone hydrophobic polymers. A catalyst, for example, an
alkaline material, such as ammonia, ammonium hydroxide or ammonium
carbonate, can be mixed with the silanol-terminated
polydiorganosiloxane and the silicone resin to promote this
crosslinking reaction. By copolymerizing the silicone resin with
the silanol terminated polydiorganosiloxane, there results a
polymer with self-adhering properties and the cohesive properties
of a soft elastomer matrix characteristic of pressure sensitive
polymers being distinguished from the hard, non-elastomeric
properties of other silicone resins. In one embodiment, hydrophobic
polymers used in the carrier are available from the Dow-Corning
Company under the brand name BIO-PSA. The modification of a ratio
of silicone resin to polydiorganosiloxane modifies the tackiness of
the polymer. This ratio can be in the range of about 70:30 to about
50:50. For example, the BIO PSA silicone sold by Dow-Corning is
available in three silicone resin to silicone polymer ratios
namely, 65/35 (low tack), 60/40 (medium tack), 55/45 (high tack).
Such a polyorganosiloxane PSA is available dissolved in either
ethyl acetate solvent or dimethicone. Modifying the silicone resin
to polydiorganosiloxane ratio of the PSA will modify the tackiness
of the PSA. For example, the BIO PSA silicone adhesive sold by
Dow-Corning is available in three silicone resin to silicone
polymer ratios namely, 65/35 (low tack). 60/40 (medium tack), 55/45
(high tack) dissolved in either ethyl acetate solvent or
dimethicone. A suitable silicone PSA is Silicone Adhesive 8-7016,
commercially available from Dow Corning.
[0015] In some embodiments the hydrophobic component is present at
a concentration of from about 20 to about 80%, by weight of the
composition. In some embodiments, the hydrophobic component is
present at a concentration of from about 40 to about 80%, by weight
of the composition. In some embodiments, the hydrophobic component
is present at a concentration of from about 60 to about 80%, by
weight of the composition. In some embodiments, the hydrophobic
component is present at a concentration of from about 70 to about
80%, by weight of the composition. In some embodiments, the
hydrophobic component is present at a concentration of about 75%,
by weight of the composition.
[0016] In some embodiments, adhesiveness is be measured using
standard adhesion tests known in the art, for example, the adhesive
test disclosed in U.S. Pat. No. 6,613,812 to Bui. In certain
embodiments, the adhesiveness between a tooth and a film formed
from a composition of the present invention can be from about at
least 500 pounds per square inch (PSI), at least 1,000 PSI, at
least 2,000 PSI, or greater.
[0017] The present inventors have discovered that particular
amounts of a dental surface adhesion enhancing agent not only
provides greater retention of the composition to the tooth surface,
but also enhances the stability of the peroxide source and helps to
maximize delivery of an effective concentration of the peroxide
source at the target site.
[0018] In some embodiments, the compositions of the present
invention optionally comprise a tartar control or anticalculus
agent. Tartar control agents among those useful herein include
salts of any of these agents, for example their alkali metal and
ammonium salts: phosphates and polyphosphates (for example
pyrophosphates), polyaminopropanesulfonic acid (AMPS), polyolefin
sulfonates, polyolefin phosphates, diphosphonates such as
azacycloalkane-2,2-diphosphonates (e.g.,
azacycloheptane-2,2-diphosphonic acid), N-methyl
azacyclopentane-2,3-diphosphonic acid,
ethane-1-hydroxy-1,1-diphosphonic acid (EHDP) and
ethane-1-amino-1,1-diphosphonate, phosphonoalkane carboxylic acids
and. Useful inorganic phosphate and polyphosphate salts include
monobasic, dibasic and tribasic sodium phosphates, sodium
tripolyphosphate, tetrapolyphosphate, mono-, di-, tri- and
tetrasodium pyrophosphates, sodium trimetaphosphate, sodium
hexametaphosphate (SHMP) and mixtures thereof. In a particular
embodiment SHMP is used, The amount of stain prevention agent
optionally present is from about 0.1% to about 10%, in another
embodiment from about 2% to about 9%, and in another embodiment
from about 5% to about 8%, or about 7%, by weight, of the
composition.
[0019] In some embodiments, the compositions of the present
invention comprise a flavoring agent. Suitable flavoring agents
include, but are not limited to, essential oils as well as various
flavoring aldehydes, esters, alcohols, and similar materials.
Examples of the essential oils include oils of spearmint,
peppermint, wintergreen, sassafras, clove, sage, eucalyptus,
marjoram, cinnamon, lemon, lime, grapefruit, and orange. Also
useful are such chemicals as menthol, carvone, and anethole. Of
these, the most commonly employed are the oils of peppermint,
spearmint and wintergreen. The flavoring agent is incorporated in
the whitening liquid composition of the present invention at a
concentration of about 0.01 to about by weight and preferably about
0.1 to about 0.5% by weight.
[0020] In some embodiments, the present invention provides a
non-aqueous whitening composition comprising: a peroxide component
comprising a peroxide source in the amount of about 0.1% to about
5% of the total weight of the composition; and an adhesion system
comprising: a hydrophobic component comprising a silicone adhesive;
and a dental surface adhesion enhancing agent, wherein the
composition when applied to the teeth is sufficiently viscous to
form an adherent, continuous layer on a dental surface and deliver
an effective amount of said peroxide source to a tooth surface.
[0021] In some embodiments, the peroxide source is selected from:
hydrogen peroxide; urea peroxide, sodium percarbonate, sodium
perborate; and a combination of two or more thereof
[0022] In some embodiments, the peroxide component further
comprises cross-linked polyvinylpyrrolidone. In some embodiments,
the peroxide source is complexed with the cross-linked polyvinyl
pyrrolidone. In some embodiments, the peroxide source is hydrogen
peroxide.
[0023] In some embodiments, the dental surface adhesion enhancing
agent comprises an additional amount of cross-linked
polyvinylpyrrolidone. In some embodiments, the additional amount of
cross-linked polyvinylpyrrolidone is not complexed with the
peroxide source.
[0024] In some embodiments, the peroxide source is present in an
amount from about 0.05% to about 0.15%, by weight of the
composition. In other embodiments, the peroxide source is present
in an amount from about 0.08% to about 0.12%, by weight of the
composition. In further embodiments, the peroxide source is present
in the amount of about 0.1%, by weight of the composition.
[0025] In some embodiments, wherein the silicone adhesive is a
pressure sensitive silicone adhesive. In some embodiments, the
pressure sensitive silicone adhesive is a copolymer prepared by
condensing a silicone resin with a polydiorganosiloxane. In sonic
embodiments, the polydiorganosiloxane is polydimethylsiloxane. In
some embodiments, the silicone resin is a silanol-containing
silicone resin.
[0026] In some embodiments, the hydrophobic component further
comprises a silicone fluid. In some embodiments, the silicone fluid
comprises a siloxane polymer.
[0027] In some embodiments, the adhesion system further comprises a
material selected from: bees wax, mineral oil, a blend of mineral
oil and polyethylene (e.g., a plastigel), petrolatum, white
petrolatum, a blend of liquid paraffin and a
butene/ethylene/styrene hydrogenated copolymer (e.g., a versagel),
a polyethylene wax, polyisobutene, a polyvinyl pyrrolidone/vinyl
acetate copolymer; and a combination of two or more thereof. In
some embodiments, the organic material comprises mineral oil.
[0028] In some embodiments, the dental surface adhesion enhancing
agent is present in an amount of about 15% to about 25%, by weight,
of the composition. In some embodiments, the dental surface
adhesion enhancing agent is present in the amount of about 16% to
about 20%, by weight, of the composition. In other embodiments, the
dental surface adhesion enhancing agent is present at a
concentration of about 18%, by weight, of the composition.
[0029] Further embodiments provide a method for whitening a tooth
comprising applying a composition according to any one of the
foregoing claims to a tooth of a mammal. In some embodiments, the
composition is applied using a pen. In some embodiments, the
composition is maintained on the surface of the tooth for a
plurality of minutes.
[0030] In some embodiments, the composition is maintained on the
surface of a tooth for from about 1 minute to about 8 hours. In
some embodiments, the composition is maintained on the surface of a
tooth for from about 5 minutes to about 4 hours. In sonic
embodiments, the composition is maintained on the surface of a
tooth for from about 10 minutes to about 120 minutes. In some
embodiments, the composition is maintained on the surface of a
tooth for from about 15 minutes to about 60 minutes. In some
embodiments, the composition is maintained on the surface of a
tooth for from about 20 minutes to about 45 minutes. In some
embodiments, the composition is maintained on the surface of a
tooth for about 30 minutes.
[0031] In some embodiments, the composition is in the form of a
gel.
[0032] In some embodiments, the compositions of the present
invention can be prepared by adding and mixing the ingredients of
the composition in a suitable vessel such as a stainless steel tank
provided with a mixer. In the preparation of the whitening
compositions described herein, the ingredients are advantageously
added to the mixer in the following order: hydrophobic component,
peroxide component, dental surface adhesion enhancing agent, and
any desired flavoring or sweetener. The ingredients are then mixed
to form a homogeneous dispersion/solution.
[0033] In some embodiments, the compositions of the present
invention are applied to the tooth of a subject, by manual
application, such as by painting the teeth with a soft applicator
brush in the same manner as application of nail polish to a finger
nail and without the intervention of a dentist or technological
operations. Application by the user, leaves a coating of the thick
liquid suspension on the teeth. Contact with saliva causes the slow
release of H.sub.2O.sub.2 from the matrix of the peroxide
component, and permits efficient delivery of the peroxide source to
the target site, e.g. the tooth. I
[0034] Typically, the compositions are applied directly to the
teeth, e.g., by painting the teeth for a time sufficient to effect
whitening. The compositions of the present invention can be used in
a regimen for whitening teeth and can be used in combination with a
whitening toothpaste and a whitening mouthwash to further enhance
the whitening results.
[0035] As used herein, "whitening" refers to a change in visual
appearance of a tooth, preferably such that the tooth has a
brighter shade. Increase in whiteness of a dental surface can be
observed visually, for example with the aid of color comparison
charts or gauges, or measured by colorimetry, using any suitable
instrument such as a Minolta Chromameter, e.g., model CR-400
(Minolta Corp., Ramsey, N.J.), The instrument can be programmed,
for example, to measure Hunter Lab values or L*a*b* values
according to the standard established by the International
Committee of Illumination (CIE). The Pa*b* system provides a
numerical representation of three-dimensional color space where L*
represents a lightness axis, a* represents a red-green axis and b*
represents a yellow-blue axis. The L* and b* axes are typically of
greatest applicability to measurement of tooth whiteness. Increase
in whiteness can be computed from differences in L*, a* and b*
values before and after treatment, or between untreated and treated
surfaces.
[0036] As used herein, "tooth" or "teeth" refers to natural
mammalian teeth, dentures, dental plates, fillings, caps, crowns,
bridges, dental implants, and the like, and any other hard surfaced
dental prosthesis either permanently or temporarily fixed within
the oral cavity.
[0037] As used throughout, ranges are used as shorthand for
describing each and every value that is within the range. Any value
within the range can be selected as the terminus of the range. In
addition, all references cited herein are hereby incorporated by
referenced in their entireties. In the event of a conflict in a
definition in the present disclosure and that of a cited reference,
the present disclosure controls.
[0038] Unless otherwise specified, all percentages and amounts
expressed herein and elsewhere in the specification should be
understood to refer to percentages by weight. The amounts given are
based on the active weight of the material.
[0039] Embodiments of the present invention are further described
in the following examples. The examples are merely illustrative and
do not in any way limit the scope of the invention as described and
claimed.
EXAMPLES
Example 1
[0040] Table 1 (below) provides the formulation for an exemplary
composition of the present invention.
TABLE-US-00001 TABLE 1 Formula I Ingredient Weight % Silicone
adhesive 30 Silicone fluid 15.55 PVP-H.sub.2O.sub.2 complex 0.55%
(0.1% H.sub.2O.sub.2) Gelled mineral oil 35 cPVP 18 Sodium
saccharin 0.3 Flavor 0.6
Example 2
[0041] An exemplary composition (Formula I) of the present
invention is compared to a similarly formulated composition
(Comparative Example I) which contains more than forty times the
amount of a peroxide source contained in Formula I.
[0042] Table 2 (below) provides the formulation for Comparative
Example I.
TABLE-US-00002 TABLE 2 Comparative Example I Ingredient Weight %
Silicone adhesive 30 Silicone fluid 14 PVP-H.sub.2O.sub.2 complex
25% (45% H.sub.2O.sub.2) Gelled mineral oil 30.1 Sodium saccharin
0.3 Flavor 0.6
[0043] Whitening efficacy is determined using a duplicate pair of
flow cells designed to accommodate a total of eight bovine enamel
blocks (four in each cell). Bovine enamel blocks are obtained
freshly stained using an established staining protocol (Indiana
University, Indianapolis, Ind.). The initial L*, a* and b* values
are matched as closely as possible prior to the experiment using a
chromameter (Minolta CR-321) based on initial L*, a* and b* values
(CH-LAB). The L, a, 1) values are measured four times at slightly
differing locations on the surface of the bovine enamel blocks.
[0044] To simulate the saliva of the human mouth, an artificial
saliva buffer solution maintained at 37.degree. C. is prepared
containing the salts usually present in saliva at levels typical to
the levels found in human saliva.
[0045] The bovine enamel blocks are placed in the flow cells and
the liquid compositions are evenly applied using a brush. Flow over
the teeth was 0.6 ml/min. for 30 min. Average initial and final
chromometer readings are read, and used to calculate .DELTA.b and
.DELTA.L.
TABLE-US-00003 TABLE 3 .DELTA.b* .DELTA.L Formula I -3.36 4.38
Comparative Example I -4.12 8.3
[0046] The data described in Table 3 (above) demonstrates that
compositions of the present invention unexpectedly provide a level
of whitening comparable to a similarly formulated composition
containing over 40.times. more whitening agent.
* * * * *