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Patent 3123187 Summary

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(12) Patent Application: (11) CA 3123187
(54) English Title: ORAL CARE COMPOSITIONS AND METHODS FOR THE SAME
(54) French Title: COMPOSITIONS DE SOIN BUCCAL ET PROCEDES POUR CELLES-CI
Status: Examination Requested
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61K 8/22 (2006.01)
  • A61K 8/23 (2006.01)
  • A61K 8/90 (2006.01)
  • A61Q 11/00 (2006.01)
(72) Inventors :
  • YUAN, SHAOTANG (United States of America)
  • PIMENTA, PALOMA (United States of America)
  • DOGO-ISONAGIE, CAJETAN (United States of America)
(73) Owners :
  • COLGATE-PALMOLIVE COMPANY (United States of America)
(71) Applicants :
  • COLGATE-PALMOLIVE COMPANY (United States of America)
(74) Agent: ROBIC
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 2018-12-26
(87) Open to Public Inspection: 2020-07-02
Examination requested: 2023-12-08
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US2018/067549
(87) International Publication Number: WO2020/139328
(85) National Entry: 2021-06-11

(30) Application Priority Data: None

Abstracts

English Abstract

Oral care compositions and methods for whitening teeth are provided. The oral care composition may include an orally acceptable vehicle, a whitening booster, and a source of hydrogen peroxide. The whitening booster may be dispersed in the orally acceptable vehicle. The whitening booster may include a salt of a monopersulfate, such as an alkali metal salt of the monopersulfate.


French Abstract

L'invention concerne des compositions de soins bucco-dentaires et des procédés pour celles-ci. La composition de soin buccal peut comprendre un véhicule acceptable du point de vue buccal, un agent activateur de blanchiment, et une source de peroxyde d'oxygène. L'activateur de blanchiment peut être dispersé dans le véhicule acceptable du point de vue buccal. L'activateur de blanchiment peut comprendre un sel d'un monopersulfate, tel qu'un sel de métal alcalin du monopersulfate.

Claims

Note: Claims are shown in the official language in which they were submitted.


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CLAIMS
What is claimed is:
1. An oral care composition, comprising:
an orally acceptable vehicle;
a whitening booster dispersed in the orally acceptable vehicle, wherein the
whitening
booster comprises a salt of a monopersulfate; and
a source of hydrogen peroxide.
2. The oral care composition of claim 1, wherein the salt of the
monopersulfate is an alkali
metal salt of the monopersulfate.
3. The oral care composition of claim 1 or 2, wherein the whitening booster
comprises
potassium monopersulfate.
4. The oral care composition of any one of the preceding claims, wherein
the whitening
booster consists essentially of the salt of the monopersulfate, optionally the
whitening booster
consists of the salt of the monopersulfate.
5. The oral care composition of any one of the preceding claims, wherein
the whitening
composition prior to use is substantially free of water.
6. The oral care composition of any one of the preceding claims, wherein
the orally
acceptable vehicle comprises a structure-building agent.
7. The oral care composition of claim 6, wherein the structure-building
agent comprises an
amphiphilic copolymer, optionally, the amphiphilic copolymer comprises a
polyvinylpyrrolidone
vinyl acetate copolymer.
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8. The oral care composition of claim 6, wherein the structure-building
agent comprises a
poloxamer, optionally, the poloxamer comprises a poly(ethylene glycol)-block-
poly(propylene
glycol)-block-poly(ethylene glycol).
9. The oral care composition of any one of the preceding claims, wherein
the source of
hydrogen peroxide comprises a cross-linked polyvinylpyrrolidone (PVP) hydrogen
peroxide
complex.
10. The oral care composition of any one of the preceding claims, wherein
the oral care
composition is a tooth whitening gel.
11. The oral care composition of any one of the preceding claims, wherein
the whitening
booster is present in an amount of from about 1 weight % to about 5 weight %,
based on a total
weight of the oral care composition.
12. A method for whitening teeth of a subject, comprising contacting the
oral care
composition of any one of the preceding claims with a surface of the teeth of
the subject in need
thereof.
13. The method of claim 12, wherein contacting the oral care composition
with the surface of
the teeth comprises directly applying the oral care composition with a
delivery device,
optionally, the delivery device is an applicator comprising a brush, a roller
ball, or a felt tip.
14. The method of claim 12 or 13, wherein contacting the oral care
composition with the
surface of the teeth comprises disposing the oral care composition in a dental
tray, and disposing
the dental tray about the teeth.
15. The method of any one of claims 12 to 14, wherein the oral care
composition is contacted
with the surface of the teeth for at least 5 minutes, optionally, at least 10
minutes, further
optionally, at least 15 minutes.
27

Description

Note: Descriptions are shown in the official language in which they were submitted.


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ORAL CARE COMPOSITIONS AND METHODS FOR THE SAME
BACKGROUND
[1] Conventional oral care products including whitening agents are often
utilized to whiten
teeth. For example, conventional oral care products including peroxides, such
as hydrogen
peroxide, are often utilized to oxidize chromophores bound to surfaces and/or
dentin of teeth to
thereby whiten the teeth. While oral care products including hydrogen peroxide
have proven to
be effective for whitening teeth, the utilization of hydrogen peroxide is
limiting. For example,
increasing concentrations of hydrogen peroxide to improve whitening may often
lead to irritation
of the teeth and gums. Further, peroxides in oral care products are often
highly reactive and
prone to decomposition, thereby reducing the whitening efficacy thereof.
[2] What is needed, then, are improved oral care products and whitening
compositions
thereof, and methods for the same.
BRIEF SUMMARY
[3] This summary is intended merely to introduce a simplified summary of
some aspects of
one or more implementations of the present disclosure. Further areas of
applicability of the
present disclosure will become apparent from the detailed description provided
hereinafter. This
summary is not an extensive overview, nor is it intended to identify key or
critical elements of
the present teachings, nor to delineate the scope of the disclosure. Rather,
its purpose is merely
to present one or more concepts in simplified form as a prelude to the
detailed description below.
[4] The foregoing and/or other aspects and utilities embodied in the
present disclosure may
be achieved by providing an oral care composition including an orally
acceptable vehicle, a
whitening booster, and a source of hydrogen peroxide. The whitening booster
may be dispersed
in the orally acceptable vehicle, and may include a salt of a monopersulfate.
[5] In at least one implementation, the salt of the monopersulfate may be
an alkali metal salt
of the monopersulfate.
[6] In at least one implementation, the whitening booster may include
potassium
monopersulfate.
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[7] In at least one implementation, the whitening booster may consist
essentially of the salt
of the monopersulfate. In another implementation, the whitening booster may
consist of the salt
of the monopersulfate.
[8] In at least one implementation, the whitening composition prior to use
may be free or
substantially free of water.
[9] In at least one implementation, the orally acceptable vehicle may
include a structure-
building agent.
[10] In at least one implementation, the structure-building agent may include
an amphiphilic
copolymer. The amphiphilic copolymer may include a polyvinylpyrrolidone vinyl
acetate
copolymer.
[11] In at least one implementation, the structure-building agent may include
a poloxamer.
The poloxamer may include a poly(ethylene glycol)-block-poly(propylene glycol)-
block-
poly(ethylene glycol).
[12] In at least one implementation, the source of hydrogen peroxide may
include a cross-
linked polyvinylpyrrolidone (PVP) hydrogen peroxide complex.
[13] In at least one implementation, the oral care composition may be a tooth
whitening gel.
[14] In at least one implementation, the whitening booster may be present in
an amount of
from about 1 weight % to about 5 weight %, based on a total weight of the oral
care composition.
[15] The foregoing and/or other aspects and utilities embodied in the present
disclosure may
be achieved by providing a method for whitening teeth of a subject. The method
may include
contacting an oral care composition with a surface of the teeth of the subject
in need thereof.
The oral care composition may be any one or more of the oral care compositions
disclosed
herein. The oral care composition may include an orally acceptable vehicle, a
whitening booster,
and a source of hydrogen peroxide. The whitening booster may be dispersed in
the orally
acceptable vehicle, and may include a salt of a monopersulfate.
[16] In at least one implementation, contacting the oral care composition with
the surface of
the teeth may include directly applying the oral care composition with a
delivery device. The
delivery device may be an applicator including a brush, a roller ball, or a
felt tip.
[17] In at least one implementation, contacting the oral care composition with
the surface of
the teeth may include disposing the oral care composition in a dental tray,
and disposing the
dental tray about the teeth.
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[18] In at least one implementation, the oral care composition may be
contacted with the
surface of the teeth for at least 5 minutes, optionally, at least 10 minutes,
further optionally, at
least 15 minutes.
[19] Further areas of applicability of the present disclosure will become
apparent from the
detailed description provided hereinafter. It should be understood that the
detailed description
and specific examples, while indicating some typical aspects of the
disclosure, are intended for
purposes of illustration only and are not intended to limit the scope of the
disclosure.
DETAILED DESCRIPTION
[20] The following description of various typical aspect(s) is merely
exemplary in nature and
is in no way intended to limit the disclosure, its application, or uses.
[21] As used throughout this disclosure, ranges are used as shorthand for
describing each and
every value that is within the range. It should be appreciated and understood
that the description
in a range format is merely for convenience and brevity, and should not be
construed as an
inflexible limitation on the scope of any embodiments or implementations
disclosed herein.
Accordingly, the disclosed range should be construed to have specifically
disclosed all the
possible subranges as well as individual numerical values within that range.
As such, any value
within the range may be selected as the terminus of the range. For example,
description of a
range such as from 1 to 5 should be considered to have specifically disclosed
subranges such as
from 1.5 to 3, from 1 to 4.5, from 2 to 5, from 3.1 to 5, etc., as well as
individual numbers within
that range, for example, 1, 2, 3, 3.2, 4, 5, etc. This applies regardless of
the breadth of the range.
[22] 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.
[23] Additionally, all numerical values are "about" or "approximately" the
indicated value,
and take into account experimental error and variations that would be expected
by a person
having ordinary skill in the art. It should be appreciated that all numerical
values and ranges
disclosed herein are approximate values and ranges, whether "about" is used in
conjunction
therewith. It should also be appreciated that the term "about," as used
herein, in conjunction
with a numeral refers to a value that may be 0.01% (inclusive), 0.1%
(inclusive), 0.5%
(inclusive), 1% (inclusive) of that numeral, 2% (inclusive) of that
numeral, 3% (inclusive)
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of that numeral, 5% (inclusive) of that numeral, 10% (inclusive) of that
numeral, or 15%
(inclusive) of that numeral. It should further be appreciated that when a
numerical range is
disclosed herein, any numerical value falling within the range is also
specifically disclosed.
[24] As used herein, "free" or "substantially free" of a material may refer to
a composition,
component, or phase where the material is present in an amount of less than
10.0 weight %, less
than 5.0 weight %, less than 3.0 weight %, less than 1.0 weight %, less than
0.1 weight %, less
than 0.05 weight %, less than 0.01 weight %, less than 0.005 weight %, or less
than 0.0001
weight % based on a total weight of the composition, component, or phase.
[25] All references cited herein are hereby incorporated by reference 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.
[26] The present inventors have surprisingly and unexpectedly discovered that
incorporating a
whitening booster, such as monopersulfate (MPS) or a salt thereof, in an oral
care product or the
whitening composition thereof provided a surprising and unexpected increase in
whitening
efficacy as compared to a conventional oral care product (i.e., whitening gel)
including hydrogen
peroxide alone. The inventors have also surprisingly and unexpectedly
discovered that the
combination of MPS and hydrogen peroxide exhibits synergistic effects (e.g.,
more than
additive) that provide a statistically significant enhancement or increase in
whitening efficacy for
oral care product or the whitening composition thereof. Particularly, oral
care products or the
whitening compositions thereof that combine MPS and hydrogen peroxide provide
whiter teeth
at a faster rate.
COMPOSITIONS
[27] Compositions disclosed herein may be or include an oral care product, an
oral care
composition, and/or a whitening composition thereof. For example, the
composition may be an
oral care product or composition including a whitening composition, or the
whitening
composition thereof. In a typical implementation, the composition may be an
oral care
composition in the form of a gel. The whitening composition may include a
carrier or an orally
acceptable vehicle combined with one or more whitening agents, one or more
sources of
hydrogen peroxide, or combinations or mixtures thereof. For example, the
whitening
composition may include the one or more whitening boosters and the one or more
sources of
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hydrogen peroxide, and the orally acceptable vehicle. In another example, the
whitening
composition may include the one or more whitening boosters and the orally
acceptable vehicle.
The one or more whitening boosters and/or the one or more sources of hydrogen
peroxide may
be combined with, dispersed in, mixed with, or otherwise contacted with the
carrier or orally
acceptable vehicle. The whitening booster may be or include one or more non-
peroxide
bleaching or whitening agents capable of or configured to interact
synergistically with one or
more components of the oral care product to enhance the whitening efficacy of
the oral care
product or the whitening composition thereof.
[28] In at least one implementation, the oral care product or the whitening
composition thereof
may be anhydrous or non-aqueous prior to use. For example, the oral care
product or the
whitening composition thereof may be free of water, substantially free of
water. As used herein,
"free of water" or "substantially free of water" may refer to a composition
that contains water in
an amount of less than 10 weight %, less than 8 weight %, less than 5 weight
%, less than 3
weight %, less than 1 weight %, less than 0.1 weight %, less than 0.05 weight
%, less than 0.01
weight %, less than 0.005 weight %, or less than 0.0001 weight %, based on a
total weight of the
oral care product or the whitening composition thereof. In another
implementation, the oral care
product or the whitening composition thereof prior to use may have "low water
content". As
used herein, "low water content" may refer to a composition that contains
water in an amount
greater than about 5 weight % or greater than about 10 weight %, and less than
about 20 weight
%, less than about 15 weight %, or less than about 10 weight %, based on a
total weight of the
oral care product or the whitening composition thereof.
[29] In one implementation, contacting the whitening composition or a
component thereof
with water may initiate the release of hydrogen peroxide. For example,
contacting the source of
hydrogen peroxide with water may initiate the release of hydrogen peroxide. In
another
example, the source of hydrogen peroxide may be maintained in a hydrophobic
phase, and
combining, mixing, or otherwise contacting the hydrophobic phase and a
separate hydrophilic
phase with one another may initiate the release of hydrogen peroxide from the
source of
hydrogen peroxide.
Sources of Hydrogen Peroxide
[30] The one or more sources of hydrogen peroxide may be or include any
compound or
material capable of or configured to interact or react synergistically with
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enhance or increase the whitening efficacy of the oral care product or the
whitening composition
thereof. For example, the one or more sources of hydrogen peroxide may be or
include any
compound or material capable of or configured to provide or release hydrogen
peroxide that
interacts or react synergistically with the whitening booster to enhance or
increase the whitening
efficacy of the oral care product or the whitening composition thereof. The
sources of hydrogen
peroxide may be capable of or configured to release hydrogen peroxide when
contacted with
water. Illustrative sources of hydrogen peroxide may be or include, but are
not limited to,
hydrogen peroxide, urea peroxide, calcium peroxide, a cross-linked
polyvinylpyrrolidone (PVP)
hydrogen peroxide complex, a polyvinylpyrrolidone (PVP) hydrogen peroxide
complex, sodium
percarbonate, or the like, or combinations thereof. The sources of hydrogen
peroxide may also
be or include, but are not limited to, PEROXYDONETm XL 1OF complex, which is
commercially available from Ashland Inc. of Covington, KY. In a typical
implementation, the
source of hydrogen peroxide includes a cross-linked polyvinylpyrrolidone (PVP)
hydrogen
peroxide complex.
[31] The amount or concentration of the source of hydrogen peroxide may vary
widely, and
may depend upon the amount or a desired amount of hydrogen peroxide provided
or otherwise
delivered by the source of hydrogen peroxide. In at least one implementation,
the source of
hydrogen peroxide may be present in an amount that provides from greater than
0.0 weight % to
less than or equal to 35.0 weight % free hydrogen peroxide, based on a total
weight of the oral
care product or the whitening composition thereof. For example, the source of
hydrogen
peroxide may be present in an amount that provides hydrogen peroxide (e.g.,
free hydrogen
peroxide) in an amount of from greater than 0.0 weight %, about 0.5 weight %,
about 1.0 weight
%, about 1.5 weight %, about 2.0 weight %, about 2.5 weight %, about 3.0
weight %, about 3.5
weight %, about 4.0 weight %, about 4.5 weight %, about 5.5 weight %, about
6.0 weight %,
about 6.5 weight %, about 7.0 weight %, about 7.5 weight %, about 8.0 weight
%, about 8.5
weight %, about 9.0 weight %, about 9.5 weight %, or about 10.0 weight % to
about 12.0 weight
%, about 14.0 weight %, about 16.0 weight %, about 18.0 weight %, about 20.0
weight %, about
22.0 weight %, about 24.0 weight %, about 26.0 weight %, about 28.0 weight %,
about 30.0
weight %, about 32.0 weight %, about 34.0 weight %, or less than or equal to
about 35.0 weight
%, based on a total weight of the oral care product or the whitening
composition thereof.
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[32] In another implementation, the source of hydrogen peroxide may be present
in an amount
that provides from greater than 0.0 weight % to less than or equal to 10.0
weight % free
hydrogen peroxide, based on a total weight of the oral care product or the
whitening composition
thereof. For example, the source of hydrogen peroxide may be present in an
amount that
provides hydrogen peroxide (e.g., free hydrogen peroxide) in an amount of from
greater than 0.0
weight %, about 0.5 weight %, about 1.0 weight %, about 1.5 weight %, about
2.0 weight %,
about 2.5 weight %, about 3.0 weight %, about 3.5 weight %, about 4.0 weight
%, or about 4.5
weight % to about 5.5 weight %, about 6.0 weight %, about 6.5 weight %, about
7.0 weight %,
about 7.5 weight %, about 8.0 weight %, about 8.5 weight %, about 9.0 weight
%, about 9.5
weight %, or about 10.0 weight %, based on a total weight of the oral care
product or the
whitening composition thereof. In another example, the source of hydrogen
peroxide may be
present in an amount that provides hydrogen peroxide in an amount of from
greater than 0.0
weight % to less than or equal to 10.0 weight %, about 0.5 weight % to about
9.5 weight %,
about 1.0 weight % to about 9.0 weight %, about 1.5 weight % to about 8.5
weight %, about 2.0
weight % to about 8.0 weight %, about 2.5 weight % to about 7.5 weight %,
about 3.0 weight %
to about 7.0 weight %, about 3.5 weight % to about 6.5 weight %, about 4.0
weight % to about
6.0 weight %, or about 4.5 weight % to about 5.5 weight %.
[33] In yet another implementation, the source of hydrogen peroxide may be
present in an
amount that provides from about 0.1 weight % to less than or equal to 2.0
weight % free
hydrogen peroxide, based on a total weight of the oral care product or the
whitening composition
thereof. For example, the source of hydrogen peroxide may be present in an
amount that
provides hydrogen peroxide (e.g., free hydrogen peroxide) in an amount of from
about 0.1
weight %, about 0.2 weight %, about 0.3 weight %, about 0.4 weight %, about
0.5 weight %,
about 0.6 weight %, about 0.7 weight %, about 0.8 weight %, about 0.9 weight
%, or about 1.0
weight % to about 1.1 weight %, about 1.2 weight %, about 1.3 weight %, about
1.4 weight %,
about 1.5 weight %, about 1.6 weight %, about 1.7 weight %, about 1.8 weight
%, about 1.9
weight %, or about 2.0 weight %. In another example, the source of hydrogen
peroxide may be
present in an amount that provides hydrogen peroxide in an amount of from
about 0.1 weight %
to about 2.0 weight %, about 0.2 weight % to about 1.9 weight %, about 0.3
weight % to about
1.8 weight %, about 0.4 weight % to about 1.7 weight %, about 0.5 weight % to
about 1.6 weight
%, about 0.6 weight % to about 1.5 weight %, about 0.7 weight % to about 1.4
weight %, about
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0.8 weight % to about 1.3 weight %, about 0.9 weight % to about 1.2 weight %,
or about 1.0
weight % to about 1.1 weight %. In yet another example, the source of hydrogen
peroxide may
be present in an amount that provides hydrogen peroxide in an amount less than
or equal to 2.0
weight %, less than or equal to 1.8 weight %, less than or equal to 1.6 weight
%, less than or
equal to 1.4 weight %, less than or equal to 1.2 weight %, less than or equal
to 1.0 weight %, less
than or equal to 0.8 weight %, less than or equal to 0.6 weight %, or less
than or equal to 0.4
weight %. In a typical implementation, the source of hydrogen peroxide may be
present in an
amount that provides hydrogen peroxide in an amount of about 35.0 weight % or
less, or about
2.5 weight % or less, or about 2.0 weight % or less.
Whitening Booster
[34] The whitening booster may be or include any compound or material capable
of or
configured to interact or react synergistically with the source of hydrogen
peroxide or the
hydrogen peroxide thereof to enhance the whitening efficacy of the oral care
product or the
whitening composition thereof. In at least one implementation, the whitening
booster may be or
include one or more non-peroxide bleaching or whitening agents. The whitening
booster or the
non-peroxide bleaching agent may be water soluble. Illustrative non-peroxide
bleaching agents
may be or include, but are not limited to, a salt of a peroxymonosulfate or a
salt of
monopersulfate (MPS). For example, the whitening booster may be or include,
but is not limited
to, an alkali metal salt of MPS, such as a potassium MPS, sodium MPS, ammonium
MPS, or the
like, or any combination thereof. MPS may be provided as a single molecule, a
compound, such
as a monopersulfate compound or MPS compound, a complex, such as a
monopersulfate
complex, or any combination thereof. In at least one implementation, the
whitening booster may
be or include an MPS compound or a mixture of two or more salts of peroxymono
sulfate. The
MPS compound may be or include a mixed salt or triple salt, such as (2KHS05-
KHSO4-K2SO4).
[35] In at least one implementation, the whitening booster may be or include
OXONE ,
which is commercially available from DuPont of Wilmington, DE. It should be
appreciated that
OXONE has an active oxygen content of about 4.5%. The active oxygen content
of the mixed
salt is about 5.2% when the salt is purified. The active oxygen content of
KHS05 is about
10.5%. It should further be appreciated that the pure mixed salt has about
half as much active
oxygen as compared to the pure form, and the 86.5% pure mixed salt (i.e.,
OXONE ) has 43%
as much active oxygen as compared to the pure form. It should also be
appreciated that
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OXONE may include about 43% potassium hydrogen peroxymonosulfate, about 23%
potassium hydrogen sulfate, about 29% potassium sulfate, about 3% potassium
peroxydisulfate,
and about 2% magnesium carbonate. MPS is also commercially available as CAROAT
from
United Initiators Inc. of Mason, OH.
[36] In at least one implementation, the whitening booster may be provided as
a solid. For
example, the whitening booster may be provided as a powder, a tablet,
granules, or the like, and
the whitening booster may be combined with the remaining components to form
the oral care
product (e.g., gel) or the whitening composition thereof. It should be
appreciated that the solid
may be free or substantially free of water. The solid may be provided in a
variety of forms,
including, but not limited to, a free flowing granulation, a tablet (e.g.,
effervescing tablet), a
caplet, granules, pellets, wafers, films, beads, or the like. In another
implementation, the
whitening booster may be provided as a liquid, mixture, or solution, such as a
liquid dispersion
of the solid.
[37] The whitening booster may be provided separate from one or more of the
remaining
components or ingredients of the whitening composition, and at the point of
use, the whitening
booster may be combined, mixed, dispersed, or otherwise contacted with the one
or more
remaining components to form the oral care product or the whitening
composition thereof. For
example, the whitening booster may be provided as a solid and contacted with
the one or more
remaining components to form or provide the oral care product or the whitening
composition
thereof.
[38] In at least one implementation, the whitening booster may be provided in
an air-tight,
moisture-proof container, package, vessel, or the like. Illustrative packages
may be or include,
but are not limited to, sealed metal foil pouches, blister packs, desiccant
capped tubes, or the
like. The packages may be made from polymeric materials, such as
polyethylene,
polypropylene, or the like or copolymers thereof, metallic materials, such as
metallic foils (e.g.,
aluminum), or both the polymeric and metallic materials. The whitening booster
may be
packaged as a single dose or multiple doses.
[39] The amount or concentration of the whitening booster may vary widely. In
at least one
implementation, the whitening booster may be provided in an amount of from
greater than 0.0
weight % to about 30 weight %, based on a total weight of the oral care
product or the whitening
composition thereof. For example, the whitening booster may be provided in an
amount from
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greater than 0.0 weight %, about 0.5 weight %, about 1 weight %, about 1.5
weight %, about 2
weight %, about 2.5 weight %, about 3 weight %, about 3.5 weight %, about 4
weight %, or
about 4.5 weight % to about 5 weight %, about 5.5 weight %, about 6 weight %,
about 6.5
weight %, about 7 weight %, about 7.5 weight %, about 8 weight %, about 8.5
weight %, about 9
weight %, about 9.5 weight %, about 10 weight %, about 15 weight %, about 20
weight %, about
25 weight %, or about 30 weight %. In another example, the whitening booster
may be provided
in an amount from greater than 0.0 weight %, about 0.1 weight %, about 0.2
weight %, about 0.3
weight %, about 0.4 weight %, about 0.5 weight %, about 0.6 weight %, about
0.7 weight %,
about 0.8 weight %, about 0.9 weight %, or about 1.0 weight % to about 1.1
weight %, about 1.2
weight %, about 1.3 weight %, about 1.4 weight %, about 1.5 weight %, about
1.6 weight %,
about 1.7 weight %, about 1.8 weight %, about 1.9 weight %, or about 2.0
weight %. In yet
another example, the whitening booster may be provided in an amount from
greater than 0.0
weight % to about 2.0 weight %, about 0.1 weight % to about 1.9 weight %,
about 0.2 weight %
to about 1.8 weight %, about 0.3 weight % to about 1.7 weight %, about 0.4
weight % to about
1.6 weight %, about 0.5 weight % to about 1.5 weight %, about 0.6 weight % to
about 1.4 weight
%, about 0.7 weight % to about 1.3 weight %, about 0.8 weight % to about 1.2
weight %, or
about 0.9 weight % to about 1.1 weight %.
[40] In at least one implementation, the amount of the whitening booster
present in the
whitening composition may be at least partially determined by or depend upon
the amount of
hydrogen peroxide provided or otherwise delivered by the source of hydrogen
peroxide. For
example, the whitening booster may be provided in an amount such that a ratio
of the whitening
booster to the amount of hydrogen peroxide provide by the source of hydrogen
peroxide or vice
versa may be from about 0.1:1 to about 5:1, or from about 0.1:1 to about 10:1,
or from about
0.1:1 to about 15:1. For example, the ratio of the whitening booster to the
amount of hydrogen
peroxide provide by the source of hydrogen peroxide or vice versa may be from
about 0.01:1,
about 0.1:1, about 0.5:1, about 1:1, about 1.5:1, or about 2:1 to about 2.5:1,
about 3:1, about
3.5:1, about 4:1, about 4.5:1, about 5:1, about 10:1, or about 15:1. In
another example, the ratio
of the whitening booster to the amount of hydrogen peroxide provide by the
source of hydrogen
peroxide or vice versa may be from about 0.1:1 to about 5:1, about 0.5:1 to
about 4.5:1, about
1:1 to about 4:1, about 1.5:1 to about 3.5:1, or about 2:1 to about 3:1.
Orally Acceptable Vehicle Or Liquid Carrier

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[41] The whitening composition may form at least a portion of or be used in
one or more oral
care products or oral care compositions. The whitening composition may be
mixed, dispersed,
dissolved, combined, or otherwise contacted with an orally acceptable vehicle
or carrier to form
the oral care product (e.g., whitening gel) or oral care compositions.
Illustrative oral care
products may include, but are not limited to, a mouthwash, a toothpaste
(dentifrice), a
prophylactic paste, a tooth powder, a tooth polish, a tooth gel (e.g., a
whitening gel), a chewing
gum, a lozenge, a whitening strip, a paint-on gel, varnish, veneer, tube,
syringe, dental tray
including a gel or paste, a gel or paste coated on an application support such
as dental floss or a
toothbrush (e.g., a manual, electric, sound, a combination thereof or
ultrasound toothbrush), or
any combination thereof. In a typical implementation, the whitening
composition may form at
least a portion of or be used in a whitening gel or a gel whitening
composition.
[42] The orally acceptable vehicle may include one or more poloxamers. The
poloxamers
may be a liquid or a paste. The poloxamer may have an average molecular weight
of less than or
equal to about 12,000 Dalton (Da), less than or equal to about 11,000 Da, less
than or equal to
about 10,000 Da, less than or equal to about 9,000 Da, less than or equal to
about 8,000 Da, less
than or equal to about 7,000 Da, or less than or equal to about 6,000 Da.
Illustrative poloxamers
may be or include, but are not limited to, one or more of PLURONIC L35
(poly(ethylene
glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol)), PLURONIC
L43,
PLURONIC L64, PLURONIC L10, PLURONIC L44, PLURONIC L62, PLURONIC
10R5, PLURONIC 17R4, PLURONIC L25R4, PLURONIC P84, PLURONIC P65,
PLURONIC P104, and PLURONIC P105, or the like, or any mixture or combination
thereof,
each of which or commercially available from BASF Corp. of Florham Park, NJ.
In a preferred
implementation, the orally acceptable vehicle includes a poly(ethylene glycol)-
block-
poly(propylene glycol)-block-poly(ethylene glycol) polymer, such as PLURONIC
L35.
[43] The orally acceptable vehicle may include a thickening system having one
or more
thickeners. The one or more thickeners may be any orally acceptable thickener
or thickening
agent configured to control the viscosity of the oral care product or the
whitening composition
thereof. Illustrative thickeners may be or include, but are not limited to,
colloidal silica, fumed
silica, polyvinylpyrrolidone (PVP), a cross-linked polyvinylpyrrolidone (PVP)
polymer, cross-
linked polyvinylpyrrolidone (PVP), or the like, or mixtures or combinations
thereof. In at least
one implementation, the thickening system includes a polyvinylpyrrolidone
(PVP), cross-linked
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polyvinylpyrrolidone (PVP) polymer, or combinations thereof. The thickening
system may also
include POLYPLASDONE XL 10F, which is commercially available from Ashland
Inc. of
Covington, KY. Illustrative thickeners may also be or include, but are not
limited to, carbomers
(e.g., carboxyvinyl polymers), carrageenans (e.g., Irish moss, carrageenan,
iota-carrageenan,
etc.), high molecular weight polyethylene glycols (e.g., CARBOWAX , which is
commercially
available from The Dow Chemical Company of Midland, MI), cellulosic polymers,
hydroxyethylcellulose, carboxymethylcellulose, and salts thereof (e.g., CMC
sodium), natural
gums (e.g., karaya, xanthan, gum arabic, and tragacanth), colloidal magnesium
aluminum
silicate, or the like, or mixtures or combinations thereof.
[44] In a more typical implementation, the thickening system may include an
organic polymer,
which may also be configured as an adhesion enhancing agent. Illustrative
organic polymers
may be or include, but are not limited to, hydrophilic polymers, such as
carbomers, such as
carboxymethylene polymers, such as acrylic acid polymers, and acrylic acid
copolymers.
carboxypolymethylene is a slightly acidic vinyl polymer with active carboxyl
groups. In a
typical embodiment, the thickening system includes a carboxypolymethylene,
such as
CARBOPOL 974 and/or 980, which are commercially available from Noveon, Inc.
of
Cleveland, OH.
[45] The amount or concentration of the thickening system and/or any one or
more of the
thickeners thereof present in the oral care product or the whitening
composition thereof may vary
widely. The amount of the thickening system and/or the thickeners thereof
present in the oral
care product or the whitening composition thereof may be from about 1 weight %
to about 99
weight % based on the total weight of the oral care product or the whitening
composition thereof.
For example, the amount of the thickening system and/or the thickeners thereof
present may be
from about 1 weight %, about 2 weight %, about 3 weight %, about 4 weight %,
about 5 weight
%, about 6 weight %, about 7 weight %, about 8 weight %, about 9 weight %,
about 10 weigh %,
about 15 weight %, about 20 weight %, or about 21 weight % to about 22 weight
%, about 23
weight %, about 24 weight %, about 25 weight %, about 26 weight %, about 27
weight %, about
28 weight %, about 29 weight %, about 30 weight %, or more, based on a total
weight of the oral
care product or the whitening composition thereof. In another example, the
amount of the
thickening system and/or the thickeners thereof present may be from about 1
weight % to about
30 weight %, about 3 weight % to about 29 weight %, about 14 weight % to about
28 weight %,
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about 15 weight % to about 27 weight %, about 16 weight % to about 26 weight
%, about 17
weight % to about 25 weight %, about 18 weight % to about 24 weight %, about
19 weight % to
about 23 weight %, or about 20 weight % to about 22 weight %. In a typical
implementation, the
amount of the thickening system and/or the thickeners thereof present in the
oral care product or
the whitening composition thereof may be from about 10 weight % to about 20
weight %, more
typically about 1.2 weight % to about 1.8 weight %, and more typically about
1.5 weight %.
[46] The orally acceptable vehicle may include one or more structure-building
agents. As
used herein, the term or expression "structure-building agent" may refer to a
material that may
not only thicken the oral care product or the whitening composition thereof,
but may also
maintain the oral care composition in a homogenous state. As used herein, the
term or
expression "homogenous" may refer to a mixture, solution, or composition
composed of or
including two or more compounds, elements, substances, or the like, that are
uniformly dispersed
into one another. A homogenous oral care composition may be capable of
maintaining or
exhibiting no phase separation after aging for at least 12 hours, at least 24
hours, at least 36
hours, at least 2 days, at least 3 days, at least 5 days, at least 10 days, at
least 15 days, at least 20
days, at least 30 days, at least 2 months, at least 3 months, at least 5
months, at least 6 months, or
at least 1 year.
[47] Without being bound by the theory, it is believed that structure-building
agents may
generally interact with the one or more components of the orally acceptable
vehicle and/or other
structure building agents to maintain the homogenous state. For example, the
structure-building
agent may be capable of or configured to form a gel or a gel structure via
self-assembly. The
structure-building agent may be capable of or configured to form a gel with
the other structure-
building agents and/or the one or more components of the orally acceptable
vehicle by
interacting with the other structure-building agents and/or the one or more
components of the
orally acceptable vehicle via any one or more intermolecular forces (e.g., van
der Waal, dipole-
dipole, hydrogen bonding, covalent bonding, etc.).
[48] In some implementations, the structure-building agent may be or
include a polymer. In
some examples, the structure-building agent may be or include an amphiphilic
copolymer, where
the amphiphilic copolymer is composed of two or more monomers, where at least
one of the
monomers is hydrophilic (e.g., vinylpyrrolidone), and where at least one of
the monomers is
hydrophobic (e.g., vinyl acetate). It should be appreciated that an
amphiphilic copolymer may be
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capable of or configured to interact with both hydrophilic and hydrophobic
components,
substances, or liquids. In at least one implementation, the structure-building
agent may be or
include, but is not limited to, a poloxamer, as described above, a cross-
linked polymer, such as
cross-linked polyvinylpyrrolidone ("PVP"), a polyvinylpyrrolidone copolymer, a

polyvinylpyrrolidone vinyl acetate copolymer, or any combination thereof. It
should be
appreciated that the cross-linked PVP swells in the presence of L35 by
absorbing L35 into its
cross-linked polymer network. The interaction between a cross-linked PVP and
L35 may
facilitate to formation of a homogenous gel by preventing a solid cross-linked
PVP from phase
separating from a liquid L35.
[49] Illustrative structure-building agent agents may be or include, but
are not limited to, N-
vinyl lactam based polymers and copolymers. The monomers for preparing a vinyl
lactam-based
polymer or co-polymer of the present application includes any monomer having 3
to 8 atoms in a
heterocyclic ring, comprising a carbonyl carbon atom and a heteroatom (such as
N, S, 0) in its
vinyl moiety. Suitable monomers include but not limited to N-vinyl-2-
pyrrolidone, N-viny1-2-
piperidone, N-vinyl-3-methyl-pyrrolidinone, N-vinyl-3-methyl-piperidone, N-
viny1-3-methyl-
caprolactam, N-vinyl-4-methyl-pyrrolidinone, N-vinyl-4-methyl-2-pyrrolidone, N-
viny1-4-
methyl-piperidone, N-vinyl-4-methyl-caprolactam, N-vinyl-5-methyl-
pyrrolidinone, N-viny1-5-
ethy1-2-pyrrolidone, N-vinyl-4-methyl-piperidone, N-vinyl-3-ethyl-
pyrrolidinone, N-viny1-4,5-
dimethyl-pyrrolidinone, N-vinyl-5,5-dimethyl-pyrrolidinone,
N-viny1-3,3,5-trimethyl-
pyrrolidinone, N-vinyl-5-methyl-5-ethyl-pyrrolidinone,
N-vinyl-3 ,4,5-trimethy1-3 -ethyl-
pyrrolidinone, N-vinyl-6-methyl-2-piperidone, N-vinyl-6-ethyl-2-piperidone, N-
viny1-3,5-
dimethy1-2-piperidone, N-vinyl-4,4-dimethy1-2-piperidone, N-vinyl-2-
caprolactam, N-viny1-7-
methyl-caprolactam, N-vinyl-7-ethyl-caprolactam, N-vinyl-3,5-dimethyl-
caprolactam, N-viny1-
4,6-dimethyl-caprolactam, N-vinyl-3,5,7-trimethyl-caprolactam, N-vinyl-2-
valerolactam, N-
vinyl-hexahydro-2-azepinone, N-vinyl-octahydro-2-azocinone, N-vinyl octahydro-
2-azoninone,
N-vinyl decahydro-2-azecinone, or the like, or combinations thereof.
[50] The amount or concentration of any one or more of the structure-building
agents present
in the oral care product or the whitening composition thereof may vary widely.
The amount of
any one or more of the structure-building agents present in the oral care
product or the whitening
composition thereof may be from about 1 weight % to about 99 weight %, based
on the total
weight of the oral care product or the whitening composition thereof. For
example, the amount
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of the thickening system and/or the thickeners thereof present may be from
about 1 weight %,
about 2 weight %, about 3 weight %, about 4 weight %, about 5 weight %, about
6 weight %,
about 7 weight %, about 8 weight %, about 9 weight %, about 10 weigh %, about
15 weight %,
about 20 weight %, or about 21 weight % to about 22 weight %, about 23 weight
%, about 24
weight %, about 25 weight %, about 26 weight %, about 27 weight %, about 28
weight %, about
29 weight %, about 30 weight %, or more, based on a total weight of the oral
care product or the
whitening composition thereof. In another example, the amount of any one or
more of the
structure-building agents present may be from about 1 weight % to about 99
weight %, about 3
weight % to about 90 weight %, about 14 weight % to about 80 weight %, about
15 weight % to
about 80 weight %, about 16 weight % to about 70 weight %, about 17 weight %
to about 60
weight %, about 18 weight % to about 50 weight %, about 19 weight % to about
40 weight %, or
about 20 weight % to about 30 weight %. In a typical implementation, the
amount of any one or
more of the structure-building agents present in the oral care product or the
whitening
composition thereof may be from about 10 weight % to about 20 weight %, more
typically about
1.2 weight % to about 1.8 weight %, and more typically about 1.5 weight %.
[51] In some implementations, the oral care product or the orally acceptable
vehicle thereof
may include a hydrophobic component or base material. The hydrophobic
component may be or
include a hydrophobic polymer, such as a silicone polymer. The term
"hydrophobic" or "water-
insoluble" as applied to polymers and as employed herein may refers to an
organic polymer that
is substantially non-aqueous and having a water solubility of less than one
gram per 100 grams
of water at 25 C. Any such silicone polymers that are compatible with the
components disclosed
herein, and that can produce the oral care product or the whitening
composition thereof having a
desired viscosity may be used.
[52] In some implementations, the hydrophobic polymers suitable for use in the
present
invention may be referred to as "siloxane" polymers, which are also generally
known in the art
as "silicone" polymers. In certain implementations, the hydrophobic polymers
may include
those in which a whitening agent may be dispersed. In a preferred
implementation, the
hydrophobic polymers may be or include, but are not limited to, silicone-based
hydrophobic
polymer, such as polyorganosiloxane, in particular polydimethylsiloxane.
[53] In some implementations, the siloxane polymers that may function as part
of the
hydrophobic component are in the form of a fluid. Polysiloxane fluids useful
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hydrophobic silicone material component include those with a viscosity, as
measured at 25 C,
of about 1 centipoise (cP) to about 1000 cP, or about 2 cP to about 500 cP, or
about 20 cP to
about 400 cP. Polysiloxane fluids for use herein may be linear or cyclic, and
may be substituted
with a wide variety of substituents. The substituents may be or include, but
are not limited to,
methyl, ethyl, phenyl substituents, or the like, or mixtures thereof. Suitable
polysiloxane fluids
may include linear polysiloxane polymers such as dimethicone and other low
viscosity analogues
of the polysiloxane materials, having a viscosity of about 200 cP or less and
cyclomethicone, and
other cyclic siloxanes having a viscosity of about 200 cP or less. Other
fluids include
polysiloxane polyether copolymers and hydroxy terminated polydimethyl-siloxane
fluid (e.g.,
Dow Corning ST-DIMETHICONOL.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 trimethylsiloxysilicate, for example, Dow Corning 593
fluid, Wacker Belsil
TMS 803. Another suitable silicone fluid from Dow Corning is Q7-9210.
[54] In some implementations, the hydrophobic component may be or include a
silicone fluid.
In some implementations, the silicone fluid may be or include a siloxane
polymer.
1551 The hydrophobic component may be present in the oral care product or the
whitening
composition thereof in an amount of from about 10 weight % to about 95 weight
%, about 10
weight % to about 80 weight %, about 10 weight % to about 60 weight %, about
10 weight % to
about 40 weight %, about 10 weight % to about 30 weight %, based on a total
weight of the oral
care product or the whitening composition thereof.
Adhesive or Adhesion Enhancing Agent
[56] In at least one implementation, the oral care product or the whitening
composition thereof
may optionally include one or more adhesives configured to improve, maintain,
and/or facilitate
the adhesion of the oral care product or the whitening composition thereof to
surfaces of the oral
cavity. The one or more adhesives may also be configured to increase the
hydrophobicity of a
film formed from the oral care product or the whitening composition thereof,
thereby allowing
the film to withstand external challenges, such as abrading, rubbing, or
brushing.
1571 Illustrative adhesives may be or include, but are not limited to,
alkyd resins, polyvinyl
acetaldehydes, polyvinyl alcohols, polyvinyl acetates, poly(ethylene oxide).
polyacrylates,
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ketone resins, polyvinylpyrolidone. polyvinylpyrolidoneivinyl acetate
copolymer, polyethylene
glycols of 200 to 1000 molecular weight, polyoxyethylene/polyoxopropylene
block copolymers
(Polyox), silicon resins, or the like, and mixtures or combinations thereof.
In at least one
implementation, the one or more adhesives may include siloxane polymers, which
are also
generally known in the art as "silicone" polymers. Illustrative silicone-based
hydrophobic
polymers may be or include, but are not limited to, polyorganosiloxane,
polydiorganosiloxane,
and the like, and combinations thereof. In at least one implementation, the
adhesion enhancing
agent includes at least one silicon pressure sensitive adhesive (PSA). Such
PSAs may be
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 implementations, 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
such 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. In at least one implementation, the adhesion enhancing
agents are
available under the trade name BIO-PSA from the Dow Corning Company of
Midland, MI. The
modification of a ratio of silicone resin to polydiorganosiloxane modifies the
tackiness of the
polymer. This ratio may be in the range of about 70:30 to about 50:50. For
example, the BIO-
PSA silicone commercially available from Dow-Corning is available in varying
silicone resin to
silicone polymer ratios, namely, 65/35 (low tack), 60/40 (medium tack), and
55/45 (high tack).
Such a polyorganosiloxane PSA is available dissolved in either ethyl acetate
solvent or
dimethicone. In at least one implementation, the adhesion enhancing agent may
include Silicone
Adhesive 8-7016, commercially available from Dow Corning Corporation of
Midland, MI.
1581 The one or more adhesives or adhesion enhancing agents may be present in
the oral care
product or the whitening composition thereof in an amount of from about 10
weight % to about
80 weight %, about 10 weight % to about 60 weight %, about 10 weight % to
about 50 weight %,
about 10 weight % to about 40 weight %, about 10 weight % to about 30 weight
%, based on a
total weight of the oral care product or the whitening composition thereof.
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Flavoring Agents
[59] The oral care product or the whitening composition thereof may also
include one or more
flavoring agents. Illustrative flavoring agents may include, but are not
limited to, essential oils
and various flavoring aldehydes, esters, alcohols, or the like. The flavoring
agents may also
include, but are not limited to, sweeteners, sucralose, dextrose,
polydextrose, sucrose, maltose,
dextrin, dried invert sugar, mannose, xylose, ribose, fructose, levulose,
galactose, corn syrup
(including high fructose corn syrup and corn syrup solids), partially
hydrolyzed starch,
hydrogenated starch hydrolysate, sorbitol, mannitol, xylitol, maltitol,
isomalt, aspartame,
neotame, saccharin and salts thereof (e.g., sodium saccharin), dipeptide-based
intense
sweeteners, cyclamates, dihydrochalcones, or the like, or mixtures thereof.
Examples of the
essential oils include oils of spearmint, peppermint, wintergreen, sassafras,
clove, sage,
eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit, and orange. In
another example, the
flavoring agents may include menthol, carvone, and anethole. In a preferred
implementation, the
flavoring agent includes peppermint and spearmint. In a more preferred
implementation, the
flavoring agent includes a Firmenich Newman Flavor.
[60] The amount of any one or more of the flavoring agent in the oral care
product or the
whitening composition thereof may be less than 1.0 weight %, less than 0.9
weight %, less than
0.8 weight %, or less than 0.7 weight %. For example, the amount of the
flavoring agent in the
oral care product or the whitening composition thereof may be about 0.0 weight
% to about 1.0
weight %, about 0.5 weight % to about 0.9 weight %, about 0.7 weight % to
about 0.8 weight %.
In a preferred implementation, the amount of the flavoring agent in the oral
care product or the
whitening composition thereof is about 0.01 weight % to about 0.4 weight %,
preferably about
0.1 weight % to about 0.3 weight %, or about 0.2 weight %.
Additional Ingredients
[61] It should be appreciated to one having ordinary skill in the art, that
the oral care products
and/or the whitening composition thereof may include other additional
ingredients/components.
For example, the oral care products and/or the whitening composition thereof
may include anti-
caries agents, desensitizing agents, viscosity modifiers, diluents, mouth feel
agents, colorants,
preservatives, or the like, or combinations or mixtures thereof. It should
further be appreciated
by one having ordinary skill in the art that while general attributes of each
of the above
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categories of materials may differ, there may be some common attributes and
any given material
may serve multiple purposes within two or more of such categories of
materials.
[62] In at least one implementation, the additional ingredients/components may
include one or
more active materials configured to prevent and/or treat one or more
conditions and/or disorders
of the oral cavity. For example, the one or more active materials may be
configured to prevent
and/or treat one or more conditions and/or disorders of hard and/or soft
tissue of the oral cavity.
The active materials may also be configured to prevent and/or treat one or
more physiological
disorders and/or conditions, and/or provide a cosmetic benefit to the oral
cavity.
[63] In at least one implementation, the oral care products and/or the
whitening composition
thereof may include an anticalculus agent. Generally, anticalculus agents may
not be compatible
with some whitening compositions, however, implementations of the present
disclosure may
incorporate anticalculus agents and the whitening composition into a single
phase oral care
product. Illustrative anticalculus agents may include, but are not limited to,
phosphates and
polyphosphates (e.g., pyrophosphates), polyaminopropanesulfonic acid (AMPS),
hexametaphosphate salts, zinc citrate trihydrate, polypeptides, polyolefin
sulfonates, polyolefin
phosphates, diphosphonates. In a typical implementation, the anticalculus
agents includes
tetrasodium pyrophosphate (TSPP), sodium tripolyphosphate (STPP), or a
combination thereof.
[64] The oral care products and/or the whitening composition thereof may
optionally include
one or more antimicrobial agents and/or one or more preservatives such as,
methylisothiazolinone (MIT), sodium benzoate, potassium sorbate, benzyl
alcohol, or the like, or
combinations thereof. In another example, the oral care composition may
include one or more
antibacterial agents selected from halogenated diphenyl ether (e.g.
triclosan), herbal extracts and
essential oils (e.g., rosemary extract, tea extract, magnolia extract, thymol,
menthol, eucalyptol,
geraniol, carvacrol, citral, hinokitol, catechol, methyl salicylate,
epigallocatechin gallate,
epigallocatechin, gallic acid, miswak extract, sea-buckthorn extract),
bisguanide antiseptics (e.g.,
chlorhexidine, alexidine or octenidine), quaternary ammonium compounds (e.g.,
cetylpyridinium
chloride (CPC), benzalkonium chloride, tetradecylpyridinium chloride (TPC), N-
tetradecy1-4-
ethylpyridinium chloride (TDEPC)), phenolic antiseptics, hexetidine,
octenidine, sanguinarine,
povidone iodine, delmopinol, salifluor, other metal ions (e.g., stannous
salts, copper salts, iron
salts), sanguinarine, propolis and oxygenating agents (e.g., hydrogen
peroxide, buffered sodium
peroxyborate or peroxycarbonate), phthalic acid and its salts, monoperthalic
acid and its salts and
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esters, ascorbyl stearate, oleoyl sarcosine, alkyl sulfate, dioctyl
sulfosuccinate, salicylanilide,
domiphen bromide, delmopinol, octapinol, and other piperidino derivatives,
nicin preparations,
chlorite salts; or mixtures of any of the foregoing. In a typical
implementation, the antibacterial
agent includes cetylpyridinium chloride (CPC). For example, all of the dual-
phase mouthwash
compositions disclosed herein may include CPC as an antibacterial agent.
[65] The oral care products and/or the whitening composition thereof may
include an
antioxidant. Any orally acceptable antioxidant may be used, including, but not
limited to,
butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), vitamin A,
carotenoids,
vitamin E, flavonoids, polyphenols, ascorbic acid, herbal antioxidants,
chlorophyll, melatonin, or
the like, or combinations or mixtures thereof.
[66] The amount or concentration of any one or more of the additional
ingredients/components present in the oral care product or the whitening
composition thereof
may vary widely. The amount of any one or more of any one or more of the
additional
ingredients/components present in the oral care product or the whitening
composition thereof
may be from about 1 weight % to about 99 weight %, based on the total weight
of the oral care
product or the whitening composition thereof. For example, the amount of any
one or more of
the additional ingredients/components present may be from about 1 weight %,
about 2 weight %,
about 3 weight %, about 4 weight %, about 5 weight %, about 6 weight %, about
7 weight %,
about 8 weight %, about 9 weight %, about 10 weigh %, about 15 weight %, about
20 weight %,
or about 21 weight % to about 22 weight %, about 23 weight %, about 24 weight
%, about 25
weight %, about 26 weight %, about 27 weight %, about 28 weight %, about 29
weight %, about
30 weight %, or more, based on a total weight of the oral care product or the
whitening
composition thereof. In another example, the amount of any one or more of the
additional
ingredients/components present may be from about 1 weight % to about 99 weight
%, about 3
weight % to about 90 weight %, about 14 weight % to about 80 weight %, about
15 weight % to
about 80 weight %, about 16 weight % to about 70 weight %, about 17 weight %
to about 60
weight %, about 18 weight % to about 50 weight %, about 19 weight % to about
40 weight %, or
about 20 weight % to about 30 weight %. In a typical implementation, the
amount of any one or
more of the additional ingredients/components present in the oral care product
or the whitening
composition thereof may be from about 10 weight % to about 20 weight %, more
typically about
1.2 weight % to about 1.8 weight %, and more typically about 1.5 weight %.

CA 03123187 2021-06-11
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[67] All ingredients for use in the compositions described herein should be
orally acceptable.
By "orally acceptable" as the term is used herein is meant an ingredient that
is present in a
composition as described in an amount and form that does not render the
composition unsafe for
use in the oral cavity.
METHODS
[68] The present disclosure also provides methods for whitening teeth in a
human or animal
subject with the oral care product and/or the whitening composition disclosed
herein. As used
herein "animal subject" may include higher order non-human mammals such as
canines, felines,
and horses. The method may include contacting the oral care product, the
whitening
composition, or the source of hydrogen peroxide thereof with water to initiate
the formation of
hydrogen peroxide. The method may also include contacting the oral care
product or the
whitening composition thereof with surfaces of the oral cavity, such as
surfaces of teeth.
[69] In some implementations, contacting the surface of the teeth with the
oral care product or
the whitening composition thereof may include directly applying the oral care
product or the
whitening composition to the teeth using a delivery device, such as a pen,
(e.g., a COLGATE
whitening pen or a COLGATE ACTISTm whitening pen, Colgate-Palmolive Company,
New
York, NY), a liquid stick having an applicator, such as a felt tip, brush,
roller hall, non-woven
pad, or the like. In another implementation, contacting the surface of the
teeth with the oral care
product or the whitening composition thereof may include disposing the oral
care product or the
whitening composition thereof in a dental tray (e.g., reservoir of the dental
tray) and disposing
the dental tray about the teeth. The oral care product or the whitening
composition may be
applied to the teeth and left for at least 2 minutes, at least 5 minutes,
typically at least 10 minutes,
or more typically at least 30 minutes. After each treatment with the tooth
whitening composition
the teeth may be treated with a tooth desensitizing formulation. Illustrative
desensitizing
formulations may contain potassium nitrate, citric acid, citric acid salts,
strontium chloride or the
like.
[70] The oral care product and/or the whitening composition thereof may be
applied and/or
contacted with the surfaces of the teeth at predetermined intervals. For
example, a daily basis, at
least once a day for multiple days, or alternatively every other day. In
another example, the oral
care product and/or the whitening composition thereof may be applied and/or
contacted with the
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WO 2020/139328 PCT/US2018/067549
surfaces of the teeth at least once a day, at least once every two days, at
least once every three
days, at least once every five days, at least once a week, at least once every
two weeks, or at least
once a month. The oral care product and/or the whitening composition thereof
may be utilized
for up to 2 weeks, up to 3 weeks, up to 4 weeks, up to 6 weeks, up to 8 weeks,
or greater.
[71] The dental tray may be of any conventional form, and may be formed from
conventionally used polymers, such as thermoplastic polymers. Thermoset
polymers also may
be used. Accordingly, the dental tray may range from highly flexible to a low
flexibility. The
thermoplastic polymers are typically used. Illustrative thermoplastic polymers
may be or
include, but are not limited to, polyethylene and polypropylene polymers,
their derivatives and
copolymers, silicone elastomers, polyurethanes and derivatives,
polycaprolactams, polystyrene
and derivatives, polybutadiene and derivatives, polyisoprene and derivatives,
and
polymethacrylate and its derivatives, or the like, or combinations thereof.
[72] All ingredients for use in the compositions described herein should be
orally acceptable.
As used herein, "orally acceptable" may refer any ingredient that is present
in a composition as
described in an amount and form that does not render the composition unsafe
for use in the oral
cavity.
EXAMPLES
[73] The examples and other implementations described herein are exemplary and
not
intended to be limiting in describing the full scope of compositions and
methods of this
disclosure. Equivalent changes, modifications and variations of specific
implementations,
materials, compositions and methods may be made within the scope of the
present disclosure,
with substantially similar results.
[74] Example 1
[75] The whitening efficacy of a control gel whitening composition (4) and
three test gel
whitening compositions (1)-(3) for whitening teeth was evaluated. Each of the
control and test
whitening compositions (1)-(4) was prepared by combining the
components/ingredients
according to Table 1. As indicated in Table 1, the control whitening
composition (4) included
about 0.1 weight % hydrogen peroxide, and the test whitening compositions (1)-
(3) included 0.1
weight % hydrogen peroxide in combination with varying amounts of a salt of
peroxymonosulfate, namely potassium peroxymonosulfate (MPS). Particularly,
the test
22

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whitening compositions (1), (2), and (3) included about 1 weight %, about 3
weight %, and about
weight % of MPS. The control whitening composition (4) represented a
commercially
available whitening gel product.
Table 1
Composition of Control and Test Whitening Compositions (1)-(4)
Ingredient (1) (2) (3) (4)
Silicone Fluid
50 50 50 48.1
(wt%)
Fumed Silica
2 3 1 1
(wt%)
MPS (-50% active solid)
2 6 10 --
(wt%)
(PEG)-(PG)-(PEG) Block Copolymer
38.25 35.25 33.25 --
(wt%)
Anticalculus Agent
3 2 2 --
(wt%)
Polyvinyl Pyrrolidone
3 2 2 24.35
(wt%)
PVP-Hydrogen Peroxide
0.55 0.55 0.55 0.55
(wt%)
Antimicrobial Agent
0.1 0.1 0.1 0.1
(wt%)
Flavoring Agent
1.1 1.1 1.1 0.9
(wt%)
White Petrolatum
-- -- -- 25
(wt%)
Total 100 100 100
100
[76] To evaluate the whitening efficacy of the control and test whitening
compositions (1)-(4),
bovine teeth stained with a tobacco solution and having L* values of about 60
were obtained. A
total of four teeth were used to evaluate each of the control and test
whitening compositions (1)-
(4). To evaluate the whitening efficacy, each of the bovine teeth were treated
with 14 whitening
cycles. Each whitening cycle included applying about 50 mg of each of the
control and test
whitening compositions (1)-(4) to respective surfaces of the bovine teeth,
soaking the teeth in a
circulated system containing a phosphate buffer maintained at a pH of about 7
for about 15
minutes, removing the control and test gel whitening compositions (1)-(4) and
the buffer from
the surfaces of the bovine teeth, and thoroughly drying the bovine teeth.
23

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[77] The L*, a*, b* values were measured with a hand-held spectrophotometer
(SPECTROSHADE Micro instrument manufactured by Medical High Technology of
Verona,
Italy). The L*, a*, b* values were compared to baseline values measured before
treatment to
calculate the change in the whiteness of each of the bovine teeth. It should
be appreciated that
the whiteness index (W*) is a measure of overall color change relative to pure
white, and is
given by formula (1), and the change in whiteness index (AW*) is measured by
formula (2). It
should further be appreciated that the lower the whiteness index (AW*) the
whiter the teeth. The
change in whiteness index (AW*), or whitening efficacy, is summarized in Table
2.
vo= ((L* _100)2 (a*)2 (b*)2)1/2 (1)
AW* = W*treated - W*basthne (2)
Table 2
Whitening Efficacy (AW*) of Control And Test Whitening Compositions (1)-(4)
Number of Treatments
0 1 2 4 8 14
(1) AW* 0 -1.56 -2.29 -3.29 -4.75 -5.70
0.1 wt% HP &
Std. Dev. 0 0.56 0.47 0.59 0.83 1.042
1 wt% MPS
(2) AW* 0 -0.95 -1.63 -2.80 -4.42 -5.78
0.1 wt% HP &
Std. Dev. 0 0.22 0.19 0.45 0.16 0.53
3 wt% MPS
(3) AW* 0 -1.41 -2.36 -3.96 -5.63 -6.99
0.1 wt% HP &
Std. Dev. 0 0.26 0.13 0.22 0.47 0.54
wt% MPS
(4) AW* 0 -0.019 -0.19 -0.49 -0.71 -1.06
0.1 wt% HP
Std. Dev. 0 0.11 0.19 0.17 0.23 0.16
[78] As illustrated in Table 2, the test gel whitening compositions (1)-(3)
all exhibited
relatively greater whitening efficacy in removing hard to remove stains, such
as tobacco stains,
as compared to the control gel whitening composition (4) which only included
hydrogen
peroxide.
[79] The present disclosure has been described with reference to exemplary
implementations.
Although a limited number of implementations have been shown and described, it
will be
appreciated by those skilled in the art that changes may be made in these
implementations
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WO 2020/139328 PCT/US2018/067549
without departing from the principles and spirit of the preceding detailed
description. It is
intended that the present disclosure be construed as including all such
modifications and
alterations insofar as they come within the scope of the appended claims or
the equivalents
thereof.

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Administrative Status

Title Date
Forecasted Issue Date Unavailable
(86) PCT Filing Date 2018-12-26
(87) PCT Publication Date 2020-07-02
(85) National Entry 2021-06-11
Examination Requested 2023-12-08

Abandonment History

There is no abandonment history.

Maintenance Fee

Last Payment of $210.51 was received on 2023-12-22


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Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Maintenance Fee - Application - New Act 2 2020-12-29 $100.00 2021-06-11
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Application Fee 2021-06-11 $408.00 2021-06-11
Maintenance Fee - Application - New Act 3 2021-12-29 $100.00 2021-12-17
Maintenance Fee - Application - New Act 4 2022-12-28 $100.00 2022-12-16
Request for Examination 2023-12-27 $816.00 2023-12-08
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Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
COLGATE-PALMOLIVE COMPANY
Past Owners on Record
None
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Abstract 2021-06-11 1 49
Claims 2021-06-11 2 65
Description 2021-06-11 25 1,400
International Search Report 2021-06-11 2 56
National Entry Request 2021-06-11 10 274
Cover Page 2021-08-19 1 29
Request for Examination 2023-12-08 4 112