Note: Descriptions are shown in the official language in which they were submitted.
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ORAL CARE COMPOSITION COMPRISING PEROXIDE
FIELD OF THE INVENTION
The present invention relates to oral care compositions comprising peroxide,
amphiphilic
polymer, and optionally water. The present invention also relates to
dentifrice compositions
comprising peroxide, amphiphilic polymer, and optionally water. The present
invention also
relates to dentifrice compositions comprising peroxide with an unexpectedly
high viscosity.
BACKGROUND OF THE INVENTION
Oral care compositions, such as dentifrice compositions, can include fluoride,
peroxide,
and/or abrasive to clean teeth, prevent cavities, and maintain the aesthetics
and health of the oral
cavity, such as the teeth and gums.
It can be desirable to have dentifrice compositions with a relatively high
level of peroxide,
such as at least about 1%, at least about 3%, or at least about 3.5%, to
achieve enhanced whitening
efficacy. However, it can be challenging to formulate dentifrice compositions
with a relatively
high level of peroxide because peroxide can be reactive with other dentifrice
components, such as
fluoride, metal ions, abrasives, etc. One approach to the formulation
challenges associated with
peroxide can be to separately package and/or apply peroxide from a separate
whitening
composition. However, consumer compliance can be lower when peroxide must be
applied from
a separate composition. Thus, it can be advantageous to provide peroxide in a
dentifrice
composition with other components, such as fluoride.
When peroxide decomposes, peroxide forms oxygen, water, and radicals. The
decomposition of peroxide can cause swelling and bursting of primary packaging
and the radicals
can lower the viscosity of oral care composition and lower its whitening
efficacy. In particular,
many thickening agents can be reactive with peroxide. As such, there is a need
for an improved
oral care composition, such as an improved dentifrice composition, including
peroxide and suitable
polymers, such as amphiphilic polymers.
SUMMARY OF THE INVENTION
Disclosed herein is an oral care composition comprising (a) peroxide; (b)
amphiphilic
polymer; (c) alkyl alcohol; and (d) from about 5% to about 60%, by weight of
the oral care
composition, of water, wherein the oral care composition has a viscosity of at
least about 10
Brookfield Units.
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Also disclosed herein is an oral care composition comprising (a) peroxide; (b)
amphiphilic
polymer; (c) alkyl alcohol; and (d) water, wherein oral care composition has a
ratio of fatty alcohol
to amphiphilic polymer of at least about 0.5.
Also disclosed herein is an oral care composition comprising (a) peroxide; (b)
amphiphilic
polymer; (c) alkyl alcohol; and (d) at least about 1.5%, by weight of the oral
care composition, of
alkyl sulfate surfactant.
DETAILED DESCRIPTION OF THE INVENTION
The present invention is directed to oral care compositions that have
peroxide, amphiphilic
polymer, and optionally water. While not wishing to being bound by theory it
is believed that
peroxide can interact with a variety of other ingredients in oral care
compositions, which can lead
to the catalytic decomposition of peroxide. When peroxide decomposes, peroxide
forms oxygen,
water, and radicals. The decomposition of peroxide can cause swelling and
bursting of primary
packaging and the radicals can lower the viscosity of oral care composition
and lower its whitening
efficacy. In particular, many thickening agents can be reactive with peroxide.
It has been unexpectedly found that the use of certain amphiphilic polymers
can effectively
thicken and increase the viscosity of oral care compositions including water
and peroxide.
Additionally, it has been unexpectedly found that the use of amphiphilic
polymer in combination
with alkyl alcohol can lead to oral care compositions with surprisingly high
viscosities.
Definitions
To define more clearly the terms used herein, the following definitions are
provided.
Unless otherwise indicated, the following definitions are applicable to this
disclosure. If a term is
used in this disclosure but is not specifically defined herein, the definition
from the IUPAC
Compendium of Chemical Terminology, 2nd Ed (1997), can be applied, as long as
that definition
does not conflict with any other disclosure or definition applied herein, or
render indefinite or non-
enabled any claim to which that definition is applied.
The term "oral care composition", as used herein, includes a product, which in
the ordinary
course of usage, is not intentionally swallowed for purposes of systemic
administration of
particular therapeutic agents, but is rather retained in the oral cavity for a
time sufficient to contact
dental surfaces or oral tissues. Examples of oral care compositions include
dentifrice, tooth gel,
subgingival gel, mouth rinse, mousse, foam, mouth spray, lozenge, chewable
tablet, chewing gum,
tooth whitening strips, floss and floss coatings, breath freshening
dissolvable strips, or denture care
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or adhesive product. The oral care composition may also be incorporated onto
strips or films for
direct application or attachment to oral surfaces.
The term "dentifrice composition", as used herein, includes tooth or
subgingival -paste, gel,
or liquid formulations unless otherwise specified. The dentifrice composition
may be a single-
phase composition or may be a combination of two or more separate dentifrice
compositions. The
dentifrice composition may be in any desired form, such as deep striped,
surface striped,
multilayered, having a gel surrounding a paste, or any combination thereof.
Each dentifrice
composition in a dentifrice comprising two or more separate dentifrice
compositions may be
contained in a physically separated compartment of a dispenser and dispensed
side-by-side.
"Active and other ingredients" useful herein may be categorized or described
herein by
their cosmetic and/or therapeutic benefit or their postulated mode of action
or function. However,
it is to be understood that the active and other ingredients useful herein
can, in some instances,
provide more than one cosmetic and/or therapeutic benefit or function or
operate via more than
one mode of action. Therefore, classifications herein are made for the sake of
convenience and are
not intended to limit an ingredient to the particularly stated function(s) or
activities listed.
The term "orally acceptable carrier" comprises one or more compatible solid or
liquid
excipients or diluents which are suitable for topical oral administration. By
"compatible," as used
herein, is meant that the components of the composition are capable of being
commingled without
interaction in a manner which would substantially reduce the composition's
stability and/or
efficacy. The carriers or excipients of the present invention can include the
usual and conventional
components of mouthwashes or mouth rinses, as more fully described
hereinafter: Mouthwash or
mouth rinse carrier materials typically include, but are not limited to one or
more of water, alcohol,
humectants, surfactants, and acceptance improving agents, such as flavoring,
sweetening, coloring
and/or cooling agents.
The term "substantially free" as used herein refers to the presence of no more
than 0.05%,
preferably no more than 0.01%, and more preferably no more than 0.001%, of an
indicated material
in a composition, by total weight of such composition.
The term "essentially free" as used herein means that the indicated material
is not
deliberately added to the composition, or preferably not present at
analytically detectable levels.
It is meant to include compositions whereby the indicated material is present
only as an impurity
of one of the other materials deliberately added.
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The term "oral hygiene regimen' or "regimen" can be for the use of two or more
separate
and distinct treatment steps for oral health. e.g. toothpaste, mouth rinse,
floss, toothpicks, spray,
water irrigator, massager.
The term "total water content" as used herein means both free water and water
that is bound
by other ingredients in the oral care composition.
For the purpose of the present invention, the relevant molecular weight (MW)
to be used is
that of the material added when preparing the composition e.g., if the chelant
is a citrate species,
which can be supplied as citric acid, sodium citrate or indeed other salt
forms, the MW used is that
of the particular salt or acid added to the composition but ignoring any water
of crystallization that
may be present.
While compositions and methods are described herein in terms of "comprising"
various
components or steps, the compositions and methods can also "consist
essentially of' or "consist
of' the various components or steps, unless stated otherwise.
As used herein, the word "or" when used as a connector of two or more elements
is meant
to include the elements individually and in combination; for example, X or Y,
means X or Y or
both.
As used herein, the articles "a" and "an" are understood to mean one or more
of the material
that is claimed or described, for example, "an oral care composition" or "a
bleaching agent."
All measurements referred to herein are made at about 23 C (i.e. room
temperature) unless
otherwise specified.
Generally, groups of elements are indicated using the numbering scheme
indicated in the
version of the periodic table of elements published in Chemical and
Engineering News, 63(5), 27,
1985. In some instances, a group of elements can be indicated using a common
name assigned to
the group; for example, alkali metals for Group 1 elements, alkaline earth
metals for Group 2
elements, and so forth.
Several types of ranges are disclosed in the present invention. When a range
of any type is
disclosed or claimed, the intent is to disclose or claim individually each
possible number that such
a range could reasonably encompass, including end points of the range as well
as any sub-ranges
and combinations of sub-ranges encompassed therein.
The term "about" means that amounts, sizes, formulations, parameters, and
other quantities
and characteristics are not and need not be exact, but can be approximate
and/or larger or smaller,
as desired, reflecting tolerances, conversion factors, rounding off,
measurement errors, and the like,
and other factors known to those of skill in the art. In general, an amount,
size, formulation,
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parameter or other quantity or characteristic is "about" or "approximate"
whether or not expressly
stated to be such. The term "about" also encompasses amounts that differ due
to different
equilibrium conditions for a composition resulting from a particular initial
mixture. Whether or
not modified by the term "about," the claims include equivalents to the
quantities. The term
5 "about" can mean within 10% of the reported numerical value, preferably
within 5% of the reported
numerical value.
The dentifrice composition can be in any suitable form, such as a solid,
liquid, powder,
paste, or combinations thereof. The oral care composition can be dentifrice,
tooth gel, subgingival
gel, mouth rinse, mousse, foam, mouth spray, lozenge, chewable tablet, chewing
gum, tooth
whitening strips, floss and floss coatings, breath freshening dissolvable
strips, or denture care or
adhesive product. The components of the dentifrice composition can be
incorporated into a film,
a strip, a foam, or a fiber-based dentifrice composition.
The oral care compositions, as described herein, comprise peroxide and
amphiphilic
polymer. Additionally, the oral care compositions can comprise other optional
ingredients, as
described below. The section headers below are provided for convenience only.
In some cases, a
compound can fall within one or more sections. For example, stannous fluoride
can be a tin
compound and/or a fluoride compound.
Peroxide
The oral care composition comprises peroxide. The peroxide can include any
suitable
source of peroxide, such as solubilized peroxide compounds and/or solid
peroxide sources.
Suitable peroxides include solid peroxides, hydrogen peroxide, urea peroxide,
calcium peroxide,
benzoyl peroxide, sodium peroxide, barium peroxide, inorganic peroxides,
hydroperoxides,
organic peroxides, polyvinylpyrrolidone-peroxide complex, crosslinked
polyvinylpyrrolidone-
peroxide complex, and/or combinations thereof.
While not wishing to being bound by theory, it is believed that peroxide
compounds that
are stabilized through the complexation with a stabilizing compound, such as
crosslinked polyvinyl
pyrrolidone-peroxide, are less available to provide an oral health benefit,
such as a whitening
benefit, when applied to the oral cavity. Thus, the peroxide can comprise
solubilized peroxide
.. compounds, such as aqueous hydrogen peroxide.
Additionally, the oral care composition can be designed, such as through the
selection of
the other components of the oral care composition, to maximize the amount of
remaining peroxide
after a defined period after initially mixing the oral care composition.
Suitable oral care
compositions include oral care compositions comprising at least about 75%, at
least about 80%, at
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least about 85%, at least about 90%, from about 90% to about 99%, or from
about 88% to about
99% of hydrogen peroxide remaining in the oral care composition the oral care
composition is
stored at 50 C for 10 days. Other suitable oral care compositions include
oral care compositions
comprising at least about 75%, at least about 80%, at least about 85%, at
least about 90%, at least
about 95%, from about 90% to about 99%, or from about 88% to about 99% of
hydrogen peroxide
remaining in the oral care composition the oral care composition is stored at
50 C for 20 days.
The oral care composition can comprise from about 0.01% to about 20%, from
about 0.01%
to about 10%, from about 1% to about 5%, at least about 1%, at least about 2%,
at least about 3%,
at least about 3.5%, at least about 4%, or greater than 3%, by weight of the
oral care composition,
of the peroxide.
While not wishing to being bound by theory, it is believed that the peroxide,
as described
herein, can be un-bound, uncomplexed, and/or only minimally stabilized by
other components in
the oral care composition. It is additionally believed that oral care
compositions comprising
peroxide that is un-bound, uncomplexed, and/or only minimally stabilized to
other components in
the oral care composition, such as amphiphilic polymer and/or other thickening
agents, can lead to
a greater rate of release of peroxide than compositions that have peroxide
adducts, such as
polyvinylpyrrolidone-peroxide, and/or other sources of bound peroxide.
Desirable oral care
compositions include oral care compositions that have a peroxide release of at
least about 10%, at
least about 15%, at least about 25%, at least about 35%, at least about 50%,
at least about 60 %, at
least about 70%, at least about 75%, at least about 80%, at least about 90%,
at least about 95%,
from about 10% to about 95%, from about 25% to about 75%, from about 20% to
about 95%, from
about 35% to about 90%, from about 40% to about 95%, from about 50% to about
90%, and from
about 60% to about 99% in a defined period of time corresponding to a single
oral care session,
such as 30 second, 45 second, 60 seconds, 75 seconds, 90 seconds, 120 seconds,
and/or 5 minutes.
Abrasive
The oral care composition comprises abrasive, such as a peroxide-compatible
abrasive.
Abrasives can be added to oral care formulations to help remove surface stains
from teeth. The
abrasive can comprise calcium abrasive, silica abrasive, carbonate abrasive,
phosphate abrasive,
alumina abrasive, other suitable abrasives, and/or combinations thereof.
The calcium abrasive can comprise calcium carbonate, dicalcium phosphate,
tricalcium
phosphate, calcium orthophosphate, calcium metaphosphate, calcium
pyrophosphate, calcium
polyphosphate, calcium hydroxyapatite, and combinations thereof
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The calcium abrasive can comprise calcium carbonate. The calcium-containing
abrasive can
be selected from the group consisting of fme ground natural chalk, ground
calcium carbonate,
precipitated calcium carbonate, and combinations thereof.
The calcium abrasive can comprise calcium pyrophosphate. While not wishing to
be bound
by theory, it is believed that particular sources of calcium pyrophosphate can
be sufficiently
compatible with peroxide to be used in an oral care composition comprising
peroxide. Calcium
pyrophosphate has at least three polymorphic phases: alpha (a), beta (0), and
gamma (y). It has been
unexpectedly found that calcium pyrophosphate with a higher proportion of the
y phase are more
compatible with peroxide, such as hydrogen peroxide. Suitable sources of
calcium pyrophosphate
can comprise a ratio of gamma phase calcium pyrophosphate to beta phase
calcium pyrophosphate
of at least about 0.75, at least about 0.8. at least about 0.9, at least about
1, from about 0.75 to about
1.5, from about 0.9 to about 1.5, or from about 1 to about 1.5.
While not wishing to being bound by theory, it is believed that abrasives that
include high
amounts of soluble metal ions are less compatible with peroxide due to
reactivity between peroxide
and metal ions. Thus, suitable sources of abrasives, such as calcium
pyrophosphate, can comprise
less than about 0.001%, less than about 0.00075%, less than about 0.0006%,
less than about
0.0005%, or less than about 0.0001%, by weight of the abrasive. Additionally,
the abrasive can be
free of, substantially free of, or essentially free of soluble metal ions.
Examples of trace metal ions
that might be present in abrasives and have been previously reported to induce
peroxide
degradation include Cr, Mn, Fe, Co, Ni, Cu, Mo, and/or combinations thereof.
As described herein, it has also been unexpectedly found that abrasives with a
slurry pH of
from about 5.4 to about 7 were more compatible with peroxide. The slurry pH
was determined by
creating a 1:3 abrasive:water slurry and determining the pH.
The carbonate abrasive can comprise sodium carbonate, sodium bicarbonate,
calcium
carbonate, strontium carbonate, and/or combinations thereof
The phosphate abrasive can comprise calcium phosphate, sodium
hexametaphosphate,
dicalcium phosphate, tricalcium phosphate, calcium orthophosphate, calcium
metaphosphate,
calcium polyphosphate, a polyphosphate, a pyrophosphate, and/or combinations
thereof.
The silica abrasive can comprise fused silica, fumed silica, precipitated
silica, hydrated silica,
and/or combinations thereof.
The alumina abrasive can comprise polycrystalline alumina, calcined alumina,
uncalcined
alumina, fused alumina, levigated alumina, hydrated alumina, and/or
combinations thereof.
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Other suitable abrasives include diatomaceous earth, barium sulfate,
wollastonite, perlite,
polymethylmethacrylate particles, tospearl, and combinations thereof
The oral care composition can comprise from about 0.01% to about 30%, from
about 0.01%
to about 15%, from about 0.01% to less than 15%, from about 1% to about 30%,
from about 1% to
less than 15%, from about 1% to about 12%, or from about 0.01% to about 10%,
by weight of the
oral care composition of the abrasive.
The oral care composition can have a Pellicle Cleaning Ratio (PCR) of at least
about 75, at
least about 90, at least about 100, from about 75 to about 250, or from about
100 to about 250.
The oral care composition can have a Relative Dentin Abrasion value of up to
about 250, up
to about 150, from about 70 to about 150, or from about 50 to about 250.
Alumina
The oral care composition can include alumina as an abrasive. The alumina can
be the sole
abrasive or used in combination with other abrasives, as described herein. The
abrasivity of alumina
can be higher than silica, thus a lower amount of alumina abrasive can be
added.
An oral care composition comprising alumina can have a hard tissue safety
value (REA) of
at least about 15, at least about 20, at least about 25, or at least about 40.
An oral care composition comprising alumina can have a pellicle cleaning ratio
(PCR) of at
least about 75, at least about 100, from about 75 to about 250, from about 50
to about 175, from
about 50 to about 150, or rom about 65 to about 155.
An oral care composition comprising alumina can have a Relative Dentin
Abrasion (RDA)
of less than about 150, less than about 125, less than about 100, or less than
about 90.
While not wishing to be bound by theory, it is believed that alumina can be
reactive with
peroxide and/or fluoride. Thus, desirable alumina abrasives include those that
are compatible with
peroxide and/or fluoride. Suitable oral care compositions include oral care
compositions comprising
at least about 75%, at least about 80%, at least about 85%, at least about
90%, at least about 95%,
from about 90% to about 99%, or from about 88% to about 99% of hydrogen
peroxide remaining
in the oral care composition the oral care composition is stored at 40 C for
30 and/or 60 days.
Other suitable oral care compositions include oral care compositions that
comprise
peroxide and alumina and have % loss of peroxide after 30 days and/or 90 days
at 40 C of less
than about 10%, less than about 5%, less than about 4%, less than about 3%,
from about 0.5% to
about 10%, from about 0.5% to about 5%, or from about 0.1% to about 5%. While
not wishing to
being bound by theory, it is believed that alumina is unexpectedly stable with
alumina, such that
only a minimal amount of peroxide is lost to peroxide decomposition and/or
degradation.
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Other suitable oral care compositions include oral care compositions that
comprise
peroxide, fluoride, and alumina and have % loss of fluoride after 30 days
and/or 90 days at 40 C
of less than about 20%, less than about 18%, less than about 15%, less than
about 10%, less than
about 5%, from about 0.5% to about 10%, from about 0.5% to about 20%, or from
about 0.1% to
about 15%. While not wishing to being bound by theory, it is believed that
alumina and peroxide
are unexpectedly stable with certain fluoride sources, such that only a
minimal loss of fluoride is
observed.
Other suitable oral care compositions include oral care compositions
comprising peroxide
and alumina and have a % increase of viscosity 30 days and/or 90 days at 40 C
of at least about
5%, at least about 10%, at least about 15%, at least about 20%, at least about
25%, at least about
35%, at least about 50%, at least about 75%, at least about 100%, from about
5% to about 125%,
from about 5% to about 50%, or from about 1%, to about 75%. While not wishing
to being bound
by theory, it is believed that the combination of alumina and peroxide are
unexpectedly stable,
which can minimize the decrease in viscosity in meta-stable peroxide
compositions normally
observed due to the decomposition of peroxide.
The oral care composition can comprise from about 0.01% to about 10%, from
about
0.01% to about 5%, from about 0.1% to about 5%, from about 0.01% to about 3%,
or from about
0.01% to about 1%, by weight of the oral care composition, of alumina.
Water
The oral care composition of the present invention can be a dentifrice
composition that is
anhydrous, a low water formulation, or a high water formulation. In total, the
oral care composition
can comprise from 0% to about 99%, from about 5% to about 60%, from about 5%
to about 75%,
about 20% or greater, about 30% or greater, about 50% or greater, up to about
45%, or up to about
75%, by weight of the composition, of water. Preferably, the water is USP
water.
The oral care composition of the present invention can include water. While
not wishing
to be bound by theory, it is believed that including water in the oral care
composition can lead to
greater availability of peroxide to provide oral health benefits, such as
whitening, while also
hydrating the oral cavity. While one option to stabilize peroxide is to
provide a complexed
peroxide in an anhydrous dentifrice composition, it is believed that peroxide
can be more
effectively delivered through the selection of the other ingredients of the
oral care composition
while simultaneously hydrating the oral cavity.
In a high water dentifrice formulation, the dentifrice composition comprises
from about
45% to about 75%, by weight of the composition, of water. The high water
dentifrice composition
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can comprise from about 45% to about 65%, from about 45% to about 55%, or from
about 46% to
about 54%, by weight of the composition, of water. The water may be added to
the high water
dentifrice formulation and/or may come into the composition from the inclusion
of other
ingredients.
5 In a low water dentifrice formulation, the dentifrice composition
comprises from about 5%
to about 45% or from about 10% to about 45%, by weight of the composition, of
water. The low
water dentifrice composition can comprise from about 10% to about 35%, from
about 15% to about
25%, or from about 20% to about 25%, by weight of the composition, of water.
The water may be
added to the low water dentifrice formulation and/or may come into the
composition from the
10 inclusion of other ingredients.
In an anhydrous dentifrice formulation, the dentifrice composition comprises
less than
about 10%, by weight of the composition, of water. The anhydrous dentifrice
composition
comprises less than about 5%, less than about 1%, or 0%, by weight of the
composition, of water.
The water may be added to the anhydrous formulation and/or may come into the
dentifrice
composition from the inclusion of other ingredients.
The dentifrice composition can also comprise other orally acceptable carrier
materials, such
as alcohol, humectants, polymers, surfactants, and acceptance improving
agents, such as flavoring,
sweetening, coloring and/or cooling agents.
The oral care composition can also be a mouth rinse founulation. A mouth rinse
formulation can comprise from about 75% to about 99%, from about 75% to about
95%, or from
about 80% to about 95% of water.
Amphiphilic Polymer
The oral care composition comprises amphiphilic polymer. The amphiphilic
polymer can
be included as a peroxide compatible thickening agent. The amphiphilic polymer
can comprise a
polymer that has a hydrophobic portion and a hydrophilic portion. For example,
the polymer can
comprise a polymer macromolecule that comprises a hydrophilic backbone and
hydrophobic
subunits. This can allow the amphiphilic polymer to remain soluble in water
while preventing
strong interactions with the peroxide.
As described herein, it is believed that peroxide can be effectively delivered
in an aqueous
chassis if the other components are designed to minimize reactivity with the
peroxide. As such, it
is desirable for the amphiphilic polymer to not strongly react with the
peroxide. Thus, it is desirable
for the amphiphilic polymer to not form an isolatable complex with the
peroxide.
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The amphiphilic polymer can include polymers that are at least partially
soluble and/or
fully soluble in water.
Suitable amphiphilic polymers include 2-acrylamido-2-methylpropane sulfonic
acid
(AMPS) polymer, copolymer, cross-polymer, or combination thereof. In one
example, the oral
care composition can contain polyacrylate crosspolymer-6 ( commercially
available as
SepiMAXTm ZEN from SEPPIC S.A., a subsidiary of the Air Liquide group, Puteaux
Cedex,
France).
The oral care composition can comprise from about 0.01% to about 10%, from
about 0.1%
to about 5%, from about 1% to about 10%, or from about 1% to about 5%, by
weight of the oral
care composition, of the amphiphilic polymer.
Alkyl Alcohol
The oral care composition can comprise alkyl alcohol. While not wishing to be
bound by
theory, it is believed that the addition of alkyl alcohol in combination with
the amphiphilic polymer
can lead to oral care compositions with unexpectedly high viscosities.
The alkyl alcohol can include compounds with an alkyl functional group and an
alcohol
functional group. The alkyl functional can be linear, branched, cyclical, or
combinations thereof.
The alkyl alcohol can include a primary alcohol, a secondary alcohol, and/or a
tertiary alcohol.
The alkyl alcohol can be represented by the general formula of CnH2n-FIOH,
wherein n can
be any whole number from 1 to 30, from 10 to 20, or from 10 to 25.
Specific examples of alkyl alcohols can include 1-heptacosanol, 1-hexacosanol,
1-
nonacosanol, 1-octacosanol, 1-tetracosanol, docosanol, heneicosan-l-ol,
pentacosan-l-ol,
tricosan-1-ol, 1,4-butanediol, 1-heptanol, 1-hexanol, 1-nonanol, 1-octanol, 1-
pentanol, 1-propanol,
2,4-dichlorobenzyl alcohol, 2-ethylhexanol, 3-nitrobenzyl alcohol, allyl
alcohol, anisyl alcohol,
arachidyl alcohol, benzyl alcohol, cetyl alcohol, cinnamyl alcohol, crotyl
alcohol, furfuryl alcohol,
isoamyl alcohol, neopentyl alcohol, nicotinyl alcohol, perillyl alcohol,
phenethyl alcohol,
propargyl alcohol, salicyl alcohol, stearyl alcohol, tryptophol, vanillyl
alcohol, veratrole alcohol,
and/or combinations thereof. The alkyl alcohol can comprise stearyl alcohol,
cetyl alcohol, and/or
combinations thereof.
The alkyl alcohol can be provided through commercial mixtures of alkyl
alcohols, such as
Lanette W, which includes cetyl alcohol: stearyl alcohol: sodium lauryl
sulfate at a 45:45:10 ratio
(available from BASF, Florham Park, NJ).
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The oral care composition can comprise from about 0.01% to about 10%, from
about 0.1%
to about 5%, from about 1% to about 10%, or from about 1% to about 5%, by
weight of the oral
care composition, of the alkyl alcohol.
The combination of amphiphilic polymer and alkyl alcohol can lead to oral care
compositions with unexpectedly high viscosities. Suitable ratios of
amphiphilic polymer:alkyl
alcohol can be at least about 0.25, at least about 0.5, at least about 0.75,
at least about 1, from about
0.25 to about 5, about 0.5 to 1.5, about 1, from about 1 to about 3, from
about 1 to about 2.5, or
from about 0.75 to about 2.25.
The oral care composition can have a viscosity of at least about 5 cP, at
least about 10 cP,
at least about 20 cP, from about 5 cP to about 20 cP, or from about 1 cP to
about 25 cP.
nil
The pH of the disclosed composition can be from about 4 to about 10, from
about 4 to about
7, from about 4 to about 8, or from about 7 to about 10.
Fluoride
The oral care composition can comprise fluoride, which can be provided by a
fluoride ion
source. The fluoride ion source can comprise one or more fluoride containing
compounds, such
as stannous fluoride, sodium fluoride, potassium fluoride, amine fluoride,
sodium
monofluorophosphate, zinc fluoride, and/or mixtures thereof.
The fluoride ion source and the tin ion source can be the same compound, such
as for
example, stannous fluoride, which can generate tin ions and fluoride ions.
Additionally, the
fluoride ion source and the tin ion source can be separate compounds, such as
when the tin ion
source is stannous chloride and the fluoride ion source is sodium
monofluorophosphate or sodium
fluoride.
The fluoride ion source and the zinc ion source can be the same compound, such
as for
example, zinc fluoride, which can generate zinc ions and fluoride ions.
Additionally, the fluoride
ion source and the zinc ion source can be separate compounds, such as when the
zinc ion source is
zinc phosphate and the fluoride ion source is stannous fluoride.
The fluoride ion source can be essentially free of, or free of stannous
fluoride. Thus, the
oral care composition can comprise sodium fluoride, potassium fluoride, amine
fluoride, sodium
monofluorophosphate, zinc fluoride, and/or mixtures thereof.
The oral care composition can comprise a fluoride ion source capable of
providing from
about 50 ppm to about 5000 ppm, and preferably from about 500 ppm to about
3000 ppm of free
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fluoride ions. To deliver the desired amount of fluoride ions, the fluoride
ion source may be present
in the oral care composition at an amount of from about 0.0025% to about 5%,
from about 0.01%
to about 10%, from about 0.2% to about 1%, from about 0.5% to about 1.5%, or
from about 0.3%
to about 0.6%, by weight of the oral care composition. Alternatively, the oral
care composition
can comprise less than 0.1%, less than 0.01%, be essentially free of, be
substantially free of, or free
of a fluoride ion source.
Metal
The oral care composition, as described herein, can comprise metal, which can
be provided
by a metal ion source comprising one or more metal ions. The metal ion source
can comprise or
be in addition to the tin ion source and/or the zinc ion source, as described
herein. Suitable metal
ion sources include compounds with metal ions, such as, but not limited to Sn,
Zn, Cu, Mn, Mg,
Sr, Ti, Fe, Mo, B, Ba, Ce, Al, In and/or mixtures thereof. The metal ion
source can be any
compound with a suitable metal and any accompanying ligands and/or anions.
Suitable ligands and/or anions that can be paired with metal ion sources
include, but are
not limited to acetate, ammonium sulfate, benzoate, bromide, borate,
carbonate, chloride, citrate,
gluconate, glycerophosphate, hydroxide, iodide, oxalate, oxide, propionate, D-
lactate, DL-lactate,
orthophosphate, pyrophosphate, sulfate, nitrate, tartrate, and/or mixtures
thereof.
The oral care composition can comprise from about 0.01% to about 10%, from
about 1%
to about 5%, or from about 0.5% to about 15% of metal and/or a metal ion
source.
Tin
The oral care composition of the present invention can comprise tin, which can
be provided
by a tin ion source. The tin ion source can be any suitable compound that can
provide tin ions in
an oral care composition and/or deliver tin ions to the oral cavity when the
oral care composition
is applied to the oral cavity. The tin ion source can comprise one or more tin
containing
compounds, such as stannous fluoride, stannous chloride, stannous bromide,
stannous iodide,
stannous oxide, stannous oxalate, stannous sulfate, stannous sulfide, stannic
fluoride, stannic
chloride, stannic bromide, stannic iodide, stannic sulfide, and/or mixtures
thereof Tin ion source
can comprise stannous fluoride, stannous chloride, and/or mixture thereof The
tin ion source can
also be a fluoride-free tin ion source, such as stannous chloride.
The oral care composition can comprise from about 0.0025% to about 5%, from
about
0.01% to about 10%, from about 0.2% to about 1%, from about 0.4% to about 1%,
or from about
0.3% to about 0.6%, by weight of the oral care composition, of tin and/or a
tin ion source.
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Alternatively, the oral care composition can be essentially free of,
substantially free of, or free of
tin.
Zinc
The oral care composition can comprise zinc, which can be provided by a zinc
ion source.
The zinc ion source can comprise one or more zinc containing compounds, such
as zinc fluoride,
zinc lactate, zinc oxide, zinc phosphate, zinc chloride, zinc acetate, zinc
hexafluorozirconate, zinc
sulfate, zinc tartrate, zinc gluconate, zinc citrate, zinc malate, zinc
glycinate, zinc pyrophosphate,
zinc metaphosphate, zinc oxalate, and/or zinc carbonate. The zinc ion source
can be a fluoride-
free zinc ion source, such as zinc phosphate, zinc oxide, and/or zinc citrate.
The zinc and/or zinc ion source may be present in the total oral care
composition at an
amount of from about 0.01% to about 10%, from about 0.2% to about 1%, from
about 0.4% to
about 1 %, or from about 0.3% to about 0.6%, by weight of the dentifrice
composition.
Alternatively, the oral care composition can be essentially free of,
substantially free of, or free of
zinc.
Polyphosphate
The oral care composition can comprise polyphosphate, which can be provided by
a
polyphosphate source. A polyphosphate source can comprise one or more
polyphosphate
molecules. Polyphosphates are a class of materials obtained by the dehydration
and condensation
of orthophosphate to yield linear and cyclic polyphosphates of varying chain
lengths. Thus,
polyphosphate molecules are generally identified with an average number (n) of
polyphosphate
molecules, as described below. A polyphosphate is generally understood to
consist of two or more
phosphate molecules arranged primarily in a linear configuration, although
some cyclic derivatives
may be present.
Preferred polyphosphates are those having an average of two or more phosphate
groups so
that surface adsorption at effective concentrations produces sufficient non-
bound phosphate
functions, which enhance the anionic surface charge as well as hydrophilic
character of the
surfaces. Preferred in this invention are the linear polyphosphates having the
formula:
X0(XP03),X, wherein X is sodium, potassium, ammonium, or any other alkali
metal cations and
n averages from about 2 to about 21. Alkali earth metal cations, such as
calcium, are not preferred
because they tend to form insoluble fluoride salts from aqueous solutions
comprising a fluoride
ions and alkali earth metal cations. Thus, the oral care compositions
disclosed herein can be free
of or substantially free of calcium pyrophosphate.
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Some examples of suitable polyphosphate molecules include, for example,
pyrophosphate
(n-2), tripolyphosphate (n-3), tetrapolyphosphate (n-4), sodaphos
polyphosphate (n-6), hexaphos
polyphosphate (n=13), benephos polyphosphate (n=14), hexarnetaphosphate
(n=21), which is also
known as Glass H. Polyphosphates can include those polyphosphate compounds
manufactured by
5 INC Corporation, ICI, Performance Products, and/or Astaris.
The oral care composition can comprise from about 0.01% to about 15%, from
about 0.1%
to about 10%, from about 0.5% to about 5%, from about 1 to about 20%, or about
10% or less, by
weight of the oral care composition, of the polyphosphate source.
Alternatively, the oral care
composition can be essentially free of, substantially free of, or free of
polyphosphate.
Orthophosphate
The oral care composition can comprise orthophosphate, which can be provided
by an
orthophosphate source. An orthophosphate source can comprise a salt including
the
orthophosphate anion, a salt including a phosphate anion (H2PO4--. HP042-, and
P043-), a
phosphoric acid compound, a polyphosphate source, which can breakdown into
orthophosphate
under a variety of conditions, and/or another suitable orthophosphate source.
The oral care composition can comprise from about 0.01% to about 15%, from
about 0.1%
to about 10%, from about 0,5% to about 5%, from about 1 to about 20%, or about
10% or less, by
weight of the oral care composition, of the orthophosphate. Alternatively, the
oral care
composition can be essentially free of, substantially free of, or free of
orthophosphate.
Surfactant
The oral care composition can comprise one or more surfactants. The
surfactants can be
used to make the compositions more cosmetically acceptable. The surfactant is
preferably a
detersive material which imparts to the composition detersive and foaming
properties. Suitable
surfactants are safe and effective amounts of anionic, cationic, nonionic,
zwitterionic, amphoteric
and betaine surfactants, such as sodium lauryl sulfate, sodium lauryl
isethionate, sodium lauroyl
methyl isethionate, sodium cocoyl glutamate, sodium dodecyl benzene sulfonate,
alkali metal or
ammonium salts of lauroyl sarcosinate, myristoyl sarcosinate, palmitoyl
sarcosinate, stearoyl
sarcosinate and oleoyl sarcosinate, polyoxyethylene sorbitan monostearate,
isostearate and laurate,
sodium lauryl sulfoacetate, N-lauroyl sarcosine, the sodium, potassium, and
ethanolamine salts of
N-lauroyl, N-myristoyl, or N-palmitoyl sarcosine, polyethylene oxide
condensates of alkyl
phenols, cocoamidopropyl betaine, lauramidopropyl betaine, palmityl betaine,
sodium cocoyl
glutamate, and the like. Sodium lauryl sulfate is a preferred surfactant. The
oral care composition
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can comprise one or more surfactants each at a level from about 0.01% to about
15%, from about
0.3% to about 10%, or from about 0.3% to about 2.5 %, by weight of the oral
care composition.
It was surprisingly found that additional amounts of anionic surfactant, such
as alkyl
sulfate surfactant and/or sodium lauryl sulfate, can lead to increased
peroxide stability. As such,
desirable compositions include compositions that comprise at least about 1.5%,
greater than
1.5%, from about 1.5% to about 10%, or greater than 1.5% to about 10%, by
weight of the oral
care composition, of anionic surfactant.
Amino Acid
The oral care composition can comprise amino acid. The amino acid can comprise
one or
more amino acids, peptide, and/or polypeptide, as described herein.
Amino acids, as in Formula II, are organic compounds that contain an amine
functional
group, a carboxyl functional group, and a side chain (R in Formula II)
specific to each amino acid.
Suitable amino acids include, for example, amino acids with a positive or
negative side chain,
amino acids with an acidic or basic side chain, amino acids with polar
uncharged side chains, amino
acids with hydrophobic side chains, and/or combinations thereof. Suitable
amino acids also
include, for example, arginine, histidine, lysine, aspartic acid, glutamic
acid, serine, threonine,
asparagine, glutamine, cysteine, selenocysteine, glycine, proline, alanine,
valine, isoleucine,
leucine, methionine, phenylalanine, tyrosine, tryptophan, citrulline,
ornithine, creatine,
diaminobutanoic acid, diaminoproprionic acid, salts thereof, and/or
combinations thereof.
Suitable amino acids include the compounds described by Formula I, either
naturally
occurring or synthetically derived. The amino acid can be zwitterionic,
neutral, positively charged,
or negatively charged based on the R group and the environment. The charge of
the amino acid,
and whether particular functional groups, can interact with tin at particular
pH conditions, would
be well known to one of ordinary skill in the art.
H3N
Formula I. Amino Acid. R is any suitable functional group
Suitable amino acids include one or more basic amino acids, one or more acidic
amino
acids, one or more neutral amino acids, or combinations thereof.
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The oral care composition can comprise from about 0.01% to about 20%, from
about 0.1%
to about 10%, from about 0.5% to about 6%, or from about 1% to about 10 % of
amino acid, by
weight of the oral care composition.
The term "neutral amino acids" as used herein include not only naturally
occurring neutral
amino acids, such as alanine, asparagine, cysteine, glutamine, glycine,
isoleucine, leucine,
methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine,
valine, but also
biologically acceptable amino acids which have an isoelectric point in range
of pH 5.0 to 7Ø The
biologically preferred acceptable neutral amino acid has a single amino group
and carboxyl group
in the molecule or a functional derivative hereof, such as functional
derivatives having an altered
side chain albeit similar or substantially similar physio chemical properties.
In a further
embodiment the amino acid would be at minimum partially water soluble and
provide a pH of less
than 7 in an aqueous solution of lg/1000m1 at 25 C.
Accordingly, neutral amino acids suitable for use in the invention include,
but are not limited
to, alanine, aminobutyrate, asparagine, cysteine, cystine, glutamine, glycine,
hydroxyproline,
.. isoleucine, leucine, methionine, phenylalanine, proline, serine, taurine,
threonine, tryptophan,
tyrosine, valine, salts thereof, or mixtures thereof. Preferably, neutral
amino acids used in the
composition of the present invention may include asparagine, glutamine,
glycine, salts thereof, or
mixtures thereof. The neutral amino acids may have an isoelectric point of
5.0, or 5.1, or 5.2, or
5.3, or 5.4, or 5.5, or 5.6, or 5.7, or 5.8, or 5.9, or 6.0, or 6.1, or 6.2,
or 6.3, or 6.4, or 6.5, or 6.6, or
6.7, or 6.8, or 6.9, or 7.0, in an aqueous solution at 25 C. Preferably, the
neutral amino acid is
selected from proline, glutamine, or glycine, more preferably in its free form
(i.e. uncomplexed).
If the neutral amino acid is in its salt form, suitable salts include salts
known in the art to be
pharmaceutically acceptable salts considered to be physiologically acceptable
in the amounts and
concentrations provided.
Humectant
The oral care composition can comprise one or more humectants, have low levels
of a
humectant, or be free of a humectant. Humectants serve to add body or "mouth
texture" to an oral
care composition or dentifrice as well as preventing the dentifrice from
drying out. Suitable
humectants include polyethylene glycol (at a variety of different molecular
weights), propylene
glycol, glycerin (glycerol), erythritol, xylitol, sorbitol, mannitol, butylene
glycol, lactitol,
hydrogenated starch hydrolysates, and/or mixtures thereof The oral care
composition can
comprise one or more humectants each at a level of from 0 to about 70%, from
about 5% to about
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50%, from about 10% to about 60%, or from about 20% to about 80%, by weight of
the oral care
composition.
Thickening Agents
The oral care composition can comprise one or more thickening agents in
addition to the
amphiphilic polymer and alkyl alcohol, as described herein. Thickening agents
can be useful in
the oral care compositions to provide a gelatinous structure that stabilizes
the dentifrice and/or
toothpaste against phase separation. Suitable thickening agents include
polysaccharides, polymers,
and/or silica thickeners.
The thickening agent can comprise one or more polysaccharides. Some non-
limiting
examples of polysaccharides include starch; glycerite of starch; gums such as
gum karaya (sterculia
gum), gum tragacanth, gum arabic, gum ghatti, gum acacia, xanthan gum, guar
gum and cellulose
gum; magnesium aluminum silicate (Veegum); carrageenan; sodium alginate; agar-
agar; pectin;
gelatin; cellulose compounds such as cellulose, microcrystalline cellulose,
carboxymethyl
cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxymethyl
cellulose,
hydroxymethyl carboxypropyl cellulose, methyl cellulose, ethyl cellulose, and
sulfated cellulose;
natural and synthetic clays such as hectorite clays; and mixtures thereof.
Other polysaccharides that are suitable for use herein include carageenans,
gellan gum,
locust bean gum, xanthan gum, carbomers, poloxamers, modified cellulose, and
mixtures thereof.
Carageenan is a polysaccharide derived from seaweed. There are several types
of carageenan that
may be distinguished by their seaweed source and/or by their degree of and
position of sulfation.
The thickening agent can comprise kappa carageenans, modified kappa
carageenans, iota
carageenans, modified iota carageenans, lambda carrageenan, and mixtures
thereof. Carageenans
suitable for use herein include those commercially available from the FMC
Company under the
series designation "Viscarin," including but not limited to Viscarin TP 329,
Viscarin TP 388, and
Viscarin TP 389.
The thickening agent can comprise one or more polymers. The polymer can be a
polyethylene glycol (PEG), a polyvinylpyrrolidone (PVP), polyacrylic acid, a
polymer derived
from at least one acrylic acid monomer, a copolymer of maleic anhydride and
methyl vinyl ether,
a crosslinked polyacrylic acid polymer, of various weight percentages of the
oral care composition
as well as various ranges of average molecular ranges. Alternatively, the oral
care composition
can be free of, essentially free of, or substantially free of a copolymer of
maleic anhydride and
methyl vinyl ether.
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The thickening agent can comprise one or more inorganic thickening agents.
Some non-
limiting examples of suitable inorganic thickening agents include colloidal
magnesium aluminum
silicate, silica thickeners. Useful silica thickeners include, for example,
include, as a non-limiting
example, an amorphous precipitated silica such as ZEODENT 165 silica. Other
non-limiting
silica thickeners include ZEODENT 153, 163, and 167, and ZEOFREE 177 and 265
silica
products, all available from Evonik Corporation, and AEROSIL fumed silicas.
The oral care composition can comprise from 0.01% to about 15%, from 0.1% to
about
10%, from about 0.2% to about 5%, or from about 0.5 % to about 2% of one or
more thickening
agents.
Dicarboxylic acid
The oral care composition can comprise dicarboxylic acid. The dicarboxylic
acid
comprises a compound with two carboxylic acid functional groups. The
dicarboxylic acid can
comprise a compound or salt thereof defined by Formula II.
0 0
F10,7NN J..,OH
Formula II. Dicarboxylic acid
R can be null, alkyl, alkenyl, allyl, phenyl, benzyl, aliphatic, aromatic,
polyethylene
glycol, polymer, 0, N, P, or combinations thereof
The dicarboxylic acid can comprise oxalic acid, malonic acid, succinic acid,
glutaric acid,
adipic acid, pimelic acid, suberic acid, azerlaic acid, sebacic acid,
undecanedioic acid,
dodecanedioic acid, brassylic acid, thapsic acid, japanic acid, phellogenic
acid, equisetolic acid,
malic acid, tartaric acid, salts thereof, or combinations thereof. The
dicarboxylic acid can comprise
suitable salts of dicarboxylic acid, such as, for example, monoalkali metal
oxalate, dialkali metal
oxalate, monopotassium monohydrogen oxalate, dipotassium oxalate, monosodium
monohydrogen oxalate, disodium oxalate, titanium oxalate, and/or other metal
salts of oxalate.
The dicarboxylic acid can also include hydrates of the dicarboxylic acid
and/or a hydrate of a salt
of the dicarboxylic acid.
The oral care composition can comprise from about 0.01% to about 10%, from
about 0.1%
to about 15%, from about 1% to about 5%, or from about 0.0001 to about 25%, of
dicarboxylic
acid.
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Other Ingredients
The oral care composition can comprise a variety of other ingredients, such as
flavoring
agents, sweeteners, colorants, preservatives, buffering agents, or other
ingredients suitable for use
in oral care compositions, as described below.
5 Flavoring agents also can be added to the oral care composition. Suitable
flavoring agents
include oil of wintergreen, oil of peppermint, oil of spearmint, clove bud
oil, menthol, anethole,
methyl salicylate, eucalyptol, cassia, 1-menthyl acetate, sage, eugenol,
parsley oil, oxanone, alpha-
irisone, marjoram, lemon, orange, propenyl guaethol, cinnamon, vanillin, ethyl
vanillin,
heliotropine, 4-cis-heptenal, diacetyl, methyl-para-tert-butyl phenyl acetate,
and mixtures thereof.
10 Coolants may also be part of the flavor system. Preferred coolants in
the present compositions are
the paramenthan carboxyamide agents such as N-ethyl-p-menthan-3-carboxamide
(known
commercially as "WS-3") or N-(Ethoxycarbonylmethyl)-3-p-menthanecarboxamide
(known
commercially as "WS-5"), and mixtures thereof. A flavor system is generally
used in the
compositions at levels of from about 0.001 % to about 5%, by weight of the
oral care composition.
15 These flavoring agents generally comprise mixtures of aldehydes,
ketones, esters, phenols, acids,
and aliphatic, aromatic and other alcohols.
Sweeteners can be added to the oral care composition to impart a pleasing
taste to the
product. Suitable sweeteners include saccharin (as sodium, potassium or
calcium saccharin),
cyclamate (as a sodium, potassium or calcium salt), acesulfame-K, thaumatin,
neohesperidin
20 dihydrochalcone, ammoniated glycyrrhizin, dextrose, levulose, sucrose,
mannose, sucralose,
stevia, and glucose.
Colorants can be added to improve the aesthetic appearance of the product.
Suitable
colorants include without limitation those colorants approved by appropriate
regulatory bodies
such as the FDA and those listed in the European Food and Pharmaceutical
Directives and include
pigments, such as TiO2, and colors such as FD&C and D&C dyes.
Preservatives also can be added to the oral care compositions to prevent
bacterial growth.
Suitable preservatives approved for use in oral compositions such as
methylparaben,
propylparaben, benzoic acid, and sodium benzoate can be added in safe and
effective amounts.
Titanium dioxide may also be added to the present composition. Titanium
dioxide is a
white powder which adds opacity to the compositions. Titanium dioxide
generally comprises from
about 0.25% to about 5%, by weight of the oral care composition.
Other ingredients can be used in the oral care composition, such as
desensitizing agents,
healing agents, other caries preventative agents, chelating/sequestering
agents, vitamins, amino
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acids, proteins, other anti-plaque/anti-calculus agents, pacifiers,
antibiotics, anti-enzymes,
enzymes, pH control agents, oxidizing agents, antioxidants, and the like.
EXAMPLES
The invention is further illustrated by the following examples, which are not
to be construed
in any way as imposing limitations to the scope of this invention. Various
other aspects,
modifications, and equivalents thereof which, after reading the description
herein, may suggest
themselves to one of ordinary skill in the art without departing from the
spirit of the present
invention or the scope of the appended claims.
Viscosity
Viscosity of the oral care compositions was measured using a Brookfield
Viscometer
(RVDV2T Pro Digital Viscometer) and a Brookfield Helipath stand. Compositions
were pre-
conditioned at 25 C for at least 6 hours using a water bath, oven, or
incubator. Sample containers
containing the oral care compositions were positioned under the spindle using
a Helipath. The
Helipath and spindle motor (2.5 rpm) were started and viscosity values were
read at 40, 45, 50, 55,
and 60 seconds. The five values were averaged to provide a readout of the
viscosity.
TABLE 1. Compositions
Example Example Example Example Example Example
A
(wt %) (wt%) (wt%) (wt%) (wt%) (wt%)
Water 56.33 56.83 57.33 56.58 56.83 57.08
Glycerin 10 10 10 10 10 10
Amphiphilic
2.25 2.25 1.25 2.25 1.75 1.5
Polymerl
SLS (28%) 5 5 5 5 5 5
Alkyl Alcohol2 1.25 0.75 1.25 1 1.25 1.25
Sodium
1.14 1.14 1.14 1.14 1.14 1.14
Monofluorophosphate
SAPP 0.7 0.7 0.7 0.7 0.7 0.7
TSPP 0.4 0.4 0.4 0.4 0.4 0.4
Sucralo se 0.3 0.3 0.3 0.3 0.3 0.3
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Calcium
10 10 10 10 10
Pyrophosphate
H202(35%) 11.43 11.43 11.43 11.43 11.43 11.43
Flavor 1.2 1.2 1.2 1.2 1.2 1.2
1Sepimax ZenTM
2Cetyl Alcohol:Stearyl Alcohol:SLS (45:45:10)
TABLE 1 shows a variety of compositions that include different amounts of
amphiphilic
5 polymer (from 1.25 wt% to 2.25 wt%) and alkyl alcohol (from 0.75 wt% to
1.25 wt%). Ex. A-F
include sodium monofluorophosphate (1.14 wt%) , sodium lauryl sulfate (1.4
wt%), calcium
pyrophosphate (10 wt%), and hydrogen peroxide (4 wt%).
TABLE 2. Viscosity
Ex. A Ex. B Ex. C Ex. D Ex. E Ex. F
Amphiphilic Polymerl (wt%) 2.25 2.25 1.25 2.25 1.75
1.5
Alkyl Alcohol2 (wt%) 1.25 0.75 1.25 1.0 1.25
1.25
Ratio of Amphiphilic Polymer to Alkyl 1.8 3.0 1 2.25 1.4 1.4
Alcohol
Total Thickening Agent (wt%) 3.5 3.0 2.5 3.25 3.0 2.75
Viscosity (BKU) 50 30 22.5 17.5 12.5 28
10 1Sepimax ZenTM
2Cetyl Alcohol:Stearyl Alcohol:SLS (45:45:10)
TABLE 2 shows the unexpectedly high viscosity of Examples A-F due to the use
of
amphiphilic polymer and alkyl alcohol in unique ratios. The ratio of the
amphiphilic polymer to
the alkyl alcohol can be at least about 1, from about 1 to about 3, from about
0.5 to about 3.5 or
from about 0.5 to about 5.
In contrast, TABLE 3 shows that when one of these is removed, the viscosity of
the oral
care composition is much less. In Example 1, the alkyl alcohol is removed and
the viscosity is 5
BKU (compared with 17.5-50 BKU of TABLE 2). In Example 2, the amphiphilic
polymer is
removed and the viscosity is 3 BKU. Example 3 include both the amphiphilic
polymer and the
alkyl alcohol in a 1:1 ratio, and the viscosity increases to 23 BKU. Thus, the
use of amphiphilic
polymer and alkyl alcohol at certain ratios led to unexpectedly high
viscosities.
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TABLE 3. Viscosity
Example
Example
Example 2
1 3
Amphiphilic Polymer' (wt%) 1.6 0 1.6
Alkyl Alcohol2 (wt%) 0 1.6 1.6
Ratio of Amphiphilic Polymer to Alkyl Alcohol N/A N/A 1
Total Thickening Agent (wt%) 1.6 1.6 3.2
Brookfield Viscosity (BKU) 5 3 23
1Sepimax ZenTM
2Cetyl Alcohol: Stearyl Alcohol: SLS (45:45:10)
The dimensions and values disclosed herein are not to be understood as being
strictly
limited to the exact numerical values recited. Instead, unless otherwise
specified, each such
dimension is intended to mean both the recited value and a functionally
equivalent range
surrounding that value. For example, a dimension disclosed as "40 mm" is
intended to mean "about
40 mm."
Every document cited herein, including any cross referenced or related patent
or application
and any patent application or patent to which this application claims priority
or benefit thereof, is
hereby incorporated herein by reference in its entirety unless expressly
excluded or otherwise
limited. The citation of any document is not an admission that it is prior art
with respect to any
invention disclosed or claimed herein or that it alone, or in any combination
with any other
reference or references, teaches, suggests or discloses any such invention.
Further, to the extent
that any meaning or definition of a term in this document conflicts with any
meaning or definition
of the same term in a document incorporated by reference, the meaning or
definition assigned to
that term in this document shall govern.
