U.S. patent application number 16/225823 was filed with the patent office on 2019-05-02 for oral care composition.
This patent application is currently assigned to Colgate-Palmolive Company. The applicant listed for this patent is Colgate-Palmolive Company. Invention is credited to Xiao Yi HUANG, Michael PRENCIPE, Yuan Hui XIE.
Application Number | 20190125636 16/225823 |
Document ID | / |
Family ID | 51019625 |
Filed Date | 2019-05-02 |
United States Patent
Application |
20190125636 |
Kind Code |
A1 |
PRENCIPE; Michael ; et
al. |
May 2, 2019 |
Oral Care Composition
Abstract
The present invention relates to an oral care composition with a
high water content which has improved robustness towards microbial
challenge. The oral care composition includes compositions
comprising from 0.125 wt % to 0.75 wt % of a water soluble source
of stannous ions, wherein the composition comprises at least 50 wt
% water and wherein the source of stannous ions is selected from
the group consisting of stannous chloride, stannous pyrophosphate,
stannous formate, stannous acetate, stannous gluconate, stannous
lactate, stannous tartrate, stannous oxalate, stannous malonate,
stannous citrate, stannous ethylene glyoxide, and mixtures
thereof.
Inventors: |
PRENCIPE; Michael; (West
Windsor, NJ) ; HUANG; Xiao Yi; (Guangzhou, CN)
; XIE; Yuan Hui; (Guangzhou, CN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Colgate-Palmolive Company |
New York |
NY |
US |
|
|
Assignee: |
Colgate-Palmolive Company
New York
NY
|
Family ID: |
51019625 |
Appl. No.: |
16/225823 |
Filed: |
December 19, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14654512 |
Jun 19, 2015 |
10195124 |
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PCT/CN2012/087272 |
Dec 24, 2012 |
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16225823 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61Q 11/00 20130101;
A61K 8/365 20130101; A61K 2800/30 20130101; A61K 8/24 20130101;
A61K 8/21 20130101; A61K 8/19 20130101; A61K 8/27 20130101 |
International
Class: |
A61K 8/24 20060101
A61K008/24; A61K 8/21 20060101 A61K008/21; A61K 8/19 20060101
A61K008/19; A61Q 11/00 20060101 A61Q011/00; A61K 8/27 20060101
A61K008/27; A61K 8/365 20060101 A61K008/365 |
Claims
1. An aqueous oral care composition comprising from 0.125 wt % to
0.75 wt % of a water soluble source of stannous ions, wherein the
composition comprises at least 50 wt % water and wherein the source
of stannous ions is selected from the group consisting of stannous
chloride, stannous pyrophosphate, stannous formate, stannous
acetate, stannous gluconate, stannous lactate, stannous tartrate,
stannous oxalate, stannous malonate, stannous citrate, stannous
ethylene glyoxide, and mixtures thereof.
2. The oral care composition of claim 1, wherein the composition
comprises from 0.125 wt % to 0.5 wt % of the source of stannous
ions.
3. The oral care composition of claim 2, wherein the composition
comprises from 0.125 wt % to 0.3 wt % of the source of stannous
ions.
4. The oral care composition of claim 2, wherein the composition
comprises from 0.15 wt % to 0.3 wt % of the source of stannous
ions.
5. The oral care composition of claim 1, wherein the source of
stannous ions is stannous chloride.
6. The oral care composition of claim 1, wherein the composition
comprises from 50 wt % to 65 wt % water.
7. The oral care composition of claim 6, wherein the composition
comprises from 52 wt % to 60 wt % water.
8. The oral care composition of claim 6, wherein the composition
comprises from 54 wt % to 55 wt % water.
9. The oral care composition of claim 1, further comprising a
fluoride ion source selected from the group consisting of sodium
fluoride, potassium fluoride, potassium monofluorophosphate, sodium
monofluorophosphate, ammonium monofluorophosphate, sodium
fluorosilicate, ammonium fluorosilicate, an amine fluoride,
ammonium fluoride, and combinations thereof.
10. The oral care composition of claim 1, further comprising a
source of zinc ions.
11. The oral care composition of claim 10, wherein the source of
zinc ions comprises zinc oxide, zinc citrate, or mixtures
thereof.
12. The oral care composition of claim 11, wherein the composition
comprises zinc citrate in an amount of from 1.5 wt % to 2.5 wt
%.
13. The oral care composition of claim 11, wherein the composition
comprises zinc oxide in an amount of from 0.5 wt % to 1.5 wt %.
14. The oral care composition of claim 1, wherein the composition
is a toothpaste, a tooth gel, a mouthrinse, a cream or an
ointment.
15. The oral care composition of claim 1, wherein the composition
is free of additional antibacterial or preservative agents.
16. The oral care composition of claim 1, wherein the composition
has improved robustness towards microbial challenge.
17. A method of improving the robustness of an oral care
composition containing at least 50 wt % water towards microbial
challenge comprising adding to the oral care composition a water
soluble source of stannous ions, wherein the source of stannous
ions is present in the oral care composition at a concentration of
from 0.1 wt % to 0.75 wt %, and wherein the source of stannous ions
is selected from the group consisting of stannous chloride,
stannous pyrophosphate, stannous formate, stannous acetate,
stannous gluconate, stannous lactate, stannous tartrate, stannous
oxalate, stannous malonate, stannous citrate, stannous ethylene
glyoxide, and mixtures thereof.
18. The method of claim 17, wherein the composition comprises from
0.15 wt % to 0.3 wt % of the source of stannous ions.
19. The method of claim 17, wherein the source of stannous ions is
stannous chloride.
20. The method of claim 17, wherein the composition comprises from
50 wt % to 60 wt % water.
Description
BACKGROUND OF THE INVENTION
[0001] Compositions having a high water content tend to support the
survival and growth of microorganisms. This problem also occurs in
oral care compositions which have a high water content. Therefore,
preservative agents such as benzyl alcohol, methylparaben,
propylparaben are often added to oral care compositions in order to
increase their robustness towards microbial challenge.
[0002] However, a need still exists for oral care compositions
which have improved robustness towards microbial attack without
requiring the presence of preservative agents in the
compositions.
SUMMARY OF THE INVENTION
[0003] A first aspect of the present invention provides an aqueous
oral care composition comprising from 0.125 wt % to 0.75 wt % of a
water soluble source of stannous ions, wherein the composition
comprises at least 50 wt % water and wherein the source of stannous
ions is selected from the group consisting of stannous chloride,
stannous pyrophosphate, stannous formate, stannous acetate,
stannous gluconate, stannous lactate, stannous tartrate, stannous
oxalate, stannous malonate, stannous citrate, stannous ethylene
glyoxide, and mixtures thereof.
[0004] Optionally, the composition comprises from 0.125 wt % to
0.75 wt % of the source of stannous ions.
[0005] Optionally, the composition comprises from 0.125 wt % to 0.5
wt % of the source of stannous ions.
[0006] Optionally, the composition comprises from 0.125 wt % to
0.35 wt % of the source of stannous ions.
[0007] Optionally, the composition comprises from 0.15 wt % to 0.3
wt % of the source of stannous ions.
[0008] Optionally, the source of stannous ions is stannous
chloride.
[0009] Optionally, the composition comprises from 50 wt % to 65 wt
% water.
[0010] Optionally, the composition comprises from 52 wt % to 60 wt
% water.
[0011] Optionally, the composition comprises from 54 wt % to 55 wt
% water
[0012] Optionally, the composition further comprises a fluoride ion
source selected from the group consisting of sodium fluoride,
potassium fluoride, potassium monofluorophosphate, sodium
monofluorophosphate, ammonium monofluorophosphate, sodium
fluorosilicate, ammonium fluorosilicate, an amine fluoride,
ammonium fluoride, and combinations thereof.
[0013] Optionally, the composition further comprises a source of
zinc ions.
[0014] Optionally, the source of zinc ions comprises zinc oxide,
zinc citrate, or mixtures thereof.
[0015] Optionally, the composition comprises zinc citrate in an
amount of from 0% to 1.5%, preferably, 1.5 wt % to 2.5 wt %.
[0016] Optionally, the composition comprises zinc oxide in an
amount of from 0% to 1.5%, preferably 0.5 wt % to 1.5 wt %.
[0017] Optionally, the composition is a toothpaste, a tooth gel, a
mouthrinse, a cream or an ointment.
[0018] Optionally, the composition is free of additional
preservative agents.
[0019] The present invention also provides an oral care composition
as described above which has improved robustness towards microbial
challenge.
[0020] In a second aspect, the present invention provides use of a
water soluble source of stannous ions for improving the robustness
towards microbial challenge of an oral care composition containing
at least 50 wt % water, wherein the source of stannous ions is
present in the oral care composition at a concentration of from 0.1
wt % to 0.75 wt %, and wherein the source of stannous ions is
selected from the group consisting of stannous chloride, stannous
pyrophosphate, stannous formate, stannous acetate, stannous
gluconate, stannous lactate, stannous tartrate, stannous oxalate,
stannous malonate, stannous citrate, stannous ethylene glyoxide,
and mixtures thereof.
[0021] Optionally, the composition comprises from 0.15 wt % to 0.3
wt % of the source of stannous ions.
[0022] Optionally, the source of stannous ions is stannous
chloride.
[0023] Optionally, the composition comprises from 50 wt % to 60 wt
% water.
[0024] The present inventors have surprisingly found that the
addition of a stannous ion source at a concentration of 0.1 wt % to
0.75 wt % to a high water content aqueous oral care composition (at
least 50 wt % water content) greatly improves the robustness of the
composition towards microbial challenge, compared to compositions
which do not contain a source of stannous ions or any other
chemical reagents that are responsible for preservation.
DESCRIPTION OF THE INVENTION
[0025] It should be understood that the detailed description and
specific examples, while indicating embodiments of the invention,
are intended for purposes of illustration only and are not intended
to limit the scope of the invention.
[0026] As used throughout, ranges are used as shorthand for
describing each and every value that is within the range. Any value
within the range can be selected as the terminus of the range.
[0027] As used herein, the words "preferred" and "preferably" refer
to embodiments of the invention that afford certain benefits, under
certain circumstances. However, other embodiments may also be
preferred, under the same or other circumstances. Furthermore, the
recitation of one or more preferred embodiments does not imply that
other embodiments are not useful, and is not intended to exclude
other embodiments from the scope of the invention.
[0028] As used herein, the term "about", when applied to the value
for a parameter of a composition or method of this invention,
indicates that the calculation or the measurement of the value
allows some slight imprecision without having a substantial effect
on the chemical or physical attributes of the composition or
method. If, for some reason, the imprecision provided by "about" is
not otherwise understood in the art with this ordinary meaning,
then "about" as used herein indicates a possible variation of up to
5% in the value.
[0029] As referred to herein, all compositional percentages are by
weight of the total composition unless otherwise indicated. As
referred to herein, "ppm" (parts per million) refers to ppm by
weight, unless otherwise indicated. As referred to herein, all
ratios refer to weight ratios, unless otherwise indicated.
[0030] In one aspect, the present invention provides an aqueous
oral care composition comprising from about 0.125 wt % to about
0.75 wt % of a water soluble source of stannous ions, wherein the
composition comprises at least 50 wt % water and wherein the source
of stannous ions is selected from the group consisting of stannous
chloride, stannous pyrophosphate, stannous formate, stannous
acetate, stannous gluconate, stannous lactate, stannous tartrate,
stannous oxalate, stannous malonate, stannous citrate, stannous
ethylene glyoxide, and mixtures thereof. Alternatively, the amount
of stannous ions throughout the application can be referred to
directly, e.g. about 0.125 wt % to about 0.75 wt % of stannous
chloride (SnCl.sub.2) would correlate to about 0.080 wt % to about
0.47 wt % of stannous ions.
[0031] In some embodiments, the composition comprises from about
0.15 wt % to about 0.75 wt % of the source of stannous ions,
optionally from about 0.15 wt % to about 0.5 wt % of the source of
stannous ions.
[0032] In some embodiments, the composition comprises from 0.15 wt
% to 0.3 wt % of the source of stannous ions, optionally from 0.20
wt % to 0.25 wt % of the source of stannous ions.
[0033] In some embodiments, the composition comprises from 0.3 wt %
to 0.5 wt % of the source of stannous ions, optionally 0.35 wt % to
0.45 wt % of the source of stannous ions.
[0034] In some embodiments, the source of stannous ions is stannous
chloride (SnCl.sub.2).
[0035] The oral care compositions of the present invention are
aqueous, and comprise at least 50 wt % water. In some embodiments,
the oral care composition comprises from 50 wt % to 65 wt % water,
optionally from 52 wt % to 60 wt % water, further optionally from
54 wt % to 55 wt % water. In some embodiments, the oral care
composition comprises from 50 wt % to 60 wt % water.
[0036] In some embodiments, the oral care compositions of the
present invention further comprise a fluoride ion source selected
from the group consisting of sodium fluoride, potassium fluoride,
potassium monofluorophosphate, sodium monofluorophosphate, ammonium
monofluorophosphate, sodium fluorosilicate, ammonium
fluorosilicate, an amine fluoride, ammonium fluoride, and
combinations thereof. One example of an amine fluoride is Olaflur
(N'-octadecyltrimethylendiamine-N,N,N-tris(2-ethanol)-dihydrofluoride).
[0037] In certain embodiments the fluoride ion source includes
sodium fluoride, amine fluorides, sodium monofluorophosphate, as
well as mixtures thereof. A preferred fluoride salt may be sodium
monofluorophosphate.
[0038] In certain embodiments, the oral care composition of the
invention may contain a fluoride ion source or fluorine-providing
ingredient in an amount sufficient to supply about 50 to about 5000
ppm fluoride ion, e.g., from about 100 to about 1000, from about
200 to about 500, or about 250 ppm fluoride ion. Fluoride ion
sources may be added to the compositions of the invention at a
level of about 0.001 wt % to about 10 wt %, e.g., from about 0.003
wt % to about 5 wt %, 0.01 wt % to about 1 wt, or about 0.05 wt %.
However, it is to be understood that the weights of fluoride salts
to provide the appropriate level of fluoride ion will obviously
vary based on the weight of the counter ion in the salt, and one of
skill in the art may readily determine such amounts.
[0039] In some embodiments, the oral care compositions of the
present invention further comprise a source of zinc ions. One or
more such sources can be present. One or more zinc ion sources may
be present in a total amount of from about 0.05 wt % to about 3 wt
%, for example from about 0.1 wt % to about 1 wt %, by total weight
of the composition.
[0040] Suitable zinc ion sources include without limitation zinc
acetate, zinc citrate, zinc gluconate, zinc glycinate, zinc oxide,
zinc sulfate, sodium zinc citrate and mixtures thereof.
[0041] In certain embodiments, the source of zinc ions comprises
zinc oxide (ZnO), zinc citrate, or mixtures thereof. In some
embodiments, the composition comprises zinc citrate in an amount of
from 1.5 wt % to 2.5 wt %, optionally in an amount of from 1.75 wt
% to 2.25 wt %. Alternatively or additionally, the composition may
comprise zinc oxide in an amount of from 0.5 wt % to 1.5 wt %,
optionally in an amount of from 0.75 wt % to 1.25 wt %.
[0042] In some embodiments, the oral care compositions of the
present invention may comprise one or more agents selected from
abrasives, diluents, bicarbonate salts, pH modifying agents,
surfactants, foam modulators, thickening agents, viscosity
modifiers, humectants, sweeteners, flavorants, pigments,
antibacterial agents, anticaries agents, anticalculus or tartar
control agents, and mixtures thereof.
[0043] In some embodiments, the compositions of the present
invention further comprise at least one abrasive.
[0044] Abrasive silicas are distinct from thickening silicas. In
general, abrasive (cleaning) silicas can be characterized as having
oil absorption levels of about 40 to 150 cc/100 g and having an
Einlehner abrasion of 3 or greater mg loss/100,000 revolutions
whereas thickening abrasives have oil absorption levels of greater
than 150 cc/100 g and having an Einlehner abrasion of less than 2
mg loss/100,000 revolutions.
[0045] Abrasives that may be used include silica abrasives such as
precipitated or hydrated silicas having a mean particle size of up
to about 20 microns, such as Zeodent 103, 105, 113, 114, 115, or
124 marketed by J.M. Huber Chemicals Division, Havre de Grace, Md.
21078, Sylodent 783 marketed by Davison Chemical Division of W.R.
Grace & Company, Sorbosil AC 43 from PQ Corporation, and
mixtures thereof. Other useful dentifrice abrasives include
aluminium oxide, aluminum silicate, calcined alumina, bentonite or
other siliceous materials, insoluble phosphates, calcium carbonate,
and mixtures thereof.
[0046] Other possible abrasive silicas include silica gels and
precipitated amorphous silica having an oil adsorption value of
less than 100 cc/100 g silica and optionally in the range of from
about 45 cc/100 g to less than about 70 cc/100 g silica. These
silicas are colloidal particles having an average particle size
ranging from about 3 microns to about 12 microns, and optionally
between about 5 to about 10 microns.
[0047] The abrasive or mixture of abrasives may be present in an
amount of from 5 to 35 wt % based on the weight of the composition,
optionally from 10 to 20 wt % based on the weight of the
composition. The abrasive or mixture of abrasives may be present in
an amount of from 12 to 17 wt % based on the weight of the
composition.
[0048] In certain embodiments, the compositions may be free of
abrasives.
[0049] In some embodiments, the oral care compositions of the
present invention comprise at least one bicarbonate salt, useful
for example to impart a "clean feel" to teeth and gums due to
effervescence and release of carbon dioxide. Any orally acceptable
bicarbonate can be used, including without limitation, alkali metal
bicarbonates such as sodium and potassium bicarbonates, ammonium
bicarbonate and the like. One or more bicarbonate salts are
optionally present in a total amount of about 0.1 wt % to about 50
wt %, for example about 0.5 wt % to 20 wt % or 1 wt % to 10 wt %,
by total weight of the composition.
[0050] In some embodiments, the compositions of the present
invention comprise at least one pH modifying agent. Such agents
include acidifying agents to lower pH, basifying agents to raise
pH, and buffering agents to control pH within a desired range. For
example, one or more compounds selected from acidifying, basifying
and buffering agents can be included to provide a pH of 2 to 10, or
in various illustrative embodiments, 2 to 8, 3 to 9, 4 to 8, 5 to
7, 6 to 10, 7 to 9, etc. Any orally acceptable pH modifying agent
can be used, including without limitation, carboxylic, phosphoric
and sulfonic acids, acid salts (e.g., monosodium citrate, disodium
citrate, monosodium malate, etc.), alkali metal hydroxides such as
sodium hydroxide, carbonates such as sodium carbonate,
bicarbonates, sesquicarbonates, borates, silicates, phosphates
(e.g., monosodium phosphate, trisodium phosphate, pyrophosphate
salts, etc.), imidazole and the like. One or more pH modifying
agents are optionally present in a total amount effective to
maintain the composition in an orally acceptable pH range.
[0051] In a still further embodiment, the compositions of the
invention comprise at least one surfactant. Any orally acceptable
surfactant, most of which are anionic, nonionic or amphoteric, can
be used. Suitable anionic surfactants include without limitation,
water-soluble salts of C.sub.8-20 alkyl sulfates, sulfonated
monoglycerides of C.sub.8-20 fatty acids, sarcosinates, taurates
and the like. Illustrative examples of these and other classes
include sodium lauryl sulfate (SLS), sodium coconut monoglyceride
sulfonate, sodium lauryl sarcosinate, sodium lauryl isoethionate,
sodium laureth carboxylate and sodium dodecyl benzenesulfonate.
Suitable nonionic surfactants include without limitation,
poloxamers, polyoxyethylene sorbitan esters, fatty alcohol
ethoxylates, alkylphenol ethoxylates, tertiary amine oxides,
tertiary phosphine oxides, dialkyl sulfoxides and the like.
Suitable amphoteric surfactants include without limitation,
derivatives of C.sub.8-20 aliphatic secondary and tertiary amines
having an anionic group such as carboxylate, sulfate, sulfonate,
phosphate or phosphonate. Betaines may also be used, a suitable
example of which is cocoamidopropyl betaine. One or more
surfactants are optionally present in a total amount of about 0.01
wt % to about 10 wt %, for example, from about 0.05 wt % to about 5
wt %, or from about 0.1 wt % to about 2 wt % by total weight of the
composition.
[0052] In some embodiments, the compositions of the invention
comprise at least one foam modulator, useful for example to
increase amount, thickness or stability of foam generated by the
composition upon agitation. Any orally acceptable foam modulator
can be used, including without limitation, polyethylene glycols
(PEGs), also known as polyoxyethylenes. High molecular weight PEGs
are suitable, including those having an average molecular weight of
200,000 to 7,000,000, for example 500,000 to 5,000,000, or
1,000,000 to 2,500,000. One or more PEGs are optionally present in
a total amount of about 0.1 wt % to about 10 wt %, for example from
about 0.2 wt % to about 5 wt %, or from about 0.25 wt % to about 2
wt %, by total weight of the composition.
[0053] In some embodiments, the compositions of the present
invention comprise at least one thickening agent, useful for
example to impart a desired consistency and/or mouth feel to the
composition. Any orally acceptable thickening agent can be used,
including without limitation, carbomers, also known as carboxyvinyl
polymers, carrageenans, also known as Irish moss and more
particularly -carrageenan (iota-carrageenan), cellulosic polymers
such as hydroxyethylcellulose, carboxymethylcellulose (CMC) and
salts thereof, e.g., CMC sodium, natural gums such as karaya,
xanthan, gum arabic and tragacanth, colloidal magnesium aluminum
silicate, colloidal silica and the like. A preferred class of
thickening or gelling agents includes a class of homopolymers of
acrylic acid crosslinked with an alkyl ether of pentaerythritol or
an alkyl ether of sucrose, or carbomers. Carbomers are commercially
available from B. F. Goodrich as the Carbopol.RTM. series.
Particularly preferred Carbopols include Carbopol 934, 940, 941,
956, 974P, and mixtures thereof.
[0054] Silica thickeners such as Zeodent 115 and Zeodent 165 (both
available from Huber Engineered Materials) and DT 267 (available
from PPG Industries or OSC--Lianji Chemical Industry Co., Ltd.) may
also be used. One or more thickening agents are optionally present
in a total amount of from about 0.01 wt % to 15 wt %, for example
from about 0.1 wt % to about 10 wt %, or from about 0.2 wt % to
about 5 wt %, by total weight of the composition.
[0055] In some embodiments, the compositions of the invention
comprise at least one viscosity modifier, useful for example to
help inhibit settling or separation of ingredients or to promote
re-dispersibility upon agitation of a liquid composition. Any
orally acceptable viscosity modifier can be used, including without
limitation, mineral oil, petrolatum, clays and organomodified
clays, silica and the like. One or more viscosity modifiers are
optionally present in a total amount of from about 0.01 wt % to
about 10 wt %, for example, from about 0.1 wt % to about 5 wt %, by
total weight of the composition.
[0056] In some embodiments, the compositions of the invention
comprise at least one humectant. Any orally acceptable humectant
can be used, including without limitation, polyhydric alcohols such
as glycerine, sorbitol (particularly as a 70% solution), xylitol or
low molecular weight polyethylene glycols (PEGs) such as PEG 600.
Many humectants also function as sweeteners. One or more humectants
are optionally present in a total amount of from about 1 wt % to
about 70 wt %, for example, from about 1 wt % to about 50 wt %,
from about 2 wt % to about 25 wt %, or from about 5 wt % to about
15 wt %, by total weight of the composition.
[0057] In some embodiments, a composition of the present invention
comprises at least one sweetener, useful for example to enhance
taste of the composition. Any orally acceptable natural or
artificial sweetener can be used, including without limitation
dextrose, 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 (such as sodium saccharin),
dipeptide-based intense sweeteners, cyclamates and the like. One or
more sweeteners are optionally present in a total amount depending
strongly on the particular sweetener(s) selected, but typically
0.005 wt % to 5 wt %, by total weight of the composition,
optionally 0.005 wt % to 0.3 wt %, further optionally 0.05 wt % to
0.1 wt % by total weight of the composition.
[0058] In some embodiments, a composition of the present invention
comprises at least one flavorant, useful for example to enhance
taste of the composition. Any orally acceptable natural or
synthetic flavorant can be used, including without limitation
vanillin, sage, marjoram, parsley oil, spearmint oil, cinnamon oil,
oil of wintergreen (methylsalicylate), peppermint oil, clove oil,
bay oil, anise oil, eucalyptus oil, citrus oils, fruit oils and
essences including those derived from lemon, orange, lime,
grapefruit, apricot, banana, grape, apple, strawberry, cherry,
pineapple, etc., bean- and nut-derived flavors such as coffee,
cocoa, cola, peanut, almond, etc., and other flavors, adsorbed and
encapsulated flavorants and the like. Also encompassed within
flavorants herein are ingredients that provide fragrance and/or
other sensory effect in the mouth, including cooling or warming
effects. Such ingredients illustratively include menthol, menthyl
acetate, menthyl lactate, camphor, eucalyptus oil, eucalyptol,
anethole, eugenol, cassia, oxanone, .alpha.-irisone, propenyl
guaiethol, thymol, linalool, benzaldehyde, cinnamaldehyde,
N-ethyl-p-menthan-3-carboxamine,
N,2,3-trimethyl-2-isopropylbutanamide,
3-(1-menthoxy)-propane-1,2-diol, cinnamaldehyde glycerol acetal
(CGA), menthone glycerol acetal (MGA) and the like. One or more
flavorants are optionally present in a total amount of from about
0.01 wt % to about 5 wt %, for example, from about 0.03 wt % to
about 2.5 wt %, optionally about 0.05 wt % to about 1.5 wt %,
further optionally about 0.1 wt % to about 0.3 wt % by total weight
of the composition.
[0059] A composition of the invention may comprise at least one
colorant. Colorants herein include pigments, dyes, lakes and agents
imparting a particular luster or reflectivity such as pearling
agents. Any orally acceptable colorant can be used, including
without limitation talc, mica, magnesium carbonate, calcium
carbonate, magnesium silicate, magnesium aluminum silicate, silica,
titanium dioxide (TiO.sub.2), zinc oxide, red, yellow, brown and
black iron oxides, ferric ammonium ferrocyanide, manganese violet,
ultramarine, titaniated mica, bismuth oxychloride, and the like.
One or more colorants are optionally present in a total amount of
from about 0.001 wt % to about 20 wt %, for example, from about
0.01 wt % to about 10 wt %, or from about 0.1 wt % to about 5 wt %,
by total weight of the composition.
[0060] The compositions of the present invention optionally
comprise an antibacterial agent such as chlorhexidine, triclosan,
quaternary ammonium compounds (for example benzalkonium chloride)
or an additional preservative agent such as parabens (for example
methylparaben or propylparaben). One or more antibacterial or
preservative agent is optionally present in the composition in a
total amount of from about 0.01 wt % to about 0.5 wt %, optionally
about 0.05 wt % to about 0.1 wt % by total weight of the
composition.
[0061] In some embodiments, the composition is free of such
additional antibacterial or preservative agents.
[0062] The composition of the present invention optionally
comprises a saliva stimulating agent useful, for example, in
amelioration of dry mouth. Any orally acceptable saliva stimulating
agent can be used, including without limitation food acids such as
citric, lactic, malic, succinic, ascorbic, adipic, fumaric and
tartaric acids, and mixtures thereof. One or more saliva
stimulating agents are optionally present in saliva stimulating
effective total amount.
[0063] The composition of the present invention optionally
incorporates one or more antisensitivity agents, e.g., potassium
salts such as potassium nitrate, potassium bicarbonate, potassium
chloride, potassium citrate, and potassium oxalate; capsaicin;
eugenol; strontium salts; chloride salts and combinations thereof.
Such agents may be added in effective amounts, e.g., from about 1
wt % to about 20 wt % by weight based on the total weight of the
composition, depending on the agent chosen. The compositions of the
present invention may also be used to treat hypersensitivity by
blocking dentin tubules when applied to a tooth.
[0064] In some embodiments, the composition of the invention
further comprises an antioxidant. Any orally acceptable antioxidant
can be used, including butylated hydroxyanisole (BHA), butylated
hydroxytoluene (BHT), vitamin A, carotenoids, vitamin E,
flavonoids, polyphenols, ascorbic acid, herbal antioxidants,
chlorophyll, melatonin, and mixtures thereof.
[0065] The composition of the present invention may additionally
optionally comprise a tartar control (anticalculus) agent as
provided below. Tartar control agents among those useful herein
include salts of the specified agents, including alkali metal and
ammonium salts. The agents include: phosphates and polyphosphates
(for example pyrophosphates), polyaminopropanesulfonic acid (AMPS),
polyolefin sulfonates, polyolefin phosphates, diphosphonates such
as azacycloalkane-2,2-diphosphonates (e.g.,
azacycloheptane-2,2-diphosphonic acid), N-methyl
azacyclopentane-2,3-diphosphonic acid,
ethane-1-hydroxy-1,1-diphosphonic acid (EHDP) and
ethane-1-amino-1,1-diphosphonate, phosphonoalkane carboxylic acids
and. Useful inorganic phosphate and polyphosphate salts include
monobasic, dibasic and tribasic sodium phosphates, sodium
tripolyphosphate, tetrapolyphosphate, monosodium pyrophosphate,
disodium pyrophosphate, trisodium pyrophosphate, tetrasodium
pyrophosphate (TSPP), tetrapotassium pyrophosphate (TKPP), sodium
trimetaphosphate, sodium hexametaphosphate and mixtures thereof.
Other useful tartar control agents include polycarboxylate polymers
and polyvinyl methyl ether/maleic anhydride (PVM/MA) copolymers,
such as GANTREZ.RTM..
[0066] In some embodiments, the composition of the present
invention further comprises a nutrient. Suitable nutrients include
vitamins, minerals, amino acids, and mixtures thereof. Vitamins
include Vitamins C and D, thiamine, riboflavin, calcium
pantothenate, niacin, folic acid, nicotinamide, pyridoxine,
cyanocobalamin, para-aminobenzoic acid, bioflavonoids, and mixtures
thereof. Nutritional supplements include amino acids (such as
L-tryptophan, L-lysine, methionine, threonine, levocarnitine and
L-carnitine), lipotropics (such as choline, inositol, betaine, and
linoleic acid), and mixtures thereof.
[0067] Embodiments of the present invention are further described
in the following examples. The examples are merely illustrative and
do not in any way limit the scope of the invention as described and
claimed.
EXAMPLES
[0068] Compositions A to G were formulated, as shown in Table 1, in
order to assess the impact of different concentrations of
SnCl.sub.2 on the robustness of a high water-content silica-based
dentifrice against microbial challenge. Each of these compositions
has a high total water content (from both CP water and from the 70%
sorbitol solution).
[0069] The Micro Robustness Index (MRI) of each of these
compositions was measured. The Micro Robustness Index is used as a
quantitative measure of a composition's ability to withstand
microbial challenge. The MRI is the result from a challenge test
assessing the antimicrobial efficacy of a compound/composition
against a pool of microorganisms including Burkholderia cepacia,
Enterobacter cloacae, Escherichia coli, Klesiella oxytoca,
Klebsiella pneumoniae, Serratia marcescens, Providencia rettgeri,
Pseudomonas aeruginosa, Pseudomonas putida, Staphylococcus aureus,
Staphylococcus saprophyticus. Samples are challenged 3 times at 30
minute intervals with an innoculum of 10.sup.7 bacteria from the
above listed pool. After 4, 6 and 24 hours, aliquots are tested to
measure the log reduction of bacteria. Using these data, the area
under the curve (AUC) is calculated and then converted into the
MRI; the higher the MRI, the greater the microrobustness of the
tested composition.
[0070] The present inventors have found that an MRI of at least
0.75 is required in order to show that a composition has an
acceptable level of robustness against microbial attack. MRI lower
than 0.75 may not adequately reduce the pool of microorganisms and
results in greater risk of microbial attack.
[0071] The Micro Robustness Index (MRI) for each of Compositions A
to F are shown in Table 1 (all FIGURES are in percent by
weight).
TABLE-US-00001 TABLE 1 A B C D E F G H Water 48.00 48.05 48.00
47.95 45.45 47.80 47.60 47.35 sorbitol-70% 22.44 22.00 22.00 22.00
22.00 22.00 22.00 22.00 solution Polyethylene 2.00 2.00 2.00 2.00
2.00 2.00 2.00 2.00 Glycol 600 sodium 0.30 0.30 0.30 0.30 0.30 0.30
0.30 0.30 saccharin AC 43 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00
ZnO -- -- -- -- 1.00 -- -- -- Zinc Citrate 2.00 2.00 2.00 2.00 --
2.00 2.00 2.00 TSPP 0.50 0.50 0.50 0.50 1.00 0.50 0.50 0.50 TKPP --
-- -- -- 2.00 -- -- -- sodium -- -- -- -- 1.00 -- -- -- bicarbonate
SnCl.sub.2 0.00 0.05 0.10 0.15 0.15 0.30 0.50 0.75 CMC 1.00 1.00
1.00 1.00 1.00 1.00 1.00 1.00 Xanthan 0.30 0.30 0.30 0.30 0.30 0.30
0.30 0.30 MFP 0.76 1.10 1.10 1.10 1.10 1.10 1.10 1.10 Silica
abrasive 10.00 10.00 10.00 10.00 10.00 10.00 10.00 10.00 Silica
thickener 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 Sodium lauryl
2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 sulfate powder Flavorant
1.20 1.20 1.20 1.20 1.20 1.20 1.20 1.20 TiO.sub.2 0.50 0.50 0.50
0.50 0.50 0.50 0.50 0.50 TOTAL 100.00 100.00 100.00 100.00 100.00
100.00 100.00 100.00 MRI 0.29 0.31 0.34 0.76 0.83 0.91 0.91 1.02
Total water 57.73 54.65 54.60 54.55 52.05 54.40 54.20 53.95
content
[0072] As shown in Table 1, Compositions A-C (which contained less
than 0.125 wt % SnCl.sub.2) had unacceptable MRI. This composition
therefore did not have an acceptable level of robustness towards
microbial challenge.
[0073] However, it can be seen from the results in Table 1 that the
high water content compositions which contained between 0.15 wt %
and 0.75 wt % SnCl.sub.2 gave MRI values of greater than 0.75.
These compositions therefore show an acceptable level of robustness
towards microbial challenge. While a concentration of 0.15 wt %
SnCl.sub.2 allowed the composition to attain the MRI>0.75
acceptance criteria, a concentration of 0.3 wt % SnCl.sub.2 allowed
the composition to attain an excellent result of MRI=0.91. In
contrast, compositions up to 0.10 wt % SnCl.sub.2 showed
insufficient MRI, not even reaching half the 0.75 target.
[0074] While additional SnCl.sub.2 could be added, the increase in
MRI was relatively negligible compared to the cost of a 66%
increase in SnCl.sub.2 (0.3 wt % vs. 0.5 wt %) or a 150% increase
in SnCl.sub.2 (0.3 wt. % vs. 0.75 wt %). Moreover, SnCl.sub.2, is
an astringent compound that tastes even worse than SnF.sub.2 (which
has a bitter, salty taste) and one of skill in the art would be
motivated to minimize the amount used once a requisite level of MRI
has been achieved.
[0075] Whilst particular embodiments of the invention have been
illustrated and described, it will be obvious to those skilled in
the art that various changes and modifications may be made without
departing from the scope of the invention as defined in the
appended claims.
* * * * *