U.S. patent application number 11/236082 was filed with the patent office on 2007-03-29 for single phase whitening dentifrice.
This patent application is currently assigned to Colgate-Palmolive Company. Invention is credited to Suman K. Chopra, Michael Prencipe, Lynette Zaidel.
Application Number | 20070071695 11/236082 |
Document ID | / |
Family ID | 37596211 |
Filed Date | 2007-03-29 |
United States Patent
Application |
20070071695 |
Kind Code |
A1 |
Chopra; Suman K. ; et
al. |
March 29, 2007 |
Single phase whitening dentifrice
Abstract
The invention provides a single phase whitening dentifrice that
includes (i) a whitening agent selected from the group consisting
of hydrogen peroxide, a bound peroxide and a solid peroxide (ii) an
abrasive and (iii) a substantially anhydrous orally acceptable
carrier, for example, polyethylene glycol. The bound peroxide may
be hydrogen peroxide and a polymer and/or any peroxide compound and
a porous cross-linked polymer, such as polymers of polyvinyl
pyrrolidone, polyacrylates, a polymethacrylates, and a
polyitaconates. The solid peroxide may be sodium perborate or urea
peroxide. The invention also provides methods of whitening the
tooth surfaces by contacting the surface with the composition.
Inventors: |
Chopra; Suman K.; (Dayton,
NJ) ; Zaidel; Lynette; (Cranford, NJ) ;
Prencipe; Michael; (West Windsor, NJ) |
Correspondence
Address: |
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY
NJ
08855
US
|
Assignee: |
Colgate-Palmolive Company
|
Family ID: |
37596211 |
Appl. No.: |
11/236082 |
Filed: |
September 27, 2005 |
Current U.S.
Class: |
424/53 |
Current CPC
Class: |
A61K 8/25 20130101; A61K
8/737 20130101; A61K 8/463 20130101; A61K 8/88 20130101; A61K 8/22
20130101; A61Q 11/00 20130101; A61K 8/8152 20130101; A61K 8/8176
20130101; A61K 8/20 20130101; A61K 8/89 20130101; A61K 8/86
20130101 |
Class at
Publication: |
424/053 |
International
Class: |
A61K 8/42 20060101
A61K008/42; A61K 8/22 20060101 A61K008/22 |
Claims
1. A single phase whitening dentifrice comprising: a whitening
agent selected from the group consisting of hydrogen peroxide, a
bound peroxide and a solid peroxide; an abrasive; and a
substantially anhydrous orally acceptable carrier.
2. The composition according to claim 1, wherein the whitening
agent is not sodium percarbonate.
3. The composition according to claim 1, wherein the bound peroxide
comprises hydrogen peroxide and a polymer.
4. The composition according to claim 1, wherein the bound peroxide
comprises a peroxide compound and a cross-linked polymer.
5. The composition according to claim 4, wherein the monomer is
selected from the group consisting of a polyvinyl pyrrolidone,
polyacrylate, a polymethacrylate, and polyitaconates.
6. The composition according to claim 1, wherein the solid peroxide
is selected from the group consisting of sodium perborate and urea
peroxide.
7. The composition according to claim 1, comprising about 0.1% to
about 30% of the whitening agent.
8. The composition according to claim 1, wherein the water content
of the composition is less than about 10%.
9. The composition according to claim 1, wherein the substantially
anhydrous carrier comprises polymers and copolymers of polyethylene
glycol, of ethylene oxide and of propylene oxide.
10. The composition according to claim 1, wherein the substantially
anhydrous carrier further comprises a surfactant, a silicone fluid,
a fumed silica, a high molecular weight PEG, a carbomer, a gum and
a synthetic gum.
11. The composition according to claim 1, further comprising a
surfactant.
12. The composition according to claim 11, wherein the surfactant
is anionic.
13. The composition according to claim 11, wherein the surfactant
is sodium lauryl sulfate.
14. The composition according to claim 1, further comprising a
fluoride salt.
15. The composition according to claim 16, further comprising a
peroxide incompatible silica abrasive.
16. The composition according to claim 16, further comprising a
surfactant.
16. A single phase whitening oral care composition, comprising: a.
a substantially anhydrous agent selected from the a N-vinyl
heterocyclic polymer cross-linked with hydrogen peroxide, a
cross-linked polymer comprising a peroxide, and a solid peroxide;
b. an anticalculus agent; and c. a substantially anhydrous
carrier.
17. The composition according to claim 16, additionally comprising
a fluoride salt.
18. The composition according to claim 16, further comprising an
active agent selected from an antimicrobial agent, an
anti-inflammatory agent, a zinc salt, a stannous salt, and
triclosan.
19. The composition according to claim 16, wherein the abrasive is
selected from calcium pyrophosphate and dicalcium phosphate.
20. A method of whitening a tooth surface, the method comprising
contacting the tooth surface with a single phase whitening
dentifrice comprising a whitening agent selected from the group
consisting of a bound peroxide and a solid peroxide; an abrasive;
and a substantially anhydrous orally acceptable carrier.
Description
BACKGROUND OF THE INVENTION
[0001] Many individuals desire a "bright" smile and white teeth,
and consider dull and stained teeth cosmetically unattractive.
Unfortunately, without preventive or remedial measures, stained
teeth are almost inevitable due to the absorbent nature of dental
material. Everyday activities such as smoking or other oral use of
tobacco products, and eating, chewing or drinking certain foods and
beverages (in particular coffee, tea and red wine), cause
undesirable staining of surfaces of teeth. Staining can also result
from microbial activity, including that associated with dental
plaque. The chromogens or color causing substances in these
materials become part of the pellicle layer and can permeate the
enamel layer. Even with regular brushing and flossing, years of
chromogen accumulation can impart noticeable tooth
discoloration.
[0002] There are a variety of compositions described in the art for
preventing or treating the discoloration of teeth. In particular,
to combat staining and brighten or restore the natural enamel
color, a variety of products containing bleaching materials are
commercially available for professional and consumer use. The
materials most commonly used in teeth whitening today are
peroxides. Peroxides are generally deemed safe from a physiological
standpoint, and can be effective to whiten teeth.
[0003] Professional dental treatments frequently include a tooth
surface preparation such as acid etching followed by the
application of highly concentrated bleaching solutions (e.g., up to
37% hydrogen peroxide) and/or the application of heat or light.
These procedures provide rapid results, but are expensive, and
often require several trips to the dentist. Alternatively, at-home
bleaching systems can be used. These systems have gained
significant popularity in the past decade because of reduced cost,
and increased convenience. Instead of time consuming and frequent
trips to the dentist, the tooth whitener is purchased at a consumer
retail store and may be easily integrated into the daily hygiene
program. At-home treatment methods include whitening strips,
abrasive toothpastes, and toothpastes that contain peroxides. These
peroxide toothpastes require the use of a dual chamber system that
separates the peroxide from other ingredients. If the contents of
the two chambers are mixed prematurely, the oxidation activity and
whitening benefits are lost.
[0004] It would be desirable to provide a whitening oral care
composition which promotes consumer compliance and utilizes a
single chamber or tube to deliver sufficient amounts of whitening
ingredients and other oral care actives without adverse reaction
between the ingredients.
BRIEF SUMMARY OF THE INVENTION
[0005] The invention provides a single phase whitening dentifrice
that includes (i) a whitening agent selected from the group
consisting of hydrogen peroxide, a bound peroxide and a solid
peroxide (ii) an abrasive and (iii) a substantially anhydrous
orally acceptable carrier, for example, polyethylene glycol. The
bound peroxide may be hydrogen peroxide and a polymer and/or any
peroxide compound and a porous cross-linked polymer, such as
polymers of polyvinylpyrrolidone, polyacrylates, a
polymethacrylates, and a polyitaconates. The solid peroxide may be
sodium perborate or urea hydroxide.
[0006] The invention also provides methods of whitening the tooth
surfaces by contacting the surface with the composition.
DETAILED DESCRIPTION OF THE INVENTION
[0007] The present invention provides single phase whitening oral
care compositions, comprising a peroxide whitening agent; a
peroxide incompatible abrasive; and a substantially anhydrous
orally acceptable carrier. In various embodiments, the
substantially anhydrous orally acceptable carrier and the
particular peroxides employed allow for a shelf-stable single tube
oral care composition where the peroxide and the peroxide
incompatible ingredients, such as abrasives, may be combined. The
oral care composition provides highly efficacious whitening and
cleaning.
[0008] The single phase oral care composition has a "low water"
content, meaning that a total concentration of water, including any
free water and all water contained in any ingredients, is less than
about 4%, about 7% or les than about 10% water. The selection of
the whitening agent in conjunction with the low water carrier
provides stabilized delivery of the whitening agent. The whitening
activity is maintained for application to the tooth or oral surface
and is maintained through storage.
[0009] Any whitening agent known or developed in the art may be
used. Preferably, the whitening agent includes solid whitening
agents and bound whitening agents which are substantially anhydrous
oxygen generating compounds. Solid whitening agents useful herein
include peroxides, metal chlorites, persulfate. Exemplary peroxide
phases include hydroperoxides, hydrogen peroxide, peroxides of
alkali and alkaline earth metals, organic peroxy compounds, peroxy
acids, pharmaceutically-acceptable salts thereof, and mixtures
thereof. Peroxides of alkali and alkaline earth metals include
lithium peroxide, potassium peroxide, sodium peroxide, magnesium
peroxide, calcium peroxide, barium peroxide, and mixtures thereof.
Organic peroxy compounds include urea peroxide, glyceryl hydrogen
peroxide, alkyl hydrogen peroxides, dialkyl peroxides, alkyl peroxy
acids, peroxy esters, diacyl peroxides, benzoyl peroxide, and
monoperoxyphthalate, and mixtures thereof. Peroxy acids and their
salts include organic peroxy acids such as alkyl peroxy acids, and
monoperoxyphthalate and mixtures thereof, as well as inorganic
peroxy acid salts such as and perborate salts of alkali and
alkaline earth metals such as lithium, potassium, sodium,
magnesium, calcium and barium, and mixtures thereof. Preferred
solid peroxides are sodium perborate, urea peroxide, and mixtures
thereof. Suitable metal chlorites include calcium chlorite, barium
chlorite, magnesium chlorite, lithium chlorite, sodium chlorite,
and potassium chlorite. The whitening agent may be preferably
bound. For example, peroxide may be bound to a polymer such as PVP
(poly(N-vinylpyrrolidone). Suitable PVP complexes are disclosed,
for example, in U.S. Pat. No. 5,122,370, the contents of which are
incorporated herein by reference. In some embodiments, it may be
desirable to use any known whitening agent except sodium
percarbonate and/or any of the percarbonate salts.
[0010] The compositions of the present invention may include any
dental abrasive or combination of dental abrasive agents known or
to be developed in the art. "Abrasive" is as used herein is meant
to include materials commonly referred to as "polishing agents" as
well. Suitable abrasive may include those previously considered to
be incompatible in a peroxide containing formulation ("a
peroxide-incompatible abrasive"). Such abrasive is one which, in an
aqueous solution with hydrogen peroxide, substantially reacts with
the hydrogen peroxide so as to reduce whitening efficacy of the
solution.
[0011] Any orally acceptable abrasive can be used, but preferably,
type, fineness (particle size) and amount of abrasive should be
selected so that tooth enamel is not excessively abraded in normal
use of the composition. Suitable abrasives include without
limitation silica, for example in the form of silica gel, hydrated
silica or precipitated silica, alumina, insoluble phosphates,
calcium carbonate, resinous abrasives such as urea-formaldehyde
condensation products and the like. Among insoluble phosphates
useful as abrasives are orthophosphates, polymetaphosphates and
pyrophosphates. Illustrative examples are dicalcium orthophosphate
dihydrate, calcium pyrophosphate, .beta.-calcium pyrophosphate,
tricalcium phosphate, calcium polymetaphosphate and insoluble
sodium polymetaphosphate. Average particle size of an abrasive, if
present, is generally about 0.1 to about 30 .mu.m, for example
about 1 to about 20 .mu.m or about 5 to about 15 .mu.m. One or more
abrasives are present in an abrasive effective total amount,
typically about 0.1% to about 40%.
[0012] In various embodiments of the present invention, the oral
composition comprises an anticalculus agent. Generally, tartar
control agents are categorized as being incompatible with some
whitening agents, but embodiments of the present invention
incorporate tartar control agents and whitening agents in a single
phase whitening composition. Suitable anticalculus agents include
without limitation phosphates and polyphosphates (for example
pyrophosphates), polyaminopropanesulfonic acid (AMPS),
hexametaphosphate salts, zinc citrate trihydrate, polypeptides,
polyolefin sulfonates, polyolefin phosphates, diphosphonates. The
anticalculus agent is present at about 0.1% to about 30%. The oral
composition may include a mixture of different anticalculus agents.
In one preferred embodiment, tetrasodium pyrophosphate (TSPP) and
sodium tripolyphosphate (STPP) are used. The anticalculus agent
comprises TSPP at about 1% and STPP at about 7% to about 10%.
[0013] The oral care composition can optionally include at least
one orally acceptable source of fluoride ions. Any known or to be
developed in the art may be used. Suitable sources of fluoride ions
include fluoride, monofluorophosphate and fluorosilicate salts. One
or more fluoride ion-releasing compound is optionally present in an
amount providing a total of about 100 to about 20,000 ppm, about
200 to about 5,000 ppm, or about 500 to about 2,500 ppm, fluoride
ions.
[0014] The carrier is preferably low water content orally
acceptable carrier and may include any known ingredients or
additives.
[0015] In preferred embodiments of this invention, the oral
composition is a dentifrice. Such dentifrices may include
toothpowder, a dental tablet, toothpaste (dental cream), tooth
powders, or gel, or any other known form known to one of skill in
the art.
[0016] The substantially anhydrous carrier may also comprise
various dentifrice ingredients to adjust the rheology and feel of
the composition such as humectants, surface active agents,
thickening or gelling agents, etc.
[0017] The compositions of the present invention preferably
comprise a surface active agent. Suitable 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, sodium lauryl sulfate, sodium cocoyl
monoglyceride sulfonate, sodium lauryl sarcosinate, sodium lauryl
isoethionate, sodium laureth carboxylate and sodium dodecyl
benzenesulfonate, and cocoamidopropyl betaine.
[0018] The compositions of the present invention optionally
comprise a thickener. 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), high molecular
weight polyethylene glycols (such as CARBOWAX.RTM., available from
The Dow Chemical Company), 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,
and colloidal and/or fumed silica and mixtures of the same. One or
more thickening agents are optionally present in a total amount of
about 0.1% to about 90%, for example about 1% to about 50% or about
5% to about 35%.
[0019] In various preferred embodiments, the carrier may comprise
polymers and/or copolymers of polyethylene glycol, of ethylene
oxide propylene oxide, and of silicone. IF such copolymers/polymers
are used, they may be selected from the commercially available
materials PLURAFLO.RTM. L4370 and PLURAFLO.RTM. L1220 (available
from BASF, Wyandotte, Mich., United States of America). It is
preferred that the carrier(s) provide a dentifrice with a viscosity
of about 10,000 CPS to about 700,000 CPS, preferably about 30,000
CPS to about 300,000 CPS.
[0020] As recognized by one of skill in the art, the oral
compositions of the present invention optionally include other
materials, such as for example, anti-caries agents, desensitizing
agents, viscosity modifiers, diluents, surface active agents, such
as surfactants, emulsifiers, and foam modulators, pH modifying
agents, abrasives, in addition to those listed above, humectants,
mouth feel agents, sweetening agents, flavor agents, colorants,
preservatives, and combinations thereof. It is understood that
while general attributes of each of the above categories of
materials may differ, there may be some common attributes and any
given material may serve multiple purposes within two or more of
such categories of materials. Preferably, the carrier is selected
for compatibility with other ingredients of the composition.
[0021] Flavorants, sweeteners, colorants, foam modulators,
mouth-feel agents and others additively may be included if desired,
in the composition.
[0022] The compositions of the present invention optionally
comprise one or more further active material(s), which is operable
for the prevention or treatment of a condition or disorder of hard
or soft tissue of the oral cavity, the prevention or treatment of a
physiological disorder or condition, or to provide a cosmetic
benefit.
[0023] The compositions may include a stannous ion or a stannous
ion source. Suitable stannous ion sources include without
limitation stannous fluoride, other stannous halides such as
stannous chloride dihydrate, stannous pyrophosphate, organic
stannous carboxylate salts such as stannous formate, acetate,
gluconate, lactate, tartrate, oxalate, malonate and citrate,
stannous ethylene glyoxide and the like. One or more stannous ion
sources are optionally and illustratively present in a total amount
of about 0.01% to about 10%, for example about 0.1% to about 7% or
about 1% to about 5%.
[0024] The compositions of the present invention optionally
comprise an antimicrobial (e.g., antibacterial) agent. A further
illustrative list of useful antibacterial agents is provided in
such as those listed in U.S. Pat. No. 5,776,435 to Gaffar et al.,
the contents of which are incorporated herein by reference. One or
more antimicrobial agents are optionally present in an
antimicrobial effective total amount, typically about 0.05% to
about 10%, for example about 0.1% to about 3%.
[0025] The compositions of the present invention optionally
comprise 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.
[0026] The compositions of the present invention optionally
comprise a sialagogue or saliva-stimulating agent, an antiplaque
agent, an anti-inflammatory agent, a desensitizing.
[0027] Methods are provided to whiten an oral surface in a human or
animal subject comprising storing in stable form a whitening oral
care composition comprising a peroxide whitening agent, a peroxide
incompatible abrasive, and a substantially anhydrous and a
substantially anhydrous orally acceptable carrier; and contacting
said composition with the oral surface. As used herein "animal
subject" includes higher order non-human mammals such as canines,
felines, and horses. The oral care composition is contacted with an
oral surface of the mammalian subject to thereby whiten teeth in a
highly efficacious manner, without any negative interaction between
the whitening agent, the peroxide incompatible abrasive, and other
ingredients.
[0028] In various embodiments, it is preferred that the oral care
composition is applied and contacted with the oral surface. The
dentifrice, prepared in accordance with the present invention is
preferably applied regularly to an oral surface, preferably on a
daily basis, at least one time daily for multiple days, but
alternately every second or third day. Preferably the oral
composition is applied to the oral surfaces from 1 to 3 times
daily, for at least 2 weeks up to 8 weeks, from four months to
three years, or more up to lifetime.
[0029] The invention is illustrated in the following non-limiting
examples.
EXAMPLES
Comparative Example I
[0030] A comparative, non-abrasive containing single phase
dentifrice is prepared by mixing the ingredients of Table 1. After
aging the dentifrice for two weeks at approximately 49.degree. C.,
the peroxide recovery was 89% of the initially present amount.
TABLE-US-00001 TABLE 1 Ingredients Weight Percentage Cross-linked
polyvinyl pyrrolidone - 16.50 hydrogen peroxide complex
Polyethylene Glycol/Ethylene Oxide Block 42.44 Copolymer (PLURAFLO
.RTM. L4370) Ethylene Oxide/Propylene Oxide Block 25.00 Copolymer
(PLURAFLO .RTM. L1220) Silicone fluid 5.00 Saccharin 0.42 Flavor
1.20 Tetrasodium pyrophosphate 1.00 Sodium tripolyphosphate 7.00
Sodium fluoride 0.24 Sodium lauryl sulfate 1.20 TOTAL 100.00
Example 1
[0031] A single phase dentifrice was prepared by mixing the
ingredients of Table 2. A peroxide incompatible silica abrasive is
included at 12.44% and increases the cleaning and whitening
benefits of the dentifrice. After aging the dentifrice for two
weeks at approximately 49.degree. C., the peroxide recovery was 77%
of the initially present amount. TABLE-US-00002 TABLE 2 Ingredients
Weight Percentage Cross-linked polyvinyl pyrrolidone - 16.50
hydrogen peroxide complex Polyethylene Glycol/Ethylene Oxide Block
30.00 Copolymer (PLURAFLO .RTM. L4370) Ethylene Oxide/Propylene
Oxide Block 25.00 Copolymer (PLURAFLO .RTM. L1220) Silicone fluid
5.00 Saccharin 0.42 Flavor 1.20 Tetrasodium pyrophosphate 1.00
Sodium tripolyphosphate 7.00 Sodium fluoride 0.24 Silica abrasive
12.44 Sodium lauryl sulfate 1.20 TOTAL 100.00
[0032] The examples and other embodiments described herein are
exemplary and not intended to be limiting in describing the full
scope of compositions and methods of this invention. Equivalent
changes, modifications and variations of specific embodiments,
materials, compositions and methods may be made within the scope of
the present invention, with substantially similar results.
* * * * *