U.S. patent application number 11/355500 was filed with the patent office on 2006-09-07 for multi-component oral care compositions.
Invention is credited to Martin S. Giniger.
Application Number | 20060198795 11/355500 |
Document ID | / |
Family ID | 36944314 |
Filed Date | 2006-09-07 |
United States Patent
Application |
20060198795 |
Kind Code |
A1 |
Giniger; Martin S. |
September 7, 2006 |
Multi-component oral care compositions
Abstract
A multi-component oral care composition including two or more
of: a preliminary component, an oral care component; and a
finishing component. Two, three, four and more component
compositions are formed hereby. Tooth whitening or cleaning is one
use hereof.
Inventors: |
Giniger; Martin S.; (New
York, NY) |
Correspondence
Address: |
HENSLEY KIM & EDGINGTON, LLC
1660 LINCOLN STREET, SUITE 3050
DENVER
CO
80264
US
|
Family ID: |
36944314 |
Appl. No.: |
11/355500 |
Filed: |
February 15, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60653421 |
Feb 15, 2005 |
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60734549 |
Nov 7, 2005 |
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60734477 |
Nov 7, 2005 |
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Current U.S.
Class: |
424/53 |
Current CPC
Class: |
A61K 8/922 20130101;
A61K 8/38 20130101; A61K 2800/88 20130101; A61K 8/365 20130101;
A61K 8/90 20130101; A61Q 11/00 20130101; A61K 8/463 20130101; A61K
8/22 20130101; A61K 2800/872 20130101; A61K 8/73 20130101; A61K
8/19 20130101; A61Q 11/02 20130101; A61K 8/925 20130101; A61K 8/03
20130101 |
Class at
Publication: |
424/053 |
International
Class: |
A61K 8/20 20060101
A61K008/20 |
Claims
1. A multi-component oral care composition comprising two or more
of: a preliminary component, an oral care component; and a
finishing component.
2. A multi-component oral care composition according to claim 1
wherein the oral care component is one or both of a whitener and a
cleaner.
3. A multi-component oral care composition according to claim 1
wherein the oral care component includes a two-component
composition.
4. A multi-component oral care composition according to claim 3
wherein the two-component composition includes a first component
including at least one acid compound; and a second component
including an alkaline source.
5. A multi-component oral care composition according to claim 3
wherein the multi-component oral care composition is a
four-component composition.
6. A multi-component oral care composition according to claim 3
wherein the two-component composition includes one or both of a
whitener and a cleaner.
7. A multi-component oral care composition according to claim 6
wherein the whitener includes one or more of a peroxide, a
peracetic acid and a salt of chlorous acid.
8. A multi-component oral care composition according to claim 6
wherein the cleaner includes one or more of a cleaning solvent, a
non-ionic surfactant and an anionic surfactant.
9. A multi-component oral care composition according to claim 8
wherein the cleaning solvent includes one or more of a de-ionized
water and an ethanol; and the non-ionic surfactant includes a
poloxamer and the anionic surfactant includes sodium laurel
sulfate.
10. A multi-component oral care composition according to claim 1
wherein the preliminary component is an alkaline component.
11. A multi-component oral care composition according to claim 10
wherein the preliminary component includes potassium hydroxide.
12. A multi-component oral care composition according to claim 1
wherein the finishing component is an acidic component.
13. A multi-component oral care composition according to claim 12
wherein the finishing component includes one or both of citric acid
and tartaric acid.
14. A multi-component oral care composition according to claim 12
wherein the finishing component is one or both of disposed in a
carrier solvent or disposed in a wax.
15. A multi-component oral care composition according to claim 1
wherein the oral care component is adapted to be used with one or
both of the preliminary component and the finishing component.
16. A multi-component oral care composition according to claim 1
wherein the preliminary component is adapted to be used with one or
both of the oral care component and the finishing component.
17. A multi-component oral care composition according to claim 1
wherein the finishing component is adapted to be used with one or
both of the preliminary component and the oral care component.
18. The multi-component composition of claim 1 further comprising
within at least one of the preliminary component, the oral care
component; and the finishing component, at least one of the
following ingredients: an antibacterial agent, ethanol, menthol,
eucalyptol, thiamine, methyl salicylate, cetylpyridium chloride,
calcium nitrate, fluoride, zinc chloride, potassium nitrate, aloe,
carnauba wax, sanguinaria extract, papain, sodium laurel sulfate, a
coloring agent, sodium saccharin, sodium citrate, carbamide
peroxide, calcium peroxide, glyceryl peroxide, benzoyl peroxide,
peppermint oil, cinnamon oil, an acid compound, a stain removing
agent, a gelling agent, and a flavoring agent.
19. A method for using a multi-component composition according to
claim 1 comprising: applying a first one of the preliminary
component, the oral care component; and the finishing component to
a user's dentition; and applying a second one of the preliminary
component, the oral care component; and the finishing component to
the user's dentition either simultaneously with the first one of
the preliminary component, the oral care component; and the
finishing component or within a period thereafter.
20. A method according to claim 19 further comprising: applying a
third one of the preliminary component, the oral care component;
and the finishing component to the user's dentition either
simultaneously with one or both of the first one of and the second
one of the preliminary component, the oral care component; and the
finishing component or within a period thereafter.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present invention claims the benefit of and priority
from the prior-filed U.S. Provisional Patent Applications, No.
60/653,421; filed Feb. 15, 2005, entitled "Whitening System Capable
of Delivering Effective Whitening Action"; and No. 60/734,549;
filed Nov. 7, 2005, entitled "Oral Care Compositions and Methods";
and No. 60/734,477 filed Nov. 7, 2005, entitled "Compositions for
Enhancing the Effects of Other Oral Care Compositions"; the subject
matter of each of which hereby being specifically incorporated
herein by reference for all that they disclose and teach.
BACKGROUND
[0002] The present invention relates to improvements in oral care
compositions, and more particularly relates to multi-component
compositions for enhancing the effects of tooth whitening and or
cleaning.
[0003] In the state of the art of oral care compositions and the
delivery of such compositions to the site of use in the oral
cavity, many means and methods have been utilized and yet numerous
issues remain. For an effective ingredient of an oral care
composition to have a therapeutic or other desirable effect,
whether for oral cleaning, treatment, or tooth whitening, the
effective ingredient must reach and maintain effective contact with
the oral care feature long enough to provide its intended effect.
Thus, dispersion and penetration into and between the surfaces of
various oral features such as the odd shapes of the nooks and
crannies of adjacent teeth is a continual issue. So too then is the
dwell or contact time necessary or at least preferred for having
the effective ingredient or ingredients of an oral care composition
maintained in contact with or otherwise disposed adjacent the
surface of the oral feature being cared for. Such issues arise in
various oral cleaning, treatment and/or tooth whitening
situations.
[0004] In tooth cleaning and/or treatment, effective ingredients
such as fluoride or an anti-gingival agent, e.g., triclosan, must
reach the areas between teeth or between a tooth and gums and/or
reach the nooks and crannies on/of teeth to provide their benefits
to those oral features. Similar activities are necessary in tooth
whitening as well.
[0005] Many different oral compositions for stain removal or tooth
whitening are available to consumers and dentists for home and
professional in-office use. Among the chemical strategies available
for removing or bleaching tooth stains, the most effective
compositions typically contain an oxidizing agent, usually a
peroxygen compound such as hydrogen peroxide, in order to attack
the chromogen molecules forming the stains in such a way as to
render them colorless, water-soluble, or both. These compositions
all require different amounts of time to achieve a desired tooth
bleaching effect. These times typically range from 90 to 120
minutes for a dentist-applied system to two weeks or more for
consumer-applied products. The slow rate of bleaching is in large
part due to the nature of the formulations developed to maintain
stability of the oxidizing composition.
[0006] Oral compositions for whitening teeth are also available
containing peracetic acid or a salt of chlorous acid dissolved or
suspended in a vehicle. Peracetic acid may be generated within a
dentifrice vehicle by combining water, acetylsalicylic acid, and a
water soluble alkali metal percarbonate. Formulations for oxygen
liberating compositions for the whitening of teeth also use either
anhydrous and/or hydrated pastes or gels such as a carbomer or
Pluronic thickened oral gel composition. Other examples of
whitening or stain removal compounds include toothpastes containing
a combination of calcium peroxide and sodium perborate oxidizing
agents, dicalcium phosphate, calcium carbonate and magnesium
carbonate cleaning agents, sorbitol humectant, cornstarch and
cellulose gum thickening agents, and an anionic detergent. Oral
compositions containing peroxyacids and alkyl diperoxy acids having
alkylene groups containing 5-11 carbon atoms are also used for
removing stains from teeth.
[0007] Another conventional whitening technique is the
administration of a light-activated gel under the supervision of a
dentist. However, patients frequently become uncomfortable,
agitated, and/or bored during many of such procedures, which
typically lasts between 11/2 to 2 hours when all set-up and
precautionary methods are included. Also, because of the length of
exposure to any or all of the gel, the light, and the acidic or
alkaline environments, teeth and oral tissues can become irritated
or experience a transient hypersensitivity reaction. Thus, any
improvement that results in decreased exposure time, increased
patient comfort and increase in bleaching efficiency is
desirable.
SUMMARY
[0008] Whitening and/or cleaning procedure(s) and/or
composition(s), particularly involving multiple components or parts
are described here. In many embodiments, an activation or enhancing
composition may be used initially to create an alkaline environment
for activating/enhancing peroxide or other oxidation whiteners or
alkaline cleaners. The alkaline environment for oxidizing whiteners
may accelerate the formation of free radicals from the peroxide or
like oxidizer to effect the oxidation of organic molecules causing
staining of the dentition. Application of a whitening or cleaning
composition to the dentition would follow as a further component or
step. Then, a finishing or post-enhancing composition could be
applied. A two or three (or four or more) step process and/or set
of components may thus be used. Any combination or sub-combination
hereof would also be included, e.g., use of a whitener/cleaner with
or without the preliminary enhancer and/or with or without the
finishing or post enhancing composition may be included. Moreover,
preliminary enhancing composition may in some instances be used
alone, or solely with a finishing composition. In some instances,
the finishing composition may be used alone as well. In these
latter examples, the preliminary and/or finishing compositions may
have effectiveness otherwise than necessarily in conjunction with a
discrete whitener or cleaner.
[0009] The primary components of a preliminary enhancing
composition hereof are a solvent and a base compound. An exemplary
solvent is water. One exemplary base that may be used is potassium
hydroxide (KOH); or other basic compounds may alternatively be used
to create the alkalinity of the preliminary composition. A
finishing composition may include an acid and/or a wax with an
optional additional element of a vegetable gelling agent, inter
alia. The whitening and/or cleaning composition may be an oxidizing
agent or other whitening agent. This may also and/or alternatively
be in a single component or may be in two or more discrete
components such as is described in co-pending application Ser. No.
______, filed Feb. 15, 2006, entitled, "Foaming Compositions and
Methods," attorney docket number 281-002-USP, which is incorporated
herein by this reference for all that it teaches or discloses. For
example, a two-component foaming oral care compositions may be
used, such a two-component foamable composition having a first
component including at least one acid compound; and a second
component including an alkaline source such as a carbonate. A
peroxide or other oxidizer or cleaning agent may be added to the
acid component to provide a tooth whitening composition. Solvent
and surfactant cleaning agents may also be used, as for example may
be included in the base component. Four components would then be
used: a preliminary enhancer, a two-component whitener/cleaner and
a finishing composition.
[0010] Thus, in use in a primary implementation, a preliminary
enhancing composition may be used as part of a tooth whitening
process to enhance the effect of a whitening composition. The
preliminary enhancing composition would generally be applied to a
user's dentition as a pre-treatment in advance of a whitening or
bleaching or cleaning composition, whether of one or more component
parts. In addition, a finishing composition may be used after the
application of the whitening or cleaning composition to neutralize
the alkaline environment in the oral cavity caused by the
preliminary or main oral care composition and return the user's
mouth to a neutral pH.
DETAILED DESCRIPTION
[0011] The detailed description set forth herein is intended as a
description of several exemplary compositions for whitening or
cleaning biological tissue such as a tooth or teeth, hereafter
dentition. The implementations hereof may also include enhancing
the effectiveness of tooth whitening and/or other oral care
compounds according to the present invention and these are not
intended to represent the only forms in which such compositions may
be prepared or utilized. The description sets forth features of and
steps for preparing and using the compositions or processes of the
present invention. It is to be understood, however, that the same
or equivalent ingredients incorporated in different embodiments of
compositions or processes may accomplish the same finctions or
achieve the same results and such compositions are also intended to
be encompassed within the spirit and scope of this description.
[0012] Many oral care compositions, for example, tooth whitening
compositions include at least one peroxide compound to create a
tooth whitening composition. The peroxide may be hydrogen peroxide
(H.sub.2O.sub.2) or it may be one or more of other peroxides, for
example, metal-ion-free peroxide compounds including urea peroxide
(carbamide peroxide), salts of peroxides formed from the alkali and
alkaline earth metals (e.g., calcium peroxide), glyceryl peroxide,
benzoyl peroxide, and other organic peroxides. The peroxide may be
a mixture of peroxides, for example, hydrogen peroxide and
carbamide peroxide, or calcium peroxide with either or both
hydrogen peroxide and carbamide peroxide.
[0013] Organic molecules, for example, chromogens, are often
involved in the stains in discolored teeth. Carbon double bonds in
organic molecules act as pigments. Chemically, peroxides give up a
free radical oxygen atom when activated by an appropriate light
source or chemical compound. Once released in the vicinity of
teeth, the free radical oxygen atom attacks the carbon-carbon
bonding structure of the organic molecule producing the stain. The
offending molecule is oxidized and the oxygen is reduced. When
there is an excess of hydroxy anion (OH.sup.-) present, the proton
(H.sup.+) ion is abstracted from the peroxide. Once the peroxide is
missing the proton that it gave to the hydroxy ion, the peroxide
molecule must give up a free radical oxygen. Thus, the reaction
allowing release of stain-removing oxygen can be driven
chemically.
[0014] The amount of whitening obtained during tooth bleaching with
peroxide compositions is generally dependent upon: (1) the length
of time the teeth are in contact with the whitening agent; (2) the
number and/or length of periods (e.g., hours and/or days) the
treatment is carried out; (3) the susceptibility of the teeth to
the bleaching agent; and (4) the concentration of active peroxide.
For maximum whitening, a long treatment time with a highly
concentrated bleaching composition has generally been
recommended.
[0015] Chemical reactions are often affected by the relative
acidity or alkalinity of the solution or environment in which the
reaction occurs. Acidity and alkalinity are measured in terms of
the relative presence or absence of hydrogen ions (H.sup.+), which
was originally termed the "power of Hydrogen" or "pH." The measure
of pH is indicated as a number on a logarithmic scale, wherein a
value of 7 represents neutrality, lower numbers indicate increasing
acidity, and higher numbers indicate increasing alkalinity. Each
unit of change on the pH scale is the negative logarithm of the
effective hydrogen ion concentration or hydrogen ion activity in
gram equivalents per liter of the solution and thus represents a
tenfold change in acidity or alkalinity.
[0016] The liberation of free radical oxygen from a peroxide to
effect stain removal can be performed by increasing the energy
level of the peroxide molecule by adding energy to it or by
chemically pushing the peroxide solution to a basic pH number.
However, hydrogen peroxide in most tooth whitening compounds is
generally carried in a slightly acidic solution in order to
stabilize the peroxide before application. Thus, the normal
application of a standard hydrogen peroxide whitening compound does
not occur in a favorable reaction environment. Contrarily, an
effective, biologically compatible environment for bleaching with
hydrogen peroxide is at a slightly basic pH of between
approximately 8.5 and 9.5, with a pH of about 8.8 and/or to about
9.0 being optimal in some implementations. Biologic compatibility
refers to a pH level that, while providing a catalytic benefit to
the peroxide bleaching reaction, does not cause damage to oral
tissues surrounding the dentition.
[0017] The present invention is directed to one or more of a
variety of issues surrounding this acid stabilization of oxidizer
products and/or a preferred alkaline environment, whether for
alkaline cleaning or for activating or enhancing the oxidizers or
other whiteners to accelerate the formation of free radicals
therefrom to effect the oxidation of organic molecules causing
staining of the dentition. In one embodiment, a preliminary
composition of an alkaline nature may provided for preliminary
application to the dentition before the application of any
whitening or cleaning compound. In this or other embodiments, a
finishing composition of an acidic nature can be applied to the
dentition after the application of the whitening or cleaning
compound.
[0018] The primary components of a preliminary composition may be
water, which functions primarily as a carrier or solvent, and a
base compound. One exemplary base that may be used is potassium
hydroxide (KOH), though other basic compounds may alternatively be
used to create the alkalinity of the composition.
[0019] The primary component of a finishing composition may be an
acidic component. Such a component may be in a carrier solvent or
disposed in a wax base. Tartaric acid and/or citric acid are
exemplar acids herefor.
[0020] The whitening and/or cleaning component compositions may
flurther include a peroxide or a salt of chlorous acid as used in
the whitening compound, as for example but not limited to, hydrogen
peroxide. Other peroxygen containing or generating compounds may
also be used herewith. In many examples, for increasing peroxide
stability during storage, a 3% di-sodium EDTA may be added to the
composition. Alternatively, stability may be enhanced by
refrigeration or otherwise storing the product in a dark, cool, dry
place.
[0021] Cleaning solvents and/or surfactants, particularly those
which may be operative or have enhanced operability in an alkaline
environment may also be used. Exemplars hereof may be ethanol
and/or de-ionized water solvents which may be used with surfactants
such as sodium lauryl sulfate (SLS) and/or poloxamer 188 (Pluronic
F68) (or other poloxamers or the like) may be used. Other
surfactants are described below.
[0022] A two-component foaming oral care composition may be used,
such a two-component foamable composition having a first component
including at least one acid compound; and a second component
including an alkaline source such as a carbonate. A peroxide or
other oxidizer or cleaning agent may be added to the acid component
to provide a tooth whitening composition. Solvent and surfactant
cleaning agents may also be used, as for example may be included in
the alkaline component. Three or Four components could then be
used: two or more of the following components: a preliminary
enhancer component, a two-component whitener/cleaner component and
a fmishing component.
[0023] A surfactant may also be included to clean the surfaces of
the user's teeth in advance of, during, and/or after application of
the whitening/cleaner composition. A peroxide may be added to any
of the present compositions to provide tooth whitening. Other
additives for taste, texture, viscosity, and other oral care or
oral hygiene purposes may also be included in any of the present
compositions.
[0024] Compositions according to the present invention may further
include a surfactant. Suitable surfactants may be anionic,
nonionic, amphoteric, zwitterionic, cationic, and mixtures thereof.
Anionic surfactants include, but are not limited to water-soluble
salts of alkyl sulfates having from 8 to 20 carbon atoms in the
alkyl radical (e.g., sodium alkyl sulfate), water-soluble salts of
sulfonated monoglycerides of fatty acids having from 8 to 20 carbon
atoms, and mixtures thereof. Examples of anionic surfactants
include sodium lauryl sulfate, sodium coconut monoglyceride
sulfonates, phospholipids, sarcosinates such as sodium lauryl
sarcosinate, taurates, sodium lauryl sulfoacetate, sodium lauroyl
isethionate, sodium laureth carboxylate, and sodium dodecyl
benzenesulfonate. Many of these anionic surfactants are disclosed
in U.S. Pat. No. 3,959,458, which is hereby incorporated herein by
reference in its entirety.
[0025] Nonionic surfactants may include, but are not limited to,
compounds comprising hydrophilic (having an affinity for water) and
hydrophobic components (lacking an affinity for water). These
surfactants may be produced by the condensation of alkylene oxide
groups, which are hydrophilic in nature, with an organic
hydrophobic compound, which may be aliphatic or alkyl-aromatic in
nature. Examples of suitable nonionic surfactants include low
viscosity poloxamers, e.g., poloxamer 188 (under trade name
Pluronic), low viscosity hydroxyethyl cellulose, polysorbates,
polyoxyethylene sorbitan esters (under trade name Tweens), fatty
alcohol ethoxylates, polyethylene oxide condensates of alkyl
phenols, products derived from the condensation of ethylene oxide
with the reaction product of propylene oxide and ethylene diamine,
ethylene oxide condensates of aliphatic alcohols, long chain
tertiary amine oxides, long chain tertiary phosphine oxides, long
chain dialkyl sulfoxides, and mixtures thereof.
[0026] Amphoteric surfactants may include, but are not limited to,
derivatives of aliphatic secondary and tertiary amines in which the
aliphatic component may be a straight chain or branched. One of the
aliphatic substituents may contain from about 8 to about 18 carbon
atoms and one may contain an anionic water-solubilizing group,
e.g., carboxylate, sulfonate, sulfate, phosphate, phosphonate,
betaines (e.g., cocamidopropyl betaine), and mixtures thereof. Many
of these nonionic and amphoteric surfactants are disclosed in U.S.
Pat. No. 4,051,234, which is hereby incorporated herein by
reference in its entirety.
[0027] Any asymmetrical molecule dissolved in water will make at
least a weak surfactant. Such weak surfactants may not normally be
effective foaming agents, but the effectiveness can be improved if
an alternatively available foaming dispenser is used. Asymmetrical
molecules as contemplated herein may include those that contain a
hydrophilic and a hydrophobic segment. One end of the molecule is
thus polar in nature and dissolves in water, while the other end is
nonpolar in nature, avoids water, and dissolves in oil and other
nonpolar compounds. When in water, their polar ends of these
surfactant molecules are oriented toward the water molecules, while
the non-polar ends attract non-polar molecules. The non-polar ends
of the surfactant molecules lift stain molecules from the tooth
surface by loosening the molecules, breaking them up, and holding
them onto the asymmetric molecules, allowing them to be washed away
with the water.
[0028] Surfactants may also be included in the oral care
compositions hereof in solid form. Solid form surfactants may
include, for example, sodium carbonate anhydrous, sodium
bicarbonate, potassium iodide, and mixtures thereof. Exemplary
surfactants may also include at least some difunctional block
copolymer surfactants, e.g., those having terminal groups of
primary hydroxyl groups, and groups comprising a hydrophobic and a
hydrophilic segment. Examples include Pluronic F68, Pluronic F88,
and mixtures thereof. The amount of a surfactant used in an oral
care composition hereof may be in a range approximated by the
amount given below.
[0029] The compositions hereof may further include ingredients for
affecting the taste and feel of the composition by a user. For
example, flavor oils such as peppermint oil or cinnamon oil may be
included to provide a pleasing flavor to the composition. Sodium
saccharin, sucralose, aspartame,,or other sweetening agents may be
used to enhance the flavor. Sodium citrate may be added as an
anticoagulant to improve the feel of the compositions in the mouth.
It may also enhance the effectiveness of any surfactant by
preventing interference from any calcium ions present.
[0030] The composition of the present invention can also include
other active ingredients, such as peroxide photo-activators. The
addition of peroxide photo-activators can also increase the
photobleaching efficiency of the foamable compositions of the
present invention. Suitable peroxide photo-activators include those
with lower oxidative state transition metal salt. The metal salt
may catalyze the bleaching action of the peroxide to produce faster
effective bleaching at lower peroxide concentrations. The preferred
transition metals are those of lower atomic numbers including lower
atomic number transition metals such as those ranging from atomic
number 21 to 30. Also, those with lower oxidative states may be
more preferred, including, e.g., Iron(II), manganese(II),
cobalt(II), copper(II) and mixtures thereof, and most preferably
Iron(II), as in a ferrous gluconate. When used, only a very small
amount of the transition metal salt is needed, for example, from
about 0.01% by weight to about 4% by weight, further for example,
from about 0.03% by weight to about 2% by weight, and even further
for example, from about 0.04% to about 1% by weight. The peroxide
photo-activator can also include alkali salts such as potassium
iodide, potassium chloride, sodium iodine, sodium chloride and
combinations thereof.
[0031] Amorphous calcium compounds such as amorphous calcium
phosphate (ACP), amorphous calcium phosphate fluoride (ACPF) and
amorphous calcium carbonate phosphate (ACCP) amorphous calcium
carbonate phosphate (ACCP), and amorphous calcium carbonate
phosphate fluoride (ACCPF) can be used in re-mineralizing teeth.
These amorphous compounds are disclosed in U.S. pat. Nos.
5,037,639, 5,268,167, 5,437,857, 5,562,895, 6,000,341, and
6,056,930, the disclosure of each of which hereby being
incorporated by reference in its entirety.
[0032] In addition to or as an alternative to amorphous calcium
compounds, amorphous strontium compounds such as amorphous
strontium phosphate (ASP), amorphous strontium phosphate fluoride
(ASPF), amorphous strontium calcium phosphate (ASCP), amorphous
strontium calcium carbonate phosphate (ASCCP), amorphous strontium
carbonate phosphate fluoride (ASCPF) and amorphous strontium
calcium carbonate phosphate fluoride (ASCCPF) may be included for
use in re-mineralization, as noted above. Such compounds are
disclosed in U.S. Pat. No. 5,534,244, the content of which hereby
incorporated by reference in its entirety.
[0033] For example, the whitening compound may include a source of
phosphate and the second component may include a source of calcium
or strontium. For example, the source of phosphate in the first
component includes monosodium phosphate (NAH.sub.2PO.sub.4),
disodium phosphate, tetrapotassium pyrophosphate and relatives
thereof. As introduced above, the whitening component may include a
source of calcium or strontium, which combines with phosphate to
form the various amorphous calcium and/or strontium phosphates. The
source of phosphate may be, for example, present in an amount of
from about 0.2% to about 5% by weight. The source of calcium,
strontium, or combinations thereof may include a calcium salt, a
strontium salt, and thereof, further for example, a calcium salt
such as calcium nitrate, in an amount of from about 0.25% by weight
to about 1.5% by weight. The source of phosphate and the source of
calcium, strontium or mixture can combine to form calcium
phosphate. When applied to the teeth, the calcium phosphate can
precipitate onto the surface of the teeth where it may be
incorporated into hydroxyapatite, assisting in remineralization of
the tooth enamel, as discussed in U.S. pat. Nos. 5,037,639;
5,268,167; 5,460,803; 5,534,244; 5,562,895; 6,000,341; and
6,056,930 noted above.
[0034] In practice, it may in some embodiments be preferred to
include as much phosphate as possible, as the phosphate salt
further acts to adjust the pH of the first component. The pH of the
system is from, for example, about 5 to about 8, or for a further
example, from about 5.5 to about 6.5.
[0035] Note also, the fluoride-containing amorphous compounds
described here may also be used in fluoridating teeth. Otherwise,
as mentioned, fluorides may be added separately and then, many, if
not all of the above amorphous compounds or solutions which form
the amorphous compounds, when applied either onto or into dental
tissue, particularly in the presence of fluoride, may operate to
promote fluoridation. Such fluoridation or other mineralization may
serve to assist in prevention and/or repair of dental weaknesses
such as dental caries, exposed roots and dentin sensitivity.
[0036] The compositions of the present invention can also include
other active ingredients, such as de-sensitizing agents and/or
antimicrobial or antibacterial agents. Even with improved
efficiency and shorter treatment time, some patients may still
experience sensitivity from tooth whitening compositions. Inclusion
of desensitizing agents in the compositions hereof may allow time
for desensitization of the oral tissue before the application of
the whitening compound. Suitable desensitizing agents can include
Eugenol and/or alkali nitrates such as potassium nitrate, sodium
nitrate, and lithium nitrate and other potassium salts such as
potassium chloride and potassium bicarbonate. The desensitizing
agent may make up to about 3% to 5% percent by weight of the
composition. Eugenol may also act as an antimicrobial or
antibacterial agent.
[0037] Further additives may include calcium nitrate and/or sodium
mono and/or dibasic hydrate. These compounds may be added to lower
the viscosity of the composition and provide a composition that has
greater ability to penetrate recesses and interstices of the
dentition. Such additives may also improve the stability of the
compositions. Potassium nitrate may alternatively and/or
additionally be added to achieve desired viscosity effects.
[0038] In addition, optional additives including emulsifiers,
flavorings, coloring agents, anti-plaque agents, anti-staining
compounds, excipients such as emollients, preservatives, other
types of stabilizers such as antioxidants, chelating agents,
tonicity modifiers (e.g., sodium chloride, manitol, sorbitol, or
glucose), spreading agents, pH adjusting agents and water soluble
lubricants, e.g., propylene glycol, glycerol, or polyethylene
glycol may be included in any of the compositions. The
concentration of each may easily be determined by a person skilled
in the art. Lecithin, a natural emulsifier found in soy and other
plants, and gum arabic, which comes from the sap of certain species
of acacia trees, can be added for use as an emulsifier, dispersant,
and/or wetting agent. Suitable preservatives may include
benzalkonium chloride, parabens, chlorhexidine acetate,
chlorhexidine gluconate, sorbic acid, potassium sorbitol,
chlorbutanol, and phenoxyethanol. Suitable emollients such as those
used for topical applications are, for example, di-n-octyl ether,
fatty alcohol polyalkylene glycol ether, 2-ethylhexyl palmitate,
and isopropyl fatty acid esters.
[0039] An exemplary formula for a preliminary composition according
to the present invention is presented here. Water may be used as
the primary carrier and solvent for the remaining ingredients.
Potassium hydroxide may be incorporated as the peroxide activator
and pH modifier. Other optional ingredients which may provide
certain flnctionalities may include tartaric acid to adjust the
final pH of the preliminary composition to a biologically
compatible level and hydrogen peroxide to initiate the whitening
process. Several non-active ingredients include Pluronic F68 as a
gelling agent, sodium laurel sulfate as a stain remover, sodium
saccharin as a sweetener, sodium citrate for improved oral
sensation, peppermint oil for flavor and scent, ethanol as an
antibacterial agent, and a color additive for visual interest.
[0040] These ingredients result in an exemplary preliminary
composition for pretreatment of dentition before application of a
tooth whitening composition. The increase in pH created by the
preliminary composition may enhance the effectiveness of the tooth
whitening compound.
[0041] Although certain steps for combining the ingredients
identified above may be indicated in the accompanying discussion
above, it should be recognized that additional or alternative
ingredients described above may also be included or substituted in
the preliminary composition. Further, the steps are merely
exemplary and other variations for mixing ingredients of the
compositions hereof are possible and contemplated.
[0042] For the finishing composition, it may be acidic and/or may
provide a tooth glossing and/or acidic finishing effect. For
stand-alone tooth glossing (i.e., without pH neutralizing), a
principal ingredient is a wax with an optional vegetable gel
component. An acidic component may be used for a finishing
composition particularly in an alkaline tooth cleaning environment,
as for example used for solvent and surfactant cleaning with
alkaline components, or an alkaline environment which may be used
for activating peroxide whiteners and/or accelerating the formation
of free radicals from the peroxide to effect the oxidation of
organic molecules causing staining of the dentition. Such a
finishing composition hereof may thus be used for post application
to the dentition after the application of any alkaline cleaning or
whitening compositions.
[0043] The primary components of many finishing compositions hereof
may be in a liquid or a substantially solid form. If in liquid
form, the solvent may be water, or the like, with an emulsifier to
aid in obtaining a solution for the wax. If in substantially solid
form, a solvent may, though may more typically, may not be used, a
wax serving as the base. In many implementations, a wax such as
carnuba, candellila, beeswax or a microcrystalline wax or the like
may be used. Exemplary acids that may be used include citric acid
or tartaric acid to form an acidic composition. Other acidic
compounds may alternatively be used. Other additives for taste,
texture, viscosity, and other oral care or oral hygiene purposes
may also be included in the composition hereof.
[0044] For the two-component oral care composition alternatives,
these may provide a foaming action as described in co-pending
application Ser. No. ______, filed Feb. 15, 2006, entitled,
"FOAMING ORAL CARE COMPOSITIONS"; attorney docket number
281-002-USP, which is hereby incorporated herein by reference. As
used herein, foaming and more particularly effervescent foaming
refers to a growing foam, generally of substantially small, or
otherwise substantially consistently-sized, orally-acceptable
bubbles. An effervescent foaming composition hereof generally
includes compositions which evolve gas by means of a chemical
reaction between an acid and a base which takes place upon exposure
of the acid and the base to each other. Thus, the acid and base are
maintained separate (even if but merely in separate phases in a
common compartment) until use when the separate components are
brought into contact with each other to create a foaming oral care
composition.
[0045] In a some two-component oral care composition embodiments,
the compositions hereof may include two components; a first one of
which containing an acid, and the second one of which containing a
base, typically a carbonate. Either or both of these components may
then also include a surfactant. Such a two-component composition
may then provide an effervescent foam when the first and second
components are brought into contact with each other. Indeed, no
agitation or external gas need be added in many such embodiments. A
surfactant such as pluronic F68 may be used to control bubble size;
e.g., smaller bubbles. This may also provide for longer lasting
bubbles/foams. Such a composition, when formed into a foam can be
used to clean oral tissues or surfaces; in one example, such may
form a denture cleanser. In many embodiments, these first and
second components are liquids which enhance stability and reduce
viscosity.
[0046] The compositions hereof may be applied to a user's dentition
in any of a variety of ways. For example, if any of the
compositions has a low viscosity, that composition may be provided
in the form of liquid or a mouth rinse. At a higher viscosity, for
example, in the form of a gel or paste, the composition may be
applied with a brush or a swab. The composition may be in the form
of a tooth paste and applied with a standard tooth brush. The
composition may also be applied with a brush more closely
resembling a paint brush. If the composition is applied with a swab
(e.g., the composition is a gel), the swab may be formed of a foam
material rather than other materials. Foam is more structurally
sound and uniformly absorptive as compared to cotton swabs or other
materials. Foam also is resistant to breaking down and does not
permanently deform.
[0047] In addition to the preliminary composition, a finishing or
post-rinse composition may also be used as part of a complete tooth
whitening or cleaning process. The primary purpose of the
post-whitening rinse compound might be to return the pH within the
user's mouth after a bleaching application to neutral. An exemplary
bleaching composition is described in copending U.S. patent
application Ser. No. ______, filed Feb. 15, 2006, entitled "Foaming
Oral care compositions and methods," attorney docket number
281-002-USP, which is hereby incorporated herein by reference. Any
other commercially available bleaching or whitening composition may
likewise be used in conjunction with the preliminary and/or
finishing compositions hereof. An exemplary finishing composition
maybe slightly acidic, for example, about 5.5 pH, to reduce the pH
from the more basic level of between 8.5 and 9.5 created by the
preliminary or oral care composition to neutral pH of about 7.
[0048] An exemplary tooth whitening process including steps of
enhancing, whitening, and rinsing. First, an alkaline enhancing or
preliminary composition according to the description herein is
applied to a user's dentition. As indicated above, application of a
preliminary composition may be by rinse, swab, or brush. The
preliminary composition may then be left on the user's dentition
for a first period of time, e.g. about 0 seconds to about 5
minutes, or for a further example, particularly if the preliminary
composition is for over-the-counter consumer use, the application
period may be on the order of about a second up to approximately a
few minutes. Alternatively, if the preliminary composition is. of a
greater pH than a consumer composition and is applied by a dental
practitioner in a clinical setting, the application period may be
of an even shorter period of time.
[0049] Once the preliminary period expires, or at substantially the
same time as application thereof to the dentition, a whitening or
cleaning or other oral care composition may then be applied to the
user's dentition. Again, the whitener or bleaching or cleaning
agent may be any of a myriad of available products available
over-the-counter or for clinical application, e.g., gels and pastes
for brush-on or tray application and adhesive strips. This oral
care composition may then be left on the user's dentition for a
second period of time, which may be varied according to the
whitening product used. The second time period may be anywhere
between several minutes, several hours, or overnight. Finally, an
acidic finishing composition according to the description herein
may be applied to the user's dentition for a third period of time.
The finishing composition may then operate to neutralize the basic
pH environment created in the user's mouth by the preliminary
composition or the oral care composition to increase the
effectiveness of the whitening or other oral care composition. The
finishing composition may be applied over a period of about a
second or less or up to a few seconds up to approximately a few
minutes to ensure effective neutralization. Note, if the finishing
composition is wax-based or has wax and/or a vegetable gelling
agent as introduced above, this may then provide a desirable tooth
glossing effect to also enhance the effect of the whitening,
cleaning or other oral care composition.
[0050] It may first be noted that either of these agents, i.e., a
pre-whitening agent and/or a post-whitening agent, may be used,
manufactured and/or sold completely separately one from another,
and indeed may be distributed apart from the whitening or cleaning
composition(s). In some instances, a user may use only a
pre-whitening agent and then a whitening composition with or
without a post-whitening agent; and in other instances, a user may
use a whitening agent and a post-whitening agent without a
pre-whitening agent. Even so, it may be preferred to use all three
in order; namely, a pre-whitening agent, then, a whitening agent or
agents (see below), and finally a post-whitening agent as described
hereinabove. In such a case, the combination may be referred to as
a three-component system (pre-whitening, whitening, and
post-whitening). In some other instances, the whitening
composition/system itself may occur in one or two or more
components as described above, and the overall system may then
reflect the total number of components. For example, when the
whitening system itself includes two components, then, a system
hereof may be a four-component system; namely, a pre-whitening
component, whitening in two component parts, and a post-whitening
component. The method of use hereof would be as described above
with the modification of including the mixing of the two parts of
the whitening composition prior to or during application thereof to
the dental surfaces, after the initial pre-whitening enhancing
application and before the post-whitening enhancing
application.
[0051] The above specification, examples and data provide a
complete description of the structure, process, and use of
exemplary embodiments of the invention. Although various
embodiments of this invention have been described above with a
certain degree of particularity, or with reference to one or more
individual embodiments, those skilled in the art could make
numerous alterations to the disclosed embodiments without departing
from the spirit or scope of this invention. Other embodiments are
therefore contemplated. It is intended that all matter contained in
the above description shall be interpreted as illustrative only of
particular embodiments and not limiting. Changes in detail or
structure may be made without departing from the basic elements of
the invention as defined in the following claims.
* * * * *