Title:
Multi-component oral care compositions
Kind Code:
A1


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, US)
Application Number:
11/355500
Publication Date:
09/07/2006
Filing Date:
02/15/2006
Primary Class:
International Classes:
A61K8/20
View Patent Images:



Primary Examiner:
ROBERTS, LEZAH
Attorney, Agent or Firm:
MARTIN GINIGER (NEW YORK CITY, NY, US)
Claims:
What is claimed is:

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

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

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.

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.

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.

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.

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.

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 1½ 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

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.

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.

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

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.

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 (H2O2) 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.

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) present, the proton (H+) 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.

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.

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+), 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 (NAH2PO4), 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.