CA2170532A1 - Baking soda toothpaste and tooth gel containing soluble pyrophosphate salts - Google Patents
Baking soda toothpaste and tooth gel containing soluble pyrophosphate saltsInfo
- Publication number
- CA2170532A1 CA2170532A1 CA 2170532 CA2170532A CA2170532A1 CA 2170532 A1 CA2170532 A1 CA 2170532A1 CA 2170532 CA2170532 CA 2170532 CA 2170532 A CA2170532 A CA 2170532A CA 2170532 A1 CA2170532 A1 CA 2170532A1
- Authority
- CA
- Canada
- Prior art keywords
- amount
- pyrophosphate
- present
- effective amount
- toothpaste
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
- A61K8/24—Phosphorous; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/34—Alcohols
- A61K8/345—Alcohols containing more than one hydroxy group
Abstract
Toothpastes and tooth gels conatining sodium bicarbonate and an alkali metal pyrophosphate salt dissolved in an aqueous sorbitol solution inbibit the formation of tartar. The toothpastes and tooth gels contain conventional ingredients such as thickness anti-caries agents, flavoring agents, and/or sweetening agents.
Description
W095/064S~PCT~S94109469 ~1 7~32 BARING 80DA -~O~ n~A8TE AND TOOTR GEh The present invention relates to a dentifrice selected from the group consisting of a toothpaste and a tooth gel which contain baking soda and an alkali metal pyrophosphate salt.
5Calculus, or tartar as it is sometimes called, is the solid, hard mass of calcified material deposited on and adhering to the surfaces of the teeth. It is composed of inorganic salts which make the calculus hard and resistant to removal. Although not entirely understood, the general concept is that plaque, which is a sticky film of oral bacteria and their products, adheres to teeth and becomes calcified with the ultimate formation on the teeth of a hard mineral-like material consisting of calcium phosphates.
Calculus is largely calcium phosphates, mainly hydroxyapatite with varying, but small, amounts of other inorganic salts.
As the mature calculus develops, it becomes visibly white or yellowish in color unless stained or discolored by some extraneous agent. ln addition to being unsightly and undesirable from an aesthetic standpoint, the mature calculus deposits can be constant sources of irritation to the gingiva. Further, the calculus can promote and retain plaque accumulations. Plaque is recognized as a prime etiological agent involved in gingivitis and periodontal disease. Additionally, plaque is porous and can retain toxic bacterial end products which are also associated with periodontal disease.
Methods for chemically reducing or preventing calculus formation have been directed at affecting the process at any of several stages in its development. One approach is to develop agents which inhibit the formation of the crystalline calcium phosphate or hydroxyapatite.
W09S/064S5 PCT~S94/09469 21 70532 ~
A wide variety of chemical and biological agents have been suggested to retard calculus formation or to remove calculus after it is formed. The chemical approach to calculus inhibition generally involves crystal growth inhibition which prevents the calculus from forming.
Generally, once formed, mechAn;cal removal by the dentist is n~c~ss~ry and is a routine dental office procedure.
The most widely used tartar control agents in dentifr~ces are sodium and potassium salts of pyrophosphoric acid. It is important that the pyrophosphate salt be in a readily available form so that the pyrophosphate ions (P2O7-4) contact the enamel surfaces during use. The bioavailability of the ion is determined by the solubility of the salt both in the liquid vehicle of the dentifrice and in the water/expectorant mixture in which the dentifrice is dispersed during brushing of the teeth.
In a dentifrice cont~;n;ng sodium bicarbonate, i.e., baking soda, and the alkali metal salts of pyrophosphoric acîd, the solubility of the pyrophosphate salt within the liquid vehicle of the dentifrice is greatly reduced. This suppression of solubility is due to the excess of sodium ions placed in solution by the sodium bicarbonate.
Therefore, there is a need to improve the solubility of alkali metal pyrophosphate salts within a baking soda toothpaste or a baking soda tooth gel.
The present invention provides a dentifrice in the form of a toothpaste or tooth gel.
The toothpaste comprises sodium bicarbonate, typically about 8-65%, preferably about 20-55%, most preferably 40-50%; an effective amount of an alkali metal pyrophosphatesalt as an anti-tartar agent; and an aqueous solution of sorbitol in an amount sufficient to dissolve at least about 50~ of the pyrophosphate salt and to provide the desired consistency to the toothpaste, typically at least about 30-70~, preferably about 40-60%.
W095/06455 2 l 1~ 5 3 2 PCT~S9~ 169 The tooth gel comprises sodium bicarbonate, typically about 5-50%, preferably about 10-40%, most preferably about 20-35%; an effective amount of an alkali metal pyrophosphate salt as an anti-tartar agent; and an aqueous solution of sorbitol in an amount sufficient to dissolve at least about 50% of the pyrophosphate salt and to provide the desired consistency to the tooth gel, typically at least about 30-70%, preferably about 35-60%.
The pyrophosphate ion is more readily available because tetrasodium pyrophosphate is more soluble in the aqueous sorbitol solution used herein as the liquid vehicle than in the conventional aqueous liquid vehicles used in most toothpastes and tooth gels.
In a toothpaste and a tooth gel, water is typically a desirable component. However, in the present toothpastes ~and tooth gels, water is not especially desirable and any additional water (i.e., water over and above that in the sorbitol solution) comprises only up to about 30%, preferably only up to 7%, of the composition. The sorbitol solution is the main liquid vehicle. The water used to dissolve the sorbitol is that amount which is effective to solubilize it. Typically, the sorbitol solution is a 70%
aqueous solution.
In translucent gels, where the refractive index is an important consideration, it is preferred to use higher ratios of sorbitol or other humectant to water than in opaque pastes. For a gel the ratio of humectant to water is typically above 0.5 to 1, preferably above 1 to 1.
Optional, but preferred, components which are typically included in the toothpastes and tooth gels are organic thickeners and/or inorganic thickeners, surfactants, flavoring agents and/or sweetening agents, coloring agents and/or pigments, an anti-caries agent such as a soluble fluoride source, buffering agents such as alkali metal orthophosphates, phosphoric acid, alkali metal glycerophosphates, tartrates and citrates, and like Wog5/064ss PCT~S94/09469 ?~7~53~ --components conventionally added to toothpastes and tooth gels. If desired, a secondary anti-calculus agent can be included. The optional components should not interfere with the solubility of the pyrophosphate in the aqueous sorbitol solution.
The present invention also provides a method of preventing tartar formation on dental enamel which comprises contacting the enamel surface in the mouth with a toothpaste or a tooth gel comprising sodium bicarbonate, an alkali metal pyrophosphate salt, and an aqueous sorbitol solution, with the amount of pyrophosphate salt dissolved in the toothpaste or the tooth gel being sufficient to provide about 0.5-4.0% pyrophosphate ions in the toothpaste or 0.5-2% pyrophosphate ions in the tooth gel.
The present invention further provides a method for increasing the solubility, in a sodium bicarbonate-cont~; n; ng dentifrice, of alkali metal pyrophosphate anti-calculus agents by adding an aqueous solution of sorbitol, as the liquid vehicle, to dissolve the sodium pyrophosphate salt formed in the presence of the sodium bicarbonate.
Suitable pyrophosphate salts which may be incorporated in the toothpastes and tooth gels of the present invention include mono-, di-, tri- or tetra-alkali metal pyrophosphates and mixtures thereof. The preferred pyrophosphate salts include disodium pyrophosphate (Na2H2P2o7)~ tetrasodium pyrophosphate (Na4P2o7)~
tetrapotassium pyrophosphate (K4P2O7), and mixtures thereof.
The pyrophosphates may be employed in their anhydrous as well as their hydrated forms. The levels of each of these salts used in the toothpastes are as follows (all are in the unhydrated form): Na2H2P2O7 - about 1-10%, preferably about 1-5%, Na4P2O7 - up to about 2%, and K4P2O7 - up to about 6%.
The levels of each of these salts used in the tooth gels are as follows (all are in the unhydrated form): Na2H2P2O7 - 0-12%, Na4P2O7 - 1-10%, preferably 1-5%, K4P2O7 - 0-6%.
~1 70532 W O 9S/064S5 PCTrUS94/09469 .
Although a particular pyrophosphate salt, e.g., disodium or tetrapotassium pyrophosphate, may be the pyrophosphate initially added to the toothpaste or the tooth gel, the actual pyrophosphate present in the toothpaste or tooth gel is dependent on both the final pH of the toothpaste or tooth gel and the salting-out effect of the sodium bicarbonate. Typically, the actual pyrophosphate is tetrasodium pyrophosphate. The quantity of dissolved pyrophosphate ion present in the toothpaste or tooth gel is dependent on the solubility, in the precençe of sodium bicarbonate, of the particular alkali metal pyrophosphate salt used, in the amount of aqueous sorbitol solution and in the added water, if present, as well as the final pH of the toothpaste or tooth gel.
The sodium bicarbonate particles may have a median particle size of about 5 to 200 microns, preferably about 10-150 microns, most preferably about 20-74 microns. The bicarbonate particles are incorporated in the toothpaste or tooth gel in varying amounts, depending upon the desired properties of the formulation. Higher levels of sodium bicarbonate, e.g., about 50-65%, allow it to be used as the sole abrasive. Such formulations remove plaque effectively, have a desirable low abrasivity, and provide an exceptionally clean feeling to the teeth and gums after brushing. Lower levels allow the incorporation of S~con~ry abrasives and permit the formulation of clearer gels.
To improve clarity in tooth gels less sodium bicarbonate is used, typically about 10-35%, preferably about 20-30% and coarser bicarbonate crystals are chosen, preferably crystals having an average particle size of greater than 44 microns, most preferably greater than 74 microns. At very low concentrations the clarity of the tooth gel is increased. If a secondary abrasive is used in the tooth gel, the abrasive selected is one which will give a clear or translucent gel. When low levels of sodium bicarbonate are used in the toothpaste, it is desirable to wogs/o6455 ~ 7 ~ 5 3 ~ PCT~S94/09469 add an opacifying agent such as titanium dioxide in an amount of up to about 5%, preferably about 0.1-1%. If one wishes to convert the present gels into an opa~ue toothpaste, one should add an opacifying agent such as titanium dioxide in an amount up to about 5%, preferably about 0.1-1%.
At very low levels, e.g., less than about 10%, the bicarbonate still enh~nc~c the clean feeling of the teeth and gums, but to a lesser degree than when high levels are used. It also provides effective buffering in the pH range of 7.5 to 9.5.
Suitable secon~Ary humectants for use herein include glycerin, propylene glycol, polypropylene glycol, and/or polyethylene glycol and other conventional humectants.
In addition to the above described required components, the toothpaste or tooth gel can contain a variety of conventionally used optional components.
Typically, the toothpastes and tooth gels contain a natural or synthetic organic thickener or gelling agent. In the toothpastes the amounts are up to about 2%, preferably about 0.1-2%. In the tooth gels the amounts are up to about 0.1-10%, preferably about 0.1-2%. Suitable organic thickeners include sodium carboxymethyl cellulose, starch, gum tragacanth, carrageenan, xanthan gum, polyacrylate salts, polyvinylpyrrolidone, hydroxyethylpropyl cellulose, hydrox~buLylmethylcellulose,hydroxypropylmethylcellulose, or hydroxyethyl cellulose, which are usually used in amounts of about 0.1-2.0%. Inorganic thickeners such as hydrated silicas may also be used in amounts of up to about 10% or greater in the toothpastes or in amounts of about 0.5%-10%
or greater in the tooth gel.
Conventional abrasives or polishing materials are useful herein as a secondary abrasive provided they do not interfere with the solubility of the pyrophosphate salt.
Suitable water-insoluble abrasives for the toothpastes include sodium metaphosphate, potassium metaphosphate, W095/06455 2 1 7 0 5 3 2 PCT~S94/09469 .
calcium pyrophosphate, aluminum silicate, zirconium silicate, hydrated silica, hydrated alumina, bentonite, and/or the like. Preferred abrasive materials which may be admixed with the sodium bicarbonate include hydrated silica, silica gel, or colloidal silica and complex amorphous alkali metal aluminosilicates. Any of the foregoing water-insoluble abrasives may be present in the toothpaste in amounts of up to about 40%, preferably in amounts up to about 20%, which amount will depend upon the amount of sodium bicarbonate used.
Suitable water-insoluble abrasives for tooth gels include colloidal silica, hydrated silica, silica gel, hydrated alumina, complex amorphous alkali metal aluminosilicates and/or the like. When visually clear gels are employed, polishing agents of hydrated or colloidal silica, alkali metal aluminosilicate complexes, and alumina are particularly useful since they have refractive indices close to the refractive indices of the gelling agent-liquid systems commonly used in the gels. Any of the foregoing water-insoluble abrasives may be present in the tooth gel in amounts of up to about 30%, preferably in amounts up to about 15~, which amount will depend upon the amount of sodium bicarbonate used.
Organic surfactants are useful herein to achieve increased cleaning action, to assist thorough and complete dispersion of the anti-calculus agent throughout the oral cavity, and to improve the detergent and foaming properties of the toothpastes and tooth gels. Anionic, nonionic or ampholytic surfactants may be used, typically in amounts of about 0.1-3%.
Examples of suitable anionic surfactants are the water-soluble salts of the higher alkyl sulfates such as sodium lauryl sulfate or other C8-C18 alkyl sulfates, water-soluble salts of higher fatty acid monoglyceride monosulfates such as the sodium salt of the monosulfate monoglyceride of hydrogenated coconut oil fatty acids, alkyl aryl sulfonates WO95~J~5S ~ 7 o 53~ PCT~S93~S~9 such as sodium dodecyl benzene sulfonate, higher alkyl sulfoacetates, higher fatty acid esters of l,2-dihydroxy propane sulfonate, and the substantially saturated higher aliphatic acyl amides of lower aliphatic amino carboxylic acids such as C12-C16 fatty acids, alkyl or acyl radicals, and the like. Examples of the last mentioned amides are N-lauroyl sarcosinate and the sodium, potassium, and ethanolamine salts of N-lauroyl, N-myristoyl, or N-palmitoyl sarcosinate which should be substantially free from soap or similar higher fatty acid materials.
Other suitable surfactants include non-ionic agents such as the condensates of sorbitan monostearate with ethylene oxide, the condensates of ethylene oxide with propylene oxide, or the condensates of propylene glycol (available under the trademark "Pluronics"). Other examples of water-soluble nonionic surfactants useful herein are the condensation products of ethylene oxide with various other compounds which are reactive therewith and have long hydrophobic ~h~;nc (e.g., C10-C20 aliphatic ch~in~) which condensation products ("ethoxamers") contain hydrophilic polyoxyethylene moieties, such as condensation products of polyethylene oxide with fatty acids, fatty alcohols, fatty amides, or polyhydric alcohols (e.g., sorbitan monostearate).
The various surfactants may be utilized alone or in admixture with one another. In toothpastes and tooth gels, the total amount used is preferably about 0.05%-5%, more preferably about 0.1%-2.0%.
Sweetening agents are also useful herein. They include saccharin, sucralose, dextrose, levulose, aspartame, D-tryptophan, dihydrochalcones, acesulfame, sodium cyclamate, and calcium cyclamate. They are generally used in amounts of up to about 2%. Also useful as sweetening agents are xylitol and mannitol in amounts of up to about 3% and 5%, respectively, in toothpastes and up to about 5% in tooth gels.
Wo95/06455 2 1 ~ Q S 3 2 PCT~S94109469 Anti-microbial agents can be included in the toothpastes to help inhibit plaque formation and gingivitis or to reduce mouth odor. For example, cationic anti-A microbial agents such as cetyl pyridinium chloride or 5 benzothonium chloride can be used. Bis-biguanides are also effective. Such agents include chlorhexidine (1,6-bis tN5-p-chlorophenyl-N-biguanido] hexane), and the soluble and insoluble salts thereof and related materials such as 1,2-bis (N5-p-trifluoromethylphenyl-N1-biguanido) ethane which are described more fully in U.S. Pat. No. 3 937.807 (issued Feb. 10, 1976 to Haefale), Belgian Pat. No. 843 244 (published Dec. 22, 1976) and Belgian Pat. No. 844,764 (published Jan. 31, 1977). If present, the secondary anti-microbials generally comprise about 0.01-0.5% of the composition. When using cationic agents, it is generally necessary to avoid using anionic surfactants in the formulation. Non-ionic anti-microbials such as triclosan can be used. These materials have the advantage of not losing efficacy in the presence of anionic surfactants.
Soluble complex phosphate salts other than the pyrophosphates may be used as secondary anti-calculus agents, e.g., tripolyphosphates and hexametaphosphates.
The toothpastes and tooth gels can include a water-soluble fluoride ion source which is effective both as a pyrophosphatase inhibitor and as an anti-caries agent.
Suitable fluoride ion sources include inorganic fluoride salts such as soluble alkali metal or alkaline earth metal salts, e.g., sodium fluoride, potassium fluoride, sodium fluorosilicate, ammonium fluorosilicate, sodium fluorozirconate and sodium monofluorophosphate. Alkali metal fluorides such as sodium fluoride, sodium monofluorophosphate, and mixtures thereof are preferred.
The amount of the soluble fluoride ion source in the dentifrice is dependent on the particular compounds used and the type of dentifrice, but it must be incorporated in an effective, but nontoxic amount, generally up to about 5.0%.
W095/06455 PCT~S94/09469 ~ 7 ~53~ ~
Any suitable minimum amount of fluoride may be used, but it is preferable to employ a quantity sufficient to release about 50 to 3500 ppm, preferably about 850-1500 ppm, of fluoride ions. In the case of sodium fluoride, the fluoride ion source is present in an amount from 0.05-0.65%, preferably about 0.18-0.35%. In the case of sodium monofluorophosphate, the amount is about 0.2-2%, more typically about 0.65%-1.20%.
Various other materials mfay be incorporated in the toothpastes and tooth gels. Examples thereof are coloring and whitening agents, preservatives, silicones, and/or chlorophyll compounds. These adjuvants are incorporated in the toothpastes and tooth gels in amounts which do not substantially adversely affect the properties and characteristics desired and are selected and used in effective amounts, depending upon the particular adjuvant and the type of toothpaste or tooth gel involved.
The pH of the toothpastes and tooth gels herein range from 7.0 to 10.0, preferably from 7.5 to 9Ø The pH is preferably achieved through a proper balancing of the bicarbonate and other additives.
The toothpastes and tooth gels herein are made using conventional mixing t~hn; ques and used in a conventional manner.
The following examples further illustrate the present invention, but it is understood that the invention is not limited thereto. All amounts and proportions referred to herein and in the appended claims are by weight and temperatures are in degree Celsius unless otherwise indicated.
mple 1 The following toothpaste cont~;n;ng about 1.3%
pyrophosphate all in solution was prepared.
Sodium bicarbonate (mean 43.374 particle size < 35) Tetrasodium pyrophosphate 2.000 W095/06455 2 1 70532 PCT~S94/09469 .
Sodium fluoride 0.243 Sorbitol (70% aqueous solution) 40.100 Glycerin 4.104 Polyethylene glycol (PEG-8)1.000 Sodium carboxymethyl cellulose0.700 (9M31F) Distilled water 5.279 Sodium saccharin 1.000 Sodium lauryl sulfate 0.300 Sodium lauroyl sarcosinate1.000 (30% solution) Flavor 0.900 TOTAL 100.000 Ex~mple 2 The following tooth gel containing about 1.3%
pyrophosphate ion all in solution was prepared.
Sodium bicarbonate (Grade 2)31.354 Tetrasodium pyrophosphate 2.000 Sodium fluoride 0.243 Sorbitol (70% aqueous 40.100 solution) Glycerin 4.104 Polyethylene glycol (PEG-8)1.000 Sodium carboxymethyl cellulose0.600 (9M8F) Distilled water 5.279 Sodium saccharin 0.650 Thicke~;ng silica (Sylox 2)4.500 Hydrated silica (Sylodent 700)8.000 Sodium lauryl sulfate 0.500 Sodium lauroyl sarcosinate1.670 (30% solution) Flavor 0.950 TOTAL 100.000 W095/064S5 PCT~S94/09469 2.~7053~ ~
~Y~mple3 3-6 The following are representative toothpastes.
5Calculus, or tartar as it is sometimes called, is the solid, hard mass of calcified material deposited on and adhering to the surfaces of the teeth. It is composed of inorganic salts which make the calculus hard and resistant to removal. Although not entirely understood, the general concept is that plaque, which is a sticky film of oral bacteria and their products, adheres to teeth and becomes calcified with the ultimate formation on the teeth of a hard mineral-like material consisting of calcium phosphates.
Calculus is largely calcium phosphates, mainly hydroxyapatite with varying, but small, amounts of other inorganic salts.
As the mature calculus develops, it becomes visibly white or yellowish in color unless stained or discolored by some extraneous agent. ln addition to being unsightly and undesirable from an aesthetic standpoint, the mature calculus deposits can be constant sources of irritation to the gingiva. Further, the calculus can promote and retain plaque accumulations. Plaque is recognized as a prime etiological agent involved in gingivitis and periodontal disease. Additionally, plaque is porous and can retain toxic bacterial end products which are also associated with periodontal disease.
Methods for chemically reducing or preventing calculus formation have been directed at affecting the process at any of several stages in its development. One approach is to develop agents which inhibit the formation of the crystalline calcium phosphate or hydroxyapatite.
W09S/064S5 PCT~S94/09469 21 70532 ~
A wide variety of chemical and biological agents have been suggested to retard calculus formation or to remove calculus after it is formed. The chemical approach to calculus inhibition generally involves crystal growth inhibition which prevents the calculus from forming.
Generally, once formed, mechAn;cal removal by the dentist is n~c~ss~ry and is a routine dental office procedure.
The most widely used tartar control agents in dentifr~ces are sodium and potassium salts of pyrophosphoric acid. It is important that the pyrophosphate salt be in a readily available form so that the pyrophosphate ions (P2O7-4) contact the enamel surfaces during use. The bioavailability of the ion is determined by the solubility of the salt both in the liquid vehicle of the dentifrice and in the water/expectorant mixture in which the dentifrice is dispersed during brushing of the teeth.
In a dentifrice cont~;n;ng sodium bicarbonate, i.e., baking soda, and the alkali metal salts of pyrophosphoric acîd, the solubility of the pyrophosphate salt within the liquid vehicle of the dentifrice is greatly reduced. This suppression of solubility is due to the excess of sodium ions placed in solution by the sodium bicarbonate.
Therefore, there is a need to improve the solubility of alkali metal pyrophosphate salts within a baking soda toothpaste or a baking soda tooth gel.
The present invention provides a dentifrice in the form of a toothpaste or tooth gel.
The toothpaste comprises sodium bicarbonate, typically about 8-65%, preferably about 20-55%, most preferably 40-50%; an effective amount of an alkali metal pyrophosphatesalt as an anti-tartar agent; and an aqueous solution of sorbitol in an amount sufficient to dissolve at least about 50~ of the pyrophosphate salt and to provide the desired consistency to the toothpaste, typically at least about 30-70~, preferably about 40-60%.
W095/06455 2 l 1~ 5 3 2 PCT~S9~ 169 The tooth gel comprises sodium bicarbonate, typically about 5-50%, preferably about 10-40%, most preferably about 20-35%; an effective amount of an alkali metal pyrophosphate salt as an anti-tartar agent; and an aqueous solution of sorbitol in an amount sufficient to dissolve at least about 50% of the pyrophosphate salt and to provide the desired consistency to the tooth gel, typically at least about 30-70%, preferably about 35-60%.
The pyrophosphate ion is more readily available because tetrasodium pyrophosphate is more soluble in the aqueous sorbitol solution used herein as the liquid vehicle than in the conventional aqueous liquid vehicles used in most toothpastes and tooth gels.
In a toothpaste and a tooth gel, water is typically a desirable component. However, in the present toothpastes ~and tooth gels, water is not especially desirable and any additional water (i.e., water over and above that in the sorbitol solution) comprises only up to about 30%, preferably only up to 7%, of the composition. The sorbitol solution is the main liquid vehicle. The water used to dissolve the sorbitol is that amount which is effective to solubilize it. Typically, the sorbitol solution is a 70%
aqueous solution.
In translucent gels, where the refractive index is an important consideration, it is preferred to use higher ratios of sorbitol or other humectant to water than in opaque pastes. For a gel the ratio of humectant to water is typically above 0.5 to 1, preferably above 1 to 1.
Optional, but preferred, components which are typically included in the toothpastes and tooth gels are organic thickeners and/or inorganic thickeners, surfactants, flavoring agents and/or sweetening agents, coloring agents and/or pigments, an anti-caries agent such as a soluble fluoride source, buffering agents such as alkali metal orthophosphates, phosphoric acid, alkali metal glycerophosphates, tartrates and citrates, and like Wog5/064ss PCT~S94/09469 ?~7~53~ --components conventionally added to toothpastes and tooth gels. If desired, a secondary anti-calculus agent can be included. The optional components should not interfere with the solubility of the pyrophosphate in the aqueous sorbitol solution.
The present invention also provides a method of preventing tartar formation on dental enamel which comprises contacting the enamel surface in the mouth with a toothpaste or a tooth gel comprising sodium bicarbonate, an alkali metal pyrophosphate salt, and an aqueous sorbitol solution, with the amount of pyrophosphate salt dissolved in the toothpaste or the tooth gel being sufficient to provide about 0.5-4.0% pyrophosphate ions in the toothpaste or 0.5-2% pyrophosphate ions in the tooth gel.
The present invention further provides a method for increasing the solubility, in a sodium bicarbonate-cont~; n; ng dentifrice, of alkali metal pyrophosphate anti-calculus agents by adding an aqueous solution of sorbitol, as the liquid vehicle, to dissolve the sodium pyrophosphate salt formed in the presence of the sodium bicarbonate.
Suitable pyrophosphate salts which may be incorporated in the toothpastes and tooth gels of the present invention include mono-, di-, tri- or tetra-alkali metal pyrophosphates and mixtures thereof. The preferred pyrophosphate salts include disodium pyrophosphate (Na2H2P2o7)~ tetrasodium pyrophosphate (Na4P2o7)~
tetrapotassium pyrophosphate (K4P2O7), and mixtures thereof.
The pyrophosphates may be employed in their anhydrous as well as their hydrated forms. The levels of each of these salts used in the toothpastes are as follows (all are in the unhydrated form): Na2H2P2O7 - about 1-10%, preferably about 1-5%, Na4P2O7 - up to about 2%, and K4P2O7 - up to about 6%.
The levels of each of these salts used in the tooth gels are as follows (all are in the unhydrated form): Na2H2P2O7 - 0-12%, Na4P2O7 - 1-10%, preferably 1-5%, K4P2O7 - 0-6%.
~1 70532 W O 9S/064S5 PCTrUS94/09469 .
Although a particular pyrophosphate salt, e.g., disodium or tetrapotassium pyrophosphate, may be the pyrophosphate initially added to the toothpaste or the tooth gel, the actual pyrophosphate present in the toothpaste or tooth gel is dependent on both the final pH of the toothpaste or tooth gel and the salting-out effect of the sodium bicarbonate. Typically, the actual pyrophosphate is tetrasodium pyrophosphate. The quantity of dissolved pyrophosphate ion present in the toothpaste or tooth gel is dependent on the solubility, in the precençe of sodium bicarbonate, of the particular alkali metal pyrophosphate salt used, in the amount of aqueous sorbitol solution and in the added water, if present, as well as the final pH of the toothpaste or tooth gel.
The sodium bicarbonate particles may have a median particle size of about 5 to 200 microns, preferably about 10-150 microns, most preferably about 20-74 microns. The bicarbonate particles are incorporated in the toothpaste or tooth gel in varying amounts, depending upon the desired properties of the formulation. Higher levels of sodium bicarbonate, e.g., about 50-65%, allow it to be used as the sole abrasive. Such formulations remove plaque effectively, have a desirable low abrasivity, and provide an exceptionally clean feeling to the teeth and gums after brushing. Lower levels allow the incorporation of S~con~ry abrasives and permit the formulation of clearer gels.
To improve clarity in tooth gels less sodium bicarbonate is used, typically about 10-35%, preferably about 20-30% and coarser bicarbonate crystals are chosen, preferably crystals having an average particle size of greater than 44 microns, most preferably greater than 74 microns. At very low concentrations the clarity of the tooth gel is increased. If a secondary abrasive is used in the tooth gel, the abrasive selected is one which will give a clear or translucent gel. When low levels of sodium bicarbonate are used in the toothpaste, it is desirable to wogs/o6455 ~ 7 ~ 5 3 ~ PCT~S94/09469 add an opacifying agent such as titanium dioxide in an amount of up to about 5%, preferably about 0.1-1%. If one wishes to convert the present gels into an opa~ue toothpaste, one should add an opacifying agent such as titanium dioxide in an amount up to about 5%, preferably about 0.1-1%.
At very low levels, e.g., less than about 10%, the bicarbonate still enh~nc~c the clean feeling of the teeth and gums, but to a lesser degree than when high levels are used. It also provides effective buffering in the pH range of 7.5 to 9.5.
Suitable secon~Ary humectants for use herein include glycerin, propylene glycol, polypropylene glycol, and/or polyethylene glycol and other conventional humectants.
In addition to the above described required components, the toothpaste or tooth gel can contain a variety of conventionally used optional components.
Typically, the toothpastes and tooth gels contain a natural or synthetic organic thickener or gelling agent. In the toothpastes the amounts are up to about 2%, preferably about 0.1-2%. In the tooth gels the amounts are up to about 0.1-10%, preferably about 0.1-2%. Suitable organic thickeners include sodium carboxymethyl cellulose, starch, gum tragacanth, carrageenan, xanthan gum, polyacrylate salts, polyvinylpyrrolidone, hydroxyethylpropyl cellulose, hydrox~buLylmethylcellulose,hydroxypropylmethylcellulose, or hydroxyethyl cellulose, which are usually used in amounts of about 0.1-2.0%. Inorganic thickeners such as hydrated silicas may also be used in amounts of up to about 10% or greater in the toothpastes or in amounts of about 0.5%-10%
or greater in the tooth gel.
Conventional abrasives or polishing materials are useful herein as a secondary abrasive provided they do not interfere with the solubility of the pyrophosphate salt.
Suitable water-insoluble abrasives for the toothpastes include sodium metaphosphate, potassium metaphosphate, W095/06455 2 1 7 0 5 3 2 PCT~S94/09469 .
calcium pyrophosphate, aluminum silicate, zirconium silicate, hydrated silica, hydrated alumina, bentonite, and/or the like. Preferred abrasive materials which may be admixed with the sodium bicarbonate include hydrated silica, silica gel, or colloidal silica and complex amorphous alkali metal aluminosilicates. Any of the foregoing water-insoluble abrasives may be present in the toothpaste in amounts of up to about 40%, preferably in amounts up to about 20%, which amount will depend upon the amount of sodium bicarbonate used.
Suitable water-insoluble abrasives for tooth gels include colloidal silica, hydrated silica, silica gel, hydrated alumina, complex amorphous alkali metal aluminosilicates and/or the like. When visually clear gels are employed, polishing agents of hydrated or colloidal silica, alkali metal aluminosilicate complexes, and alumina are particularly useful since they have refractive indices close to the refractive indices of the gelling agent-liquid systems commonly used in the gels. Any of the foregoing water-insoluble abrasives may be present in the tooth gel in amounts of up to about 30%, preferably in amounts up to about 15~, which amount will depend upon the amount of sodium bicarbonate used.
Organic surfactants are useful herein to achieve increased cleaning action, to assist thorough and complete dispersion of the anti-calculus agent throughout the oral cavity, and to improve the detergent and foaming properties of the toothpastes and tooth gels. Anionic, nonionic or ampholytic surfactants may be used, typically in amounts of about 0.1-3%.
Examples of suitable anionic surfactants are the water-soluble salts of the higher alkyl sulfates such as sodium lauryl sulfate or other C8-C18 alkyl sulfates, water-soluble salts of higher fatty acid monoglyceride monosulfates such as the sodium salt of the monosulfate monoglyceride of hydrogenated coconut oil fatty acids, alkyl aryl sulfonates WO95~J~5S ~ 7 o 53~ PCT~S93~S~9 such as sodium dodecyl benzene sulfonate, higher alkyl sulfoacetates, higher fatty acid esters of l,2-dihydroxy propane sulfonate, and the substantially saturated higher aliphatic acyl amides of lower aliphatic amino carboxylic acids such as C12-C16 fatty acids, alkyl or acyl radicals, and the like. Examples of the last mentioned amides are N-lauroyl sarcosinate and the sodium, potassium, and ethanolamine salts of N-lauroyl, N-myristoyl, or N-palmitoyl sarcosinate which should be substantially free from soap or similar higher fatty acid materials.
Other suitable surfactants include non-ionic agents such as the condensates of sorbitan monostearate with ethylene oxide, the condensates of ethylene oxide with propylene oxide, or the condensates of propylene glycol (available under the trademark "Pluronics"). Other examples of water-soluble nonionic surfactants useful herein are the condensation products of ethylene oxide with various other compounds which are reactive therewith and have long hydrophobic ~h~;nc (e.g., C10-C20 aliphatic ch~in~) which condensation products ("ethoxamers") contain hydrophilic polyoxyethylene moieties, such as condensation products of polyethylene oxide with fatty acids, fatty alcohols, fatty amides, or polyhydric alcohols (e.g., sorbitan monostearate).
The various surfactants may be utilized alone or in admixture with one another. In toothpastes and tooth gels, the total amount used is preferably about 0.05%-5%, more preferably about 0.1%-2.0%.
Sweetening agents are also useful herein. They include saccharin, sucralose, dextrose, levulose, aspartame, D-tryptophan, dihydrochalcones, acesulfame, sodium cyclamate, and calcium cyclamate. They are generally used in amounts of up to about 2%. Also useful as sweetening agents are xylitol and mannitol in amounts of up to about 3% and 5%, respectively, in toothpastes and up to about 5% in tooth gels.
Wo95/06455 2 1 ~ Q S 3 2 PCT~S94109469 Anti-microbial agents can be included in the toothpastes to help inhibit plaque formation and gingivitis or to reduce mouth odor. For example, cationic anti-A microbial agents such as cetyl pyridinium chloride or 5 benzothonium chloride can be used. Bis-biguanides are also effective. Such agents include chlorhexidine (1,6-bis tN5-p-chlorophenyl-N-biguanido] hexane), and the soluble and insoluble salts thereof and related materials such as 1,2-bis (N5-p-trifluoromethylphenyl-N1-biguanido) ethane which are described more fully in U.S. Pat. No. 3 937.807 (issued Feb. 10, 1976 to Haefale), Belgian Pat. No. 843 244 (published Dec. 22, 1976) and Belgian Pat. No. 844,764 (published Jan. 31, 1977). If present, the secondary anti-microbials generally comprise about 0.01-0.5% of the composition. When using cationic agents, it is generally necessary to avoid using anionic surfactants in the formulation. Non-ionic anti-microbials such as triclosan can be used. These materials have the advantage of not losing efficacy in the presence of anionic surfactants.
Soluble complex phosphate salts other than the pyrophosphates may be used as secondary anti-calculus agents, e.g., tripolyphosphates and hexametaphosphates.
The toothpastes and tooth gels can include a water-soluble fluoride ion source which is effective both as a pyrophosphatase inhibitor and as an anti-caries agent.
Suitable fluoride ion sources include inorganic fluoride salts such as soluble alkali metal or alkaline earth metal salts, e.g., sodium fluoride, potassium fluoride, sodium fluorosilicate, ammonium fluorosilicate, sodium fluorozirconate and sodium monofluorophosphate. Alkali metal fluorides such as sodium fluoride, sodium monofluorophosphate, and mixtures thereof are preferred.
The amount of the soluble fluoride ion source in the dentifrice is dependent on the particular compounds used and the type of dentifrice, but it must be incorporated in an effective, but nontoxic amount, generally up to about 5.0%.
W095/06455 PCT~S94/09469 ~ 7 ~53~ ~
Any suitable minimum amount of fluoride may be used, but it is preferable to employ a quantity sufficient to release about 50 to 3500 ppm, preferably about 850-1500 ppm, of fluoride ions. In the case of sodium fluoride, the fluoride ion source is present in an amount from 0.05-0.65%, preferably about 0.18-0.35%. In the case of sodium monofluorophosphate, the amount is about 0.2-2%, more typically about 0.65%-1.20%.
Various other materials mfay be incorporated in the toothpastes and tooth gels. Examples thereof are coloring and whitening agents, preservatives, silicones, and/or chlorophyll compounds. These adjuvants are incorporated in the toothpastes and tooth gels in amounts which do not substantially adversely affect the properties and characteristics desired and are selected and used in effective amounts, depending upon the particular adjuvant and the type of toothpaste or tooth gel involved.
The pH of the toothpastes and tooth gels herein range from 7.0 to 10.0, preferably from 7.5 to 9Ø The pH is preferably achieved through a proper balancing of the bicarbonate and other additives.
The toothpastes and tooth gels herein are made using conventional mixing t~hn; ques and used in a conventional manner.
The following examples further illustrate the present invention, but it is understood that the invention is not limited thereto. All amounts and proportions referred to herein and in the appended claims are by weight and temperatures are in degree Celsius unless otherwise indicated.
mple 1 The following toothpaste cont~;n;ng about 1.3%
pyrophosphate all in solution was prepared.
Sodium bicarbonate (mean 43.374 particle size < 35) Tetrasodium pyrophosphate 2.000 W095/06455 2 1 70532 PCT~S94/09469 .
Sodium fluoride 0.243 Sorbitol (70% aqueous solution) 40.100 Glycerin 4.104 Polyethylene glycol (PEG-8)1.000 Sodium carboxymethyl cellulose0.700 (9M31F) Distilled water 5.279 Sodium saccharin 1.000 Sodium lauryl sulfate 0.300 Sodium lauroyl sarcosinate1.000 (30% solution) Flavor 0.900 TOTAL 100.000 Ex~mple 2 The following tooth gel containing about 1.3%
pyrophosphate ion all in solution was prepared.
Sodium bicarbonate (Grade 2)31.354 Tetrasodium pyrophosphate 2.000 Sodium fluoride 0.243 Sorbitol (70% aqueous 40.100 solution) Glycerin 4.104 Polyethylene glycol (PEG-8)1.000 Sodium carboxymethyl cellulose0.600 (9M8F) Distilled water 5.279 Sodium saccharin 0.650 Thicke~;ng silica (Sylox 2)4.500 Hydrated silica (Sylodent 700)8.000 Sodium lauryl sulfate 0.500 Sodium lauroyl sarcosinate1.670 (30% solution) Flavor 0.950 TOTAL 100.000 W095/064S5 PCT~S94/09469 2.~7053~ ~
~Y~mple3 3-6 The following are representative toothpastes.
Sodium bicarbonate42.28755.000 8.00020.000 Tetrasodium 2.000 2.000 6.0004.000 pyrophosphate Tetrapotassium0.000 0.000 0.0003.000 pyrophosphate Hydrated silica0.000 0.000 0.0004.300 abrasive Thickening silica0.0000.000 0.0003.000 Titanium dioxide0.0000.000 0.0000.200 Calcium pyrophosphate0.000 0.0008.000 0.000 Sodium fluoride0.243 0.243 0.2430.243 Sorbitol (70%40.100 40.100 40.10040.100 solution) Glycerin 5.000 5.000 5.0005.000 Polyethylene glycol 0.000 0.0001.000 1.000 (PEG-8) Sodium carboxymethyl 0.600 0.6000.600 0.600 cellulose Distilled water6.000 5.279 5.27910.000 Sodium saccharin0.6500.650 0.6500.650 Sodium lauryl sulfate0.500 0.5000.500 0.500 Sodium lauroyl1.670 1.670 1.6701.670 sarcosinate (30% solution) Flavor 0.950 0.950 0.9500.950 W095/06455 2 1 7 0 5 32 PCT~S94/09469 .
TOTAL 100.00 100.00 100.00 100.00 O o o O
Approximate % of 80% 50% 75% 55%
pyrophosphate which is in solution Examples 7-10 The following are representative tooth gels.
' 10 7 8 9 10 Sodium bicarbonate25.00050.000 5.000 12.000 Tetrasodium 2.000 1.000 6.000 4.000 pyrophosphate Tetrapotassium 0.000 0.000 0.000 3.000 pyrophosphate Sodium fluoride 0.243 0.243 0.243 0.000 Sodium o.ooo o.000 .ooo 0.780 monofluorophosphate Sorbitol (70% aqueous 44.882 39.984 62.000 58.692 solution) Glycerin 5.150 10.000 5.000 6.220 Polyethylene glycol0.0001.500 1.000 2.000 (PEG-8) Sodium carboxymethyl0.6000.300 0.600 0.300 cellulose Sodium saccharin0.650 0.650 0.500 0.800 Hydrated silica 4.500 0.000 12.000 6.000 abrasive (Sylodent 700) W095/06455 PCT~S94/09469 ~7053~ ~
Thickening silica8.000 0.000 6.000 4.000 (Sylox 2) Sodium lauryl sulfate0.5000.5001.000 1.500 Sodium lauroyl 1.670 0.870 0.000 0.000 5 sarcosinate (30% solution) Flavor 0.800 0.950 0.655 0.700 Color 0.005 0.003 0.002 0.008 TOTAL 100.00 100.00 100.00 100.00 O O O O
Approximate % of 100% 100% 65% 60%
pyrophosphate which is in solution ~xamples 11-14 The following are additional representative toothpastes Sodium bicarbonate35.00043.22014.979 65.0t)0 Tetrasodium 0.000 0.000 2.500 2.000 pyrophosphate Tetrapotassium 3.400 5.000 0.000 0.000 pyrophosphate Disodium dihydrogen0.0000.200 0.000 0.0t)0 pyrophosphate Hydrated silica 5.500 0.000 5.000 0.000 abrasive Thickening silica0.000 0.000 5.000 0.000 W095/06455 2 1 7 0 5 3 2 PCT~S94/09469 .
Titanium dioxide 0.100 0.000 0.500 0.000 Sodium fluoride 0.243 0.000 0.221 0.243 Sodium 0.000 0.780 0.000 0.000 monofluorophosphate Sorbitol (70% solution)44.657 40.100 35.000 24.327 Xylitol 3.000 0.000 0.000 0.000 Mannitol 0.000 0.000 5.000 0.000 Glycerin 4.000 0.000 4.000 4.000 Polyethylene glycol1.0001.000 0.000 1.000 (PEG-8) Sodium carboxymethyl0.3000.600 0.800 0.300 cellulose Distilled water 0.000 6.000 25.000 0.000 Sodium saccharin 0.650 0.700 0.500 0.800 Sodium lauryl sulfate1.2000.300 0.800 0.330 Sodium lauroyl 0.000 1.000 0.000 1.000 sarcosinate (30% solution) Flavor 0.950 1.100 0.700 1.000 TOTAL 100.000100.000 100.000 100.000 Approximate % of 100% 70% 80% 75%
pyrophosphate which is in solution W09S/OG45S PCT~S94/09469 53~ --2x mple~ 15-18 The following are additional representative tooth gels.
Sodium bicarbonate 32.000 43.220 29.500 20.000 Tetrasodium 0.000 0.000 2.500 5.000 pyrophosphate Tetrapotassium 3.400 5.000 0.000 0.000 pyrophosphate Disodium dihydrogen 0.000 0.195 0.000 0.000 pyrophosphate Sodium fluoride 0.243 0.000 0.243 0.000 Sodium 0.000 0.780 0.000 0.780 monofluorophosphate Sorbitol (70% aqueous43.15740.10040.000 42.000 solution) Xylitol 5.000 0.000 0.000 0.000 Mannitol 0.000 0.000 4.882 0.000 Glycerin 0.000 0.000 5.000 0.000 Polyethylene glycol 1.000 1.000 1.000 0.000 (PEG-8) Sodium carboxymethyl0.300 0.600 0.600 0.300 cellulose Distilled water 0.000 6.000 0.000 9.367 Sodium saccharin 0.646 0.700 0.650 0.800 Hydrated silica abrasive4.1000.0004.500 4.000 (Sylodent 700) W095~q~5 ~1 7 ~ 5 3 2 PCT~S94/09469 .
Thickening silica (Sylox8.000 0.000 8.000 15.000 2) Sodium lauryl sulfate 1.200 0.300 0.500 0.330 ~odium lauroyl 0.000 1.000 1.670 1.000 5 sarcosinate (30% solution) Flavor 0.950 1.100 0.950 1.000 Color 0.004 0.005 0.005 0.003 TOTAL 100.00 100.00 100.00100.000 O O O
Approximate % of 100% 55~ 100% 50%
pyrophosphate which is in solution Ex~mple 19 This example shows the effect of sodium bicarbonate (NaHCO3) on the solubility of tetrasodium pyrophosphate.
Wt % of P2O7-4 in Solution With Saturated Without NaHCO3 NaHCO3 Distilled Water 4.03 1.77 Glycerin 0.04 0.12 70% Aqueous Sorbitol Solution 5.97 4.18 18% Aqueous Mannitol Solution - 2.09 60% Aqueous Xylitol Solution - 2.44 The results show that, in the presence of sufficient sodium bicarbonate to saturate the water, the solubility of the pyrophosphate ion (P2O7-4) was suppressed from 4.03~ to 1.77%. The results show that, in the absence of sodium W095/064S5 ~ 7 ~ 5 3 ~ PCT~S9~91~9 bicarbonate, the pyrophosphate is more soluble in the 70%
aqueous sorbitol solution than it is in the distilled water.
While the presence of the bicarbonate in the aqueous sorbitol solution also suppressed the pyrophosphate solubility, the decrease was not as great as that observed with water. The pyrophosphate was not soluble in glycerin in either case. The results further show that other similar polyols, i.e., mannitol and xylitol, were not as effective as sorbitol, in increasing pyrophosphate solubility in the presence of bicarbonate.
~xamPle 20 This example shows the solubility of tetrasodium pyrophosphate in various dentifrice solvent systems saturated with sodium bicarbonate. The percent solubility of the pyrophosphate ion (P2O7-4) is given as weight %.
Water* ÇlYcerin* 70% Sorbitol Wt. ~ P2Q7-Solution 1 0 0 1.77 0 1 0 0.1 0 0 1 4.1 1/2 1/2 0 0.44 1/2 0 1/2 2.1 0 1/2 1/2 1.73 1/3 1/3 1/3 1.01 2/3 1/6 1/6 1.15 1/6 2/3 1/6 1.48 1/6 1/6 2/3 2.0~3 *Weight fraction of solvent system.
Woss/064SS 2 1 7 0 ~ 3 2 PCT~S94/09469 .
The results show that the best solubility (4.18%) was in the 70% aqueous sorbitol solution and the worst solubilities were in solvent systems cont~; n; ng no aqueous sorbitol solution (0.12% for glycerin and 0.44% for a glycerin/water mixture).
In addition to the levels and combinations of ingredients shown in these examples, others can be used which are consistent with the invention disclosed and claimed herein.
TOTAL 100.00 100.00 100.00 100.00 O o o O
Approximate % of 80% 50% 75% 55%
pyrophosphate which is in solution Examples 7-10 The following are representative tooth gels.
' 10 7 8 9 10 Sodium bicarbonate25.00050.000 5.000 12.000 Tetrasodium 2.000 1.000 6.000 4.000 pyrophosphate Tetrapotassium 0.000 0.000 0.000 3.000 pyrophosphate Sodium fluoride 0.243 0.243 0.243 0.000 Sodium o.ooo o.000 .ooo 0.780 monofluorophosphate Sorbitol (70% aqueous 44.882 39.984 62.000 58.692 solution) Glycerin 5.150 10.000 5.000 6.220 Polyethylene glycol0.0001.500 1.000 2.000 (PEG-8) Sodium carboxymethyl0.6000.300 0.600 0.300 cellulose Sodium saccharin0.650 0.650 0.500 0.800 Hydrated silica 4.500 0.000 12.000 6.000 abrasive (Sylodent 700) W095/06455 PCT~S94/09469 ~7053~ ~
Thickening silica8.000 0.000 6.000 4.000 (Sylox 2) Sodium lauryl sulfate0.5000.5001.000 1.500 Sodium lauroyl 1.670 0.870 0.000 0.000 5 sarcosinate (30% solution) Flavor 0.800 0.950 0.655 0.700 Color 0.005 0.003 0.002 0.008 TOTAL 100.00 100.00 100.00 100.00 O O O O
Approximate % of 100% 100% 65% 60%
pyrophosphate which is in solution ~xamples 11-14 The following are additional representative toothpastes Sodium bicarbonate35.00043.22014.979 65.0t)0 Tetrasodium 0.000 0.000 2.500 2.000 pyrophosphate Tetrapotassium 3.400 5.000 0.000 0.000 pyrophosphate Disodium dihydrogen0.0000.200 0.000 0.0t)0 pyrophosphate Hydrated silica 5.500 0.000 5.000 0.000 abrasive Thickening silica0.000 0.000 5.000 0.000 W095/06455 2 1 7 0 5 3 2 PCT~S94/09469 .
Titanium dioxide 0.100 0.000 0.500 0.000 Sodium fluoride 0.243 0.000 0.221 0.243 Sodium 0.000 0.780 0.000 0.000 monofluorophosphate Sorbitol (70% solution)44.657 40.100 35.000 24.327 Xylitol 3.000 0.000 0.000 0.000 Mannitol 0.000 0.000 5.000 0.000 Glycerin 4.000 0.000 4.000 4.000 Polyethylene glycol1.0001.000 0.000 1.000 (PEG-8) Sodium carboxymethyl0.3000.600 0.800 0.300 cellulose Distilled water 0.000 6.000 25.000 0.000 Sodium saccharin 0.650 0.700 0.500 0.800 Sodium lauryl sulfate1.2000.300 0.800 0.330 Sodium lauroyl 0.000 1.000 0.000 1.000 sarcosinate (30% solution) Flavor 0.950 1.100 0.700 1.000 TOTAL 100.000100.000 100.000 100.000 Approximate % of 100% 70% 80% 75%
pyrophosphate which is in solution W09S/OG45S PCT~S94/09469 53~ --2x mple~ 15-18 The following are additional representative tooth gels.
Sodium bicarbonate 32.000 43.220 29.500 20.000 Tetrasodium 0.000 0.000 2.500 5.000 pyrophosphate Tetrapotassium 3.400 5.000 0.000 0.000 pyrophosphate Disodium dihydrogen 0.000 0.195 0.000 0.000 pyrophosphate Sodium fluoride 0.243 0.000 0.243 0.000 Sodium 0.000 0.780 0.000 0.780 monofluorophosphate Sorbitol (70% aqueous43.15740.10040.000 42.000 solution) Xylitol 5.000 0.000 0.000 0.000 Mannitol 0.000 0.000 4.882 0.000 Glycerin 0.000 0.000 5.000 0.000 Polyethylene glycol 1.000 1.000 1.000 0.000 (PEG-8) Sodium carboxymethyl0.300 0.600 0.600 0.300 cellulose Distilled water 0.000 6.000 0.000 9.367 Sodium saccharin 0.646 0.700 0.650 0.800 Hydrated silica abrasive4.1000.0004.500 4.000 (Sylodent 700) W095~q~5 ~1 7 ~ 5 3 2 PCT~S94/09469 .
Thickening silica (Sylox8.000 0.000 8.000 15.000 2) Sodium lauryl sulfate 1.200 0.300 0.500 0.330 ~odium lauroyl 0.000 1.000 1.670 1.000 5 sarcosinate (30% solution) Flavor 0.950 1.100 0.950 1.000 Color 0.004 0.005 0.005 0.003 TOTAL 100.00 100.00 100.00100.000 O O O
Approximate % of 100% 55~ 100% 50%
pyrophosphate which is in solution Ex~mple 19 This example shows the effect of sodium bicarbonate (NaHCO3) on the solubility of tetrasodium pyrophosphate.
Wt % of P2O7-4 in Solution With Saturated Without NaHCO3 NaHCO3 Distilled Water 4.03 1.77 Glycerin 0.04 0.12 70% Aqueous Sorbitol Solution 5.97 4.18 18% Aqueous Mannitol Solution - 2.09 60% Aqueous Xylitol Solution - 2.44 The results show that, in the presence of sufficient sodium bicarbonate to saturate the water, the solubility of the pyrophosphate ion (P2O7-4) was suppressed from 4.03~ to 1.77%. The results show that, in the absence of sodium W095/064S5 ~ 7 ~ 5 3 ~ PCT~S9~91~9 bicarbonate, the pyrophosphate is more soluble in the 70%
aqueous sorbitol solution than it is in the distilled water.
While the presence of the bicarbonate in the aqueous sorbitol solution also suppressed the pyrophosphate solubility, the decrease was not as great as that observed with water. The pyrophosphate was not soluble in glycerin in either case. The results further show that other similar polyols, i.e., mannitol and xylitol, were not as effective as sorbitol, in increasing pyrophosphate solubility in the presence of bicarbonate.
~xamPle 20 This example shows the solubility of tetrasodium pyrophosphate in various dentifrice solvent systems saturated with sodium bicarbonate. The percent solubility of the pyrophosphate ion (P2O7-4) is given as weight %.
Water* ÇlYcerin* 70% Sorbitol Wt. ~ P2Q7-Solution 1 0 0 1.77 0 1 0 0.1 0 0 1 4.1 1/2 1/2 0 0.44 1/2 0 1/2 2.1 0 1/2 1/2 1.73 1/3 1/3 1/3 1.01 2/3 1/6 1/6 1.15 1/6 2/3 1/6 1.48 1/6 1/6 2/3 2.0~3 *Weight fraction of solvent system.
Woss/064SS 2 1 7 0 ~ 3 2 PCT~S94/09469 .
The results show that the best solubility (4.18%) was in the 70% aqueous sorbitol solution and the worst solubilities were in solvent systems cont~; n; ng no aqueous sorbitol solution (0.12% for glycerin and 0.44% for a glycerin/water mixture).
In addition to the levels and combinations of ingredients shown in these examples, others can be used which are consistent with the invention disclosed and claimed herein.
Claims (20)
1. A toothpaste consisting essentially of:
a. about 10-65% sodium bicarbonate;
b. an alkali metal pyrophosphate salt in an amount effective as an anti-tartar agent, of which amount at least 50% is dissolved in the toothpaste; and c. an aqueous solution of sorbitol, as a main liquid vehicle, in an amount which is sufficient to dissolve at least about 50% of the amount of the alkali metal pyrophosphate salt added and to provide the desired consistency to the toothpaste.
a. about 10-65% sodium bicarbonate;
b. an alkali metal pyrophosphate salt in an amount effective as an anti-tartar agent, of which amount at least 50% is dissolved in the toothpaste; and c. an aqueous solution of sorbitol, as a main liquid vehicle, in an amount which is sufficient to dissolve at least about 50% of the amount of the alkali metal pyrophosphate salt added and to provide the desired consistency to the toothpaste.
2. The toothpaste of Claim 1, wherein the amount of the alkali metal pyrophosphate salt is sufficieint to provide about 0.5-5% by weight of dissolved pyrophosphate ions.
3. The toothpaste of Claim 2, wherein the sodium bicarbonate is about 20-55%; wherein the pyrophosphate salt added is selected from the group consisting of tetrasodium pyrophosphate, disodium dihydrogen pyrophosphate, tetrapotassium pyrophosphate, and mixtures thereof; and wherein the aqueous sorbitol solution is about 70% aqueous.
4. The toothpaste of Claim 3, wherein the sodium bicarbonate is about 40-50%; wherein the pyrophosphate salt added is tetrasodium pyrophosphate present in an amount of about 1-10%, disodium dihydrogen pyrophosphate present in an effective amount of up to about 2%, or tetrapotassium pyrophosphate present in an effective amount of up to about 6%; and wherein the about 70% aqueous solution of sorbitol is about 30-70% of the toothpaste.
5. The toothpaste of Claim 4, wherein the about 70%
aqueous solution of sorbitol is about 40-60% of the toothpaste and wherein the pyrophosphate salt added is tetrasodium pyrophosphate in an amount of about 1-5%.
aqueous solution of sorbitol is about 40-60% of the toothpaste and wherein the pyrophosphate salt added is tetrasodium pyrophosphate in an amount of about 1-5%.
6. The toothpaste of Claim 5, wherein the amount of pyrophosphate ions present in the toothpaste is about 0.5-2%.
7. The toothpaste of Claim 2, further consisting essentially of:
added water in an effective amount up to about 30%;
a humectant other than sorbitol in an effective amount up to about 2%;
a water-insoluble abrasive in an effective amount up to about 40%;
an opacifying agent in an effective amount up to about 5%;
an organic thickener in an effective amount up to about 2%;
an inorganic thickener in an effective amount up to about 10%;
an effective amount of a surfactant;
an effective amount of a flavoring agent;
a sweetening agent in an effective amount up to about 5% ; and/or an effective amount of an anti-caries agent.
added water in an effective amount up to about 30%;
a humectant other than sorbitol in an effective amount up to about 2%;
a water-insoluble abrasive in an effective amount up to about 40%;
an opacifying agent in an effective amount up to about 5%;
an organic thickener in an effective amount up to about 2%;
an inorganic thickener in an effective amount up to about 10%;
an effective amount of a surfactant;
an effective amount of a flavoring agent;
a sweetening agent in an effective amount up to about 5% ; and/or an effective amount of an anti-caries agent.
8. The toothpaste of Claim 7, wherein the water is present in an effective amount up to about 6%; wherein the water-insoluble abrasive is calcium pyrophosphate present in an effective amount of up to about 8% or hydrated silica present in an effective amount of up to about 5.5%; the humectant is polyethylene glycol present in an effective amount of up to about 2%; wherein the opacifying agent is titanium dioxide; wherein the inorganic thickening agent is silica present in an effective amount of up to about 5%;
wherein the surfactant is sodium lauryl sulfate present in an amount of about 0.3-1.4% and sodium lauroyl sarcosinate, as a 30% solution, present in an amount of about 1.7%;
wherein the amount of the flavoring agent is about 0.05-2%;
wherein the sweetening agent is sodium saccharin present in an amount of about 0.5-0.8%, xylitol present in an effective amount of up to about 3%, or mannitol present in an effective amount of up to about 5%; wherein the anti-caries agent is a fluoride source present in an amount sufficient to provide about 50-3500 ppm of fluoride ions and is selected from the group consisting of sodium fluoride and sodium monofluorophosphate.
wherein the surfactant is sodium lauryl sulfate present in an amount of about 0.3-1.4% and sodium lauroyl sarcosinate, as a 30% solution, present in an amount of about 1.7%;
wherein the amount of the flavoring agent is about 0.05-2%;
wherein the sweetening agent is sodium saccharin present in an amount of about 0.5-0.8%, xylitol present in an effective amount of up to about 3%, or mannitol present in an effective amount of up to about 5%; wherein the anti-caries agent is a fluoride source present in an amount sufficient to provide about 50-3500 ppm of fluoride ions and is selected from the group consisting of sodium fluoride and sodium monofluorophosphate.
9. A tooth gel consisting essentially of:
a. about 10-50% sodium bicarbonate;
b. an alkali metal pyrophosphate salt present in an amount which is effective as an anti-tartar agent, of which amount at least 50% is dissolved in the tooth gel; and c. an aqueous solution of sorbitol, as a main liquid vehicle, in an amount which is sufficient to dissolve at least about 50% of the amount of the alkali metal pyrophosphate salt added and to provide the desired con-sistency to the tooth gel.
a. about 10-50% sodium bicarbonate;
b. an alkali metal pyrophosphate salt present in an amount which is effective as an anti-tartar agent, of which amount at least 50% is dissolved in the tooth gel; and c. an aqueous solution of sorbitol, as a main liquid vehicle, in an amount which is sufficient to dissolve at least about 50% of the amount of the alkali metal pyrophosphate salt added and to provide the desired con-sistency to the tooth gel.
10. The tooth gel of Claim 9, wherein the amount of the alkali metal pyrophosphate salt is sufficient to provide about 0.5-6% by weight of dissolved pyrophosphate ions.
11. The tooth gel of Claim 10, wherein the sodium bicarbonate is about 10-40%; wherein the pyrophosphate salt added is selected from the group consisting of tetrasodium pyrophosphate, disodium dihydrogen pyrophosphate, tetrapotassium pyrophosphate, and mixtures thereof; and wherein the aqueous sorbitol solution is an about 70%
aqueous sorbitol solution.
aqueous sorbitol solution.
12. The tooth gel of Claim 11, wherein the sodium bicarbonate is about 20-35%; wherein the pyrophosphate salt added is tetrasodium pyrophosphate present in an amount of about 1-10%, disodium dihydrogen pyrophosphate present in an effective amount of up to about 12%, or tetrapotassium pyrophosphate present in an effective amount of up to about 6%; and wherein the about 70% aqueous solution of sorbitol is about 30-70% of the tooth gel.
13. The tooth gel of Claim 12, wherein the about 70%
aqueous solution of sorbitol is about 35-60%; wherein the added tetrasodium pyrophosphate is about 1-5%; and wherein the amount of pyrophosphate ions present in the tooth gel is about 0.5-2%.
aqueous solution of sorbitol is about 35-60%; wherein the added tetrasodium pyrophosphate is about 1-5%; and wherein the amount of pyrophosphate ions present in the tooth gel is about 0.5-2%.
14. The tooth gel of Claim 9, further consisting essentially of:
added water in an effective amount up to about 10%;
a water-insoluble abrasive in an effective amount up to about 20%;
an organic thickener in an effective amount up to about 2%;
an inorganic thickener in an effective amount up to about 15%;
an effective amount of a surfactant;
an effective amount of a flavoring agent;
a sweetening agent in an effective amount up to about 5% ; and/or an effective amount of an anti-caries agent.
added water in an effective amount up to about 10%;
a water-insoluble abrasive in an effective amount up to about 20%;
an organic thickener in an effective amount up to about 2%;
an inorganic thickener in an effective amount up to about 15%;
an effective amount of a surfactant;
an effective amount of a flavoring agent;
a sweetening agent in an effective amount up to about 5% ; and/or an effective amount of an anti-caries agent.
15. The tooth gel of Claim 14, wherein the water is present in an effective amount about 6%; wherein the humectant is polyethylene glycol present in an amount of about 1-2%; wherein the thickeners are carboxymethyl cellulose present in an amount of about 0.3-0.6% and/or silica present in an amount of about 10-20%; wherein the surfactant is sodium lauryl sulfate and/or sodium lauroyl sarcosinate present in an amount of up to about 1.7%;
wherein the flavoring agent is present in an amount of about 0.05-2%; wherein the sweetening agent is sodium saccharin present in an amount of about 0.5-0.8%, xylitol present in an effective amount of up to about 5%, or mannitol present in an effective amount of up to about 5%; and wherein the anti-caries agent is a fluoride source present in an amount sufficient to provide about 50-3500 ppm of fluoride ions and is selected from the group consisting of sodium fluoride and sodium monofluorophosphate.
wherein the flavoring agent is present in an amount of about 0.05-2%; wherein the sweetening agent is sodium saccharin present in an amount of about 0.5-0.8%, xylitol present in an effective amount of up to about 5%, or mannitol present in an effective amount of up to about 5%; and wherein the anti-caries agent is a fluoride source present in an amount sufficient to provide about 50-3500 ppm of fluoride ions and is selected from the group consisting of sodium fluoride and sodium monofluorophosphate.
16. A method for preventing tartar formation on dental enamel which comprises contacting the enamel surface in the mouth with a dentifrice selected from the group consisting of a toothpaste and a tooth gel, which dentifrice consists essentially of sodium bicarbonate, an alkali metal pyrophosphate salt, and an aqueous sorbitol solution, with the amount of pyrophosphate salt dissolved in the toothpaste or the tooth gel being sufficient to provide about 0.5-2%
pyrophosphate ions.
pyrophosphate ions.
17. The method of Claim 16, wherein the sodium bicarbonate is present in an amount of about 10-65% in the toothpaste or about 10-50% in the tooth gel; wherein the pyrophosphate salt is selected from the group consisting of tetrasodium pyrophosphate, disodium dihydrogen pyrophosphate, tetrapotassium pyrophosphate, and mixtures thereof; and wherein the aqueous sorbitol solution is an about 70% solution present in an amount of about 30-70% of the toothpaste or the tooth gel.
18. A method of improving the solubility of an alkali metal pyrophosphate salt in a sodium bicarbonate-containing dentifrice, selected from the group consisting of a toothpaste and a tooth gel, by adding an aqueous solution of sorbitol, as a main liquid vehicle, to the toothpaste or the tooth gel to dissolve about 50% the pyrophosphate salt formed in the toothpaste or the tooth gel in the presence of the sodium bicarbonate.
19. The method of Claim 18, wherein the sodium bicarbonate is present in an amount of about 10-65% in the toothpaste or about 5-50% in the tooth gel; wherein the aqueous solution of sorbitol is a 70% aqueous solution used in an amount sufficient to dissolve at least 50% of the pyrophosphate salt added to the dentifrice; and wherein the pyrophosphate salt is selected from the group consisting of tetrasodium pyrophosphate, disodium dihydrogen pyrophosphate, and tetrapotassium pyrophosphate and mixtures thereof.
20. The method of Claim 19, wherein the amount of dissolved pyrophosphate is about 0.5-5% by weight.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11437193A | 1993-08-30 | 1993-08-30 | |
| US08/114,372 US5376360A (en) | 1993-08-30 | 1993-08-30 | Baking soda toothpaste containing soluble pyrophosphate salts |
| US08/114,372 | 1993-08-30 | ||
| US08/114,371 | 1993-08-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2170532A1 true CA2170532A1 (en) | 1995-03-09 |
Family
ID=26812112
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2170532 Abandoned CA2170532A1 (en) | 1993-08-30 | 1994-08-29 | Baking soda toothpaste and tooth gel containing soluble pyrophosphate salts |
Country Status (3)
| Country | Link |
|---|---|
| AU (1) | AU7636094A (en) |
| CA (1) | CA2170532A1 (en) |
| WO (1) | WO1995006455A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021063384A1 (en) * | 2019-09-30 | 2021-04-08 | The Procter & Gamble Company | Dentifrice compositions comprising bicarbonate salt and neutral amino acid |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11304888B2 (en) | 2019-04-29 | 2022-04-19 | Sunstar Americas, Inc. | Oral care composition |
| CN113967173A (en) * | 2020-07-24 | 2022-01-25 | 高露洁-棕榄公司 | Oral care compositions comprising sodium lauroyl sarcosinate and betaine |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3927202A (en) * | 1973-01-29 | 1975-12-16 | Colgate Palmolive Co | Dentifrices |
| CA1023666A (en) * | 1973-01-29 | 1978-01-03 | Eric Baines | Transparent dentifrices |
| US4340583A (en) * | 1979-05-23 | 1982-07-20 | J. M. Huber Corporation | High fluoride compatibility dentifrice abrasives and compositions |
| US4690776A (en) * | 1985-02-27 | 1987-09-01 | Smigel Irwin E | Method of manufacture of a toothpaste composition |
| US4623536A (en) * | 1985-06-13 | 1986-11-18 | Church & Dwight Co., Inc. | Sodium bicarbonate containing toothpaste |
| US4603046A (en) * | 1985-08-23 | 1986-07-29 | Charles Of The Ritz Group Ltd. | Improved sunscreen or sunblock composition |
| US4966777A (en) * | 1985-09-13 | 1990-10-30 | Colgate-Palmolive Company | Anticalculus oral composition |
| GB8608565D0 (en) * | 1986-04-05 | 1986-05-14 | Beecham Group Plc | Oral hygiene compositions |
| GB8615534D0 (en) * | 1986-06-25 | 1986-07-30 | Beecham Group Plc | Composition |
| US5041280A (en) * | 1987-10-01 | 1991-08-20 | Epilady Usa, Inc. | Toothpaste composition for stain removal |
| US4943429A (en) * | 1988-05-23 | 1990-07-24 | Church & Dwight Co., Inc. | Dentifrice gels containing sodium bicarbonate |
| US5180576A (en) * | 1991-08-30 | 1993-01-19 | Church & Dwight Co., Inc. | Anticalculus dentifrices |
| US5240697A (en) * | 1991-10-17 | 1993-08-31 | Colgate-Palmolive Company | Desensitizing anti-tartar dentifrice |
| US5215740A (en) * | 1991-10-25 | 1993-06-01 | Church & Dwight Co., Inc. | Buffering system for anticalculus dentifrices |
| US5290542A (en) * | 1993-04-08 | 1994-03-01 | The Procter & Gamble Company | Oral compositions for treating plaque and gingivitis |
| US5326554A (en) * | 1993-04-23 | 1994-07-05 | The Procter & Gamble Company | Oral compositions for treating plaque and gingivitis |
-
1994
- 1994-08-29 WO PCT/US1994/009469 patent/WO1995006455A1/en active Application Filing
- 1994-08-29 CA CA 2170532 patent/CA2170532A1/en not_active Abandoned
- 1994-08-29 AU AU76360/94A patent/AU7636094A/en not_active Abandoned
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021063384A1 (en) * | 2019-09-30 | 2021-04-08 | The Procter & Gamble Company | Dentifrice compositions comprising bicarbonate salt and neutral amino acid |
| CN114449995A (en) * | 2019-09-30 | 2022-05-06 | 宝洁公司 | Dentifrice composition comprising bicarbonate salt and neutral amino acid |
Also Published As
| Publication number | Publication date |
|---|---|
| WO1995006455A1 (en) | 1995-03-09 |
| AU7636094A (en) | 1995-03-22 |
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