MXPA06014976A - Dental compositions with sensitivity relief - Google Patents

Abstract

A one-component prescription fluoride treatment composition having both fluoride efficacy and sensitivity relief is disclosed. The composition includes at least one metal fluoride and a nerve desensitizing agent such as potassium nitrate. The invention further includes a composition having at least one metal fluoride less than about 1.15%by weight of at least one metal fluoride;less than about 5 percent by weight of at least one alkali metal salt having desensitizing effect;at least one carrier;and at least one foaming agent that has thickening property. The composition may be formulated into a gel, a paste or any other convenient form, some of which contain abrasives.

Description

DENTAL COMPOSITIONS WITH SENSITIVITY RELIEF FIELD OF THE INVENTION The present invention relates to improvements in tooth treatment compositions. In particular, this invention relates to compositions suitable for fluoride treatment and sensitivity alleviation.

BACKGROUND OF THE INVENTION Multiple attempts have been made to offer relief of dentine sensitivity. The stannous ion has been linked to the treatment of dentine hypersensitivity. US Patent No. 5,690,912 teaches that for the stannous ion to be effective in the treatment of dentine hypersensitivity, it must be stable and freely available and must not be in chemical combination with other ingredients. The patent discloses a preparation for oral hygiene containing SnF2 in combination with 87-97% by weight of anhydrous glycerin and 2-10% by weight of polyethylene glycol with an average molecular weight of 1000.

In addition SnF2, other materials generally known as "nerve agents" or "nerve desensitizing agents" have been used in the treatment of hypersensitive teeth. These agents, it is said, reduce the excitability of the nerve in a sensitive tooth, and one of the best known agents used in commercial toothpastes for sensitive teeth for this purpose is potassium nitrate, and is described in the Patent No. 3,863,006. Examples of other agents of this category may be other potassium salts such as potassium bicarbonate, potassium chloride and the like, as well as sodium and lithium nitrates.

Another approach to regulate dentinal hypersensitivity is the use of compounds to partially or completely occlude the tubules. Examples of these "tubule blocking agents" may be the following: filled polystyrene beads (US Patent No. 5,211,939); apatite (U.S. Patent No. 4,634,589); a polyacrylic acrylic polymer with a common molecular weight from about 450,000 to about 4,000,000 (US Patent No. 5,270,031); and some clays (US Patent No. 5,589,159). Still others have tried to treat the sensitivity of dentin by inducing the growth of minerals inside the dentinal tubules. Another approach (described in US Patent Nos. 5,735,942 and 5,891,233) is the use of bioactive glass to treat tooth sensitivity. In general, most of these inventions evidently present problems of incompatibility of the fluoride and the abrasive nature of these inorganic solids can also be a problem.

The efficacy of fluoride in caries prophylaxis is well established, and the topical application of aqueous solutions of some water-soluble fluorides is rather a routine procedure in dental offices and clinics. The toothpaste compositions having some fluorides have been recognized as effective against caries by the American Dental Association. It is also known that some metal ions, for example, stannous fluoride (SnF2), can have a significant effect on the anticariogenic efficacy of fluorides, and it has been used in orthodontics since 1950 to treat some oral states. Likewise, in the 1950s it was documented in the scientific literature that the use of a source of stannous ions together with fluoride gives a more effective anticariogenic product than that which obtains only fluorine (JC Muhler et al., JADA 51, 665 (nineteen ninety five)). Topical application of SnF2 has also consistently demonstrated drastic reductions in tooth decay activity with minimal adverse effect, it has also been clinically indicated to be effective in reducing dentinal hypersensitivity. This last therapeutic effect is considered due, to a large extent, to the stannous ion component (Sn2 +) of the salt. More recently, relatively low concentrations of In (III) have been shown to coact with fluorides to offer a high level of anticariogenic activity (US Patent No. 3,175,951, issued March 30, 1965).

US Patent No. 5,693,314 teaches that attempts to include mixtures of a desensitizing agent such as SnF2 with another source of sensitizer such as potassium nitrate in a single dentifrice composition are of limited effect. In addition, the prolonged contact between the SnF2 ion and the nitrate in a single dentifrice results in a reaction of these ions that produce potentially toxic materials. Thus, the solution is to keep the two sources of sensitizers separated from one another, and to combine them for the first time only on the surface of the tooth to avoid any appreciable formation of insoluble tin or reaction product of tin.

US Patent No. 5,932,192 again teaches a two-component tin salt and potassium salt composition, to prevent tin compounds from reacting with water and other common ingredients for oral care and forming insoluble tin. The specific levels of water content within the potassium salt component (at least 44% by weight) and the total oral content (at least 22% by weight) are said to reduce the astringency, acidity and acidity of the tin salt .

US Patent No. 6,416,745 teaches dental compositions and methods for the treatment of dentinal hypersensitivity based on anionic liposomes which are capable of inducing mineral formation in the dentinal tubules by blocking them partially or completely. The compositions of the liposomes and a suitable carrier are mentioned as being capable of providing additional agents useful in the treatment of dentinal hypersensitivity by combining tin fluoride directly with another desensitizing agent to further take advantage of the known anticariogenic and antimicrobial action of SnF2.

Thus, it is clear that those skilled in the relevant art realize that to take advantage of the efficacy of tin fluorides when adding additional desensitizing agents to a free-selling composition, a two-component system or agents such as liposomes are needed.

Therefore, it would be convenient to have a unicomponent composition that has the efficacy of fluoride and sensitivity relief that a dental professional can easily administer to the teeth of patients during office visits.

SUMMARY OF THE INVENTION The present invention relates to one-component prescription fluoride treatment compositions that have relief of the sensitivity and efficacy of fluoride.

In one embodiment, a composition contains an effective amount of at least one fluoride source for maximum efficiency, up to about 5% by weight of at least one alkali metal salt with desensitizing effect and a carrier.

In another embodiment, a composition contains an effective amount of at least one fluoride source for maximum efficiency; up to about 5% by weight of a mixture of at least one alkali metal salt having a desensitizing effect and an amorphous calcium and / or strontium phosphate; and a carrier.

The present invention also relates to the use of foaming agents that when present in small amounts can also act as thickening agents. Examples include a hydrophobic component and a hydrophilic component. The use of these foaming agents tends to decrease the amount of thickening agents normally used to formulate a toothpaste, dental gel or any other thickened state, and thus reduce any unwanted effects that the thickener could have on the efficacy of fluorides and / or the relief of sensitivity.

In one aspect, the optional additives include abrasives, thickeners, binders, additional carriers, surfactants, foaming agents, water, sweeteners, preservatives, vitamins, flavorings, coloring agents, anti-plaque agents, anti-staining compounds, pH adjusting agents. or mixtures of these may also be dispersed in the carrier, the amount or type depends on the physical form of the composition.

In another aspect, the compositions may be formulated in the form of toothpastes, gels, dentifrices to be brushed or applied to the teeth, in the form of mouth rinses or other forms of supply to be prescribed and / or administered by a dental professional. . Examples of the alternative forms can be a dental powder, a buccal adhesive patch, an oral spray, some coating that can adhere to the oral cavity and the like.

The present invention, together with the above advantages and others, can be better understood from the following detailed description of the embodiments of the following invention.

DETAILED DESCRIPTION OF THE INVENTION The detailed description set forth below is proposed as a description, however, it should be understood that the same or equivalent functions and components may be incorporated and these other modalities are also intended to be included within the spirit and scope of the invention. invention.

Unless otherwise indicated, all technical and scientific terms used herein have the same meaning commonly understood for a person skilled in the art to which this invention pertains. Although some methods, devices and materials similar or equivalent to those described herein may be used in the practice or testing of the invention, the exemplified methods, devices and materials are now described.

The fluoride sources are effective in the treatment of dental caries can be the metal fluoride salts such as sodium fluoride, sodium monofluorophosphate, potassium fluoride, lithium fluoride, ammonium fluoride, tin fluoride; zinc ammonium fluoride, tin fluoride ammonium, calcium fluoride and ammonium cobalt fluoride, and water soluble amine hydrofluorides. In general, useful examples are sodium fluoride and tin fluoride.

It is well known in the art that the effectiveness of fluoride treatment depends on the solubility of the fluoride compound and the availability of the fluoride ions, as the primary method of analyzing the efficacy of fluoride in a clinical sense is to measure "total" fluoride and "available." For example, the total fluoride of the compositions of the present invention is at least about 5000 ppm, and more, for example, the total fluoride of the composition is at least about 5300 ppm. The available fluoride ion is at least, for example, about 4900 ppm, more eg about 5000 ppm.

Although acid fluoride solutions are among the most effective in delivering fluoride ions, they can usually also cause tooth demineralization. The pH of the composition in this way is maintained at about 5.5 or greater, or better, to stay between about 7 to about 8.5. The addition of some metal ions such as indium III, however, has been shown to prevent demineralization at low pH by decreasing the enamel solubility, so its use can potentially extend the possible pH range that will be used.

In general, pH ranges can be achieved by including a pH adjusting agent in the composition. Exemplary adjusters may be those that do not interfere with the activity of the fluorides and may include potassium hydroxide or hydrochloric acid. The least desirable, although useful in some cases, are those that can potentially impede or impede fluoride activity, such as tetrapotasium pyrophosphate phosphates and nitrates.

The amount of the fluoride source that is used in the present invention to provide maximum efficiency is, for example, up to about 1.2% by weight and more, for example, up to about 1.15% by weight.

Suitable desensitizing agents may include alkali nitrates such as potassium nitrate, sodium nitrate and lithium nitrate; and other potassium salts such as potassium chloride and potassium bicarbonate. The most commonly used can be potassium nitrate.

The percentage of desensitizing agent can be present up to, for example, about 5% by weight, more, for example, up to about 4% by weight and even more, for example, up to about 3% by weight. At these exemplary levels, the efficacy of fluoride does not deteriorate significantly. However, when the amount present is significantly above 5%, some degradation of the fluoride efficiency is observed.

The presence of additional metal salts, such as salts which desensitizing effects, is generally considered to inhibit the solubility of the fluoride salt and hence the efficacy of the fluoride treatment. Since the prescription type dental composition usually contains at least 3 to 4 times the amount of fluoride normally present in an over-the-counter toothpaste, it is also reasonable to believe that its higher level of efficacy will be severely compromised if other salts are present. , thus frustrating the purpose of having a higher concentration of fluoride in the first place. Based on the foregoing, any of the salts that can impede or potentially impede the activity of fluoride, such as tetrapotasium pyrophosphate phosphates, and nitrates, although not present in significant amounts to damage pH-adjusting properties, are not generally recommended. as pH adjusting agents, as described above.

Surprisingly, the present inventors have found that when the percentage of the desensitizing salts is present, for example, in less than about 5% or any of the above-mentioned desirable amounts, the efficacy of the fluoride is retained or affected in a minimal amount.

Furthermore, it is also surprising and contrary to the above teaching that the fluoride and the desensitizing agent can be formulated in a unicomponent composition without the presence of agents such as liposomes that are designed to keep the fluoride material separate from the desensitizing agent until the time of use. .

In addition, of the aforementioned desensitizing agents, it is also possible to use amorphous calcium compounds such as amorphous calcium phosphate (ACP), amorphous calcium fluoride phosphate (ACPF) and amorphous calcium carbonate phosphate (ACCP), amorphous calcium carbonate phosphate ( ACCP), amorphous calcium fluoride carbonate phosphate (ACCPF) or mixtures thereof. These agents can also remineralize the teeth, collectively known herein as "amorphous calcium phosphates". These amorphous compounds are described in U.S. Patent Nos. 5,037,639, 5,268,167, 5,437,857, 5,562,895, 6,000,341 and 6,056,930, the description of each of which is hereby incorporated by reference in its entirety.

In addition to the amorphous calcium compounds, the amorphous strontium compounds such as amorphous strontium phosphate (ASP), amorphous strontium fluoride phosphate (ASPF), amorphous strontium calcium phosphate (ASCP), amorphous strontium calcium carbonate phosphate (ASCCP), amorphous strontium phosphate fluoride carbonate (ASCPF), amorphous calcium strontium phosphate carbonate (ASCCPF) and mixtures of these can also be used. These compounds are collectively "amorphous strontium phosphate" when used in the present. In addition, these can also be used as agents for remineralization, as already mentioned. These compounds are described in US Patent No. 5,534,244, the content of which is hereby incorporated by reference in its entirety.

Some of the above compounds can also be used to apply fluoride to the teeth. All previous amorphous compounds or solutions that form amorphous compounds, when applied on or in dental tissue, prevent and / or repair dental weakness, such as dental caries, exposed roots and dentine sensitivity.

Amorphous compounds are usually present separately, for example, a first component may include a source of phosphate and a second component may include a source of calcium or strontium. When the two components are mixed the phosphate source and the calcium source, strontium or mixture can combine to form amorphous calcium phosphate, which when applied to the teeth, can precipitate on the surface of the tooth where it can be incorporated into the hydroxyapatite , helping in the remineralization of tooth enamel, as well as decreasing sensitivity, as already mentioned. The discussion of remineralization can be found in US Patents Nos. 5,037,639, 5,268,167, 5,460,803, 5,534,244, 5,562,895, 6,000,341 and 6,056,930 mentioned above and incorporated herein by reference.

Although the source of calcium or strontium is kept separate from the phosphate source, a separate container or compartment is not the only way to effect separation. The separation can also be carried out by means of distance, or a separation that can consist of encapsulating the source of calcium or strontium in a capsule, layer or an immobilized medium, generally mentioned as a component, and the source of phosphate in another capsule, layer or an immobilized medium, also generally known as a component.

For example, the phosphate source may include monosodium phosphate (NatAPO,.), Disodium phosphate, tetrapotassium pyrophosphate and [lacuna] thereof. As already mentioned, the second component, for example, consists of a calcium or strontium source that combines with phosphate to form the different amorphous calcium and / or strontium phosphates.

The phosphate source is, for example, present in an amount from about 0.2% to about 2% by weight, in addition, for example between about 0.2% to about 1% by weight. These can be used alone or in combination with other sensitivity alleviating agents such as the aforementioned nitrates.

The source of calcium, strontium or combinations of these in the second component, for example, may include a calcium salt, a strontium salt and [lacuna] thereof, up to for example, a calcium salt such as calcium nitrate, in an amount from about 0.25% by weight to about 1.5% by weight, for example, about 0.3% to about 1% by weight.

In practice, it is convenient to include as much phosphate as possible without impairing the activity of the fluoride, in view of the fact that the phosphate salt can also act to adjust the pH of the composition, as already mentioned.

Carriers or humectants considered for use in the inventive compositions may include polyols such as glycerol, sorbitol, polyethylene glycols, propylene glycols, hydrogenated, partially hydrolyzed polysaccharides, and the like. A single carrier or a combination of carriers is also provided. The carriers are generally present in amounts up to, for example, about 80%, more for example, from about 15 to about 70, and even more for example about 25 to about 60% by weight for the paste formulations. of teeth.

The composition may also contain additional or optional ingredients, some of which are commonly or appropriately incorporated into the compositions for oral health care, depending on the form of the composition. These ingredients may be abrasives, thickeners, surfactants, foaming agents, binders, water, sweeteners, preservatives, vitamins, flavorings, coloring agents, anti-plaque agents, anti-staining compounds, pH adjusting agents and combinations of these.

Additional or optional ingredients may be to impart a particular function to the composition, for example, if the composition is desired to have an abrasive property, then abrasives are used. Suitable abrasives may include silicas and hydrates such as amorphous fumed silicas; alumina and hydrates thereof, such as alpha alumina trihydrate; silicates such as magnesium trisilicate, zirconium silicate, aluminosilicate such as calcined aluminosilicate and aluminum silicate; carbonates such as magnesium carbonate and calcium carbonate; polymethyl methacrylate; polyethylene powder; xerogels, hydrogels and silica aerogels and the like. Also suitable as abrasive agents are calcium pyrophosphate, insoluble sodium metaphosphate, dicalcium orthophosphate, particulate hydroxyapatite and the like. Depending on the form that the oral composition of the present invention is going to take, such as gel or paste, the abrasive agent or agents may be present in an amount up to, for example, 30% by weight, more eg, from about 1. to about 25% by weight, even more for example, from about 10 to about 25% by weight, particularly when the composition is formulated into a toothpaste.

At the same time, the thickeners can be added to the composition to form, for example, a paste or a gel. Some silicas mentioned above can also function as a thickener. Other thickeners may include carrageenan, pectin, poloxamer, synthetic and natural waxes. When present, the thickener can be in a concentration, for example, from about 0.1 to about 20% by weight, more for example, from about 1 to about 15% by weight.

When abrasives are present to provide the composition with the desired abrasivity, the activity of the fluoride ions does not deteriorate in general. Although some of the abrasive materials, such as silicas, also thicken the composition if they are present in larger amounts, a composition containing more silica may not require other thickeners or may need less than other thickeners to produce a paste or gel. However, too much abrasive material, on the other hand, may not be desirable, not only because they may tend to impart excessive abrasion of the resulting composition, but also because an excessive amount of an abrasive material, especially silica, may tend to inhibit the activity. of fluoride.

The foaming agents can also be used in the composition. Especially useful foaming agents are those which include a hydrophilic component and a hydrophobic component, such as the copolymers of ethylene oxide and propylene oxide. Hydrophobic components can be present in the foaming compounds, for example, from about 30 to about 40% by weight, more for example, from about 31 to about 38% by weight and even more for example from about 33 to about 36% by weight. The combinations of the foaming agents having the aforementioned desirable characteristics may also be useful. Commercial examples may include pluronic P84, available from BASF Corporation (North Mount Olive, New Jersey, EOA).

Any material that can thicken and provide another additional desired function in a composition will be advantageous to a large extent if it does not impair the activity of the fluoride at the same time to a significant degree. Surprisingly, it was found that when a small amount of the exemplary foaming agent is added to the compositions of the present invention, it also provides a thickening effect, thereby in effect reducing the amount of thickeners required. Thus, any actual or potential harmful effects of fluoride that could be caused by the use of some thickeners or excessive ones are diminished. This thickener effect is also improved when some surfactants are also present.

Useful surfactants, such as soap, which may be anionic, nonionic, cationic, amphoteric and / or zwitterionic, may be present in amounts up to, for example, about 15%, more for example about 0.1 to about 15% , even more for example, about 0.25 to about 10% by weight. Anionic and / or nonionic surfactants are especially useful. These useful surfactants can be sodium lauryl sulfate, sodium lauroyl sarcocinate, sodium dodecylbenzenesulfonate and mixtures thereof, although it is also possible to use others.

It is also possible to use binders in the compositions of the invention. Suitable ones may include carboxymethylcellulose, carboxyethylcellulose, polyvinylpyrrolidone, hydroxyethylcellulose and hydroxypropylcellulose, as well as xanthan gums, Irish moss and tragacanth gum, carrageenan, pectin and mixtures thereof. The binders may be present in the amount, for example, from about 0.01 to about 10% by weight, more for example, about 0.1 to about 2% by weight. Some binders can also act as thickeners and vice versa, although binders in general can usually impart other properties, such as abrasion, the ability to bind and hold together other ingredients. Again, those chosen can include those that do not significantly impede the effectiveness of fluoride.

Any artificial sweetener, including saccharin, is suitable for inclusion to impart a sweet taste if desired, and may be present in concentrations, for example, from about 0.1 to about 5% by weight, more eg 0.2 to about 2% by weight.

In addition to sweeteners, the flavorings normally used in the dental formulation can be used and can include natural flavorings such as peppermint, and good grass, artificial flavors such as tutti fruti, grape, cherry and others. Appropriate flavors are usually included in low amounts, for example, from about 0.01 to about 5% by weight, more for example, from about 0.1 to about 2% by weight.

The compositions according to the present invention may contain antibacterial agents such as phenolics and salicylamides, and sources of some metal ions such as zinc, silver and tin, for example in the form of salt such as zinc chloride, copper and tin, and nitrate. silver. These are again present in small quantities when they are used.

The dyes / colorants suitable for compositions for oral health care, ie, FD blue & C # 1, yellow FD & C # 10, red FD & C # 40, et cetera, can be used in the present formulations also, if a composition with color is desired. Additional preservatives such as benzoates and sorbates, vitamins such as vitamins C and E, anti-plaque agents such as copper salts, strontium salts and magnesium salts may also be included.

Anti-staining compounds such as silicone polymers, herbal extracts and mixtures of these may also be present.

Except where otherwise indicated, references to toothpaste should be considered as applying to gels as well, and mouthwashes or mouthwashes include mouth rinses and similar preparations. Mouthwashes may include ethanol in a concentration of, for example, from 0 to 60%, more eg, from 5 to 30% by weight.

A dentifrice composition according to the present invention can be prepared by mixing the ingredients in any conventional manner, for example, by creating a gel with the water and gelling agent before the addition of the water soluble ingredients. The surfactant is then added before the addition of the hydrophobic ingredients with mixing. The mixture is then packaged in a conventional toothpaste container such as a tube. The compositions of the present invention are understood to be applied by a dental professional during a visit to the office, to the surface of the teeth by conventional brushing, coating, painting or other technique of direct or indirect application.

Although the present invention has been described, the present invention will also be described with reference to the following non-limiting examples.

EXAMPLES Method of analysis Determination of total fluoride: The analysis for total fluoride of the toothpaste was done with the procedure identified as number 1 in the monograph of the FDA with the updated procedures. The test was done in triplicate in a recent sample using direct potentiometry.

Slides of the full dentifrice in triplicate of 0.25 g of samples were diluted to 25 mL with deionized water. The slurries were stirred for 20 minutes to ensure uniform distribution. After the 1: 1 dilution with TISAB II (buffer for the adjustment of the total ionic strength), the solutions were analyzed to determine the fluoride content using a specific electrode for fluoride ions and a digital pH meter. In the same way, a fluoride standard curve was prepared as a control.

Determination of the soluble ionic fluoride: The analysis of the soluble ionic fluoride of the toothpaste was done with the procedure identified as number 29 in the monograph of the FDA with updated procedures. The analysis was done in triplicate in recent and aged samples (90 days at 37 ° C) using direct potentiometry. The intermediate analysis at 1:10 dilution was made to monitor the progress of the stability test.

Complete toothpaste in sample sizes of approximately 0.25 g, 2.5 g and 4 g of each of the samples were then layered with 25 mL (or 12 mL for 1: 3) deionized water (1: 100, 1:10 and 1 : 3 dilution) for exactly 5 minutes. The slurries were then immediately centrifuged for 10 minutes at 10,000 rpm. One (1) mL of each supernatant was added to 1 mL of TISAB II. The solutions were analyzed for fluoride using a specific electrode for fluoride ions and a digital pH meter. In the same way, a fluoride standard curve was prepared as a control. The mV values obtained in the samples were compared with the control.

Examples 1-2 These examples were made in the following manner with the components and their respective amounts as listed in Table 1.

The components of phase A were mixed in a Hobart mixer until - the CMC 2MXF (carboxymethylcellulose, available from Hercules Incorporated, Aqualon Division, Hercules Plaza (Wllmington, DE)) was dispersed in glycerin. Then, the ingredient of phase B with half the amount of water was mixed in a different mixer and heated to 55 ° C to better dissolve the components before the addition of phase B to phase A. The other Half of the water was used to rinse the container containing materials from phase B to phase A.

The zeodents (available from JM Huber Corporation, Edison, NJ) were intensively mixed until dispersed in the combination of phase A and phase B. when Pluronic P84 (an ethylene oxide / propylene oxide copolymer available from BASF Corporation, New Jersey), a foaming agent, the mixture thickened in evident form.

Then, the flavor and surfactant of phase D were added to the thickened dispersion with moderate mixing until dispersion. Finally, Extralarge Timicale Sparkle HOS (titanium dioxide / mica, available from Engelhard Corporation, Iselin, NJ) was added and mixed in vacuum to remove all air / foam.

The efficacy of fluoride was analyzed at the Institute of Oral Health Research at Indiana University (Indianapolis, IN) and the results are documented in Table 2.

Table 1 Table 2 Having described the invention with reference to the accompanying demonstrations and examples of the invention, it is contemplated that other changes may be made without departing from the spirit and scope of the invention as set forth in the appended claims.

MODALITIES OF THE INVENTION The first embodiment relates to a one-component prescription fluoride treatment composition which contains: an effective amount of at least one metal fluoride; to less than about 5% by weight of at least one desensitizing agent; and at least one carrier; characterized in that the composition provides sensitivity relief without harming the fluoride efficacy of the composition.

The composition for treatment of fluoride by prescription is characterized in that the carrier consists of a polyol.

The aforementioned fluoride treatment composition is characterized in that the polyol is selected from the group consisting of glycerol sorbitol, polyethylene glycols, propylene glycols, partially hydrolyzed, hydrogenated polysaccharides, and mixtures thereof.

The composition for fluoride treatment by prescription mentioned above is characterized in that the metal fluoride is sodium fluoride.

The composition for fluoride treatment by prescription mentioned above is characterized in that the metal fluoride constitutes up to 1.15% of the composition The aforementioned prescription fluoride treatment composition further contains at least one ingredient selected from the group consisting of abrasives, thickeners, binders, surfactants, foaming agents, water, sweeteners, preservatives, vitamins, flavorings, coloring agents, anti-aging agents. - Plate, anti-staining agents and pH adjusting agents.

The composition for fluoride treatment by prescription mentioned above is characterized in that the abrasive component is selected from a group consisting of silicas and hydrates thereof; alumina and hydrates thereof; silicates; aluminosilicate; carbonates; xerogels, hydrogels, silica aerogels; calcium pyrophosphate, insoluble sodium metaphosphate, dicalcium orthophosphate, particulate hydroxyapatite and mixtures thereof.

The above-mentioned fluoride treatment composition is characterized in that the abrasive component is selected from a group consisting of amorphous fumed silicas; alpha alumina trihydrate; magnesium trisilicate; zirconium silicate; Calcined aluminum silicate; Aluminum silicate; magnesium carbonate, calcium carbonate and mixtures of these.

The composition for fluoride treatment by prescription mentioned above is characterized in that the foaming agent consists of a hydrophobic and a hydrophilic component.

The composition for fluoride treatment by prescription mentioned above is characterized in that the foaming agent consists of a copolymer of ethylene oxide and propylene oxide.

The aforementioned fluoride treatment composition is characterized in that the hydrophobic component is present in about 30 to about 40%.

The aforementioned fluoride treatment composition is characterized in that the foaming agent is present in an amount of less than about 2%.

The second embodiment of the one-component prescription fluoride treatment composition contains: less than about 1.15% by weight of at least one metal fluoride; less than about 5% by weight of at least one desensitizing agent; at least one carrier; and at least one foaming agent having thickener property wherein the composition provides sensitivity relief without harming the efficacy of the composition's fluoride.

The composition for fluoride treatment by prescription mentioned above is characterized in that the foaming agent consists of a hydrophilic component and a hydrophobic component.

The aforementioned fluoride treatment composition is characterized in that the foaming agent is a copolymer of ethylene oxide and propylene oxide.

The aforementioned fluoride treatment composition is characterized in that the foaming agent is present in an amount of less than 2%.

The aforementioned fluoride treatment composition is characterized in that the hydrophobic component is present in about 30 to about 40 percent.

The composition for fluoride treatment by prescription mentioned above is characterized in that the propylene oxide is present in about 30 to about 40 percent The third embodiment of the one-component prescription fluoride treatment composition contains: up to about 1.15% by weight of at least one metal fluoride; up to about 5% by weight of at least one alkali metal salt having a desensitizing effect; at least one carrier; up to about 2% of at least one foaming agent having foaming and thickening effect; up to about 25% by weight of an abrasive agent; and up to about 1.5 percent of at least one surfactant selected from the group consisting of anionic, non-ionic and combinations thereof; wherein the composition provides sensitivity relief without harming the effectiveness of the composition's fluoride.

The composition for fluoride treatment by prescription mentioned above is characterized in that the foaming agent consists of the hydrophilic and hydrophobic components.

The composition for fluoride treatment by prescription mentioned above is characterized in that the foaming agent consists of the copolymer of ethylene oxide and propylene oxide. foaming agent and the surfactant provide the thickening effect.

The aforementioned fluoride treatment composition is characterized in that the surfactants are selected from a group consisting of sodium lauryl sulfate, sodium lauroyl sarcosinate, sodium dodecylbenzene sulfonate and combinations thereof.

The aforementioned fluoride treatment composition is characterized in that the total fluoride of the composition is at least 4,800 pp to about 5,000 ppm.

The aforementioned fluoride treatment composition is characterized in that the desensitizing agent is selected from the group consisting of alkali nitrates, potassium carbonates, potassium chloride, amorphous calcium phosphate, amorphous strontium phosphate and mixtures thereof.

The aforementioned fluoride treatment composition is characterized in that the alkali nitrates are selected from the group consisting of potassium nitrate, sodium nitrate and lithium nitrate.

The aforementioned fluoride treatment composition is characterized in that the desensitizing agent consists of amorphous calcium phosphate, amorphous strontium phosphate or mixtures of these in an amount up to about 1 weight percent.

Claims (19)

1. A composition for treatment of fluoride by prescription, unicomponent, containing: up to 1.15% of at least one metal fluoride; to less than about 5% by weight of at least one desensitizing agent; and at least one carrier. wherein the composition provides sensitivity relief without harming the effectiveness of the composition's fluoride.

2. The composition for treatment of fluoride by prescription of claim 1, characterized in that the carrier consists of a polyol.

3. The composition for treatment of fluoride by prescription of claim 2, characterized in that the polyol is selected from the group consisting of glycerol sorbitol, polyethylene glycols, propylene glycols, partially hydrolyzed, hydrogenated polysaccharides, and mixtures thereof.

4. The composition for treatment of fluoride by prescription of claim 1, 2 or 3, characterized in that the metal fluoride is selected from the group consisting of sodium fluoride, sodium monofluorophosphate, potassium fluoride, lithium fluoride, calcium fluoride and combinations of these.

5. The fluoride treatment composition by prescription of claim 1, 2, 3 or 4 characterized in that the composition contains from about 4900 ppm to about 5000 ppm of available fluoride.

6. The fluoride treatment composition by prescription of claim 1-5 further contains at least one ingredient selected from the group consisting of abrasives, thickeners, binders, surfactants, foaming agents, water, sweeteners, preservatives, vitamins, flavorings, coloring agents, anti-plaque agents, anti-staining agents and pH adjusting agents.

7. The composition for fluoride treatment by prescription of claim 6, characterized in that the abrasive component is selected from a group consisting of silicas and hydrates thereof; alumina and hydrates thereof; silicates; aluminosilicate; carbonates; polymethyl methacrylate; polyethylene powder; xerogels, hydrogels, silica aerogels; calcium pyrophosphate, insoluble sodium metaphosphate, dicalcium orthophosphate, particulate hydroxyapatite and mixtures thereof.

8. The composition for fluoride treatment by prescription of claim 7, characterized in that the abrasive component is selected from a group consisting of amorphous fumed silicas; alpha alumina trihydrate; magnesium trisilicate; zirconium silicate; Calcined aluminum silicate; Aluminum silicate; magnesium carbonate, calcium carbonate and mixtures of these.

9. The composition for treatment of fluoride by prescription of claim 6, 7 or 8, characterized in that the foaming agent consists of a hydrophobic and a hydrophilic component.

10. The composition for treatment of fluoride by prescription of claim 6, 1, 8 or 9, characterized in that the foaming agent consists of a copolymer of ethylene oxide and propylene oxide.

11. The composition for fluoride treatment by prescription of claim 10, characterized in that the hydrophobic component is present in about 30 to about 40%.

12. The composition for treatment of fluoride by prescription of claim 11, characterized in that the foaming agent is present in an amount of less than about 2%.

13. The one-component prescription fluoride treatment composition of claims 1-5, which contains: at least one carrier; up to about 2% of at least one foaming agent comprising the foaming and thickening effect; up to about 25% by weight of an abrasive agent; and up to about 1.5% of at least one surfactant selected from the group consisting of anionic, non-ionic and combinations thereof. wherein the composition provides sensitivity relief without affecting the efficacy of the composition's fluoride.

14. The composition for fluoride treatment by prescription of claim 13, characterized in that the combination of the foaming agent and surfactant provides the thickening effect.

15. The composition for treatment of fluoride by prescription of any of the preceding claims, characterized in that the total fluoride of the composition is at least about 4800 ppm at about 5000 ppm.

16. The fluoride treatment composition by prescription of any of claims 1-14, characterized in that the total fluoride of the composition is at least about 5000 ppm at about 5300 ppm.

17. The composition for treatment of fluoride by prescription of any of the preceding claims, characterized in that the desensitizing agent is selected from the group consisting of alkali nitrates, potassium carbonates, potassium chloride, amorphous calcium phosphate, amorphous strontium phosphate and mixtures of these.

18. The composition for treatment of fluoride by prescription of claim 17, characterized in that the alkali nitrates are selected from the group consisting of potassium nitrate, sodium nitrate and lithium nitrate.

19. The composition for fluoride treatment by prescription of claim 17, characterized in that the desensitizing agent consists of amorphous calcium phosphate, amorphous strontium phosphate or mixtures of these in an amount up to about 1% by weight.