Compositions comprising a potassium salt active ingredient, including oral compositions for reducing dental nerve and dentin sensitivity comprising a non-menthol flavoring Number:7,435,409 from the United States Patent and Trademark Office (PTO) owispatent

Title: Compositions comprising a potassium salt active ingredient, including oral compositions for reducing dental nerve and dentin sensitivity comprising a non-menthol flavoring

Abstract: The subject invention provides a detergent composition comprising an effective amount of a soluble potassium salt, a sodium (C.sub.8-C.sub.24) alkylsulfate in an amount effective to remove or loosen debris and/or stains from a surface, and a polar surfactant, said surfactant comprising a hydrophobic portion selected from a (C.sub.6-C.sub.30) alkyl group and a polymeric silicone group, wherein the molar ratio of the surfactant to the sodium (C.sub.8-C.sub.24) alkylsulfate is greater than or equal to about 1:1. Detergent compositions of the invention include oral compositions for removing and loosening plaque and/or stains from a dental surface and oral compositions for reducing dental nerve and/or dentin sensitivity. The subject invention further provides an oral composition for reducing dental nerve and/or dentin sensitivity comprising an effective amount of an ingredient that possesses activity in reducing dental nerve and/or dentin sensitivity, an orally-acceptable vehicle, and a flavoring that does not contain a substantial amount of menthol in an amount effective to provide flavor to said composition. The subject invention also provides a mint flavoring that does not comprise a substantial amount of menthol, said mint flavoring being either a dementholated natural mint extract or a synthetic blend.

Patent Number: 7,435,409 Issued on 10/14/2008 to Nelson,   et al.

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Inventors:	Nelson; Dennis G. A. (Mountain Lakes, NJ), Gallopo; Andrew R (Morris Plains, NJ)
Assignee:	McNeil-PPC, Inc. (New Brunswick, NJ)
Appl. No.:	11/378,168
Filed:	March 17, 2006

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Current U.S. Class:	424/49
Current International Class:	A61K 8/00 (20060101)
Field of Search:	424/49

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References Cited [Referenced By]

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U.S. Patent Documents

3627822	December 1971	Sunby
3863006	January 1975	Hodosh
3929579	December 1975	Yoshimura et al.
3985869	October 1976	Yoshimura et al.
4057621	November 1977	Pashley et al.
4283385	August 1981	Dhabbar et al.
4346493	August 1982	Goudsmit
4400373	August 1983	Hodosh
4432114	February 1984	Goudsmit
4581292	April 1986	Shinpo et al.
4618488	October 1986	Maeyama et al.
4631185	December 1986	Kim
4645662	February 1987	Nakashima et al.
4657758	April 1987	Golddemberg et al.
4751072	June 1988	Kim
4756903	July 1988	Shinpo
4933171	June 1990	Bristow et al.
4992258	February 1991	Mason
5015466	May 1991	Parran, Jr. et al.
5015467	May 1991	Smitherman
5043183	August 1991	Gershon et al.
5087444	February 1992	Jackson et al.
5098711	March 1992	Hill et al.
5153006	October 1992	Hodosh
5160737	November 1992	Friedman et al.
5165913	November 1992	Hill et al.
5178870	January 1993	Schaeken et al.
5182099	January 1993	Jonsson et al.
5188820	February 1993	Cummins et al.
5188822	February 1993	Viccaro et al.
5227154	July 1993	Reynolds
5229103	July 1993	Eagle et al.
5240696	August 1993	Van Der Ouderaa et al.
5240697	August 1993	Norfleet et al.
5242693	September 1993	Kurihara et al.
5252577	October 1993	Breuer et al.
5256402	October 1993	Prencipe et al.
5258173	November 1993	Waterfield
5270031	December 1993	Lim et al.
5275805	January 1994	Nabi et al.
5284648	February 1994	White
5296215	March 1994	Burke et al.
5310542	May 1994	Au et al.
5328682	July 1994	Pullen et al.
5338538	August 1994	Tricca et al.
5352439	October 1994	Norfleet et al.
5362480	November 1994	Au et al.
5374417	December 1994	Norfleet et al.
5403577	April 1995	Friedman
5409902	April 1995	Carson et al.
5416075	May 1995	Carson et al.
5437858	August 1995	Hungerbach et al.
5438076	August 1995	Friedman et al.
5449509	September 1995	Jackson et al.
5451401	September 1995	Zerby et al.
5486350	January 1996	Norfleet et al.
5487906	January 1996	Dixit et al.
5490978	February 1996	Spaltro et al.
5500448	March 1996	Cummins et al.
5503823	April 1996	Norfleet et al.
5505933	April 1996	Norfleet et al.
5522726	June 1996	Hodosh
5534243	July 1996	Dixon, Jr. et al.
5534244	July 1996	Tung
5560905	October 1996	Lukacovic
5565190	October 1996	Santalucia et al.
5571501	November 1996	Toy
5578293	November 1996	Prencipe et al.
5578294	November 1996	Lukacovic
5589159	December 1996	Markowitz et al.
5589160	December 1996	Rice
5597552	January 1997	Herms et al.
5599525	February 1997	Hsu et al.
5599527	February 1997	Hsu et al.
5603920	February 1997	Rice
5681549	October 1997	McLaughlin et al.
5686063	November 1997	McLaughlin et al.
5695745	December 1997	Barton et al.
5756074	May 1998	Ascione et al.
5827505	October 1998	Hughes et al.
5833956	November 1998	Gorlin et al.
6004538	December 1999	Hughes et al.
6015547	January 2000	Yam
6193958	February 2001	Edwards et al.
6432388	August 2002	Alvarez Hernandez
7153493	December 2006	Nelson et al.

Foreign Patent Documents

	1040819		Oct., 2000		EP
	8551380		Jun., 1980		JP
	11191187		May., 1987		JP
	2221690		Jan., 1990		JP
	9286094		Apr., 1994		JP
	1243897		Jan., 1997		JP
	17596697		Jul., 1997		JP
	9304663		Mar., 1993		WO
	9408559		Apr., 1994		WO
	9412599		Jun., 1994		WO
	9421767		Dec., 1994		WO
	9421768		Dec., 1994		WO
	9421770		Dec., 1994		WO

Primary Examiner: Gitomer; Ralph
Attorney, Agent or Firm: Little; Darryl C. Federman; Evan J.

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Claims

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What is claimed is:

1. An oral liquid composition for reducing nerve sensitivity comprising: (a) from about 0.01% by weight to about 5% by weight of an orally-acceptable, soluble potassium salt; (b) from about 0.01% by weight to about 10% by weight of a sodium (C.sub.8-C.sub.24) alkylsulfate; (c) from about 0.01% by weight to about 20% by weight of an orally-acceptable polar surfactant, said surfactant selected from the group consisting of a C.sub.6-C.sub.30), fatty acid mono or diester of ethoxylated sorbitan, a (C.sub.6-C.sub.30) fatty acid diester of polyethylene glycol, a sodium salt of a (C.sub.6-C.sub.30) fatty acyl sarcosinate, a (C.sub.6-C.sub.30) fatty acyl ester of sarcosine acid, a sodium salt of a (C.sub.6-C.sub.30) fatty acyl taurate, a sodium salt of a (C.sub.6-C.sub.30) fatty acyl methyltaurate, a (C.sub.6-C.sub.30) fatty acyl ester of taurine, a (C.sub.6-C.sub.30) fatty acyl ester of methyltaurine acid, a (C.sub.6-C.sub.30) fatty acyl betaine, a (C.sub.6-C.sub.30) fatty acyl quaternary ammonium chloride, dimethicone copolyols, polydimethylsiloxane phosphate esters, polydimethylsiloxane copolyol phosphate esters, polydimethylsiloxane phosphobetaines, polydimethylsiloxane copolyol phosphobetaines, polydimethylsiloxane taurates, polydimethylsiloxane copolyol taurates, acetylated polydimethylsiloxane copolyols, and polydimethylsiloxane quaternium compounds, polydimethylsiloxane copolyol quaternium compounds; and (d) an orally-acceptable aqueous vehicle comprising from about 50% by weight to about 85% by weight water; wherein the potassium salt is dissolved in the composition and wherein the molar ratio of the surfactant of (c) to the sodium (C.sub.8-C.sub.24) alkylsulfate is greater than or equal to about 1:1 such that when a.), b.), c) are dissolved in d.), the resultant composition is free of visible potassium alkyl sulfate precipitates.

2. The oral liquid composition according to claim 1, wherein the soluble potassium salt of the composition comprises a potassium pyrophosphate salt in an amount effective, optionally in combination with other pyrophosphate salts, to remove or loosen plaque and/or stains when the composition is orally applied to a dental surface.

3. The oral liquid composition according to claim 2, wherein the soluble potassium salt of the composition comprises soluble potassium salt that possesses activity in reducing dental nerve and/or dentin sensitivity in an amount effective to reduce dental nerve and/or dentin sensitivity when the composition is orally applied to a dental surface.

4. The oral liquid composition according to claim 3, wherein the soluble potassium salt that possesses activity in reducing dental nerve and/or dentin sensitivity is potassium nitrate.

5. The oral liquid composition according to claim 4, further comprising a flavoring that does not comprise a substantial amount of menthol.

6. The oral liquid composition according to claim 5 wherein the flavoring that does not comprise a substantial amount of menthol is a mint flavoring.

7. The oral liquid composition according to claim 1, wherein the soluble potassium salt is selected from the group consisting of a potassium pyrophosphate salt, potassium nitrate, and mixtures thereof.

8. An oral composition in the form of a rinse for reducing dental nerve and/or dentin sensitivity comprising (a) from about 0.1% to about 5% potassium nitrate; (b) from about 0.02% to about 2% SLS; (c) from about 0.1% to about 20% by weight of an orally-acceptable polar surfactant, said surfactant selected from the group consisting of a (C.sub.6-C.sub.30) fatty acid mono diester of ethoxylated sorbitan, a (C.sub.6-C.sub.30) fatty acid diester of polyethylene glycol, a sodium salt of a (C.sub.6-C.sub.30) fatty acyl sarcosinate, a (C.sub.6-C.sub.30) fatty acyl ester of sarcosine acid, a sodium salt of a (C.sub.6-C.sub.30) fatty acyl taurate, a sodium salt of a (C.sub.6-C.sub.30) fatty acyl methyltaurate, a (C.sub.6-C.sub.30) fatty acyl ester of taurine, a (C.sub.6-C.sub.30) fatty acyl ester of methyltaurine acid, a (C.sub.6-C.sub.30) fatty acyl betaine, a (C.sub.6-C.sub.30) fatty quaternary ammonium chloride, dimethicone copolyols, polydimethylsiloxane phosphate esters, polydimethylsiloxane copolyol phosphate esters, polydimethylsiloxane phosphobetaines, polydimethylsiloxane, copolyol phosphobetaines, polydimethylsiloxane taurates, polydimethylsiloxane copolyol taurates, acetylated polydimethylsiloxane copolyols, and polydimethylsiloxane quaternium compounds, polydimethylsiloxane copolyol quaternium compounds; and (d) an orally-acceptable aqueous vehicle comprising from about 50% by weight to about 85% by weight water; wherein the potassium salt is dissolved in the composition and wherein the molar ratio of the surfactant of (c) to the sodium (C.sub.8-C.sub.24) alkylsulfate is greater than or equal to about 1:1 such that when a.), b.), c.) are dissolved in d.), the resultant composition is free of visible potassium alkyl sulfate precipitates.

9. An oral composition in the form of a rinse for removing or loosening plaque and/or stains from dental surfaces comprising (a) from about 0.1% to about 5% of a potassium salt selected from the group consisting of dipotassium pyrophosphate, tetrapotassium pyrophosphate, tripotassium pyrophosphate, monopotassium pyrophosphate, and combinations thereof; (b) from about 0.02% to about 2% SLS; (c) from about 0.1% to about 20% by weight of an orally-acceptable polar surfactant, said surfactant selected from the group consisting of a (C.sub.6-C.sub.30) fatty acid mono or diester of ethoxylate sorbitan, a (C.sub.6-C.sub.30) fatty acid diester of polyethylene glycol, a sodium salt of a (C.sub.6-C.sub.30) fatty acyl sarcosinate, a (C.sub.6-C.sub.30) fatty acyl ester of sarcosine acid, a sodium salt of a (C.sub.6-C.sub.30) fatty acyl taurate, a sodium salt of a (C.sub.6-C.sub.30) fatty acyl methyltaurate, a (C.sub.6-C.sub.30) fatty acyl ester of taurine, a (C.sub.6-C.sub.30) fatty acyl ester of methyltaurine acid, a (C.sub.6-C.sub.30) fatty acyl betaine, a (C.sub.6-C.sub.30) fatty acyl quaternary ammonium chloride, dimethicone copolyols, polydimethylsiloxane phosphate esters, polydimethylsiloxane copolyol phospohate esters, polydimethylsiloxane phosphobetaines, polydimethylsiloxane copolyol phosphobetaines, polydimethylsiloxane taurates, polydimethylsioxane copolyol taurates, acetylated polydimethylsiloxane copolyols, and polydimethylsiloxane quaternium compounds, polydimethylsiloxane copolyol quaternium compounds; and (d) an orally-acceptable aqueous vehicle comprising from about 50% by weight to about 85% by weight water; wherein the potassium salt is dissolved in the composition and wherein the molar ratio of the surfactant of (c) to the sodium (C.sub.8-C.sub.24)alkylsulfate is greater than or equal to about 1:1 such that when a.), b.), c.) are dissolved in d.), the resultant composition is free of visible potassium alkyl sulfate precipitates.

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Description

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This application claims the benefit of U.S. patent application Ser. No. 10/630,526, filed on Jul. 30, 2003 now U.S. Pat. No. 7,153,493 which claims the benefit to U.S. patent application Ser. No. 10/042,712, filed on Mar. 21, 2002 now abandoned, which claims the benefit of U.S. patent application Ser. No. 09/503,431, filed on Feb. 14, 2000 now abandoned, which claims the benefit of U.S. Provisional Patent Application No. 60/124,258, filed on Mar. 12, 1999, the entirety of which is hereby incorporated by reference as if fully set forth herein.

FIELD OF THE INVENTION

The present invention relates to detergent compositions useful in the healthcare and hard surface and fabric cleaning fields.

BACKGROUND OF THE INVENTION

Sodium alkylsulfate surfactants, e.g., sodium lauryl sulfate (SLS), are generally not substantially compatible with compounds that contain potassium because an insoluble potassium alkyl sulfate precipitate forms when the sodium alkylsulfate is combined with a potassium salt. While the solubility of SLS in water is about 10% on a gram per gram basis experiments indicate that the solubility of potassium lauryl sulfate is less than approximately 0.02%.

Thus, many aqueous compositions which contain SLS cannot contain a potassium salt which might otherwise be useful as an active ingredient. If the potassium salt and SLS do coexist in a composition the usefulness of that potassium salt is not being optimized since a portion of the potassium ion of the salt is being occupied in the insoluble potassium lauryl sulfate precipitate. Alternatively, if a potassium salt is a required ingredient in a composition nonionic surfactants can be used instead of SLS to avoid a potassium lauryl sulfate precipitation. However, such nonionic surfactants are in many instances not as effective as SLS as wetting or cleaning agents. For example, oral care compositions which contain nonionic surfactants instead of SLS are not as effective in removing dental plaque. It would thus be beneficial in the healthcare and surface and fabric cleaning fields if SLS could be combined with a potassium salt without forming an insoluble potassium lauryl sulfate precipitate.

Numerous potassium salts are useful in detergent compositions. Potassium pyrophosphate salts, for example, can have detergent building activity in detergent compositions that comprise a wetting agent such as SLS. However, the detergent building activity of the potassium pyrophosphate salt in such compositions may not be optimal due to the formation of the potassium lauryl sulfate precipitate described above. For example, U.S. Pat. No. 5,338,538 to Tricca et al. relates to liquid compositions for loosening and removing plaque that comprise SLS and a detergent builder selected from dialkali metal pyrophosphate salts, tetraalkali metal pyrophosphate salts, and mixtures thereof. The preferred pyrophosphate salts are disodium pyrophosphate and tetrasodium pyrophosphate. It may be useful to be able to add potassium pyrophosphate salts to compositions such as those referred to in U.S. Pat. No. 5,338,538. This is because potassium pyrophosphate salts can be more soluble than sodium pyrophosphate salts and a higher concentration of pyrophosphate in solution could, thus, be achieved. Also, replacing all or some sodium pyrophosphate salt with potassium pyrophosphate would reduce the sodium content of the oral composition, which some consumers may find preferable.

Furthermore, many potassium salts possess therapeutic activities which are useful in healthcare compositions. For example, several potassium salts are believed to possess activity in reducing dental nerve and/or dentin sensitivity. Such potassium salts could therefore be included in oral compositions designed for the treatment of sensitive teeth and gums. U.S. Pat. No. 4,751,072 to Kim, for example, relates to a method for reducing sensory nerve activity in hypersensitive teeth and for desensitizing hypersensitive dentin that involves applying a potassium salt selected from potassium bicarbonate and potassium chloride. Also, U.S. Pat. No. 5,403,577 to Friedman refers to a sustained-release oral composition for treating and preventing dental hypersensitivity comprising an anti-hypersensitivity agent selected from a group of active ingredients including potassium nitrate, potassium bicarbonate, and potassium chloride. Moreover, potassium ions are believed to block nerve conduction in vitro (Peackock, J., and Orchardson, R., 1995, J. Dent. Res. 74(2):634-641). However, any SLS present in such a sensitivity composition comprising a potassium salt may result in the formation of the aforementioned insoluble potassium lauryl sulfate precipitate.

SUMMARY OF THE INVENTION

The subject invention provides an oral composition comprising:

a) from about 0.01% by weight to about 20% by weight of an active ingredient which is an orally-acceptable, soluble potassium salt;

b) from about 0.01% by weight to about 10% by weight of a sodium (C.sub.8-C.sub.24) alkylsulfate;

c) from about 0.01% by weight to about 20% by weight of an orally-acceptable polar surfactant, said surfactant comprising a hydrophobic portion selected from a (C.sub.6-C.sub.30) alkyl group and a polymeric silicone group; and

d) an orally-acceptable aqueous vehicle;

wherein the molar ratio of the surfactant of (c) to the sodium (C.sub.8-C.sub.24) alkylsulfate of (b) is greater than or equal to about 1:1.

The subject invention further provides an oral composition as recited above, suitable for loosening or removing plaque and/or stains present on dental surfaces, wherein the soluble potassium salt of the composition comprises a potassium pyrophosphate salt in an amount effective, optionally in combination with other pyrophosphate salts, to remove or loosen plaque and/or stains when the composition is orally applied to a dental surface.

The subject invention further provides an oral composition as recited above, suitable for reducing dental nerve and/or dentin sensitivity, wherein the soluble potassium salt of the composition comprises a potassium salt capable of reducing dental nerve and/or dentin sensitivity in an amount effective to reduce dental nerve and/or dentin sensitivity when the composition is orally applied to a dental surface.

The subject invention further provides an oral composition for reducing dental nerve and/or dentin sensitivity comprising an effective amount of an ingredient that possesses activity in reducing dental nerve and/or dentin sensitivity, an orally-acceptable vehicle, and a flavoring that does not contain a substantial amount of menthol, said flavoring in an amount effective to provide flavor to said composition.

The subject invention further provides a mint flavoring that does not comprise a substantial amount of menthol, said mint flavoring being either a dementholated natural mint extract or a synthetic blend.

The subject invention further provides an aqueous detergent composition comprising an effective amount of an active ingredient that is a soluble potassium salt, a sodium (C.sub.8-C.sub.24) alkylsulfate in an amount effective to remove or loosen debris and/or stains from a surface, and a polar surfactant, said surfactant comprising a hydrophobic portion selected from a (C.sub.6-C.sub.30 ) alkyl group and a polymeric silicone group, wherein the molar ratio of the surfactant to the sodium (C.sub.8-C.sub.24) alkylsulfate is greater than or equal to about 1:1.

The subject invention further provides a method for inhibiting the formation of a potassium alkylsulfate precipitate in an aqueous composition comprising a soluble potassium salt and a sodium (C.sub.8-C.sub.24) alkylsulfate, which method comprises including a polar surfactant in said composition in an amount of about equal to or greater than the amount of sodium (C.sub.8-C.sub.24) alkylsulfate in the composition, which polar surfactant comprises a hydrophobic portion selected from the group consisting of a (C.sub.6-C.sub.30) alkyl group and a polymeric silicone group.

The subject invention further provides a method of loosening and/or removing dental plaque and/or stains while simultaneously reducing dental nerve and/or dentin sensitivity in an oral cavity of a mammal, comprising administering to the oral cavity of said mammal an effective amount of an oral composition as described herein.

The subject invention further provides a method of loosening and/or removing dental plaque and/or stains in an oral cavity of a mammal, comprising administering to the oral cavity of said mammal an effective amount of an oral composition as described herein.

The subject invention further provides a detergent composition as described herein, suitable for loosening and/or removing dirt, debris, and/or stains from skin and/or hair.

The subject invention further provides a method of loosening and/or removing dirt, debris, and/or stains from skin or hair, comprising administering to said skin or hair an amount of a composition as described herein effective in removing or loosening dirt, debris, or stains.

The subject invention further provides a detergent composition as described herein, suitable for loosening and/or removing dirt, debris, and/or stains from a hard surface and/or a fabric.

The subject invention further provides a method of loosening or removing dirt, debris, and/or stains from a hard surface or a fabric, comprising administering to said hard surface or fabric an amount of a composition as described herein effective in removing or loosening dirt, debris, or stains.

DETAILED DESCRIPTION OF THE INVENTION

The subject invention provides an oral composition which comprises a sodium alkylsulfate and a potassium salt, said compositions further comprising a surfactant in order to inhibit the formation of a potassium lauryl sulfate precipitate.

The subject invention can, however, be applied to any composition, not just oral compositions, that contains both a sodium (C.sub.8-C.sub.24) alkylsulfate and a potassium salt. For example, the subject invention can also have applications in hair and/or body shampoos, bubble baths, shaving creams, dishwashing detergents, upholstery cleaners (such as, fabric, vinyl, and leather cleaners), carpet detergents, laundry detergents, and hard surface cleaners. All of the aforementioned compositions possess detergent properties, either as a primary function (as in the case of, for example, a shampoo) or a secondary function (as in the case of, for example, a shaving cream), and all can use a sodium alkylsulfate, such as SLS, as a wetting agent. Therefore, any such composition could benefit from the present invention, which permits the inclusion of a soluble potassium salt, e.g. a potassium pyrophosphate salt, that can impart desirable characteristics to said composition, for example enhanced detergent capability.

Accordingly, the subject invention also provides a detergent composition comprising an effective amount of a soluble potassium salt, a sodium (C.sub.8-C.sub.24) alkylsulfate, and a polar surfactant, said surfactant comprising a hydrophobic portion selected from the group consisting of a (C.sub.8-C.sub.30) alkyl group and a polymeric silicone group, wherein the molar ratio of the surfactant to the sodium (C.sub.8-C.sub.24) alkylsulfate is greater than or equal to about 1:1. The subject invention further provides a method for inhibiting the formation of a potassium alkylsulfate precipitate from forming in a composition comprising a soluble potassium salt and a sodium (C.sub.8-C.sub.24) alkylsulfate, which method comprises including a polar surfactant in said composition in an amount of about equal to or greater than the amount of sodium (C.sub.8-C.sub.24) alkylsulfate in the composition, which polar surfactant comprises a hydrophobic portion selected from a (C.sub.6-C.sub.30) alkyl group and a polymeric silicone group.

As used herein, the term "detergent composition" refers to a composition which has as either a primary or a secondary function the ability to loosen or remove debris and/or stains from a surface. In one embodiment, a detergent composition of the present invention is an oral composition.

As used herein, unless otherwise indicated, the term "oral composition" refers to a detergent composition, as defined above (having a detergent property as either a primary or secondary function), useful for oral care, including compositions for the care of teeth and/or gums. Examples of forms the detergent compositions of the present invention can have include gels, pastes, and liquids (oral rinses). The term "gel" refers to a visually-clear semisolid composition. Gels according to this invention can have various viscosities. One of ordinary skill can also formulate the compositions of the present invention into other forms that are known in the art. Examples of other forms include, but are not limited to, creams, tablets, and granulations.

Oral compositions of the present invention include, for example, dentifrices. A dentifrice is a composition, in a form such as a paste or gel, which composition comprises an abrasive, and which composition is useful for removing and/or loosening plaque, debris and/or stains from teeth and gums. Other oral compositions of the invention include oral rinses, for example mouthwashes for treating oral malodor and rinses that have as their primary function detergent properties for removal and/or loosening of plaque. "Oral rinses" are to be distingushed from dentifrices in that oral rinses do not include an abrasive.

The amounts of ingredients and the solubilities recited as percentages throughout this application, unless otherwise indicated, refer to the amount by weight of such ingredient or solute compared to the total weight of the composition containing the ingredient or solute. For example, a composition comprising from about 0.01% by weight to about 20% by weight of an orally-acceptable polar surfactant comprises from about one ten-thousandth to about two tenths of a gram of the polar surfactant per gram of the total composition (i.e., from about one one-hundredth to about 20 grams of the polar surfactant per 100 grams of total composition).

A composition of the present invention comprises a soluble potassium salt as an active ingredient. The term "active ingredient" refers to, unless otherwise indicated, any substance that possesses a therapeutic, hygienic or cosmetic activity in a detergent composition (for example an oral composition), or possesses an activity that enhances the aesthetic or sensory properties of the detergent composition, or possesses activity that enhances the detergent properties of the detergent composition. For example, certain potassium salts, such as potassium sorbate, possess bacteriostatic activity and can therefore be an active ingredient because they are useful in a detergent composition as a preservative. As another example, certain potassium salts, such as potassium pyrophosphate salts, have mineral-chelating activity in water and can serve as an active ingredients because they behave as detergent builders, enhancing the ability of the sodium alkylsulfate in the detergent composition to remove and loosen debris, such as plaque, and/or stains. Other potassium salts, such as potassium nitrate and potassium chloride, can be an active ingredient because they can reduce dental nerve and/or dentin sensation. Still other potassium salts, for example potassium phosphate, can be an active ingredient because they can buffer a detergent composition to a selected pH, for example a pH of about 7. Other potassium salts having particular properties known in the art can be selected as an active ingredient, and compositions comprising such potassium salts are part of the subject invention.

If a composition of the present invention is to be applied to the skin and/or hair of a living animal, including a human, then the potassium salt therein must be acceptable for application without harmful side effects when used as intended. Likewise, if the composition is for oral use, then the potassium salt therein must be orally-acceptable, i.e. acceptable for use by humans or other animals in the oral cavity without harmful side effects. Orally-acceptable potassium salts and potassium salts that are acceptable for application to skin and/or hair of living animals can be determined by those of ordinary skill in the art.

The term "orally applied" as used herein, unless otherwise indicated, means application to the oral cavity of a living animal. "Oral application" includes, but is not limited to, brushing the oral cavity and/or teeth in the oral cavity, rinsing the oral cavity and gargling, and spraying into the oral cavity.

A "soluble potassium salt", for purposes of this application and unless otherwise indicated, is any organic or inorganic potassium salt that is soluble in an aqueous solution. Preferably, the soluble potassium salt is any potassium salt that has a solubility of greater than or equal to about 5% in water, meaning that an aqueous composition of the potassium salt (consisting solely of water and the potassium salt) can contain at least about 0.05 grams of the potassium salt, if not more, in solution. Thus, one hundred grams of an aqueous solution consisting of a potassium salt that is at least about 5% soluble in water contains at least about 5 grams of the potassium salt and at most about 95 grams of water.

The active ingredient is present in the compositions of the present invention in an "effective amount", which means that the ingredient, i.e., the soluble potassium salt, is present in the composition in an amount that is at least sufficient to provide the activity for which the potassium salt has been selected. An effective amount can be determined by one of ordinary skill in the art, for example by preparing a series of pre-formulations, each comprising a different amount of the potassium salt, testing each pre-formulation for the activity of the potassium salt, and determining the minimum amount of the potassium salt required to provide the desired activity. Generally, the amount of soluble potassium salt effective for a hard surface or fabric cleaner is from about 0.1% to about 50%, and for a healthcare composition is from about 0.1% to about 20%.

Some specific examples of orally-acceptable, soluble potassium salts that can be used as an active ingredient in an oral composition of the present invention include potassium pyrophosphate salts, such as dipotassium pyrophosphate, tetrapotassium pyrophosphate, tripotassium pyrophosphate, and monopotassium pyrophosphate. Pyrophosphate salts have activity as detergent builders and thus are useful in loosening and removing plaque and/or stains present on dental surfaces. A composition of the present invention can comprise a combination of pyrophosphate salts, for example a combination of potassium pyrophosphate salts, each of which has activity as a detergent builder. Oral compositions of the present invention can furthermore optionally comprise potassium pyrophosphate salts in combination with other pyrophosphate salts, such as, for example, disodium pyrophosphate or tetrasodium pyrophosphate, to remove or loosen plaque and/or stains when the composition is orally applied to a dental surface.

Other specific examples of potassium salts that can be used in an oral composition of the present invention are potassium salts that are active in reducing dental nerve and/or dentin sensitivity. Potassium salts that possess activity in reducing dental nerve and/or dentin sensitivity are known in the art, and any such potassium salt is useful in the present invention. Examples of potassium salts that are active in reducing dental nerve and/or dentin sensitivity include, but are not limited to, potassium nitrate, potassium citrate, potassium chloride, potassium oxalate, potassium bicarbonate, potassium phosphate, monobasic potassium phosphate, dibasic potassium phosphate, tribasic potassium phosphate, and potassium pyrophosphate salts. Mixtures of such salts can be used in the present invention. In a preferred embodiment, the potassium salt capable of reducing dental nerve and/or dentin sensitivity is potassium nitrate.

A composition of the present invention can comprise a mixture of soluble potassium salts. Each potassium salt in the mixture can have the same or similar activity (for example, they each can have activity as a detergent builder, enhancing removal or loosening of debris and/or stains) or potassium salts in the mixture can have different activities (for example, one salt can have activity as a detergent builder and another salt in the mixture can have activity in reducing dental nerve sensation).

The amount of the soluble potassium salt ranges preferably from about 0.01% by weight to about 20% by weight of a healthcare composition of the present invention, preferably from about 0.1% by weight to about 50% by weight of a hard surface cleaner of the present invention, and preferably from about 0.1% by weight to about 50% by weight of a fabric cleaner composition of the present invention. If the composition is a dentifrice, a preferred amount of potassium salt in such dentifrice is from about 1% to about 10%. If the composition is an oral rinse, a preferred amount of potassium salt in such an oral rinse is from about 0.1% to about 5%.

In specific oral compositions of the present invention for removing and loosening plaque and stains, a potassium pyrophosphate salt is present in the composition in an amount effective, optionally in combination with other pyrophosphate salts as described above, to provide at least about 0.3%, more particularly from about 0.3% to about 5%, by weight P.sub.2O.sub.7.sup.-4 based on the weight of the total composition. In order to provide this amount of P.sub.2O.sub.7.sup.-4, compositions of this invention for loosening or removing plaque and/or stains from dental surfaces preferably contain from about 0.02% by weight to about 1% by weight potassium pyrophosphate salt based on the weight of the total composition.

Regarding the sodium alkylsulfate ingredient of the compositions of the present invention, the term sodium (C.sub.8-C.sub.24) alkylsulfate refers to any sodium (C.sub.8-C.sub.24) alkylsulfate or mixture of sodium (C.sub.8-C.sub.24) alkylsulfates. The term "alkyl", as used herein, refers to any hydrocarbon, either saturated or unsaturated, and either straight, branched, or cyclic. Reference to a specific sodium (C.sub.8-C.sub.24) alkylsulfate, such as SLS, includes both the pure sodium (C.sub.8-C.sub.24) alkylsulfate as well as various grades of the sodium (C.sub.8-C.sub.24) alkylsulfate which contain relatively small amounts of different sodium (C.sub.8-C.sub.24) alkylsulfates. For example, the term "SLS" includes both compositions of pure SLS as well as various grades of SLS which can contain other sodium alkylsulfates that can have generally from 10 to 14 carbons their alkyl portion and that can further have one or more unsaturated bonds in their alkyl portions. Sodium (C.sub.8-C.sub.24) alkylsulfates, such as SLS, are useful as wetting agents, loosening or removing debris and/or stains, in detergent compositions. When the sodium (C.sub.8-C.sub.24) alkylsulfate is free from interaction with a potassium salt ingredient, as is provided by the present invention, a greater amount of debris and stain removal can be obtained. Examples of sodium (C.sub.8-C.sub.24) alkylsulfates which are useful in the present invention include, but are not limited to, SLS, sodium myristyl sulfate, sodium palmityl sulfate, sodium stearyl sulfate, sodium palmitoleyl sulfate, sodium oleyl sulfate, sodium capryl sulfate, and sodium caprylyl sulfate. The aforementioned sodium (C.sub.8-C.sub.24) alkylsulfates comprise 12, 14, 16, 18, 16 (with one unsaturated carbon-carbon bond), 18 (with one unsaturated carbon-carbon bond), 10, and 8 carbons, respectively. An example of a sodium alkylsulfate having 24 carbons which can be used in the subject invention is sodium nervonyl acid. Preferably, the compositions of the subject invention comprise SLS.

Preferably, the amount of sodium (C.sub.6-C.sub.24) alkylsulfate in a composition of the present invention is from about 0.01% to about 10% by weight of the composition for a healthcare composition, from about 0.1% to about 50% by weight for a hard surface cleaner, and from about 0.1 to about 50% for a fabric cleaner composition. The amount of sodium (C.sub.8-C.sub.24) alkylsulfate of a dentifrice of the subject invention is preferably from about 0.1% to about 5% by weight of the composition. For an oral rinse, the amount of the sodium (C.sub.8-C.sub.24) alkylsulfate ingredient is preferably from about 0.02% by weight to about 2% by weight of the composition. More preferably for a hard surface cleaner, the amount is from about 1% to about 50%, and more preferably for a fabric cleaner from about 1% to about 50%.

The polar surfactant used in the compositions of the present invention can be any polar surfactant that comprises a hydrophobic portion selected from the group consisting of a (C.sub.6-C.sub.30) alkyl group, wherein "alkyl" is as defined above, and a polymeric silicone group. If the composition is for oral use or for application to skin and/or hair of a living animal, then the surfactant must not cause harmful side effects to the animal when used as intended. Determination of surfactants acceptable for such uses is known in the art. A "polar" surfactant for purposes of this invention is a surfactant that comprises a hydrophilic group and a hydrophobic group. Polar surfactants can be anionic, cationic, nonionic or amphoteric. One of ordinary skill in the art can determine whether a surfactant is polar.

A "polymeric silicone group" is any group that comprises repeating units which comprise a silicone atom. In a preferred embodiment, a polymeric silicone group comprises repeating --Si(R.sup.1)(R.sup.2)O-- units, wherein R.sup.1 and R.sup.2 of each unit is independently the same or different, and wherein each --Si(R.sup.1)(R.sup.2)O-- unit in the polymeric silicone group can have the same or different R.sup.1 and/or R.sup.2 groups, R.sup.1 and R.sup.2 each being a (C.sub.1-C.sub.6) alkyl. Preferably each R.sup.1 and R.sup.2 in a polymeric silicone group is methyl or ethyl. More preferably, each R.sup.1 and R.sup.2 is a methyl.

Polar surfactants which comprise a hydrophobic portion which is a polymeric silicone group can include, but are not limited to, dimethicone copolyols (i.e., ethoxylated and/or propoxylated polydimethylsiloxane polymers) and derivatives thereof wherein the ethoxylated/propoxylated portion of the compounds is derivatized such as polydimethylsiloxane phosphate esters, polydimethylsiloxane phosphobetaines, polydimethylsiloxane taurates, acetylated polydimethylsiloxane copolyols, and polydimethylsiloxane quaternium compounds. Surfactants comprising a polymeric silicone group are also described, among other places, in Imperante, J. et al., 1994, Cosmetics & Toiletries Vol. 108, No. 4, p. 79, and Imperante, J. et al., 1994, Cosmetics & Toiletries Vol. 109, No. 3, p. 81, which are hereby incorporated by reference in their entireties.

Some specific examples of derivatized polydimethylsiloxane copolyols are sodium dimethicone copolyol acetyl methyltaurate, e.g. PECOSIL.TM. DCT (Phoenix Chemical, Inc., Somerville, N.J.); dimethicone copolyol myristyl ammonium chloride, e.g. PECOSIL.TM. SM-40 (Phoenix Chemical, Inc.); and dimethicone copolyol phosphate, e.g. PECOSIL.TM. PS-100, PECOSIL.TM. PS-150, and PECOSIL.TM. PS-200, from Phoenix Chemical, Inc., and SILPHOS.TM. A100 (Siltech, Norcross, Ga.). As discussed above, other polydimethylsiloxane copolyols are known in the art and can be used in the present invention.

In another embodiment, the polar surfactant comprises a hydrophobic portion comprising a (C.sub.6-C.sub.30) alkyl group. The (C.sub.6-C.sub.30) alkyl group can be saturated or unsaturated. Polar surfactants that comprise a hydrophobic portion comprising a (C.sub.6-C.sub.30) alkyl group can be determined by one of ordinary skill in the art. Examples of polar surfactants that comprise a hydrophobic portion comprising a (C.sub.6-C.sub.30) alkyl group include, but are not limited to, (C.sub.6-C.sub.30) fatty acid mono and diesters of ethoxylated sorbitan such as PEG-40 diisostearate (e.g. EMSORB.TM. 2726 PEG-40 Sorbitan Diisostearate (Henkel Corporation (Gulph Mills, Pa.)), PEG-2 sorbitan isostearate, and PEG-40 sorbitan laurate; (C.sub.6-C.sub.30) fatty acid diesters of polyethylene glycol such as PEG-175 distearate and PEG-150 distearate (e.g., LIPOPEG.TM. 6000-DS (Lipo Chemicals Inc. (Paterson, N.J.)); sodium salts of (C.sub.6-C.sub.30) fatty acyl sarcosinates such as sodium lauroyl sarcosinate (e.g., HAMPOSYL.TM. L-30 (Hampshire (Lexington, Mass.)) and sodium cocoyl sarcosinate (e.g., HAMPOSYL.TM. C-30 (Hampshire); (C.sub.6-C.sub.30) fatty acyl esters of sarcosine acid such as lauroyl sarcosine (e.g., HAMPOSYL.TM. L (Hampshire) and oleoyl sarcosine (e.g., HAMPOSYL.TM. 0 (Hampshire)); sodium salts of (C.sub.6-C.sub.30) fatty acyl taurates and methyltaurates such as sodium lauroyl taurate, sodium methyl cocoyl taurate (e.g., a surfactant from the TAURANOL.TM. WS series (Finetex Inc., Elmwood Park, N.J.)), and sodium methyl oleoyl taurate (e.g., a surfactant from the TAURANOL.TM. M series (Finetex Inc.)); (C.sub.6-C.sub.30) fatty acyl esters of taurine and methyltaurine acid; (C.sub.6-C.sub.30) fatty acyl betaines such as cocamidopropyl betaine (e.g., TEGO.TM. Betaine ZF and TEGO.TM. Betaine E (both of Goldschmidt Chemical Corp., Hopewell, Virginia)); and (C.sub.6-C.sub.3) fatty acyl quaternary ammonium chlorides such as dimethicone copolyol myristyl ammonium chloride (e.g. PECOSIL.TM. SM-40, supra). "PEG"in the foregoing examples and throughout this application is an abbreviation for "polyethylene glycol". Other polar surfactants which comprise a (C.sub.6-C.sub.30) alkyl group can be determined by those of ordinary skill in the art.

In general, polar surfactants that comprise a hydrophobic portion selected from the group consisting of a (C.sub.6-C.sub.30) alkyl group and a polymeric silicone group can be found in texts recognized in the art such as The CTFA International Cosmetic Ingredient Dictionary (Cosmetics Tioleteries and Fragrances Association (Washington D.C.)), which is hereby incorporated by reference in its entirety.

The following procedure can, moreover, be used to screen surfactants, such as those ascertained from The CTFA International Cosmetic Ingredient Dictionary, above, for use in inhibiting formation of a p