FI81256B - STABIL ANTIPLAQUETANDKRAEM OCH PROCESS FOER DESS FRAMSTAELLNING. - Google Patents

Description

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The present invention relates to a composition of anti-plaque toothpaste having improved foaming, improved taste, soluble active ingredient, improved fluoride stability, improved compatibility of all components, improved extrusion properties from various containers, and improved cost-effectiveness, cost-effectiveness to make it.

Hitherto, it has been difficult to form a cosmetically acceptable anti-plaque toothpaste consisting of a quaternary ammonium compound and betaine surfactant with the wetting system being entirely glycerin or entirely sorbitol. In addition, the use of glycerin / polyethylene glycol or sorbitol / polyethylene glycol blends in which glycerin or sorbitol was present in more than 10% by weight of the composition showed marginal cosmetic stability. However, after extensive solubility tests with different mixtures of components in benzethonium chloride (BTC) toothpaste, a compatible system of water, BTC, betaine, salts, and glycerin was found, depending on the order of addition of these components.

Thus, it has been found that using a specific method, stable formulations of anti-plaque toothpaste containing a quaternary ammonium compound and betaine surfactant can be prepared using glycerin or sorbitol as a wetting agent. An essential feature of this method is the formation of two separate phases and then the combination of the two phases to form a stable system. One of these phases contains an active quaternary ingredient (benzethonium chloride or cetylpyridinium chloride) dissolved in betaine surfactant (coconut amidopropyl betaine) and a spice and is defined as the oil gel phase. The second phase contains water, a wetting agent and a nonionic gelling agent, e.g. hydroxyethylcellulose and optionally a compound containing sodium saccharin and fluorine, e.g. sodium monofluorophosphate and is defined as the aqueous gel phase. The dentifrice may be added to the combined phases as a final step or it may be added to the aqueous gel phase before it is combined with the oil gel phase. The final product has improved chemical and cosmetic stability and improved taste.

A conventional method for preparing bactericidal toothpastes containing a quaternary ammonium compound as the active material is described in U.S. Patent Nos. 4,118,476 and 4,188,372 and forms a gel with a wetting agent (glycerin, sorbitol, polyethylene glycol), polyethylene glycol, thickener and a sweetening agent and a polishing agent, a spice, a bactericidal agent, water and finally an antifouling agent (a compound containing a phosphorus group or a compound containing mellitic acid).

Methods for stabilizing toothpaste against precipitation and flocculation resulting from incompatibility of a bactericidal agent with an alkali metal hydroxyalkylcellulose have also been previously described in the art, as disclosed in U.S. Patents Nos. 3,842,168 and 3,843,779. , a bactericidal agent in an anhydrous mixture of carboxyethylcellulose, sodium saccharin and a wetting agent, and then a surfactant is added to form a gel to which a polishing material and a spice are added in a final step. In the latter patent, the bactericidal agent is added alone or in combination with a surfactant to a mixture of glycerin, water, sodium saccharin, carboxymethylcellulose and a surfactant, followed by the addition of a polish and a spice. The addition of the surfactant must take place before or at the same time as the addition of the bactericidal agent in order to prevent precipitation in the toothpaste.

However, no cosmetic and chemically stable anti-plaque toothpaste containing an anti-plaque quaternary ammonium compound, zwitterionic betaine surfactant, li 3 81256 glycerol and / or sorbitol wetting agent, non-gelled using a predetermined sequence of steps to form two separate gel phases, an oil gel phase consisting of a quaternary ammonium compound, a betaine surfactant and a spice; and an aqueous gel phase consisting of water, a wetting agent and a gelling agent; combining the two gel phases into a single base gel and adding a dentifrice to the combined gel phase as a final step or to the aqueous gel phase before adding the oil gel phase.

It has now been found that stable formulations of plaque-preventing toothpaste containing a quaternary ammonium compound and a betaine surfactant can be prepared using glycerin or sorbitol as a wetting agent using a predetermined sequence of steps to form an oil gel -the gelling agent and water (which may substantially contain salts, i.e. sodium saccharin and sodium monofluorophosphate or other fluoride salt), combine the oil and aqueous phases to form a stable base gel phase and add a tooth abrasive as a final step. This method can be varied by adding a polishing agent to the aqueous gel and then adding the oil gel to the mixture of aqueous gel and abrasive. This toothpaste is prepared at ambient temperature, i.e. each step in the entire series of steps is performed at ambient (room) temperature. The essential features of the invention are set out in the appended claims.

Accordingly, the main object of the present invention is to form a stable anti-plaque toothpaste based on quaternary active ingredients and betaine surfactant with improved compatibility of all components by forming two separate gel phases which are combined to form a stable overall gel system.

Another object of the present invention is to provide a cosmetic 4 81256 and chemically stable anti-plaque toothpaste containing glycerin and / or sorbitol as a wetting agent compatible with the betaine and quaternary active ingredients.

Yet another object of the present invention is to provide a stable anti-plaque toothpaste containing a nonionic gum resin such as hydroxyethylcellulose as a gelling agent to stabilize the betaine quat system and prevent deactivation of the quaternary active ingredient.

Another object of the present invention is to provide a cosmetically (physically) and chemically stable anti-plaque toothpaste which also contains a fluoride-generating compound without adversely affecting the cosmetic stability of the toothpaste.

Other objects, advantages and novel features of the present invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instruments and combinations particularly pointed out in the appended claims.

To achieve the above and other objects, and in accordance with the present invention, as disclosed and extensively described herein, a novel stable anti-plaque toothpaste of the present invention comprising an anti-plaque quaternary ammonium compound, betaine zwitterionic surfactant, a spice and a wetting agent selected from , comprising glycerin, sorbitol and mixtures thereof, and a nonionic gelling agent, is prepared at ambient temperature by a method of forming two separate gel phases, an oil gel phase consisting of an anti-plaque quaternary ammonium compound, betaine and a spice; and an aqueous gel phase consisting of water, a wetting agent and a nonionic gelling agent; combining the two gel phases to form a single gel phase; adding a tooth abrasive to said combined gel phase. The order of addition can be varied by adding a tooth abrasive to the aqueous gel phase before combining it with the oil gel phase. However, it is necessary that two separate gel phases be prepared prior to the addition steps. The addition of salts, such as a fluorine-containing compound and / or sodium saccharin, which are preferred compounds, is done by dissolving the composition in an amount of water before mixing the water with a wetting agent and a gelling agent to form an aqueous gel phase.

More particularly, this invention relates to a novel process for preparing a cosmetic and chemically stable, anti-plaque toothpaste comprising two phases, an oil gel phase, and an aqueous gel phase, comprising the steps of: a) dispersing an amount of an anti-plaque quaternary ammonium b) mixing said dispersion of a quaternary ammonium compound and a spice with a composition amount of betaine surfactant to form an oil gel phase; c) dispersing said composition amount of nonionic gelling agent into combining the two gel phases to form a stable base gel phase, f) adding a dentifrice to the aqueous gel phase or the base gel stirring into phase i and g) recovering a stable, anti-plaque toothpaste.

The oil gel phase is in the form of a viscous, translucent gel. The aqueous gel phase is transparent. The stable base gel phase resembles an emulsified system.

This method can be modified by adding and mixing the dentifrice with the aqueous gel phase and then adding the oil gel phase to the mixture of the dentifrice and the aqueous gel phase.

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Sodium saccharin and / or a fluorine-containing compound, which are optionally preferred additives, are dissolved in an amount of water in the composition before being added to the dispersion of wetting agent and gelling agent and forming an aqueous gel phase.

The novel forming method of the present invention, which uses only a glycerin and / or sorbitol wetting agent in a quaternary betaine system, provides chemical and cosmetic stability to the toothpaste as well as improved taste. The search properties of a benzethonium chloride (BTC) betaine toothpaste containing 20% glycerin or sorbitol wetting cine are greatly improved compared to BCT toothpaste containing 20% polyethylene glycol (PEG 600). The stability provided by the glycerin and / or sorbitol wetting agent does not extend to other wetting agents such as polyethylene glycol. Precipitation has been observed in the gel phase containing 20% PEG 600 wetting agent in BCT toothpaste. The precipitate was analyzed using an IR spectrophotomeric method and was found to consist of BTC, saccharin and betaine.

Fluoride stability studies with BTC toothpaste have confirmed that much of the loss of MFP is due to hydrolysis in a system containing only PEG 600 wetting agent. It can also be the cause of other phenomena (i.e., adsorption or insolubility). A solubility problem has been observed with PEG 600 and monofluorophosphate (MFP). Stability studies of MFP in BTC toothpaste show that the hydrolysis of MFP occurs to a large extent in a system containing only PEG 600 wetting agent. However, a system containing glycerin-wetting agent BTC toothpaste alone shows much less loss of MFP. In fact, a system containing only glycerin wetting agent meets the current requirement for the shelf life of MFP (more than 600 ppm total soluble fluoride, half of which is MFP), while a system containing only PEG 600 wetting agent does not (see table). I alla).

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Table I

MFP stability in BTC toothpaste with 20% PEG 600 wetting agent system and 20% glycerin wetting agent system

Wetting PH Soluble F Ion-F as MFP F substance I 9w * I 3w 6w 9w * I 3w 6w 9w * I 3w 6w 9w * PEG 8.2 10.1 980 660 570 520 57 289 439 431 920 370 130 < 100

Glycerin 7.8 8.3 980 870 790 7yu 26 55 85 106 950 810 700 680 *) w = weeks.

This table clearly shows the poor stability of MFP in the PEG 600 wetting agent alone and the very good stability of the MFP in the glycerin only formulation.

HPLC (high pressure liquid chromatography) analysis was performed with both glycerin and sorbitol-BTC toothpaste formulation at the beginning and after nine weeks of accelerated aging at 49 ° C. Two BTC extraction methods (water and acetone) do not show a decrease in BTC recovery after accelerated aging (see Table II).

Table II

HPLC analysis of glycerol and sorbitol-BTC toothpaste formulation at baseline and after 9 weeks of accelerated aging (49 ° C )_

Analysis at the beginning Analysis after old

Wetting agent Water extraction Acetone extraction Water extraction Acetone extraction 20% glycerin 0.42 0.54 0.47 0.52 20% sorbitol 0.36 0.48 0.45 0.46 8 81256

The glycerin and / or sorbitol wetting agent system constitutes about 18-23% by weight of the toothpaste mixture.

Cationic bactericidal materials are well known in the art. See, e.g., the section "Quaternary Ammonium and Related Compounds" in the article "Antiseptics and Disinfectants" in the Kirk-Othmer Encyclopedia of Chemical Technology, 2nd Edition (Part 2, pages 632-635), which is incorporated herein by reference. Cationic materials with bactericidal activity (i.e., which are microbicidal) are used against bacteria and have been used in oral formulations to counteract the formation of plaque caused by bacteria in the oral cavity.

The most common of these bactericidal, plaque-inhibiting quaternary ammonium compounds is benzethonium chloride, also known as Hyamine 1622 or diisobutylphenoxyethoxyethyldimethylbenzylammonium chloride and cetylpyridium chloride. In the oral mixture, this material is very effective in promoting oral hygiene by reducing the formation of dental plaque and tartar, which is generally associated with a reduction in the diseases surrounding the tooth. Other cationic bactericides of this type are those mentioned, for example, in U.S. Patents 2,984,639, 3,325,402, 3,431,208 and 3,703,583 and GB-1,319,396.

Other bactericidal, plaque-inhibiting quaternary ammonium compounds are those in which one or two of the substituents on the quaternary nitrogen have a carbon chain (typically an alkyl group) of about 8-20, typically 10-18 carbon atoms, while other substituents have a smaller number of carbon atoms. (typically an alkyl or benzyl group), such as 1 to 7 carbon atoms, typically being methyl or ethyl groups. Dodecyltrimethylammonium bromide, benzyldimethylstearylammonium chloride, cetylpyridium chloride and quaternized 5-amino-1,3-bis (2-ethylhexyl) -5-methylhexahydropyrimide are typical bactericidal quaternary ammonia.

The toothpaste composition of the present invention contains an effective amount

II

9 81256 a plaque-inhibiting quaternary ammonium compound, preferably about 0.1-1% by weight of the mixture.

The ability of quaternary ammonium compounds to inhibit the formation of dental plaque is well known. However, they are deactivated by anionic surfactants such as sodium lauryl sulfate, which is commonly used in toothpaste formulations. Replacing anionic surfactants with nonionic surfactants eliminates the deactivation problem but results in products with poor foaming. However, the incorporation of surfactant betaines into plaque-inhibiting dental preparations based on quaternary active ingredients unexpectedly improves foaming of these compositions without deactivating quaternary bactericidal agents.

The betaine component of the toothpaste mixture in question has the general formula: R 2 is an alkyl group having 10 to about 20 carbon atoms, preferably 12 to 16 carbon atoms, or an amido radical:

O H

R-C-N- (CH 2) - L · 3.

wherein R is an alkyl group having about 10 to 20 carbon atoms and a is an integer from 1 to 3; R 2 and R 2 are both alkyl groups having 1 to 3 carbons and preferably 1 carbon; R 1 is an alkylene or hydroxyalkylene group having 1 to 4 carbon atoms and optionally one hydroxyl group. Typical alkyl dimethyl betaines include desyl betaine or 2- (N-Decyl-N, N-dimethylammonio) acetate, coconut betaine, or 2- (N-coconut-N, N-dimethylammonio) acetate, myristyl betaine, palmityl betaine, palmityl betaine, stearyl betaine, etc. Amidobetaines include coconut amidoethyl betaine, coconut amidopropyl betaine, lauramidopropyl betaine, etc.

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Betaines, which are zwitterionic materials, act as a blowing agent in toothpaste compositions containing a quaternary compound. They act cationically over a wide pH range but do not deactivate quaternary, antimicrobial activity.

In addition to the interference shown by betaines with quaternary activity, laboratory foam experiments have shown that formulations containing both a quaternary ammonium compound (quat) and betaine foam 2-3 times better than formulations of a nonionic compound and quat.

Zwitterionic betaines are fully compatible with antimicrobial, anti-plaque quaternary agents and impart cleansing and improved foaming properties to a quaternary compound-containing toothpaste composition without deactivating its antimicrobial properties. The amount of betaine effective in providing improved foaming can range from about 3-5% by weight of the total composition.

Cosmetic stability problems occur with all zwitterionic toothpastes, such as leakage of aroma from the seam. The aroma exudes and does not dissolve in the zwitterionic surfactant. However, stability evaluations of these new anti-plaque toothpastes containing glycerin and / or sorbitol wetting agent show satisfactory aroma stability during nine weeks of aging at 49 ° C. The flavoring ingredient, which is an essential ingredient in toothpaste, constitutes about 0.5-2% by weight thereof. Any suitable spice can be used. Examples of suitable spice ingredients are spice oils such as mint, peppermint, winter, sassafras, cloves, sage, eucalyptus, marjoram, cinnamon, lemon and orange oils and methyl salicylate.

The sweetener may also be used as a spice supplement. Suitable sweeteners are water soluble and include sucrose, lactose, maltose, sorbitol, sodium cyclamate and saccharin in an amount of 0.01 to 0.5% by weight.

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Another essential ingredient in said toothpaste is a gelling agent which is a non-ionic rubber resin in an amount of about 0.8-1.5% by weight. It has been found that large organic anionic molecules, such as carboxymethylcellulose, have the potential to deactivate quaternary bactericidal activity.

Thus, hydroxyethylcellulose, a nonionic, small organic molecule, provides a stable, slimy gel for the betaine quasystem of this invention and is a preferred gelling agent. Other nonionic gelling agents such as hydroxymethylcellulose and the like may be used.

Fluoride-producing compounds, which are preferably additives in the toothpaste in question, are characterized by their ability to release fluoride ions into water and by their non-reaction with other compounds of the toothpaste. These materials include inorganic fluoride salts such as soluble alkali metal, alkaline earth metal and heavy metal salts, for example sodium fluoride, potassium fluoride, ammonium fluoride, lead fluoride, copper fluoride such as cuprofluoride, zinc fluoride, barium fluoride, stannous fluoride, such as stannous fluoride, such as stannous fluoride or stannous fluoride. -silicate, sodium fluorozirconate, sodium mononofluorophosphate, aluminum mono- and difluorophosphate and fluorinated sodium calcium pyrophosphate. Alkali metal and tin fluorides such as sodium and stannofluorides, sodium monofluorophosphate and mixtures thereof are preferred.

The amount of fluoride-producing compound depends to some extent on the type of compound, its solubility and toothpaste, but it must be a non-toxic amount. In a solid oral preparation such as a toothpaste or ointment, an amount of the compound which releases up to 1% by weight of the preparation is considered satisfactory. Any suitable minimum amount of such compound may be used, but it is preferred to use sufficient compound to release 0.005-1 and preferably about 0.1% fluoride ion. Typically, in the case of alkali metal fluorides and stannofluoride, this component is present in an amount of up to 2% by weight based on the weight of the preparation. In the case of sodium morphofluorophosphate, the compound may be present in an amount of up to 7.6% by weight, typically 0.76%.

The toothpaste prepared in accordance with the present invention contains conventional water-insoluble polishing materials or dentifrices in amounts of about 35-65% by weight of the total mixture. Suitable examples of dental abrasives or polishing materials are sodium metaphosphate, potassium metaphosphate, tricalcium phosphate, dihydrated calcium phosphate, anhydrous dicalcium phosphate, zirconite phosphate, calcium pyrophosphate, magnesium orthophosphate, trimagnesium, trimagnesium Preferred abrasives are alumina-containing abrasives such as calcined alumina and hydrated alumina and mixtures thereof. The abrasive is added to the water gel phase or to the single gel after combining the oil gel and water gel phases.

The toothpaste of this invention may also contain conventional additives such as colorants and bleaches, preservatives and ammonized materials such as monoammonium glycyrrhizinate. These additives may each be added to the toothpaste in minimum amounts of up to 5% by weight and preferably up to 1%, provided that they do not interfere with the foaming, anti-plaque and stability properties of the finished product. The oil phase typically constitutes about 3.6-8% by weight of the toothpaste.

In an embodiment of the present invention, to promote oral hygiene, the toothpaste of the present invention is regularly applied to tooth enamel by brushing the teeth for 30-90 seconds at least once a day.

The following examples illustrate the nature of the present invention in more detail, but it is to be understood that the invention is not limited thereto. Mixtures are prepared in the usual manner and all concentrations mentioned in this and the appended claims are by weight unless otherwise indicated.

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Example 1

Glycerin Moisturizer / Anti-Plaque Toothpaste Ingredients%

Water (deionized) 19.34

Sodium saccharin 0.30

Sodium monofluorophosphate 0.76

Hydroxyethylcellulose 1.10

Glycerin 20.00

Benzethonium chloride 0.50

Spice 1, 00

Coconut amidopropyl betaine 5.00

Calcined alumina 10.00

Hydrated alumina 42.00

The benzethonium chloride is dispersed in the spice and this dispersion is mixed with betaine to form an oil gel. Sodium saccharin and sodium monofluorophosphate (MFP) are dissolved in water. Hydroxyethylcellulose is dispersed in glycerin and this mixture is added to a water-saccharin-MFP solution with stirring to form a water-gel, the oil and water gels are mixed together to form a stable base gel. Calcined alumina and hydrated alumina are mixed into the base gel to form a final toothpaste that is effective against plaque-associated bacteria while having excellent chemical and cosmetic stability and adequate foaming properties. This toothpaste is prepared at room temperature.

Example 2

Example 1 is repeated except that the 20% glycerin content is replaced by 20% sorbitol. The resulting product is equally effective against plaque-associated bacteria and also has excellent chemical and cosmetic stability and adequate foaming properties.

Stability studies of MFP show that both new glycerin and sorbitol toothpastes have an excellent stability profile of MFP. In Example 1 (20% glycerin), the total value of soluble fluoride was initially 990 ppm and the MFP value F was 950 ppm. Example 2 (20% sorbitol) had a total soluble fluoride value of 120 ppm and an MFP value of F of 980 ppm (see Table III).

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Table III

Stability profile of MFP of new glycerin-only BTC toothpaste and new sorbitol-only BTC toothpaste__ (9 weeks (w) aging at 49 ° C)

Eg Moisturizer PH as Solvent-F MFP F;

nen F

I 9w I 9w I 9w I 9w 1 Glycerin alone 7.8 8.0 990 820 43 94 950 730 2 Sorbitol alone 7.6 7.7 1020 960 43 45 980 910

The pH profiles of both formulations showed only a slight increase after 9 weeks of aging at 49 ° C. After accelerated aging, the total soluble fluoride values and MFP values as F were 820 ppm and 730 ppm in Examples 1 and 960 ppm, respectively, in Example 2, respectively.

Changes can be made to the above configurations. For example, coconut amidopropyl betaine can be replaced in the examples by other betaines, such as lauramidopropyl betaine, coconut betaine, etc. Likewise, the abrasives specifically mentioned in the examples can be replaced by other abrasives. Likewise, the sodium monofluorophosphate used in the specific examples can be replaced by other fluorine-containing compounds such as sodium fluoride, potassium fluoride, etc. The benzethonium chloride can also be replaced by cetylpyridinium chloride or other anti-plaque quaternary ammonium substances. Sodium saccharin can also be replaced by sodium cyclamate.

It is to be understood that the above detailed description is given by way of illustration only and that changes may be made therein without departing from the spirit of the invention. The "Summary" above is intended solely to facilitate the researchers and should not be weighed against the scope of the invention.

Claims (15)

15 81 256 A chemically and physically stable, anti-plaque toothpaste, characterized in that it contains about 0.1 to 1% by weight of a anti-plaque quaternary ammonium compound, about 3 to 5% by weight of betaine surfactant, about 0.5 to 2% by weight of a spice, about 18-23% by weight of a glycerin and / or sorbitol wetting agent system and about 0.8-1.5% by weight of a nonionic gelling agent, a toothpaste prepared by a process for preparing two separate gel phases, an oil gel phase consisting of quaternary ammonium compound, betaine and spice; and an aqueous gel phase consisting of water, a wetting agent and a nonionic gelling agent; combining said gel phases into a single gel phase, and adding 35-65% by weight of a water-insoluble tooth abrasive as a final step, or adding said abrasive to the aqueous gel phase before adding the gel gel phase. Toothpaste according to claim 1, characterized in that it further contains a fluoride-producing compound dissolved in the amount of water in the composition before the formation of the aqueous gel phase. Toothpaste according to Claim 2, characterized in that it contains a water-soluble sweetener which is dissolved in the amount of water in the composition before the formation of the aqueous gel phase. Toothpaste according to claim 3, characterized in that said sweetener is sodium saccharin. Toothpaste according to Claim 1, characterized in that the nonionic gelling agent is present in hydroxyethylcellulose in an amount of about 0.8 to 1.5% by weight. Toothpaste according to Claim 1, characterized in that the tooth abrasive is an alumina-containing abrasive. i6 81 256 Toothpaste according to claim 2, characterized in that the fluoride-providing compound is present in an amount sufficient to release about 0.005 to 1% by weight of fluoride ion in the toothpaste. Toothpaste according to Claim 7, characterized in that the fluoride-providing compound is sodium monofluorophosphate. Toothpaste according to Claim 1, characterized in that the betaine is coconut amidopropyl betaine. Toothpaste according to Claim 6, characterized in that the abrasive is a mixture of hydrotreated alumina and calcined alumina. Toothpaste according to Claim 4, characterized in that the sodium saccharin constitutes about 0.01 to 0.5% by weight thereof. 12. A method of making a cosmetic and chemically stable anti-plaque toothpaste comprising an effective amount of an anti-plaque quaternary ammonium compound, about 3-5% by weight of betaine surfactant, about 0.5-2% by weight of spice, about 18-23% by weight a glycerin and / or sorbitol wetting agent, about 0.8-1.5% by weight of a nonionic gelling agent and about 35-65% by weight of a water-insoluble tooth abrasive, the method consisting essentially of two separate phases, an oil gel phase and forming an aqueous gel phase before combining the two gel phases into a single gel phase, characterized in that it comprises the following sequence of steps: a) dispersing the amount of the composition of the anti-plaque quaternary ammonium substance in the amount of spice of the composition; b) mixing said dispersion of the quaternary ammonium compound and the spice to form an amount of betaine surfactant to form an oil gel phase; c) dispersing the amount of nonionic gel composition in the amount of glycerin and / or sorbitol wetting agent in the composition; d) mixing said dispersion of gelling agent and wetting agent with an amount of water in the composition to form an aqueous gel phase; e) combining the two gel phases to form a stable base gel phase; f) adding the dentifrice to the aqueous gel phase or to the base gel phase with stirring; and g) recovering a stable anti-plaque toothpaste. A method according to claim 12, characterized in that the water-soluble sweetener, the fluorine-containing compound or both are dissolved in an amount of water in the composition before it is added to the dispersion of the wetting agent and gelling agent in the formation of the aqueous gel phase. A method according to claim 13, characterized in that the sweetener is sodium saccharin and said fluorine-containing compound is sodium monofluorophosphate. A method according to claim 12, characterized in that said nonionic gelling agent is hydroxyethylcellulose.