MXPA01007713A - Oral care chewing gums and confections - Google Patents

Abstract

The present invention pertains to a method for providing dental hygiene which method employs a low moisture chewing gum orconfectionery product containing as active ingredients, a combination of sodium bicarbonate and casein phosphopeptide-amorphous calcium phosphate. The invention also concerns the chewing gums and confectionery products that can provide dental health benefits and methods for their preparation.

Description

MASK GUMS AND CONFECTIONERY PRODUCTS FOR ORAL CARE BACKGROUND OF THE INVENTION Field of the Invention: This invention relates to a method for promoting dental hygiene in particular by reducing plaque, whitening teeth, preventing the demineralization of teeth and providing remineralization of teeth. The method employs a chewing gum or confectionery products that contain as active ingredients, a combination of sodium bicarbonate and calcium phosphate phosphopeptide-amorphous casein. The invention also relates to chewing gums and confectionery products that can provide dental health benefits and methods for their preparation.

Previous Art: The formation of dental caries in teeth has been well studied. Caries is understood as the result of the accumulation of plaque in the teeth and the production of organic acids (plaque acids) when the microorganisms of the sugars and starches in the food ferment. Before they are washed by saliva, the acids accumulated on the plate long enough to lower the pH and cause some of the enamel, a phosphorus-calcium mineral known as hydroxyapatite, to dissolve, that is, demineralize that can lead to dental caries (decomposition of the teeth) and sensitivity.

The plaque itself, which is a sticky film of the oral bacterium and its products, can become calcified without the last formation of a hard mineral in the tooth. Tartar or tartar, as it is sometimes called, is the hard, solid mass of the calcified material deposited on and adhered to the surfaces of the teeth. As a mature tartar develops, it becomes visibly white or yellowish in color. The formation of the plaque can lead to gingivitis and subsequent periodontal disease. Efforts have been made over the years to address the problem of plaque buildup and the dissolution or demineralization of tooth enamel and the resulting formation of tooth decay. It is known to use sodium bicarbonate (NaHCO3) in dental care for the purpose of reducing plaque and whitening teeth and also to reduce oral malodor. Also known as baking soda or baking soda or monosodium salt of carbonic acid, sodium bicarbonate in toothpastes such as pastes and oral rinses, commonly in combination with sodium chloride. This can stabilize plaque acids, which causes demineralization of the teeth by returning the oral pH to a more favorable pH. In high concentrations, it is bactericidal against most periodontal pathogens. Sodium bicarbonate has recently been favored over other alternatives because of its low cost, it is safe if swallowed, its low abrasion due to its high solubility and compatibility with fluoride. Sodium bicarbonate has been used in chewing gums as a filler, a stabilizer, a plaque remover, as an abrasive when used in large quantities.

U.S. Patent 3,590,120 discloses a chewing gum containing a dental plaque removal agent and a dental polishing agent. Sodium bicarbonate is believed to be an agent for the removal of dental plaque. U.S. Patent 4,170,633 discloses chewing gums for the release of alkyl sulfates as plaque inhibiting agents. Baking soda is used as a stabilizer. U.S. Patent 4,592,407 describes chewing gums for the reduction of dental plaque containing glycerol monolaurate. Baking soda is used as a filler. U.S. Patent Nos. 5,702,687, 5,693,334, 5,618,517 and 5,629,035 describe chewing gums for dental care containing organically encapsulated sodium bicarbonate.

Casein amorphous phosphopeptide calcium phosphate complexes are known to have anticariogenic intensification effects on teeth when used as dendritics. The complexes, also known as CPP-ACP complexes or calcium phosphate-calcium casein peptone, are amorphous calcium phosphate stabilized by casein phosphopeptides. CPP-ACP depress demineralization and improve remineralization while stabilizing plaque acid. This acts by locating the phosphate and calcium ions in the dental plaque on the tooth surface. This increased level of calcium and phosphate in dental plaque helps to stabilize plaque acid and maintain a state of supersaturation of calcium and phosphate in solution, that is, in saliva. It is also known to use casein phosphopeptides alone for the prevention of caries and plaque formation. The use of chewing gum as a carrier of CPP-ACP has been suggested.

The North American patents 5,130,123 and 5,227,154 describe the casein phosphopeptides in the prevention of dental caries. International publication WO 98/40406 discloses calcium phosphate-phosphopeptide complexes to provide anti-caries efficacy.

Although it would be very desirable to combine in a release system the benefits of sodium bicarbonate for the reduction of plaque and bleaching of teeth with remineralization and strengthening of the teeth provided by the CPP-ACP, it is known that bicarbonate Sodium will react with calcium phosphate to form calcium carbonate. The combination of sodium bicarbonate with CPP-ACP, could precipitate calcium carbonate and therefore decrease the supply of calcium ions and concomitantly decrease the efficacy of CPP-ACP. A combination of the two components for dental care in a system such as traditional oral rinses and pastes would result in a decrease or deactivation of the remineralization efficacy of the CPP-ACP.

SUMMARY OF THE INVENTION The present invention relates to a method for providing dental hygiene in which method a low moisture chewing gum is employed comprising: (a) from about 10% to about 95% by weight of gum base; (b) from about 0.1% to about 15% by weight of sodium bicarbonate and (c) from about 0.01% to about 30% by weight of CPP-ACP.

The present invention further relates to a method for providing dental hygiene employing a low moisture confectionery product comprising: (a) from about 10% to about 95% by weight of confectionery base, (b) from about 0.1% to about 15% by weight of sodium bicarbonate and (c) from about 0.01% to about 30% by weight of CPP-ACP.

The invention also relates to chewing gums and confectionery products containing active ingredients.

DETAILED DESCRIPTION OF THE INVENTION The present invention, as stated above, relates to chewing gums and low moisture confectionery products that reduce plaque, whiten teeth, prevent dental demineralization and provide remineralization of teeth in the oral cavity. . Chewing gums and confectionery products contain active ingredients, a combination of sodium bicarbonate and amorphous calcium phosphate-casein phosphopeptide complexes. The present invention overcomes the problem of combining the ingredients in an oral delivery system by the use of a low moisture solid system such as a chewing gum or a confectionery product. Low humidity means that a chewing gum or confectionery contains less than 2% moisture. A chewing gum without sugar is also preferred.

In the chewing gums and the confectionery products of the present invention, the ingredients can not be mixed before use by the consumer, that is, they could not be mixed under storage. Chewing gums and confectionery products actually "compartmentalize", that is, separate the two components. In a further embodiment of the invention each component should be in a separate and discrete layer of the chewing gum or the confectionery product. In yet another embodiment of the invention one or both of the components may be encapsulated to prevent contact until the chewing gum or confectionery product is consumed.

Chewing gums and confectionery products may contain from 0.1% to 15% by weight of sodium bicarbonate and from 0.01% to 30% by weight of CPP-ACP.

It is preferred to use from 0.1% to 10% by weight of sodium bicarbonate and from 0.01% by weight % by weight of CPP-ACP. For chewing gums it is desirable to have the CPP-ACP and the sodium bicarbonate present in a weight ratio of about 1: 5.

Chewing gums, due to prolonged contact with the oral cavity in use and due to the fact that a gum base can provide sustained release of the active compounds, provide an excellent release system of the active ingredients and are preferred. The invention also refers to confectionery products, in particular candy confectionery, especially confectionery of pressed sweets. Confectionery of conventionally pressed sweets such as tablets contains approximately 0.5% moisture or less and provides an excellent release system for the active ingredients.

The manufacture of chewing gums and confectionery such as pressed tablets are well known and are described in E.B. Jackson Ed. "Sugar Confectionery Manufacture", 2nd. Edition, Blackie Academic & Professíonal Press, Glasgow UK, (1990), on pages 259 and 236 respectively and in R. Lee and E. B. Jackson, Eds. "Sugar Confectionery and Chocolate Manufacture", Chapman and Hall, UK, (1992) on pages 332 and 286 respectively.

The chewing gums can be any convenient formulation. The formulation of the gum may be sugar free or may contain sugar. It generally comprises one or more synthetic or natural elastomers that are supplemented by chewing gum ingredients. These ingredients include one or more solvents, plasticizers, fillers, flavoring agents, coloring agents and / or sweetening agents. The elastomers which are suitable for use herein include substances of vegetable origin such as chewing gum, jelutong, gutta-percha, guayule and laurea gum. Elastomers such as butadiene-styrene copolymers, isoprene-isobutylene copolymers, polyethylene, polyisobutylene, polyvinyl acetate and mixtures thereof which are also useful. The elastomer generally comprises from about 14% to 50% by weight, preferably from about 20% to about 30% by weight of the chewing gum composition. Polyvinyl acetates may also be used with elastomers to provide rubber extension or elasticity.

The chewing gum composition may contain elastomeric solvents to help soften the polymer component. Said elastomeric solvents may include methyl, glycerol or pentaerythritol esters of rosins or modified rosins, such as hydrogenated, dimerized or polymerized rosins or mixtures thereof. Terpene resins, including polyterpene and mixtures thereof, are also useful. The solvent may be employed in an amount ranging from about 10% to 75% and preferably about 15% to about 50% by weight of the chewing gum composition.

A variety of traditional ingredients used as plasticizers or emulsifiers such as lanolin, lecithin, glycerol monostearate, stearic acid, glycerol triacetate, triacetin, glycerin and the like can be incorporated into the chewing gum composition to obtain a variety of textures and consistency properties. These additional materials also include waxes such as natural waxes, petroleum waxes and microcrystalline waxes and fats and oils including animal fats such as lard and tallow, vegetable oils such as safflower and soybean oil, partially hydrogenated and hydrogenated vegetable oil and cocoa butter. These ingredients are generally used in amounts of above about 30% by weight, preferably 1% to 25% by weight and more preferably from about 3% to about 7% by weight of the final chewing gum composition.

The composition of the chewing gum may additionally include conventional coloring agents such as titanium dioxide, in amounts above 2% and fillers such as dicalcium phosphate, magnesium carbonate, aluminum hydroxide, alumina, aluminum silicates, talc , calcium carbonate, cellulose and combinations thereof in amounts from 5 to 35% by weight of the final composition.

The chewing gum composition may also contain bulk sweeteners including sugars such as sucrose, dextrose, maltose, fructose and the like and sugar alcohols such as sorbitol, mannitol, xylitol, maltitol, isomalt, erythritol and hydrogenated starch hydrolysates and combinations thereof. Mass sweeteners may be present in amounts in excess of 90% by weight of the final composition. High intensity sweeteners such as aspartate, acesulfame salts, aliatam saccharin and the like may also be present. These sweeteners may be present in amounts above 1% by weight of the final gum composition.

The chewing gum may contain flavoring agents in addition to improving the flavoring compositions in amounts above 3.5%. Generally any food additive such as those described in "Chemicals Used In Food Processing", publication 1274, pages 63-258, by the National Academy of Sciences may be used.

The chewing gum is generally manufactured by methods known in the art by sequentially adding the various components of the chewing gum to any commercial mixer or die cutter in a batch or continuous process. After the ingredients have been thoroughly mixed, the dough is discharged and formed.

The preparation of confectionery formulations has historically been well known and has changed very little over the years. In general, a confectionery of cooked confectionery has a base composed of a mixture of sugar and other agents for the volume of carbohydrates in an amorphous or crystalline condition having from about 0.5% to about 5% humidity. In the present description the moisture content is 2% or less. The base usually contains more than about 75% sugar (sucrose) and more than 65% corn syrup, with a higher proportion of sucrose than corn syrup. Additional ingredients such as flavoring agents, sweetening agents, acidulants, colorants and the like may also be added. Cooked hard candies can also be prepared from non-fermentable sugars such as sorbitol, mannitol, xylitol, maltitol, erythritol, hydrogenated starch hydrolysates and the like. A general description of the composition and preparation of hard confectionery products can be found in E.B. Jackson, Ed. "Sugar Confectionery Manufacture", 2nd. Edition, Blackie Academic & Professional Press, Glasgow UK, (1990), on pages 129-169.

Said confectionery can be routinely prepared by conventional methods such as those involving fire pots, steam pots, and clean surface pots which are also referred to as high pressure atmospheric pots. Once the dough has been properly tempered, it can be cut into manageable portions or formed into different sizes. A variety of forming techniques can be used depending on the shape and size of the desired final product.

Soft candy confectionery includes sugar pastes, mastic candies, chocolate candies, marshmallows and nougats and the like and may also include jams and gelatins. Soft confectionery preparation, such as nougat, involves conventional methods, such as the combination of two primary components, called (1) a high-cooking syrup such as corn syrup or the like and (2) a texture frappe relatively light, generally prepared from egg albumin, gelatin, vegetable proteins, such as soy-derived compounds, milk-derived compounds such as milk proteins and mixtures thereof. Additional ingredients such as the improved flavoring agent, flavoring agents, bulking agents for the additional carbohydrates, colorants, preservatives, medicaments and mixtures thereof and the like can also be added subsequently under agitation. A general description of the composition and preparation of such confectionery can be found in E.B. Jackson, Ed. "Sugar Confectionery and Manufacture", 2nd. Edition, Blackie Academic & Professional Press, Glasgow UK, (1990) on pages 170-235.

The confectionery of compressed tablets, a preferred embodiment, contains particular materials and forms in structures under pressure. This confectionery generally contains sugars or sugar substitutes in amounts above 95% by weight of the composition and excipients of the typical tablets such as binders and lubricants as well as the improved flavoring agent, flavoring agents, colorants and the like.

The following examples are provided to illustrate the preferred embodiments of the invention.

Example 1 This example shows the precipitation of calcium carbonate after mixing sodium bicarbonate with CPP-ACP under conditions in which the imitation mixes the two components in the environment of the oral cavity for a brief period of contact and under prolonged contact time .

The amount of CPP-ACP and sodium bicarbonate combined for the test were based on an in vivo pre-test to determine how much CPP-ACP and sodium bicarbonate would be expected to be extracted in the oral cavity, after chewing, of a gum containing CPP-ACP and sodium bicarbonate in a weight ratio of 1: 5 present in approximately 1% CPP-ACP and 5% sodium bicarbonate.

The in vivo test is performed first to determine the release of CPP-ACP. A panel of a fifth person chewed a chewing gum containing 1% CPP-ACP. The release of CPP-ACP was determined as 2.43 mg / ml. Using these data and assuming a similar release for sodium bicarbonate, the concentrations of CPP-ACP and sodium bicarbonate released into the oral cavity were determined to be 0.63% CPP-ACP and 2% sodium bicarbonate for a concentration end of CPP-ACP = 3 mg / ml. CPP-ACP and sodium bicarbonate in these concentrations were incubated in a 30 ml pooled human saliva with moderate agitation at 37 ° C for 3 minutes for the precipitation test in the gum consumption in 1 hour to show as the contact for a long time would precipitate calcium carbonate. The resulting pH of the incubation solution was approximately 7. The solution was filtered, the remainder was rinsed with deionized H2O to remove any soluble calcium and the result was analyzed for the calcium content by analysis of the Atomic Absorption. As a control of an aqueous solution of 30g of a 0.3% solution of CPP-ACP was passed through the filter paper. 0.3 mg of precipitated calcium was noted. Also, the same experiment was repeated for saliva and a solution of 2% sodium bicarbonate and 1.7 mg calcium were retained through the filter paper. Incubation of 0.3% CPP-ACP with 2% sodium bicarbonate in 30 g of saliva for 3 minutes resulted in 2.5 mg of calcium retained by the filter paper, which is calculated as approximately 0.5 mg of calcium precipitation. The insoluble calcium related to 3.7% of the total CPP-ACP precipitated in 3 minutes. Using the same calculation for the 1 hour incubation, 15.6% CPP-ACP interacted and precipitated.

The following table shows the results of several test periods: The test showed that approximately 4% of 1% CPP-ACP is consumed in 3 min. and approximately 16% of 1% in 1 hr. A concomitant reduction in activity could be expected. The result indicates that for the short period of time necessary to release CPP-ACP and sodium bicarbonate from a chewing gum in the oral cavity (a 10 min chew of a rubber containing 1% CPP) ACP and 5% sodium bicarbonate). The CPP-ACP has very little chance of losing effectiveness. However, as expected, the interactions of sodium bicarbonate and CPP-ACP increase with prolonged exposure, which may indicate potential loss of CPP-ACP efficacy during storage itself in the presence of moisture.

Example 2 This example shows the efficacy of CPP-ACP in remineralization when used in a chewing gum containing CPP-ACP and sodium bicarbonate in the weight ratio of 1: 5. A granule type chewing gum was formulated as follows: Rubber Granule: The rubber has a total shipping size (two pieces) of 2.9 g providing approximately 20.6 mg of CPP-ACP.

The rubber was used in a test designed as a pass test of four double-bond routes of a product for Use in two weeks with a break of one week between temporary tests. A sugar-free gum formulated without the active ingredients was used for comparison. The gums were chewed four times a day for 20 minutes each chewed. The test subjects collected the minimum for the proportion of salivary flow. A removable palate device with inserts of half a plate of human enamel containing the lesion of the demineralized sub-surface was used. The other half of each enamel plate was stored and used as the demineralized control lesion. The devices were worn by the subjects during the chewing of the rubber and 20 minutes after chewing. At the end of each treatment the enamel plates were removed, they were paired with their respective demineralized control and the enamel remineralization was measured by microradiography to determine the percentage of remineralization of the test enamel plate against the demineralized enamel plate. The following table shows the average percentage resulting from remineralization. The average percentage of remineralization obtained for a gum containing only CPP-ACP as the active is also provided for comparison. (This gum released 18.8 mg of CPP-ACP. The gum of the inventive containing 20.6 mg averaged about 10%).

Remineralization percentage Proof.

Comparison: The results demonstrate that CPP-ACP in the presence of sodium bicarbonate results in a significant remineralization when compared to a sugar free gum as a control. The test further shows that the remineralization is equivalent to that provided by a rubber containing CPP-ACP as the active.

Claims (12)

1. A method for providing dental hygiene whose method comprises chewing a low moisture chewing gum comprising: (a) from about 10% to about 95% by weight of the gum base and (b) from about 0.1% to about 15% by weight of sodium bicarbonate and (c) from about 0.01% to about 30% by weight of CPP-ACP.

2. The method according to claim 1 wherein the gum is a sugar free gum.

3. The method according to claim 1, wherein the gum comprises: (a) from about 0.1% to about 10% by weight of sodium bicarbonate and (b) from about 0.01% to about 10% by weight of CPP-ACP .

4. A method for providing dental hygiene wherein the method comprises chewing a low moisture confectionery product comprising: (a) from about 10% to about 95% by weight of the confectionery base, (b) from about 0.1% to about 15% by weight of sodium bicarbonate and (c) from about 0.01% to about 30% by weight of CPP-ACP.

5. The method according to claim 4, wherein the confectionery product is a confectionery of pressed confectionery.

6. The method according to claim 4, wherein the confectionery product comprises: (a) from about 0.1% to about 10% by weight of sodium bicarbonate and (b) from about 0.01% to about 10% by weight of CPP - ACP.

7. A chewing gum comprising: (a) from about 10% to about 95% by weight of the gum base and (b) from about 10% to about 95% by weight of the gum base and (c) from about 0.01% to about 30% by weight of CPP-ACP.

8. The gum according to claim 7, wherein the gum is a gum without sugar.

9. The gum according to claim 7, wherein the gum comprises: (a) from about 0.1% to about 10% by weight of sodium bicarbonate and (b) from about 0.01% to about 10% by weight of CPP-5 ACP. *

* 10. A confectionery confection comprising: (a) from about 10% to about 95% by weight of the confectionery base, 10 (b) from about 0.1% to about 15% by weight of sodium bicarbonate and (c) ) from about 0.1% to about 30% by weight of CPP-ACP.

11. The confectionery product according to claim 10, wherein the confectionery is a confectionery product of pressed confectionery.

12. The confectionery product according to claim 10, wherein the confectionery product comprises: (a) from about 0.1% to about 10% by weight of sodium bicarbonate and (b) from about 0.01% to about 10% by weight weight of CPP- ACP. 25