Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
  • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
  • A61K8/365—Hydroxycarboxylic acids; Ketocarboxylic acids
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
  • A23G4/00—Chewing gum
  • A23G4/06—Chewing gum characterised by the composition containing organic or inorganic compounds
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
  • A23G4/00—Chewing gum
  • A23G4/06—Chewing gum characterised by the composition containing organic or inorganic compounds
  • A23G4/064—Chewing gum characterised by the composition containing organic or inorganic compounds containing inorganic compounds
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P19/00—Drugs for skeletal disorders
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Definitions

• the present invention relates generally to chewing gums. More specifically, the present invention relates to chewing gums that can provide dental benefits.
• tooth decay is the most prevalent human disorder.
• the Merck Manual Sixteenth Edition, p. 2480.
• many steps have been taken to reduce dental caries and tooth decay, such as fluoridation and improved dental care, tooth decay continues to be a significant problem. This is especially true in the adult population; 80% of the tooth decay occurs in 20% of the population. See Featherstone, An Updated Understanding of the Mechanism of Dental Decay and its Prevention, Nutrition Quarterly, Vol. 14, No. 1, 1990, pp. 5-11.
• a thin layer of dental enamel forms a protective coating over the tooth.
• This coating consists mainly of calcium, phosphate, and other ions in a hydroxyapatite-like structure.
• the enamel contains 2 to 5 percent carbonate; this carbonate content makes the enamel susceptible to acid dissolution. See, Featherstone, id. at 6.
• Tooth decay begins when the Streptococcus mutans, that reside principally in the plaque that adheres to a tooth surface, metabolizes the fermentable carbohydrates that are consumed by the host. During the metabolism of the fermentable carbohydrates by the bacteria, lactic acid and other organic acids are secreted as a by-product. These acids reduce the pH of the surrounding plaque/tooth environment. When the pH of the plaque/tooth environment drops below a critical level of 5.5 to 5.7, hydroxyapatite (calcium phosphate hydroxide, Ca 10 (PO 4 ) 6 (OH) 2 ), the key component of tooth enamel, begins to dissolve. This critical pH can change depending on the concentration of the key ions. Typically, the dissolution begins below the tooth's porous surface.
• the natural remineralization process involves, in part, the flow of saliva over the plaque.
• the saliva can raise the pH of the environment. Additionally, calcium and phosphate ions in the saliva precipitate out to replace the hydroxyapatite that was dissolved by the organic acids created during the metabolism of the fermentable carbohydrates.
• this remineralization process only occurs at significant levels when the pH is above the critical level (5.5 to 5.7). Therefore, if the saliva does not sufficiently raise the pH, significant remineralization will not occur. But, the remineralization process may be enhanced by fluoride in the oral cavity that speeds up new crystal growth and makes a flurorapatite-like material that is precipitated on the surface of the crystals inside the caries lesion. See, Featherstone, id. at 7.
• Calcium containing compositions are used in chewing gum. Specifically, a number of current chewing gum products use calcium carbonate as a base filler. Additionally, calcium carbonate is used in chewing gum formulas to modify chewing texture. Calcium carbonate is very water insoluble. Accordingly, even though calcium carbonate is added to a chewing gum base, it does not release in sufficient levels into the mouth of chewer in order to enhance the remineralization of tooth enamel.
• U.S. Patent No. 5,378,171 discloses a sugar chewing gum with dental health benefits that includes calcium glycerophosphate.
• the present invention provides a composition and method for the remineralization of enamel.
• sugar free chewing gum is provided that includes a therapeutically effective amount of calcium and a food grade acid. It has been found that the food grade acids when added to a calcium containing base will convert insoluble calcium carbonate to its more soluble salt. This will allow the calcium to be released into the salvia in the mouth of the chewer. This provides calcium that can be used to enhance remineralization and/or reduce demineralization of tooth enamel.
• the present invention provides a sugar free chewing gum comprising an insoluble portion, a water soluble portion, a flavor, calcium carbonate, and a food grade acid.
• the food grade acid is chosen from the group consisting of: lactic acid; phosphoric acid; citric acid; malic acid; ascorbic acid; formic acid; fumaric acid; succinic acid; and tartaric acid.
• the calcium carbonate comprises approximately 0.1% to about 20% by weight of the chewing gum.
• the chewing gum includes at least one additional oral health ingredient.
• the food grade acid comprises approximately 0.4% to about 5% by weight of the chewing gum.
• a sugar free chewing gum in an embodiment of the present invention, includes a water soluble portion, a water insoluble portion, a sufficient amount of an insoluble calcium salt containing composition to produce a calcium ion concentration in the mouth of the chewer of at least 100 ppm, and a food grade acid.
• the food grade acid is chosen from the group consisting of: lactic acid; phosphoric acid; citric acid; malic acid; ascorbic acid; formic acid; fumaric acid; succinic acid; and tartaric acid.
• the calcium carbonate containing composition comprises approximately 0.1% to about 20% by weight of the chewing gum.
• the food grade acid comprises approximately 0.4% to about 5% by weight of the chewing gum.
• a method for enhancing the remineralization of teeth comprises the steps of: providing a sugarless chewing gum including a water soluble portion, a water insoluble portion, calcium carbonate, and a food grade acid; and chewing the sugarless chewing gum.
• two pieces of chewing gum are chewed at a time.
• the chewing gum is chewed at least twice a day. In an embodiment, the chewing gum produces a calcium ion concentration in the saliva of the mouth of the chewer of at least 100 ppm.
• the chewing gum produces a calcium ion concentration in the saliva of the mouth of the chewer of at least 300 ppm.
• the chewing gum produces a calcium ion concentration in the saliva of the mouth of the chewer of at least 500 ppm.
• the calcium ion concentration is maintained in the saliva for at least 2 minutes.
• An advantage of the present invention is to provide a method for preventing or reducing the risk of dental caries. Another advantage of the present invention is to provide a method for the remineralization of enamel.
• a still further advantage of the present invention is to treat dental caries.
• an advantage of the present invention is to provide a chewing gum that can be used to improve dental health. Further, an advantage of the present invention is to provide a chewing gum that does not have the sensory drawbacks of other sources of calcium. Moreover, an advantage of the present invention is to provide an easy and enjoyable way to improve dental health.
• a further advantage of the present invention is that it provides a chewing gum having dental benefits and a reduced cost. Still further, an advantage of the present invention is to provide a composition and method for delivering a therapeutic agent over a prolonged period of time to the oral region.
• FIGURE 1 illustrates graphically saliva extraction data, setting forth calcium released over time, for Examples 6-8 discussed infra.
• the present invention provides methods and compositions for the remineralization of tooth enamel.
• the present invention provides methods and compositions for preventing and/or treating dental caries.
• a chewing gum is provided that includes a therapeutically effective amount of calcium and a food grade acid; the chewing gum of the present invention can improve dental health when chewed.
• a variety of food grade acids can be used. Such acids include lactic acid, phosphoric acid, citric acid, malic acid, ascorbic acid, formic acid, fumaric acid, succinic acid, and tartaric acid and mixtures thereof.
• citric acid converts calcium carbonate to calcium citrate
• lactic acid converts calcium carbonate to calcium lactate
• phosphoric acid converts calcium carbonate to calcium phosphate.
• These acids have been found to maintain a pH level of approximately 5 to 7 in the gum as the acids are converted to their respective salts. Because the food grade acid, e.g., citric acid, when added to a sugarless chewing gum containing calcium carbonate converts the insoluble calcium carbonate to its more soluble salt, it can enhance remineralization.
• Food acids are typically much less expensive than the corresponding calcium salts.
• Calcium carbonate is very inexpensive and typically is present in chewing gum products.
• the chewing gums of the present invention are less expensive to manufacture than gums formulated with the equivalent calcium salt.
• the chewing gum will comprise approximately 0.1 % to about 20% by weight calcium carbonate preferably approximately 1% to about 15% by weight, and most preferably approximately 3% to about 12% by weight calcium carbonate.
• Sufficient calcium carbonate should be present in the chewing gum to create a calcium concentration in the saliva of at least 100 ppm, preferably at least 300 ppm, and most preferably at least 500 ppm for at least one minute, preferably more than two minutes, and most preferably for four minutes upon chewing the gum.
• the food grade acid e.g., citric acid
• the food grade acid e.g., citric acid
• the chewing gum mass but may also be pre-blended with calcium carbonate prior to mixing.
• citric acid may be utilized in the present invention including phosphoric, lactic, malic, tartaric, formic, fumaric, succinic, and ascorbic acids. It has been found that these acids are more effective than others in generating calcium ions in saliva during chewing. Although the inventors do not want to be bound to any specific theory, they believe the reason for this is due to the dissociation constants of the acids and to the solubility of the resultant calcium salt.
• the chewing gum composition may be any sugarless chewing gum formula. Such formulas typically contain a major amount of a sugar alcohol bulking agent, a substantial portion of gum base, minor amounts of syrups, softeners, flavors, color and high intensity sweeteners. Low calorie gums which contain reduced levels of sugar alcohols and increased levels of base and/or low calorie or calorie-free bulking agents are also anticipated.
• the product may be formed into tabs, sticks, chunks or coated pellets. A piece size of approximately 1 to about 5 grams is preferred.
• Chewing gum generally consists of a water insoluble gum base, a water soluble portion, and flavors.
• the water soluble portion dissipates with a portion of the flavor over a period of time during chewing.
• the gum base portion is retained in the mouth throughout the chew.
• the insoluble gum base generally comprises elastomers, resins, fats and oils, softeners, and inorganic fillers.
• the gum base may or may not include wax.
• the insoluble gum base can constitute approximately 5 to about 95 percent, by weight, of the chewing gum, more commonly, the gum base comprises 10 to about 50 percent of the gum, and in some preferred embodiments, 20 to about 35 percent, by weight, of the chewing gum.
• the chewing gum base of the present invention contains about 20 to about 60 weight percent synthetic elastomer, 0 to about 30 weight percent natural elastomer, about 5 to about 55 weight percent elastomer plasticizer, about 4 to about 35 weight percent filler, about 5 to about 35 weight percent softener, and optional minor amounts (about one percent or less) of miscellaneous ingredients such as colorants, antioxidants, etc.
• Synthetic elastomers may include, but are not limited to, polyisobutylene with GPC weight average molecular weight of about 10,000 to about 95,000, isobutylene- isoprene copolymer (butyl elastomer), styrene-butadiene copolymers having styrene- butadiene ratios of about 1:3 to about 3:1, polyvinyl acetate having GPC weight average molecular weight of about 2,000 to about 90,000, polyisoprene, polyethylene, vinyl acetate- vinyl laurate copolymer having vinyl laurate content of about 5 to about 50 percent by weight of the copolymer, and combinations thereof.
• Preferred ranges are, for polyisobutylene, 50,000 to 80,000 GPC weight average molecular weight, for styrene-butadiene, 1:1 to 1 :3 bound styrene-butadiene, for polyvinyl acetate, 10,000 to 65,000 GPC weight average molecular weight with the higher molecular weight polyvinyl acetates typically used in bubble gum base, and for vinyl acetate- vinyl laurate, vinyl laurate content of 10-45 percent.
• Natural elastomers may include natural rubber such as smoked or liquid latex and guayule as well as natural gums such as jelutong, lechi caspi, perillo, sorva, massaranduba balata, massaranduba chocolate, nispero, rosindinha, chicle, gutta hang kang, and combinations thereof.
• the preferred synthetic elastomer and natural elastomer concentrations vary depending on whether the chewing gum in which the base is used is adhesive or conventional, bubble gum or regular gum, as discussed below.
• Preferred natural elastomers include jelutong, chicle, sorva and massaranduba balata.
• Elastomer plasticizers may include, but are not limited to, natural rosin esters such as glycerol esters of partially hydrogenated rosin, glycerol esters polymerized rosin, glycerol esters of partially dimerized rosin, glycerol esters of rosin, pentaerythritol esters of partially hydrogenated rosin, methyl and partially hydrogenated methyl esters of rosin, pentaerythritol esters of rosin, synthetics such as terpene resins derived from alpha- pinene, beta-pinene, and/or d-limonene; and any suitable combinations of the foregoing.
• natural rosin esters such as glycerol esters of partially hydrogenated rosin, glycerol esters polymerized rosin, glycerol esters of partially dimerized rosin, glycerol esters of rosin, pentaerythritol
• the preferred elastomer plasticizers will also vary depending on the specific application, and on the type of elastomer which is used.
• Fillers/texturizers may include magnesium and calcium carbonate, ground limestone, silicate types such as magnesium and aluminum silicate, clay, alumina, talc, titanium oxide, mono-, di- and tri-calcium phosphate, cellulose polymers, such as wood, and combinations thereof.
• calcium carbonate is the preferred filler but other fillers may be used if calcium carbonate is added separately.
• Softeners/emulsifiers may include tallow, hydrogenated tallow, hydrogenated and partially hydrogenated vegetable oils, cocoa butter, glycerol monostearate, glycerol triacetate, lecithin, mono-, di- and triglycerides, acetylated monoglycerides, fatty acids (e.g. stearic, palmitic, oleic and linoleic acids), and combinations thereof.
• fatty acids e.g. stearic, palmitic, oleic and linoleic acids
• Colorants and whiteners may include FD&C-type dyes and lakes, fruit and vegetable extracts, titanium dioxide, and combinations thereof.
• the base may or may not include wax.
• An example of a wax-free gum base is disclosed in U.S. Patent No. 5,286,500, the disclosure of which is incorporated herein by reference.
• a typical chewing gum composition includes a water soluble bulk portion and one or more flavoring agents.
• the water soluble portion can include bulk sweeteners, high intensity sweeteners, flavoring agents, softeners, emulsifiers, colors, acidulants, fillers, antioxidants, and other components that provide desired attributes.
• Softeners are added to the chewing gum in order to optimize the chewability and mouth feel of the gum.
• the softeners which are also known as plasticizers and plasticizing agents, generally constitute between approximately 0.5 to about 15% by weight of the chewing gum.
• the softeners may include glycerin, lecithin, and combinations thereof.
• Aqueous sweetener solutions such as those containing sorbitol, hydrogenated starch hydrolysates, corn syrup and combinations thereof, may also be used as softeners and binding agents in chewing gum.
• Bulk sweeteners typically constitute 5 to about 95% by weight of the chewing gum, more typically, 20 to 80% by weight, and more commonly, 30 to 60% by weight of the gum.
• Sugarless sweeteners include, but are not limited to, sugar alcohols such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolysates, maltitol, and the like, alone or in combination.
• High intensity artificial sweeteners can also be used, alone or in combination with the above.
• Preferred sweeteners include, but are not limited to sucralose, aspartame, salts of acesulfame, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, and the like, alone or in combination.
• Such techniques as wet granulation, wax granulation, spray drying, spray chilling, fluid bed coating, coacervation, and fiber extension may be used to achieve the desired release characteristics.
• Usage level of the artificial sweetener will vary greatly and will depend on such factors as potency of the sweetener, rate of release, desired sweetness of the product, level and type of flavor used and cost considerations. Thus, the active level of artificial sweetener may vary from 0.02 to about 8%. When carriers used for encapsulation are included, the usage level of the encapsulated sweetener will be proportionately higher. Combinations of sugar and/or sugarless sweeteners may be used in chewing gum.
• the softener may also provide additional sweetness such as with aqueous sugar or alditol solutions.
• a low caloric bulking agent can be used.
• low caloric bulking agents include: polydextrose; Raftilose, Raftilin;
• Fructooligosaccharides (NutraFlora); Palatinose oligosaccharide; Guar Gum Hydrolysate (Sun Fiber); or indigestible dextrin (Fibersol).
• Palatinose oligosaccharide Guar Gum Hydrolysate (Sun Fiber); or indigestible dextrin (Fibersol).
• Guar Gum Hydrolysate (Sun Fiber); or indigestible dextrin (Fibersol).
• other low calorie bulking agents can be used.
• flavoring agents can be used.
• the flavor can be used in amounts of approximately 0.1 to about 15 weight percent of the gum, and preferably, 0.2 to 5%.
• Flavoring agents may include essential oils, synthetic flavors or mixtures thereof including, but not limited to, oils derived from plants and fruits such as citrus oils, fruit essences, peppermint oil, spearmint oil, other mint oils, clove oil, oil of wintergreen, anise and the like.
• Artificial flavoring agents and components may also be used. Natural and artificial flavoring agents may be combined in any sensorially acceptable fashion.
• Additional oral health ingredients may be added including but not limited to pH control agents (such as urea and buffers), other inorganic components for tartar or caries control (phosphates, fluorides), and anti-plaque/anti-gingivitis agents (including chlorhexidene, CPC, triclosan). Any additional ingredients must be safe and effective and not react undesirably with calcium carbonate or the food grade acid of choice.
• pH control agents such as urea and buffers
• other inorganic components for tartar or caries control phosphates, fluorides
• anti-plaque/anti-gingivitis agents including chlorhexidene, CPC, triclosan. Any additional ingredients must be safe and effective and not react undesirably with calcium carbonate or the food grade acid of choice.
• examples of the present invention are as follows:
• Example 4 is a pre-blended mixture of calcium carbonate and citric acid. Any food grade acid may be substituted in any desired amount.
• Example 5 does not use additional calcium carbonate in the formula. Rather, the acid can react with the calcium carbonate that exists in the base.
• test results for inventive examples 7 and 8 are consistent with data expected based on salt solubility. Calcium carbonate becomes more soluble in an acidic solution. Results are consistent with expectations based on the strength of the acid employed and the solubility of the corresponding salt generated. Moreover, more calcium can be released during the chew to enhance beneficial dental properties with a higher solubility of calcium salts.
• Each of the experimental samples exhibited a sour, acidic character in the initial chew.
• the experimental gums started to become similar to the control after thirty seconds with the sour/tart notes disappearing. Additionally, the two experimental samples exhibited a thin, weak, bubble.
• the sample containing the 1.00% citric acid was considered to be closest to the control.

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• 2000
  • 2000-03-21 CN CN00806222A patent/CN1348365A/zh active Pending
  • 2000-03-21 WO PCT/US2000/007410 patent/WO2000062762A1/en not_active Application Discontinuation
  • 2000-03-21 CA CA002370130A patent/CA2370130A1/en not_active Abandoned
  • 2000-03-21 JP JP2000611899A patent/JP2002542185A/ja active Pending
  • 2000-03-21 PL PL00351082A patent/PL351082A1/xx not_active Application Discontinuation
  • 2000-03-21 BR BR0009773-0A patent/BR0009773A/pt not_active IP Right Cessation
  • 2000-03-21 AU AU39035/00A patent/AU3903500A/en not_active Abandoned
  • 2000-03-21 EP EP00918175A patent/EP1173154A4/de not_active Withdrawn
  • 2000-03-21 RU RU2001126546/13A patent/RU2226060C2/ru not_active IP Right Cessation

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