Drug – bio-affecting and body treating compositions – Chewing gum type
Reexamination Certificate
2002-05-03
2002-11-19
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Chewing gum type
C424S440000, C424S057000
Reexamination Certificate
active
06482395
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention is related to oral products capable of remineralizing subsurface dental lesions and/or mineralizing exposed dentinal tubules. More particularly, this invention is related to oral products capable of remineralizing subsurface dental lesions and/or remineralizing exposed dentinal tubules, wherein the oral products contain discrete cationic and anionic phases which do not react with on another prior to use of the product. This invention is further related to methods of using the oral products of this invention to remineralize subsurface dental lesions and/or mineralize exposed dentinal tubules.
The primary component of the enamel and dentin in teeth is calcium phosphate in the form of calcium hydroxyapatite. This material is highly insoluble at normal oral pHs but tends to dissolve in acidic media. Thus, when teeth are exposed to acids, e.g., acids generated during the bacteria-induced glycolysis of sugar in the oral cavity, lesions (i.e., demineralized areas) can form below the surface of intact enamel. Dental caries, the leading cause of tooth damage in humans, usually begins with these subsurface lesions, which are formed before a cavity is even detectable. If unchecked, the surface enamel above a subsurface lesion will eventually collapse, leading to cavitation and subsequent loss of tooth structure.
Subsurface remineralization can arrest and repair the carious lesions before any permanent structural damage to the tooth occurs. Unlike surface remineralization processes, which deposit calcium phosphate onto the tooth surface, subsurface remineralization processes precipitate calcium phosphate in the subsurface enamel where demineralization initially occurs.
Saliva is supersaturated with calcium and orthophosphate ions and, therefore, can help protect teeth against demineralization and remineralize teeth which have become demineralized. However, because saliva contains only modest levels of these ions, saliva-promoted remineralization tends to be slow.
The remineralization process can be speeded up by increasing the concentrations of dissolved calcium and orthophosphate ions in the oral cavity. However, this is not easy to do because, at the pH levels in the oral cavity, calcium and orthophosphate ions have a strong affinity for one another and tend to rapidly precipitate calcium phosphate. If such precipitation occurs too soon, subsurface remineralization, which requires that the calcium and orthophosphate ions remain soluble for a period of time sufficient to permit their diffusion into the demineralized subsurface of the dental enamel, will be reduced or prevented.
Thus, to achieve subsurface remineralization, precipitation of the calcium phosphate must be delayed until sufficient levels of the calcium and orthophosphate ions have reached the subsurface of the tooth.
A number of remineralizing products and methods have been developed which are designed at least in part to prevent premature reaction between calcium and orthophosphate ions used in such product or method. Reference is made, for example, to U.S. Pat. Nos. 4,083,955; 4,080,440; 4,606,912; 4,610,873; 4,397,837; 4,348,381; 4,177,258; 4,183,915; 4,460,565; 5,037,639; 5,268,167; 5,427,768; 5,437,857; and 5,460,803. Reference is also made to commonly assigned U.S. Pat. Nos. 5,571,502; 5,603,922; 5,605,675; 5,614,175; 5,645,853; 5,817,296; 5,833,957; 5,858,333; 5,866,102; and 5,895,641.
U.S. Pat. No. 4,083,955 (Grabenstetter et al.). discloses a method for remineralizing subsurface dental enamel, wherein a calcium salt solution and a phosphate salt solution are sequentially applied to dental enamel to effect subsurface remineralization thereof. The delivery system for the calcium and phosphate salt solutions can be in the form of two separate delivery vehicles, each containing one component, or in the form of a single delivery vehicle which contains both components but releases them sequentially. Examples of two-vehicle systems include mouthwash-mouthwash, toothpaste-toothpaste, candy drop-candy drop, nutritional substance-nutritional substance, and toothpowder-toothpowder. Examples of one-vehicle systems include a toothpaste wherein one ingredient is encapsulated for delayed release, a two-compartment bottle, a lozenge with a laminated structure so that first one ionic ingredient is released and then the other, a chewing gum made so that one ingredient is released before the other, and a nutritional substance in which one ingredient is released before the other.
U.S. Pat. No. 4,080,440 (DiGiulio et al.) discloses a method and a two-part product for remineralizing subsurface lesions in dental enamel, wherein the product contains a cationic part composed of a water-soluble calcium salt and an anionic part composed of a water-soluble phosphate salt. Remineralization is carried out by mixing a solution containing the cationic part with a solution containing the anionic part to form a metastable solution which is then promptly applied to the teeth. DiGiulio et al. teaches that the cationic and anionic parts are stored separately in the product to avoid premature precipitation of calcium phosphate. The product, examples of which include two-part mouthwashes and two-part toothpastes, may be in the form of a kit composed of separately packaged solutions of the respective cations and anions. As a two-part toothpaste, the product may be packaged in a codispensing toothpaste tube.
U.S. Pat. Nos. 4,606,912 and 4,610,873 (both to Rudy et al.) are each directed to an aqueous mouthwash solution which is maintainable as a one-bottle solution and capable of remineralizing caries lesions in teeth. The solution is made by forming an aqueous solution containing a source of calcium ions and a chelating agent for calcium ions, causing the chelation of at least 50% of the calcium ions, and subsequently adding a source of phosphate ions to the aqueous solution. The Rudy et al. patents teach that by bringing about the chelation of at least 50% of the calcium ions, the precipitation of calcium phosphate from the solution is avoided.
U.S. Pat. Nos. 4,177,258, 4,183,915 and 4,348,381 (all to Gaffar et al.) are each directed to stable, one-part aqueous compositions capable of remineralizing carious lesions in dental enamel and composed of a solution of water having dissolved therein a source of calcium ions and a source of phosphate ions, a fluoride compound and an antinucleating agent. The Gaffar et al. patents teach that the antinucleating agent prevents spontaneous precipitation of calcium phosphate on the enamel surfaces and thereby permits diffusion of the remineralizing components to the subsurface lesions. The Gaffar et al. patents. further teach that the aqueous remineralizing composition is suitably prepared as a dental mouthrinse and also can be incorporated into other dentifrice compositions such as a dental cream or gel, mouth spray, troche, chewable tablet, lozenge and the like.
U.S. Pat. No. 4,460,565 (Weststrate et al.) discloses an anticariogenic remineralizing dentifrice containing two or more fluorine compounds, at least one water-soluble phosphate salt and at least one compound providing calcium ions. Examples of such dentifrices include toothpastes, prophylactic pastes, tooth polishes, mouth waters, application liquids, gels, and specific chewing gums. Weststrate et al. teaches that the specific calcium complexes used as the source of calcium ions therein are capable of retaining the calcium in an active form in dentifrices-without deactivating the phosphate and fluoride ions.
U.S. Pat. Nos. 5,037,639; 5,268,167; 5,437,857; 5,427,768; and 5,460,803 (all to Tung) involve the use of amorphous calcium compounds such as amorphous calcium phosphate (ACP), amorphous calcium phosphate fluoride (ACPF) and amorphous calcium carbonate phosphate (ACCP) for use in remineralizing teeth. These amorphous compounds or solutions which form the amorphous compounds when applied either onto or into dental tissue prevent and/or repair dental weaknesses such as dental caries, exposed roots and dentin sens
Barth Jordan
Usen Norman
Winston Anthony E.
Church & Dwight & Co., Inc.
Shear Stephen B.
LandOfFree
Remineralizing-mineralizing oral products containing... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Remineralizing-mineralizing oral products containing..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Remineralizing-mineralizing oral products containing... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2984885