Dentifrice for the mineralization and remineralization of teeth

Details Dentifrice for the mineralization and remineralization of teeth Dentifrice for the mineralization and remineralization of teeth

2000-09-14

2002-04-16

Rose, Shep K. (Department: 1614)

Drug, bio-affecting and body treating compositions

Dentifrices

C514S690000, C424S050000

Reexamination Certificate

active

06372198

ABSTRACT:

BACKGROUND OF THE INVENTION
1 . Technical Field
The present invention relates generally to dentifrices, and more particularly to dentifrice compositions containing enhanced levels of minerals for mineralizing and remineralizing teeth, as well as various chemical compounds for promoting beneficial oral cavity health.
2 . Discussion
A dentifrice is a substance or preparation used with a toothbrush to aid mechanical cleaning of the accessible surfaces of the teeth. A typical formulation for a dentifrice (e.g., toothpaste) contains varying amounts of humectants (e.g., glycerine, sorbital, propylene glycol, xylitol, polyethylene glycol), water, buffers/salts/tartar controls (e.g., tetrasodium pyrophosphate, sodium tripolyphosphate), organic thickeners and gums (e.g., sodium carboxylmethyl cellulose, cellulose ethers, xanthan gum, carrageenans, sodium alginate, and carbopols), inorganic thickeners (e.g., silica thickeners, sodium aluminum silicates, and clays), abrasives (e.g., hydrated silica, dicalcium phosphate digydrate, calcium carbonate, sodium bicarbonate, calcium pyrophosphate, and alumina), active ingredients (e.g., fluoride, and TRICLOSAN™), surfactants (e.g., sodium lauryl sulfate, sodium N-lauryl sarcosinate, pluronics, sodium lauryl sulfoacetate), and flavors and sweeteners (e.g., wintergreen, cinnamon, peppermint, etc.).
On the basis of clinical studies involving the use of dentifrices containing sodium monofluorophosphate, Na
2
PFO
3
, as the active ingredient have been accepted by the Council on Dental Therapeutics of the American Dental Association (ADA) as effective in helping to prevent caries. Examples of dentifrices containing sodium monofluorophosphate are Colgate with MFP and Macleans Fluoride. When incorporated in dentifrice formulations at a level of ca. 0.76%, sodium monofluorophosphate has been shown to be of benefit in 17-38% reduction of dental caries. These findings are in the same general range as those reported for dentifrices already accepted by the ADA that contain 0.4% stannous fluoride (SnF
2
) (e.g., Crest and Aim).
In addition to the prevention of caries, there has been increasing interest by the dental health industry in the mineralization and remineralization of tooth enamel. Enamel is the term given to the bony outer surface of teeth. Enamel, as well as other structures of the tooth (e.g., dentin), are generally comprised of apatite (e.g., calcium phosphate in the form of calcium hydroxyapatite). Through malnutrition, disease, neglect, and certain dental procedures (e.g., bleaching), the tooth enamel can become demineralized and, as a result, subject to decay, thus leading to the formation of caries, lesions or cavities. For example, the consumption of sugary foods and beverages tends to enable the proliferation of plaque bacteria which in turn produces an acidic environment in the mouth which eventually leads to the demineralization of the tooth, absent appropriate intervention. The mode of demineralization is thought to involve the highly increased solubility of calcium phosphate salts in acidic oral cavity environments, as opposed to the high insolubility of calcium phosphate salts in normal pH oral cavity environments.
Although saliva, which is supersaturated with calcium and phosphate ions, aids somewhat in the natural remineralization process of enamel and dentin, it is a very slow process (due, in part, to the low solubility of calcium phosphate at the pH of saliva) whose benefits can be overcome in persistently acidic oral cavity environments. It is generally known that fluoride ions can enhance the natural remineralization process, thus, this is the reason why many commercially available dentifrices now contain various forms of fluoride ions, e.g., in the form of stannous fluoride or sodium monofluorophosphate.
One readily commercially available product that supposedly addresses the issue of mineralization and remineralization of various surface and subsurface tooth structures, such as enamel and dentin, is marketed under the tradename ENAMELON™ and is manufactured by Enamelon, Inc. (Cranbury, N.J.). With respect to ENAMELON™ brand dentifrice, the manufacturer claims that it contains a source of calcium ions, a source of phosphate ions, and a source of fluoride ions that act in manner that promotes the mineralization/remineralization of various surface and subsurface tooth structures, such as the enamel and the dentin.
A more complete discussion of tooth mineralization and remineralization can be found in the following U.S. patents, the entire specifications of which are incorporated herein by reference:
U.S. Pat. No. 4,083,955 discloses that two compositions containing respectively a cation and an anion, such as calcium ion and phosphate ion, are sequentially applied to dental enamel resulting in remineralization of subsurface dental enamel.
U.S. Pat. No. 4,327,079 discloses a dentifrice composition containing synthetic hydroxyapatite powder which is neutral or weakly alkaline or contains 0.1 to 20% by weight of NaCl and/or KCl and 0.003 to 3% by weight of MgCl
2
.
U.S. Pat. No. 4,356,168 discloses an opacified dental cream which effects dental remineralization and reduces caries formation.
U.S. Pat. No. 4,357,317 discloses a dental cream composition containing a binary fluorine providing system which provides about 1000-1670 ppm (0.1-0.16% by weight) fluorine from sodium monofluorophosphate and sodium fluoride wherein sodium fluoride provides about 30-35% by weight of the fluorine in amount of about 300-580 ppm (0.02-0.058% by weight).
U.S. Pat. No. 4,397,837 discloses compositions for the remineralization and prevention of demineralization of the teeth of animals including humans in the form of two phases, one phase containing a water-soluble calcium compound and the other phase containing a water-soluble phosphate and optionally a water-soluble fluorine compound.
U.S. Pat. No. 4,425,324 discloses a hazed toothpaste which can effect dental remineralization and reduce caries formation.
U.S. Pat. No. 4,460,565 discloses a dentifrice containing two or more fluorine compounds, at least one soluble salt producing phosphate ions, and at least one substance providing calcium ions, and as a result thereof having good remineralization properties.
U.S. Pat. No. 4,518,430 discloses compositions that are remineralizers and dental cements, as well as methods for their use.
U.S. Pat. No. 4,606,912 discloses solutions for optimizing the environmental conditions within the human oral cavity which enhances the functioning of cells of the oral cavity and promotes remineralization of teeth.
U.S. Pat. No. 5,571,502 discloses non-aqueous compositions and methods utilizing same which are useful to remineralize subsurface dental enamel.
U.S. Pat. No. 5,603,922 discloses remineralization, without demineralization, by applying to the teeth a composition which is present in either one or in two phases and which does not react to any large extent until introduced into the oral cavity and upon such introduction does not rapidly precipitate.
U.S. Pat. No. 5,605,675 discloses the remineralization of dental enamel by applying to the teeth a composition which is present in two phases which do not react with one another until introduced into the oral cavity.
U.S. Pat. No. 5,605,677 discloses a toothpaste containing typical components and a combination of silicas and dicalcium phosphate dihydrate (brushite) as its polishing component provides for particularly good restoration of the surface of teeth.
U.S. Pat. No. 5,614,175 discloses non-aqueous compositions and methods utilizing same which are useful to remineralize subsurface dental enamel.
U.S. Pat. No. 5,618,549 discloses a method of treating a living organism having a disease associated with demineralization or mineralization defects of an existing bone by applying in a spongy portion of the bone or in a medullary canal of the bone at least one biocompatible and bioabsorbable calcium salt in the form of particles having dimensions less than 8 mm.
U.S. Pat. No. 5,645,853 discloses chewing gum compositions and

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