Drug – bio-affecting and body treating compositions – Dentifrices – Fluorine or fluorine compound containing
Reexamination Certificate
2000-03-29
2001-04-10
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Fluorine or fluorine compound containing
C424S049000, C424S057000
Reexamination Certificate
active
06214321
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to oral compositions and methods employing such compositions for the remineralization of dental enamel.
2. The Related Art
In the mouth, there is a natural equilibrium between hydroxyapatite being dissolved from the enamel of teeth and hydroxyapatite being formed on or in the teeth from substances occurring naturally in the saliva. This equilibrium is shifting continuously. Among other factors, it is determined by diet and physical condition. If the equilibrium is such that hydroxyapatite is dissolved, a cariogenic condition arises which is referred to as demineralization. If the equilibrium is such that hydroxyapatite is being formed in demineralized enamel, this is referred to as remineralization. By remineralization, pre-existing tooth decay and caries can be reduced or eliminated by natural means.
It has long been known that fluoride-providing compounds, even in low concentrations, promote the remineralization process. They thereby reduce pre-existing carious conditions in the tooth structure. Fluoride is most effective during the developmental years from childhood to young adulthood. Improved remedies are necessary, especially beyond the formative years.
Attempts have been made to arrest or prevent progression of caries by incorporation of calcium and phosphate ions through dietary and dentifrice means. A significant hurdle to this approach has been maintaining the calcium and phosphate ions available in a non-precipitated form. Two phase or separately compartmented calcium and phosphate compositions have been proposed. GB Patent 1,408,922 (Raff et al.) suggests a two-compartment tube, the first being filled with a toothpaste containing calcium chloride and the second containing disodium hydrogen phosphate. Upon dispensing, the compositions are mixed thereby causing the precipitation of calcium phosphate onto the teeth.
A similar approach is reported by Tung in U.S. Pat. No. 5,037,639 and U.S. Pat. No. 5,268,167. The restorative compositions disclosed therein employ amorphous calcium phosphate or solutions which will form amorphous calcium phosphate suspended in a carrier. Suitable carriers were said to include gels, chewing gum, powders, mouthrinses, carbonated solutions and toothpaste. These compositions are said to have long range structure; however, they are thought to be homogeneous when measured on an Angstrom Scale. Under physiological conditions the amorphous calcium compounds have high solubilities, high formation rates and high rates of conversion to apatite. The rates of formation and conversion allow remineralization of the dental tissue to occur at a greater speed. Doubts have been raised however with respect to the efficacy of such treatment. Better systems need to be developed.
Accordingly, it is an object of the present invention to provide an oral product and method for building stronger, healthier teeth.
Another object of the present invention is to provide an oral product and method for remineralizing enamel which can be accomplished by a consumer without intervention of a dentist.
These and other objects of the present invention will become more readily apparent through the following summary and detailed discussion.
SUMMARY OF THE INVENTION
An oral product is provided for remineralizing teeth which includes:
(i) a first composition comprising from about 0.01 to about 30% by weight of a water-soluble calcium phosphate or monolithic combination of water soluble calcium and phosphate salts, the composition having a pH less than 7; and
(ii) a second composition including from about 0.01 to about 30% by weight of an alkaline material and an anticaries effective amount of a fluoride ion source, the second composition having a pH greater than 7.5 and stored separately from the first composition in a manner to avoid contact between the phosphate and the alkaline material.
DETAILED DESCRIPTION OF THE INVENTION
Unlike much of the previous technology, it has been found that remineralization products do not need to separate calcium from phosphate ions in a storage system prior to use. Now it has been discovered that a water soluble calcium phosphate salt can be stored within one composition held at a low pH. Activation of this composition to deposit hydroxyapatite onto teeth is achieved by mixing this first composition with a second composition containing fluoride and having a high pH.
Although not wishing to be bound by any theory, it is theorized that upon mixing against the teeth, the soluble calcium phosphate of the first composition interacts with fluoride of the second composition. The alkaline environment of the second composition then causes precipitation of a calcium fluoro phosphate amorphous salt. Transformation of a monocalcium salt cascades downward to the di, octa and then eventually fluoridated hydroxyapatite in the presence of the high pH. Preferably fluoride should only be in the second composition so that it co-precipitates as an element of hydroxyapatite.
Separate storage of the two compositions of this invention may be accomplished through a dual compartment dispenser. U.S. Pat. No. 4,687,663 (Schaeffer) discloses a dual-compartment package respectively storing a peroxide gel and a bicarbonate paste. Pump packaging with multiple compartments is reported in U.S. Pat. No. 5,038,963 (Pettengill et al.) and U.S. Pat. No. 5,020,694 (Pettengill) which are embodied in a U.S. product known as Mentadent® Baking Soda & Peroxide.
Of course, delivery of compositions according to the present invention is not limited to unitary albeit multicompartmented dispensers nor to totally segregated compartments. The dispenser may be a system in the form of two individual tubes quite separate from one another but packaged within a kit. Ribbons of the dentifrice from each tube are delivered to a toothbrush with mixing of the compositions occurring in the mouth. Delivery may also be from a single chambered tube except that each of the two compositions are semi solid strips positioned side-by-side touching but not mixing with one another. The relatively high viscosity of the products prevents any substantial transference of either pH change or components between the two strips. Illustrative of this technology is a U.S. product sold by Colgate® under the Baking Soda & Peroxide brand. Still another method of delivery may be a single composition such as a paste or gel housing an alkaline environment. Monocalcium phosphate compositions may be dispersed throughout the alkaline composition yet separated from contact by a coating encapsulating the phosphate. Activation occurs in the mouth through the presence of water or saliva which penetrates the encapsulating coating releasing phosphate salt to interact with the alkaline environment.
A critical component of the first composition of this invention is a water soluble calcium phosphate salt. By the term “water soluble” is meant a solubility of at least 0.1 gram in 100 ml water at 25° C. Most preferred is monocalcium hydrogen phosphate but also of potential use are calcium polyol phosphates (e.g. calcium glycerophosphate) and monocalcium ammonium phosphate salts. Monolithic compositions of water soluble calcium and phosphate salts may be employed as alternatives to pre-formed water soluble calcium phosphates. By the term “monolithic” is meant separate water soluble calcium salts and phosphate salts which from solution may metathesize into calcium phosphates in solution or later upon mixing with the second composition. Illustrative calcium salts include the halides, sulphates, nitrates, citrates, sugars and C
1
-C
6
carboxylates. Most preferred is calcium chloride, calcium sulphate and calcium acetate. The monolithic partner phosphate salts may be alkali, ammonium or combination salts thereof. Examples include sodium ammonium phosphate, sodium phosphate, ammonium phosphate and potassium phosphate. The water-soluble calcium phosphate salts or the monolithic calcium and phosphate salts (by weight of calcium and phosphate ions only) may be present in amoun
Barrow Stephen Roy
Lee G. Jae
Williams David Robert
Ziemkiewicz Alexander George
Chesebrough-Pond's USA Co. division of Conopco, Inc.
Honig Milton L.
Rose Shep K.
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