Drug – bio-affecting and body treating compositions – Dentifrices – Fluorine or fluorine compound containing
Reexamination Certificate
1999-09-13
2001-03-27
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Fluorine or fluorine compound containing
C424S049000, C424S057000
Reexamination Certificate
active
06207139
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to new anti-tartar systems, dentifrice compositions containing these systems and their use in controlling tartar accumulation on teeth.
2. The Related Art
Tartar, known also as calculus, is a hard mineralized deposit which forms around teeth. This formation arises from deposition of crystals of calcium phosphate in the pellicle and the extracellular matrix of dental plaque. Various forms of calcium phosphate have been identified but the most difficult to remove and thermodynamically most stable form is called hydroxyapatite (HAP). Amorphous forms of calcium phosphate are believed to be the precursors of HAP. Regular brushing can usually remove the amorphous forms but is not fully effective to dislodge the final stable calculus form. Therefore it is desirable to prevent amorphous forms of calcium phosphate from transforming into HAP. The art has recognized that agents which interfere with the formation of HAP crystallization will be effective anti-tartar agents.
Soluble inorganic pyrophosphate salts have over the last decade set the commercial standard as tartar control agents. This technology has been reported by Parran, Jr. et al. in a series of patents including U.S. Pat. No. 4,590,077, U.S. Pat. No. 4,515,772 and U.S. Pat. No. 4,684,518.
Anionic polymers, especially carboxylate group functionalized polymers have been widely reported as effective against calculus. Commercially most significant has been the use of synthetic, linear anionic polymers of higher molecular weight in combination with the inorganic pyrophosphates. This technology derives from work done by Gaffar et al. reported in a series of patents including U.S. Pat. No. 4,627,977, U.S. Pat. No. 4,806,340, U.S. Pat. No. 4,806,342, U.S. Pat. No. 4,808,400 and U.S. Pat. No. 4,808,401. Anionic polymers described therein were found to inhibit the action of pyrophosphatase in the mouth and therefore allowing greater efficacy of the inorganic pyrophosphate. The commercially operative polymer is a methyl vinyl ether/maleic anhydride copolymer, available under the GAF trademark Gantrez.
Organic phosphonic acid derivatives, some in polymeric form, have been disclosed in U.S. Pat. No. 3,934,002 (Haefele). EP 0 341 662 (Amjad) cites a tartar inhibiting oral composition that includes a fluoride source, a dental abrasive, a carboxylate polymer and various phosphonic acids and their derivatives. A phosphated acrylic acid/hydroxyethyl methacrylate/alkyl methacrylic acid ester copolymer has been suggested in GB 2 139 635B (Causton) as useful in an oral composition for treating teeth.
Evident from the foregoing review of the art is the considerable effort expended to devise better tartar control compositions. By no means, however, has any of the reported art been able to more than attenuate the problem. There is considerable room for improvement over the known control agents.
Accordingly, it is an object of the present invention to provide a product of improved efficacy in controlling formation of tartar.
A still further object of the present invention is to provide a tartar control product of improved taste, safety and appearance.
These and other objects of the present invention will become more apparent in light of the detailed description and Examples which follow.
SUMMARY OF THE INVENTION
An anti-tartar dental product is provided comprising:
(i) a container;
(ii) an oral composition stored within the container, the composition including:
(a) 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
(b) a second composition including from about 0.01 to about 30% by weight of an alkaline material and an anti-caries 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;
(iii) instructions printed on the container directing use of the composition to control tartar when applied to the teeth.
A method is provided for controlling dental tartar which includes:
(i) obtaining a product which includes:
(a) 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
(b) a second composition comprising from about 0.01 to about 30% by weight of an alkaline material and an anti-caries 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;
(ii) extruding a portion of first and second compositions onto a toothbrush; and
(iii) brushing the teeth with the combination of first and second compositions.
DETAILED DESCRIPTION OF THE INVENTION
Products intended for remineralization of teeth ordinarily employ calcium and phosphate ions. Naturally there is great concern that these ions can be diverted from remineralization to calculus forming hydroxyapatite. Now it has been discovered that when a water soluble calcium phosphate salt is stored within one composition held at a low pH and mixed after storage with a second composition having a high pH, the result is a significant reduction in normal tartar formation against the teeth.
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 toothpaste.
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. Illu
Barrow Stephen Roy
Lee G Jae
Williams David Robert
Ziemkiewicz Alexander George
Honig Milton L.
Rose Shep K.
Unilever Home & Personal Care USA , division of Conopco, Inc.
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