Drug – bio-affecting and body treating compositions – Dentifrices – Oxygen or chlorine releasing compound containing
Reexamination Certificate
2002-02-22
2003-02-04
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Oxygen or chlorine releasing compound containing
C424S435000, C424S401000
Reexamination Certificate
active
06514483
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to a system for whitening human teeth, and more particularly to a strip for applying a whitening agent to teeth in order to remove stains from the surface thereof.
BACKGROUND OF THE INVENTION
THE PRIOR ART
A tooth is comprised of an inner dentin layer and an outer hard enamel layer that is the protective layer of the tooth. The enamel layer of a tooth is naturally an opaque white or slightly off-white color. It is this enamel layer that can become stained or discolored. The enamel layer of a tooth is composed of hydroxyapatite mineral crystals that create a somewhat porous surface. It is believed that this porous nature of the enamel layer is what allows staining agents and discoloring substances to permeate the enamel and discolor the tooth.
Many substances that a person confronts or comes in contact with on a daily basis can “stain” or reduce the “whiteness” of one's teeth. In particular, the foods, tobacco products and fluids such as tea and coffee that one consumes tend to stain one's teeth. These products or substances tend to accumulate on the enamel layer of the tooth and form a film over the teeth. These staining and discoloring substances can then permeate the enamel layer. This problem occurs gradually over many years, but imparts a noticeable discoloration of the enamel of one's teeth.
Means known to the art to effect whitening of teeth include the application, as by brushing, to the teeth of peroxide containing dentifrice compositions of the type disclosed in U.S. Pat. No. 5,256,402 and U.S. Pat. No. 5,814,309.
More recently a variety of over-the-counter tooth whitening systems have become available, including a whitening system comprised of a thin strip of plastic film having applied to a surface thereof a tooth whitening composition as described in U.S. Pat. Nos. 5,894,017, 5,891,453 and 6,045,811. Although these systems produce a whitening effect when applied to stained teeth, the art is continually seeking new systems to improve and heighten tooth whitening.
SUMMARY OF THE INVENTION
According to the present invention there is provided a system for applying a composition containing agents to whiten the stained surface of the teeth wherein there is provided a thin film capable of adhering to moist tooth surfaces comprising a dried, water hydratable matrix comprised of one or more polymers of ethylene oxide, and a water soluble plasticizer, the matrix having incorporated therein a solid water soluble whitening agent in an amount effective, when solubilized by saliva in the oral cavity to be released from the film, to whiten the teeth to which the film is applied.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The water hydratable poly(ethylene) oxide films of the present invention can be made in thickness of about 20 to about 1500 micrometer (&mgr;m) and preferably about 50 to about 1000 &mgr;m The dried film contains the solid peroxide whitening agent in an inactive state. Hydration of the film by saliva in the oral cavity solubilizes the water soluble solid whitening agent incorporated in the ethylene oxide polymer matrix whereby the whitening agent is activated and released to the tooth surfaces to which the film is applied.
The rate at which the whitening agent is solubilized and thereafter released into contact with tooth surfaces is controlled by varying the film thickness, polymer properties, as well as the whitening agent concentration, such concentration generally varying from about 0.1 to about 30% by weight and preferably about 0.5 to about 25% by weight of the film.
The solid whitening agents suitable for the practice of the present invention include peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates, and combinations thereof. Suitable peroxide compounds include hydrogen peroxide, urea peroxide, calcium peroxide, and mixtures thereof. Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite. The preferred chlorite is sodium chlorite. A preferred percarbonate is sodium percarbonate. Preferred persulfates are Oxones™.
Ethylene oxide polymers useful for purposes of the present invention include homopolymers or mixtures of ethylene oxide polymers of varying molecular weight ranging from about 10,000 Daltons and up to about 10,000,000 Daltons and preferably in the range of about 100,000 to about 1,500,000 Daltons. Such ethylene oxide polymers are commercially available from various sources. Poly(ethylene) oxide in the molecular weight range of 10,000 to 1,000,000 Daltons is available from the Union Carbide Company under the tradename “Polyox” and are preferred for purposes of the present invention. The ethylene oxide polymer comprises about 50 to about 95% by weight of the film of the present invention and preferably about 60 to about 85% by weight.
The plasticizer useful for purposes of the present invention are selected from glycols such as propylene glycol, polyethylene glycol, polyhydric alcohols such as glycerin and sorbitol and glycerol esters such as glycerol triacetate. The plasticizer comprises about 5 to about 30% by weight of the film of the present invention and preferably about 10 to about 25% by weight.
Glycerin is the preferred plasticizer for use in the present invention as well as propylene glycol or polyethylene glycol such as is available from Union Carbide Corporation as their series of Carbowaxes which range in molecular weight from 200 to 600 Daltons.
In addition to the incorporation of peroxide whitening agents and plasticizer there may also be included in the film matrix minor amounts, e.g., 0.01 to 2% by weight of ingredients such as antioxidants, preservatives, flavors and colorants.
One side of the ethylene oxide polymer film can be also coated with a thin protective coating layer, e.g., of 10 nanometers (nm) to 500 microns (um) thickness which serves as a barrier to prevent release of the solublized whitening agent from the matrix to the oral mucosa, thereby achieving unidirectional release of the whitening agent solely on the tooth surfaces.
The coating material is applied in a sufficiently thin layer so as not to interfere with the flexibility of the film and to allow the whitening strip to conform to an arrangement of a row of teeth.
The coating materials can be one or a combination of high molecular weight (that is, molecular weights greater than 1,000,000 Dalton) and include, ethyl cellulose, itt propyl cellulose, isopropyl cellulose, butyl cellulose, t-butyl cellulose, cellulose acetate, and derivatives of polyvinyl alcohol such as polyvinyl acetate and shellac.
The ethylene oxide polymer film of the present invention can be prepared using conventional extrusion or solvent casting processes. For example, to prepare a film by solvent casting poly(ethylene) oxide, the ethylene oxide polymer or mixture of polymers is dissolved in a sufficient amount of a solvent which is compatible with the polymer. Examples of suitable solvents include water, alcohols, acetone, ethyl acetate or mixtures thereof. After a solution has been formed, a plasticizer is added with stirring, and heat is applied if necessary to aid dissolution, until a clear and homogeneous solution has been formed, followed by the addition of the whitening agent and any other ingredients such as flavors. The solution is coated onto a suitable carrier material and dried to form a film. The carrier material must have a surface tension which allows the polymer solution to spread evenly across the intended carrier width without soaking in to form a destructive bond between the two substrates. Examples of suitable carrier materials include glass, stainless steel, teflon, polyethylene-impregnated kraft paper.
The film used in the instant invention does not contain a wax, ethylene terephthalate and/or polyethylene terephthate, polyethylene, Teflon®, ethylvinyl acetate, ethylenevinyl alcohol, polyesters, hydroxypropyl cellulose, polystyrene, polyurethane, and/or an antimicrobial agent.
Drying of
Viscio David B.
Xu Guofeng
Colgate - Palmolive Company
Shapiro Paul
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