Drug – bio-affecting and body treating compositions – Dentifrices
Reexamination Certificate
2001-01-03
2002-04-23
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
C424S053000
Reexamination Certificate
active
06375933
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a dentifrice composition useful for reducing oral malodor, and more particularly to a dual component dental composition containing zinc and chlorite ion releasable compounds.
2. The Prior Art
“Oral composition” means a composition for topical applications to the oral cavity to clean and care for the teeth as well as the oral cavity surfaces. Representative of such compositions are oral hygiene products for delivering therapeutic and cosmetic benefits to the oral cavity such as mouthwashes or rinses, toothpaste, dental gels, tooth powder, chewing gum, lozenges, strips and similar products. The benefits delivered by oral compositions include the suppression of dental calculus formation and the prevention of dental disorders such as caries, periodontitis and gingivitis as well as the elimination of halitosis.
Dental plaque is a deposit which forms on teeth and consists of inorganic and organic components derived from saliva, food and bacteria which are present in the oral cavity. When plaque undergoes calcification it forms dental calculus composed largely of calcium and orthophosphate arranged in a crystal lattice called hydroxyapatite.
Oral malodor, clinically referred to as halitosis, is caused by the putrefactive activity of microorganisms on appropriate substrate components of dental plaque, debris adhering to mucous membranes and salivary cellular elements to produce volatile sulfur compounds primarily hydrogen sulfide, methyl mercaptan and traces of methyl sulfide.
Methods of inhibiting volatile sulfur compounds to reduce the production of mouth odor have included the use of oral compositions such as toothpastes and mouthrinses containing chlorite ions or zinc ions have been disclosed by the prior art, as for example, U.S. Pat. No. 6,132,702. U.S. Pat. No. 4,992,259. U.S. Pat. No. 5,753,217 discloses a method of reducing oral malodor comprising preparing a solution of sodium chlorite and a zinc salt and applying the solution as a mouth rinse, wherein the sodium chlorite concentration in the solution is between 500 and 1000 parts per million (ppm) and wherein the concentration of Zn ion in the solution is between 200 and 500.
Although useful as anti-malodor agents, applicants assays of the efficacy of chlorite ion releasable compounds as well as zinc ion releasable compounds have indicated that such compounds are not fully effective in suppressing oral malodor, and that efficacy improvements are necessary for full acceptance by consumers of oral care products containing these agents.
SUMMARY OF THE INVENTION
In accordance with the present invention there is provided a method to suppress oral malodor to provide long lasting breath protection wherein there is applied to the oral cavity a multicomponent dentifrice comprised of two separately housed, semi-solid aqueous components; the first component containing a zinc salt as the source of zinc ions and a chlorite salt as a source of chlorite ions in an orally acceptable vehicle having a substantially neutral pH of about 6.0 to 7.5 and the second component having an acid pH of from about 2.0 to about 6.0, whereby upon mixing and combination of the two components the pH of the final dentifrice is no greater than 6.5 with the generation of chlorine dioxide whereby there is effected an unexpected reduction in breath volatile sulfur compounds (VSC) responsible for breath malodor.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
In use, the components of the two component dentifrice of the present invention comprise a first substantially neutral pH dentifrice component, and a second acidic dentifrice component. The two components are preferably formulated with water, humectants, surfactant and abrasive to have similar physical characteristics, so that the two components may be simultaneously delivered in desired predetermined amounts by extrusion when separately housed in a multicompartmented container such as a tube or pump device.
The neutral pH dentifrice component of the present invention, has a pH of about 6.0 to 7.5 and preferably about 6.8. The acidic dentifrice component is prepared using a similar vehicle to which an acid compound has been added to adjust the pH of such dentifrice component in the acid range of about 2.0 to about 6.0 and preferably about 4.0 to about 5.5. The pH of the final dentifrice after components are combined for use is no greater than 6.5 and preferably between about 5.8 and about 6.4.
The humectant used in the preparation of the dentifrice components is generally a mixture of humectants, such as glycerol, sorbitol and a polyethylene glycol of molecular weight in the range of 200 to 1000, but other mixtures of humectants and single humectants may also be employed. The humectant content is in the range about of 10% to about 80% by weight and preferably about 20 to about 50% by weight of the dentifrice component. The water content is in the range of about 10 to about 40% by weight and preferably about 20 to about 30% by weight.
Thickeners include organic and inorganic thickeners. Inorganic thickeners which may be included in the dentifrice components include amorphous silicas such as Zeodent 165 available from Huber Corporation, and Sylox 15 from W. R. Grace.
Organic thickeners of natural and synthetic gums and colloids may also be used to prepare the dentifrice components of the present invention. Examples of such thickeners are carrageenan (Irish moss), xanthan gum, sodium carboxymethyl cellulose, starch, polyvinylpyrrolidone, hydroxyethylpropylcellulose, hydroxybutyl methyl cellulose, hydroxypropyl methyl cellulose, and hydroxycthyl cellulose.
The inorganic thickener may be incorporated in the dentifrice components of the present invention at a concentration of about 0.5 to about 5% by weight and preferably about 1 to about 3% by weight. The organic thickener may be incorporated in the compositions of the present invention at a concentration of about 0.1 to about 3% by weight and preferably about 0.4 to about 1.5% by weight.
Surfactants may be incorporated in the dentifrices to provide foaming properties. The surfactant material is preferably anionic or nonionic in nature. Suitable examples of anionic surfactants arc higher alkyl sulfates such as potassium or sodium lauryl sulfate which is preferred, higher fatty acid monoglyceride monosulfates, such as the salt of the monosulfated monoglyceride of hydrogenated coconut oil fatty acids, alkyl aryl sulfonates such as sodium dodecyl benzene sulfonate, higher fatty sulfoacetates, higher fatty acid esters of 1,2 dihydroxy propane sulfonate.
The surfactant is generally present in the dentifrice component compositions of the present invention at a concentration of about 0.5 to about 10.0% by weight and preferably about 1.0 to about 5.0% by weight.
Abrasives may be incorporated in the dentifrice components of the present invention and preferred abrasives are siliceous materials, such as silica. A preferred silica is a precipitated amorphous hydrated silica, such as Sorbosil AC-35, marketed by Crosfield Chemicals, or Zeodent 115 from Huber Company but other abrasives may also be employed, including hydroxyapatite, sodium metaphosphate, potassium metaphosphate, tricalcium phosphate, calcium phosphate dihydrate, anhydrous dicalcium phosphate, calcium pyrophosphate, magnesium orthophosphate, trimagnesium phosphate, calcium carbonate, sodium bicarbonate, alumina trihydrate, aluminum silicate, calcined alumina and bentonite.
The concentration of abrasive in the dentifrice component compositions of the present invention will normally be in the range of 2 to about 40% by weight and preferably 5 to 25% by weight.
Zinc ion releasable compounds useful in the practice of the present invention are generally water soluble zinc salts including zinc nitrate, zinc citrate, zinc chloride, zinc sulfate, zinc bicarbonate and zinc oxalate with zinc nitrate being preferred. The zinc salt is generally incorporated in the neutral pH dentifrice component at a concentration of about 0.25 to about 10% by
Gebreselassie Petros
Liu Xiaoyan
Masters James G.
Subramanyam Ravi
Williams Malcolm
Colgate - Palmolive Company
Rose Shep K.
Shapiro Paul
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