Effervescent dual component dentifrice having reduced...

Drug – bio-affecting and body treating compositions – Dentifrices

Reexamination Certificate

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Reexamination Certificate

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06333024

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a two component effervescent dentifrice wherein upon mixing of the separate components during brushing, significantly enhanced consumer perceived sensory sensations are provided which instill in the consumer a perception of enhanced product cleaning performance.
2. The Prior Art
The addition of alkali metal bicarbonates to toothpaste for medicinal, general cleansing, or aesthetic purposes is known in the art. These bicarbonates are used as abrasives or polishing agents in dentifrice compositions providing moderate abrasion to remove debris and stained pellicle from tooth surfaces which are accessible to the toothbrush bristles.
Further, it is known that bicarbonate-acid mixtures in toothpaste compositions will create an effervescent effect and that such effervescent effect can provide certain sensory and tooth cleaning benefits. For example, U.S. Pat. No. 5,885,871 discloses a two component effervescent dentifrice composition wherein the effervescent signal produced by the dentifrice derives from the evolution of carbon dioxide upon the mixing of a high alkaline pH paste (pH range 8-9) and a low acid pH (pH 2-4) gel. Such dentifrice is comprised of a first alkali metal salt containing dentifrice component and a second acid-containing dentifrice component; the first and second components being separated prior to use; wherein, the pH of the two components when combined upon application to the teeth is between about 6.0 and about 7.1; whereby, the dentifrice provides enhanced removal of plaque growth and a tingly mouth feel.
There is an ongoing need for new and novel sensory benefits to promote the use of toothpaste, especially by children, for the benefits of such use as in cleaning of the tooth surfaces to remove plaque growth and the oral decay and disease associated therewith.
SUMMARY OF THE INVENTION
The present invention is directed to a two component effervescent dentifrice composition, having a first alkali metal bicarbonate containing dentifrice component and a second acid-containing dentifrice component; the first and second components being separated prior to use, wherein, the effervescent signal generated upon the combination and mixing of the components is enhanced by the presence in the combination of a naturally occurring alkyl vanillyamide, the presence of which provides a unique and consumer measurable sensation during brushing which instills in the consumer a perception of enhanced product cleaning performance.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
An example of a naturally occurring alkyl vanillyamide is capsaicin, a trans-8-methyl-N-vanillyl-S nonenamide. Capsaicin is found in high concentration in fruit of plants of the Capsicum genus. Chili pepper, red pepper and paprika are all species of Capsicum. Capsicum is the dry powder obtained by grinding up the fruits of these plants. Capsicum oleoresin (or capsaicin oleoresin) is the liquid concentrate extracted from the dry powder. Capsaicin, a white crystalline material, is obtained from the liquid concentrate. Other examples of alkyl vanillyamides useful in the practice of the present invention include piperine, piperocaine and piperitone. Capsaicin is the preferred alkyl vanillyamide and is included in the dentifrice composition of the present invention in the range of about 0.001% to about 1.0% by weight and preferably about 0.05 ppm (parts per million) to about 3.5 ppm.
In the preparation of the effervescent dual component dentifrice composition of the present invention, the first component contains an alkali metal bicarbonate and the alkyl vanillyamide and the second component contains an acid. The components when combined, are combined in approximately equal weight proportions, so that only about one-half of the concentration of any particular ingredient within either component will be present when the components are combined and applied to the teeth, as by brushing. Both components are formulated with similar vehicle ingredients, with the significant exception being the presence of the bicarbonate and alkyl vanillyamide in the first component and the acid in the second component. This similarity of vehicle ingredients is to provide similar physical characteristics to promote similar rheology so that the two components are delivered simultaneously in the desired equal measure by extrusion from a dual compartmented tube or pump device.
The Bicarbonate Salt Component
The dentifrice component containing the alkali metal bicarbonate salt is stable and non-effervescent and contains from about 5 to about 15 percent by weight of the bicarbonate salt. It is preferred that the pH of the dentifrice when the components are mixed in the mouth, as by brushing, be from about 6.0 to about 7.4. To obtain this pH in the combined dentifrice, the quantity of bicarbonate in the first component is preferably from about 10 to about 12 percent by weight whereby the pH of the first component is from about 7.5 to 9.5 and preferably from about 8.5 to 9.0. This quantity of bicarbonate salt will, in the combined dentifrice, provide the desired pH and resulting effervescence, with the added benefit that the salty taste associated with bicarbonate salts is minimized.
Alkali metal bicarbonate salts used in the practice of the present invention, includes potassium bicarbonate and sodium bicarbonate; however, sodium bicarbonate is preferred. Sodium bicarbonate is a powder composed of relatively soft particles compared to most conventional abrasive particles used in toothpastes. The size of the sodium bicarbonate particles may vary from course to fine; it is preferred that they be largely below about 0.4 mm in diameter, with a major proportion by weight being below about 0.01 mm. in diameter.
Certain therapeutic ingredients, which are basic in nature and not compatible with the acidic dentifrice component are incorporated in the bicarbonate salt component of the dual component dentifrice of the present invention. Examples of such therapeutic ingredients include anti-tartar agents, such as sodium tripolyphosphate and tetrasodium pyrophosphate and anticavity agents such as sodium fluoride and sodium monofluorophosphate. These ingredients are incorporated in the dentifrice composition components at concentrations ranging from 0.5 to 8% by weight.
The Acidic Component
The acidic component of the dentifrice composition of the present invention, which is maintained physically separate from the bicarbonate salt component prior to combination and mixing, includes within the dentifrice vehicle an acidic compound such as malic acid, alginic acid, citric acid, succinic acid, lactic acid, tartaric acid, potassium bitartrate, acid sodium citrate, phosphoric acid, and acid phosphate, pyrophosphate salts, such as monosodium phosphate and disodium pyrophosphate. It is preferred that sodium dihydrogen phosphate, o-phosphoric acid, or sodium acid pyrophosphate be used individually or in combination. The amount of acid compound used ranges from about 1 to about 16% by weight of the acidic dentifrice component and preferably from about 2 to about 5% by weight, such that the pH of the acidic dentifrice component is from about 1.5 to about 4.5, and preferably from about 2.5 to about 3.5.
Dentifrice Vehicle Common to Both Components
In the preparation of both dentifrice components of the present invention, the respective acid or bicarbonate ingredient is incorporated within a pharmaceutically-acceptable vehicle suitable for use in the oral cavity, which contains water, humectant, surfactant and a polishing agent or abrasive.
The humectant is generally a mixture of humectants, such as glycerol, sorbitol and polyethylene glycol of a molecular weight in the range of 200-1000, but other mixtures of humectants and single humectants may also be employed. The humectant content within each of the two components is in the range about of 10% to about 30% by weight and preferably about 10 to about 20% by weight. The water content which is from about 20% to about 55%, and preferably fr

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