Drug – bio-affecting and body treating compositions – Dentifrices – Ammonia – amine – or derivative thereof
Reexamination Certificate
2001-05-02
2002-09-10
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Ammonia, amine, or derivative thereof
C429S049000
Reexamination Certificate
active
06447758
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an oral care composition which contains a cationic antibacterial compound effective in retarding bacterial plaque accumulation on teeth and more particularly to a dual component dentifrice composition containing a cationic antibacterial compound which achieves plaque reduction with superior foaming characteristics.
2. The Prior Art
Dental plaque is a soft deposit which forms on teeth and is comprised of an accumulation of bacteria and bacterial by-products. Plaque adheres tenaciously at the points of irregularity or discontinuity, e.g., on rough calculus surfaces, at the gum line and the like. Besides being unsightly, plaque is implicated in the occurrence of gingivitis and other forms of periodontal disease.
A wide variety of antibacterial agents have been suggested in the art to retard plaque formation and the oral infections and dental disease associated with plaque formation. For example, cationic antibacterial compounds such as cetyl pyridinium chloride are well known to the art for their antibacterial activity and have been used in oral compositions to counter plaque formation by bacterial accumulation in the oral cavity. However, these compounds present a problem when formulated in a dentifrice in that they are deactivated by traditional anionic surfactants such as sodium lauryl sulfate. Stable, clinically effective dental formulations have been made with quaternary ammonium compounds and nonionic surfactants, but these formulations are very poor foamers and result in inferior products.
Anionic surfactants, such as sodium lauryl sulfate (SLS) are conventionally included in oral formulations, to provide solubilization, dispersion, emulsification and wetting of the other ingredients present, especially flavor oils. Further, these surfactants are extremely effective in providing a cosmetic effect in promoting the foaming of the oral composition. Oral compositions with strong foaming ability are preferred by consumers, since it is perceived that the greater the foaming, the better the composition cleans the tooth and other oral surfaces, removing stain, plaque and debris therefrom.
There is a clear need in the art to formulate a dentifrice product capable of delivering a cationic antibacterial agent effective in the retardation of bacterial plaque accumulation on teeth whereby the surfactant present in the dentifrice imparts strong foaming characteristics to the dentifrice composition without inhibiting the bioavailability of the antibacterial compound.
SUMMARY OF THE INVENTION
The present invention encompasses a dual component dental composition which when applied to teeth contains a combination of a cationic antibacterial compound, and an anionic surfactant ingredient normally incompatible with the antibacterial compound whereby reduction of plaque is accomplished during tooth brushing accompanied by a superior foaming benefit.
The present invention is based upon the discovery that when a separately maintained first cationic antibacterial compound containing dental component which is free of an anionic surfactant ingredient and a second anionic surfactant containing dentifrice component, which surfactant is normally incompatible with the antibacterial containing component, are simultaneously combined and thereafter applied to the surface of the teeth, an undiminished antiplaque efficacy is unexpectedly obtained with superior foaming properties when the teeth are brushed with the combined components.
In one embodiment of the present invention, a dual component dentifrice composition of the present invention is provided which is comprised of separate cationic antibacterial compound and anionic surfactant containing paste components which are housed in a container wherein the components are maintained separate from each other and are not combined and admixed until simultaneous application to teeth is to be performed by the user as by brushing. Unexpectedly, when the separately maintained dental components are contacted with each other immediately prior to application to teeth, the anionic surfactant does not appreciably immediately react to inactivate the antiplaque efficacy of the cationic antibacterial compound, thereby allowing the cationic antibacterial compound in its full efficacious form, to be applied to the teeth simultaneously in the presence of an anionic surfactant which imparts strong foaming characteristics to the combined dentifrice components.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
In the practice of the present invention the dental component containing the cationic antibacterial agent ingredient is formulated as a paste using a vehicle containing a safe and effective amount of the cationic antibacterial compound.
Cationic antibacterial agents useful in the practice of the present invention are well known in the art. See, for instance the section on “Quaternary Ammonium and Related Compounds” in the article on “Antiseptics and Disinfectants” in Kirk-Othmer Encyclopedia of Chemical Technology, 2
nd
edition (vol. 2, pp. 632-635), incorporated herein by reference. Cationic compounds which possess antibacterial activity (i.e., are germicides) are used against bacteria and have been used in oral compositions to counter plaque formation caused by bacteria in the oral cavity.
Among the most common of these antibacterial antiplaque quaternary ammonium compounds is benzethonium chloride, or diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride, and cetyl pyridinium chloride. In a dentifrice preparation this material is highly effective in promoting oral hygiene by reducing the formation of dental plaque and calculus, which is generally accompanied by a reduction in periodontal diseases.
Other antibacterial antiplaque quaternary ammonium compounds useful in the practice of the present invention include those in which one or two of the substituents on the quaternary nitrogen has a carbon chain length (typically alkyl group) of some 8 to 20, typically 10 to 18, carbon atoms while the remaining substituents have a lower number of carbon atoms (typically alkyl or benzyl group), such as 1 to 7 carbon atoms, typically methyl or ethyl groups. Dodecyl trimethyl ammonium bromide, benzyl dimethyl stearyl ammonium chloride, cetyl pyridinium chloride and quaternized 5-amino-1,3-bis(2-ethylhexyl)-5-methyl hexa hydro-pyrimidine are typical quaternary ammonium antibacterial agents.
The cationic antibacterial agent is included in the dentifrice component at a concentration of about 0.10 to about 1.5% by weight and preferably about 0.3 to about 1.2% by weight.
Anionic surfactants useful in the practice of the present invention include long chain fatty or ploy-lower alkoxy groups plus hydrophilic radicals. They will usually be in the form of salts, especially water soluble salts of alkali metals. Useful anionic surfactants include the higher fatty acid monoglyceride monosulfates, such as the sodium salts of the monosulfated monoglycerides of hydrogenated coconut oil fatty acid; higher alkyl sulfates, such as sodium lauryl sulfate; higher alkyl aryl sulfonates, such as sodium linear dodecyl benzene sulfonate; higher olefin sulfonates, such as sodium higher olefin sulfonate in which the olefin group is 12 to 21 carbon atoms; higher alkyl alkali sulfoacetates such as sodium lauryl sulfoacetate; higher fatty acid esters of 1,2-dihydroxypropane sulfonates; the substantially saturated higher aliphatic acyl amides of lower aliphatic aminocarboxylic acid alkali metal salts, such as those having 12 to 16 carbon atoms in the fatty acyl radicals; higher alkyl poly-lower alkoxy (of 10 to 100 alkoxies) sodium sulfates; higher fatty acid sodium and potassium soaps of coconut oil and tallow, and the like. The anionic surfactant, sodium lauryl sulfate, is preferred in the practice of the present invention.
The anionic surfactant is incorporated in the dentifrice component at a concentration of about 1.0 to about 5.0% by weight and preferably about 2.0 to about 3.0% by weight.
The individual dentifrice co
Boyd Thomas
Carale M. Teresa R.
Herles Susan M.
Prencipe Michael
Rose Shep K.
Shapiro Paul
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