Drug – bio-affecting and body treating compositions – Dentifrices – Ammonia – amine – or derivative thereof
Reexamination Certificate
2001-06-27
2002-03-12
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Ammonia, amine, or derivative thereof
C424S048000, C424S049000, C424S435000, C424S440000, C424S464000
Reexamination Certificate
active
06355229
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to oral compositions containing cetylpyridinium chloride as an active antibacterial agent which may be used to inhibit formation of plaque, oral malodor, gingivitis, periodontal disease and the like. The oral composition contains the active agent and an effective amount of guar hydroxypropyltrimonium chloride which enables the active agent to more effectively bind to tooth surfaces to perform its antibacterial function.
BACKGROUND OF THE INVENTION
Cetylpyridinium chloride (CPC) is well known as an antibacterial agent especially for the inhibition of plaque formation. This antibacterial agent has been used in commercial mouthwash products such as Scope® and Cepacol® and several other types of oral care products. The environment of such commercial mouthwash products enables cetylpyridinium chloride to freely contact those oral surfaces which may harbor unwanted microorganisms. These microorganisms contribute to both the initiation and progression of gingivitis, plaque, periodontal disease, and/or breath malodor in the oral cavity of warm-blooded animals. Such conditions are usually treated by reducing the presence of the microorganisms in the oral cavity through the use of dental care products containing antibacterial agents including cetylpyridinium chloride.
The antibacterial activity of cetylpyridinium chloride is, without being bound to the theory, believed to be linked to the cationic charge of its amine group. Thus, cetylpyridinium chloride is attracted to and binds to negatively-charged protein moieties on the cell membrane or cell wall of the microorganism and to tooth surfaces which are also typically negatively charged. The resulting attachment to microorganisms disrupts the cell wall structure causing leakage of the intracellular fluids, eventually killing the associated microorganism. However, cetylpyridinium chloride is generally not effective in many systems because of its tendency to complex with components that carry a negative charge. When bound to negatively charged particles in this manner, cetylpyridinium chloride is unavailable for effective contact with tooth surfaces and microorganisms, thereby rendering the active agent ineffective for its intended purpose.
For this reason, cetylpyridinium chloride has not been totally effective in typical oral care products for the treatment and/or prevention of gingivitis, plaque, periodontal disease, and/or breath malodor. For example, toothpaste compositions typically include anionic surfactants and artificial sweetening agents. These components of toothpaste compositions typically bind to cetylpyridinium chloride and thereby render the same ineffective or substantially less effective as an antibacterial agent. Other components typically found in a toothpaste composition such as abrasives also bind to cetylpyridinium chloride. Accordingly, the use of cetylpyridinium chloride in toothpaste compositions has been problematic. Even in commercial mouthwash products that contain cetylpyridinium chloride, the availability of cetylpyridinium chloride at tooth surfaces is very low and therefore its antibacterial effectiveness is limited.
It would be an advance in the art of oral compositions if such compositions contain an effective amount of cetylpyridinium chloride in which antibacterial activity is not materially diminished by the presence of other components which tend to bind to the active agent.
SUMMARY OF THE INVENTION
The present invention is generally directed to an oral composition in which cetylpyridinium chloride is present as an antibacterial agent as part of an effective oral hygiene program. In a particular aspect of the present invention, there is provided an oral composition comprising:
a) an antibacterial effective amount of cetylpyridinium chloride;
b) an effective amount of guar hydroxypropyltrimonium chloride sufficient to bind to compounds which undesirably bind to cetylpyridinium chloride thereby enabling the cetylpyridinium chloride to effectively bind to tooth surfaces and perform an antibacterial function; and
c) an orally acceptable carrier.
The invention further relates to a method of reducing the presence of microorganisms in an oral cavity of a warm-blooded animal, the method comprising administering to the oral cavity an effective amount of the above oral composition.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to compositions and methods of reducing the presence of microorganisms in an oral cavity of a warm-blooded animal in the course of treating and/or preventing breath malodor, and diseases of the oral cavity (e.g. plaque, gingivitis, periodontal disease) in the warm-blooded animal, by topically applying to the oral cavity, a safe and effective amount of the oral composition of the present invention.
The oral composition of the present invention includes an antibacterial effective amount of cetylpyridinium chloride typically in the range of from about 0.01 to 1.0% by weight, preferably from about 0.1 to 0.75% by weight, and other oral care components which do not materially prevent cetylpyridinium chloride from binding to tooth surfaces to perform an antibacterial function. A typical toothpaste composition may contain 0.5% by weight of cetylpyridinium chloride while a typical mouthwash composition may contain 0.125% by weight. The phrase “do not materially prevent” as used herein means that a sufficient amount of cetylpyridinium chloride is and remains available to bind to oral surfaces including tooth surfaces to perform an effective antibacterial function in the oral cavity.
The oral compositions of the present invention may be in the form of mouthwashes, gargles, dentifrices, anti-plaque compositions and as a general antiseptic composition, for example, in the form of denture cleansing tablets or solutions. Such oral compositions contain a number of components which have an active oral hygiene function or provide the compositions with a supporting function and do not interfere with the function of the active components. Examples of active components are tooth whiteners, antibacterial agents, abrasives or polishing materials, desensitizing agents, and the like. Examples of supporting components include organic surfactants which assist in the thorough and complete dispersion of one or more active agents, orally acceptable carriers, sweetening agents, preservatives, humectants, thickeners, and the like. The organic surfactants may and usually do provide both active cleaning as well as supporting functions.
The oral composition of the present invention may be in the form of a solution such as a mouthwash, a denture cleanser, a gargle or the like, or may be in the form of a semi-solid or solid such as a toothpaste, a gel dentifrice, a dental powder, a denture cleansing tablet, a chewing gum, or a solid lozenge or the like.
Cetylpyridinium chloride is cationic and therefore is attracted to negative surfaces and moieties. Tooth surfaces typically have a negative charge and therefore there is a natural attraction of cetylpyridinium chloride for tooth surfaces. However, many conventional oral care products contain components, including those found in toothpaste, which are anionic. Such negatively charged components bind to cetylpyridinium chloride and therefore make the antibacterial agent less available for binding to tooth surfaces and microorganisms.
In accordance with one aspect of the present invention, it has been discovered that the employment of guar hydroxypropyltrimonium chloride at least reduces and may substantially eliminate the ability of such compounds to bind to and diminish the antibacterial activity of cetylpyridinium chloride.
By way of example, certain sweetening agents known for use in oral compositions, such as saccharin, acesulfame, and cyclamate have been found to bind to and thereby inhibit the antibacterial activity of cetylpyridinium chloride when compared to compositions which do not contain such particular sweetening agents. In the oral composition of the present invention, the presence of typ
Church & Dwight & Co., Inc.
Fishman Irving M.
Rose Shep K.
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