Drug – bio-affecting and body treating compositions – Chewing gum type
Reexamination Certificate
1999-12-02
2002-08-20
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Chewing gum type
C424S049000, C424S054000, C424S440000, C426S003000
Reexamination Certificate
active
06436369
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to dental care products. More specifically, the present invention relates to anti-plaque products.
Of course, one of the most common maladies is dental caries. Most individuals at some time in their lives will experience dental caries. Except for the common cold, tooth decay is the most prevalent disorder.
The role of dental plaque in the formation of caries, as well as periodontal disease, is well documented. In this regard, the interaction of three factors results in dental caries: susceptible tooth surface; the proper microfora; and a suitable substrate for the microfora. Laboratory and clinical evidence points to
Streptococcus mutans
as the primary pathogen for initiating carious lesions; its virulence stems from its ability to synthesize extracellular polysaccharide. Lactic acid, a byproduct of the synthesis, contributes to tooth demineralization. Mono- and disaccharide sugars serve as the principal substrates for the process. Dental plaque—a combination of these polysaccharides, microorganisms, salivary glycoproteins, and desquamated mucosal cells—serves as a localized site of acid production. See Merck Manual, 16th Edition, pp. 2480-2481.
Even the most thorough toothbrushing and flossing fails to remove all plaque. This is especially true with respect to the plaque that is located between the teeth which can prove to cause the most damage.
Accordingly, in assisting in removing plaque, it is important to provide an oral hygiene supplement. These oral hygiene supplements include specially prepared chewing gums and oral rinses that are enhanced with antimicrobial ingredients. These compositions have proven effective. However, the level and use of the antimicrobial combinations are directly related to their effectiveness. Unfortunately, the antimicrobial ingredients have negative sensory effects such as bitterness and dental staining.
Therefore, there is a need for improved anti-plaque supplements which are delivered as emulsions to lower the effective dosage.
SUMMARY OF THE INVENTION
The present invention provides an improved anti-plaque emulsion. The improved emulsion comprises triclosan, a surfactant, and an emulsifier. The use of an emulsion improves oral contact between the teeth/plaque and the actives which allows the user to lower the triclosan levels without negatively affecting the antimicrobial benefits. Therefore, because a lower level of antimicrobial agent is utilized, the negative sensory effects of the antimicrobial agent are minimized.
To this end, in an embodiment the present invention provides an anti-plaque emulsion comprising an emulsifier, triclosan, and a surfactant.
In an embodiment, the surfactant is cetylpyridinium chloride (CPC).
In an embodiment, triclosan comprises approximately 3% to about 30% weight percent of the emulsion.
In an embodiment, the surfactant comprises approximately 0.1% to about 10% weight percent of the emulsion.
In another embodiment of the present invention, the invention provides an anti-plaque chewing gum comprising a water insoluble portion and a water soluble portion including an emulsifier, triclosan, and surfactant.
In an embodiment, the surfactant is cetylpyridinium chloride (CPC).
In an embodiment, triclosan comprises approximately 3% to about 30% weight percent of the emulsion.
In an embodiment, the surfactant comprises approximately 0.1% to about 10% weight percent of the emulsion.
In an embodiment, each piece of gum includes approximately 1 mg to about 6 mg of triclosan.
In an embodiment, the gum is in pellet form.
In a still further embodiment, a method for reducing plaque is provided comprising the step of chewing a gum comprising an emulsifier, triclosan and a surfactant.
In an embodiment of the method, the gum is chewed for at least 5 minutes.
In an embodiment of the method, the gum is chewed at least three times per day.
Accordingly, an advantage of the present invention is that it provides an improved anti-plaque emulsion.
Furthermore, an advantage of the present invention is that it provides an anti-plaque emulsion that has a reduced level of antimicrobial agent but still provides antimicrobial activity.
Moreover, an advantage of the present invention is that it provides an antimicrobial emulsion that can be used in a variety of different vehicles.
Further, an advantage of the present invention is that it provides an improved anti-plaque chewing gum.
Another advantage of the present invention is that it provides an improved anti-plaque mouthwash.
Still further, an advantage of the present invention is that it provides an improved anti-plaque product that can comprise an oral paste, gel, or powder.
Further, an advantage of the present invention is that it provides an anti-plaque product having improved taste/reduced bitterness.
Moreover, an advantage of the present invention is that it provides an anti-plaque product having improved sensory acceptability.
Additionally, an advantage of the present invention is that it provides an improved method for producing anti-plaque emulsions.
Still, an advantage of the present invention is that it provides an improved method for reducing plaque and gingivitis.
Additional features and advantages of the present invention are described herein, and will be apparent from the detailed description of the presently preferred embodiments.
DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS
The present invention provides an improved anti-plaque emulsion. It has been surprisingly found, that pursuant to the present invention, an emulsion having a low level of antimicrobial agent can be combined with a surfactant in an emulsifier to optimize the benefits of the antimicrobial agent.
The benefit to using an emulsion to carry the actives is that it enables the saliva to disperse the emulsion across the dental surfaces allowing the actives to afford a more complete oral contact with plaque covered surfaces. The emulsion is very important as it enables water insoluble actives to become beneficial in the saliva. If the actives were not in an emulsion the saliva alone would not extract the actives out of the oral hygiene product no matter how high the antimicrobial level. Since antimicrobials are effective in an emulsion, the level of the antimicrobial agent can be lowered which minimizes the negative sensory effects. At the same time the antimicrobial is maintained at a level that is sufficiently low to minimize the agents' negative sensory effects.
In this regard, it has been found that by creating an emulsion using triclosan and a surfactant, that reduced levels of triclosan can be used and an effective anti-plaque emulsion provided. This emulsion allows for improved oral contact and therefore improved antimicrobial effect is achieved. The emulsion, and its method of preparation, improve the intimate contact between the oral plaque and the plaque fighting ingredients. This combination has also been found to maximize the efficacy of the active ingredients. Moreover, the combination allows the active ingredients to be used in lower levels so that the bad taste of the ingredients as well as staining effect is minimized.
The antimicrobial material of the present invention can be used in a variety of vehicles. In this regard, anti-plaque benefits can be provided via a chewing gum, mouthwash, oral paste, gel, or powder. Any vehicle to which the delivery system of the present invention can be added can be used.
Pursuant to the present invention, reduced levels of triclosan can be used. It has been surprisingly found that higher usage levels of triclosan did not show any dental benefit. However, when a pellet gum coating consisting in part of a lower triclosan level mixed in an emulsion with a surfactant (also at a reduced level), emulsifier and flavor benefits were surprisingly evident.
The level of triclosan in an emulsion should be approximately 3% to about 30% weight percent of the emulsion, preferably approximately 7% to 20% and most preferably approximately 15%. The level of the surfactant should be approxi
Barabolak Roman M.
Witkewitz Dave L.
Bell Boyd & Lloyd LLC
Rose Shep K.
Wm. Wrigley Jr. Company
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