Drug – bio-affecting and body treating compositions – Dentifrices
Reexamination Certificate
2002-10-31
2003-12-30
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
C424S687000, C424S688000, C424S689000, C424S692000
Reexamination Certificate
active
06669928
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to oral compositions for preventing and ameliorating periodontal disease, and particularly to toothpaste compositions.
BACKGROUND OF THE INVENTION
Many individuals suffer from gum disease, which can cause discomfort and, if left untreated, the loss of teeth. Gum, or periodontal, disease starts when bacteria normally present in the oral environment are allowed to multiply excessively, producing a sticky film referred to as plaque that coats the teeth. Plague that builds up along the gumline can cause gingivitis, or gum inflammation, particularly if the plaque remains and hardens into tartar. The failure to conscientiously remove the plaque through brushing and flossing and regular cleaning by dental professionals can lead to periodontitis. Normal methods of treatment of periodontitis include planing and scaling of pockets to remove deep plaque and tartar, and/or the local application of local antibiotics. Among the bacteria found normally in the mouth, predominantly six types live at the interface of the gum tissue and the teeth. Five of these bacteria consume sugars and lactose normally found in the mouth, and release lactic acid. The sixth bacteria, Veillonella, consumes lactic acid. Lactic acid generated by the bacteria slowly etches out the tooth enamel and tooth mass, thus creating pockets. More bacteria propagates into a larger space, eventually creating larger pockets. These bacterial pockets irritate the gum tissue, eventually causing bleeding and discomfort, leading the way for other types of bacteria to attack the bleeding gum tissue. This is believed to be the mechanism that starts periodontal disease.
In order to avoid the discomfort and potential loss of teeth caused by periodontitis, it is thus important to undertake daily dental cleaning. Most individuals utilize a tooth paste that includes a mild abrasive for daily brushing of their teeth. Commercially available toothpastes are compounded to include a mild abrasive, and are typically formulated with a pH that is slightly acidic or near neutral. Highly basic, i.e., high pH, tooth pastes are not commercially available.
An alkaline powder oral hygiene composition having a pH in excess of 9.0 has been disclosed by U.S. Pat. No. 5,645,821 to Libin. This reference further discloses formulating a paste or cream utilizing this composition. The composition includes magnesium hydroxide, calcium carbonate and magnesium carbonate in water with a gelling agent, such as glycerin, and an anionic surfactant. However, glycerin has been found by the present inventors to be unable to withstand the highly alkaline environment of such a composition for an extended period of time.
SUMMARY OF THE INVENTION
The present invention provides a periodontal composition compounded to include at least one alkaline agent to render a gel or paste having a pH of at least 9.0 to 11.0, and preferably 9.5 to 10.0. The preferred alkaline agent included in the composition is potassium hydroxide, and the composition preferably also includes calcium carbonate, magnesium carbonate and aluminum hydroxide. Of these agents, potassium hydroxide is the most basic compound utilized. Also suitably included in the composition (which can have the consistency of a liquid or suspension, but is preferably compounded as a stable gel or paste) are other excipients including: thickeners that are capable of withstanding the high pH environment without degradation (such as xanthane gum and microcrystalline cellulose); organoleptic agents such as gum arabic and polyethylene glycol; flavorings such as sodium or potassium chloride, acesulfame potassium, sodium saccharine, and mint flavorings; stabilizers such as colloidal silica; mild abrasive agents such as microcrystalline (not fumed) silica; a foaming agent such as sodium lauryl sulfate or sodium lauryl phosphate; and a fluoride compound such as stannous fluoride or sodium monofluorophosphate for anti-cavity effect.
The composition is believed to be effective at inhibiting periodontal disease caused by lactic acid-forming bacteria that thrive along the gumline and in gum pockets. The composition is also believed to be effective at reversing mild periodontal disease of this nature. The pH adjustment provided by the composition is believed to not only neutralize the acids formed by the bacteria, but also to inhibit the growth of the bacteria itself because periodontal bacteria thrives in an acidic environment, but not in the alkaline environment provided in accordance with the present invention. The composition has also been found effective at inhibiting and speeding the healing of canker sores.
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Baker, K.A., “Oral Health Products,”Oral Health, pp. 653-687, prior to May 13, 1999.
Baker, Karen A.,Oral Health Products, Oral Health, pp. 653-687, prior to May 13, 1999.
Christensen O'Connor Johnson & Kindness PLLC
Rose Shep K.
TAMER International, Ltd.
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