Gums containing antimicrobial agents

Details Gums containing antimicrobial agents Gums containing antimicrobial agents

1999-08-19

2001-06-19

Clardy, S. Mark (Department: 1616)

Drug, bio-affecting and body treating compositions

Dentifrices

C424S054000, C424S058000, C424S405000, C426S003000, C426S532000, C514S900000, C514S902000

Reexamination Certificate

active

06248309

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to gums and gum-like products that include antimicrobial agents capable of inhibiting the growth of oral pathogenic bacteria believed to be responsible for periodontal diseases and dental caries.
BACKGROUND OF THE INVENTION
Periodontal disease and dental caries are of major public health and economic interest worldwide. It is now widely recognized that both of these oral diseases are caused by bacteria which grow in masses on the teeth and in the gingival area. A commonly used descriptive term for these bacterial masses is “dental plaque”. In the case of periodontal disease, Schluger et al. (Schluger, Yuodelis, Page & Johnson,
Periodontal Diseases,
second edition, pp. 153-262, Lea & Febiger, 1990) report that dental plaque bacteria, growing in the area where the teeth and gingival tissues meet, cause an inflammation of the gingiva called “gingivitis”. This is characterized by swollen, edematous gingiva (“gums”) which are reddened and bleed easily. If plaque removal is inadequate, gingivitis may progress to “periodontitis” or periodontal disease in many individuals. Periodontitis generally is characterized by a chronic inflammation of the tissues around the teeth, which leads to a resorption of supporting bone. Periodontal disease is the leading cause of tooth loss among adults. Dental caries (cavities) are also caused by bacteria, with
Streptococcus mutans
being the principal etiologic agent (McGhee, Michalek & Cassell,
Dental Microbiology,
p. 279, Harper & Row, 1982).
The prevention of dental plaque or the removal thereof has long been the focus of development, with the ultimate goal of inhibiting both caries and periodontal diseases. While the formation of dental plaque can be inhibited to a certain extent by brushing the teeth at frequent intervals, brushing alone is not sufficient to effectively prevent the formation of dental plaque or remove substantially all of the dental plaque that has formed on the teeth. Since brushing alone is often not sufficient to prevent dental caries or periodontal disease due to pathogenic plaque bacteria, chemical methods using anti-bacterials such as chlorhexidine, benzalkonium chloride, and cetylpyridinium chloride have been proposed.
In addition, the use of natural products for the treatment of teeth and gums is old in the art, having been practiced and documented since the mid-1880s. Since then, numerous patents have disclosed compositions of oral products containing natural product extracts.
There are numerous natural essential oils available. Many of these oils are described in Kirk Othmer Encyclopedia of Chemical Technology, 4th ed., vol. 17, pp. 603-674, John Wiley & Sons, Inc. Morton Pader, in “Oral Hygiene Products and Practice,”
Cosmetic Science and Technology Series,
vol. 6, at pp. 356-373, Marcel Dekker, Inc., describes sanguinaria extract as an anti-plaque agent with antimicrobial properties. Pader also describes that volatile oils such as eucalyptol, menthol, thymol, methylsalicylate have varying degrees of antimicrobial activity, and antiplaque activity has been reported under appropriate test conditions. Pader describes that cinnamon oil is a very weak antiseptic, and that eucalyptus oil and eucalyptol are antiseptic. Pader notes that some essential oils are used in other products primarily for flavor. Among these are cinnamon, cassia, clove, thyme, peppermint, anise and anethol. Pader also describes that these essential oils have detectable antimicrobial activity.
It is known that hinokitiol, citral, geraniol, cocamidopropyl betaine, berberine, and juniper berries oil, individually exhibit antimicrobial properties against certain bacteria.
U.S. Pat. No. 3,940,476 describes a method for inhibiting the formation of dental plaque, which comprises topically applying to the teeth as an active ingredient an amount of either one or a combination of (a) allyl isothiocyanate, (b) uranine, (c) obtusastyrene, (d) citral, (e) citronellol, (f) nerol, or (g) geraniol.
U.S. Pat. No. 4,913,895 describes an oral composition including a linear polyphosphate or a cyclic polyphosphate and menthol, anethol, or mixtures thereof in an aqueous medium. The composition is reported to have antibacterial effects and prevent the development of calculus and periodontal diseases.
U.S. Pat. No. 4,966,754 describes that certain essential oils and combinations thereof possess antimicrobial properties against
Aspergillus niger, Candida albicans, Staphylococcus aureus,
and
Pseudomonas aeruginosa
and therefore are useful as preservatives in cosmetic compositions. A blend of 14 essential oils is described as providing desirable antimicrobial properties against the noted microorganisms. The described combination is disclosed as being suitable as a preservative for cosmetic compositions.
U.S. Pat. No. 4,999,184 describes oil compositions containing certain pyrophosphate salts which are reported to provide an anticalculus benefit.
U.S. Pat. No. 5,316,760 describes a mouthcare product that contains a combination of
Urtica dioica
extract and an extract of
Juniperus communis.
The combination of these extracts is described as leading to a synergistic reduction of both dental plaque and bleeding or inflammation of the gingiva.
Achillaea millefolium
extract is also described as being a suitable additive to the combination of the
Urtica dioica
and
Juniperus communis
extracts.
U.S. Pat. No. 5,472,684 describes a composition including thymol and eugenol, and optionally a sesquiterpene alcohol, such as farnesol, that reportedly has antiplaque and antigingivitis effects. Australian tea tree oil, sage oil, and eucalyptol are described as enhancing the antiplaque and antigingivitis activity of mouth rinses formulated from the disclosed compositions.
JP Publication 03-109314 describes a chemically stable anticarious agent containing glabridin and glabrene as an active ingredient that is obtained by extracting licorice root with an organic solvent having a medium polarity. Benzene, ethyl ether, chloroform, methylene chloride, ethyl acetate, n-butyl acetate, isobutyl acetate and n-propyol acetate are described as suitable medium polarity solvents. JP 58-57320 describes a methanol extract of Glycyrrhiza as a plaque suppressant. JP 63-198616 describes an anticariogenic substance including gymnemic acid in combination with glycyrrhizin extracted from the root of
Glycyrrhiza glabra.
JP 3-255031 describes a composition for preventing gingival disease that contains a thyme extract and a purified oil or oleoresin, such as rosemary oil. JP 59-175410 describes an antiseptic agent containing a natural essential oil or a natural essential oil in combination with another antiseptic substance. Rosemary oil, lemon oil, citronella oil, and basil oil are described as natural essential oils. Citral and geraniol are described as an antiseptic substance.
One property that characterizes the effectiveness of an antimicrobial agent as an antiplaque and anticalculus agent is the minimum inhibitory concentration, or MIC, of the agent. The MIC is the minimum concentration in micrograms per milliliter of an antimicrobial agent at which no bacterial growth is observed. At concentrations below the MIC, an antimicrobial agent is ineffective at killing or inhibiting the growth and reproduction of bacteria. At concentrations above the MIC, an antimicrobial agent is effective at killing or inhibiting the growth and reproduction of bacteria.
Typically, antimicrobial agents are introduced into the oral cavity at an initial concentration. Almost immediately, the initial concentration begins to decrease due to the dynamics of the oral cavity. Eventually, the concentration of the antimicrobial agent within the oral cavity will fall below the MIC. Thus, it has been a goal of those working to develop antiplaque and anticalculus formulations to use antimicrobial agents that have low MICs.
One method of introducing antimicrobial agents to the oral cavity has been to use a dentifrice or a mouthwash or rinse as a delivery mechanism. While these

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