Anti-caries oral care compositions and their methods of use

Details Anti-caries oral care compositions and their methods of use Anti-caries oral care compositions and their methods of use

1999-03-25

2001-05-29

Rose, Shep K. (Department: 1614)

Drug, bio-affecting and body treating compositions

Dentifrices

Reexamination Certificate

active

06238648

ABSTRACT:

TECHNICAL FIELD
The present invention relates to oral care compositions, including therapeutic rinses, tooth pastes and gels comprising a combination of a non-cariogenic carbohydrate and a polyalcohol. This invention further relates to a method for treating or preventing conditions in the mouth that favor formation of tooth caries.
BACKGROUND ART
Dental caries is a progressive condition in which loss of hydroxyapatite mineral reduces the structural integrity of the teeth. Current understanding of dental caries suggests a bacterial etiology which is interdependent upon dietary factors, host defense mechanisms and time. When each of these components are present, dental caries occur. In part, the ability to control dental caries depends upon the effectiveness of oral hygiene treatments including dentifrice and mouth rinse. It is widely acknowledged that caries prevention is dependent upon the compatibility of the components comprising the oral hygiene products. For example, ii is well established that caries are reduced by the addition of fluoride (e.g. sodium fluoride, stannous fluoride, etc.) to a highly compatible dentifrice system. It is also acknowledged that dietary habits, in particular, consumption of carbohydrates such as sucrose can have profound impact on the incidence of dental caries.
Production of acids resulting from plaque's carbohydrate consumption contributes to caries lesion formation. The addition of sweeteners such as sorbitol and, or xylitol to gums, candies and foods have been found to help reduce the incidence of dental caries via significant increases in plaque pH and measurable decreases in plaque
S. mutans
levels; see U.S. Pat. No. 5,804,165, Arnold, issued Jul. 24, 1996; herein incorporated by reference. The combination of a non-cariogenic sweetener and a suitable fluoride system could provide a potentially powerful approach to controlling dental caries. While caries control has been observed in studies evaluating the benefits of long-term consumption of non-carogenic carbohydrates, bacterial effects have not been consistently shown for all xylitol containing dentifrices.
Some polyalcohols such as glycerol or propylene glycol have been shown to increase antimicrobial activity of hydrophobic preservative compounds such as methyl and propyl p-hydroxybenzoate (parabens). U.S. Pat. No. 5,800,803, Mirajkar et al., issued Feb. 10, 1997, assigned to Colgate, discloses increased uptake of anti-microbials such as triclosan in formulations containing propylene glycol. It is believed that these polyalcohols increase activity via perterbation of the cellular membranes. The degree of membrane perterbation may be related to the hydrophobicity of the polyalcohol. Low molecular weight glycols such as propylene or butylene glycol have also been used as preservatives in both foods and pharmaceutical products. The preservative properties are thought to be manifested through the reduction of water activity. Polyalcohols have also been used as humectants in oral products including dentifrice.
SUMMARY OF THE INVENTION
The present invention relates to oral care compositions, including tooth pastes (including gels and gels for subgingival application), mouth rinses, mouth sprays, chewing gums, and lozenges as more fully described hereinafter. These compositions comprise:
(a) a safe and effective amount of a non-cariogenic carbohydrate; and
(b) a polyalcohol;
wherein said polyalcohol is used in a level sufficient to promote greater uptake of said non-cariogenic carbohydrate by plaque, thereby resulting in creating an environment that does not favor development of caries.
This invention further relates to a method for preventing and treating conditions in the mouth that favor formation of caries by the use of compositions as disclosed above.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to compositions and methods of treating or preventing the formation of caries. The methods of treating and preventing caries includes applying compositions comprising a non-cariogenic carbohydrate and a polyalcohol wherein when used in the oral cavity promotes uptake of the non-cariogenic carbohydrate by plaque.
Production of acids resulting from plaque's carbohydrate consumption contributes to caries lesion formation. Significant increases in plaque pH and measurable decreases in plaque
S. mutans
levels have been observed in studies evaluating the benefits of long-term consumption of non-cariogenic carbohydrates such as xylitol containing foods or gums. However, such pH and bacterial effects have not been consistently shown for all non-cariogenic carbohydrate containing dentifrices perhaps as the result of relatively short brushing periods, insufficient non-cariogenic carbohydrate dose and/or inadequate non-cariogenic carbohydrate delivery. Although the amount of non-cariogenic carbohydrate present in dentifrice could be established analytically, such analysis would not demonstrate that plaque bacteria could uptake the non-cariogenic carbohydrate.
The present invention encompasses a dentifrice composition which when applied to the teeth contains a non-cariogenic carbohydrate and a polyalcohol that enhances uptake of the non-cariogenic carbohydrates such that acid produced through plaque metabolism of sugars is temporarily disrupted. When used as part of a regular oral hygiene program, this composition could result in fewer carious lesions on the teeth. This result means that non-cariogenic carbohydrates can be more efficiently delivered to plaque bacteria resulting in higher cellular concentrations during relatively short brushing times compared to formulations which do not contain this combination. The higher cellular concentrations of non-cariogenic carbohydrate in plaque bacteria means a longer periods of metabolic disruption. Cumulatively longer periods of metabolic disruption could lead to fewer carious lesions.
A. Non-Cariogenic Carbohydrates
As discussed above, compositions of the present invention comprise non-cariogenic carbohydrates that can disrupt caries formation. Said non-cariogenic carbohydrates are used in the composition of the present invention from about 1% to about 65%, preferably about 2.5% to about 20% and most preferably about 5% to about 10% by weight of the composition.
Non-cariogenic carbohydrates are known in the art. See the following articles, all herein incorporated by reference: Carlsson, J.
Potentials of the Oral Microflora to Utilize Sugar Substitutes as Energy Source
,. In, Proc. ERGOB Conference, Geneva, Karger, Basil, (1978) pp. 205-210; Makinen, K. K.
Latest Dental Studies on Xylitol and Mechanism of Action of Xylitol in Caries Limitation
, Progress in Sweeteners, Elsevier Science Publishers, Ltd., London, (1989) pp.331-362.; Makinen, K. K. and P. Isokangas,
Relationship Between Carbohydrate Sweeteners and Oral Diseases
, Progress in Food and Nutrition Science 12:73-109, (1988); Trahan, L.,
Xylitol: a review of its action on mutans streptococci and dental plaque—its clinical significance
, International Dental Journal 45:77-92, (1995); Birkhed, D. et al.,
Microbiological Aspects of Some Caloric Sugar Substitutes
, International Dental Journal, 35:9-17 (1985); Kawanabe J. et al,
Noncariogenicity of Erythritol as a Substrate
, Caries Research, 26:358-362, (1992); Park, K.K. et al.;
Acidogenicity of High
-
intensity Sweeteners and Polyols
, American Journal of Dentistry, 8:23-26, (1995); Linke, H.
Sweeteners and Dental Health: the Influence of Sugar Substitutes on Oral Microorganisms
, Developments in Sweeteners, Elsevier Applied Science, (1987).
The non-cariogenic carbohydrates are sugars selected from the group of monosaccharides and disaccharides corresponding to the following empirical formula:
x
H
y
O
z
wherein when a monosaccharides, x is from about 4 to about 6, y is from about 10 to about 14 and z is from about 4 to about 6. When a disaccharides, x is about 12, y is about 22 and z is about 11. The preferred sugars corresponding to the structure above are selected from the group consisting of erythritol, xyli

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