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Dual component dental composition containing enzyme

Dual component dental composition containing enzyme description/claims

This application is a continuation of U.S. Ser. No. 11/191,501, filed Jul. 28, 2005 which claims priority to U.S. Ser. No. 10/229,551, filed Aug. 28, 2002.

Oral compositions such as toothpastes, gels and mouth washes are designed to loosen and remove plaque in conjunction with a regular toothbrushing regimen. Dental plaque is present to some degree, in the form of a film, on virtually all dental surfaces. It is a by product of microbial growth, and comprises a dense microbial layer consisting of a mass of microorganisms embedded in a polysaccharide matrix. Plaque itself adheres firmly to dental surfaces and is removed only with difficulty even through a rigorous brushing regimen. Moreover, plaque rapidly reforms on the tooth surface after it is removed. Plaque may form on any part of the tooth surface, and is found particularly at the gingival margin, in cracks in the enamel, and on the surface of dental calculus. The problem associated with the formation of plaque on the teeth lies in the tendency of plaque to build up and eventually produce gingivitis, periodontitis and other types of periodontal disease, as well as dental caries and dental calculus.

It is known to the art to incorporate antimicrobial agents in oral compositions wherein these agents destroy or inhibit oral bacteria. Other agents are also incorporated in the oral composition to enhance the efficacy of the antimicrobial agents. For example, it is known to incorporate enzymes in oral compositions which disrupt or interfere with plaque formation and bacterial adhesion to tooth surfaces as disclosed in U.S. Pat. Nos. 2,527,686; 3,991,177; 3,194,738; 4,082,841; 4,115,546; 4,140,759; 4,152,418; 4,986,981; 5,000,939; 5,370,831; 5,431,903; 5,537,856; 5,849,271.

A problem encountered with the use of enzymes in oral care compositions is that often the enzyme of choice is not compatible with surfactants, namely ionic surfactants such as anionic surfactants which are preferred for use in oral compositions such as dentifrices and mouthwashes to achieve increased prophylactic action, provide superior foaming properties and render the compositions more cosmetically acceptable. Anionic surfactants such as the higher alkyl sulfates are not compatible with enzymes as the surfactant facilitates denaturing of the enzyme and loss in activity. As a result, the use of this desirable class of surfactants has been avoided by the art in the preparation of enzyme containing dentifrices.

The present invention is based upon the discovery that when a dual component dentifrice comprised of separately housed dentifrice components in which a first component contains an ionic or other surfactant normally incompatible with an enzyme and the second component contains the enzyme, when the components are mixed and combined during use, the enzyme is not found to denature but retains its activity in the presence of the normally incompatible ionic surfactant for at least the period of time involved in toothbrushing.

In accordance with the present invention there is provided a method for combining the plaque dispersion properties of active enzymes and the superior foaming action of ionic surfactants using a multicomponent dentifrice which dentifrice is comprised of separately housed, semi-solid aqueous components; the first component containing the enzyme in an orally acceptable vehicle and a second component containing an ionic surfactant in an orally acceptable vehicle whereupon combination of the components provides a dentifrice having superior foaming properties without antiplaque enzyme activity being significantly affected.

In use, the components of the two component dentifrice of the present invention comprise a first enzyme containing dentifrice component, and a second ionic surfactant containing dentifrice component. The two components are preferably combined for use in approximately equal weight proportions, so that about one-half of the concentration of any particular ingredient within either component will be present when the components are combined and applied to the teeth, as by brushing. Both components are preferably formulated to have similar physical characteristics, so that the two components may be simultaneously delivered in the desired predetermined amounts by extrusion when separately housed in a multicompartmented tube or pump device.

The enzymes useful in the practice of the present invention include enzymes extracted from natural fruit products such as well-known protein substances within the class of proteases, which breakdown or hydrolyze proteins. The proteolytic enzymes are obtained from natural sources or by the action of microorganisms having a nitrogen source and a carbon source. Examples of proteolytic enzymes useful in the practice of the present invention include the naturally occurring enzymes papain (from papaya), bromelain (from pineapple), as well as serine proteases such as chymotrypsin. Additional enzymes include ficin and alcalase.

Enzymes such as proteolytic enzymes are included in the first dentifrice component of the present invention at a concentration of about 0.010 to about 10.0% by weight and preferably about 0.2 to about 5% by weight.

Papain obtained from the milky latex of the Papaya tree is the proteolytic enzyme preferred for use in the practice of the present invention and is preferably incorporated in the oral care composition of the present invention in an amount of about 0.2 to about 5% by weight, such papain having an activity of 150 to 900 units per milligram as determined by the Milk Clot Assay Test of the Biddle Sawyer Group (see J. Biol. Chem., vol. 121, pages 737-745).

Enzymes which may beneficially be used in combination with the proteolytic enzymes include carbohydrases such as glucoamylase, alpha-amylase, beta-amylase, dextranase and mutanase, tannase and lipases such as plant lipase, gastric lipase and pancreatic lipase.

Glucoamylase is a saccharifying glucoamylase of Aspergillus niger origin. This enzyme can hydrolyze both the alpha-D-1,6 glucosidic branch points and the alpha-1,4 glucosidic bonds of glucosyl oligosaccharides. The product of this invention comprises about 0.01 to 10% of the carbohydrases. The lipase enzyme is derived from a select strain of Aspergillus niger. The enzyme has maximum lipolytic activity at pH 5.0 to 7.0 when assayed with olive oil. The enzyme has 120,000 lipase units per gram. Among the carbohydrases useful in accordance with this invention are glucoamylase, alpha and beta-amylase, dextranase and mutanase.

Other enzymes which may be denatured in the presence of anionic surfactants and used in the practice of the present invention include other carbohydrases such as alpha-amylase, beta-amylase, dextranase and mutanase and lipases such as plant lipase, gastric lipase, pancreatic lipase, pectinase, tannase lysozyme and serine proteases.

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• Utility Patent

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