Aqueous enzymatic denture adhesives

Details Aqueous enzymatic denture adhesives Aqueous enzymatic denture adhesives

2002-01-29

2004-02-24

Lankford, Jr., Leon B. (Department: 1651)

Drug, bio-affecting and body treating compositions

Enzyme or coenzyme containing

Oxidoreductases

C424S050000, C424S077000, C424S094200, C435S189000, C435S192000, C523S120000

Reexamination Certificate

active

06696058

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to enzymatic denture adhesive compositions and, more particulary, to stabilized, aqueous, enzymatic denture adhesives, which, upon oral application, produce an anti-bacterial and bacteriostatic effect in the oral cavity by activation of the enzyme system within the adhesive.
Denture adhesives are used by denture wearers to secure loose fitting dentures. When a denture is first made, it fits tightly in the mouth. However, with the passage of time, the mouth changes and the denture often becomes less secure, with loss of the initial tight fit.
When this occurs, the patient has three choices: (a) obtain a new denture, (b) reline the old denture, or (c) use a denture adhesive. For those who choose denture adhesives, there are diverse products from which a selection can be made. These include powders, gels, pastes, and sheets. The adhesives are based on water soluble gums and polymers such as carboxymethyl cellulose, gum arcacia, gum tragacanth, poly(ethylene oxide), polyvinylpyrrolidone, vinyl methyl ether maleic anhydride, polyacrylamides, acetic polyvinyl compounds, polyacrylic acid derivates and the like.
The most common denture adhesives are those sold as pastes. The pastes are usually a combination of gums and powders combined with oil and/or other vehicle. The denture wearer squeezes the paste from a dispensing tube onto the denture which is then fitted into the mouth. Denture powders based on gums and/or polymers are also widely used by sprinkling the powder onto the denture which is then positioned in the mouth. Denture adhesives are also sold as sheets or films prepared from gums or polymers.
Regardless of the physical form of these adhesives, they all require contact with water to become effective. It is only when the gums and polymers become wet that they develop their adhesive properties. Normally, these adhesives work very well in the mouth. However, for denture wearers who suffer from dry mouth (xerostomia), dentures adesives work poorly or not at all because there is insufficient saliva to activate these adhesives, Also, because saliva is naturally antibacterial, people who suffer from dry mouth have an increased risk of periodontal disease, cavities and mouth odors.
The invention herein is directed to water-based denture adhesive compositions which incorporate (a) a hydro-activated anti-bacterial enzyme system and (b) a thickener so as to provide the composition with an enzyme immobilizing visvosity to inhibit enzymatic action during processing and in the denture adhesive package prior to oral application. The aqueous denture adhesive, with its anti-bacterial system, is particularly well suited for denture wearers who suffer from impaired saliva flow and provides those denture users with oral protection that would otherwise be present with normal saliva flow.
2. Related Art
2A. Enzyme Systems
It is disclosed in the prior art that enzymatic anti-bacterial systems, predicated on oxidoreductase enzymes such as glucose oxidase, can be incorporated into oral care products and other products such as powder milk (U.S. Pat. No. 4,617,190) and bandages (U.S. Pat. No. 4,576,817) for producing an anti-bacterial effect in a defined environment.
U.S. Pat. No. 4,150,113 (Hoogendoorn et al., 1979) and U.S. Pat. No. 4,178,362 (Hoogendorn et al., 1979) disclose, respectively, an enzymatic toothpaste and an enzymatic chewable dentifrice containing glucose oxidase which acts on glucose present in saliva and tooth plaque to produce hydrogen peroxide. The patentees note that oral bacteria, through enzyme systems having SH-Groups, effect glycolysis of food products containing sugars and point out that lactoperoxidase, which is present in saliva, provides the means for transferring oxygen from hydrogen peroxide to oral bacteria resulting in the oxidation of the SH-containing enzymes into inactive disulfide enzymes. It is further disclosed that the dentifrice may be formulated with potassium thiocyanate.
U.S. Pat. No. 4,269,822 (Pellico et al., 1981) discloses an antiseptic dentifrice containing an oxidizable amino acid substrate and an oxidoreductase enzyme specific to such substrate for producing hydrogen peroxide and ammonia upon oral application of the dentifrice, with pre-application stability being maintained by limiting the quantity of any water present in the dentifrice.
U.S. Pat. No. 4,537,764 (Pellico et al., 1985) discloses an enzymatic dentifrice containing Beta-D-glucose and glucose oxidase for producing hydrogen peroxide upon oral application of the dentifrice, with pre-application stability being maintained by limiting any water in the dentifrice to not more than about 10 wt. % based on the weight of the dentifrice.
U.S. Pat. No. 4,564,519 (Pellico et al., 1986) discloses a di-enzymatic chewable dentifrice which contains, for example, glucose and glucose oxidase for producing hydrogen peroxide upon chewing the dentifrice and further contains a thiocyanate salt and lactoperoxidase for interacting with hydrogen peroxide to produce a hypothiocyanate (sic) bacterial inhibitor, with pre-application stability being maintained by limiting any unbound water in the chewable dentifrice to an amount not more than about 1.0 wt. % and limiting the total water, bound and unbound, to not more than about 10 wt. %.
U.S. Pat. No. 4,578,365 (Pellico et al., 1986) discloses a di-enzymatic dentifrice which contains, for example, glucose and glucose oxidase for producing hydrogen peroxide upon oral application of the dentifrice and further contains a thiocyanate salt and lactoperoxidase for interacting with hydrogen peroxide to produce a hypothiocyanate (sic) with pre-application stability being maintained by limiting any water in the dentifrice to not more than about 10 wt. % based on the weight of the dentifrice.
U.S. Pat. No. 5,176,899 (Montgomery, 1993) discloses an aqueous enzymatic dentifrice which contains, for example, Beta-D-Glucose and glucose oxidase for producing hydrogen peroxide upon oral application of the dentifrice and, optionally, contains a thiocyanate salt and lactoperoxidase for interacting with hydrogen peroxide to produce a hypothiocyanite (OSCN—) bacteriostatic agent, with pre-application stability being maintained by processing and packaging the dentifrice under vacuum conditions so as to limit the level of dissolved oxygen in the dentifrice.
U.S. Pat. No. 5,336,494 (Pellico, 1994) discloses an orally chewable, enzymatically coated pet product which contains, for example, Beta-D-glucose and glucose oxidase for producing hydrogen peroxide upon oral chewing of the product and may further contain a peroxidase and an alkali metal salt of an oxygen accepting anion such as potassium iodide for interacting with hydrogen peroxide to produce hypoiodite, an anionic bacterial inhibitor.
U.S. Pat. No. 5,453,284 (Pellico, 1995) discloses an aqueous enzymatic dentifrice having a water content in excess of 10 wt. % and which contains, for example, Beta-D-glucose and glucose oxidase for producing hydrogen peroxide upon oral application of the dentifrice and may further contain a peroxidase and an oxidizable alkali metal salt such as the thiocyanate, chloride or iodide salt of sodium or potassium for interacting with hydrogen peroxide to produce an anionic bacterial inhibitor, with pre-application stability being maintained by the addition of a water soluble thickener in an amount to provide the dentifrice with a viscosity from about 800 to about 75,000 centipoises.
2B. Denture Adhesives
U.S. Pat. No. 4,518,721 (Dhabhar et al., 1985) discloses a hydrophillic denture adhesive containing sodium carboxymethylcellulose, poly(ethylene oxide), polyethylene glycol and glycerin.
U.S. Pat. No. 4,804,412 (Komiyama, 1989) discloses a denture adhesive containing polyvinyl acetate and polypropylene oxide and which may further include other ingredients such as enzymes, as for example, dextranase, mutanase, levanase and in(s)ulinase.
U.S. Pat. No. 5,760,102 (Hall et al., 1998) discloses an aqueous denture adhesive containing

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