Drug – bio-affecting and body treating compositions – Chewing gum type
Reexamination Certificate
2002-05-15
2004-04-27
Krass, Frederick (Department: 1614)
Drug, bio-affecting and body treating compositions
Chewing gum type
C424S058000, C424S440000, C424S078310, C426S003000, C426S004000, C426S005000, C426S006000, C426S660000
Reexamination Certificate
active
06726897
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to confectionery compositions that comprise polyphosphate with an average anion chain length of greater than or equal to 3; a metal cation wherein the ratio of polyphosphate to metal cation is in the range of from about 10:1 to about 1:1 and wherein the confectionery composition comprises less than 10%, by weight of the composition, water. Preferably this invention relates to non-cariogenic or so called “sugar free” chewing gum confectionery compositions. More particularly this invention relates to compositions that treat or prevent oral malodour, treat or prevent calculus and have surface conditioning effects in the oral cavity of a subject. Compositions of the present invention are suitable for use by humans or animals.
BACKGROUND OF THE INVENTION
Oral malodour or halitosis, which is commonly referred to as bad breath, is the result of volatile sulphur compounds, carboxylic acids and amines building up in the oral cavity. The malodourous compounds are generated primarily through putrefactive action of oral microorganisms on sulphur containing amino acids, peptones or proteins found in the mouth. Such micro-organisms are readily available in saliva and dental plaque and may be derived from proteinaceous food particles trapped between the teeth, in the gingival crevice or adhering to the mucous membranes and the irregular surface of the tongue as well as exfoliated oral epitheleum, food debris and the like. In addition oral malodour may be the result of poor oral hygiene, digestive system problems, disease, diet or a combination of any of these factors. Not only is oral malodour unpleasant but its presence can be indicative of poor oral hygiene and can also be one of the first signs of some more severe underlying problems. This is because the build up of putrid matter which causes malodour can also lead to the formation of plaque, the origin of dental caries, gingivitis and dental calculus. Regular brushing of teeth can help to minimise oral malodour. However, even regular brushing is not sufficient to remove all of the food and oral bacteria deposits that adhere to the oral surfaces and, in severe cases it is unable to eliminate oral malodour.
To date oral malodour products have been formulated to comprise a wide range of materials that kill the oral bacteria contributing to the oral malodour. Such materials include agents such as triclosan, chlorhexidine, quaternary ammonium salts and camphorated parachlorophenol. However, these materials can be harsh, and can only be dosed in limited daily amounts and as such are not necessarily suitable for use in a product to be used several times a day. In some cases they may also cause undesirable side effects such as staining, altered taste etc.
More recently trends have been directed towards the use so called natural materials, especially extracts, to provide a wide range of benefits in personal care products. Herbal extracts of gold thread and honeysuckle have been reported (JP 57-85319/U.S. Pat. No. 5,741,138); herbal curry plant extract has been disclosed in JP 10-182,388 for combating halitosis; cranberry extract has been disclosed in WO 96/28135 for is antimicrobial and antibacterial properties; and DE 4,221,103 discloses compositions comprising a wide range of herbal extracts for oral hygiene. Polyphenols have been identified as an important active in a wide range of herbal extracts. Examples of oral care disclosures include WO 01/17494 which discloses dentifrice compositions comprising tea polyphenols; US/PCT/00/11258 which discloses dentifrice compositions comprising polyphenol herbal extracts; and EP 1,013,261 which discloses a spray liquid comprising polyphenol for the masking of halitosis. Whilst the teachings of the prior art are directed towards compositions with limited deodorising or anti-bacterial effects the products themselves have limited activity and are unstable leading to unattractive discolouration over time and further reduction in efficacy. There remains a need for a stable oral care product that is able to deliver effective malodour control benefits.
Metal cations have also been considered for inclusion in oral compositions for treating oral malodour. Disclosures include U.S. Pat. No. 5,833,952 which discloses compositions comprising tin salts, optionally in combination with zinc salts; WO 99/17735 which discloses a metal ion amino acid chelate; U.S. Pat. No. 6,123,925 which discloses a dentifrice comprising ceramic particles in combination with anti-microbial metal ions. However there remain several problems in preparing compositions comprising metal ions for combating oral malodour. These include that the presence of high level of metal cation can often destabilise other elements of the composition, the metal ions become easily chelated to other products and are therefore not efficacious, tightly controlled regulatory limits and the products tend to be highly astringent thus having unacceptable taste profiles. Despite these disadvantages the use of metal cations for combating oral malodour has several benefits. These include that the materials are very cheap, the materials are easy to work with and the metal cations have good recorded efficacy. Thus there remains a desire to continue to work with metal cations to develop a stable, pleasant oral care product able to deliver effective and long lasting malodour benefits.
Oral malodour is closely linked with the build up of plaque. Dental plaque is the name given to a deposit of material that accumulates on the teeth and adjacent surfaces of the oral cavity. It is the product of microbial growth in the oral cavity, primarily derived from the food/sugar residues in the mouth. Mucoproteins, minerals and food deposits present in the saliva, and dead cells in the mouth, also contribute to the formation of plaque. The build up of plaque enhances the formation of calculus, a hard mineral material that deposits on teeth. Calculus is formed when calcium phosphate crystals, which become entangled in the plaque film, become sufficiently closely packed together to aggregate and become resistant to deformation. The build up of both plaque and calculus on the teeth leads to a general decline in oral health resulting in an increase in the rate of formation of dental caries, an increase in the prevalence of gum disease and can also contribute to the staining of teeth and the presence of malodour. If left untreated these conditions can lead to severe oral disease and deterioration of the gums and teeth.
Several anti-plaque and anti-calculus agents are known in the art. One such material is linear or cyclic dehydrated polyphosphate, which is known to be an effective calcium/magnesium ion suppressor, a sequestrant and/or chelating agent and an effective inhibitor of calculus formation. Well-known examples are the water soluble hexametaphosphates, tripolyphosphate and pyrophosphates and the like. These materials have been widely disclosed in oral care compositions such as dentifrice. Examples of such disclosures include U.S. Pat. No. 5,094,844 which discloses oral compositions comprising tripolyphosphate; U.S. Pat. No. 4,460,565 which discloses oral compositions comprising two or more fluoride compounds and an agent capable of supplying calcium ions to the teeth optionally in conjunction with a cyclic phosphate; WO 99/12517 which discloses oral compositions comprising tripolyphopshate, pyrophosphate and PVP; JP 10-182388 which discloses compositions comprising cyclic and linear condensed phosphoric acid and curry extract and JP 9-295942 which discloses an agent for preventing tooth decay comprising at least 1 meta phosphate. Such polyphosphates are also known to provide a buffering effect within oral compositions comprising zinc (U.S. Pat. Nos. 4,170,632 and 4,170,633 both to Wagenknecht). In addition, the pending patent application PCT/US00/30808 reports that long chain linear polyphosphates with an average anion chain length of greater than or equal to 4 provide novel surface conditioning benefits to the teeth and mucosa. Th
Emelyn Deleon Hiland
Krass Frederick
The Procter & Gamble Co.
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