Drug – bio-affecting and body treating compositions – Chewing gum type
Reexamination Certificate
2002-05-15
2004-05-04
Krass, Frederick (Department: 1614)
Drug, bio-affecting and body treating compositions
Chewing gum type
C424S058000, C424S440000, C424S725000, C426S003000, C426S004000, C426S005000, C426S006000, C426S660000
Reexamination Certificate
active
06730291
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to confectionery compositions that comprise a first metal cation and a second metal cation wherein the ratio of the first metal cation to the second metal cation is in the range of from about 50:1 to 1:50 and wherein the composition comprises less than 10% water. Preferably this invention relates to non-cariogenic or so called “sugar free” confectionery compositions. More particularly this invention relates to portable oral care compositions that treat or prevent oral malodour. 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 micro organisms 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.
There is currently a movement in the oral care industry to develop portable oral care product forms which can be used several times a day, particularly after eating. It is hoped that such a product will improve the oral hygiene of consumers. In addition, such a product would make it easier to provide good oral hygiene to children and pets where it is not always easy or possible to regularly brush the teeth.
Confectionery compositions which are popular with both children and adults alike and which are retained in the oral cavity for substantial periods of time during consumption, would seem to make an ideal product form for a portable oral care product. The art of the development and manufacture of a wide range of confectionery compositions is well known. However, the high sugar content of such confectionery compositions has been recognised as a contributory factor in poor dental health. Developments have been made to produce “sugar free”, or non-cariogenic, confectionery which retain their organoleptic properties but which do not contribute to the formation of dental plaque. More recently research has turned to developing confectionery compositions, particularly “sugar free” confectionery compositions, particularly chewing gum compositions, which comprise one or more oral care agents. One such example is WO 99/44436, which discloses coated chewing gum compositions, which comprise materials with known oral care benefits. However, although chewing gum products have several advantages, they also have several disadvantages in that the chewing of gum is considered unsightly by some consumers and is not acceptable in certain societies. In addition, the chewing gum product format is not ideal for administering to pets and children. As such there is a need for a confectionery oral care product form, or range of forms, which are acceptable in a wide range of societies but which maintain high degrees of oral care efficacy, particularly anti-plaque and anti-calculus efficacy.
Surprisingly it has now been found that, when an oral composition is prepared comprising a first metal cation and a second metal cation wherein the ratio of the first metal cation to the second metal cation is in the range of from about 50:1 to about 1:50 and wherein the composition comprises less than 10% water, a composition is obtained which has effective oral malodour benefits. Furthermore, by formulating the product in a wide range of confectionery forms, portable oral care, which provides comparable benefits to frequent brushing, has been developed which is acceptable to a wide range of consumers and cultures and in addition is in a form which is easily administered to pets and children.
Since the absolute levels of specific metal cations are often controlled by tight regulations it can be difficult to formulate a product comprising suf
Emelyn Deleon Hiland
Krass Frederick
The Procter & Gamble Co.
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