Drug – bio-affecting and body treating compositions – Dentifrices – Plant extract of undetermined constitution
Reexamination Certificate
2002-05-15
2004-03-16
Krass, Frederick (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Plant extract of undetermined constitution
C424S048000, C424S440000, C424S736000, C424S766000, C424S776000, C424S777000, C426S003000, C426S004000, C426S005000, C426S006000, C426S660000
Reexamination Certificate
active
06706256
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to oral care compositions, including confectionery compositions, that comprise an effective amount of a antibacterial seed or pulp extract from the Citrus or Vitis plant family; an oral care active selected from the group consisting of anti-calculus agents; anti-plaque agents; fluoride ion source; desensitising agents; oral malodour control agents; H2 antagonists; and mixtures thereof; and a pharmaceutically acceptable carrier. Preferably this invention relates to oral care compositions comprising grape, and/or grapefruit seed extract. More preferably this invention relates to the use of these extracts in combination with one or more transition metal cations. This invention also relates to a method of treating or preventing 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.
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.
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.
A new class of compound has recently come to light that has antibacterial benefits. These compounds are the seed and pulp extract from the Citrus or Vitis plant family. Examples of prior art which disclose Citrus pulp and seed extracts include U.S. Pat. No. 5,631,001 which discloses an oral compositions comprising grapefruit pulp and seed extract mixture; JP 6-40,834 which discloses a spray compositions comprising grape fruit seed extract; RO 103,501 which discloses a mouthwash composition comprising alcoholic extracts of citrus plants; JP 4-346,933 discloses an anti-bacterial agent for addition to dentifrice compositions comprising the hexane soluble portion of citrus peel; FR 2,791,893 which discloses oral or topical compositions comprising grapefruit seed extracts; JP 6-40867 which discloses compositions for the prevention and treatment of periodontis comprising citrus fruit seed extract and JP 9-143,084 which discloses an anti-cariogenic agent which comprises grape fruit seed extract. Examples of prior art which disclose Vitis seed extract include JP 11-302,142 which discloses food compositions for the prevention of periodontis comprising a polyphenol extract which is optionally obtained from grape; JP 2000-69,945 which discloses a beverage comprising grape extract; and U.S. Pat. No. 5,891,465 which discloses nutritional supplements comprising a wide range of lipid encapsulated materials for administration as a liquid or aerosol spray wherein the preferred supplement comprises grape extract. Whilst the teachings of the prior art discloses how to formulate simple compositions, including simple oral care compositions comprising the seed or pulp antibacterial extracts there remains a need to prepare a product which is able to not only deliver the extract but also to combine this with a further oral care active such that the final product has multiple activity and can deliver more holistic oral care benefits. In addition the oral malodour benefits of such extracts have not previously been discussed. Furthermore it is likely that such extracts, in common with other similar plant extracts, are unstable in complex formulations. As such there remains a need to stabilise compositions comprising such materials.
As well as improving the oral malodour benefits of oral care products there is also an industry move to develop portable oral care products. This enables consumers to use such products several times a day, especially immediately after eating and throughout the day which will prevent the build up of food deposits which can enhance activity o
Hiland Emelyn Deleon
Krass Frederick
The Procter & Gamble Co.
Zea Betty J.
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