WO2013075920A2

WO2013075920A2 - An oral care composition

Info

Publication number: WO2013075920A2
Application number: PCT/EP2012/071649
Authority: WO
Inventors: Gautam Banerjee; Kishore BHONSLE; Uma Madhavan; Kalpana Kamalakar Nayak; Deleep Kumar ROUT; Maya Treesa Saji; Smitha Ashok Upadhyaya
Original assignee: Unilever N.V.; Unilever Plc; Hindustan Unilever Limited; Conopco, Inc., D/B/A Unilever
Priority date: 2011-11-25
Filing date: 2012-11-01
Publication date: 2013-05-30
Also published as: IN2014MN00931A; CN103987364B; BR112014012497A2; CN103987364A; WO2013075920A3; EP2782550A2

Abstract

The present invention relates to oral care composition and a method of disinfecting the oral cavity. We have found that oral care composition having a combination of selective antimicrobial agents and polyphenol provides improved antimicrobial benefits. The combination surprisingly shows synergistic effects that are an order of magnitude better than those shown individually by the antimicrobial agents.

Description

AN ORAL CARE COMPOSITION

FIELD OF INVENTION

The present invention relates to an oral care composition and a method of disinfecting the oral cavity. The invention has been developed primarily for use in oral care compositions and will be described hereinafter with reference to these applications. However, it will be appreciated that the invention is not limited to this particular field of use.

BACKGROUND AND RELATED ART

Oral hygiene is one of the most important aspects of personal care among consumers. Consumers all over the world use different types of products for oral care. People routinely brush their teeth at least two times a day with a toothbrush and a dentifrice composition, which may be a toothpaste or a toothpowder. Use of such brushing ensures maintaining good oral hygiene by minimising oral bacteria that accumulate in the mouth over the course of sleeping in the night or during the course of the day when people eat their food and consume beverages. Brushing, thus minimises problems like cavities, tartar, gingivitis, caries, and bad breath, also known as halitosis. In spite of brushing teeth twice a day, many people suffer from various forms of one or more of the above named diseases and this is believed to be caused by bacteria acting in the oral mucosa over the about twelve hour period between brushing.

In solving the above oral care problems, the approach so far has been to use synthetic materials (e.g. Triclosan or alcohol) which are believed by many consumers to be harsh on them. Consumers, more and more, especially of late, prefer using products that contain natural materials. Further, in many countries, culturally or otherwise, people are reluctant to using alcohol in their mouthwashes.

Combinations of antimicrobial agents providing improved antimicrobial efficacy are known in oral care compositions. US2007258996AA (The Sterilex Corporation) discloses an antimicrobial composition and a method for treating a microbial infection. The application teaches an antimicrobial composition having a synergistic combination of three or more agents independently selected from sequestering agents, carbohydrates, terpenes, terpenoids, peptides, alkaloids, plant-derived oils, dyes and stains, sulfonates, phenols, esters, fatty acids, or dibenzofuran derivatives. At least two of the three or more agents are not of the same type of compound.

EP1013261 A1 (Mitsui & Co. Limited, 2000) discloses a mouth spray composition providing for masking bad breath for a long duration and for giving significant refreshing effect. The application discloses a composition having tea-polyphenol, 1 -menthol and/or 1 -carvone. The application discloses composition having high levels of ethanol. Ethanol is among the fast acting and potent antimicrobials but people consider it to be harsh. It is also considered unacceptable in some cultures.

We have found that oral care composition having a combination of selective antimicrobial agents and a polyphenol provides improved antimicrobial benefits. The combination surprising shows synergistic effects that are an order of magnitude better than those shown individually by the antimicrobial agents.

Advantageously, this benefit is observed even when the concentration of the antimicrobial agent is very small thus obviating the issues arising from possible negative sensory aspects of using high concentrations of such actives. It was also found that the composition also provides for anti-inflammatory benefits. OBJECT OF THE INVENTION

It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art. Other objects of the present invention will become apparent to those skilled in the art by reference to the specification.

SUMMARY OF THE INVENTION

According to the first aspect, disclosed is an oral care composition comprising:

(i) 0.01 to 10 wt% antimicrobial agent selected from an essential oil active comprising thymol or terpineol or eugenol or geraniol; triclosan or a mixture thereof;

(ii) 0.1 to 5 wt% polyphenol; and,

(iii) an orally acceptable base;

wherein the polyphenol comprises at least 50% of catechins.

According to a second aspect, disclosed is a method of disinfecting the oral cavity comprising the steps of:

a. applying a composition of the first aspect of the invention onto the oral cavity; and,

b. cleaning the cavity to be substantially free of the composition.

According to a third aspect, disclosed is a use for a composition according to the first aspect of the invention for disinfecting the oral cavity.

DETAILED DESCRIPTION OF THE INVENTION

These and other aspects, features and advantages will become apparent to those of ordinary skill in the art from a reading of the following detailed description and the appended claims. For the avoidance of doubt, any feature of one aspect of the present invention may be utilized in any other aspect of the invention. The word "comprising" is intended to mean "including" but not necessarily "consisting of or "composed of." In other words, the listed steps or options need not be exhaustive. It is noted that the examples given in the description below are intended to clarify the invention and are not intended to limit the invention to those examples per se. Similarly, all percentages are weight/weight percentages unless otherwise indicated. Except in the operating and comparative examples, or where otherwise explicitly indicated, all numbers in this description and claims indicating amounts of material or conditions of reaction, physical properties of materials and/or use are to be understood as modified by the word "about". Numerical ranges expressed in the format "from x to y" are understood to include x and y. When for a specific feature multiple preferred ranges are described in the format "from x to y", it is understood that all ranges combining the different endpoints are also contemplated. The oral care composition of the invention includes an antimicrobial agent, polyphenol and an orally acceptable base.

Antimicrobial agent

The oral care composition includes 0.01 to 10 wt% of an antimicrobial agent, preferably 0.01 to 5 wt%, more preferably 0.01 to 1 wt% still more preferably 0.01 to 0.5 wt% and further preferably from 0.01 to 0.2 wt%. The antimicrobial agent is selected from an essential oil active including thymol or terpineol or eugenol or geraniol ; triclosan (TCN) or a mixture thereof.

The essential oil active preferably includes thymol or terpineol or eugenol or mixture thereof. Other optional essential oil actives may be included in the composition of the invention. These include but are not limited to amyl salicylate, carvacrol, cymene, e.g. p-cymene, dihydroeugenolhexyl eugenol, hexyl salicylate, isoeugenol, methyl eugenol, methyl isoeugenol, methyl salicylate, tert butyl cresol, and vanillin or non- aromatic essential oils. Examples of non-aromatic essential oils of terpenoid compounds include cedrene, cineole, citral (including geranial and neral), citronellal, citronellol, eucalyptol (also known as 1 ,8 cineole) paradihydrolinalool, dihydromyrcenol (DH myrcenol), farnesol, geraniol, hexyl cinnamaldehyde, hydroxycitronallol, hydroxycitronellal, isocitral, limonene, d-limonene, linalool, longifolene, menthol, nerol, nerolidiol, pinene, e.g. a-pinene, phellendrene, terpinene, e.g. a-terpinene and γ-terpinene, terpineol, e.g. γ-terpineol and terpin- 4-ol, and tetrahydromyrcenol (THM). Preferred compositions have 0.01 to 5 wt% terpineol more preferably 0.01 to 2 wt% terpineol; 0.01 to 2 wt% thymol more preferably 0.01 to 0.8 wt% thymol and 0.001 to 2 wt% eugenol more preferably 0.002 to 0.1 wt% eugenol.

Triclosan is 2', 4, 4'-trichloro, 2-hydroxy-diphenyl ether. Preferred compositions include 0.05 to 0.3 wt% triclosan. Polyphenol

The oral care composition include 0.1 to 5 wt% polyphenol having at least 50% catechins, preferably 0.2 to 4 wt%, more preferably 0.5 to 4 wt%, even more preferably 1 to 3 wt%, and optimally 1 .0 to 2.5 wt% of polyphenol.

Polyphenols are a group of chemical substances found in plants, characterized by the presence of more than one phenol unit or building block per molecule.

Polyphenols are generally divided into hydrolyzable tannins (gallic acid esters of sugars) and phenylpropanoids, such as lignins (secoisolariciresinol diglycoside), flavonoids, and condensed tannins. The largest class and best studied

polyphenols are the flavonoids, which include several thousand compounds, among them the flavonols (Quercetin, Gingerol, Kaempferol, Myricetin,

Resveratrol, Rutin), flavones (Apigenin, Luteolin), catechins (Epicatechin,

Catechin Gallates, Theaflavin), flavanones (Hesperiden, Naringenin, Silibenin, Eriodictyol), anthocyanidins (Pelargonidin, Peonidin, Cyanidin, Delphinidin, Malvidin) isoflavonoids (Daidzein, Genistein, Glycitein) and coumestans

(coumestrol).

It is preferred that the polyphenol includes at least 60% of catechins, more preferably at least 70%, even more preferably at least 80% and optimally 100% catechins.

Preferably the catechins include at least 25% epigallocatechin gallate.

Preferably the polyphenols are extracted from green tea (Camellia sinensis).

Preferred commercially available polyphenols having at least 60% catechins include Sunphenon 90 LB and Sunphenon 80SK (Taiyo Kagaku Co., Ltd).

Orally acceptable base

The oral care composition includes an orally acceptable base. The orally acceptable base depends on the format in which the oral care composition is delivered. Most suitable formats are an mouthwash, a toothpaste or a

toothpowder.

The present inventors wish to achieve the antimicrobial efficacy using easily available and natural actives and would like to minimize use of harsh

antimicrobials like low molecular weight (Ci to C3) alcohol e.g. ethanol. Thus according to a preferred aspect of the present invention, the composition comprises less than 2wt% , more preferably less than 1wt%, further more preferably less than 0.5wt% of such an alcohol, and ideally low molecular weight (Ci to C3) alcohols are absent from the composition.

Mouthwash When the composition is formulated as an mouthwash, the orally acceptable base is water. The desired antibacterial efficacy of the mouthwash according to the present invention can be obtained without the use of low molecular weight (Ci to C3) alcohols e.g. ethanol or isopropyl alcohol, i.e. the composition is substantially free of low molecular weight alcohol. By the term substantially free of low molecular weight alcohols is meant that the alcohol may be present in an amount which does not significantly affect the microbial kill. Preferably, Ci to C3 alcohols are present at less than 2%, more preferably less than 1 % and most preferably absent from the composition of the invention. Thus, according to an aspect of the present invention, there is provided an antimicrobial mouthwash composition comprising (a) 0.01 to 10 wt% of an antimicrobial agent selected from an essential oil active including thymol or terpineol or eugenol or geraniol, Triclosan or a mixture thereof; (b) 0.1 to 5 wt% of polyphenol wherein the polyphenol comprises at least 50% of catechins; and, (c) 80 to 99.5 wt% water.

The mouthwash of the invention preferably includes 0.05 to 10 wt%, more preferably 0.05 to 8 wt%, most preferably 0.5 to 5 wt% of a surfactant. The surfactant is preferably cationic, anionic, or zwitterionic, most preferably cationic.

When an anionic surfactant is present it is preferably chosen from alkali or alkaline earth metal salts of alkyl sulphonic acid, fatty acid, or alkyl ether sulphate.

When a zwitterionic surfactant is present it is preferably chosen from betaines, sulphobetains, hydroxyl sulphobetains, or amino carboxylates. When a cationic surfactant is present it is preferably benzalkonium chloride, alkyl pyridinium chloride or quaternary ammonium gemini surfactants. The mouthwash composition of the invention is used for disinfecting the oral cavity either by using the composition with no dilution or after diluting the composition with water. The preferred weight ratio of composition to water for the dilution step is in the range of 1 :1 to 1 :200, more preferably 1 :5 to 1 :50, further more preferably 1 :15 to 1 :30 and ideally about 1 :20.

Toothpaste

The oral care composition may be delivered in a toothpaste format. When the composition is a toothpaste, the orally acceptable base is an abrasive which may be calcium carbonate or abrasive silica. When calcium carbonate is the abrasive, the toothpaste is in an opaque paste format. When abrasive silica is used, the toothpaste is usually delivered in a transparent gel format.

The toothpaste preferably includes 2 to 15 wt% of a surfactant, preferably 2.2 to 10 wt%, more preferably 2.5 to 5 wt% of the total composition. Preferred surfactants are anionic or amphoteric in nature. The anionic surfactant is preferably an alkali metal alkyl sulphate, more preferably a sodium lauryl sulphate (SLS). Mixtures of anionic surfactants may also be employed. The amphoteric surfactant is preferably a betaine, more preferably an alkylamidopropyl betaine (wherein the alkyl group is a linear Cio~Cis chain), and most preferably is cocoamidopropyl betaine (CAPB). Mixtures of amphoteric surfactants may also be employed.

Opaque toothpaste: Preferably the orally acceptable base in opaque toothpaste includes 15 to 70 wt% calcium carbonate, more preferably 30 to 60 wt%. Calcium carbonate (also known as chalk) is available in many forms and some of these forms are used in oral care compositions. Two commonly used forms are FGNC (fine ground natural chalk) and PCC (precipitated calcium carbonate). Of the total chalk content in the oral care composition, FGNC, is generally present in 35 to 100% preferably from 75 to 100% and especially from 95 to 100%, the balance being PCC. Typically, the compositions include 30 to 65 wt%, preferably 35 to 55 wt% and most preferably from 40 to 55 wt% of FGNC. FGNC generally includes particles of weight-based median particle size preferably of 1 to 15 μιτι, more preferably of 2 to 10 μιτι and further preferably of 4 to 7 μιτι.

The composition may also include other known "non-chalk" abrasives to improve the abrasive action. Such abrasives include dicalcium phosphate dihydrate (DCPD) and silica.

In addition to calcium carbonate, one can also include abrasive silica in opaque toothpastes for enhanced abrasive action. When present, the composition includes 4 to 15 wt%, preferably 6 to 12 wt%, and further more preferably 7 to 10 wt% of abrasive silica. Alternatively the composition may include 0.0.1 to 2 wt%, preferably 0.1 to 0.8 wt%, further more preferably 0.3 to 0.7 wt% of perlite.

Water in the opaque toothpaste is generally included at 15 to 40 wt%, preferably 20 to 30 wt% of the composition.

Preferred compositions include a humectant, e.g. xylitol, glycerol or sorbitol.

Glycerol and sorbitol are particularly preferred. Preferably, the compositions include 0.1 to 20 wt% humectants, more preferably 1 to 15 wt%, most preferably 5 to 13 wt%.

Preferably the composition also includes an alkali-metal bicarbonate salt.

Preferably the alkali-metal bicarbonate salt is a sodium salt. The composition preferably includes 1 to 30 wt%, more preferably 2 to 20 wt% and optimally 3 to 8 wt% of the alkali-metal bicarbonate salt.

Gel toothpaste:

Gel toothpaste preferably includes abrasive silica. The preferred abrasive silica has a low refractive index of 1 .41 to 1 .47 and more preferably of 1 .435 to 1 .445. Preferably the abrasive silica has a weight mean particle size of between 5 and 15 micrometers, a BET (nitrogen) surface area of between 10 and 100 m2/g and an oil absorption of about 70 - 150 cm3/100 g. Typical examples of suitable low refractive index abrasive silicas are Tixosil 63 and 73 (ex Rhone Poulenc); Sident 10 (ex Degussa); Zeodent 1 13 (ex Zeofinn); Zeodent 124 (ex Huber), Sorbosil AC series supplied by Crosfield such as Sorbosil ACII, Sorbosil AC39 and Sorbosil AC35, particularly Sorbosil AC 77 (ex Crosfield Chemicals). The amount of silica in the gel toothpaste composition is preferably 2 to 60 wt%, usually 2 to 20 wt% and more preferably 5 to 12 wt%.

Thickening silica may also be incorporated in gel toothpaste, usually at 4 to 12 %, preferably 5 to 10% by weight of the composition. Examples of preferred grades of medium thickening silica includes MFIL (ex. Madhu Silica India), TC15 (from PQ Corp UK), Zeodent 165 (ex. Huber), or Tixosil 43 (from Rhodia).

Water in the gel toothpaste is generally included at 8 to 14%, preferably 8 to 10% by weight of the composition. These amounts of water are exclusive of water which are incorporated in the composition from aqueous solutions of other ingredients e.g. sorbitol.

The opaque or gel type of toothpaste may also include an anti-caries agent, binders, thickeners, flavours, stabilizing agents, polymers, vitamins, buffers and anti-calculus agents. Thus, according to a preferred aspect of the invention there is provided a toothpaste composition having (a) 0.01 to 10 wt% of an antimicrobial agent selected from an essential oil active including thymol, terpineol, eugenol, geraniol; triclosan or a mixture thereof; (b) 0.1 to 5 wt% of polyphenol wherein the polyphenol comprises at least 50% of catechins; (c) 2 to 70 wt% of an abrasive selected from calcium carbonate or silica; and (d) 8 to 40 wt% water.

Toothpowder Toothpowder usually have very high percentage of abrasives, typically 90 to 99.9 wt%, preferably 90 to 95 wt%. Chalk (FGNC) is the most preferred abrasive but PCC may also be used.

The desired amount of foam is provided by including an anionic surfactant e.g. Sodium Lauryl Sulphate in the toothpowder composition. Preferably the

composition includes 2 to 3 wt% of surfactant. Other ingredients like silica or sodium monofluorophosphate may be included at up to 1 wt% in the composition.

Sweeteners such as xylitol, sorbitol, glycerol or sachharin may be included.

Flavours such as spearmint or peppermint may be included at up to 1 wt% of the toothpowder composition.

According to yet another aspect of the present invention there is provided a toothpowder composition having (a) 0.01 to 10 wt% of an antimicrobial agent selected from an essential oil active including thymol, terpineol, eugenol, geraniol; triclosan or a mixture thereof; (b) 0.1 to 5 wt% of polyphenol wherein the

polyphenol includes at least 50% of catechins; and (c) 90 to 99.5 wt% of an abrasive selected from calcium carbonate or silica.

Thus, in the disclosed composition the orally acceptable base is preferably selected from water, silica or calcium carbonate. pH buffer The oral care composition preferably also includes a pH buffer. By "pH buffer" it is meant herein a system composed of a compound or a combination of compounds, whose pH changes only slightly when a strong acid or base is added. Thus, the presence of a pH buffer in the composition allows its pH to be maintained for a longer period of time during the shelf-life of the compositions, as compared to the same compositions without the pH buffer. Preferably the pH of the oral care compositions is 4 to 7. The preferred pH buffer is selected from citric acid, sodium citrate or a mixture thereof. Preferably the composition includes 0.001 to 15 wt% of a pH buffer, more preferably from 0.01 to 10 wt %, still more preferably from 0.01 to 5% and most preferably from 0. 1 to 3%. An aspect of the present invention provides for a method of disinfecting the oral cavity including the steps of (a) applying a composition of the first aspect of the invention onto the oral cavity; and, (b) cleaning the cavity to be substantially free of the composition. By cleaning is meant that the composition is substantially removed from the oral cavity. The composition, when in liquid form (e.g. a mouthwash) is simply spat out. When the composition is in powder, paste or gel form the composition may be rinsed off from the oral cavity using suitable amount of water. When the composition is a toothpaste, it is generally brushed on to the teeth or gums in the oral cavity before the step of rinsing. Rinsing is usually done by taking water and washing or gargling the mouth with this water. Yet another aspect of the present invention provides for use of the disclosed composition for disinfecting the oral cavity.

The invention preferably provides for non-therapeutic benefits.

EXAMPLES

Efficacy of various mouthwash compositions against S. mutans biofilm Streptococcus mutans (S. mutans) is a Gram-positive, facultatively anaerobic bacterium commonly found in the human oral cavity. S. mutans is the leading cause of dental caries (tooth decay) worldwide and is considered to be the most cariogenic of all of the oral streptococci. S. mutans sticks to the surface of teeth and subsists on a diverse group of carbohydrates. While metabolising sugar and other energy sources, the microbe produces acid that causes cavities in teeth. Mouthwash connpositions were prepared as follows. A buffer solution of citric acid and sodium citrate was prepared at a ratio of 1 :6. To this buffer solution Sodium Lauryl Sulfate (SLS) was added to get a 0.34 wt% buffered SLS solution. A mixture of essential oil actives was prepared by mixing Thymol, Terpineol and Eugenol in the ratio of 0.5:1 :0.1 .

Comparative compositions were prepared by adding either essential oil active (Thymol, Terpineol, Eugenol, Menthol, Geraniol) or Sunphenon 80SK (a purified polyphenol extract of green tea extract having 60% catechins) to the buffered SLS solution described above. The formulations of the comparative compositions are shown in Table 1 .

Compositions according to the invention were prepared by mixing 0.05 wt % of the essential oil actives mixture having thymol, terpineol and eugenol as described above to the buffered SLS surfactant solution. To this mixture, 1 .5 wt % of Sunphenon 80SK was added and water was added to make up the final composition. In one preferred composition, 0.5 wt% of Triclosan and 1 .5 wt % of Sunphenon 80SK was added to the buffered SLA surfactant solution and the final composition was made up with water. The formulations of the preferred

compositions are given in Table 2.

The mouthwash compositions were tested for their efficacy as an antibacterial composition against biofilm forming bacterium S. mutans. S.mutans ATCC 25175 was sub cultured in BHI broth (Brain Heart Infusion Broth- Difco- 37 grams per liter) and allowed to grow in a CO2 incubator (5% CO2) at 37°C for 16 hours. The cell density of the culture in BHI broth having 2% sucrose was adjusted to

10⁸cfu/ml (optical density ~ 0.3 at 620nm). In a first set of examples the culture of S.mutans was grown on a 6 welled plate at 37°C in a CO2 incubator (5% CO2) for a incubation period of 24 hours to form a biofilm. In a second set of examples the culture was grown for an incubation period of 72 hours to form a thick biofilm. The media was replaced after every 24hr period. After the incubation period of 24 / 72 hours the BHI broth media was removed and the biofilm that had developed on the plates were washed with 1 X PBS. 2 ml of each of the mouthwash compositions was contacted with the biofilm for a period of 1 minute. The mouthwash was then removed and 2ml of a neutralizer was added to the biofilm. The treated biofilm cells were then scraped with a cell scraper, mixed and serially diluted with D/E neutralizer (Difco - 39 g/L). 1 ml of this was plated on BHI agar and incubated in CO2 incubator for 48 hours. The colonies formed were counted after 48 hours incubation. The reduction in the number of colonies after applying the comparative compositions is given in Table 1 and after applying the preferred compositions is given in Table 2, calculated as Iog10 (no. of colonies in control) - Iog10 (no. of colonies after treatment).

Table 1 -Comparative examples

Ingredient (wt%) Comp*-a Comp*-b Comp*-c Comp*-d Comp*-e Comp*-f Comp*-g

Terpineol - 0.015 - - - - -

Thymol - 0.03 0.05 - - - -

Eugenol - 0.003 - 0.05 - - -

Menthol - - - - 0.5 - -

Geraniol - - - - - 0.5 -

Triclosan - - - - - - 0.5

SLS 0.34 0.34 0.34 0.34 0.34 0.34 0.34

Citric acid 0.2 0.2 0.2 0.2 0.2 0.2 0.2

Sodium citrate 1.2 1.2 1.2 1.2 1.2 1.2 1.2

Sunphenon 80SK 1.5 - - - - - -

Water to 100 to 100 to 100 to 100 to 100 to 100 to 100

Log reduction in 0.0 3.6 - - - - - 24hrs old biofilm

Log reduction in 0.1 0.9 0.7 0.4 0.7 0.5 0.8 72hrs old biofilm Table 2-Examples according to the invention

Tables 1 and 2 show that there is an improvement in reduction of microbial count in a biofilm when the essential oil active is in combination with polyphenol having at least 50% catechins, while the separate components by themselves show substantially less bacterial reduction in the biofilm.

Efficacy of various mouth wash formulations in reducing inflammation

Mouthwash compositions were prepared as follows. A buffer solution of citric acid-sodium citrate was prepared at a ratio of 1 :6. To the buffer solution Sodium Lauryl Sulfate (SLS) was added to make a 0.34 wt% SLS solution (Control). A mixture of essential oil actives Thymol, Terpineol and Eugenol in the ratio of 0.5:1 :0.1 was prepared. Comparative composition (Comp h) was obtained by adding the mixture of essential oil active to the buffer solution having sodium lauryl sulphate (0.34 wt% SLS solution).

Preferred composition (Example 7) was prepared by adding into the buffer solution having sodium lauryl sulphate (0.34 wt% SLS solution ) the mixture of essential oil active and green tea extract and finally making up the volume by addition of water. The various mouth wash compositions are given in Table 3.

An in-vitro assay was conducted for the anti- inflammation study. Blood samples were collected from 3 healthy volunteers by vein puncture into heparin containing vacutainers. Each fresh blood sample was diluted by adding 1 ml of the blood sample into 7.5ml of Rosewell Park Memorial Institute (RPMI) medium. 0.5ml of the diluted blood samples were distributed in 24 well plates. The blood samples were stimulated with 0.5ml of the comparative composition and the preferred composition (2x) with or without the inflammatory stimulant E.coli LPS (2X) to finally obtain 1 x concentration of comparative or the preferred composition. After the stimulation the samples were incubated in an incubator for 24hrs at 37°C and 5% CO2. After the incubation period, the culture plate was centrifuged at 3000rpm for 10 minutes; the supernatant was collected in aliquots and stored at -70°C till further analysis. The content of cytokines namely TNF a and IL-6 were quantified with diluted samples of culture supernatant. Cytokines are produced as an inflammatory reaction with E.coli LPS. A lower content of cytokines namely TNF a or IL-6 indicates better efficacy of the mouth wash compositions in providing antiinflammatory benefits. Table 3

Table 3 shows that the composition of the invention (Example 7) provides better anti-inflammatory benefits than the comparative composition (Comp^* h).

Claims

Claims:

1 . An oral care composition comprising:

(ii) 0.1 to 5 wt% polyphenol; and,

(iii) an orally acceptable base;

wherein the polyphenol comprises at least 50% of catechins.

2. A composition as claimed in claim 1 wherein the catechins comprise at least 25 % epigallocatechin gallate.

3. A composition as claimed in claim 1 or claim 2 wherein the essential oil active comprises thymol or terpineol or eugenol or mixtures thereof.

4. A composition as claimed in any one of the preceding claims comprising 0.05 to 15 wt% surfactant.

5. A composition as claimed in claim 4 wherein the surfactant is cationic.

6. A composition as claimed in claim 5 wherein the cationic surfactant is benzalkonium chloride or cetyl trimethyl ammonium bromide.

7. A composition as claimed in any one of the preceding claims comprising of a pH buffer selected from citric acid or sodium citrate or a mixture thereof.

8. A composition as claimed in any one of the preceding claims having a pH of 4 to 7.

9. A composition as claimed in any one of the preceding claims wherein the orally acceptable base comprises water, silica or calcium carbonate.

10. A composition according to claim 9 which is an antimicrobial mouthwash comprising 80 to 99.5 wt% water.

1 1 . A composition according to claim 9 which is a toothpaste comprising 2 to 70 wt% of an abrasive selected from calcium carbonate or silica; and 8 to 40 wt% water.

12. A composition according to claim 9 which is a toothpowder comprising 90 to 99.5 wt% of an abrasive selected from calcium carbonate or silica.

13. A method of disinfecting the oral cavity comprising the steps of:

(i) applying a composition as claimed in any one of the preceding claims onto the oral cavity; and,

(ii) cleaning the cavity to be substantially free of the composition.

14. A method as claimed in claim 13 wherein the composition is brushed on to the teeth or gums in the oral cavity before the step of rinsing.

15. Use of a composition as claimed in any one of the preceding claims for disinfecting oral cavity.