FIELD OF THE INVENTION
The present invention relates to an oral care composition. More particularly, the present invention relates to a whitening oral care composition with enhanced whitening efficacy and stability.
BACKGROUND OF THE INVENTION
Tooth brushing with a dentifrice composition is the most common oral hygiene practice in the general population. Individuals brush teeth for multiple reasons, such as avoiding bad breath, refreshing themselves, preventing dental diseases and having an attractive smile.
Presently, there is increased interest, awareness and preference amongst individuals towards whiter teeth with the perception that it contributes to great smile and enhanced physical attractiveness. Whiter shades of teeth have been shown to positively correlate with enhanced social acceptance and overall health of an individual. The aesthetic and social benefit associated with whiter teeth has led to the ever increasing demand for tooth whitening toothpastes. Whitening toothpastes generally comprise chemical or mechanical means to remove the stubborn stains caused by tea, coffee, red wine, and chewing and smoking tobacco. Among the most important ingredients incorporated into these whitening toothpastes are abrasive agents, such as silica; anti-tartar agents, such as pyrophosphates; and adsorbing agents, such as charcoal.
The abrasive agents remove the stains and smoothen the tooth surface. As a result, when light interacts with the teeth surface it gives the perception that the tooth is whiter and polished. Generally, a combination of abrasive materials is preferred in the whitening toothpaste composition. Silicas mechanically clean the teeth as well as thicken the dentifrices. Hydrated silica is inert and is compatible with Sodium fluoride (NaF) and sodium monofluorophosphate (MFP). Silicas are currently the most frequently used abrasives in toothpastes. They are regarded as more expensive compared with other abrasive materials.
Recent studies seem to suggest that activated charcoal powder can be used as a “natural” tooth-whitening agent, achieved by brushing with the powder. Activated charcoal is created by the partial oxidation of various organic materials, then treated to increase its surface area for use as a general-purpose antidote. It contains a highly convoluted surface that can bind materials or gas, and carry it safely through the digestive system with a highly absorptive surface. Activated charcoal is administered in emergency medical situations, such as a drug overdose or poisoning. Its absorbing ability may produce ion exchange in the mouth via its nano-sized pores that may bind and remove tooth-staining agents.
Tetrasodium pyrophosphate, also called sodium pyrophosphate, tetrasodium phosphate or TSPP, is a colourless transparent crystalline chemical compound with the formula Na4P2O7. It is extensively used as an anti-tartar agent in toothpaste. Tetrapotassium pyrophosphate, K4P2O7, is another anti-tartar agent finding increasing use in dentifrice compositions. Citrates, pyrophosphates, polyphosphates, Ethylenediamine tetraaceticacid (EDTA) act on the enamel surface by chelating with calcium and desorb the stain molecules from the pellicle. Polyphosphates have surface binding properties and they work by blocking the stain molecular receptors and desorption of stain molecules from pellicle and enamel surfaces.
PCT publication WO 1995006455 A1 discloses a toothpaste consisting essentially of about 10-65% sodium bicarbonate; an alkali metal pyrophosphate salt in an amount effective as an anti-tartar agent, of which amount at least 50% is dissolved in the toothpaste; and an aqueous solution of sorbitol, as a main liquid vehicle, in an amount which is sufficient to dissolve at least about 50% of the amount of the alkali metal pyrophosphate salt added and to provide the desired consistency to the toothpaste.
Korean patent No. KR 100494627 B1 discloses a dentifrice composition for tooth whitening comprising 0.1-4.0 wt% of water soluble pyrophosphate, and 0.1-5.0 wt% of ultra metaphosphate as a tooth whitening agent. It further contains polishing agent, humectant, agonist, binding agent, foaming agent, perfumery, colorings, preservative, acidity controller and the like.
PCT Publication WO 2015195138 A1 discloses a dentifrice composition comprising 3.00% sodium tripolyphosphate, 2.44% tetra potassium pyrophosphate and 22.0% high cleaning silica. Numerous toothpastes are also available commercially which comprise phosphates, pyrophosphates, silicas and charcoal powder in varying proportions.
Abrasive agents are meant to clean and polish teeth by enabling the removal of soft deposits and stains adequately thereby achieving a smooth and glistening surface. However, a high concentration of the abrasive agent results in abrasion of the teeth. Further, the use of whitening toothpastes is usually associated with some adverse effects such as enamel and dentin abrasion. This may result in tooth sensitivity which increases proportionately with the concentration of abrasives present. Whitening toothpastes are also not recommended for patients with erosion, abrasion or recession and for patients with a history of gastroesophageal reflux. The use of whitening toothpaste should also be avoided after consuming acidic beverages. Regarding pyrophosphates, a major health concern to be aware of, includes its relatively low lethal human dose. Studies have also found that nausea, vomiting, and diarrhoea are not just possible after consumption but likely. Furthermore, exposure can also cause skin rashes and visual disturbances.
In view of the aforestated issues, there exists a need in the art for an oral care composition comprising low concentrations of pyrophosphates and providing optimum teeth whitening performance, without associated adverse effects.
Hence, the primary object of the present invention is to provide a whitening oral care composition with enhanced stain removal efficacy which helps in restoring the natural colour of tooth enamel.
Another object of the present invention is to provide a teeth whitening composition containing charcoal, in the presence of which, the amount of pyrophosphates required in silica based oral care compositions, is minimized.
Yet another object of the present invention is to provide a whitening oral care composition that is stable during long term storage and remains effective to clean and whiten the teeth.
SUMMARY OF THE INVENTION
The present invention provides an oral care composition that possesses improved teeth whitening efficacy and is stable on long term storage.
In accordance with an aspect of the invention, there is provided a teeth whitening composition, comprising:
a) Abrasives in an amount in the range from 0 to 50.0% w/w;
b) Tetrasodium pyrophosphate in an amount in the range from 0 to 3.0% w/w;
c) Tetrapotassium pyrophosphate in an amount in the range from 0 to 1.5% w/w; and
d) Charcoal powder in an amount in the range from 0 to 5.0% w/w.
In accordance with another aspect of the invention, there is provided a whitening oral care composition, comprising:
a) The teeth whitening composition as claimed in claim 1; and
b) Ingredients selected from the group consisting of humectants, binders, thickeners, surfactants, sweetening agents, herbal extracts, anti-calculus agents, flavours, colorant, water, preservatives, sodium silicate, titanium dioxide, magnesium stearate, ethyl alcohol, magnesium aluminometasilicate (MAS), sodium bicarbonate, mica, isomalt, gum base and combinations thereof.
The whitening oral care composition may be in the form of a tablet, toothpaste, toothpowder, chewing gum, dentifrice, mouthwash, mouth spray or an oral rinse.
In accordance with an embodiment of the invention, the abrasive is selected from the group consisting of precipitated silica, abrasive silica, hydrated silica, silica gel, mica, natural chalk (FGNC), precipitated calcium carbonate (PCC), dicalcium phosphate dihydrate (DCPD) and combinations thereof and is present in an amount in the range from 0 to 50.0% w/w.
In accordance with an embodiment of the invention, the herbal extract is one of black pepper (Piper nigrum L.), long pepper (Piper longum L.), ginger (Zingiber officinale L.), prickly ash/tomar (Zanthoxylum armatum L.) or combinations thereof and present in an amount in the range from 0.1 to 5% w/w, more preferably in an amount of 0.25 to 2.5% w/w.
In accordance with another embodiment of the invention, the sweetening agent is selected from the group consisting of saccharin, dextrose, levulose, aspartame, sucralose, sodium saccharin, D-tryptophan, dihydrochalcones, acesulfame, sodium cyclamate, stevia and combinations thereof and is present in an amount in the range from 0.15 to 0.75% w/w.
In accordance with another embodiment of the invention, the anti-calculus agent is selected from the group consisting of tripolyphosphate, hexametaphosphate, trisodium phosphate, disodium phosphate and combinations thereof and is present in an amount in the range from 0.02 to 0.10% w/w.
In accordance with another embodiment of the invention, the flavour is selected from the group consisting of vanillin, sage, marjoram, parsley oil, spearmint oil, cinnamon oil, oil of wintergreen (methylsalicylate), peppermint oil, clove oil, baby oil, anise oil, eucalyptus oil, citrus oil, fruit oils, fruit essences, bean and nut-derived flavours, adsorbed and encapsulated flavours and combinations thereof and is present in an amount in the range from 0.2 to 4.0% w/w.
In accordance with another embodiment of the invention the surfactant is selected from the group consisting of sodium lauryl sulfate, sodium hydrogenated coconut oil, fatty acid monoglyceride monosulfate, sodium N-lauroyl sarcosine and its salts, polysorbate 20, sodium cocoate, cocamidopropyl betaine (CAPB), decyl glucoside and combinations thereof and is present in an amount in the range from 0.30 to 10.0% w/w.
In accordance with another embodiment of the invention, the thickening agent is present in an amount in the range from 0.0 to 10.0% w/w.
In accordance with another embodiment of the invention, the humectant is selected from the group consisting of glycerin, sorbitol, xylitol, propylene glycol, polyethylene glycol (PEG), PEG-40 hydrogenated castor oil and combinations thereof and is present in an amount in the range from 2.0 to 42.0% w/w.
In accordance with another embodiment of the invention, the binder is selected from the group consisting of xanthan gum, carrageenan, sodium carboxymethylcellulose, hydroxypropylmethylcellulose (HPMC), hydroxyethylcellulose (HEC), acrylate polymers and combinations thereof and is present in an amount in the range from 0.2 to 1.2% w/w, preferably 0.80% w/w.
In accordance with yet another embodiment of the invention, the preservative is selected from the group consisting of methyl paraben, propyl paraben, sodium benzoate, benzyl alcohol, phenoxy ethanol and combinations thereof, and present in an amount in the range of 0.1 to 1% w/w, preferably 0.25% w/w.
In accordance with still another embodiment of the invention, sodium silicate is present in an amount in the range of 0.1 to 1% w/w, preferably 0.60% w/w; titanium dioxide is present in an amount in the range from 0.40 to 0.50% w/w; magnesium stearate is present in an amount in the range from 0.25 to 1.5% w/w; magnesium aluminometasilicate (MAS) is present in an amount of about 4.0% w/w; sodium bicarbonate is present in an amount of about 45.0% w/w; ethyl alcohol is present in an amount in the range from 0.0 to 5.0% w/w; and colorant is present in an amount in the range from 0 to 0.1% w/w, preferably 0.0125 % w/w.
In accordance with yet another aspect, the whitening oral care composition comprises the teeth whitening composition, thickeners, sweetening agents, humectants, surfactants, binders, herbal extracts, anti-calculus agents, preservatives, flavours, sodium silicate, titanium dioxide and water, wherein the whitening oral care composition is a toothpaste.
In accordance with still another aspect, the whitening oral care composition comprises the teeth whitening composition, thickeners, abrasives, sweetening agents, surfactants, herbal extracts, anti-calculus agents, flavours, magnesium aluminosilicate (MAS), magnesium stearate and isomalt, wherein the whitening oral care composition is a tablet.
In accordance with yet another aspect, the whitening oral care composition comprises the teeth whitening composition, thickeners, abrasives, sweetening agents, surfactants, herbal extracts, anti-calculus agents, flavours, magnesium stearate, sodium bicarbonate and water, wherein the whitening oral care composition is a tooth powder.
In accordance with another aspect, the whitening oral care composition comprises the teeth whitening composition, sweetening agents, humectants, herbal extracts, anti-calculus agents, flavours, magnesium stearate, and gum base, wherein the whitening oral care composition is a chewing gum.
In accordance with still another aspect, the whitening oral care composition comprises the teeth whitening composition, sweetening agents, humectants, surfactants, herbal extracts, anti-calculus agents, flavours, ethyl alcohol and water, wherein the whitening oral care composition is a mouthwash.
DETAILED DESCRIPTION OF THE INVENTION
Discussed below are some representative embodiments of the present invention. The invention in its broader aspects is not limited to the specific details and representative methods. The illustrative examples are described in this section in connection with the embodiments and methods provided. The invention according to its various aspects is particularly pointed out and distinctly claimed in the attached claims read in view of this specification.
It is to be noted that, as used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a composition containing “a compound” includes a mixture of two or more compounds. It should also be noted that the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
The expression of various quantities in terms of “%” or “% w/w” means the percentage by weight of the total solution or composition unless otherwise specified.
The present invention, in its product and process aspects, is described in detail as follows:
The terms "teeth" and "tooth," as used herein, refer to the teeth of warm-blooded animals, including a human.
Teeth whitening composition combats the discoloration of teeth by removing calculus or plaque or stains adherent to tooth surfaces in the oral cavity of individual or subject, hence giving whiter teeth that signifies a practice of good oral hygiene. Products and substances that are presently available to whiten teeth may include a variety of different ingredients, but the primary active ingredients are abrasive agents such as silica, anti-tartar agents such as pyrophosphates and adsorbing agents such as charcoal.
In a first aspect, the present invention relates to a teeth whitening composition, comprising:
a) Abrasives in an amount in the range from 0 to 50.0% w/w ;
b) Tetrasodium pyrophosphate in an amount in the range from 0 to 3.0% w/w;
c) Tetrapotassium pyrophosphate in an amount in the range from 0 to
1.5% w/w; and
d) Charcoal powder in an amount in the range from 0 to 5.0% w/w.

An abrasive is one of the most important ingredients in a teeth whitening composition, as it cleans and polishes teeth by removing solid insoluble particles, debris and residual stains. Examples of abrasives that can be used in the present invention include, but not limited to, precipitated silica, abrasive silica, hydrated silica, silica gel, mica, fine ground natural chalk (FGNC), precipitated calcium carbonate (PCC), dicalcium phosphate dihydrate (DCPD) and combinations thereof. The abrasives are present in an amount in the range from 0 to 50.0% w/w. Preferably, silica abrasives are used in the preparation of whitening oral care composition of the present invention.
Furthermore, sodium and potassium salts of pyrophosphoric acid are the most widely used tartar control agents in oral care composition. Pyrophosphate ions (P2O7-4) act by desorption of stain molecules from pellicle and enamel surface thus helps the tooth in regaining its original colour. The teeth whitening composition of the present invention comprises tetrasodium pyrophosphate and tetrapotassium pyrophosphate as anti-tartar agents. Preferably, tetrasodium pyrophosphate is present in an amount in the range from 0 to 3.0 % w/w, whereas tetrapotassium pyrophosphate is present in an amount in the range from 0 to 1.5 % w/w.
Another important constituent of the present teeth whitening composition is charcoal powder, present in an amount in the range from about 0 to 5.0% w/w. The expression "charcoal powder", as used herein, also refers to finely-divided charcoal or powdered carbon, or activated charcoal, all of which are hereinafter referred to by the term "charcoal powder". Charcoal powder that can be used in the present invention may be of vegetable or animal origin. Preferably, the charcoal powder is bamboo shell charcoal powder or coconut shell charcoal powder. The size of the charcoal particles useful for the present invention ranges from 3 to 90 µ, preferably from 25 to 90 µ and the most preferable size is 30 µ. Charcoal powder possess a high absorptive capacity and is capable of binding the surface staining molecules present on pellicle and enamel surface of teeth thus plays a significant role in teeth whitening.
Teeth whitening composition forms an essential part of whitening oral care composition of the present invention. As used herein, an "oral care composition" refers to a composition for which the intended use can include oral care, oral hygiene, or improvement of oral appearance, or for which the intended method of use can comprise administration to the oral cavity.
In accordance with another aspect of the invention, there is provided a whitening oral care composition, comprising:
(a) The teeth whitening composition; and
(b) Ingredients selected from the group consisting of humectants, binders, thickeners, surfactants, sweetening agents, herbal extracts, anti-calculus agents, flavours, colorant, water, preservatives, sodium silicate, titanium dioxide, magnesium stearate, ethyl alcohol, magnesium aluminometasilicate (MAS), sodium bicarbonate, isomalt, gum base and combinations thereof.
The oral care composition is in a form selected from the group consisting of toothpaste, tooth powder, tablet, chewing gum, mouthwash, mouth spray and oral rinse.
In one embodiment of the present invention, the whitening oral care composition comprises the teeth whitening composition and ingredients namely thickeners, sweetening agents, humectants, surfactants, binders, herbal extracts, anti-calculus agents, preservatives, flavours, sodium silicate, titanium dioxide and water, wherein the whitening oral care composition is a toothpaste.
In another embodiment of the present invention, the whitening oral care composition comprises the teeth whitening composition and ingredients namely thickeners, abrasives, sweetening agents, surfactants, herbal extracts, anti-calculus agents, flavours, magnesium aluminosilicate (MAS), magnesium stearate and isomalt, wherein the whitening oral care composition is a tablet.
In yet another embodiment of the present invention, the whitening oral care composition comprises the teeth whitening composition and ingredients namely thickeners, abrasives, sweetening agents, surfactants, herbal extracts, anti-calculus agents, flavours, magnesium stearate, sodium bicarbonate and water, wherein the whitening oral care composition is a tooth powder.
In another embodiment of the present invention, the whitening oral care composition comprises the teeth whitening composition and ingredients namely sweetening agents, humectants, herbal extracts, anti-calculus agents, flavours, magnesium stearate, and gum base, wherein the whitening oral care composition is a chewing gum.
In another embodiment of the present invention, the whitening oral care composition comprises the teeth whitening composition and ingredients namely sweetening agents, humectants, surfactants, herbal extracts, anti-calculus agents, flavours, ethyl alcohol and water, wherein the whitening oral care composition is a mouthwash.
In another embodiment of the present invention, the whitening oral care composition comprises the teeth whitening composition and ingredients namely sweetening agents, humectants, surfactants, herbal extracts, anti-calculus agents, flavours, ethyl alcohol and water, wherein the whitening oral care composition is a oral rinse.
In another embodiment of the present invention, the whitening oral care composition comprises the teeth whitening composition and ingredients namely sweetening agents, humectants, surfactants, herbal extracts, anti-calculus agents, flavours, ethyl alcohol and water, wherein the whitening oral care composition is a mouth spray.
The above stated functional ingredients included in the whitening oral care composition not only stabilize and improve the appearance of the composition but also impart medicinal properties for dealing with the numerous maladies of the oral cavity.
One of the most important ingredients of the present teeth whitening oral care composition is an orally acceptable thickening agent, preferably thickening silica, present in an amount in the range from 0 to 10% w/w. Further, the present teeth whitening oral care composition consists of an additional anti-calculus agent along with pyrophosphate wherein the anti-calculus agent is present in an amount in the range from 0.02 to 0.10% w/w. Anti-calculus agent possesses strong enamel restoring qualities and is selected from the group consisting of tripolyphosphate, hexametaphosphate, trisodium phosphate, disodium phosphate and combination thereof. Preferably, the secondary anti-calculus agent is trisodium phosphate.
In order to make the whitening oral care composition attractive and appealing to consumers, flavours and sweeteners are added to it. Flavours added to the oral care composition of the present invention include, but not limited to, vanillin, sage, marjoram, parsley oil, spearmint oil, cinnamon oil, oil of wintergreen (methylsalicylate), peppermint oil, clove oil, baby oil, anise oil, eucalyptus oil, citrus oil, fruit oils, fruit essences, bean and nut-derived flavours, adsorbed and encapsulated flavourants and combination thereof. Preferably, the flavour is present in an amount in the range from 0.2 to 4.0% w/w.
Further, sweetening agents added to the composition of the present invention include, but not limited to, saccharin, dextrose, levulose, aspartame, sucralose, sodium saccharin, D-tryptophan, dihydrochalcones, acesulfame, sodium cyclamate, stevia and combination thereof. In a preferred embodiment, the sweetening agents are saccharin and sucralose, present in an amount in the range from 0.15 to 0.75% w/w.
A number of herbal extracts can be used in the present invention as they mimic the function of artificial chemical agents used in traditional toothpastes to fight plaque, freshen breath and prevent gum disease. Preferably, the herbal extracts are present in an amount in the range from 0.1 to 5% w/w, and more preferably 0.25 to 2.5% w/w. Examples of herbs that can be used in the present invention, include but not limited to the following:
• achyranthes, Achyranthes aspera
• aloe, Aloe spp., including A. barbadensis, A. ferox and A. vera
• banyan, Ficus bengalensis
• bakula, Mimusops elengi
• basil, Ocimum basilicum and O. minimum
• betel, Piper betle
• black pepper, Piper nigrum
• camphor, Cinnamomum camphora
• catechu, Acacia catechu
• chamomile, Matricaria chamomilla
• chebula, Terminalia chebula
• Chinese skullcap, Scutellaria baicalensis
• cinnamon, Cinnamomum lourerii and C. zeylandicum & C. sinensis
• clove, Syzygium aromaticum
• dill, Anethum spp., including A. graveolens and A. sowa
• eucalyptus, Eucalyptus globulus
• fennel, Foeniculum vulgare
• gardenia, Gardenia jasminoides
• ginger, Zingiber officinale
• grape, Vitis vinifera
• juniper, Juniperus communis
• lemongrass, Cymbopogon spp., including C. citratus and C.flexuosus
• licorice, Glycyrrhiza spp., including G. glabra and G. uralensis
• long pepper (pipli), Piper longum
• madhuca, Madhuca longifolia
• marigold, Calendula officinalis
• neem (margosa), Azadirachta indica
• neroli (bitter orange blossom), Citrus aurantium
• nutmeg (mace), Myristica fragrans
• parsley, Petroselinum sativum
• peelu, Salvadora persica
• peppermint, Mentha piperita
• pine, Pinus spp., including P. palustris and P. sylvestris
• pomegranate, Punica granatum
• prickly acacia (babul), Acacia nilotica
• rosemary, Rosmarinus officinalis
• saffron, Crocus sativus
• sandalwood, Santalum spp., including S. album and S. spicatum
• spearmint, Mentha spicata
• spilanthes (akarkara), Spilanthes calvi
• tea (including green tea and oolong tea), Camellia sinensis
• thyme, Thymus spp., including T. serpyllum and T vulgaris
• tomar (prickly ash), Zanthoxylum armatum
• tulsi (holy basil), Ocimum sanctum
• turmeric, Curcuma longa
• vajradanti, Potentilla fulgens
• walnut, Juglans regia
In a preferred embodiment, the herbal extract is of black pepper (Piper nigrum L.), long pepper (Piper longum L.), ginger (Zingiber officinale L.), prickly ash or tomar (Zanthoxylum armatum L.) and combinations thereof.
Normally, upon exposure to environment, the oral care composition hardens due to evaporation of water. Hence, in order to prevent the loss of water and hardening upon exposure to air, the whitening oral care composition of the present invention optionally contains humectants selected from the group consisting of glycerin, sorbitol, xylitol, propylene glycol, polyethylene glycol (PEG), PEG-40 Hydrogenated castor oil and combinations thereof and it is present in an amount in the range from 2.0 to 42.0% w/w.
One of the important constituent of present oral care composition is a surfactant. The term “surfactant” used herein refers to an organic compound that is amphiphilic, meaning it contains both hydrophobic group (their tail) and hydrophilic group (their head). Therefore, a surfactant contains both a water-insoluble (or oil-soluble) component and a water-soluble component. The purpose of a surfactant is to loosen and break down substances on the teeth that would otherwise not be soluble, meaning they could not be dissolved and rinsed away with water. Examples of surfactants that can optionally be used in the present invention include, but not limited to, sodium lauryl sulfate, sodium hydrogenated coconut oil, fatty acid monoglyceride monosulfate, sodium N-lauroyl sarcosine or its salt, polysorbate 20, sodium cocoate, cocamidopropyl betaine (CAPB), decyl glucoside and combinations thereof and is present in an amount in the range from 0.30 to 10.0% w/w. Preferably, the surfactant is sodium lauryl sulphate.
The whitening oral care composition in the form of toothpaste contains binder to provide desirable consistency or viscosity to the composition. The binder also enables the solid phase to be adequately suspended in the liquid phase, to prevent phase separation. Non-limiting examples of binders that can be used in the present invention include xanthan gum, carrageenan, sodium carboxy-methylcellulose, hydroxy-propylmethylcellulose (HPMC), hydroxy-ethylcellulose (HEC), Acrylate polymers and combinations thereof, present in an amount of 0.2 to 1.2% w/w, and preferably 0.80% w/w. Preferably, the binder is xanthan gum.
Another important constituent of oral care composition in the form of toothpaste comprises preservative, present in an amount of 0.1 to 1% w/w, and preferably 0.25% w/w. The preservative used increases the shelf life of oral care composition by preventing the growth of micro-organisms such as bacteria, viruses and fungi. Non-limiting examples of the anti-microbial preservatives that can be used in the present invention include methyl paraben, propyl paraben, sodium benzoate, benzyl alcohol, phenoxy ethanol and combination thereof. Preferably, the preservative is sodium benzoate.
Further, the oral care composition in the form of toothpaste comprises ingredients titanium dioxide, sodium silicate and optionally a colouring agent. Titanium dioxide, a white powder which adds opacity to the compositions, may also be added to the present composition. Preferably, titanium dioxide is present in an amount in the range from 0.40 to 0.50% w/w.
Further, colouring agents or colorants may also be added to the present composition. The toothpastes according to the invention may contain dyes and/or pigments/lakes. Non limiting examples of colouring agents, colorants, dyes, pigments or lakes that can be used in the present invention, include but not limited to FD&C Blue 1, FD&C Yellow 5, FD&C Red 40, FD&C Yellow 6, FD&C Blue 2, FD&C Red 4, FD&C Green 6, FD&C Yellow 5 lake, FD&C Blue 1 lake, FD&C Red 40 lake, FD&C Yellow 6 lake, black iron oxide, red iron oxide, and brown iron oxide, each of which can be used individually or in combination. Preferably, the colorant is present in an amount of 0 to 0.1% w/w, and more preferably in an amount of 0.0125% w/w.
Still further, the composition of the present invention may also contains sodium silicate, which controls the pH of the finished product and prevents the corrosion (rusting) of metallic materials used in packaging of oral care composition. Preferably, the teeth whitening oral care composition of the present invention contains sodium silicate in an amount of 0.1 to 1% w/w and more preferably in an amount of 0.60% w/w.
The oral care composition in the form of tablet typically contains Magnesium stearate and magnesium aluminosilicate (MAS). Magnesium stearate is a lubricant, present in an amount in the range from 0.25 to 1.5% w/w. Further, magnesium aluminosilicate (MAS) may be added for improvement of the quality of tablets, powder, granules and capsules and is present in an amount of about 4.0% w/w.
Sodium bicarbonate is bactericidal against most periodontal pathogens, and is an ingredient of present composition in the form of toothpowder, present in an amount in the range from 0.0 to 45.0% w/w.
Further, the teeth whitening composition in the form of mouthwash/ mouth rinse/ mouth spray comprises of an additional solvent, preferably ethyl alcohol and is present in an amount in the range from 0.0 to 5.0% w/w.
The oral care composition is administered using an applicator or is administered using a finger or is chewable.
The present invention is more particularly described in the following non-limiting examples that are intended as illustrations only since numerous modifications and variations within the scope of the present invention will be apparent to a skilled artisan. Unless otherwise noted, all parts, percentages, and ratios reported in the following examples are on a weight basis, and all reagents used in the examples were obtained or made available from the chemical suppliers.
Examples 1 to 8
Stability Studies:
The teeth whitening oral care compositions in the form of toothpaste (Examples or test items 1 to 2 and 4 to 8), i.e., test items 1 to 8, were kept at low temperature (=10 °C) and high temperature (=40 °C) for three months for determining their stabilities.
Table 1: Stability status of toothpaste compositions in 3 months
Ingredients Formulations (% w/w)
Ex 1 Ex 2 Ex 4 Ex 5 Ex 6 Ex 7 Ex 8
Tetrasodium pyrophosphate (TSPP) 0.35 - - - 3.5 3.5 0.35
Tetrapotassium pyrophosphate (TPPP) 0.15 - - - 1.5 1.5 0.15
Abrasive silica 24 24 24 10 22 22 24
Thickening silica 1 1 1 10 1 1 1
Charcoal powder 0.25 0.25 - - 0.25 2.00 2.00
Xanthan Gum 0.80 0.80 0.80 0.80 0.80 0.80 0.80
Saccharin 0.25 0.25 0.25 0.25 0.25 0.25 0.25
Herbal Extract 0.25 0.25 0.25 0.25 0.25 0.25 0.25
Sorbitol solution
(70%w/v) 42.0 42.0 42.0 42.0 42.0 42.0 42.0
Trisodium Phosphate 0.20 0.20 0.20 0.20 0.20 0.20 0.20
Sodium Lauryl Sulphate 2.00 2.00 2.00 2.00 2.00 2.00 2.00
Sodium benzoate 0.25 0.25 0.25 0.25 0.25 0.25 0.25
Polyethylene Glycol 3 3 3 3 3 3 3
Mica 0.05 0.05 0.05 0.05 0.05 0.05 0.05
D&C Red#40 - - - 0.0125 - - -
Aroma 1.6 1.6 1.6 1.6 1.6 1.6 1.6
Titanium Dioxide - - 0.50 - - - -
Aqua Q.S. Q.S. Q.S. Q.S. Q.S. Q.S. Q.S.
Stability Stable Syneresis, oil separation at high temperature or crystallization at low temperature

As illustrated in table-1, only test item 1, 2, 4 & 5 were found stable and were further evaluated for teeth whitening efficacy. Test item 6, 7 and 8 showed tip syneresis and crystallization on long term storage at low temperature (=10°C). Further, it was observed that toothpaste compositions with higher concentration of pyrophosphates exhibits crystallization problem whereas toothpastes with increased amount of charcoal powder also results in tip syneresis.
Test item 3 is commercially available toothpaste consisting of the following ingredients: Water, sorbitol, hydrated silica, glycerine, pentasodium triphosphate, tetrasodium pyrophosphate, sodium lauryl sulphate, aroma, PEG-32, cellulose gum, sodium fluoride, cocomidopropyl betaine, sodium saccharin, charcoal powder, and limonene.
Teeth whitening efficacy studies
Dense Hydroxyapatite (HAP) disc (9.5 mm diameter x 2 mm thick; 95% purity; Clarkson Chromatography products, INC, USA) stained with a solution comprising tea and coffee, was used as a substrate to determine the teeth whitening efficacy of stable dentifrice compositions given in test item 1 to 5 of table 1. The whitening effect of HAP discs were measured using colour difference meter/Spectrophotometer after two weeks of application of above test item compositions. Based on the resultant mean total colour difference, ?E, which is a measure of the whitening efficacy of a composition, it was observed that test item 1 gives best results for stain removal/teeth whitening efficacy as shown below in table 2.
Table 2: Absolute mean difference in ?E value after 2 weeks usage
Treatment groups Details Day-14
Test item-1 Charcoal Toothpaste-Option 1 5.68
Test item-2 Charcoal Toothpaste-Option 2 3.52
Test item-3 Charcoal Toothpaste-Option 3 4.09
Test item-4 Whitening toothpaste-Option 4 4.34
Test item-5 Whitening toothpaste-Option 5 3.31

Examples 9-17
Table 3 lists the ingredients and their amounts present in the teeth whitening oral care composition of the present invention. The unit of each value is percent weight of the composition. Ingredients are combined and mixed by conventional means as known by one of ordinary skill in the art.
Table 3: Compositions of teeth whitening Toothpaste
Ingredients Ex
9 Ex 10 Ex 11 Ex 12 Ex 13 Ex 14 Ex 15 Ex 16 Ex 17
TSPP 3.0 0.35 - - - 0.35 - 0.35 0.35
TPPP 1.50 0.15 - - - 0.15 - 0.15 0.15
Calcium Carbonate 40.0 40.0 40.0 42.0 42.0 43.0 43.0 43.0 43.0
Thickening Silica 1.0 2.0 3.0 3.0 3.0 2.0 2.0 2.0 2.0
Charcoal Powder 2.0 2.0 2.0 2.0 2.0 2.0 1.80 0.50 0.25
Xanthan Gum 0.80 0.80 0.80 0.80 0.80 0.80 0.80 0.80 0.80
Saccharin 0.15 0.15 0.15 0.15 0.15 0.15 0.15 0.15 0.15
Herbal Extract 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50
Sorbitol Solution (70% w/v) 30.0 30.0 30.0 30.0 30.0 30.0 30.0 30.0 30.0
Sodium Silicate 0.60 0.60 0.60 0.60 0.60 0.60 0.60 0.60 0.60
Trisodium Phosphate 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10
Sodium Lauryl Sulphate 2.60 2.60 2.60 2.60 2.60 2.60 2.60 2.60 2.60
Sodium Benzoate 0.25 0.25 0.25 0.25 0.25 0.25 0.25 0.25 0.25
Titanium Dioxide - - - - - 0.50 0.40 - -
Aroma 1.6 1.6 1.6 1.6 1.6 1.6 1.6 1.6 1.6
Aqua Q.S. Q.S. Q.S. Q.S. Q.S. Q.S. Q.S. Q.S. Q.S.
Q.S. = Quantity sufficient
Examples 18-21
Table 4 lists the ingredients and their amounts present in the teeth whitening oral care composition of the present invention. The unit of each value is percent weight of the composition. Ingredients are combined and mixed by conventional means as known by one of ordinary skill in the art.
Table 4: Compositions of teeth whitening tablet
Ingredients Ex 18 Ex 19 Ex 20 Ex 21
TSPP 0.35 - 0.35 0.35
TPPP 0.15 - 0.15 0.15
Calcium Carbonate 5.0 6 6 -
Silica 0.5 2.0 2.0 3.0
Charcoal Powder 4.0 0.25 0.25 0.25
Sucralose 0.75 0.15 0.15 0.15
Herbal Extract 2.50 2.50 2.50 2.50
Trisodium Phosphate 0.10 0.10 0.10 0.10
Sodium Lauryl Sulphate 10.0 10.0 10.0 10.0
Neusilin 4.0 4.0 4.0 4.0
Aroma 4.0 4.0 4.0 4.0
Magnesium Stearate 1.5 1.5 1.5 1.5
Isomalt Q.S. Q.S. Q.S. Q.S.
Q.S. = Quantity sufficient

Examples 22-23
Table 5 lists the ingredients and their amounts present in the teeth whitening oral care composition of the present invention. The unit of each value is percent weight of the composition. Ingredients are combined and mixed by conventional means as known by one of ordinary skill in the art.
Table 5: Compositions of teeth whitening Tooth powder
Ingredients Ex 22 Ex 23
TSPP 0.02 0.02
TPPP 0.05 0.05
Calcium Carbonate 90.0 -
Silica 0.5 45.0
Sodium Bicarbonate - 45.0
Charcoal Powder 4.0 4.0
Sodium saccharin 0.30 0.30
Herbal Extract 1.50 1.50
Trisodium Phosphate 0.10 0.10
Sodium Lauryl Sulphate 1.0 1.0
Aroma 1.0 1.0
Magnesium Stearate 0.3 0.3
Water Q.S. Q.S.
Q.S. = Quantity sufficient

Example 24
Table 6 lists the ingredients and their amounts present in the teeth whitening oral care composition of the present invention. The unit of each value is percent weight of the composition. Ingredients are combined and mixed by conventional means as known by one of ordinary skill in the art.
Table 6: Composition of teeth whitening Chewing Gum
Ingredients Ex 24
TSPP 0.02
TPPP 0.05
Silica 0.50
Charcoal Powder 1.00
Xylitol 5.00
Herbal Extract 1.50
Trisodium Phosphate 0.10
Sodium Saccharin 0.30
Aroma 1.00
Magnesium Stearate 0.25
Gum Base Q.S.
Q.S. = Quantity sufficient

Examples 25-26
Table 7 lists the ingredients and their amounts present in the teeth whitening oral care composition of the present invention. The unit of each value is percent weight of the composition. Ingredients are combined and mixed by conventional means as known by one of ordinary skill in the art.
Table 7: Compositions of teeth whitening Mouthwash/Oral rinse/Mouth spray
Ingredients Ex 25 Ex 26
TSPP 0.035 0.35
TPPP 0.035 0.15
Silica 0.01 0.01
Sorbitol 15.0 5.0
Glycerin 5.0 15.0
Ethyl alcohol - 5.0
Propylene Glycol 2.0 2.0
Charcoal Powder 0.5 0.5
Xylitol 5.00 5.00
Herbal Extract 1.50 1.50
Trisodium Phosphate 0.02 0.02
Sodium Saccharin 0.30 0.30
Aroma 0.2 0.2
Polysorbate 20 0.30 0.30
PEG-40 Hydrogenated Castor Oil 2.00 2.00
Water Q.S. Q.S.
Q.S. = Quantity sufficient

While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is thereof intended to cover in the appended claims such changes and modifications that are within the scope of the invention.

We claim:
1. A teeth whitening composition, comprising:
e) Abrasives in an amount in the range from 0 to 50.0% w/w;
f) Tetrasodium pyrophosphate in an amount in the range from 0 to 3.0% w/w;
g) Tetrapotassium pyrophosphate in an amount in the range from 0 to 1.5% w/w; and
h) Charcoal powder in an amount in the range from 0 to 5.0% w/w.
2. A whitening oral care composition, comprising:
c) The teeth whitening composition as claimed in claim 1; and
d) Ingredients selected from the group consisting of humectants, binders, thickeners, surfactants, sweetening agents, herbal extracts, anti-calculus agents, flavours, colorant, water, preservatives, sodium silicate, titanium dioxide, magnesium stearate, ethyl alcohol, magnesium aluminometasilicate (MAS), sodium bicarbonate, mica, isomalt, gum base and combinations thereof.
3. The whitening oral care composition as claimed in claim 2, wherein the whitening oral care composition is in a form selected from the group consisting of a tablet, toothpaste, toothpowder, chewing gum, dentifrice, mouthwash, mouth spray and oral rinse.
4. The whitening oral care composition as claimed in claim 2, wherein the abrasives is selected from the group consisting of precipitated silica, abrasive silica, hydrated silica, silica gel, mica, natural chalk (FGNC), precipitated calcium carbonate (PCC), dicalcium phosphate dihydrate (DCPD) and combinations thereof and is present in an amount in the range from 0 to 50.0% w/w.
5. The whitening oral care composition as claimed in claim 2, wherein the herbal extract is one of black pepper (Piper nigrum L.), long pepper (Piper longum L.), ginger (Zingiber officinale L.), prickly ash/tomar (Zanthoxylum armatum L.) or combinations thereof and present in an amount in the range from 0.1 to 5% w/w.
6. The whitening oral care composition as claimed in claim 5, wherein the herbal extract is present in an amount in the range from 0.25 to 2.5% w/w.
7. The whitening oral care composition as claimed in claim 2, wherein the sweetening agent is selected from the group consisting of saccharin, dextrose, levulose, aspartame, sucralose, sodium saccharin, D-tryptophan, dihydrochalcones, acesulfame, sodium cyclamate, stevia and combinations thereof and is present in an amount in the range from 0.15 to 0.75% w/w.
8. The whitening oral care composition as claimed in claim 2, wherein the anti-calculus agent is selected from the group consisting of tripolyphosphate, hexametaphosphate, trisodium phosphate, disodium phosphate and combinations thereof and is present in an amount in the range from 0.02 to 0.10% w/w.
9. The whitening oral care composition as claimed in claim 2, wherein the flavour is selected from the group consisting of vanillin, sage, marjoram, parsley oil, spearmint oil, cinnamon oil, oil of wintergreen (methylsalicylate), peppermint oil, clove oil, baby oil, anise oil, eucalyptus oil, citrus oil, fruit oils, fruit essences, bean and nut-derived flavours, adsorbed and encapsulated flavours and combinations thereof and is present in an amount in the range from 0.2 to 4.0% w/w.
10. The whitening oral care composition as claimed in claim 2, wherein the surfactant is selected from the group consisting of sodium lauryl sulfate, sodium hydrogenated coconut oil, fatty acid monoglyceride monosulfate, sodium N-lauroyl sarcosine and its salts, polysorbate 20, sodium cocoate, cocamidopropyl betaine (CAPB), decyl glucoside and combinations thereof and is present in an amount in the range from 0.30 to 10.0% w/w.
11. The whitening oral care composition as claimed in claim 2, wherein the thickening agent is present in an amount in the range from 0.0 to 10.0% w/w.
12. The whitening oral care composition as claimed in claim 2, wherein the humectant is selected from the group consisting of glycerin, sorbitol, xylitol, propylene glycol, polyethylene glycol (PEG), PEG-40 hydrogenated castor oil and combinations thereof and is present in an amount in the range from 2.0 to 42.0% w/w.
13. The whitening oral care composition as claimed in claim 2, wherein the binder is selected from the group consisting of xanthan gum, carrageenan, sodium carboxymethylcellulose, hydroxypropylmethylcellulose (HPMC), hydroxyethylcellulose (HEC), acrylate polymers and combinations thereof and is present in an amount in the range from 0.2 to 1.2% w/w.
14. The whitening oral care composition as claimed in claim 2, wherein the binder is present in an amount of 0.80% w/w.
15. The whitening oral care composition as claimed in claim 2, wherein the preservative is selected from the group consisting of methyl paraben, propyl paraben, sodium benzoate, benzyl alcohol, phenoxy ethanol and combinations thereof, and is present in an amount in the of 0.1 to 1% w/w.
16. The whitening oral care composition as claimed in claim 15, wherein the preservative is present in an amount of 0.25% w/w.
17. The whitening oral care composition as claimed in claim 2, wherein sodium silicate is present in an amount in the range of 0.1 to 1% w/w, preferably 0.60% w/w.
18. The whitening oral care composition as claimed in claim 2, wherein titanium dioxide is present in an amount in the range from 0.40 to 0.50% w/w.
19. The whitening oral care composition as claimed in claim 2, wherein magnesium stearate is present in an amount in the range from 0.25 to 1.5% w/w.
20. The whitening oral care composition as claimed in claim 2, wherein magnesium aluminometasilicate (MAS) is present in an amount of about 4.0% w/w.
21. The whitening oral care composition as claimed in claim 2, wherein sodium bicarbonate is present in an amount of about 45.0% w/w.
22. The whitening oral care composition as claimed in claim 2, wherein ethyl alcohol is present in an amount in the range from 0.0 to 5.0% w/w.
23. The whitening oral care composition as claimed in claim 2, wherein colorant is present in an amount in the range from 0 to 0.1% w/w, preferably 0.0125 % w/w.
24. The whitening oral care composition as claimed in claims 2 to 18, comprising the teeth whitening composition, thickeners, sweetening agents, humectants, surfactants, binders, herbal extracts, anti-calculus agents, preservatives, flavours, sodium silicate, titanium dioxide and water, wherein the whitening oral care composition is a toothpaste.
25. The whitening oral care composition as claimed in claims 2 to 12, 19 and 20; comprising the teeth whitening composition, thickeners, abrasives, sweetening agents, surfactants, herbal extracts, anti-calculus agents, flavours, magnesium aluminosilicate (MAS), magnesium stearate and isomalt, wherein the whitening oral care composition is a tablet.
26. The whitening oral care composition as claimed in claims 2 to 10, 16 and 18, comprising the teeth whitening composition, thickeners, abrasives, sweetening agents, surfactants, herbal extracts, anti-calculus agents, flavours, magnesium stearate, sodium bicarbonate and water, wherein the whitening oral care composition is a tooth powder.
27. The whitening oral care composition as claimed in claims 2 to 9, 12 and 20, comprising the teeth whitening composition, sweetening agents, humectants, herbal extracts, anti-calculus agents, flavours, magnesium stearate, and gum base, wherein the whitening oral care composition is a chewing gum.
28. The whitening oral care composition as claimed in claims 2 to 10, 12 and 22, comprising the teeth whitening composition, sweetening agents, humectants, surfactants, herbal extracts, anti-calculus agents, flavours, ethyl alcohol and water, wherein the whitening oral care composition is a mouthwash.