Title of Invention	A SYNERGISTIC FORMULATION USEFUL AS NATURAL HERBAL TOOTH POWDER
Abstract	The present invention provides a synergistic formulation useful as natural herbal tooth powder and comprises Zanthoxylum spp., ginger, sandal wood, roasted alum, common salt, Spilanthes spp., Pistacia spp., Qurercus spp. and Usnea spp. in the proportions 20-25%; 25-30%; 8.25-8.5; 8-9%; 15.0-16.5%; 2.0-2.5%; 8.0-8.5% and 4.0% respectively.

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The invention relates to a synergistic formulation useful as a natural herbal tooth powder. More particularly, the invention relates to a herbal tooth powder formulation useful for the treatment of bleeding and swollen gums, toothache, yellowing an straining of teeth, foul odour of mouth and sensitivity to hot/cold water/food. The formulation of the present invention has replaced synthetic compounds by a composition based on herbs, alum and common salt. The traditional herbal preparations for dental care comprise of various types of herbal powders and chewing sticks made out of young woody stem or root pieces. The table-1 gives a list of plants which are used for oral health by the people of India. It is compiled from the literature reports (Almass K., Al-Lafi, Tr., World Health Forum 16:206-210, 1995; Chopra et al., Glossary of Indian Medicinal Plants, 1956; Manandhar NP, J. Econ. Tax. Bot, 12:408-413, 1996; Rao etal. Ethnobot, 8: 88-91, 1996; Rispler-Chaim V, J Royl Asiatic Soc. V2:: 13-20, 1992 and Sushil Kumar et_al. Medicinal Plants in Skin Care, CIMAP, 76-89, 1994). Table 1: The plants that are employed for toothcare in India. SI. Botanical and Indian Purpose and method of use No. common names 1. Acacia catechu Catechu paste is used to treat (Katha) the bleeding gums and for tooth hypersensitivity 2. A. nilotica Fresh twig is used as tooth (Kikar) brush for keeping the gums and teeth healthy and clean 3. Achyranthes aspera Twig is used for brushing teeth (Puthkanda, Latjira) to treat dental problems 4. Azadirachta indica (Neem) 5. Aristolochia bracteolata (Kidamari) 6. Cinnamomiim camphor a (Kapur) 7. Cinnamomum verum (Dalchini) 8. Curcuma longa (Turmeric) 9. Eucalyptus globulus (Karpoora) 10. Ficus bengalensis (Bargad) 11. Juglans regia (Akhrot) 12. Madhuca longifolia (Mahua) 13. Mimusops elengi (Maulsari) 14. Myristica fragrans (Jaiphal) 15. Ocimum sanctum (Tulsi) Fresh twig is used as tooth brush to prevent gum diseases and pyorrhoea Root juice is applied to the site of toothache for relieving pain Tender twigs are chewed or the paste of stem bark is applied in aching teeth Powdered stem bark is applied to teeth in the treatment of caries and pyorrhoea Powder of rhizome is used in tooth powder for curing pyorrhoea To prevent tooth decay and to provide relief form pain the leaf oil is applied to the site of pain Aerial root is used as tooth brush and the latex is applied in toothache Stem bark is used in tooth powders to make the teeth healthy Stem bark is used in tooth powder for gum pain and toothache Bark is used in tooth powder for the protection of gums and teeth Fruit paste is applied on teeth to cure dental caries and pyorrhoea Leaves are chewed as such for the treatment of bad breath and leaf paste is useful for tooth hypersensitivity 16. Piper betel (Pan) 17. Piper longum (Piplamus) 18. Piper nigrum (Goal mirch) 19. Potentilla fulgens (Vajardanti) 20. Punica granatum (Anar) 21. Salvador a persica (Pilu) 22. Syzygium aromaticum (Laung) 23. Spilanthes calva (Akarkara) 24. Zanthoxylum armatum (Tejbal) Leaf paste is suggested for dentinal hypersensitivity Fruit in the form of powder is applied for dental caries Fine powder of seeds is applied to teeth in toothache, pyorrhoea and gum bleeding Root powder is applied in gingivitis Stem bark or fruits rind is used as component of dental powder Twig is used as tooth brush for cleaning the teeth. Roots are used in dental caries, and to relieve toothache Clove oil is applied for toothache, dental caries and pyorrhoea Flowers chewed in toothache. Plant made into paste is applied in toothache Twig is used as tooth brush for cleaning the teeth. Fruit powder is applied to teeth in toothache. At present, a number of tooth powders are available in India which contain cheap pulverized items that are not very effective as well as harmful for gums and teeth and have toxic effects. Composition of some of the herbal tooth powder available in market are given below. S.No. Product name Manufacturer and address Ingredients Red Tooth Powder Dabur India Ltd. 22, Site IV Sahibabd, Ghaziabad Pudina satva (Mentha sp.), lavang ka tail (Syzygium aromaticum), Tomer beej (Zanthoxylum acanthopodium), Kapoor, Kalimarich (Piper nigrum), Pippali (Piper longum), Sunthi (Zingiber offrcinale), Tambaku (Nicotiana tabacum) 2. Vicco Vajradanti Vicco Laboratories Babbul (Acacia nilotica), 25, Jerbi Wadia Road, Janibhul, Lavang (Syzygium Parel,Bombay-4000\2aromaticum), Manjishtha (Rubia cordifolia), Dalchini (Cinnamomum zeylanicum), Vajradanti (Potentilla fulgens), Acrod, Khair patang, Akkal Kadha, Babul, Jeshthamadh, Kabachini (Piper cubaba), Anant root (Hemidesmus indicus), Ajwain (Trachyspertnim ammi), Jaifal (Myhstica fragrans), Trifala (Emblica officinals, Terminalia chabula, Terminalia belerica), rice husk, sugar, alum, salt. Lordent Toothpowder Meghdoot dantusha Lord's Cosmetics International A-21/27, Naraina Industrial Area, Phase-II New Delhi-110028 Meghdoot Gramodhyog Seva Sansthan, Meghdoot Buliding Chandganj Garden, Lucknow Extract ofPlantago, Calendula and creosote Sonth (Zingiber officinale), Pipal (Ficus religiosa), Kalimirch (Piper nigrum), Tomar beej (Zanthoxylum acanthopodium), Samundar Jhag, Akarkara (Anacyclus 5. Payorin 6. Hamdard Manjan 7. MDH Dant powder 8. Payakil Dawakhana Tibbiya College, AMU, Alighrh Hamdard (Wakf) Laboratories Hamdard Marg, Delhi-110 006 Super Delicocies Pvt. Ltd. Gurukul Pharmacy Hardwar pyrethrum) Manjuphal, Maulshri (Mimosops elengi), Sengdha salt. Amla (Emblica officinalis) Sokhta, Gile gaimuliya, Taj galmi, Kafoor khlis, Hamize fahmi, Roghan Asfaidar Ilaichi (Electtaria cardamo-mum) kalan, Amla (Emblica officinalis) dry, Post halaila zard (Terminalia chebula), Banslochan (Bambusa bambos), Zanjbeel (Zingiber officinale), Sangjarahat, Filfil siyah (Piper nigrum), Kabab khandan, Khoolanjan (Alpinia galanga), Namak Sambhar, Mileh firangi, Sat paudina (Mentha spp) i) Acacia nilotica ii) Embelia tsjenam-cottam iii) Areca catechu \v) Juglans regia v) Curcuma amada vii) Syzygium aromaticum viii) Alpinia galanga Ficus elastica, Piper nigrum Menthol, Eucalyptus_oil. Acacia nilotica Suglans regia, Camphor a officinatum, Azadirachta indica, Arcila vitrolutcum, Zanthoxylum armatum. The above described formulations suffer from a number of disadvantages. 1 Some formulations have harmful components e.g. Nicotiana tabacum which ultimately spoil the teeth and gum. 2. Adulteration of plant material is often there. Therefore, the formulations have not been found very effective. 3. The product very often have cheap materials and expansive items are not used in the prescribed quantity. Therefore, the final product is not very useful. 4. Very often the amount of base material is more compared to active components and thus the product is not very useful. The present invention relates to a formulation of herbal tooth powder for teeth and gums. Since the components in the formulation are from herbal source it is very safe and ecofriendly and do not produce any adverse effect. The formulation of present invention consist of (a) Powder of Zanthoxylum fruits that contain essential oil with disinfectant and antiseptic properties (Farooqi et al., J. Med. Arom PI Sci., 20:441-450, 1998), (b) resinous exudate of Pistacia lentiscus a filler for carious teeth with teeth cleansing properties and able to remove foul odour of the mouth (Sushil Kumar et al.. Medicinal Plants in Skin Care, CIMAP, 76-89, 1994), (c) powder of dried ginger (Zingiber officinale) with anti-inflammatory and antibacterial properties (Chopra et al.. Glossary of Indian Medicinal Plants, 1956), (d) powder of Spilanthes calva which stimulates secretion of saliva (Farooqi et al.. J. Med. Arom. PI. Sci., 20:441-450, 1998), (e) powder of gall nuts of Quercus infectoria plant with astringent effect and able to check foul odour of mouth, toothache and swollen gums (The Wealth of India - Raw Materials, 1994), (f) powder of Usnea longissima, Santalum album, plants (The Wealth of India- Raw Material, 1994), alum and common salt. A combination of medicinal plants powder with alum and common salt can be used as a good house hold tooth powder which results in the protection of teeth from different diseases. The main diseases of the teeth include plaque, caries and pyorrhoea. Proper dental care is necessary for eliminating tooth decay and periodental diseases. The people living in Indian subcontinent largely depend on the traditional systems for the treatment of toothache, caries and other diseases related to teeth. The traditional herbal preparations for dental care comprise of various types of herbal powders and chewing sticks made out of young woody stems or root pieces. The natural herbal products are in demand for use to control dental diseases. The natural herbs are harmless as they don't have side effects. They also have low mammalian toxicity and can be handled safely. The plants used in this formulation are very useful in pyorrhoea, tooth hypersensitivity, and are reported to be useful for relieving gum inflammation and tooth ache (Farooqi et al., J. Med. Arom. P1. Sci., 20:441-450, 1998). Zanthoxylum armatum plant as called toothache fruit as its main use is in toothache. Fruits of Z. armatum contain essential oil (1.5%). The main constituent of oil is linalool. The oil is disinfectant and antiseptic; therefore, fruit powder is used for toothache. Therefore, Z. armatum fruits are used as a component in the prepration of this formulations. Pistacia lentiscus, resinous exudate was also used in the prepration of dental powder. The resin has pleasent smell due to the presence of essential oil (12%) and is used as a filler for carrious teeth, for cleansing of teeth and to remove foul odour of the mouth. Powder of dried ginger (Zingiber officinale) was used as it contain resin and essential oil and it has anti-inflammatory and antibacterial properties (Sushil Kumar et al.. Medicinal Plants in Skin Care, CIMAP, 76-89, 1994),. In the present formulation, the powder of Spilanthes calva was also used as it has property of stimulating secretion of saliva (Farooqi et al., J. Med. Arom. PI. Sci., 20:441-450, 1998). Paste of its flower is used in toothache or flower as such is chewed in toothache. Powder of gallnuts of Quercus inflectoria plant was used due to its astringent properties (The Wealth of India - Raw Materials, 1994). The powder is rich in tannic acid (50-70%). It is very useful for foul odour of mouth, toothache and swollen gums. Powder of Usnea longissima was used as it contain usnic acid and volatile oil and considered useful for gums in traditional system of medicine. It is filamentous, pendulus lichen common in temperate and alpine Himalayas (The Wealth of India - Raw Materials, 1994). Santalum album powder was used as it is used for local inflammation in traditional systems of medicine. The powder is rich in essential oil (1.5-6%) (Chopra et al.. Glossary of Indian Medicinal Plants, 1956). The herbal powder is useful for bleeding and swollen gums, yellowing/staining of teeth, foul odour of mouth, toothache as well as for sensitivity to cold/hot water/food. The composition of the formulation is new, very safe, eco-friendly and does not produce any harmful effects. The herbal components used in this formulation have not been used in other dental powder so far. The main object of the present invention was to provide a formulation useful as natural herbal tooth powder which obviates the drawbacks of the present tooth powders. Another object is to provide a good tooth powder which can give effective protection to teeth and free them from any toxicity or toxic residue and irritation when regularly used. It should be cosmetically acceptable having pleasant odour and should not leave stain on teeth or fingers after use. Brightening the teeth by removing stains would be a prerequisite of the formulation. Still another object of the present invention is to provide a formulation which contains natural aromatic and medicinal herbs useful for gums and teeth, which are safe, biodegradable and have very low mammalian toxicity. The components in the formulation are from herbal source and are very safe and ecofriendly and therefore do not produce any adverse effect on the gums and teeth. It comprises of powders of Zanthoxylum armatum which is useful for toothache, powder of Zingiber officinale which is antiseptic due to presence of essential oil and resin, powser Spilanthes calva, whose flowers are chewed in toothache, resinous exudate of Pistacia lentiscus which has pleasant smell due to essential oil content and used as a filling for carious teeth. It is also used for cleansing the teeth and to remove the bad odour of the mouth. Powder of gall nuts of Quercus infectoria plant has been used for its astringent effect. It is also used for foul odour of the mouth, toothache and swollen gums . Usnea longissima powder was used to make the powder soft and to improve the odour as it is rich in volatile oil and usnic acid A process for the preparation of synergistic compositor useful as natural herhal tooth powder which comprising. a. 20-25% of zomthoxyllum armature powder obtained from its flower, leaves or roots b. 25-30% of ginger, powder obtained from rhingome or leaves of gimgilur officimale c. 8.25-8.5% of samdal need powder obtained from samdal need hard wood or soft wood d. 8-9% of roasted alum e. 15.0-16.5% of common salt f. 2.0-2.5% of spilamtnes spp ohtained from the flower or plants of spilamthes calva g. 2.0-2.5% of pistaica spp. Obtained from resined eandate of pistacia lentiscus h. 8.0-8.5% of Querces spp powder obtained from gallment of the plant Quercus infectoria i. Alent 4% Usnea powder obtained from Usnea longissiana lichens. j. The ratio of a-I physically mixed in a synergfistic manner to get the said tooth powder. The invention further provides a synergistic formulation which is useful for the treatment of bleeding and swollen gums , toothache ,yellowing and staining of teeth, foul odour of mouth and sensitivity to hot/cold water/food. In an embodiment of the invention , Zanthoxylum armatum powder used may be procured from flowers , fruits and leaves of the plant. In another embodiment of the invention , Gingiber officinale powder used may be such as from rhizome, leaves and stem. In yet another embodiment of the invention , the sandalwood powder used is from sandalwood hard wood or soft wood. In still another embodiment the powder of Spilanthes calva used may be from flowers of plants and it stimulates secretion of saliva. In still another embodiment Qurecus infecteria powder may be obtained from gallnuts of plants and it has astringent effect. In yet another embodiment of the invention Usnea powder may be obtained from Usnea longissima lichens. The composition is not merely a mixture of the constituents. It is new and the ingredients have synergistic effect. Examples 1-4 illustrates as to how formulation has been developed and forms the basis for the development of herbal tooth powder as stated in examples 5 to 7. EXAMPLE-1 Powder of Zanthoxylum flowers, turmeric, ginger (dried), salt and alum (after roasting) were mixed in the following proportion : Zanthoxylum powder 20g Ginger powder 20g Turmeric powder 50g Salt 10g Alum (roasted) 10g The formulation was distributed for testing on a limited scale. It was not found very effective. EXAMPLE-2 Another sample was prepared and this time following composition was used. Ginger dried 25g Alum powder (roasted) lOg zanthoxylum powder 20g Usnea powder 20g Turmeric powder 50g Salt 20g The formulation was leaving stain on fingers. EXAMPLE - 3 Essential oil of different plants was used along with Pistacia lentiscus. Some components of Example-2 were omitted. weight % Dried ginger powder 20g 28.6 Zanthoxyhim powder 17g 24.3 Spilanthes calva 2.5g 3.57 Pistacia lentiscus 2. Og 2.85 Turmeric 5.0g 7.1 Usnea powder 6.5g 9.3 Alum powder 6.8g 9.7 Salt 5.0g 7.5 Tulsi oi 150 drops Eucalyptus oil 50 drops Clove oil 50 drops The formulation was effective to some extent. EXAMPLE - 4 Sandal wood powder and fruits of Quercus infectoria were added and essential oils and turmeric were omitted. weight % Zanthoxyhim powder 90g 26.5 Ginger (dried) 60g 17.6 Usneajspp. Powder 45g 13.2 Alum roasted 30g 8.8 Sandal wood powder 45g 13.2 Spilanthes calva 15g 4.4 Pistacia lentiscus 15g 4.4 Quercus infectoria 20g 5.8 Common salt 20g 5.8 The product was given to different persons. The effect of Spilanthes on the tongue was more pronounced. So its quantity was decreased in the final formulation. The invention is illustrated with the help of following examples and should not construed to limit the scope of invention. 13 Zanthoxylum Ginger powder Sandal wood powder Alum roasted Common salt Spilanthes powder Pistacia lenticis Quercus infectoria Usnea powder EXAMPLE-5 300g 300g lOOg lOOg 200g 30g 30g lOOg 50g weight % 25 25 8.25 8.25 16.50 2.50 2.50 8.0 4.0 Zanthoxylum Ginger powder Sandal wood powder Alum roasted Common salt Splanthes powder Pistacia lenticis Quercus infectoria Usnea powder EXAMPLE-6 weight % 20 30 8.5 8.0 16.0 2.0 2.0 8.5 4.0 Zanthoxylum Ginger powder Sandal wood powder Alum roasted Common salt Spilanthes powder Pistacia lenticis Quercus infectoria Usnea powder EXAMPLE-7 weight % 22 28 8.5 9.0 15.0 2.0 2.0 8.5 4.0 Samples were given to 54 persons on a prescribed proforma during August 98 to December 98. Response was satisfactory. Statistical Analysis of Survey Project surveyed : Herbal tooth powder Sample size : 54 human beings Area covered Methodology Precisions Lucknow - 96% Outside Lucknow - 4% Direct contact questionnaire method 1. Subjects were asked to return the filled questionnaire. instructions for use. Questionnaire contained 3. The product was advised to be used with brush or finger either in the morning or night time. Age group and sex of subjects Effectiveness of Dental problems for which powder was used Relief noticed The group sampled ranged between 8-72 years with 63% male and 37% female (Table - 1). Taste - 78% reported that taste is good/ acceptable and 29% reported that taste needs improvement to be more plesant to tongue (Table - 2). Odour - 72% opined that odour was pleasant while 6% reported that odour needs improvement for better aroma (Table - 3). Texture - 24% reported that texture is fine while 41% reported that it should be made more fine (Table - 4). 34% people used that product for bleeding gums, while 38% used it for swollen gums. About 33% persons tested the tooth powder for yellowing/staining of teeth while 26% used it for foul odour of mouth. 20% checked it for sensitivity to cold/hot water/food, 16% for toothache and 8% for loosening of teeth (Table - 5). About 60% persons reported it moderately effective for bleeding gums, swollen gums, toothache, yellowing/staining of teeth and foul odour of mouth as well as sensitivity to cold/hot water/food. Any adverse effect was not reported on teeth, tongue and in oral cavity. House hold grinder was used for powdering the ingredients. The formulation is not a mere admixture resulting in mere aggregation of the properties of individual ingredients but a synergistic mixture resulting in enhanced effectiveness for tooth problems. In examples 5-7 the synergistic effect of the formulation of the present invention is detailed. Table 1: Age distribution (Table Removed) Table 3 :Odour (Table Removed) Table 4:Texture Texture of the product No. of users Percentage Fine 13 24 Can be made more powdered 22 41 Not commented 19 35 Table 5:Problems and effectivity Problems Persons Highly Moderately Low/slow No action Total used(%) effective effective effective (%) (Table Removed) Includes multiple uses by individual respondants Advantage 1. The product composition is safe to be used orally as the components used in the formulation are of herbal origin and do not produce any adverse effect on the gums and teeth. 2. The product is ecofriendly and economically viable. 3. No harmful components like N tabacum is used which ultimately spoils the teeth and gums. We claim: 1. A process for the preparation of synergistic composition useful as natural herbal tooth powder which comprising: a. 20-25% Zanthoxylum armatum powder obtained from its flowers, leaves or roots b. 25-30% of ginger powder obtained from rhizome or leaves of Zingiber officinale. c. 8.25-8.5% of sandalwood powder obtained from sandalwood hard wood or soft wood d. 8-9% of roasted alum; e. 15.0-16.5% of common salt; f. 2.0-2.5 % of Spilanthes spp obtained from flower or plants of Spilanthes calva; g. 2.0 -2.5 of Pistacia spp. obtained from resinous exudates of Pistacia lentiscus ; h. 8.0-8.5% of Quercus spp powder obtained from gallnut of the plant Quercus infectoria.; i. about 4% Usnea powder obtained from Usnea longissima lichens; j. the ratio of a-i physically mixed in a synergistic manner to get the said tooth powder. 2. A process for the preparation of synergistic composition useful as natural herbal tooth powder substantially as herein described with reference to the examples accompanying the specification.

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