MXPA06003333A - Morinda citrifolia-based oral care compositions and methods - Google Patents

Abstract

Methods and formulations that utilize components of the Indian Mulberry plant, scientifically known as Morinda citrifolia L., to treat one or more oral and dental disorders, including periodontal diseases such as gingivitis and periodontitis, tooth decay, halitosis, and other mouth disorders and irritations.

Description

COMPOSITIONS AND METHODS FOR ORAL CARE BASED ON MORINDA CITRIFOLIA FIELD OF THE INVENTION The present invention relates to a composition for oral care and, more particularly, to an oral care composition for stimulating healthy teeth and gums comprised of components of the Indian Morera plant, scientifically known as Morinda citrifolia L. .

BACKGROUND OF THE INVENTION Teeth are the only body tissue in mammals that does not undergo metabolic replacement or replacement, which makes them almost indestructible. Despite this, the teeth are constantly subjected to bacterial attacks, which can cause the decalcification of the tooth enamel and the erosion of the surrounding oral tissues over time. Teeth are hard, calcified structures embedded in the bone of the jaws of vertebrates that perform the primary function of chewing. Humans and most other mammals have a temporary set of teeth, the deciduous or milk teeth; in humans, they usually appear between 6 and 24 months of age. The same in a total number of 20: 2 central incisors, 2 lateral incisors, 2 canines or fangs, and 4 premolars in each jaw. At approximately six years of age, the preliminary teeth begin to be shed as the permanent set replaces them. The last of the permanent teeth (wisdom teeth) may not appear until they are 25 years old, and in some people they do not fully emerge. The permanent teeth in general are 32 in total: 4 incisors, 2 canines, 4 premolars, and 4 (or 6, if the wisdom teeth are developed) molars in each jaw. The canines or fangs in humans are the smallest found in any mammal. Among all mammals, the tooth consists of a crown, the portion visible in the mouth, and one or more roots embedded in a gingival cavity. The portion of the gum that surrounds the root, known as the periodontal membrane, protects the tooth in its bony cavity. The maxilla serves as a firm anchor for the root. The center of the crown is filled with soft pulpy tissue, which contains blood vessels and nerves; This tissue extends towards the tip of the root by means of a channel. What surrounds the pulp and makes up the largest volume of the tooth is a hard, bone substance, the dentine. The root portion has an overlayer of cement, while the crown portion has an additional layer of enamel, the hardest substance in the body. An adequate diet is necessary for the development and maintenance of healthy teeth, especially calcium, phosphorus, and vitamins D and C. The most common disorder that affects the teeth is dental caries (caries produced in the teeth). A widely accepted explanation of the tooth decay process is that the bacteria in the saliva convert the carbohydrate particles in the mouth into lactic acid, which attacks the enamel, the dentin, and, if left untreated, the tooth pulp . Regular cleaning and semi-annual dental examinations are important to prevent tooth decay and gum or gum disorders. Fluoridation of public water supplies and the use of fluoride toothpastes also help prevent cavities. A periodontal disease, including gingivitis, is an infection of the tissues that surround and support the teeth, including the gums, in the periodontal ligament and the alveolar bone. Although various factors can aggravate periodontal disease, the main cause of periodontal disease is linked to the bacteria contained in dental plaque.

The plaque is a colorless, viscous film of bacteria and sugars that is constantly formed on the teeth. The plaque causes cavities when the acids in the plaque attack the teeth after feeding, causing the tooth enamel to break over time, resulting in tooth decay and halitosis. If left untreated, periodontal disease may develop, and eventually lead to the loss of a tooth, as well as contributing to conditions such as, for example, stroke, diabetes, premature birth, heart disease and respiratory disease. Microorganisms play an essential role in the development of caries, endodontic and periodontal diseases that can destroy oral tissues. A 1999 report indicated that more than 50% of all children, 85% of all adults over 18, and more than 50% of the elderly over 75 years of age suffer from caries injuries. Caries from active lesions must often be removed to prevent the progressive breakdown of the remaining tooth structure. The elimination of caries is the main reason for the restoration of teeth. Secondary caries is also directly responsible for 50% of all restoration deficiencies. The net effect of dental caries in the United States is that 90 million restorations must be replaced, and 200 million restorations must be placed each year. Additionally, millions of teeth that are not taken into account are removed, and 15 million teeth undergo root canal therapy every year in the United States. In the United States alone, approximately $ 60 billion dollars are spent annually in professional dental treatments, $ 172 billion in medical products, $ 122 billion in prescription drugs, and $ 50 billion in other medical products. In the rest of the world it is estimated that more than $ 200 billion dollars are spent on professional dental treatments. Many bacterial species that inhabit the oral cavity have been identified. However, due to bacterial interactions, nutrient availability and low oxygen potentials in root canals with a necrotic tip, the number of bacterial species in endodontic infections is restricted. These selective conditions lead to the predominance of anaerobic microorganisms that survive and multiply, causing infections that stimulate local bone resorption, and are more resistant to endodontic treatment. Cleaning is one of the main objectives of the preparation of the root canals. A total cleaning eliminates microorganisms and allows a better adaptation of the filling materials and improves the action of intracanal drugs. The choice of an irrigant is of great importance because it acts as a lubricant during the instrumentation, the abundant washing of debris and the exit of the bacteria from the canal, and reacts with the tip, the necrotic tissues and the microorganisms and their byproducts. Sodium hypochlorite has been used extensively for several decades for this purpose. Its excellent tissue dissolving properties and antimicrobial activity make it the preferred irrigant for the treatment of teeth with pulpal necrosis, even though it has several undesired characteristics such as, for example, tissue toxicity at high concentrations, risk of emphysema when It is over-sealing, allergic potential and unpleasant smell and taste. In addition, the sodium hypochlorite does not completely clean the surfaces of the walls. Chlorhexidine has been studied for its various properties; These include antimicrobial activity and biocompatibility with the aim of being an alternative for sodium hypochlorite. However, its ability to clean the walls of the root canals was recently found to be inferior to that of the sodium hypochlorite. These problems suggest that sodium hypochlorite and other alternative medications, including chlorhexidine, are not fully optimized; and new irrigants must be evaluated to be used as dental medicines. The ideal irrigant should have an antimicrobial action, low toxicity and good biocompatibility with the oral tissues, and should also have the ability to clean the walls of the root canals and eliminate the rub layer. The rub layer is a 1 mm thick layer of denatured cutting debris produced on the surface of the cavity subjected to instrumentation, and is composed of dentin, odontodiastic processes, non-specific inorganic contaminants and microorganisms. The removal of the rub layer from the walls of the root canals subjected to instrumentation is controversial. Its elimination provides a better sealing of the endodontic filling material for the dentin, and will prevent the leakage of microorganisms within the oral tissues. The infiltration of microorganisms in oral tissues should be avoided because these often cause complications that lead to treatment failure.

In this way, while in recent decades there have been improvements in the alternatives for the treatment of patients with periodontal disease and other oral and dental disorders, research is continuously trying to obtain improved treatment methods, since some of the treatments are inconveniences. Therefore, an improvement in the technique could be to increase or even replace the treatments currently used with other treatments to provide increased results in the treatment of oral and dental diseases and disorders. These methods of treatment and the compositions are discussed and claimed herein.

SUMMARY OF THE INVENTION The present invention relates to a composition for oral care and, more particularly, to an oral care composition for stimulating dental and gum health comprising the components of the Indian Morera plant, known scientifically as Mor inda citrifolia L. Mor inda citrifolia has beneficial antimicrobial properties while being biocompatible and therefore has significant medicinal potential as part of a dental treatment. Certain embodiments of the present invention utilize the components of the Hindu Morera plant, known scientifically as Morinda citrifolia L., to treat one or more oral and dental disorders, among which are included periodontal diseases such as, for example, gingivitis and periodontitis, caries. dental, halitosis, and other oral irritations. The present invention incorporates the components of the Morinda citrifolia plant as the constituents of the oral care compositions for treating and preventing various disorders related to the mouth and teeth. Certain embodiments of the present invention comprise an excipient base component and an active component comprising Morinda citrifolia in an amount of up to fifty percent by weight. In view of the foregoing, certain embodiments of the present invention provide a dental formulation capable of enhancing the immune response to gingival diseases or dental caries. In addition, certain embodiments of the present invention provide an oral dental formulation and the method to reduce gingival bleeding by reducing inflammation in the gingival sulcus and increasing the density of gingival collagen. Certain embodiments of the present invention provide an oral dental formulation and method for reducing loss of periodontal fixation by reducing plaque formation and / or plaque adhesion to surrounding teeth and oral tissues. Also, certain embodiments of the present invention provide an oral dental formulation and method for reducing the permeability of the epithelial cell wall to bacterial toxins, and further to reduce the activity of the enzyme collagenase in the presence of bacteria. Still another object of certain embodiments of the present invention is to provide an oral dental formulation and method for increasing cellular respiration and oxygen saturation of the cells in the mouth. Certain embodiments of the present invention provide a dental formulation and the method to reduce the incidence and duration of canker sores. Certain embodiments of the present invention provide a dental formulation and method for cleaning teeth, removing surface staining from teeth, and banqueting teeth. Certain embodiments of the present invention provide an oral dental formulation and method for treating and preventing gum and gum disease and dental caries in mammals and also for improving general overall dental health.

In addition, certain embodiments of the present invention provide an oral dental formulation and method for reducing halitosis in mammals. These and other features and advantages of the present invention will be shown or made fully apparent from the following description and the appended claims. The features and advantages can be understood and obtained by means of the particular instruments and combinations indicated in the appended claims. In addition, the features and advantages of the invention can be learned by practicing the invention or will be apparent from the description, as will be shown hereafter.

DETAILED DESCRIPTION OF THE INVENTION The present invention can be incorporated into other specific forms without departing from its spirit or essential characteristics. The described modalities will be considered in all aspects only as illustrative and not restrictive. The scope of the invention, therefore, is indicated by the appended claims in lieu of the foregoing description. All changes that fall within the meaning and variation of the equivalency of the claims will encompass within its scope.

In the sense in which it is used in this specification, the thermal "oral disorder" or "dental disorder" refers to any type of disease, condition, attribute or disorder affecting any of the surrounding teeth, gums and oral tissues. . Examples of these oral or dental disorders include periodontal diseases such as, for example, gingivitis and periodontitis, dental caries, halitosis, irritations and oral lesions, and other conditions affecting the teeth, gums and / or surrounding oral tissues. The term "Morinda citrifolia" refers to any component of the Morinda citrifolia plant. { L.), including the fruit juice of Morinda citrifolia, its extracts, the fruit juice concentrates, its essence or extract, leaves, leaf powder, leaf extracts, bark, extracts of the bark, root, extract of the root, bark of the root and extracts of the root bark. The term "Tahitian Noni® Juice" refers to a product that includes the processed components of the Morinda citrifolia L. plant. In one embodiment, the Tahitian Noni® Juice includes the juice of the fruit of Morinda citrifolia L. reconstituted from of a French Polynesia juice puree. The Tahitian Noni® Juice may also include other natural juices, such as, for example, natural grape juice concentrate, a natural cranberry juice concentrate, and / or other natural juice concentrate. In a further embodiment, the Tahitian Noni® Juice is processed from dehydrated or pulverized Morinda citrifolia L. Tahitian Noni® Juice can be obtained from Morinda Inc., which has a principal address at 5152 N. Edgewood Dr. # 100, Provo, UT, 84604. In the sense in which it is used herein, a " effective amount "is an amount sufficient to obtain beneficial or desired effects. An effective amount can be administered in one or more administrations, applications or dosages. For example, an effective amount of Morinda citrifolia is an amount sufficient to reduce dental plaque, suppress the development of bacteria, and reduce adhesiveness of the plaque, thereby inhibiting the formation of dental caries. These effective amounts can be determined without undue experimentation by those skilled in the art. According to the present invention, the components of the plant Morinda citrifolia (L.) can be used in combination with an excipient base to treat and / or prevent an oral or dental disorder. Certain embodiments of the present invention may be in the form of a dietary supplement, a topically applied oral dental formulation, or any other form known to those of skill in the art. The following discussion of the present invention is grouped into three subtitles, namely, "General Analysis - of Morinda citrifolia and the methods used to make the processed Morinda citrifolia products" "Formulations and methods of administration" and "Oral care". The use of the subtitles is for the convenience of the reader only and should not be interpreted as limiting in any way. It will be readily understood that the elements of the present invention, as generally described and illustrated in the figures herein, could be combined and used in a wide variety of different formulations and methods. Thus, the following more detailed description of the embodiments of the system and the method of the present invention is not intended to limit the scope of the invention, as claimed, but rather is simply representative of the presently preferred embodiments of the invention. 1. General analysis of Morinda citrifolia and the methods used to elaborate the products of processed Morinda citrifolia The Hindu Morera or Noni plant, scientifically known as Morinda Citrifolia L. ("Morinda citrifolia"), is a shrub or small tree up to 10 m high. The leaves are arranged oppositely with an elliptical to oval shape. The small white flowers are contained in a cluster similar to the head, globose, fleshy. The fruit is long, fleshy, and ovoid. At maturity, they are creamy white and edible, although they have an unpleasant taste and smell. The plant is native to Southeast Asia and has been extended in earlier times to a low area of India to eastern Polynesia. It grows randomly in the wild, and has been cultivated in plantations and small plots of individual growth. The flowers of Morinda citrifolia are small, white three to five tubular lobes with fragrance and approximately 1.25 cm. long. The flowers develop into fruits composed of many small drupes fused in an ovoid body, ellipsoid or round plate, lumpy, with waxy, white, or greenish-white or yellowish, semi-translucent skin. The fruit contains "eyes" on its surface, similar to a potato. The fruit is juicy, bitter, dull yellow or yellowish white, and contains many bones with two alveoli endowed with wings, oblong-triangular, hard reddish brown, each containing four seeds.

When fully ripe, the fruit has a pronounced smell similar to stale cheese. Although the fruit has been eaten by various nationalities as food, the most common use of the Morinda citrifolia plant was as a source of red and yellow dye. Recently, there has been an interest in the nutritious and healthy benefits of the Morinda citrifolia plant, discussed further below. Because the fruit of Morinda citrifolia is for all practical purposes inedible, the fruit must be processed in order to be savored for human consumption and included in the nutraceutical used to stimulate oral care. The juice of the processed Morinda citrifolia fruit can be prepared by separating the seeds and husks from the juice and pulp of a mature Morinda citrifolia fruit; filtering the pulp of the juice; and packing the juice. Alternatively, instead of packaging the juice, it can be immediately included as an ingredient in another food product, frozen or pasteurized. In some modalities, the juice and the pulp can be turned into puree in a homogeneous mixture that will be combined with other ingredients. Other processes include lyophilizing fruit and juice. Fruit and juice can be reconstituted during the production of the final juice product. Still other processes include air drying of fruit and juices, before being chewed. The present invention also contemplates the use of fruit juice and / or pureed fruit juice extracted from the plant of Morinda citrifolia. In a currently preferred process for the production of fruit juice of Morinda citrifolia, the fruit is either manually chopped or minced by mechanical equipment. The fruit can be harvested when it is at least 2-3 cm. (one inch) and up to 24-36 cm. (12 inches) in diameter. Preferably the fruit has a color that varies from dark green to yellowish green to a white color, and the nuances of color between them. The fruit is completely cleaned after harvesting and before any processing occurs. The fruit is allowed to mature or age from 0 to 14 days, with most of the fruit being kept for 2 to 3 days. The fruit matures or gets old when placed on equipment in such a way that it is not in contact with the ground. It is preferably covered with a fabric or mesh material during aging, although it can be aged without being covered. When it is ready for an additional process, the fruit has a light color, of a light green, light yellow, white or translucent color. The fruit is inspected to see if it has not been spoiled or so that it has an excessively green color or a firm firmness. The hard green and spoiled fruit is separated from the acceptable fruit. The mature and aged fruit is preferably placed in containers with plastic lids for further processing and transportation. The aged fruit containers can be maintained from 0 to 120 days. Most fruit containers are held for 7 to 14 days before processing. Optionally the containers can be stored under conditions of cooling products or ambient conditions / room temperature before further processing. The fruit is unpacked from the storage containers and processed through a manual or mechanical separator. The seeds and husks are separated from the juice and the pulp. The juice and pulp can be packed in containers for storage and transportation. Alternatively, the juice and pulp can be processed immediately into a finished juice product. The containers can be stored in conditions of cooling products, freezing, or room temperature. The juice and pulp of Morinda citrifolia are preferably mixed in a homogeneous combination, after which they are mixed with other ingredients, such as, for example, flavorings, sweeteners, nutritive ingredients, botanicals and dyes. The finished juice product is preferably heated and pasteurized at a minimum temperature of 83 ° C (181 ° F) or higher up to 100 ° C (212 ° F). Another product manufactured is the purée and puree juice of Morinda citri folia, in any concentrated or diluted form. The puree is essentially the pulp separated from the seeds and is different from the fruit juice product described herein. Each product is filled and sealed in a final plastic container, glass, or other suitable material that can withstand the processing temperatures. The containers are kept at the filling temperature or can be quickly cooled and then placed in a shipping container. The shipping containers are preferably wrapped with a material and in a manner that maintains or controls the temperature of the product in the final containers. The juice and pulp can be further processed by separating the pulp from the juice through filtering equipment. The filtering equipment preferably consists of: a decanter by centrifugation, a sieve filter with a size of 0.01 microns to 2000 microns, more preferably less than 500 microns, a filter press, filtration by reverse osmosis, and any other standard commercial filtration devices. The operating filter pressure preferably ranges from 0.007 kg / cm2 (0.1 psig.) To approximately 70.31 kg / cm2 (1000 psig.). The preference flow rate varies from 0.1 g.p.m. up to 1000 g.p.m., and more preferably between 5 and 50 g.p.m. The wet pulp is washed and filtered at least once and up to 10 times to remove any juice from the pulp. The moist pulp typically has a fiber content of10 to 40 weight percent. The wet pulp is preferably pasteurized at a temperature of 83 ° C (181 ° F) minimum and then it is packaged in barrels for further processing or it becomes a product with a high fiber content. The product of Morinda citrifolia processed can also exist as a dietary fiber. Still further, the product of Morinda citrifolia processed may also exist in the form of an essence. The essence of Morinda citrifolia typically includes a mixture of different fatty acids such as triglycerides, such as, for example, palmitic, stearic, oleic, and linoleic acids, and other fatty acids present in smaller amounts. In addition, preferably the essence includes an antioxidant to inhibit the corruption of the essence. Preferably, conventional food grade antioxidants are used. By drying the wet pulp can be further processed. Drying methods can include lyophilization, drying in barrels, drying in trays, drying in the sun, and spray drying. The Morinda pulp of dried trifolia may include a moisture content in the range of 0.1 to 15 weight percent and more preferably 5 to 10 weight percent. The dried pulp preferably has a fiber content in the range of 0.1 to 30 weight percent, and more preferably 5 to 15 weight percent. The high fiber product may include moist or dried Morinda citrifolia pulp, complementary fiber ingredients, water, sweeteners, flavorings, agents, coloring agents, and / or nutritive ingredients. The complementary fiber ingredients can include fiber products based on vegetables, either commercially available or developed in private. Examples of some typical fiber products are guar gum, gum arabic, soy fiber, oat fiber, pea fiber, fig fiber, citrus pulp sacks, hydroxymethyl cellulose, cellulose, seaweed, food grade wood or wood pulp. wood, hemicellulose, etc. Other complementary fiber ingredients can be derived from grains or grain products. The concentrations of these other fiber raw materials typically range from 0 to 30 percent by weight, and most preferably from 10 to 30 percent by weight. Typical sweeteners may include, but are not limited to: natural sugars derived from corn, beet, sugar cane, potato, tapioca, or other sources containing starch that can be converted chemically or enzymatically to crystalline pieces, powders and / or syrups. In addition, sweeteners may consist of artificial sweeteners or high intensity sweeteners, some of which are aspartame, sucralose, stevia, saccharine, etc. The concentration of sweeteners can vary between 0 to 50 weight percent of the formula, and more preferably between about 1 and 5 weight percent. Typical flavors may include, but are not limited to: artificial and / or natural flavor or ingredients that contribute to a pleasant taste. The concentration of flavors may vary, for example, from 0 to 15 weight percent, of the formula. Colors may include artificial or natural food grade coloring agents having a concentration ranging from 0 to 10 weight percent of the formula. Typical nutritional ingredients may include vitamins, minerals, trace elements, herbs, botanical extracts, bioactive chemicals and compounds at concentrations between 0 to 10 weight percent. Examples of vitamins that can be added to the fiber composition include, but are not limited to: vitamins A, Bl to B12, C, D, E, folic acid, pantothenic acid, biotin, etc. Examples of minerals and trace elements that can be added to the fiber composition include, but are not limited to: calcium, chromium, copper, cobalt, boron, magnesium, iron, selenium, manganese, molybdenum, potassium, iodine, zinc, phosphorus, etc. Herbs and botanical extracts include but are not limited to: alfalfa plant, bee pollen, chlorella powder, Dong Quai powder, Ecchinacea root, Gingko Biloba extract, horsetail herb, Indian mulberry, Shitake mushroom, seaweed spirulina, grape seed extract, etc. Typical bioactive chemicals may include, but are not limited to: caffeine, ephedrine, L-carnitine, creatine, lycopene, etc. The juice and pulp can be dried using a variety of methods. The juice and pulp mixture can be pasteurized or treated enzymatically before drying. The enzymatic process begins with the heating of the product at a temperature between 23.88 ° C (75 ° F) and 57.22 ° C (135 ° F). Then it can be treated with either an individual enzyme or a combination of enzymes. These enzymes include, but are not limited to: amylase, lipase, protease, cellulase, bromelain, etc. The juice and the pulp can also be dried with other ingredients, such as, for example, those described above together with the product with high fiber content. The typical nutritive profile of dehydrated juice and pulp is 1 to 20 percent moisture, 0.1 to 15 percent protein, 0.1 to 20 percent fiber, and the content of vitamins and minerals. 'The filtered juice and the water coming from washing, the wet pulp preferably mix together. The filtered juice can be evaporated under vacuum at a brixium of 40 to 70 and a humidity of 0.1 to 80 percent, more preferably 25 to 75 percent. The resulting concentrated Morinda citrifolia juice may or may not be pasteurized. For example, the juice could be pasteurized in circumstances where the sugar content or water activity was slow enough to prevent the development of microbes. It is packaged for storage, transport and / or additional processing.

In accordance with the present invention, an oral care composition in the form of a dietary supplement or an oral dental formulation applied topically or otherwise is used to treat and / or prevent one or more oral or dental disorders. The amount used per treatment may depend on several factors, including the type of oral or dental disorder, the physical characteristics of the patient, etc. The plant of Morinda citrifolia is rich in natural ingredients. Those ingredients that have been discovered include: (from the leaves); alanine, anthraquinones, arginine, ascorbic acid, aspartic acid, calcium, beta-carotene, cysteine, cystine, glycine, glutamic acid, glycosides, histidine, iron, leucine, isoleucine, methionine, niacin, phenylalanine, phosphorus, proline, resins, riboflavin , serine, beta-sitosterol, thiamin, threonine, tryptophan, tyrosine, ursolic acid and valine; (from flowers): acacetin-7-o-beta-d (+) -glucopyranoside, 5,7-dimethyl-apigenin-4 '-o-beta-d (+) -galactopyranoside, and 6,8-dimethoxy- 3-methylanthraquinone-lo-beta-rhamnosyl-glucopyranoside; (of the fruit): acetic acid, asperulósido, butanoic acid, benzoic acid, benzyl alcohol, 1-butanol, caprylic acid, decanoic acid, (E) -β-dodecene-gamma-lactone, acid (Z, Z, Z) - 8, 11, 14-eicosatrienoic, elaidic acid, ethyl decanoate, ethyl hexanoate, ethyl octanoate, ethyl palmitate, (Z) -6- (ethylthiomethyl) benzene, eugenol, glucose, heptanoic acid, 2-heptanone, hexanal, hexanamide, hexandioic acid, hexanoic acid (hexoic acid), 1-hexanol, 3-hydroxy-2-butanone, lauric acid, limonene, linoleic acid, 2-methylbutanoic acid, 3-methyl-2-buten-l-ol , 3-methyl-3-buten-l-ol, methyl decanoate, methyl elaidate, methyl hexanoate, methyl 3-methylthio-propanoate, methyl octanoate, methyl oleate, methyl palmitate, 2-methylpropanoic acid, 3-methylthiopropanoic acid, myristic acid, nonanoic acid, octanoic acid (octoic acid), oleic acid, palmitic acid, potassium, scopoletin, undecanoic acid, (Z, Z) -2, 5-undecadien-l-ol, and vomifol; (from roots): anthraquinones, asperuloside (rubicloric acid), damnacanth, glucosides, morindadiol, morindin, morindon, mucilaginous matter, nor-damnacanth, rubiadine, blondometh monomethyl ester, resins, soranjidiol, sterols, and anthraquinone monomethyl ether trihydromethyl; (from the root bark): alizarin, chloro-rubin, glycosides (pentose, hexose), morindadiol, morindanigrin, morindin, morindone, resinous matter, monomethyl ester, monomethyl ether of blondina and soranjidiol; (from wood): anthraggal-2, 3-dimethyl ether; (from tissue culture): damnacanth, lucidin, lucidin-3-primeveroside, and morindone-6-beta-primeveroside; (from the plant): alizarin, alizarin-alpha-methyl ether, anthraquinones, asperuloside, hexanoic acid, morindadiol, morindone, morindogenin, octanoic acid and ursolic acid. The present invention comprises using all parts of the M. citrifolia plant alone, in combination with each other, or in combination with other ingredients. The above listed portions of the M. citrifolia plant are not an exhaustive list of the parts of the plant that will be used but rather are simply exemplary. Thus, while some of the parts of the M. citrifolia plant were not mentioned above, (for example, the fruit seed, the pericarp of the fruit, the bark or the plant) the present invention contemplates the use of all parts of the plant. Recently, as mentioned, many health benefits have been discovered from the use of products containing Morinda citrifolia. A benefit of Morinda ci trifolia was found in its ability to isolate and produce Xeronine, which is a relatively small physiologically active alkaloid within the body. Xeronine occurs in virtually all healthy cells of plants, animals and microorganisms. Even though Morinda citrifolia has a negligible amount of free Xeronin, contains appreciable amounts of the Xeronin precursor, called Proxeronin. In addition, Mor inda citrifolia contains the inactive form of the enzyme Proxeronasa that releases Xeronin from Proxeronin. A document entitled "The Pharmacologically Active Ingredient of Noni" by R. M. Heinicke of the University of Hawaii, indicates that Morinda citrifolia is "the best raw material to be used in the isolation of xeronine", due to the constituent blocks of proxeronine and proxerone. These constituent blocks help in the isolation and production of xeronine within the body. The function of essential nutrient xeronine quadruples. First, xeronine serves to activate the inactive enzymes found in the small intestine. These enzymes are decisive for efficient digestion, calming nerves, and total physical and emotional energy. Secondly, xeronine protects and maintains the shape and elasticity of the protein molecules in such a way that they can be able to pass through the cell walls and can be used to form a healthy tissue. Without these nutrients entering the cell, it can not perform its work effectively. Without proxeronine to produce xeronine our cells, and subsequently the body, suffer. Third, xeronine helps in enlarging the membranous pores of the cells. This enlargement allows longer chains of peptides (amino acids or proteins) to be admitted into cells. These chains that are not used then are wasted. Fourth, the xeronine that is produced from proxeronine, helps in the enlargement of the pores to allow a better absorption of nutrients. Each tissue has cells, which contain proteins, that have receptor sites for the absorption of xeronin. Certain of these proteins are inert forms of enzymes, which require the absorbed xeronine to be activated. In this way, xeronine, by converting the procollagenase system of the body into a specific protease, rapidly and safely removes dead skin tissue. Other proteins become potential receptor sites for hormones after they react with xeronine. In this way, the action of Morinda citrifolia to make a person feel good is probably caused by xeronine that converts certain brain receptor proteins into active sites for the absorption of endorphin, the hormone that makes you feel good. Other proteins form pores through the membranes in the intestines, blood vessels and other organs of the body. The absorption of xeronine in these proteins changes the configuration of the pores and thus affects the passage of molecules through the membranes. Because of its many benefits, Morinda citrifolia is known to provide several anecdotal effects in individuals who have cancer, arthritis, headaches, indigestion, malignancies, broken bones, high blood pressure, diabetes, pain, infection, asthma, dental pains, spots , deficiency of the immune system, and others. Compositions containing Morinda citrifolia may be in a form suitable for oral use, for example, as tablets, or lozenges, aqueous or oily suspensions, dispersible powders or granules, emulsions, syrups or elixirs. The compositions intended for oral use can be prepared according to any method known in the art for the manufacture of Morinda citrifolia compositions and these compositions can contain one or more agents selected from the group consisting of sweetening agents, flavoring agents, coloring agents and conservative agents. The tablets contain Morinda citrifolia in combination with non-toxic, pharmaceutically acceptable excipients, which are suitable for the manufacture of tablets. These excipients may be, for example, inert diluents, granulating and disintegrating agents, binding agents., and lubricating agents. The tablets may be uncoated or they may be coated by known techniques to delay disintegration and absorption in the gastrointestinal tract and thereby provide a sustained action over a prolonged period. For example, a time delay material such as, for example, glyceryl monostearate or glyceryl distearate may be employed. The aqueous suspensions contain Morinda citrifolia in combination with suitable excipients for the preparation of the aqueous suspensions. These excipients are suspending agents, for example, sodium carboxymethylcellulose, methylcellulose, hydroxypropylmethylcellulose, sodium alginate, polyvinylpyrrolidone, tragacanth gum and acacia gum.; the dispersing or wetting agents can be a phosphatide occurring in nature, for example, lecithin, or the condensation products of an alkylene oxide with fatty acids, for example polyoxyethylene stearate, or condensation products of ethylene oxide with long-chain aliphatic alcohols, for example, heptadecaethylene-oxicetanol, or condensation products of ethylene oxide with partial esters derived from fatty acids and a hexitol such as, for example, polyoxyethylene sorbitan monooleate, or condensation products of ethylene oxide with esters partial derivatives of fatty acids and hexitol anhydrides, for example, polyethylenesorbitan monooleate. 2. Formulations and methods of administration The present invention provides methods for oral care and formulations comprising Morinda citrifolia such as, for example, toothpastes, gels, tooth powders, mouthwashes, mouthwashes, gums, mouth dews and lozenges comprising Morinda. cy trifolia. The form of Morinda citrifolia can be fruit juice, its extracts, fruit juice concentrate, noni essence, leaf powder, or leaf extracts. Morinda citrifolia is incorporated in various carriers or nutraceutical compositions suitable for the treatment of mammals in vivo. The processed Morinda citrifolia can be incorporated into a toothpaste, or gel, powder, granules, disintegrable tablet, mouthwash, pills or chewing gum. The compositions may further comprise water, flavoring agents, active compounds, emulsifiers, alcohol, sweeteners, thickening agents, surfactants, suspending agents, astringents and drug extracts, toning agents, flavor correctors, abrasives or polishers, deodorants, preservatives, buffers. of flavor, bleaching agents, substances for wound healing and inhibiting inflammation, dyes, dyes, pigments, abrasives, polishers, microbial agents, pH buffers and other additives and fillers. The oral care compositions may also comprise: water, flavoring agents, and other active compounds. In addition, the oral care compositions may comprise other ingredients selected from the group consisting of emulsifiers, alcohol, sweeteners, thickening agents, surfactants, astringents and drug extracts, toning agents, flavor correctors, abrasives or polishers, deodorants, preservatives. flavor, bleaching agents, substances for the healing of wounds and that inhibit inflammation, dyes, dyes, pigments, abrasives, polishers, antimicrobial agents, pH buffers, and the like and combinations thereof, as well as, other additives and filling materials, the selection and quantity thereof will depend on the nature of the composition for oral care. The active ingredients can be extracted from various parts of Morinda citrifolia plants using various alcohol or alcohol-based solutions, such as for example, methanol, ethanol and ethyl acetate, and other alcohol-based derivatives using any processes known in the art. .

The processed Morinda citrifolia product is an active ingredient or contains one or more active ingredients, such as, for example, Quercetin and Rutin, and others, to effect oral care. The active ingredients of Quercetin and Rutin are present in amounts by weight ranging from 0.01-10 percent of the total formulation or composition. These amounts can also be concentrated in a more potent concentration in which they are present in amounts ranging from 10 to 100 percent. Additionally, chemical and mechanical extraction methods are contemplated by the present invention including chromatographic systems. The processed Morinda citrifolia product can be formulated into other various ingredients to produce various compositions, such as, for example, a nutraceutical composition, an internal composition, or others. The ingredients that will be used in a nutraceutical composition are any that are safe for introduction into the body of a mammal, and particularly a human being, and can exist in various forms, such as, for example, liquids, tablets, lozenges, aqueous solutions o oily, dispersible powders or granules, emulsions, syrups, elixirs, etc. In addition, because the nutraceutical composition is likely to be consumed orally, one or more agents selected from the group consisting of sweetening agents, flavoring agents may be contained., coloring agents, preservatives and other medicinal agents as directed. The carrier medium can comprise any ingredient capable of being introduced into the body of a mammal, and which is capable of providing the carrier medium for the processed Morinda citrifolia product. Formulations with specific carrier media are well known in the art and will not be redescribed in detail herein. The purpose of the carrier medium is as established, to provide a means for incorporating the product of Morinda citrus trifolia processed into the body of the subject to be treated. The carrier for the components of the compositions herein can be any orally acceptable vehicle suitable for use in the oral cavity. These carriers include the usual components of toothpastes, dental powders, prophylaxis pastes, pills, gums and the like and will be described more fully hereinafter.

Flavoring Agents and Sweeteners Flavoring agents useful for the invention are any food grade or pharmaceutically acceptable flavoring agent, and specific flavoring agents will depend on the type of oral care composition. Preferably, the flavoring agent comprises natural flavoring essences, including those selected from the group consisting of mint essence, wintergreen essence, spearmint essence, clove bud essence, parsley essence, eucalyptus essence and the like. Combinations of essences and oils with other flavoring agents can also be used. Suitable flavoring agents may also be selected from a list comprising menthol, menthol, anethole, methyl salicylate, eucalyptol, cassia, ethyl acetate, sage, eugenol, oxanone, alpha-irisone, marjoram, lemon, orange, propenyl guaethol acetyl, cinnamon, vanilla, thymol, linalool, cinnamaldehyde, glycerol acetal and the like, and combinations thereof. The flavoring agent may comprise combinations of natural flavorings and other flavoring agents such as, for example, the compounds identified above. Also, the flavoring agent may comprise cooling agents such as, for example, menthol, N-substituted p-menthane-3-carboxamides (such as, for example, p-methane-3-carboxamide of N-ethyl), 3,1-ethoxypropane , 1,2-diol and the like, combinations thereof. Flavoring agents are generally used in the compositions at levels between about 0.001% to 5%, by weight of the composition. Any food grade and / or pharmaceutically acceptable sweetener can be used in the mouthwash, mouthwash, mouthwash, gum or lozenge compositions, including saccharin, fructose, xylitol, saccharin salts, thaumatin, aspartame, D-tryptophan, dihydrochalcones , acesulfame and cyclamate salts, especially sodium cyclamate and sodium saccharin, and combinations thereof. In addition to the flavoring and sweetening agents, optional ingredients, refreshing agents, saliva production, preventive agents, and numbing agents can be used in the compositions of the present invention. Preferred preventive agents include nicotinate capsid and esters, such as, for example, benzyl nichotinate. Preferred numbing agents include benzocaine, lidocaine, clove bud essence, and ethanol. These agents are present in the compositions at a level between about 0.001% to 10%, preferably between about 0.1% to 1% by weight of the composition. The cooling product may be any of a wide variety of materials. These materials include carboxamides, menthol, ketals, diols, and mixtures thereof. Preferred cooling products in the compositions herein are carboxamide paramentane agents such as, for example, N-ethyl-p-menthane-3-carboxamide, commercially known as "S-3", N, 2, 3-trimethyl. -2-isopropylbutanamide, known as "WS-23", and mixtures thereof. Additional preferred cooling products are selected from the group consisting of menthol, 3-1-menthoxypropan-1, 2-diol, menthone glycerolacetal, and menthyl lactate. The terms menthol and menthyl, in the sense in which they are used herein, include dextro- and levogytary isomers of these compounds and racemic mixtures thereof. TK-10 is described in U.S. Patent No. 4,459,425, Amano et al., Issued July 10, 1984. WS-3 and other agents are disclosed in U.S. Patent No. 4,136,163, Watson, et al., granted on January 23, 1979.

Other active ingredients The active compounds of the oral care composition will depend on the nature and use of the composition. In general, the active compounds for oral care compositions mask oral malodor, they attack the chemicals that produce the bad oral odor, they exterminate or inhibit the development of bacteria in the mouth that cause the bad smell of the breath or halitosis, they attack the tartar, they eliminate the dirt of the teeth and the mouth and / or whiten the teeth . For example, in embodiments of the invention wherein oral care compositions are in the form of mouthwashes, mouthwashes, mouth rubs, lozenges and the like, active components include active oral hygiene, antibacterial substances, anti-bacterial agents, avoid sensitivity, anti-plaque agents and combinations thereof, such as, for example, those selected from the group consisting of chlorine dioxide, fluoride, alcohols, triclosan, domifeno bromide, cetilpridiniochlor, calcium lactate, lactate salts of calcium and the like, and combinations thereof. In embodiments of the invention, where oral care compositions are in the form of dentifrices, such as, for example, toothpaste, gels and the like, the active components include active ingredients for oral hygiene, antibacterial substances, agents for preventing sensitivity, anti-plaque agents and combinations thereof, such as those selected from the group consisting of sodium fluoride, tin fluoride, sodium monofluorophosphate, triclosan, cetylpyridinium chloride, zinc salts, pyrophosphate, calcium lactate, salts of calcium lactate, 1-hydroxyethane-1, 2-diphosphonic acid, 1-phosphonopropane-1,2,3-tricarboxylic acid, azacycloalkan-2, 2-diphosphonic acids, cyclic aminophosphonic acids and the like, and combinations thereof . Oral compositions herein may also include other active agents, such as, for example, antimicrobial agents. These agents include water-insoluble non-cationic antimicrobial agents such as, for example, halogenated diphenylethers, phenolic compounds including phenol and its homologs, mono- and poly-alkyl and aromatic halophenols, resorcinol and its derivatives, bisphenolic and halogenated salicylanilide compounds, esters benzoic and halogenated carbanilides.

Water-soluble antimicrobials include quaternary ammonium salts and bis-biquanide salts, among others. Triclosan monophosphate is an additional water-soluble antimicrobial agent. Quaternary ammonium agents include those in which one or more of the substitutes at the quaternary nitrogen atom has a carbon chain length (typically the alkyl group) between about 8 to 20, typically between about 10 to 18 carbon atoms , while the remaining substitutes (typically the benzyl alkyl group) have a smaller number of carbon atoms, such as for example, between about 1 to 7 carbon atoms, typically methyl or ethyl groups. Dodecyltrimethylammonium bromide, tetradecylpyridinium chloride, domiphene bromide, N-tetradecyl-4-ethylpyridinium chloride, dodecyldimethyl (2-phenoxyethyl) ammonium bromide, benzyldimethylstearylammonium chloride, cetylpyridinium chloride, 5-amino-1,3-bis hexahydropyrimidine (2-ethylhexyl) -5-methyl quaternized, benzalkonium chloride, benzethonium chloride and methylbenzethonium chloride are examples of antibacterial quaternary ammonium agents. Other compounds are bis [4- (R-amino) -1-pyridinium] alkanes as set forth in U.S. Patent No. 4,206, 215, issued June 3, 1980, to Bailey. Other antimicrobials such as, for example, copper bisglycinate, copper glycinate, zinc citrate and zinc lactate may also be included. Enzymes are another type of active that can be used in the compositions herein. Useful enzymes include those belonging to the category of proteases, lithic enzymes, plaque matrix inhibitors and oxidases: proteases include papain, pepsin, trypsin, ficin, bromelain; lytic cell wall enzymes include lysozyme; inhibitors of the plaque matrix include dextranses, mutanases; and the oxidases include glucose oxidase, lactate oxidase, galactose oxidase, uric acid oxidase, peroxidases include horseradish peroxidase, myeloperoxidase, lactoperoxidase, chloroperoxidase. The oxidases also have bleaching / cleansing activity, in addition to the antimicrobial properties. These agents are disclosed in United States Patent No. 2,946,725, July 26, 1960, by Norris et al. and in U.S. Patent No. 4,051,234, September 27, 1977, Gieske et al. Other antimicrobial agents include chlorhexidine, triclosan, triclosan monophosphate and oring essences such as, for example, thymol. Triclosan agents and others of this type are disclosed in Parran, Jr. et al., U.S. Patent No. 5,015,466, issued May 14, 1991 and U.S. Patent No. 4,894,220, January 16. 1990 by Nabi et al. These agents, which provide anti-plaque benefits, may be present at levels between about 0.01% to 5.0% by weight of the dentifrice composition.

Thickening Agents To prepare the toothpastes or gels, some thickening material may be added to provide a convenient consistency to the composition, to provide the convenient release characteristics of the active at the time of use, to provide stability on a skin, and to provide the stability of the composition, etc. Preferred thickening agents are polymers of carboxyvinyl, carrageenan, hydroxyethyl cellulose, laponite and water soluble salts of cellulose ethers such as, for example, sodium carboxymethyl cellulose and sodium carboxymethyl hydroxyethyl cellulose. Natural gums can also be used, such as, for example, Baraya gum, swamp gum, gum arabic and tragacanth gum. The magnesium-aluminum colloidal silicate or the finely divided silica can be used as part of the thickening agent to further improve the texture. The thickening agent or binder for the toothpaste, may be selected from the group consisting of finely particulate gel silicas and nonionic hydrocolloids, such as, for example, carboxymethyl cellulose, sodium hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl guar, hydroxyethyl starch, polyvinyl pyrrolidone, vegetable gums, such as, for example, tragacanth, agar, carrageenans, gum arabic, xanthan gum, guar gum, locust bean gum, carboxyvinyl polymer, fumed silica, silica clay and the like and combinations thereof. The thickening agent or binder can be used with or without a carrier, such as, for example, glycerin, polyethylene glycol (PEG-400), or combinations thereof, however, when a carrier is used, up to about a thickening agent or binder at 5%, preferably between about 0.1% to 1.0%, is combined with about 95.0% up to about 99.9% of the carrier, preferably between about 99.0% up to 99.9%, based on the total weight of the thickening agent / carrier combination. A preferred class of thickening or gelling agents includes a class of homopolymers of acrylic acid crosslinked with an alkyl ether of pentaerythritol and an alkyl ether of sucrose, or carbomers. The copolymers of lactide and glycolide monomers, the copolymer has the molecular weight in the variation between about 1,000 to 120,000 (numerical average), are useful for the delivery of the assets in the periodontal pockets or around the periodontal pockets as a "carrier in subgingival gel ". These polymers are described in U.S. Patent No. 5,198,220, issued March 30, 1993, and U.S. Patent No. 5,242,910, issued September 7, 1993, both by Damani, and the patent of United States No. 4,443,430, Mattei, issued April 7, 1984. Agents can be used by thickening in an amount between about 0.1% to 15%, preferably between about 2% to 10%, more preferably between about 4% to 8% by weight of the total toothpaste or gel composition. Higher concentrations can be used for • chewing gums, pills (including breath mints), sachets, non-abrasive gels and subgingival gels. Any food grade or pharmaceutically acceptable thickener or binder can be used in the buccal wash, mouth rinse, mouth spray, gum or lozenge compositions. The thickening agent or binder can be dispersed in a carrier, such as, for example, glycerin, polyethylene glycol or combinations thereof (thickening agent / dispersion of the carrier). Thickeners and binders are those selected from the group consisting of xanthan gum, polymeric polyester compounds, natural gums (e.g., karaya gum, gum arabic, tragacanth gum), carrageenan hydroxymethylcellulose, methylcellulose, carboxymethylcellulose, arrowroot powder or maranta, starches, in particular corn starch and potato starch and the like, and combinations thereof. The thickening agent or binder can be used with or without a carrier, however, when a carrier is used, up to about 5% of the thickening agent or binder, preferably between about 0.1% to 1.0%, is combined with about 95.0% up to 99.9% of the carrier, preferably about 99.0% up to 99.9%, based on the total weight of the thickener / proton combination.

Blotting agents Blotting agents that can be used in the mouthwash, mouthwash, mouthwash, gum or lozenge compositions include those selected from the group consisting of calcium citrate, rosin esters of wood, vegetable gum emulsion, caprylic triglycerides / Caprices, certain gums similar to guar gum or gum arabic and essences with high stability.

Abrasives or Polishers Any of the usual abrasives or polishers, including those selected from the group consisting of gypsum, calcium carbonate, dicalcium phosphate, insoluble sodium metaphosphate, aluminum silicates, calcium pyrophosphate, finely particulate synthetic resins, silicas, can be used. aluminum oxide, aluminum oxide trihydrate, hydroyapatite and the like, or combinations thereof. The abrasive or polisher may preferably be complete or predominantly finely particulate xerogel silica, hydrogel silica, precipitated silica, aluminum oxide trihydrate and finely particulate aluminum oxide or combinations thereof.

Surfactants The surfactants useful in toothpastes or gels are those selected from the group consisting of surfactants with a high foam-anion content, such as, for example, sodium linear C 2 -i 8 alkyl sulphates; sodium salts of linear C12_15aqluylpolyglycol ether sulfates containing from 2 to 6 glycol ether groups in the molecule; alkyl- (C? 2-? 6) -benzene sulfonates; linear alkane- (C? 2-? 6) sulfonates; monoalkyl (C 2 2 8) -sulfosuccinic acid esters; monoglycerides of sulfated fatty acid; sulfated fatty acid alkanolamides; alkyl- (C? 2_? 8) - sulfoacetic acid esters; and acylsarcosides, acyltauride and acyl isothionates all containing from 8 to 18 carbon atoms in the acyl entity. Nonionic surfactants, such as for example fatty acid mono- and diglyceride ethoxylates, fatty acid sorbitan esters and block polymers of ethylene oxide-propylene oxide are also suitable. Particularly preferred surfactants are sodium lauryl sulfate and sarcosinate. Combinations of surfactants can be used. One of the preferred optional agents of the present invention is a surfactant, preferably one selected from the group consisting of sarcosinate surfactants, isethionate surfactants and taurate surfactants. The alkali metal or ammonium salts of these surfactants are preferred for use herein. Most preferred are the sodium and potassium salts of the following: lauroyl sarcosinate, myristoyl sarcosinate, palmitoyl sarcosinate, stearoyl sarcosinate and oleoyl sarcosinate. This surfactant may be present in the compositions of the present invention between about 0.1% to 2.5%, preferably between about 0.3% to about 2.5% and more preferably between about 0.5% to 2.0% by weight of the total composition. Optionally other suitable compatible surfactants can be used or in combination with the sarcosinate surfactant in the compositions of the present invention. Suitable optional surfactants are described more fully in U.S. Patent No. 3,959,458, May 25, 1976 to Agricola et al .; U.S. Patent No. 3,937,807, February 10, 1976 to Haefele; and U.S. Patent No. 4,051,234, September 27, 1988 to Gieske et al. Preferred anionic surfactants useful herein include the water soluble salts of alkyl sulfates having from 10 to 18 carbon atoms in the alkyl radical and the water soluble salts of sulfonated monoglycerides of fatty acids which. they have 10 to 18 carbon atoms. Sodium lauryl sulfate and coconut and sodium monoglyceride sulfonates are examples of anionic surfactants of this type. Mixtures of anionic surfactants can also be used. Preferred cationic surfactants useful in the present invention can be broadly defined as derivatives of aliphatic quaternary ammonium compounds having a long alkyl chain having between about 8 to 18 carbon atoms such as, for example, lauryltrimethylammonium chloride, cetylpyridinium chloride , cetyltrimethylamide bromide, di-isobutylphenoxyethyl-dimethylbenzylammonium chloride; alkyltrimethylammonium nitrite and coconut; 'cetylpyridinium fluoride; etc. Preferred compounds are the quaternary ammonium fluorides described in U.S. Patent No. 3,535,421, October 20, 1970, to Briner et al., Wherein the quaternary ammonium fluorides have detergent properties. Certain cationic surfactants may also act as germicides in the compositions set forth herein. Cationic surfactants such as, for example, chlorhexidine, although they are suitable for use in the present invention, are not preferred because of their ability to stain hard tissues of the oral cavity. Those skilled in the art are aware of this possibility and should incorporate cationic surfactants only with this limitation in mind. The preferred nonionic surfactants that can be used in the compositions of the present invention can be broadly defined as the compounds produced by the condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound that can be aliphatic or alkylaromatic by nature. Examples of suitable nonionic surfactants include pluronics, polyethylene oxide condensates of alkyl phenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylene diamine, condensates of ethylene oxide of aliphatic alcohols, long chain tertiary amine oxides, long chain tertiary phosphine oxides, long chain dialkyl sulfoxides and mixtures of these materials. The preferred zwitterionic synthetic surfactants useful in the present invention can be broadly described as aliphatic quaternary ammonium derivatives, phosphonium and sulfonium compounds, in which the aliphatic radicals can be straight or branched chain, and wherein one of the aliphatic substituents contains between about 8 to 18 carbon atoms and one contains a solubilization group in anionic water, for example, carboxy, sulfonate, sulfate, phosphate or phosphonate. Preferred betaine surfactants are disclosed in U.S. Patent No. 5,180,577 to Polefka et al. Awarded on January 19, 1993. Typical alkyldimethylbetaines include decylbetaine or 2- (N-decyl-N, N-dimethylammonium) acetate, cocobetaine 2- (N-coc-N, N-dimethylammonium) acetate, myristylbetaine, pal itylbetaine, laurylbetaine, cetilbetaína, cetilbetaína, esteariulbetaína, etc. Amidobetaines are exemplified by cocoamidoethyl betaine, cocoamidopropyl betaine, lauramidopropyl betaine and the like. The betaines of choice are preferably cocoamidopropylbetaine and, more preferably, lauramidopropylbetaine.

Chelating Agents Another preferred optional agent is a chelating agent such as, for example, tartaric acid and the pharmaceutically acceptable salts thereof, citric acid and alkali metal citrates and mixtures thereof. The chelating agents are capable of forming a complex calcium found in the cell walls of bacteria. Chelating agents can also break up plaque by removing calcium from calcium bridges, which helps keep this biomass intact. However, it is not convenient to use a chelating agent that has an affinity for calcium that is too high, since this can result in dental demineralization, which is contrary to the aims and intentions of the present invention.

Sodium and potassium citrate are the preferred alkali metal citrates, of which sodium citrate is most preferred. A combination of citric acid / alkali metal citrate is also preferred. Preferred herein are alkali metal salts of tartaric acid. To a greater extent, dipotassium tartrate, dipotassium tartrate, sodium potassium tartrate, sodium acid tartrate and potassium acid tartrate are preferred for use herein. The amounts of the chelating agent suitable for use in the present invention are between about 0.1% to 2.5%, preferably between about 0.5% to 2.5% and more preferably between about 1.0% to 2.5%. The chelating agent, with salt of tartaric acid, can be used alone or in combination with other optional chelating agents. Other optional chelating agents can be used. Preferably, these chelating agents have a calcium binding constant between about 101 to 105 to provide improved cleaning with reduced plate and stone formation. Another group of agents suitable for use as chelating agents in the present invention are soluble pyrophosphates. The pyrophosphate salts used in the compositions herein can be any of the alkali metal pyrophosphate salts. Specific salts include tetraalkali metal pyrophosphate, dialkali metal acid pyrophosphate, trialkaline metal monoacid pyrophosphate and mixtures thereof, wherein the alkali metals are preferably sodium or potassium. The salts are useful in their hydrated as well as unhydrated forms. An effective amount of pyrophosphate salt useful in the present invention will generally be enough to provide at least 1.0% pyrophosphate ion, preferably between about 1.5% to 6%, most preferably between about 3.5% to 6% of these ions . It should be appreciated that the level of pyrophosphate ions is that which is capable of being provided to the composition (ie, the theoretical amount at a suitable pH), and that the pyrophosphate forms other than P207 may be present when a pH of the Final product. The pyrophosphate salts are described in more detail in Kirk & Othmer, Encyclopedia of Chemical Technology, Second Edition, Volume 15, Interscience Publishers (1968). Optional agents that will be used in place or in combination with the pyrophosphate salt include those materials known as polyaminopropanesulfonic acid (AMPS), zinc citrate trihydrate, polyphosphates (eg, tripolyphosphate, hexametaphosphate), diphosphonates ( for example, EHDP, AHP), polyphosphonates, phosphonate copolymers, polypeptides (such as, for example, polyaspartic polyglutamic acids), and mixtures thereof. Examples of phosphonate copolymers are the diphosphonate polymers derived in U.S. Patent No. 5,011,913 to Behedict et al. A preferred polymer is diphosphonate modified polyacrylic acid. Suitable phosphonate-containing polymers such as by U.S. Patent No. 5, 980,776 to Zakikhani, et al. The polyphosphates are also optionally included in the compositions herein. It is understood that a polyphosphate generally consists of two or more phosphate molecules arranged mainly in a linear configuration, although some cyclic derivatives may be present. In addition to the pyrophosphates and tripolyphosphates which are technically polyphosphates, they are also desired polyphosphates having about four or more phosphate, ie tetrapolyphosphate and hexametaphosphate, among others. Polyphosphates greater than tetrapolyphosphates usually occur as amorphous vitreous materials. In this invention, the linear "glassy" polyphosphates are preferred. These polyphosphates can be used alone or in combination thereof. Yet another possible group of chelating agents suitable for use in the present invention are the polymeric anionic polycarboxylates. These materials are well known in the art, they will be employed in the form of their free or partially or preferably neutrally soluble alkali metals in fully neutralized water (eg, potassium and preferably sodium) or ammonium salts. Preferred are 1: 4 to 4: 1 copolymers of maleic anhydride or acid with another polymerizable ethylenically unsaturated monomer, preferably methyl vinyl ether (methoxyethylene) having a molecular weight (MW) of from about 30,000 to about 1,000,000. Other functional polymeric polycarboxylates include those such as, for example, the 1: 1 copolymers of maleic anhydride with ethyl acrylate, hydroxyethyl methacrylate, N-vinyl-2-pyrrolidone, or ethylene, and copolymers of acrylic acid with methyl methacrylate or hydroxyethyl, acrylate of methyl or ethyl, isobutyl vinyl ether or N-vinyl-2-pyrrolidone. Additional functional polymeric carboxylates are disclosed in U.S. Patent No. 4,138,477, February 6, 1979 to Gaffar and U.S. Patent No. 4,183,914, January 15, 1980 to Gaffar et al., And include copolymers of maleic anhydride with styrene, isobutylene or ethylvinyl ether, poly-acrylic, poly-itaconic and polymaleic acids, and sulfoacrylic oligomers of PM as low as 1,000 available as Uniroyal ND-2.

Fluoride source It is common to have an additional water-soluble fluoride compound present in dentifrices and other oral compositions in an amount sufficient to provide a fluoride ions concentration in the composition at 25 ° C, and / or when used between approximately 0.0025% up to 5.0% by weight, preferably between about 0.005% up to 2.0% by weight, to provide an additional anti-caries effectiveness. A wide variety of materials that provide fluoride ions in the compositions herein can be employed as sources of soluble fluoride. Examples of materials that provide suitable fluoride ions are found in U.S. Patent No. 3,535,421, October 20, 1970 to Briner et al. and U.S. Patent No. 3,678,154, July 18, 1972 to Widder et al. Representative fluoride ions sources include tin fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, and many others. Tin fluoride and sodium fluoride are particularly preferred, as well as mixtures thereof.

Assets for teeth whitening and tooth-color modifying substances The teeth whitening agents that can be used in the oral care compositions of the present invention include bleaching agents and oxidants such as, for example, peroxides, perborates, percarbonates, peroxyacids, persulfates , metal chlorites, and combinations thereof. Suitable peroxide compounds include hydrogen peroxide, urea peroxide, calcium peroxide and mixtures thereof. A preferred percarbonate is sodium percarbonate. Other suitable bleaching agents include potassium, ammonium, sodium and lithium persulfates and mono- and tetrahydrate perborate, and sodium pyrophosphate peroxyhydrate. Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite. The preferred chlorite is sodium chlorite. The additional bleaching assets can be hypochlorite and chlorine dioxide. In addition to bleaching agents such as teeth whitening agents, tooth color modifying substances can be considered among the active oral care agents useful in the present invention. These substances are suitable to modify the color of the teeth for consumer satisfaction. These substances comprise particles that when applied to the surface of the tooth modify that surface in the terms of absorption and, or reflection of light. These particles provide a benefit of appearance when a film containing these films is applied on the surface of a tooth or teeth. The most useful particles in the present invention include pigments and dyes commonly used in the cosmetic arts. There are no specific limitations for the pigment and, or, the dye used in the composition of the present other than the limitation of the effect it has on the light source on the tooth surface. The pigments and dyes include organic white pigments, inorganic pigments, talking agents, filler powders and the like. Specific examples are selected from the group consisting of talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, aluminum-magnesium silicate, silica, titanium dioxide, zinc oxide, red iron oxide, brown iron oxide, yellow iron oxide, black iron oxide, ferric ammonium ferrocyanide, violet manganese, ultramarine, nylon powder, polyethylene powder, methacrylate powder, polystyrene powder, silk powder, crystalline cellulose, starch, mica with titanium, mica with titanium and iron oxide, bismuth oxychloride, and mixtures thereof. Those selected from the group consisting of titanium dioxide are preferred to a greater extent, bismuth oxychloride, zinc oxide and mixtures thereof. Pigments that are generally recognized as safe are listed in C.T.F.A. Cosmetic Ingredient Handbook, 3rd Edition, Cosmetic and Fragrance Assn., Inc., Washington D.C. (1982). Pigments are typically used as opacifiers and colorants. These pigments can be used as treated particles, or as the pigments of raw material by themselves. The typical pigment levels are selected for the particular impact desired by the consumer. For example, for teeth that are particularly dark or stained, pigments in a sufficient amount could typically be used to lighten the teeth. On the other hand, when on the individual teeth the spots on them are lighter than on other teeth, the pigments can be useful to darken the teeth. Pigment and dye levels are generally used in the variation between about 0.05% up to 20%, preferably between about 0.10% up to 15% and more preferably between about 0.25% up to 10% of the composition.

Humectants Another optional component of topical oral carriers, of the compositions of the present invention is a humectant. The humectant serves to maintain the toothpaste compositions from damage to exposure to the air, to provide the compositions with a moist sensation in the mouth, and, so that the particular humectants impart a desirable flavor sweetness to the compositions of the toothpaste. the toothpaste. The humectant, on a pure humectant base, generally comprises between about 0% to 70%, preferably between about 5% to 25% by weight of the composition herein. Suitable humectants for use in the compositions of the present invention include: edible polyhydric alcohols such as, for example, glycerin, sorbitol, xylitol, butylene glycol, polyethylene glycol and propylene glycol, especially sorbitol and glycerin.

Alkali metal bicarbonate salt The present invention also includes an alkali metal bicarbonate salt. The alkali metal bicarbonate salts are soluble in water and unless stabilized, tend to release carbon dioxide in an aqueous system. Sodium bicarbonate, also known as sodium or potassium bicarbonate, is the preferred alkali metal bicarbonate salt. The composition herein may contain between about 0.5% to 30%, preferably between about 0.5% to 15%, and most preferably between about 0.5% to 5% of an alkali metal bicarbonate salt.

Miscellaneous carriers The water used in the preparation of the commercially suitable oral compositions should preferably have a low ionic content and be free of organic impurities. Water in general comprises between about 10% to 50%, and preferably between about 20% to 40% by weight of the aqueous toothpaste compositions herein. These amounts of water include the free water that is added plus that which is introduced with other materials, such as for example, with sorbitol. Titanium dioxide can also be added to the composition herein. Titanium dioxide is a white powder that adds opacity to the compositions. Titanium dioxide in general comprises between about 0.25% up to 5% by weight of the dentifrice compositions. Other optional agents that may be used in the compositions herein include dimethicone copolyols selected from alkyl- and alkoxy-dimethicone copolyols, such as, for example, C12 to C20 alkyldimethicone copolyols and mixtures thereof. The copolyol of cetyldimethicone marketed under the trade name Abil EM90 is very preferred. The dimethicone copolyol is generally present at a level between about 0.01% to 25%, preferably between about 0.1% to 5%, more preferably between about 0.5% to 1.5% by weight. The dimethicone copolyols help to provide positive benefits of sensation in the teeth.

Preservatives and pH buffers The preservatives and antimicrobial agents that can be used in toothpaste or gels include those selected from the group consisting of p-hydroxybenzoic acid; methyl, ethyl or propyl ester; sodium sorbate; sodium benzoate, bromochlorophen, esters of phenylsalicylic acid, thymol, and the like; and combinations thereof. The pH of the present compositions is preferably adjusted through the use of buffering agents. Buffering agents, in the sense in which they are used herein, refer to agents that can be used to adjust the pH of the compositions to a variation between about .5 to 9.5. Buffering agents include monosodium phosphate, trisodium phosphate, sodium hydroxide, sodium carbonate, sodium acid pyrophosphate, citric acid and sodium citrate. Buffering agents can be administered at a level between approximately 0.5% to 10%, by weight of the compositions herein. The pH of the dentifrice compositions is measured from a 3: 1 aqueous suspension of toothpaste, for example, 3 parts of water to 1 part of toothpaste. Suitable pH buffers include those selected from the group consisting of primary, secondary or tertiary alkyl phosphates, citric acid, sodium citrate, and the like or combinations thereof. Substances for wound healing and which inhibit inflammation include those selected from the group consisting of active substances of allantoin, urea, azulene, chamomile and acetylsalicylic acid derivatives, and the like, or combinations thereof.

Dyes [0122] Food grade and / or pharmaceutically acceptable coloring agents can be used in the present invention, as understood by one skilled in the art. An example of a pigment is titanium dioxide (such as, for example, U.S.P. grade available from Whittaker, Clark &Daniels) to provide a bright white color. The food grade, and / or pharmaceutically acceptable agents, dyes or colorants, as understood by one skilled in the art, can be used in these compositions, including, FD &C dyes including blue FD &C primary No. 1, blue FD &C No. 2, green FD &C No. 3, yellow FD &C No. 5, yellow FD &C No. 6, red FD &C No. 3, red FD &C No. 33 and red FD & C No. 40 and blue plates FD &C No. 1, blue FD &C No. 2, yellow FD &C No. 5, yellow FD &C No. 6, red FD &C No. 2, red FD &; C No. 3, red FD &C No. 33, red FD &C No. 40 and combinations thereof. Dyes and similar dyes can also be used. A composition preferably contains between about 0.1% to 10% of these agents, preferably between about 0.1% to 1% by weight of the composition. Typical mouthwash, mouthwash, mouthwash, gum, and lozenge compositions will comprise between about 30% to 80% water, between about 2% to 35% humectant, between about 1% to 50% of active compounds comprising at least Morinda citrifolia, about 0.01% up to 0.50% of at least one sweetener, between about 0.01% up to 0.50% of at least one thickening agent or binder that can be dispersed in about 2.5% up to 10% of a carrier, such as example, glycerin, polyethylene glycol (PEG-400) or combinations thereof, between about 0.03% to 3% of at least one surfactant and between about 0.01% to 1% of at least one flavoring agent. Optionally, typical compositions for mouthwash, mouthwash, mouthwash, gum or lozenge comprise between about 0.01% to 1.0% dyes, including dyes and pigments between about 0.01% to 1.0% of clouding agents. The compositions may further comprise between about 0.01% to 1.0% titanium dioxide. In another embodiment of the invention, the oral care composition is in the form of a dentifrice, such as, for example, a toothpaste or gels. Toothpaste and gels in general are understood to be paste-like or gel-like preparations that are applied directly to teeth in general by brushing, and toothpastes can be a combination of pastes and gels, as well as combinations of gels or toothpaste with mouthwashes or mouthwashes. Gums and lozenges can also be used as dentifrices with the proviso that they include the active ingredients normally associated with the dentifrice compositions. The dentifrice composition in general will comprise between about 5% to 20% water, between about 5% to 75% humectant, between about 0.25% to 3.0% of at least one thickening agent or binder that can be dispersed between about 2.5% up to 10% of a carrier, such as, for example, glycerin, polyethylene glycol (PEG-400), or combinations thereof, between about 0.01% to 0.05% sweeteners, between about 5% to 40% abrasives and polishes, between about 0.5% up to 3.0% of surfactants, between approximately 0.01% up to 50.0% of active compounds that comprise Morinda ci trifolia and that can be included in the active ingredients for oral hygiene, antibacterial substances, agents to avoid sensitivity, anti-plaque agents and combinations thereof, and between about 0.25% to 3.0% flavoring agents. The dentifrice compositions may also comprise filler materials and additives, such as, for example, between about 0.05% to 1.0% of a preservative and / or antimicrobial agents, between about 0.50% to 10.0% of buffers, between about 0.05% to 5.0% of substances for wound healing and that inhibit the inflammation, between about 0.01% up to 2.0% dyes, such as, for example, colors, dyes or special effect particles, and between about 0.05% up to 10.0% bleaching agents, such as, for example, hydrogen peroxide, and pyrophosphates. Various embodiments of the formulations are provided below. However, these are only intended to be exemplified as one skilled in the art will recognize other formulations or compositions comprising the processed Morinda citrifolia product. In an exemplary embodiment, the present invention further incorporates a method for administering a nutraceutical composition comprising Morinda citrifolia for oral care. The method comprises the steps of(a) formulating a nutraceutical composition comprising a portion of a processed Morinda citrifolia product present in an amount between about 0.01 and 95 weight percent, wherein the composition also comprises a carrier, such as, for example, water or purified water , and other natural or artificial ingredients; (b) administering the nutraceutical composition in the body such that the processed Morinda citrifolia product is sufficiently internalized; (c) repeating the above steps as often as necessary to provide an effective amount of the Morinda citrifolia product processed. The step of administering the nutraceutical composition in the body comprises ingesting the composition orally through one or several means. Specifically, the nutraceutical composition can be prepared as a liquid, gel, solid, or some other type that would allow the composition to be digested, chewed quickly and conveniently or otherwise exposed to tissues present in the mouth of a mammal. In addition, the processed Morinda citrifolia can be incorporated into a toothpaste or gel, powder, granules, disintegrable tablet, mouthwash, pills or chewing gum. The following tables illustrate or represent some of the preferred formulations or compositions contemplated by the present invention. As stated, these are only intended as examples and should not be construed as limiting in any way.

TABLE 1: Toothpaste powder, granules, or disintegrable tablets Ingredient% by weight calcium carbonate 50.0 Morinda citrifolia 31.0 microcrystalline cellulose 14.6 PluronieF121. 2.0 xanthan gum 1.0 Methocel K15MP 0.5 Flavor 0.5 Monoantimony 0.4 Glycyrrhizinate One of the embodiments of this invention is a toothpaste in the form of paste. A typical formula for a toothpaste according to the claims of this invention continues in table two.

TABLE 2: Toothpaste Ingredient% by weight Morinda citrifolia 35.9 Water 33.4 Calcium carbonate 24.1 Pluronic .0 Cellulose gum 1.5 Methocel 0.5 dipotassium glycyrrhizinate 0.4 One of the embodiments of this invention is a gel-shaped dentifrice. A typical formula for OA Flavor TABLE 3: tooth gel Ingredient% by weight Morinda citrifolia 38.0 Water 33.3 Thickener silica 10 Glycerin 7.3 Abrasive silica 5 Pluronic 4 Cellulose gum 1.5 Methocel 0.5 Disodium glycyrrhizinate 0.2 Taste 0L2 One of the embodiments of this invention is a hard or soft tablet for the prevention of plaque that will be suctioned by the user. A typical formula for a tablet according to the claims of this invention is shown in table four.

TABLE 4: Toothpaste Ingredient% by weight Morinda citrifolia 91.6 Pluronic acid 4.0 Cellulose gum 1.0 Methocel 0.5 Calcium carbonate 2.0 Flavor 0.5 Dipotassium glycyrrhizinate 0.4 One of the embodiments of this invention is a chewing gum for plaque prevention. A typical formula for a chewing gum according to the claims of this invention is shown in table five.

TABLE 5: Tooth chewing gum Ingredient% by weight Rubber base 20.0 Morinda citrifolia 67.5 Calcium carbonate 5.0 Glycerin 3.0 Pluronic 2.0 Cellulose gum 1.0 Metocel 0.5 Flavor 0.5 Onoammonium glyceride 0.4 xanthan gum 0.1 One of the modalities of this invention is a mouthwash for the prevention of license plate. A typical formula for a mouthwash is shown in table six.

TABLE 6: Mouthwash Ingredient% by weight Water 65.49 Morinda CI trifolia 32.1 Pluronic 1.0 Cellulose gum 0.24 Methocel 0.12 Taste 0.5 Disodium glycyrrhizinate 0.4 Preservative 0.1 Sodium fluoride 0.05 In a preferred method, one who wishes to stimulate oral care as described above, takes or administers, at least one ounce of mouthwash (shown in table six) in the morning, and at least one ounce at night, just before going to rest. In one example, this does not mean that it is limiting in any way, the beneficial Morinda citrifolia is processed in Tahitian Noni® Juice manufactured by Morinda, Incorporated of Orem, Utah.

Another preferred method of the present invention, someone who wishes to stimulate oral care as described above uses the toothpaste described above with a brushing mechanism to apply the paste to his teeth. After brushing with the toothpaste of the present invention, the person maintains at least one ounce of mouthwash, of the present invention, in his mouth, for a sufficient period of time. In a preferred embodiment of the invention, this method is repeated multiple times during the day comprising early in the morning, just before going to rest and after meals. These particular methods of introducing a composition may comprise any method of actually introducing the composition to the subject for the purposes of the subject for the purpose of promoting the stimulation of oral care. Although there are many particular methods, the present invention recognizes that the composition can be introduced by a variety of mechanisms including orally. No matter which method is used, it is important to regulate the amount of the active ingredient to which the subject is exposed in such a way that the objectives for proper oral care are carried out. The following examples are established and present the effects of oral care with Morinda ci trifolia. These examples are not intended to be limiting in any way, but rather to be merely illustrative of the benefits and advantages of using Morinda citrifolia for oral care. 3. Stimulation of oral care The present invention can be incorporated into other specific forms without departing from its spirit or essential characteristics. The described modalities will be considered in all their aspects only as illustrative and not restrictive. The scope of this invention, therefore, is indicated by the appended claims rather than by the foregoing description. All the changes that are within the meaning and variation of equivalence of the claims will remain within its scope. The present invention capitalizes on these properties by incorporating the components of the Morinda citrifolia plant as constituents of the oral care compositions to treat and prevent various mouth and dental related disorders. Certain embodiments of the present invention comprise an excipient-based component and an active component comprising Morinda cy trifolia in an amount of up to fifty percent by weight.

Example 1: Prevention of gingival disease In view of the foregoing, an object of certain embodiments of the present invention is to provide an oral dental formulation capable of reinforcing the immune response to gingival diseases or dental caries. In this embodiment of the present invention, one who wishes to stimulate oral care as described above uses the toothpaste described above with a brushing mechanism to apply the paste to his teeth. After brushing with the toothpaste of the present invention, the person maintains at least one ounce of oral wash described above in his mouth, for a period of time sufficient to inhibit gingival diseases or dental caries. In a preferred embodiment of the present invention, this method is repeated multiple times during the day comprising early in the morning, just before resting and after meals. These particular methods for introducing a composition can comprise any method for actually introducing the composition to the subject in order to stimulate oral care including the use of the toothpaste powder described above, the granules, disintegrable tablets, paste, gel, lozenge, gum or mouthwash alone or in combination with each other. No matter which method is used, it is important to regulate the amount of the active ingredient to which the subject is exposed in such a way that the objectives for proper oral care are carried out.

Example 2: Increase in Collagen Density A further objective of certain embodiments of the present invention is to provide an oral dental formulation and method to reduce gingival bleeding by reducing inflammation in the gingival sulcus and increasing the density of gingival collagen. In this embodiment of the present invention, one who wishes to stimulate oral care as described above uses the toothpaste described above with a brushing mechanism to apply the paste to his teeth. After brushing with the toothpaste of the present invention, the person maintains at least one ounce of oral wash described above in his mouth, for a period of time sufficient to increase the density of the gingival collagen. In a preferred embodiment of the present invention, this method is repeated multiple times during the day comprising early in the morning, just before going to rest and after meals. These particular methods for introducing a composition may comprise any method for actually introducing the composition to the subject in order to stimulate oral care including the use of the toothpaste powder described above, granules, disintegrable tablets, paste, gel, lozenge, gum or mouthwash. alone or in combination with each other. No matter which method is used, it is important to regulate the amount of the active ingredient to which the subject is exposed in such a way that the objectives of proper oral care are carried out.

Example 3: Reduce plaque Another objective of certain embodiments of the present invention is to provide an oral dental formulation and the method to reduce loss of periodontal fixation by reducing plaque formation and / or plaque adhesion to teeth and tissues. surrounding oral In this embodiment of the present invention, one who wishes to promote oral care as described above, uses the toothpaste described above with a brushing mechanism to apply the paste to his teeth. After brushing with the toothpaste of the present invention, the person maintains at least one ounce of the mouth wash described above in his or her mouth, for a period of time sufficient to reduce plaque formation and / or plaque adhesion to the plaque. the teeth and the surrounding oral tissues. In a preferred embodiment of the present invention, this method is repeated multiple times during the day comprising early in the morning, just before going to rest and after meals. These particular methods for introducing a composition can comprise any method for actually introducing the composition to the subject in order to stimulate oral care including the use of the toothpaste powder, granules, disintegrable tablets, paste, gel, lozenge, gum or mouthwash described above. alone or in combination with each other. No matter which method is used, it is important to regulate the amount of the active ingredient to which the subject is exposed in such a way that the objectives of proper oral care are carried out.

Example 4: Reduce bacterial activity Another objective of certain embodiments of the present invention is to provide an oral dental formulation and method for reducing the permeability of the epithelial cell wall to bacterial toxins, and further reducing the activity of the enzyme collagenase in the presence of of bacteria. In this embodiment of the present invention, one who wishes to stimulate oral care as described above, uses the toothpaste described above with a brushing mechanism to apply the paste to his teeth. After brushing with the toothpaste of the present invention, the person maintains at least one ounce of the mouth wash described above in his mouth, for a period of time sufficient to reduce the activity of the enzyme collagenase in the presence of bacteria. In a preferred embodiment of the present invention, this method is repeated multiple times during the day including early in the morning, just before going to rest and after meals. These particular methods for introducing a composition can comprise any method for actually introducing the composition to the subject in order to stimulate oral care including the use of the powder, dentifrice, granules, disintegrable tablets, paste, gel, lozenge, gum or mouthwash described. formerly alone or in combination with each other. No matter which method is used, it is important to regulate the amount of the active ingredient to which the subject is exposed in such a way that the objectives of proper oral care are carried out.

Example 5: Increase in cellular respiration Still another objective of certain embodiments of the present invention is to provide an oral dental formulation and the method for increasing cellular respiration and oxygen saturation of the cells in the mouth. In this embodiment of the present invention, one who wishes to stimulate oral care as described above, uses the toothpaste described above with a brushing mechanism to apply the paste to his teeth. After brushing with the toothpaste of the present invention, the person maintains at least one ounce of oral wash described above in his mouth, for a period of time sufficient to increase cellular respiration and oxygen saturation of the cells in the mouth. . In a preferred embodiment of the present invention, this method is repeated multiple times during the day comprising early in the morning, just before going to rest and after meals. These particular methods for introducing a composition can comprise any method for actually introducing the composition to the subject in order to stimulate oral care including the use of the toothpaste powder, granules, disintegrable tablets, paste, gel, lozenge, gum or mouthwash described above. alone or in combination with each other. No matter which method is used, it is important to regulate the amount of the active ingredient to which the subject is exposed in such a way that the objectives of proper oral care are carried out.

Example 6: Inhibiting Canker Sores An additional object of certain embodiments of the present invention is to provide an oral dental formulation and the method to reduce the incidence and duration of canker sores in the mouth. In this embodiment of the present invention, one who wishes to stimulate oral care as described above uses the toothpaste described above with a brushing mechanism to apply the paste to his teeth. After brushing with the toothpaste of the present invention, the person maintains at least one ounce of oral wash described above in his mouth, for a period of time sufficient to reduce the incidence and duration of canker sores in the mouth. In a preferred embodiment of the present invention, this method is repeated multiple times during the day comprising early in the morning, just before going to rest and after meals. These particular methods for introducing a composition can comprise any method for actually introducing the composition to the subject in order to stimulate oral care including the use of toothpaste, granules, disintegrable tablets, paste, gel, lozenge, gum or mouthwash alone or in the combination with each other. No matter what method is used, it is important to regulate the amount of active ingredient to which the issue is exposed so that the appropriate oral care goals are met.

Example 7: Stain Removal Another object of certain embodiments of the present invention is to provide an oral dental formulation and method for cleaning teeth, removing surface stains from teeth, and bleaching teeth. In this embodiment of the present invention, one who wishes to stimulate oral care as described above uses the toothpaste described above with a brushing mechanism to apply the paste to his teeth. After brushing with the toothpaste of the present invention, the person maintains at least one ounce of oral wash described above in his or her mouth, for a period of time sufficient to clean the teeth, remove surface stains from the teeth, and whiten the teeth. teeth. In a preferred embodiment of the present invention, this method is repeated multiple times during the day comprising early in the morning, just before going to rest and after meals. These particular methods for introducing a composition can comprise any method for actually introducing the composition to the subject in order to stimulate oral care including the use of toothpaste., granules, disintegrable tablets, paste, gel, pill, rubber or mouthwash alone or in combination with each other. No matter what method is used, it is important to regulate the amount of active ingredient to which the issue is exposed so that the appropriate oral care goals are met.

Example 8: Improve dental health Still another objective of certain embodiments of the present invention is to provide an oral dental formulation and method for treating and preventing gingival diseases and caries in mammals and in general improving overall dental health. In this embodiment of the present invention, one who wishes to stimulate oral care as described above uses the toothpaste described above with a brushing mechanism to apply the paste to his teeth. After brushing with the toothpaste of the present invention, the person maintains at least one ounce of oral wash described above in his mouth, for a sufficient period of time to treat and prevent gingival diseases and caries in mammals and further improve overall global dental health. In a preferred embodiment of the present invention, this method is repeated multiple times during the day comprising early in the morning, just before going to rest and after meals. These particular methods for introducing a composition can comprise any method for actually introducing the composition to the subject in order to stimulate oral care including the use of toothpaste, granules, disintegrable tablets, paste, gel, lozenge, gum or mouthwash alone or in the combination with each other. No matter what method is used, it is important to regulate the amount of active ingredient to which the issue is exposed so that the appropriate oral care goals are met.

Example 9: Reduce Halitosis A further objective of certain embodiments of the present invention is to provide an oral dental formulation and method for reducing halitosis in mammals. In this embodiment of the present invention, one who wishes to stimulate oral care as described above uses the toothpaste described above with a brushing mechanism to apply the paste to his teeth. After brushing with the toothpaste of the present invention, the person maintains at least one ounce of oral wash described above in his mouth, for a period of time sufficient to reduce the halitosis in mammals. In a preferred embodiment of the present invention, this method is repeated multiple times during the day comprising early in the morning, just before going to rest and after meals. These particular methods for introducing a composition can comprise any method for actually introducing the composition to the subject in order to stimulate oral care including the use of toothpaste, granules, disintegrable tablets, paste, gel, lozenge, gum or mouthwash alone or in the combination with each other. No matter what method is used, it is important to regulate the amount of active ingredient to which the issue is exposed so that the appropriate oral care goals are met.

Example 10: Antimicrobial Properties of Morinda Ci Trifolia Products Processed Research conducted in support of this invention demonstrates that processed Morinda citrifolia products have antimicrobial activity. The minimum inhibitory concentration (MIC) of an antibacterial is defined as the maximum dilution of the product that will still inhibit the development of a test microorganism. The minimum lethal concentration (MLC) of an antibacterial is defined as the maximum dilution of the product that will kill a test organism. The MIC / MLC values can be determined by various standard test procedures. The most common methods used are the tube dilution method and agar dilution methods. The tube dilution method proposed for this product to determine the MIC, and the aliquots in plates from dilutions that demonstrate the possible inhibition of development to determine the MLC. Serial dilutions of the products were made in bacterial development medium. The test organisms were added to the dilutions of the products, they were incubated, and they were marked for their development. All tests were performed in triplicate. This procedure is a standard analysis for antimicrobials. The procedure incorporates the content and intent of the methodology recommended by the American Society for Microbiology (ASM, for its acronym in English). The tube dilution method employs dilutions of the test product in a medium for bacterial development, inoculation with a predetermined test organism concentration, and visualization of development after incubation. Tube dilution procedures are limited to products that do not precipitate or cloud the development medium within the expected final variation. Cell cultures were prepared from a stock solution, the test organisms were transferred to broth for soybean casein digestion (SCOB) and incubated at 37 ± 2 ° C for 24-48 hours for the bacteria, and 20-25 ° C for the yeast. If necessary, the suspensions were adjusted to approximately 108 colony forming units (CFU) per ml, by visual turbidity, in physiological saline solution (PHSS) and a standard plate count was performed to determine initial titers. . The yeast culture was placed on Sabouraud dextrose agar (SDEX) and incubated at 20-25 ° C for 2-4 days, S. mutans was incubated at 37 ± 2 ° C for 3-5 days. days, and all other bacteria were incubated at 37 ± 2 ° C for 18-24 hours. The tests were carried out at a neutral pH. The pH was recorded before and after the adjustments had been made. Each test product was diluted 1: 2 serially in sterile water. It was selected that dilutions could be displayed at the end of the MIC / MLC. Each evaluation of the test product was done in triplicate for each organism. The product dilutions were added to an equal volume of 2X SCDB to provide an additional 1: 2 dilution.

Three tubes were prepared for positive control for each test organism by mixing sterile water with equal volumes of 2X SCDB. Three tubes were prepared for negative control by mixing the highest tested dilution of the test product with equal volumes of 2X SCDB. The test organisms were not added to these tubes. Three tubes were prepared for medium control by mixing sterile water with equal volumes of 2X SCDB. No test organisms were added to these tubes. Approximately 0.05 ml of each suspension of the test organism was added to the sample and to the positive control tubes. The bacteria test tubes were incubated at 37 ± 2 ° C for 18-24 hours and the yeast test tubes were incubated at 20-25 ° C for 2-4 days. After incubation, the development was marked as negative (0) or positive (+) for each tube. Only tubes that were suspected to have no development were tested for MLC. An aliquot of 1.0 ml was removed from each tube and serial dilutions 1/10 in neutralizing broth were made up to 1/1000. Each aliquot of each dilution was placed on neutralizing agar (NUAG, for its acronym in English). For a positive control, 10-100 CFU were placed on NUAG. Negative control was carried out when plating 2X SCDB on NUAG. Plates were incubated 20-25 ° C for 2-4 days for yeast, and 37 ± 2 ° C for 18-24 hours for all bacteria except for S. mutans. The lowest dilution of the test product was tested for MLC and also tested for neutralization recovery for each test organism. In triplicate, aliquots of 0.5 ml of the most concentrated test product were placed on NUAG. The plates were seeded with 10-100 CFU of each test organism. For comparison, three NUAG plates without the test product were also seeded with the same 10-100 CFU for each of the test organisms. With the exception of S. mutans, all organisms were inhibited by the neutralized concentrate of Morinda citrifolia at a concentration of 1: 2. None of the dilutions tested was able to demonstrate lethality for any of the organisms. Neither inhibition nor lethality was demonstrated by the neutralized Noni concentrate when tested against S. mutans. The MIC results for all organisms are summarized in Tables 1-7. The MLC results for each organism are summarized in Tables 8-13. Because S. mutans had no dilution, it was noted that it had no development for the MIC portion of the test, MLC was not performed for this organism. Neutralization recoveries for all test organisms ranged from 40-97%. The recovery of neutralization of the neutralizing medium used in the study is summarized in Table twenty.

TABLE 7: Results MIC Escherichia coli 0157H7 ATCC # 43885 Valuation: 7.0 x 108 CFU / ml TABLE 8: Results MIC Staphylococcus aureus ATCC # 653? Valuation: 6.5 x 108 CFU / ml TABLE 9: Results MIC Bacillus subtilis ATCC # 19659 Titration: 8.5 x 107 CFU / ml TABLE 10: Results MIC Salmonella choleraesuis serotype enteritidis ATCC # 13706 Rating: 4.8 x 108 CFU / ml TABLE 11: Results MIC Listeria monocytogenes ATCC # 19111 Evaluation: 3.9x 108 CFU / ml TABLE 12: Results MIC Candida albicans ATCC # 10231 Valuation 1.3 x 108 CFU / ml TABLE 13: Results MIC Streptococcus mutans ATCC # 25175 Titration: 1.0 x 10 ° CFU / ml TABLE 14: Counts on plate MLC Escherichia coli 01 57H7 ATCC # 43888 Note: Volume on plate = 0.5 ml TNTC = Too many to be counted TABLE 15: Counts on plate MLC Staphylococcus aureus ATCC # 6538 TNTC = Too many to be counted TABLE 16: MLC plate counts Bacilus subtilis ATCC # 19659 TABLE 17: Plate counts MLC Salmonella choleraesuis serotype enteritidis ATCC # 13706 TNTC = Too many to be counted TABLE 18: Counts on plate MLC hysteria moriocytogenes ATCC # 19111 TNTC = Too many to be counted TABLE 19: Counts on plate MLC Candida albicans ATCC # 10231 TNTC = Too many to be counted TABLE 20: Neutralization Example 11: Morinda citrifolia processed as a dental medicament A simple investigation can be enhanced to validate the development of Morinda ci trifolia as a dental medicament. The present invention contemplates three areas of research that confirm the safety and efficacy of the use of Morinda citrifolia as an agent for oral care. First, the research will be conducted to examine the in vitro antimicrobial activity of Morinda citrifolia against common periodontal and endodontic pathogens. Second, the research will be conducted to examine the effectiveness of Morinda citrifolia to clean and disinfect the root canals. Third, the research will be conducted to assess the in vitro biocompatibility of Morinda citrifolia for oral tissues. The antimicrobial action of irrigants is tested using in vitro cultures of common endodontic periodontal pathogens. The most widely accepted and used technique is to evaluate the test materials using the standardized single disk method. This technique involves the inoculation of discs with test substances, in the present invention Morinda citrifolia to assess its antimicrobial activity. The advantage of using this standard technique is the ease of interpretation of the antimicrobial activity and the high degree of reproducibility that can be carried out. The effectiveness of the test materials for cleaning and disinfecting the root canals can be assessed using scanning electron microscopy to visualize the adherence and elimination of microbes. The elimination of microbes after an endodontic therapy is important to avoid the failure of a subsequent treatment for the complications created by the persistence of microbes. It is also important to remove any layer of dentine rub to try to improve the sealing of endodontic materials with dental surfaces. Improper sealing of endodontic materials can allow microbes to leak into oral tissues and this can create treatment complications that lead to failure. If the test materials prove to have an effective antimicrobial activity and are effective in cleaning and disinfecting the root canals, they must be evaluated for safety before they can be used as part of a dental treatment. The toxicity of potential drugs is examined using tests to measure biocompatibility. The interaction between tissues and materials is called biocompatibility. Biocompatibility is measured according to the assessment criteria defined by the International Organization for Standardization (ISO) and the International Dental Federation. These organisms produce the ISO 10993- and 7405 indications that specify the pre-clinical evaluation tests for devices and materials that will be used as part of a dental treatment. Dental materials that pass ISO pre-clinical evaluation tests can be used worldwide as standards that incorporate national and local standards. , The standards include the requirements of the Food and Drug Administration of the United States and the American Dental Association. The ideal irrigant should have an antimicrobial action, low toxicity and good biocompatibility for oral tissues, and should have the ability to clean the walls of the root canals and eliminate the rub layer. The rub layer is a 1 mm thick layer of denatured cutting debris produced on the surfaces of the cavity subjected to instrumentation, and is composed of dentin, odonto-hygroscopic processes, non-specific inorganic contaminants and microorganisms. The removal of the rub layer from the walls of the root canals subjected to instrumentation is controversial. Its elimination provides a better sealing of the endodontic filling material for the dentin, and will prevent the leakage of microorganisms in the oral tissues. Infiltration of microorganisms in oral tissues should be avoided because they often cause complications that lead to treatment failure. 1. Examination of the in vitro antimicrobial activity of Morinda citrifolia against common endodontic periodontal pathogens The antimicrobial effects of Morinda citrifolia do not have to be proven on common periodontal and endodontic pathogens. The purpose of this part of the proposal is to evaluate the in vitro antimicrobial activity of Morinda citrifolia on seven commonly isolated oral microbial pathogens. Isolates of specific microbes will be obtained from the American Type Culture Collection (ATCC). Pure cultures should be stored in covered 1.5 ml glass vials at -68 ° C to -72 ° C. After removing these vials from the freezer, they will be allowed to thaw before being inoculated into the sterile test tubes containing the broth development medium. The suspension will be shaken in a Vortex mixer and incubated for 3 to 5 days at 37 ° C in a Coy anaerobic chamber containing an atmosphere of 85% nitrogen, 10% hydrogen and 5% carbon dioxide. For all types of broth, a control sample (without added inoculum) will be treated in the same way as inoculated tubes to ensure sterility. After the inoculation period, the purity of each culture in the broth stage will be tested with gram-tention microscopy before inoculation on agar plates. After shaking the cultures using a Vortex mixer, inoculation on sheep blood agar plates was performed by soaking sterile cotton swabs in the cultures, removing the excess inoculated by pressing the swab against the side of the test tube, and then distributing the inoculum uniformly through the total agar surface. The plates were allowed to air dry for 2 to 3 minutes. The susceptibility of the various microorganisms to Morinda citrifolia was evaluated using the standardized single disc method similar to that used for the antibiotic sensitivity test. The sterile white disks were carefully placed on the agar surface using sterile handling procedures. The discs were then loaded with 10 μl of various concentrations of Morinda citrifolia. Disks with clinamycin were used as a positive control, and sterile disks loaded with sterile saline instead of Morinda citrifolia were used as a negative control. The discs were arranged spatially on the surface of the blood agar as far apart as possible (approximately 3 cm), while maintaining a distance of at least 2 cm from the edges of the Petri dish. The time elapsed between the withdrawal of the anaerobic chamber culture suspension, the distribution of the inoculum, the placement of the discs and the loading of the various experimental treatments was estimated at 15 minutes. For each microbial species, five replicates of the three disk spatial arrangements on agar plates (15 plates per bacterial species) will be prepared. A concentrated solution of Morinda citrifolia will be diluted in ten concentrations (dosages, Ix, lOx, lOOx and l, 000x) and will be loaded on blank discs. The pH of all dilutions with Morinda citrifolia will be adjusted to be identical to the stock solution (eg, pH 8.9). The sown plates were incubated for 5 to 7 days in an anaerobic chamber. The zones of inhibition produced by the various concentrations of Morinda citrifolia were measured using a compass. A reading of 7 mm (diameter of the disc) indicates the absence of a zone of inhibition for bacterial development. The other edge of the zone of inhibition will be defined as the additional concentric zone from the edges of the disk where the inhibition of complete Bactrian development occurs. In an effort to estimate the minimum inhibitory concentration of Morinda ci trifolia for each of the 6 microbial species, intermediate doses of Morinda citrifolia will be calculated from the concentrations that produced greater zones of inhibition and those that did not inhibit bacterial development. Five of each of these inhibitory doses will be made. All data will be analyzed using a statistical test with Analysis of Variance (ANOVA, for its acronym in English) one way, followed by the test multiple comparison Scheffe post hoc at a level of significance of P <; 0.05. This statistical procedure is among the most conservative and reliable methods available to analyze the approximate data. 2. Examination of the efficacy of Morinda citrifolia for cleaning and disinfecting the root canals Human teeth will be collected from clinics with the approval of the Internal Review Board. Sixty intact, freshly extracted permanent teeth were selected, which were not stored in antibacterial or fixative solutions and which had not received medications for the root canals. All the teeth had an individual root canal, and the root lengths varied from 12 to 16 mm. Conventional access preparations will be prepared and root canals subjected to 1 mm instrumentation beyond the apical foramen with Hedstroem size 50 files. Irrigation with sterile water was performed during preparation. After preparation of the root canal, the enlarged apical foramen were sealed with epoxy resin to prevent bacteria leakage. To make it easier to handle and identify teeth, they will be mounted vertically in blocks of plaster and sterilized in an autoclave for 20 minutes at 121 ° C. The pure developmental culture of Enterococco faecalis ATTCC 29212 in Brain-Heart Infusion Broth (BHF-Difco) will be used to contaminate the root canals inside the extracted teeth. The root canals will be inoculated with 10 FL of 1.5 x 108 CFU ml of suspension using sterile 1 ml tuberculin syringes. The blocks of plaster will be placed inside stainless steel boxes and incubated at 37 ° C for 24 hours. After incubation, the contaminated teeth will be divided into six groups according to the irrigation regime used: (1) teeth (or 0) with the root canals irrigated with 2 ml of Morinda citrifolia using an optimum concentration determined from the phase 1 of this proposal; (2) teeth (n 10) with root canals irrigated with 2 ml of 2% chlorhexidine solution; (3) teeth (n 10) with root canals irrigated with 2 ml of 6% sodium hypochlorite solution; (4) teeth (n 10) with root canals irrigated with 2 ml of 0.9% sterile saline as a treatment for negative control; (5) teeth (n = 10) with root canals irrigated with a mixture of 2 ml of Morinda citrifolia and 2% chlorhexidine solution; (6) teeth (n 10) with root canals irrigated with a mixture of 2 ml of Morinda citrifolia and 6% sodium hypochlorite solution. The 6 irrigation treatments (described above) will be delivered using a 2 ml sterile plastic syringe and a 24 gauge needle. The needle will be inserted into the root canals approximately 1 mm away from the walls, and 2 ml of the irrigant will be delivered. . The irrigant will be placed in the canal for 5 minutes and removed, followed by irrigation with 1 ml of sterile saline. The effectiveness of the 6 irrigation treatments for cleaning and disinfecting the root canals will be assessed by micrographic images of high power of the root canals using an electronic scanning machine (SEM). The teeth will be prepared for use in the SEM by fixing the dental tissues in 10% formalin solution at 18 ° C for 24 hours. The teeth were then post-fixed in osmium tetroxide (1% w / w) for 2 hours before dehydrating in a graduated series of ethanol solutions (20%, 50%, 70%, 90%, for 15 minutes each, followed by 3x 10 minutes of 100% ethanol). They will be removed and the solutions placed in hexamethyldicilizano for 5 minutes to fix the dehydrated specimens. The pieces of tooth will be dried on filter paper for drying. The dry specimens will be mounted on stereoscopes of aluminum, either with conductive carbon cement or with quick-setting Araldite. The dry mounted specimens will be coated with a tin metal layer of 20-30 mm gold / palladium on a Poiaron E5000 metalizer coater and observed on a Strip 200 SEM. The SEM micrographs were obtained at x2, 000 increase using software for digital image analysis. The total of 60 specimens (each opening in two) will be examined and the micrographic images will be stored as digital files in an Acer Computer connected to the SEM. Each of the root canals will be explored in its entirety to obtain an overview of the general surface topography. The micrographs will be taken from characteristic areas representative of the general surface topography of each specimen. The surfaces of the dentin root canals will be evaluated for the presence of the rub layer and the microorganisms using one of the semi-quantitative visual criteria of the scale from zero to four. The efficacy of Morinda citrifolia and the irrigation treatments to clean and disinfect the root canals will be assessed using the semi-quantitative criteria: 0: no elimination of microorganisms or rubbing layer of the root canals. 1: less than 50% elimination of microorganisms and rub layer. 2: approximately .50% - elimination of microorganisms and rub layer. 3: more than 50% elimination of microorganisms and rub layer but not complete elimination. 4: complete elimination of microorganisms and rub layer. 3. Assessment of the in vitro biocompatibility of Morinda citrifolia for oral tissues Toxicology studies were performed on rats for the acute toxicity titers of Morinda citrifolia. Via an esophageal tube fifteen thousand mg / kg were administered. The animals were observed for 14 days after treatment. All the animals survived and no adverse clinical signs were named. No signs of severe organ toxicity were observed after necropsy. Two studies were conducted using guinea pigs to assess the allergenic risk of Morinda citrifolia. Both study designs included an induction phase and a rest period, followed by a reinforcement with Morinda citrifolia. The first study involved two test groups of six animals each, a group for positive control, and a group for negative control. After reinforcement, the animals were observed for 24 hours. In this study, no allergic reactions were observed to Morinda ci trifolia. The second study involved forty-five guinea pigs. The study consisted of several test groups using various forms and concentrations of Morinda ci trifolia with groups for accompanying negative control. The test groups were induced three times each week for two weeks. After thirty-two days of the rest, all animals were boosted and assessed for the symptoms of an allergic response. No positive allergic reactions were observed in any Noni group after reinforcement in the animals. A 13-week oral toxicity study was conducted to further assess the systemic safety of Morinda citrifolia. Eighty Sprague Dawley rats were assigned in four groups; a control group and three dose groups. Daily doses of esophageal tube included 0.4 ml / kg, 4 ml / kg, and 8 ml / kg. The animals were observed for adverse clinical signs, food consumption, and weight gain. Additionally, blood samples were extracted by hematology and clinical chemistry at the conclusion of the study. In addition, weights of selective organs were measured and tissue samples from organs were removed for microscopic examination. The totality of the groups did not show differences related to the treatment in body and organ weights, food consumption, clinical examinations, blood chemistry, hematological measurements, and tissue histological examination. A second 13-week oral toxicity study of Morinda citrifolia was performed. This study covers higher doses than the previous 13-week study. Three dosage groups were included in this study. The samples evaluated were of an individual resistance to Morinda ci trifolia, a Morinda citrifolia, concentrated 2.5 times, and a Morinda citrifolia concentrated 4 times. The concentrated samples were used to achieve a dosage equivalent of 50 ml / kg of body weight and 80 ml / kg of body weight. The protocol and measurements for the second 13-week study were the same as the first. The results of this study show that the level of unobservable adverse effects (NOAEL, for its acronym in English) was higher than 20 ml of the 4 times of Morinda citrifolia / kg / day. This is equivalent to 80 ml of Morinda citrifolia / kg / day. In perspective, this amount is 8% of the weight of the animal's body weight. There was no upper limit for safe consumption that had already been determined for these studies. The data indicate that Morinda ci trifolia can be consumed safely in effective amounts. Beyond the biocompatibility analyzes already carried out, there are several classification sets that can be used to evaluate the safety of Morinda citrifolia before it can be used as a dental material. The classification tests for measuring the biocompatibility of dental materials were specified by the ISO. The ISO is a worldwide federation of national standards bodies (ISO member bodies). The standards of ISO 7405 [International Standards Organization 2003] specifically cover dental materials and ISO 10993 standards [International Standards Organization 2003] specifically covers medical devices, which also include dental materials. International standards are a harmonization and combination of national standards, including the American Dental Association ANSI-ADA, document number 41 [Acceptance program guidelines, 1998; American Dental Association, 1997], British Standard 5736 [1989], and Deutches Institut fur Normung DIN V 13 930 [1996]. The ISO defines a dental material as a substance or combination of substances specially prepared and / or presented for use by authorized persons in the practice of dental procedures and / or their associates. The established primary goal of ISO 10993 entitled the biological evaluation of medical devices is the protection of human beings [Organización de Normas Internacionales, 2003]. This is the most current total guidelines document for the selection of tests, which will be used for the evaluation of relevant biological responses for doctors or dental material and device safety. ISO 7405 is entitled the preclinical evaluation of biocompatibility of medical devices used in dentistry - test methods for dental materials [Organization of International Standards, 2003] is related to the pre-clinical testing of materials used in dentistry and supplements ISO 10993. The ISO 10993 and ISO 7405 guidelines have recommended standards for the biological evaluation of dental materials. In summary these are included; (i) this corresponds to the manufacturer of dental material to select the appropriate tests, based on the intended use of the material, and the known or assumed toxicity profile of the material of its components. (ii) A manufacturer may select one of three cytotoxicity tests with preference due to cost, experience or other reasons. (iii) New materials should be evaluated using initial cytotoxicity and secondary tests for tissue selection before extensive animal testing and clinical trials. (iv) The test results should always be interpreted taking into consideration the manufacturers established to use the material. To carry out phase II of this research proposal, we try to evaluate the Morinda citifolia according to the first phase of the biological test program recommended by the ISO. On the condition that these tests are successful. Then the other preclinical phases of the biological test program will be conducted in a subsequent investigation. The permanent cell line of mouse fibroblasts (clone L-929) has provided a means for a good reproducibility of the cytotoxicity test between different laboratories and materials. This cell line is easy to develop and has been widely used for the biological selection of dental materials. The L-929 cell line will be developed for confluence in 50 ml of culture plasters using Dulbecco's Modified Eagles Medium (VWR, Suwanee, GA, USA), 10% Fetal Bovine Serum (VWR, Suwanee, GA, USA), and 1% penicillin and streptomycin (VWR, Suwanee, GA, USA). Cell cultures will be determined in a 5% carbon dioxide incubator at 37 ° C throughout the trial period.

Immediately, before the test, the cells will be stained with a stain of neutral red vital dye (VWR, Suwanee, GA, USA). A thin layer of agar will be prepared and placed on top of the cell cultures using a sterile technique. A millipore cellulose acetate filter is placed in contact with the confluent cell cultures. A concentrated solution of Morinda citrifolia will be diluted in ten concentrations (dosages: Ix, lOOx, lOOx, and l, 000x) and 50 μl will be loaded onto the filters. For each concentration, five replicates will be prepared. The trial period will be 24 hours. During this time, any filtering substances must be diffused through the pores of the 0.45 μm filter to exert any cytotoxic effect on the cells. The appearance of the test filters between the contact areas with Morinda citrifolia-cell will be recorded according to a labeling system to classify the cytotoxicity response. The presence of toxic substances that can be filtered from Morinda citrifolia will be manifested by a loss of dye inside the cells as they are lysed. The ability of this simple strategy to determine the cytotoxic risk of an in vitro material and generalize this for in vivo systems has been successful because the results are easy to interpret.

Claims (51)

1. NOVELTY OF THE INVENTION Having described the present invention, it is considered as a novelty and, therefore, the content of the following CLAIMS is claimed as property 1. A nutraceutical composition for stimulating oral care characterized in that it comprises: one of a quantity Effective of the processed Morinda citrifolia product and an effective amount of an extract of Morinda citrifolia; and a carrier. The composition according to claim 1, characterized in that the Morinda citrifolia is selected from the group consisting of Morinda citrifolia fruit, Morinda citrifolia fruit extract, Morinda citrifolia fruit juice concentrate, Morinda citrifolia essence, leaf powder of Morinda citrifolia, and extract of leaves of Morinda citrifolia. 3. The composition according to claim 1, characterized in that the carrier comprises ingredients selected from the group consisting of an emulsifier, alcohol, sweeteners, thickening agents, surfactants, suspending agents, astringents and extracts for toning, flavor corrective, abrasive agents. or polishers, deodorants, preservatives, flavoring buffers, bleaching agents, substances for the healing of wounds and to inhibit the 'inflammation, dyes, dyes, pigments, abrasives, polishes, antimicrobial agents, pH buffers and combinations thereof. 4. The composition according to claim 1, characterized in that the carrier further comprises substances selected from the group consisting of glycerin, edible polyhydric alcohols, polyols and combinations thereof. The composition according to claim 4, characterized in that the polyols are selected from the group consisting of glycerol, propylene glycol, propylene glycol glycerol, polyethylene glycol, isomalt, xylitol, maltitol, sorbitol, mannitol and combinations thereof. 6. The composition according to claim 1, characterized in that the carrier is comprised of flavoring agents selected from the group of compounds consisting of mint essence, gauteria essence, spearmint essence, clove bud essence, parsley essence, essence of the eucalyptus, menthol, menthol, anethole, methyl salicylate, eucalyptus, cassia, 1-methylacetate, sage, eugenol, oxanone, alpha-iris, marjoram, lemon, orange, propenyl guaethol acetyl, cinnamon, vanilla, thymol, linalool, cinnamaldehyde glycerol acetal, N-substituted 3-carboxamides p-mentan-3, 1-methoxypropane-1,2-diol and combinations thereof. The composition according to claim 1, characterized in that the carrier is further comprised of active compounds selected from the group consisting of chlorine dioxide, fluoride, alcohols, triclosan, domifeno bromide, cetilpridiniochlor, calcium lactate, calcium lactate salts , sodium fluoride, tin fluoride, sodium monofluorophosphate, cetylpyridinium chloride, zinc salts, pyrophosphate, 1-hydroxyethane-1,2-diphosphonic acid, 1-phosphonopropane-1,2,3-tricarboxylic acid, azacycloalkan 2, 2-diphosphonic, cyclic aminophosphonic acids combinations thereof. The composition according to claim 1, characterized in that it is in the form of toothpaste, gel, mouthwash, mouthwash, gum, mouthwash, lozenge, subgingival irrigation fluid, coated fiber, an interproximal toothbrush, an applied solution topically, drops of sweet gum, pieces of candy, candy bars, and nougat or combinations thereof. The composition according to claim 8, characterized in that the coated fiber also comprises dental floss. 10. The composition according to claim 8, characterized in that the coated fiber further comprises a bristle for a dental brush. The composition according to claim 1, further characterized in that it comprises a sweetener. The compositions according to claim 11, characterized in that the carrier is comprised of a sweetener selected from the group consisting of saccharin, fructose, xylitol, saccharin salts, thaumatin, aspartame, D-tryptophan, dihydrochalcones, acesulfa e, cyclamate salts, and combinations thereof. The compositions according to claim 1, characterized in that the carrier is comprised of clouding agents selected from the group consisting of calcium citrate, rosin esters, vegetable gum emulsion, caprylic / capric triglycerides, guar gum, gum arabic and high-strength essences. stability. 14. The compositions according to claim 1, characterized in that the carrier is comprised of abrasives or polishers selected from the group consisting of gypsum, calcium carbonate, dicalcium phosphate, aluminum silicates, calcium pyrophosphate, finely particulate synthetic resins, silicas, aluminum, aluminum oxide trihydrate, hydroyapatite, finely insoluble sodium metaphosphate macroparticles, xerogel silica, hydrogel silica, precipitated silica, aluminum oxide trihydrate and finely particulate aluminum oxide and combinations thereof. 15. The compositions according to the claimi 1, characterized in that the carrier is comprised of preservatives and antimicrobial agents selected from the group consisting of p-hydroxybenzoic acid, methyl ester, ethyl ester, propyl ester, sodium sorbate, sodium benzoate, bromochlorophen, phenylsalicylic acid esters, thymol and combinations thereof. same. 16. The compositions according to claim 1, characterized in that the carrier is comprised of pH buffers selected from the group consisting of primary, secondary or tertiary alkali phosphates, citric acid, sodium citrate and combinations thereof. The compositions according to claim 1, characterized in that the carrier is comprised of substances for wound healing and inhibiting inflammation selected from the group consisting of allantoin, urea, azulene, chamomile active substances, acetylsalicylic acid derivatives and combinations of the same. 18. The composition according to claim 1, characterized in that the carrier comprises a gelling agent. The composition according to claim 18, characterized in that the gelling agent is selected from the group consisting of polycarboxylic acids, polycarboxylic acid salts, p.lisaccharides, polysaccharide derivatives, proteins, protein derivatives, polyalkylene oxides and fumed silica. The composition according to claim 1, characterized in that the effective amount of Morinda citrifolia comprises between about 8 and 33 weight percent of the composition, and wherein the carrier comprises between about 75 and 90 weight percent of the composition. The composition according to claim 1, characterized in that the effective amount of Morinda citrifolia is between about 10 and 50 weight percent of the composition, and wherein the carrier comprises between about 48 and 88 weight percent of the composition . 22. The composition according to claim 1, characterized in that the composition comprises a paste for prophylaxis. The composition according to claim 1, characterized in that the effective amount of Morinda citrifolia comprises between about 5 and 25 weight percent of the composition, and wherein the carrier comprises glycerin, calcium carbonate and silica. The composition according to claim 21, characterized in that the glycerin comprises between 10 and 50 weight percent of the carrier, the calcium carbonate comprises between 20 and 40 weight percent of the carrier, and the silica comprises between about 20 and 40 percent by weight of the carrier. 25. A method for the treatment and prevention of oral and dental disorders, the method characterized in that it comprises: providing an effective amount of Morinda citrifolia; combine a carrier with the effective amount of Morinda citrifolia to produce a composition for oral care; administering an effective amount of the composition for oral care to a patient. The method according to claim 25, characterized in that the Morinda citrifolia is selected from the group consisting of Morinda citrifolia fruit, Morinda citrifolia fruit extract, Morinda citrifolia fruit juice concentrate, Morinda citrifolia essence, leaf powder of Mor inda citrifolia, and extract of leaves of Morinda citrifolia. 27. The method according to claim 25, characterized in that the administration of the oral care composition further comprises topically applying the oral care composition to at least one of the patient's teeth, gums and surrounding oral tissues. The method according to claim 25, characterized in that the administration of the composition for oral care further comprises orally administering the oral care composition to the patient as a dietary supplement. 29. The composition according to claim 25, characterized in that the Morinda citrifolia is selected from the group consisting of Morinda citrifolia fruit., Morinda citrifolia fruit extract, Morinda citrifolia fruit juice concentrate, Morinda citrifolia essence, Morinda citrifolia leaf powder, and Morinda citrifolia leaf extract. The method according to claim 25, characterized in that the carrier is comprised of ingredients selected from the group consisting of emulsifying agents, alcoholics, sweeteners, thickeners, surfactants, suspending agents, astringents and extracts of toning, flavor corrective, abrasive agents. or polishers, deodorants, preservatives, flavor buffers, bleaching agents, substances for wound healing and inhibiting inflammation, dyes, dyes, pigments, abrasives, polishers, antimicrobial agents, pH buffers and combinations thereof. The method according to claim 25, characterized in that the carrier further comprises substances selected from the group consisting of glycerin, edible polyhydric alcohols, polyols and combinations thereof. 32. The method according to claim 31, characterized in that the polyols are selected from the group consisting of glycerol, propylene glycol, propylene glycol glycerol, polyethylene glycol, isomalt, xylitol, maltitol, sorbitol, mannitol and combinations thereof. The method according to claim 25, characterized in that the carrier is comprised of flavoring agents selected from the group of compounds consisting of mint essence, gauteria essence, spearmint essence, clove bud essence, parsley essence, essence eucalyptus, menthol, menthol, anethole, methyl salicylate, eucalyptol, cassia, 1-methyl acetate, sage, eugenol, oxanone, alpha-iris, marjoram, lemon, orange, propenyl guaethol acetyl, cinnamon, vanilla, thymol, linalool , glycollacetal cinnamaldehyde, N-substituted p-mentan-3-carboxamides, 3,1-methoxypropan-1,2-diol and combinations thereof. 34. The method according to claim 25, characterized in that the carrier is additionally comprised of active compounds selected from the group consisting of chlorine dioxide, fluoride, alcohols, triclosan, domifeno bromide, cetilpridinio chloro, calcium lactate, lactate salts of calcium, sodium fluoride, fluoride tin, sodium monofluorophosphate, cetilpyridinium chloride, zinc salts, pyrophosphate, 1-hydroxyethane-l, 2-diphosphoric acid, 1-phosphonopropan-1,2,3-tricarboxylic acid, azacycloalken-2 acids , 2-diphosphonic, cyclic aminophosphonic acids and combinations thereof. 35. The method according to claim 25, characterized in that the composition is in the form of toothpaste, gel, mouthwash, mouthwash, gum, mouthwash, lozenge, subgingival irrigation fluid, coated fiber, and interproximal toothbrush, a solution applied topically, drops of sweet gum, pieces of candy, candy bars, and nougat or combinations thereof. 36. The method according to claim 35, characterized in that the fiber further comprises dental floss. 37. The method according to claim 35, characterized in that the coated fiber further comprises a toothbrush bristle. 38. The method according to claim 25, characterized in that it also comprises a sweetener. 39. The method according to claim 38, characterized in that the carrier is comprised of a sweetener selected from the group consisting of saccharin, fructose, xylitol, saccharin salts, thaumatin, aspartame, D-tryptophan, dihydrochalcones, acesulfame, cyclamate salts, and combinations thereof. 40. The method according to claim 25, characterized in that the carrier is comprised of clouding agents selected from the group consisting of calcium citrate, rosin esters, vegetable gum emulsion, caprylic / capric triglycerides, guar gum, gum arabic and essences with high-stability 41. The method according to claim 25, characterized in that the carrier is comprised of abrasives or polishers selected from the group consisting of plaster, calcium carbonate, dicalcium phosphate, aluminum silicates, calcium pyrophosphate, finely particulate synthetic resins, silicas, aluminum oxide, aluminum oxide trihydrate, hydroyapatite, finely insoluble sodium metaphosphate particulate, xerogel silica, hydrogel silica, silica precipitated, aluminum oxide trihydrate and finely particulate aluminum oxide and combinations thereof. 42. The methods according to claim 25, characterized in that the carrier is comprised of preservatives and antimicrobial agents selected from the group consisting of p-hydroxybenzoic acid, methyl ester, ethyl ester, propyl ester, sodium sorbate, sodium benzoate, bromochlorophen, acid esters phenylsalicylic, thymol and combinations thereof. 43. The methods according to claim 25, characterized in that the carrier is comprised of pH buffers selected from the group consisting of primary, secondary or tertiary alkali phosphates, citric acid, sodium citrate and combinations thereof. 44. The methods according to claim 25, characterized in that the carrier is comprised of substances for wound healing and inhibition of inflammation selected from the group consisting of allantoin, urea, azulene, chamomile active substances, acetylsalicylic acid derivatives and combinations of the same. 45. The method according to claim 25, characterized in that the carrier comprises a gelling agent. 46. The method according to claim 45, characterized in that the gelling agent is selected from the group consisting of polycarboxylic acids, polycarboxylic acid salts, polysaccharides, polysaccharide derivatives, proteins, protein derivatives, polyalkylene oxides and fumed silica. 47. The method according to claim 25, characterized in that the effective amount of Morinda citrifolia comprises between about 8 and 33 weight percent of the composition, and wherein the carrier comprises between about 75 and 90 weight percent of the composition. 48. The method according to claim 25, characterized in that the effective amount of Morinda citrifolia is between about 10 and 50 weight percent of the composition, and wherein the carrier comprises between about 48 and 88 weight percent of the composition . 49. The method according to claim 25, characterized in that the method comprises a paste for prophylaxis. 50. The method according to claim 25, characterized in that the effective amount of Morinda citrifolia comprises between about 5 and 25 weight percent of the composition, and wherein the carrier comprises glycerin, calcium carbonate and silica. 51. The method according to claim 25, characterized in that glycerin comprises between 10 and 50 weight percent of the carrier, the calcium carbonate comprises between 20 and 40 weight percent of the carrier and the silica comprises between about 20 and 40 percent in weight of the carrier.