MXPA06002818A - Formulations and methods for treating breast cancer with morinda citrifolia and methylsulfonymethane - Google Patents

Abstract

The present invention advances prior art techniques, formulations, and methods for treating mammary breast cancer during its initial phases, as well as for preventing mammary breast cancer, by providing a safe, nutraceutical formulation comprising Morinda citrifolia, methylsulfonylmethane (MSM), and other ingredients.

Description

FORMULATIONS AND METHODS TO TREAT BREAST CANCER WITH Morinda citr ± folia and METILSULFONILMETANO FIELD OF THE INVENTION The present invention relates to the inhibition and treatment of breast cancer using a nutraceutical composition comprising an amount of a processed Morinda citrifolia product.

BACKGROUND OF THE INVENTION Breast cancer is the second leading cause of cancer death in women (after lung cancer). Even though improvements in detection have been allowed (ie, the introduction of routine mammography), there has been a gradual long-term increase in the incidence of breast cancer since the early 1970s, but due to the treatment More effective achieved by such early detection, overall mortality begins to reduce around the mid-1990s. Breast tissue cancers can arise in the subdivisions or lobes (lobular carcinoma) or ducts (ductal carcinoma) of the breast . Lobular carcinoma often affects both breasts.

The epidemiological study has identified certain risk factors that increase the likelihood that a woman will develop breast cancer, although not all women with breast cancer have these features, and many women with all these traits do not develop the disease. Risk factors include age (the incidence of breast cancer is rare in women under 35 years of age-most cases occur in women over 60 years of age); a history of breast cancer in a close blood relative; and a history of breast cancer or benign proliferative breast tissue diseases. A high cumulative exposure to female sex hormones (estrogen and progesterone) appears to increase the risk of some breast cancers. Hormone-related risk factors include early menstruation (before 12 years of age), late menopause (after 55 years of age), having no children or postponing pregnancy, and obesity in older women 50 years old. Many other possible assocons are under study, such as those that refer to the replacement of estrogen post enopausal, consumption of alcohol and fats, lack of exercise, and exposure to pesticides and other environmental chemicals. Like all cancers, breast cancers are the result of changes in the structure or function of genes that are important for the regulation of cell growth, differenton, or repair. Changes acquired in a number of specific genes have been assocd with the disease; These are changes that occur during a person's lifetime but that are not inherited or transmitted. About 5% of women with breast cancer have an inherited susceptibility to the disease, and most of these women have an inherited mutation in one of two genes. In 1994 it was discovered that women who inherit a mutated BRCAl gene have an almost 85% chance of developing breast cancer and an increased chance of developing uterine cancer. BRCAl normally acts to prevent tumors by repairing the damage to the genetic material caused by oxidation, a chemical process that naturally occurs in the body during metabolism. Defective BRCAl genes can not prepare this damage, allowing its effects to accumulate over time. Cells with oxidative damage to the genes that control their growth can proliferate, or become cancerous. The defective gene can be inherited from either parent, but it appears to cause breast cancer in women only. Young women who develop breast cancer often come from families that carry a BRCA1 mutation. BRCA1 mutations account for almost half of the known hereditary breast cancers. Another gene named BRCA2 has also been identified. BRCA2 mutations have been associated with breast cancers in both women and rare breast cancers in males. Both genes also play a role in some ovarian cancers and sporadic (non-hereditary) breast cancers. The search for a natural way to prevent cancer in humans is an urgent task for researchers in cancer prevention. The majority of women who develop breast cancer, they do not have a genetic risk factor. Therefore, exposure to environmental carcinogens can play an important role in the development of breast cancer in humans. Based on scientific evidence, most chemical carcinogens need to be activated by enzymes to transform them into a form that easily binds to genetic DNA to form DNA adducts. The formation of DNA-carcinogen adducts is an important marker of "DNA damage" that predicts the possibility of developing cancer. Most scientists agree that carcinogen-induced DNA adduct formation is a critical early step in the multiple stages of carcinogenesis. The DNA-carcinogen adducts can be repaired by the body's enzymes. Unrepaired adducts are fixed after a cell cycle. Unresolved, fixed damage to DNA will be responsible for the mutation and the consequent development of cancer. Therefore, avoiding the formation of the DNA-carcinogen adduct is a key step for the prevention of cancer in the stage of initiation of carcinogenesis. A formulation that can prevent and / or block the formation of DNA adducts induced by carcinogens can prevent cancer at the stage of initiation of multi-stage carcinogenesis. Cigarette smoking has been implicated in the pathogenesis of emphysema, ischemic heart disease, and cancer. A series of serious reports by the US Public Health Service and other international scientific organizations have conclusively documented a causal relationship between cigarette smoking and cancer in men and women. There are forty-eight known chemical carcinogens among the four thousand compounds detected in cigarettes. More recently, it has been reported that there are two hundred and twenty-seven possible carcinogens in cigarettes. It has been estimated that some 1 x 1017 oxidizing molecules are present in each puff of cigarette smoke. It is known that free radicals cause oxidative damage and the consequent peroxidation of lipids, which are involved in the pathogenesis of human diseases. The induction of lipid peroxidation is largely the result of free radical reactions with polyunsaturated fatty acids in biological membranes. Unsaturated bonds undergo auto-catalytic or enzymatic processing to form deleterious lipid hydroperoxides. The active lipid hydroperoxides can be rapidly converted to aldehydes, such as malondialdehyde, and alkenes, such as 4-hydroxynonenal. All of these are very active to bind to DNA and are responsible for important autochthonous cellular damage. Increasing evidence indicates that cyclo-oxygenase-2 ("COX-2") inhibitors may be involved in the development of breast, colon, and lung cancer. The interest in the chemoprevention of cancer with COX-2 inhibitors has been stimulated by epidemiological observations that the use of aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) is associated with the reduced incidence of colon and breast cancer. . The main objective of the activity of NSAIDs is the enzyme cyclo-oxygenase (COX). Two isoforms of COX have been identified: COX-1, the constitutive isoform, and COX-2, the inducible form of the enzyme. COX-2 may experience rapid induction in response to chemical carcinogens. It has been suggested that over-expression of COX-2 can lead to increased angiogenesis and inflammatory reaction. Therefore, inhibition of COX-2 should have a general preventive effect against cancer through anti-inflammatory activity and should reduce angiogenesis. Some studies suggest that physical activity, proper nutrition, and the administration of certain drugs can reduce a woman's risk of developing this deadly disease. Although progress has been made in the treatment of breast cancer, there is not yet an effective way to prevent or inhibit the development of breast cancer. Therefore, finding a natural way to avoid breast cancer in humans becomes a top priority for scientists working in this field.

BRIEF DESCRIPTION OF THE INVENTION The present invention overcomes the techniques, formulations and methods for treating breast cancer during its initial phases, as well as in the prevention and inhibition of breast cancer, of the prior art, by providing a nutraceutical, safe formulation comprising Morinda cit trifolia, methylsulfonylmethane (MSM), and other ingredients. Preferred example embodiments of the present invention improve existing systems and methods, and in some cases, can be used to overcome one or more problems associated with or related to said already existing systems and methods. According to the invention as it is modalized and broadly described in the present description, the present invention presents a nutraceutical formulation for treating and inhibiting cancer of breast tissue comprising processed Mo inda citrifolia present in an amount between 0.001 and 99.9 percent in approximately weight. In a preferred exemplary embodiment, the nutraceutical formulation further comprises methylsulfonylmethane (MSM) present in an amount between about 0.001 and 99.9 weight percent. These and other features and advantages of the present invention will be indicated or made more fully apparent in the following description and the appended claims. The features and advantages can be practiced and obtained by means of the instruments and combinations indicated particularly in the appended claims. Also, the features and advantages of the invention can be learned by practicing the invention or will be apparent from the description, as indicated below in the present invention.

BRIEF DESCRIPTION OF THE FIGURES The foregoing objects and characteristics and other objects and features of the present invention will be more fully apparent from the appended figures when considered in conjunction with the following description and appended claims. Although the figures show only typical embodiments of the invention, and therefore are not considered as limiting the scope of the invention, the accompanying figures help explain the invention in greater detail. Figure 1 is a graphical representation of the effectiveness of some compounds contained in Morinda ci trifolia on the predominance of tumors according to the present invention. Figure 2 is a graphic representation of the preventive effects of compounds containing Morinda citrifolia on estrogen-induced mammary gland tumorigenesis in female ACI rats according to the present invention. Figure 3 is a graphic representation of the relative body weight of rats implanted with estrogen to induce tumorigenesis, in which some rats have been treated with compounds containing Morinda citrifolia to counteract the effects of estrogen-induced tumorigenesis in accordance with the present invention. Figure 4 is a graphic representation of the relative size of tumors in rats treated with various compounds. Figure 5 is a graphical representation of the conversion of dimethyl sulfoxide to methylsulfonylmethane according to some embodiments of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED MODALITIES The present invention relates to techniques, formulations, and methods for treating breast cancer during its early stages, as well as for inhibiting breast cancer, by providing a nutraceutical, safe formulation comprising Morinda citrifolia, methylsulfonylmethane (MSM), and other ingredients. Preferred example embodiments of the present invention improve existing systems and methods, and can be used to overcome one or more problems associated with or related to said already existing systems and methods. The following description of the present invention is grouped into three subtitles, in specific "General discussion of Morinda citrifolia and the methods used to produce processed Morinda citrifolia products", "Formulations and methods of administration" and "Prevention, inhibition and treatment of breast cancer". The use of the subtitles is solely for the convenience of the reader and should not be considered as limiting in any way. It will be readily understood that the elements of the present invention, as described and illustrated in general terms in the figures in the present invention, can be combined and used in a wide variety of different formulations and methods. Therefore, the following more detailed description of the embodiments of the system and method of the present invention is not intended to limit the scope of the invention, as claimed, but is only representative of the presently preferred embodiments of the invention. 1. General discussion of Morinda citrifolia and the methods used to produce processed Morinda citrifolia products The Hindu mulberry or Noni plant, scientifically known as Morinda citrifolia L. (Morinda citrifolia), is a shrub or small tree up to 10 meters high. The leaves have an opposite arrangement with an elliptical or oval shape. The small white flowers are contained in a cluster head, globose, fleshy. The fruits are large, fleshy, and ovoid. When ripe, these are creamy white and are edible, but have an unpleasant smell and taste. The plant is native to Southeast Asia and was disseminated in earlier times in a large area from India to eastern Polynesia. It grows randomly in Nature, and has been grown in plantations and on small individual croplands. The flowers of Morinda citrifolia are small, white, with three to five lobes, tubular, fragrant, and approximately 1.25 cm in length. The flowers develop as compound fruits consisting of many small drupes fused in a lumpy, ovoid, ellipsoid or round body, with a waxy, white or greenish-white or yellowish, semi-translucent shell. The fruit contains "eyes" on its surface in a manner similar to that of potatoes. The fruit is juicy, bitter, dull yellow or yellowish white, and contains numerous stones of two cells, winged, oblong-triangular, hard, reddish brown, of which each contains four seeds. When fully ripe, the fruit has a pronounced smell of stale cheese. Although the fruit has been consumed by several nations as food, the most common use of the Morinda citrifolia plant has been that of a source of red and yellow dye. Recently, there has been an interest in the nutritional and health benefits of the Morinda citrifolia plant, which are discussed in more detail below. Because the fruit of Morinda citrifolia is for all practical purposes not edible, the fruit must be processed to make it more palatable for human consumption and to be included in the nutraceutical product used to prevent, inhibit and / or treat cancer. breast. The juice of the processed fruit of Morinda citrifolia can be prepared by separating the seeds and husks from the juice and pulp of a ripe fruit of Morinda citrifolia, by filtering the juice pulp; and packing the juice. Alternatively, instead of packaging the juice, the juice can be immediately included as an ingredient in another food product, can be frozen or pasteurized. In some modalities, the juice and the pulp can be pureed until obtaining a homogeneous combination that is mixed with other ingredients. Other procedures include freezing fruit and juice. Fruit and juice can be reconstituted during the production of the final juice product. Even other procedures include air drying the fruit and juices before they are chewed. The present invention also contemplates the use of fruit juice and / or fruit puree juice extracted from the Morinda citrifolia plant. In a currently preferred process for producing fruit juice of Morinda citrifolia, the fruit is harvested by hand or harvested using mechanical equipment. The fruit can be harvested when it has a diameter of at least 2-3 cm and up to 24-36 cm. The fruit preferably has a color that varies from a dark green color to yellow-green to a white color, and the color graduations between them. The fruit is thoroughly cleaned after it is harvested and before any processing occurs. The fruit is left to mature or age from 0 to 14 days, keeping most of the fruit for 2 to 3 days. The fruit ripens or ages by placing it on the equipment so that it does not make contact with the ground. This is preferably covered with a cloth or mesh material during aging, or it can be matured without being covered. When it is ready for further processing, the fruit is a light color, from light green, light yellow, white or translucent color. The fruit is inspected for spoilage or for an excessively green color and hard firmness. The damaged and hard green fruit is separated from the acceptable fruit.

The matured and aged fruit is preferably placed in containers lined with plastic for additional processing and transportation. The containers of aged fruit can be stored from 0 to 120 days. Most fruit containers are stored for 7 to 14 days before processing. The containers can optionally be stored under refrigerated conditions or ambient temperature conditions before further processing. The fruit is unpacked from the storage containers and processed through a manual or mechanical separator. The seeds and the skin are separated from the juice and the pulp. The juice and pulp can be packed inside containers for storage and transportation. Alternatively, juice and pulp can be processed immediately as a finished juice product. The containers can be stored in refrigerated, frozen, or room temperature conditions. The juice and pulp of Mor inda citrifolia are preferably combined as a homogeneous mixture after which they can be mixed with other ingredients, such as flavorings, sweeteners, nutritional ingredients, botanicals, and colorants. The finished juice product is preferably heated and pasteurized at a minimum temperature of 83 ° C or higher up to 100 ° C. Another product manufactured is the puree and puree juice of Morinda citrifolia, either in the form of a concentrate or in a diluted form. The mash which is essentially the pulp separated from the seeds and is different from the fruit juice product described in the present invention. Each product is filled and sealed inside a final container of plastic, glass or other suitable material that can withstand processing temperatures. The containers are kept at filling temperature or they can be cooled quickly and then placed in a container for shipping. The shipping containers are preferably wrapped with a material and in such a way as to maintain or control 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 filtration equipment. The filtration equipment preferably consists of, but is not limited to, a centrifugal decanter, a mesh filter with a size of 0.01 microns up to 2000 microns, preferably less than 500 microns, a filter press, reverse osmosis filtration, and any other standard commercial filtration devices. The operating pressure of the filter preferably varies from 7.03 x 10 ~ 3 kg / cm2 gauge (0.1 psig) to approximately 70.3 kg / cm2 (1000 psig). The flow rate of preference ranges from 0.3785 l / m (0.1 g / m) to 3.785 l / m (1000 g / m), and more preferably between 18.925 and 189.25 l / m (5 and 50 g / m) . The wet pulp is washed and filtered at least once and up to 10 times to remove any juice from the pulp. The wet pulp typically has a fiber content of 10 to 40 weight percent. The wet pulp is preferably pasteurized at a minimum temperature of 83 ° C and then either packed in drums for further processing or converted into a product with a high fiber content. The product of Mor inda citrifolia processed can also exist as a dietary fiber. Even the processed Morinda citrifolia product can also exist in the form of an oil. Morinda citrifolia oil typically includes a mixture of several different fatty acids such as triglycerides, such as palmitic, stearic, oleic, and linoleic fatty acids, and other fatty acids present in minor amounts. In addition, the oil preferably includes an antioxidant to inhibit oil spoilage. Preferably, conventional food grade antioxidants are used. The plant of Morinda citrifolia is rich in natural ingredients. 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, thiamine, threonine, tryptophan, tyrosine, ursolic acid, and valine; (from the 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; (from the fruit): acetic acid, asperuloside, butanoic acid, benzoic acid, benzyl alcohol, 1-butanol, caprylic acid, decanoic acid, (E) -6-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, hexanodioic 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-1-ol, and vomifol; (from the roots): anthraquinones, asperuloside (rubicloric acid), damnacanth, glucosides, morindadiol, morindin, morindon, mucilaginous matter, nor-damnacanth, rubiadine, blondomin monomethyl ether, resins, soranjidiol, sterols, and monomethyl ether trihydroxymethyl anthraquinone; (from the root bark): alizarin, chlororrubin, glycosides (pentose, hexose), morindadiol, morindanigrin, morindin, morindone, resinous matter, monodilic ether blondina, and soranjidiol; (from wood): anthragalol-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, asperulósido, hexanoico acid, morindadiol, morindona, morindogenina, octanoico acid, and ursólico acid. The present invention contemplates using all parts of the M. citrifolia plant alone, in combination with one another or in combination with other ingredients. The portions of the M. citrifolia plant listed above are not an exhaustive list of the parts of the plant that will be used, but are only examples. Therefore, although some of the parts of the plant of M. citrifolia (for example, the seeds of the fruit, the pericarp of the fruit, the bark of the plant) are not mentioned previously, the present invention contemplates the use of all the parts of the plant. Recently, as mentioned, many health benefits have been discovered that arise from the use of products containing Morinda citrifolia. A benefit of Morinda citrifolia lies 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 xeronine, it contains appreciable amounts of the xeronine precursor, called proxeronin. In addition, Morinda citrifolia contains the inactiya form of the enzyme proxeronase which liberates xeronine from proxeronin. A document entitled, "The Pharmacologically Active Ingredient of Noni" by RM 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 building blocks of proxeronine and proxeronase. These building blocks help in the isolation and production of xeronine within the body. The function of the essential nutrient xeronine is fourfold. First, xeronine serves to activate the latent enzymes found in the small intestine. These enzymes are critical for efficient digestion, for soothing nerves, and for general physical and emotional energy. Second, xeronine protects and maintains the shape and flexibility of protein molecules so that they can pass through cell walls and can be used to form healthy tissue. Without these nutrients passing into the cell, the cell can not perform its work efficiently.

Without proxeronine to produce xeronine our cells, and therefore the body, suffer. Third, xeronine helps granulate the membrane pores of cells. This enlargement allows larger chains of peptides (amino acids or proteins) to be admitted into the cell. If these chains are not used, they are wasted. Fourth, xeronine, which is made from proxeronine, helps to enlarge the pores to allow a more adequate absorption of nutrients. Each tissue has cells that contain proteins that have receptor sites for the absorption of xeronin. Some of these proteins are the inert forms of enzymes that require absorbed xeronine to become active. Therefore, xeronine, by converting the pro-collagenase 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. Therefore, the action of Morinda ci trifolia to make a person feel good is probably due to the fact that xeronine converts certain brain receptor proteins into active sites for the absorption of endorphin, the well-being hormones. Other proteins form pores through the membranes in the intestines, blood vessels and other bodily organs. The absorption of xeronine in these proteins changes the shape of the pores and therefore affects the passage of molecules through the membranes. Due to its many benefits, it is known that Morinda citrifolia provides a number of anecdotal effects in individuals who have cancer, arthritis, headaches, indigestion, malignant tumors, broken bones, high blood pressure, diabetes, pain, infection, asthma, pain of teeth, spots, immune system failure, and others.

The 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 said compositions can contain one or more agents that are selected from the group consisting of sweetening agents, flavoring agents. , coloring agents and preservatives. The tablets contain Morinda citrifolia in intimate admixture with pharmaceutically acceptable non-toxic excipients, which are suitable for the manufacture of tablets. Such excipients may be, for example, inert diluents, granulating and disintegrating agents, binding agents, and lubricating agents. The tablets may be uncoated or these may be coated using 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 glyceryl monostearate or glyceryl distearate may be employed.

The aqueous suspensions contain Morinda ci trifolia in intimate admixture with excipients suitable for the manufacture of aqueous suspensions. Said excipients are suspending agents, for example, sodium carboxymethylcellulose, methylcellulose, hydroxypropylmethylcellulose, sodium alginate, polyvinylpyrrolidone, gum tragacanth and gum acacia; dipersing agents or humectants which may be a phosphatide of natural origin, for example lecithin, or condensation products of an alkylene oxide with fatty acids, for example polyoxyethylene stearate, or condensation products of ethylene oxide with aliphatic chain alcohols long, for example heptadecaethylene-oxicetanol, or condensation products of ethylene oxide with partial esters obtained from fatty acids and a hexitol such as polyoxyethylene sorbitol mono-oleate, or condensation products of ethylene oxide with partial esters obtained from fatty acids and hexitol anhydrides, for example polyethylene sorbitan mono-oleate. 2. Formulations and methods of administration The present invention provides nutraceutical formulations and methods for preventing, inhibiting and treating breast cancer with a nutraceutical formulation based on Morinda citrifolia without any significant tendency to cause side effects. Morinda citrifolia is incorporated in various vehicles or nutraceutical compositions suitable for in vivo treatment of a patient. For example, processed Morinda citrifolia can be ingested, introduced or fed through an intravenous injection, or it can be internalized in some other way as appropriate and directed. Methylsulfonylmethane ("MSM") is a sulfur donor compound that occurs in nature and has been found in plants, milk, and urine of bovines and humans. MSM is a normal oxidizing product of dimethylsulfoxide (DMSO). Sulfur is the sixth most abundant macro-mineral in breast milk and the third most abundant mineral in the human body based on the percentage of total body weight and is an essential element for the structure of each living cell. MSM has a wide range of health benefits including analgesic, anti-inflammatory, anti-allergy benefits, while increasing immune function by providing organic sulfur and essential methyl groups from the nutritional point of view. A scientific study reports that MSM marked with 35S is incorporated in the essential amino acids that contain sulfur such as in methionine and cysteine of guinea pig serum protein; therefore, MSM can provide a source of sulfur for essential amino acids that contain sulfur in animals and humans. In an exemplary embodiment, the nutraceutical composition of the present invention comprises one or more of a processed Morinda citrifolia product present in an amount by weight between about 0.01 and 100 percent by weight, and preferably between 0.01 and 95 percent by weight. combined weight with methylsulfonylmethane ("MSM"), present in an amount between about 0.001 and 99.9 weight percent. Several modalities of formulations are provided below. However, these are intended to be only examples because the person skilled in the art will recognize other formulations or compositions comprising the processed Morinda citrifolia product. The processed Morinda citrifolia product is an active ingredient or contains one or more active ingredients, such as quercetin and rutin, and others, to effect the prevention, inhibition and treatment of breast cancer. The effects of the processed Morinda citrifolia product are increased synergistically by the presence of methylsulfonylmethane ("MSM") in the formulation. One embodiment of the present invention comprises a product of processed Morinda citrifolia combined in the formulation with MSM that prevents, inhibits and / or treats breast cancer. The active ingredients can be extracted from various parts of the Morinda ci trifolia plants using various alcohols or alcohol-based solutions, such as methanol, ethanol, and ethyl acetate, and other alcohol-based derivatives using any method known in the art. technique. The active ingredients of quercetin and rutin are present in amounts by weight ranging from 0.01-10 percent of the formulation or total composition. These amounts can also be concentrated in a more potent concentration in which these are present in amounts ranging from 10 to 100 percent. The processed Morinda citrifolia product can be formulated with some other ingredients to produce various compositions, such as a nutraceutical composition, an internal composition, or others. The ingredients to be used in a nutraceutical composition are any that are safe for introduction into the body of a mammal, and particularly a human, and can exist in various forms, such as liquids., tablets, pills, aqueous or oily solutions, powders or dispersible granules, emulsions, syrups, elixirs, etc. Also, because the nutraceutical composition will likely be consumed orally, it may contain one or more agents that are selected from the group consisting of sweetening agents, flavoring agents, coloring agents, preservatives, and other medicinal agents as appropriate. indicate The ingredients to be used in a topical dermal composition are also any that are safe for internalization within the body of a mammal and can exist in various forms, such as gels, lotions, creams, ointments, etc., each comprising one or more carrier agents. The ingredients for formulations administered systemically may also comprise any known in the art. In an exemplary embodiment, the present invention also provides a method for administering a nutraceutical composition to a mammal for the prevention, inhibition or treatment of breast cancer. The method comprises the steps of (a) formulating a nutraceutical composition comprising in part a product of processed Morinda citrifolia present in an amount between about 0.01 and 95 weight percent and methylsulfonylmethane ("MSM"), present in an amount between 0.001 and about 80 weight percent, in which the composition also comprises a vehicle, such as 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 internalized sufficiently; (c) Repeat the above steps as frequently as necessary to provide an effective amount of the processed Morinda citrifolia product. The step of administering the nutraceutical composition within the body comprises ingesting the composition orally through one or several means. Specifically, the nutraceutical composition can be formulated as a liquid, gel, solid, or some other type that allows the composition to be rapidly and conveniently digested. Once sufficiently internalized, the nutraceutical composition administered can begin to act to prevent, inhibit or treat breast cancer in the individual. In addition, the step of administering the nutraceutical composition may include injecting the composition into the body using an intravenous pump. In an exemplary embodiment, the nutraceutical composition is administered by taking between 59.15 ml of the nutraceutical composition every two hours each day, or at least twice per day. The nutraceutical composition is taken on an empty stomach, which means in a period of time at least two hours before consuming any food or drink. Of course, the person skilled in the art will recognize that the amount of composition and frequency of use may vary from individual to individual. It is contemplated that a person may ingest less than 14.79 ml, or more than 295.73 ml of the nutraceutical composition claimed in the present invention. Therefore, the present invention contemplates the administration of 29,573 ml, 59.15 ml, 88.72 ml or any volume of the formulations necessary to achieve the desired result including more than 295.73 ml per administration. The following tables illustrate or represent some of the preferred formulations or compositions contemplated by the present invention. As indicated, these are only intended as example modalities and should not be considered as limiting in any way. Formulation one -, r Ingredients Percent by weight Juice of puree or 100% fruit juice Morinda citrifolia Formulation two Ingredients Percent by weight Juice of fruit of Morinda citrifolia 50-99.99% 20 Water 0.1-50% Formulation three Ingredients Percent by weight Morinda fruit juice citrus trifolia 50-99.99% Fruit juices not based on Morinda 0.1-50% 5 citrifolia Formulation four Ingredients Percent by weight Fruit juice of Morinda citrifolia 50-90% Water 0.1-50% Fruit juices not based on Morinda 0.1-30% citrifolia Formulation five Ingredients Percent by weight Juice of puree of Morinda citrifolia 50-99.9% Water 0.1-50% Formulation six Ingredients Percent by weight Juice of puree of Morinda citrifolia 50-99.9% Fruit juices not based on Morinda 0.1-50% citrifolia Formulation seven Ingredients Percent by weight Juice of puree of Morinda citrifolia 50-90% Water 0.1-50% Fruit juices not based on Morinda 0.1-30% citrifolia Formulation eight Ingredients Percent by weight Dietary fiber of Morinda 0.1-50% citrifolia Water 1-99.9% Fruit juices not based on Morinda 1-99.9% citrifolia Formulation nine Ingredients Percent by weight Dietary fiber of Morinda 0.1-50% citrifolia Water 1-99.9% Juice of puree or fruit juice of 1-99.9% Morinda citrifolia Formulation ten Ingredients Percent by weight Oil of Morinda citrifolia 0.1-50% Medium carrier 70-99.9% Other ingredients 1-95% Formulation eleven Ingredients Percent by weight Product of Morinda citrifolia 10-80% Carrier medium 20-90% Formulation twelve Ingredients Percent by weight Product of Morinda citrifolia 5-80% Carrier medium 20-95% Formulation thirteen Ingredients Percent by weight Oil or oil extract of 0.1-50% Morinda citrifolia Carrier medium 20-90% Formulation fourteen Ingredients Percent by weight Puree juice or fruit juice of 0.1-80% Morinda citrifolia Oil of Morinda citrifolia 0.1-50% Carrier medium 20-90% Formulation fifteen Ingredients Percent by weight Concentrated puree juice or 100% fruit juice concentrate from Morinda citrifolia Formulation sixteen Ingredients Percent by weight Concentrated puree juice or 50-99.99% concentrate of fruit juice of Morinda ci trifolia Water 0.1-50% Formulation seventeen Ingredients Percent by weight MSM 0-80% Juice of puree or fruit juice of 20-100% Morinda citrifolia Formulation eighteen Ingredients Percent by weight MSM 0.1-49.9% Fruit juice of Morinda citrifolia 50-99.8% Water 0.1-50% Formulation nineteen Ingredients Percent by weight MSM 0.1-49.9% Fruit juice of Morinda citrifolia 50-99.99% Fruit juices not based on Morinda 0.1-50% citrifolia Formulation twenty Ingredients Percent by weight MSM 0.1-49.8% Morinda fruit juice citrus trifolia 50-90% Water 0.1-50% Fruit juices not based on Morinda 0.1-30% citrifolia In a preferred method, a person who wishes to prevent, inhibit or treat breast cancer as described above takes, or is administered, at least 29,573 ml of formulation 1 in the morning on an empty stomach, and at least 29,573 ml at night on an empty stomach, just before going to sleep. In one example, which is not intended to be limiting in any way, the beneficial Morinda citrifolia is processed as the Taitian Noni® juice manufactured by Morinda, Incorporated of Orem, Utah. In accordance with the present invention, these particular methods for introducing an internal composition may comprise any method for actually introducing the internal composition to the individual for the purpose of preventing, inhibiting, or treating breast cancer. Although the particular methods are many, the present invention recognizes that the internal composition can be introduced intravenously, transdermally, orally, or systemically. Regardless of which method is used, it is important to regulate the amount of active ingredient to which the individual is exposed in order to achieve the appropriate anti-cancer objectives. The carrier medium can comprise any ingredient that can be introduced into the body of a mammal, and that can provide the carrier medium for the processed Morinda citrifolia product and MSM. Specific carrier media formulations are known in the art and are not described in greater detail in the present invention. The purpose of the carrier medium is, as indicated, to provide means to incorporate the product of processed Morinda citrifolia and MSM into the internal composition that can be introduced into the body of the individual to be treated. The following examples indicate and present the effects of preventing, inhibiting, or treating breast cancer with Morinda citrifolia. These examples are not intended to be limiting in any way, but are only illustrative of the benefits and advantages of using Morinda ci trifolia to prevent, inhibit and treat breast cancer. 3. Prevention, inhibition and treatment of breast cancer The following examples indicate and present the effects of Morinda citrifolia on carcinogenic cells. These examples are not intended to be limiting in any way, but are only illustrative of the beneficial, convenient, and relief effects of Morinda citrifolia on carcinogenic cells, including carcinogenic cells located in the mammary glands. Other non-limiting examples of the present invention are described below. The present invention describes formulations and methods for preventing, inhibiting and treating breast cancer during the stages of breast cancer initiation using a nutraceutical composition formulated with an amount of a processed Morinda citrifolia product. The present invention relates to the synergistic cancer prevention effects of Morinda ci trifolia, and of a combination regimen of Morinda citrifolia and ethylsulfonylmethane in the breast cancer initiation stage.

EXAMPLE ONE Morinda formula and method of administration. citrifolia. and metiltylfonylmethane In the present example, a patient with breast cancer wishes to treat the condition with an over-the-counter preparation, and without a prescription. To treat cancer, the individual consumes an identified prescribed amount of a food product composition containing fruit juice of processed Morinda citrifolia and methylsulfonylmethane ("MSM"). The person intermittently consumes the food product containing the fruit juice of Morinda ci trifolia processed and MSM until the carcinogenic cells are inhibited, blocked, and / or destroyed. In another embodiment of the present invention, a person interested in preventing or inhibiting the development of carcinogenic tissue can consume food product compositions containing fruit juice of processed Morinda citrifolia and MSM. The person intermittently consumes the food product containing the fruit juice of processed Morinda citrifolia and MSM for an indefinite period to avoid or continuously inhibit the development of carcinogenic tissues.

EXAMPLE TWO Prevention, inhibition and treatment of cancer with products of processed Morinda citrifolia and methylsulfonylmethane The products of Morinda citrifolia processed have preventive effects against cancer in the stage of initiation of chemical carcinogenesis. This hypothesis is examined using two carcinogenic models in animals, and a human clinical study of a group of common smokers. Models in animals include the following: model of mammary gland tumorigenesis induced by DMBA, and a model of acute liver damage induced by a carcinogen of the liver ', carbon tetrachloride (CC14). These are classic extrinsic carcinogenic models. The DNA adduct formation induced by DMBA is chosen, in addition to the histological examination by light and electronic microscopy, as a sensitive bio-marker to evaluate the preventive effect of the products of Morinda citrifolia processed in the stage of initiation of stage carcinogenesis multiple In the mammary gland carcinogenic model, the focus is on the pathogenic changes after the administration of DMBA, to monitor the mechanisms of carcinogenesis and DNA adduct formation by DMBA in breast tissue. In the model of acute liver damage, the foci are the histopathological changes of the liver tissue and the free radical levels of superoxide anion (SAR) and of lipid hydroperoxide (LPO) after the administration of CC14. The DNA adduct formation by carcinogenic DMBA is used as a marker to examine whether products of processed Morinda citrifolia may or may not prevent DNA damage induced by carcinogen. The preventive effects against cancer of the products of Morinda citrifolia processed in the stage of initiation of carcinogenesis of the mammary gland, induced by DMBA, in female Sprague-Dawley (SD) rats are examined. The experiment begins on day 35 after birth with water in a control group matched in terms of age, a group of DMBA, and a group of products of Morinda citrifolia processed at 5%. DMBA (25 mg / kg) is administered orally on day 50 after birth in the DMBA and processed Morinda citrifolia products groups. The products of Morinda citrífolia processed are supplied continuously for an additional 90 days after the administration of DMBA. All animals are sacrificed at the 8th month after the administration of DMBA to examine the pathological changes in the mammary glands by light microscopy. Compared with controls, the group treated with DMBA presents a variety of lesions, including epithelial hyperplasias (12.5%), benign tumors (25%), and carcinomas in situ (25%). No benign tumors or carcinomas are found in the processed Morinda citrifolia product group, which presents normal histology or light hyperplasia. These results indicate that processed Morinda citrifolia products can prevent breast cancer at the stage of initiation of chemical carcinogenesis. In another study, the preventive effect of processed Morinda citrifolia products on liver damage induced by carbon tetrachloride (CC14) in female SD rats is examined by light microscopy (LM) and electron microscopy (EM). The hepatic sections in the placebo and product groups of Morinda citrifolia processed demonstrate normal lobular architecture and normal ultra structure at the LM level. Hepatic sections in the placebo + CC14 group show acute liver damage at the LM level: which includes lipid-containing or necrotic, vacuolated, focal hepatocytes surrounding the central veins and focal inflammatory cells scattered along the lobe. There is a significant decrease in the number of swollen, lipid-containing and apoptotic hepatocytes in the product group of Morinda citrifolia processed + CC14, compared to the placebo + CC14 group. At the MS level, depletion of glycogen and lipid droplets are observed in the cellular plasma in both groups treated with CC14. Tumouted mitochondria, disorganization of the rough endoplasmic reticulum (RER) with ribosome loss, and abundant focal areas of smooth endoplasmic reticulum (SER) are scattered throughout the cytoplasm. As an interesting aspect, the Golgi complexes in the placebo + CC14 group contain small, low density vesicles. The Golgi complexes in the product group of Morinda citrifolia processed + CC14 contain large vesicles with increased electron density, and the Golgi cistern piles are well developed. Those in the placebo + CC14 group are often swollen and diminished. The possible mechanism of the preventive effect against cancer of products of Mor inda citrifolia processed is studied. Female SDE rats are divided into two groups of 6 each. The control group is supplied with drinking water and regular rat feed, ad libitum. Morinda citrifolia products processed into 10% water in drinking water and rat feed, ad libi tum, are administered to the group of Morinda citrus processed products. One week later, three animals from each group receive intragastric 25 mg / kg of 5% dimethyl sulfoxide containing DMBA in corn oil. All animals are sacrificed 24 hours later. DNA is isolated from liver, lung, heart, and kidney. DNA adducts are analyzed by the technique of post-labeling with P. After one week of consumption, the product group of processed Morinda citrifolia shows a reduction both in the number and in the level of DNA adducts by DMBA from of each of the four organs studied. Quantitative estimation after radioactive counting indicates that processed Morinda citrifolia products reduce the amount of DNA adduct formation by 80% in the kidney, 42% in the liver, 41% in the lung, and 26% in the heart. Even more dramatic experimental results are obtained using male C57 BL-6 mice. The products of processed Morinda citrifolia can reduce the formation of DNA adducts by DMBA in 90% in kidney, 70% in liver, 60% in heart, and 50% in lung. This is the first finding of the preventive effect against cancer in the stage of initiation of carcinogenesis by the products of Morinda citrifolia processed. These data indicate that processed Morinda citrifolia products can prevent cancer at the stage of initiation of carcinogenesis. In order to explore the mechanisms of the cancer preventive effect of Morinda citrus processed products, antioxidant activity is examined. The study is designed to measure how well processed Morinda citrifolia products purify superoxide anion (SAR) radicals and quench lipid peroxides (LPO) using the TNB test and the LMB test., respectively. The purification activity of SAR is examined in vitro by the nitroblue tetrazolium test (TNB). In the TNB test, the SARs reduce TNB to formazan blue, which absorbs to 602 mm. A SAR scavenger, such as the products of processed Morinda citrifolia, reduces absorbance by reaction with SAR. In this test, a calibration curve is produced when SARs are generated from NADH under aerobic conditions, with phenazine methosulfate as a catalyst. In the LMB test, the LPO oxidize the leucomethylene to methylene blue in the presence of hemoglobin. The resulting blue color can be quantified spectrophotometrically at 660 nm. The products of Morinda citrifolia processed in vitro show a dose-dependent inhibition of both LPO and SAR. The activity of SAR purification of processed Morinda citrifolia products is compared with that of three known antioxidants: vitamin C, grape seed powder, and pycnogenol at the daily dose per serving level recommended by the Recommended Daily Dose recommendations. the United States of America (US RDA) or the manufacturer's recommendations. Under the experimental conditions, it is demonstrated that the activity of SAR purification of processed Morinda citrifolia products is 2.8 times that of vitamin C, 1.4 times that of picnogenol, and 1.1 times that of grape seed powder. Therefore, Morinda ci processed trifolia products have a great potential for purifying reactive oxygen free radicals. Carbon tetrachloride is a liver carcinogen and inducer of lipid hydroperoxidation. To further confirm the antioxidant activity of the Morinda citrifolia products processed in vivo, a model of liver damage induced by carbon tetrachloride in female SD rats is selected. Ten percent of Morinda citrifolia product processed in drinking water for 12 days can reduce liver LPO and SAR up to 20% and 50% of those observed in the placebo group 3 hours after CC14 administration. In conclusion, processed Morinda citrifolia products can protect the liver against exposure to extrinsic carcinogenic CC14. Antioxidants in processed Morinda citrifolia products can protect individuals against cigarette smoke by scavenging oxygen free radicals and quenching lipid peroxides. In order to examine this hypothesis, a 1-month, double-blind, randomized, placebo-controlled clinical trial is designed to test the protective effect of Morinda citrifolia products processed on plasma SAR and LPO in common smokers. Individuals are supplied daily with 59.15 ml of processed Morinda citrifolia (n = 38) or placebo (n = 30) products, twice a day for 30 days. The levels of SAR and LPO in plasma are determined before and after the test using the TNB and LPO tests, respectively. No effect was observed in SAR (0.23 ± 0.15 against 0.21 + 0.18 μmoles / ml) and LPO (0.58 ± 0.22 versus 02.59 ± 0.21 μmoles / ml, P <; 0.05) in plasma, respectively. These results indicate that products of Mor inda citrifolia processed can protect individuals against the oxidative damage induced by smoking tobacco. DNA adducts induced by specific products will soon be analyzed by smoking, by lipid peroxides and by related decomposition products such as malondialdehyde. Data from the in vitro study, model of CC14-induced liver damage from female SD rats, and from common smokers indicate that processed Morinda citrifolia products are a strong antioxidant that can scavenge reactive oxygen free radicals and quench hydroperoxides lipids, thereby reducing the risk of cancer.

EXAMPLE THREE Anti-inflammatory action and selective inhibition of COX-2 with processed Morinda citrifolia products In this study, the selectivity of COX-2 inhibition of the products of Morinda citrifolia processed against COX-1 in vitro is investigated. The inhibitions of Morinda citrus processed products on COX-2 and COX-1 activities are compared with those of traditional NSAIDs such as aspirin, indomethacin, and a known selective COX-2 inhibitor, Celebrex. The activities of COX-1 and COX-2 are determined based on the levels of PGE2 generated during incubations of human platelets with the analyzed compounds and / or vehicle using the ELA test of Amersham. The Cl of the products of Morinda citrifolia processed, aspirin, indomethacin, and Celebrex on COX-1 are 5%, 4.55 μmol / 1, 0.01 μmol / 1, and 1.4 μmol / 1, respectively, and for COX-2 are 3.8% , 595 pmol / 1, 0.4 pmol / 1, and 0.47 pmol / 1, respectively. The data is converted to an IC50 quotient of C0X-2 / C0X-1. This is 0.76 for the processed Morinda citrifolia products, 119 for aspirin, 40 for indomethacin, and 0.34 for Celebrex. These results show that the C0X-2 inhibition selectivity of the processed Morinda citrifolia products can be compared with that of Celebrex. The discovery of the selective inhibition of COX-2 of processed Morinda citrifolia products is very significant because the products of Morinda citrifolia processed is a natural fruit juice without side effects. This is the first scientific evidence for a strong anti-inflammatory activity in processed Morinda citrifolia products, which can also be a cancer prevention mechanism. The anti-inflammatory activity of processed Morinda citrifolia products is observed in a model of acute hepatic damage in female SD rats induced by CC14. A decrease was observed in the inflammatory foci and in the lymphocytes surrounding the areas of the central vein at 6 hours after the administration of CC14 in animals previously treated with products of Morinda citrifolia processed at 10% for 12 days in the water. drink compared to the CC14 group without processed Morinda citrifolia products.

EXAMPLE FOUR Effect of compounds containing Morinda citrifolia on mammary tumors induced by E2 Sixty female rats of 5 weeks of age are divided into 4 groups of 15 rats each and placed on regular diets. Another eight female rats serve as matched controls in terms of age. A group of experimental rats are given a 5% placebo in the drinking water, the second experimental group is given 5% Morinda citrifolia juice in the drinking water, the third experimental group is given methylsulfonylmethane ("MSM ") at 5% in the drinking water, and the fourth experimental group is supplied with a combination of 5% Morinda citrifolia juice and 5% MSM in the drinking water. Two weeks later, all animals are subcutaneously implanted with a 25 mg tablet containing 22.5 mg of 17β-estradiol (E2) mixed with 2.5 mg of cholesterol. Each experimental group is provided with its respective formulation for ninety days after implanting the estrogen (E2). Control animals matched in age receive a tablet implant of 25 mg of cholesterol. As seen in Figures 1-4, the animals in the placebo group have a significant body weight loss when compared to the control group with cholesterol. Animals in the Morinda group of trífolia or in the MSM group have slight loss of body weight. None of the rats receiving the tablets consisting of cholesterol present mammary gland tumors. All rats with an E2 implant in the placebo group have mammary gland tumors. One hundred percent (100%) of the rats in this group have three to seven tumors. Seventy-one percent (71%) of the rats in the Morinda citrifolia group have two to five tumors. Fifty-seven percent (57%) of the rats in the MSM group have one to four tumors. Forty-three percent (43%) of the rats in the combination group have zero to three tumors. The average tumor area in the placebo group, group of Morinda ci trifolia, group of MSM, and the combination group at 180 days after the E2 implant is 17, 12, 10 and 6 mm2, respectively. The survival rates of the control, placebo, Morinda citrifolia, MSM and combination groups one hundred and sixty days after E2 implantation are 100%, 0%, 47%, 73%, and 87%, respectively. The survival rates of each group at one hundred and eighty days after the implantation of E2 are 100%, 0%, 0%, 20% and 60%, respectively. At two hundred days, the survival rates of each group are 100%, 0%, 0%, 0%, and 27%, respectively.

EXAMPLE FIVE Synergistic effect of Morinda citrifolia and methylsulfonylmethane The products of Morinda citrifolia processed, in specific fruit juice, and methylsulfonylmethane ("MSM") have cancer inhibitory effect in the stage of initiation of mammary gland carcinogenesis induced by DMBA in SD rats females The combination of Morinda citrifolia and MSM has a cancer-inhibiting synergistic effect in the stage of initiation of mammary gland carcinogenesis induced by DMBA in female SD rats. In the research supporting the present invention, the preventive effects against cancer of Morinda citrifolia, MSM, and its combination in the stage of initiation of chemical carcinogenesis of multiple stages in a carcinogenic model of breast tissue in animals induced by DMBA in female SD rats. In the experiment, seventy-five female SD rats are divided into 5 groups: control groups matched in age, DMBA, 5% of Morinda citrifolia + DMBA, 5% of MSM + DMBA, and 5% of Morinda citrifolia + 5% of MSM + DMBA. The experiment begins on day 35 after birth supplying water to the control group matched in age and to the DMBA group, while 5% of Morinda citrifolia, 5% of MSM, 5% of Morinda citrifolia + 5% of MSM to the groups of Morinda citrifolia, MSM, and Morinda ci trifolia + MSM + DMBA. DMBA (25 mg / kg) is administered orally on day 50 after birth in the DMBA, Morinda ci trifolia + DMBA, MSM + DMBA, and Morinda citrifolia + MSM + DMBA groups. Morinda citrifolia, MSM, Morinda citrifolia + MSM is continuously supplied for an additional 90 days after administration of DMBA. All animals are sacrificed in the 9th month after treatment with DMBA to examine the pathological changes in the mammary glands by light microscopy. Compared with the control group matched in age, the group treated with DMBA shows a variety of lesions, including epithelial hyperplasia (12.5%), benign tumors (25%), and carcinomas in situ (25%). No benign tumors or carcinomas were observed in the control groups matched in age, Morinda citrifolia and MSM, which only show normal histology or mild hyperplasia (10% in the control group matched in age, 60% in the Morinda citrifolia group , 75% in the MSM group). In the combination group of Morinda citrifolia and MSM, light hyperplasia is significantly reduced to 37.5%, which is 50% lower than that of the 5% MSM group, and 37.5% lower than that of the 5% Morinda group citrifolia (p <0.05). The results indicate that a combination regimen of Morinda citrifolia and MSM has a preventive synergistic effect against cancer in the stage of initiation of mammary gland carcinogenesis in the breast tumor model induced by DMBA. Therefore, this synergistic combination regimen can contribute to the prevention of breast cancer of human tissue at the stage of initiation of carcinogenesis. This is the first finding that reveals this synergistic effect in the prevention of breast cancer. The advantages of this specific combination provide an effective, natural, safe, economical method to prevent breast cancer and does not provide toxicity for long-term use. It is worth mentioning that this combination regimen has been provided only 90 days after the administration of the carcinogen. Further studies are needed to determine if this combination regimen may or may not completely prevent the mammary gland tumor completely with long-term treatment, and whether this may be a possible strategy for the prevention of cancer. The combination regimen can revert the initiated cell back to the normal state. Although illustrative embodiments of the invention have been described in the present description, the present invention is not limited to the various preferred embodiments described therein, but includes any and all modalities having modifications, omissions, combinations (e.g. through various modalities), adaptations and / or alterations that could be appreciated by those skilled in the art based on the present description.

The limitations in the claims should be broadly interpreted on the basis of the language employed in the claims and are not limited to the examples described in the present description or during the processing of the application, examples of which should be considered as non-exclusive. For example, in the present description, the term "preferably" is not exclusive and means "preferably, but not limited to." The present invention can be modalized in other specific forms without departing from its scope or essential characteristics. The modalities described should be considered in all respects only as illustrative and not restrictive. Therefore, the field of the invention is indicated by the appended claims rather than indicated by the foregoing description. All the changes that come within the meaning and range of equivalence of the claims are covered within their field.

Claims (12)

NOVELTY OF THE INVENTION Having described the present invention, it is considered as a novelty and therefore the content of the following is claimed as property: CLAIMS

1. - A nutraceutical composition for inhibiting and treating breast cancer, said nutraceutical composition comprising: one of a product of Morinda citrifolia processed and an extract present in an amount between 0.001 and 99.9 weight percent approximately, and methylsulfonylmethane present in an amount between 0.001 and approximately 99.9 weight percent.

2. The nutraceutical formulation according to claim 1, characterized in that said product of processed Morinda ci trifolia is constituted by at least one of the following: juice of the fruit of Morinda citrifolia, extract of oil of Morinda citrifolia, dietary fiber of Morinda citrifolia, Morinda citrifolia puree juice, Morinda citrifolia puree, Morinda citrifolia fruit juice concentrate, Morinda citrifolia puree juice concentrate, elements extracted from Morinda citrifolia.

3. - The nutraceutical formulation according to claim 1, characterized in that said product of Morinda ci trifolia is used with a carrier medium.

4. - The nutraceutical formulation according to claim 1, characterized in that said composition is administered by a method comprising one or more of the following methods: orally, transdermally, by injection, intravenously, topically or via sys- temic.

5. The nutraceutical formulation according to claim 1, characterized in that said composition is constituted by 0.1-49.9% by weight of methylsulfonylmethane, 50-90% by weight of juice of the fruit of Morinda citrifolia, 0.1-50% by weight of water and 0.1-30% by weight of fruit juices not based on Morinda citrifolia.

6. The nutraceutical formulation according to claim 1, characterized in that said composition is constituted by 0.1-49.9% by weight of methylsulfonylmethane, 50-90% by weight of juice of the fruit of Morinda citrifolia, and 0.1-30% by weight of fruit juices not based on Morinda citrifolia.

7. - The nutraceutical formulation according to claim 1, further comprising 0.1-50% by weight of water.

8. - A nutraceutical composition for preventing and inhibiting DNA adduct formation, said nutraceutical composition comprises: product or processed extract of Morinda citrifolia present in an amount between 0.001 and 99.9 weight percent approximately, and methylsulfonylmethane present in an amount between 0.001 and 80 weight percent approximately.

9. - The nutraceutical formulation according to claim 8, characterized in that said processed product of Morinda citrifolia is constituted by one or more of the following: juice of the fruit of Morinda citrifolia, extract of oil of Morinda citrifolia, dietary fiber of Morinda citrifolia , Morinda citrifolia puree juice, Morinda citrifolia puree, Morinda citrifolia fruit juice concentrate, Morinda citrus trifle juice concentrate, elements extracted from Morinda citrifolia.

10. The nutraceutical formulation according to claim 8, characterized in that said product of Morinda citrifolia is used with a carrier medium.

11. The nutraceutical formulation according to claim 8, characterized in that said composition is administered by a method comprising one or more of the following methods: orally, transdermally, by injection, intravenously, topically or systemically.

12. The nutraceutical formulation according to claim 8, characterized in that said composition is constituted by 0.1-49.9% by weight of methylsulfonylmethane, 50-90% by weight of fruit juice of Morinda ci trifolia, 0.1-50% by weight of water and 0.1-30% by weight of fruit juices not based on Morinda citrifolia. 13.- The nutraceutical formulation according to claim 8, characterized in that said composition is constituted by 0.1-49.9% by weight of methylsulfonylmethane, 50-90% by weight of juice of the fruit of Morinda citrifolia, and 0.1-30% by weight of fruit juices not based on Morinda ci trifolia. 14. The nutraceutical formulation according to claim 8, further comprising 0.1-50% by weight of water. 15. A nutraceutical composition for chemically preventing and inhibiting carcinogenesis in the initial stage by chemically blocking the carcinogens, purifying the free radicals, extinguishing the lipid peroxides, and inhibiting COX-2, said nutraceutical composition comprising: product or processed extract of Morinda citrifolia present in an amount between 0.001 and 99.9 weight percent approximately, and methylsulfonylmethane present in an amount between 0.001 and 80 weight percent approximately. 16. The nutraceutical formulation according to claim 15, characterized in that said processed product of Morinda citrifolia is constituted by one or more of the following: juice of the fruit of Morinda citrifolia, extract of oil of Morinda citrifolia, dietary fiber of Morinda citrifolia , Morinda citrifolia puree juice, Morinda citrifolia puree, Morinda citrifolia fruit juice concentrate, Morinda citrifolia puree juice concentrate, elements extracted from Morinda citrifolia. 17. The nutraceutical formulation according to claim 15, characterized in that said product of Morinda citrifolia is used with a carrier medium. 18. The nutraceutical formulation according to claim 15, characterized in that said composition is administered by a method comprising one or more of the following methods: orally, transdermally, by injection, intravenously, via Topical or administered systemically. 19. The nutraceutical formulation according to claim 15, characterized in that said composition is constituted by 0.1-49.9% by weight of methylsulfonylmethane, 50-90% by weight of fruit juice of Morinda citrifolia, 0.1-50% by weight of water and 0.1-30% by weight of fruit juices not based on Morinda cítri folia. 20. The nutraceutical formulation according to claim 15, characterized in that said composition is constituted by 0.1-49.9% by weight of methylsulfonylmethane, 50-90% by weight of juice of the fruit of Morinda ci trifolia, and 0.1-30% by weight. Weight of fruit juices not based on Morinda ci trifolia. 21. The nutraceutical formulation according to claim 1, further comprising 0.1-50% by weight of water. 22. A method for treating, inhibiting, and preventing cancer of breast tissue comprising: administering a nutraceutical composition to a patient, characterized in that said nutraceutical composition comprises a product or processed extract of Morinda citrifolia present in an amount between 0.001 and 100 about one hundred percent by weight, and methylsulfonylmethane present in an amount between about 0.001 and about 99 weight percent. 23. A method according to claim 22, characterized in that said processed product of Morinda citrifolia is constituted by one or more of the following: juice of the fruit of Morinda ci trifolia, extract of oil of Morinda citrifolia, dietary fiber of Morinda citrifolia , Morinda citrifolia puree juice, Morinda citrifolia puree, Morinda citrifolia fruit juice concentrate, Morinda citrifolia puree juice concentrate, elements extracted from Morinda citrifolia. 24. A method according to claim 22, characterized in that said product of Morinda citrifolia is used with a carrier medium. 25. A method according to claim 22, characterized in that said composition is administered by a method comprising one or more of the following methods: orally, transdermally, by injection, intravenously, topically or administered systemically. 26.- A method according to claim 22, characterized in that said composition is constituted by 0.1-49.9% by weight of methylsulfonylmethane, 50-90% by weight of juice of the fruit of Morinda citrifolia, 0.1-50% by weight of water and 0.1-30% by weight of fruit juices not based on Morinda citrifolia. 27. A method according to claim 22, characterized in that said composition is constituted by 0.1-49.9% by weight of methylsulfonylmethane, 50-90% by weight of juice of the fruit of Morinda citrifolia, and 0.1-30% by weight of fruit juices not based on Morinda citrifolia. 28. A method according to claim 22, further comprising 0.1-50% by weight of water. 29. A method according to claim 22, characterized in that 29,573 ml or more are administered daily to the patient. 30. A method according to claim 22, characterized in that at least 88,719 ml or more are administered daily to the patient. 31.- A method to chemically prevent and inhibit carcinogenesis in the initial stage by chemically blocking the carcinogens, purifying the free radicals, extinguishing the lipid peroxides, and inhibiting COX-2, said method comprises the steps of: administering a nutraceutical composition to a patient, characterized in that said nutraceutical composition comprises a product or processed extract of Morinda citrifolia present in an amount between about 0.001 and 100 weight percent, and methylsulfonylmethane present in an amount between about 0.001 and about 99 weight percent. 32. A method according to claim 31, characterized in that said processed product of Morinda ci trifolia is constituted by one or more of the following: juice of the fruit of Morinda citrifolia, extract of oil of Morinda ci trifolia, dietary fiber of Morinda citrifolia, Morinda citrifolia puree juice, Morinda citrifolia puree, Morinda citrifolia fruit juice concentrate, Morinda citrifolia puree juice concentrate, elements extracted from Morinda citrifolia. 33. A method according to claim 31, characterized in that said product of Morinda citrifolia is used with a carrier medium. 34. A method according to claim 31, characterized in that said composition is administered by a method comprising one or more of the following methods: orally, transdermally, by injection, intravenously, topically or administered systemically. 35.- A method according to claim 31, characterized in that said composition is constituted by 0.1-49.9% by weight of methylsulfonylmethane, 50-90% by weight of juice of the fruit of Morinda citrifolia, 0.1-50% by weight of water and 0.1-30% by weight of fruit juices not based on Morinda ci trifolia. 36. A method according to claim 31, characterized in that said composition is constituted by 0.1-49.9% by weight of methylsulfonylmethane, 50-90% by weight of juice of the fruit of Morinda citrifolia, and 0.1-30% by weight of fruit juices not based on Morinda citrifolia. 37. A method according to claim 31, further comprising 0.1-50% by weight of water. 38. A method according to claim 31, characterized in that 29,573 ml or more are administered daily to the patient. 39.- A method according to claim 31, characterized in that at least 88,719 ml or more are administered daily to the patient. 40.- A method to chemically prevent and inhibit carcinogenesis in the initial stage by chemically blocking the carcinogens, purifying the free radicals, extinguishing the lipid peroxides, and inhibiting COX-2, said method comprises the steps of: administering a nutraceutical composition to a patient, characterized in that said nutraceutical composition comprises a product or processed extract of Morinda cit trifolia present in an amount between about 0.001 and 100 weight percent, and methylsulfonylmethane present in an amount between about 0.001 and about 99 weight percent. 41. A method according to claim 40, characterized in that said processed product of Morinda ci trifolia is constituted by one or more of the following: juice of the fruit of Morinda citrifolia, extract of oil of Morinda citrifolia, dietary fiber of Morinda citrifolia , Morinda citrifolia puree juice, Morinda citrifolia puree, Morinda citrifolia fruit juice concentrate, Morinda citrifolia puree juice concentrate, elements extracted from Morinda citrifolia. 42. A method according to claim 40, characterized in that said product of Morinda citrifolia is used with a carrier medium. 43. A method according to claim 40, characterized in that said composition is administered by a method comprising one or more of the following methods: orally, transdermally, by injection, intravenously, topically or administered systemically. 44.- A method according to claim 40, characterized in that said composition is constituted by 0.1-49.9% by weight of methylsulfonylmethane, 50-90% by weight of juice of the fruit of Morinda ci trifolia, 0.1-50% by weight of water and 0.1-30% by weight of fruit juices not based on Morinda citrifolia. 45. A method according to claim 40, characterized in that said composition is constituted by 0.1-49.9% by weight of methylsulfonylmethane, 50-90% by weight of juice of the fruit of Morinda citrifolia, and 0.1-30% by weight of Fruit juices not based on Morinda ci trifolia. 46. A method according to claim 40, further comprising 0.1-50% by weight of water. 47. A method according to claim 40, characterized in that 29,573 ml or more are administered daily to the patient. 48. A method according to claim 40, characterized in that at least 88,719 ml or more are administered daily to the patient. 49.- A method to prevent, inhibit and treat breast cancer, comprising the steps of: adding one or more processed products of Morinda citrifolia to an alcohol-based solution; isolate and extract an active ingredient of Morinda ci trifolia from said solution; combining said extracted active ingredient with about 100-2000 milligrams of ethylsulfonylmethane to form a nutraceutical composition exposing said nutraceutical composition to an area afflicted by one or more carcinogenic cells, characterized in that said extracted active ingredient inhibits, prevents, and destroys the growth of said cells carcinogenic 50.- A method according to claim 49, characterized in that said processed product of Morinda ci trifolia is constituted by one or more of the following: juice of the fruit of Morinda citrifolia, extract of oil of Morinda citrifolia, dietary fiber of Morinda citrifolia , Morinda citrifolia puree juice, Morinda citrus trifolia purée, Morinda citrifolia fruit juice concentrate, Morinda citrifolia puree juice concentrate. 51. A method according to claim 49, characterized in that said nutraceutical composition is used with a carrier medium. 52. A method according to claim 49, characterized in that said composition is administered by a method comprising one or more of the following methods: orally, transdermally, by injection, intravenously, topically or administered systemically. 53. A method according to claim 49, characterized in that said composition is constituted by approximately 100-2000 milligrams of methylsulfonylmethane, 50-90% by weight of juice of the fruit of Morinda cit trifolia, 0.1-50% by weight of water and 0.1-30% by weight of fruit juices not based on Morinda citrifolia. 54.- A method according to claim 49, characterized in that said composition is constituted by approximately 100-2000 milligrams of methylsulfonylmethane by weight, 50-90% by weight of juice of the fruit of Morinda citrifolia, and 0.1-30% by weight of fruit juices not based on Morinda citrifolia. 55. A method according to claim 49, further comprising 0.1-50% by weight of water. 56.- A method according to claim 49, characterized in that 29,573 ml or more are administered daily to the patient. 57. A method according to claim 49, characterized in that at least 88,719 ml or more are administered daily to the patient. 58. The method according to claim 49, characterized in that said alcohol-based solution is selected from the group consisting essentially of methanol, ethanol, and ethyl acetate, and other alcohol-based derivatives. 59. A method for inhibiting, preventing, and destroying carcinogenic cells within the mammary region of the breast, said method comprising the steps of: administering orally at least one ounce of a food product comprising juice of the fruit of Morinda citrifolia processed and methylsulfonylmethane on an empty stomach in the morning; and orally administering at least one ounce of said food product before going to sleep at night.