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Anti-inflammatory humate compositions and methods of use thereofRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Plant Material Or Plant Extract Of Undetermined Constitution As Active Ingredient (e.g., Herbal Remedy, Herbal Extract, Powder, Oil, Etc.)Anti-inflammatory humate compositions and methods of use thereof description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060233894, Anti-inflammatory humate compositions and methods of use thereof. Brief Patent Description - Full Patent Description - Patent Application Claims
PRIORITY CLAIM [0001] The present application is a continuation under 35 U.S.C. .sctn.120 of U.S. patent application Ser. No. 10/336,484, filed Jan. 3, 2003, titled "Anti-Inflammatory Humate Compositions and Methods of Use Thereof", issued as U.S. Pat. No. ______ on ______. FIELD OF THE INVENTION [0002] The present invention relates to anti-inflammatory humate compositions and their methods of use. In particular, it relates to humate compositions containing natural humate and other anti-inflammatory chemicals. It additionally relates to the use of humate in treating inflammation either alone or in combination with other anti-inflammatory chemicals. BACKGROUND OF THE INVENTION [0003] Chemical studies of the composition of humates such as Menefee Humate.RTM. and leonardite have revealed that they are mainly composed of the mixed salts of acid radicals found in soil humus, a product of the decay of organic matter that contains both humic and nonhumic material. Such acid radicals are collectively termed "humic acids", having individual factions named humin, humic acid, ulmic acid and fulvic acid. [0004] Humic acids, defined as the portion of soil humus that is soluble in alkaline solution, but insoluble in acid solution, are a form of organic matter that often is added to the soil to increase fertility. Humic acids are found in rotting vegetable matter and can be detected in the black slime of an ordinary compost pit in a home garden. They are also found in the brown organic matter of a variety of soils, as well as in peats, manure, lignite, leonardite, brown coals, and the Menefee Humate.RTM.. [0005] The exact structure of the humic acids is unknown. However, humic acids appear to be associations of molecules forming aggregates of elongated bundles of fibers at low pH, and open flexible structures perforated by voids at high pH. These voids, of varying dimensions, trap organic or inorganic particles of appropriate electronic charge. Humic acids do not have a single unique structure, but are a mixture of intermediate chemical products resulting from the decomposition and conversion of lignin and other plant materials to hard coal. Humic acids apparently are formed by the bacterial and chemical degradation of plant tissue, but in soils they also may be formed by certain secondary processes such as polymerization of polyphenols leached by rain from surface leaf litter, and condensation of phenols, quinones, and proteins that are provided by the action of soil micro-organisms and small animals on soil carbohydrates. As a result, humic acids are best characterized in terms of their origin and soil environment, rather than in rigid terms of chemical composition or chemical properties. [0006] The humic acids have a large cation exchange capacity and hold multivalent metallic elements, such as micronutrient elements, very strongly. The molecular weight of the humic acids range from 800 to 500,000, with the weight average molecular weight ranging from about 5,000 to about 50,000. The cation exchange capacity of the humic acids varies from about 200 to about 600 meq CaCO.sub.2 per 100 grams at pH 7, depending upon the origin of the extracted acids. Humic acids are polyelectrolytes and are believed to form complexes with clay particles thus enabling humic acids to bind multivalent elements with great tenacity. When the cation exchange sites on the humic acid molecule are filled predominantly with hydrogen ions, the material, considered to be an acid, is insoluble in water. However, when the predominant cations at the exchange sites are other than hydrogen, the material is called a "humate." Humates of monovalent alkali metals or ammonia are soluble in water. Such humates are referred to as "soluble". The humates of most multivalent metals are insoluble in water. Such humates are referred to as "insoluble". The term "humate" as used herein refers to both humate as well as the humic acids found in humate. [0007] Humate has been used for decades as plant fertilizer and as an animal food supplement because of its general ability to produce healthier animals. More recently it has been used as a dietary supplement (See U.S. Pat. No. 5,626,881.) A variety of studies have explored it effects in animals. For example, humic acids' capacity to increase uptake of iron when administered as a humic acid/iron chelate was studied by Fuchs and Kunhert (Dtsch. tierarzti, 97(5): 208-9 (1990)). Low molecular weight humic acids have been found to be effective at crossing mitochondrial membranes (Viser, S.A. , The Science of the Total Environment, 62: 347-354 (1987)). Humic acids have also been shown to to absorb mutagenic chemicals and prevent their disruptive effects in bacteria (Sato, T., et al., Mutation Research, 162: 173-178 (1986); Sate, T., et al., Mutation Research, 176: 199-204 (1987)). [0008] The effects of humate or humic acids on immune system function have also been studied. Overall, humic acids and humate have been found to stimulate immune cells or the immune response. (See Gau, R.J., et al., Toxicol. Appl. Pharmacol. 166(1): 59-67 (2001); Lange, N., et al., Arch. Exper. Vet. Med., 2: 140-6 (1987); Reide, U.N., et al., Virchows Archir. B. Cell Pathol., 60: 27-34 (1991); and Kuhnert et al., Dtsch. tierarztl. 96(1): 3-10 (1989).) Thus it came as some surprise when Ye et al. (Ye, S.B., et al., Acta Acad. Med. Sichuan 2: 127-9 (1985)) reported that intraperitoneal injection of Hong Yuan peat-derived sodium humate reduced swelling of inflamed rat paws. [0009] Although it is not impossible for an immune-stimulatory agent to reduce inflammation, which is partially due to immune response, agents with these properties in combination are not common. Unfortunately, direct intraperitoneal injection of large amounts of humate as described in Ye et al. is not practical for non-experimental purposes. For example, Ye et al. injected 50 mg/kg of soluble sodium humate; an equivalent amount for an adult human weighing 100 kg would be 5 g of humate. Even if the humate were solubilized in a very concentrated solution, this would require injection of an uncomfortably large volume of liquid. Additionally, although humate is generally beneficial, overly large amounts of it are actually less effective as an anti-inflammatory agent than smaller amounts and may cause other, unknown health problems. [0010] Inflammation is signaled by redness, swelling, heat, and pain as a reaction of the body against injury or assault. A variety of chemicals have been implicated as chemical mediators of the inflammatory reaction, including histamine, serotonin, kinins, prostaglandins, platelet-activating factors, leukotrienes, and, from nerve endings, substance P. Mediators of the acute inflammatory reaction seem to play roles in one or more of increasing vascular permeability, attracting leukocytes, producing pain, local edema, and necrosis. [0011] There are steroid and non-steroid, anti-inflammatory drugs known to the art. U.S. Pat. No. 4,579,844, inventors Rovee et al., issued Apr. 1, 1986, discloses topically treating an inflammatory condition of the skin by use of the prostaglandin synthetase inhibitor concurrently with a corticosteroid. U.S. Pat. No. 4,404,198, inventor Kelley, issued Sep. 13, 1983, discloses the topical application of a composition including phenyl salicylate to treat inflammation. U.S. Pat. No. 3,980,778, inventors Ayer et al., issued Sep. 14, 1976, discloses asteroid for use in the topical, oral or parenteral treatment of skin and mucous membrane inflammations. Numerous other anti-inflammatory medications, ranging from aspirin, acetaminophen and ibuprofen to newer COX-2 inhibitors and ketoprofin. [0012] The wide variety of anti-inflammatory drugs is indicative of the fact that not all drugs are suitable for every indication or each individual patient. Despite this variety, there are still a number of patients whose needs are not well-met by the available range of anti-inflammatory drugs when administered in customary fashions. SUMMARY OF THE INVENTION [0013] The present invention provides a novel anti-inflammatory composition including humate as well as another composition including humate with at least one other anti-inflammatory chemical. The anti-inflammatory compositions may be for oral, topical or injection administration to an animal, including a human. In an exemplary embodiment, the humate is prehistoric humate such as Menefee Humate.RTM. derived from the Menefee Geological Formation in N. Mex. Additionally, in an exemplary embodiment the humate comprises at least 50% humic acids. [0014] When the mode of administration is oral or topical, the humate may be insoluble, granular humate, other insoluble humate, or soluble humate. When the mode of administration is by injection, the humate is preferably soluble. In an exemplary embodiment, the humate comprises between approximately 0.1% and 1.0% and, more specifically, approximately 0.5% by weight of the composition. Alternatively, the humate composition may be administered orally in such a way that between approximately 0.1% and 1.0% and, more specifically, approximately 0.5% by weight of the animal's total food intake is humate. [0015] The humate composition may also contain at least one additional anti-inflammatory agent. In an exemplary embodiment, this second agent is a nonsteroidal anti-inflammatory drug. For example, it may be an indole derivative such as indomethacin. [0016] The invention also includes a method of reducing inflammation in a tissue of an animal, including a human, by supplying a composition containing humate to the tissue through oral, topical or injection administration. In an exemplary embodiment, if the humate is supplied orally it may constitute approximately 0.1% and 1.0% and, more specifically, approximately 0.5% by weight of the total food consumed by the animal. [0017] The method may also include the additional step of supplying a second anti-inflammatory agent to the tissue of an animal, including a human, through oral, topical or injection administration. In an exemplary embodiment, the dosage of the second anti-inflammatory agent is reduced as compared with the dosage that would be administered if no composition containing humate were administered. The second anti-inflammatory agent may be supplied in the composition containing humate or it may be supplied in a separate composition from that containing humate. If the second agent is supplied separately from the humate it may be supplied approximately contemporaneously with the composition containing humate using the same type of administration. In a further exemplary embodiment, the humate acts a carrier to facilitate transport of the second anti-inflammatory agent to the tissue or cell where it exerts its activity. In another exemplary embodiment, a synergistic effect between the humate and other anti-inflammatory agent occurs. [0018] In an exemplary embodiment, the composition containing humate is supplied orally in such a manner that humate constitutes approximately 0.1% and 1.0% and, more specifically, approximately 0.5% by weight of the animal's food intake and the second anti-inflammatory composition is indomethacin administered in the amount of approximately 3 mg/kg animal. The inflammation may be acute or chronic. One example of chronic inflammation is arthritis. [0019] The invention additionally includes a method of increasing the therapeutic effect in an animal, including a human, of a therapeutic chemical by administering the therapeutic chemical with humate. The administration of humate may be contemporaneous and in the same manner as the administration of the therapeutic chemical, such as when they are in a single composition. [0020] In an exemplary embodiment, the humate serves as a carrier for the therapeutic chemical and facilitates its delivery to a tissue or cell of the animal where the therapeutic chemical exerts its therapeutic effect. The humate and therapeutic chemical may be administered orally, topically or by injection. Continue reading about Anti-inflammatory humate compositions and methods of use thereof... 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