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(12) Patent Application Publication (10) Pub. No.: US 2005/0238693 A1 Whyte (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2005/0238693 A1 Whyte (43) Pub US 2005O238693A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2005/0238693 A1 Whyte (43) Pub. Date: Oct. 27, 2005 (54) PROCESS FOR THE PREPARATION AND May 22, 2002 (AU)............................................. PS 248O ACTIVATION OF SUSBSTANCES AND A MEANS OF PRODUCING SAME Publication Classification (75) Inventor: Susan Kay Whyte, Dalkeith Wa (AU) (51) Int. Cl." ............................ A61N 1/00; A61K 38/00; A61K 48/00; AO1N 43/04; Correspondence Address: AO1N 25/00; A61K 47/00 MCKENNA LONG & ALDRIDGE LLP (52) U.S. Cl. ........................... 424/439; 504/116.1; 514/2; 1900 KSTREET, NW 514/44; 607/1 WASHINGTON, DC 20006 (US) (57) ABSTRACT (73) Assignee: Chemstop Pty Ltd., Dalkeith (AU) The present invention relates to a proceSS for the preparation and activation of a Substance and a means for producing the (21) Appl. No.: 10/514,992 activated Substance. In particular, the invention relates to a method of treating a disease in a Subject in need of Such (22) PCT Fed: May 20, 2003 treatment, comprising the Step of administering a Substance (86) PCT No.: PCT/AU03/00607 or active agent which comprises one or more components which have been agitated Such that a harmonic of between (30) Foreign Application Priority Data 20 to 50 Hz has been produced, in an amount effective to treat Said disease, with the proviso that the disease is not an May 20, 2002 (AU)............................................. PS 2400 airway disorder. Patent Application Publication Oct. 27, 2005 Sheet 1 of 4 US 2005/0238693 A1 i FIGURE 1. Patent Application Publication Oct. 27, 2005 Sheet 2 of 4 US 2005/0238693 A1 12 l4 5 8 2. 2.2 FIGURE 2 Patent Application Publication Oct. 27, 2005 Sheet 3 of 4 US 2005/0238693 A1 Roor mean free path . in bulk liquid . Characteristic Crossover SE scale of point Confiring media Roton-roton interactions. FIGURE 3 Patent Application Publication Oct. 27, 2005 Sheet 4 of 4 US 2005/0238693 A1 FBRSN TTR Citief 2 fit FIGURE 4 US 2005/0238693 A1 Oct. 27, 2005 PROCESS FOR THE PREPARATION AND 0006 Trace elements including zinc, magnesium and ACTIVATION OF SUSBSTANCES AND A MEANS Selenium are Some of the elements involved in antioxidant OF PRODUCING SAME defence mechanisms. Inadequate intake of these nutrients have been associated with ischemic heart disease, arthritis, FIELD OF THE INVENTION Stroke and cancer, where pathogenic role of free radicals is Suggested (Lall et al, Supra). 0001. The present invention relates to a process for the preparation and activation of a Substance and a means for 0007 Whilst certain vitamin and mineral supplements producing the activated Substance. In particular, the inven are known, as are Specific treatments for the remedy of tion relates to a process of preparing a Substance, wherein certain of the medical conditions mediated by free radicals the Substance is activated Such that the efficacy and/or and ROS, there is no formulation available capable of bioavailability of the Substance is increased by agitating the preventing and treating effectively a wide range of medical Substance or one or more components of the Substance So conditions mediated by free radicals. that a specific harmonic is obtained. In one embodiment the 0008 Further, the role played by nutrition in protecting activated Substance is capable of regulating the cytochrome against the effects of ROS have only recently been acknowl Pso pathways and thereby overcoming or at least alleviating edged. The biological antioxidant defence System includes conditions associated with reactive oxygen species (ROS). glutathione reductase, glutathione-s-transferase, glutathione peroxidase, phospholipid hydroperoxide glutathione peroxi BACKGROUND OF THE INVENTION dase, Superoxide dismutase (SOD) which is a Selenium dependent enzyme and catalase, together with the antioxi 0002. It is well appreciated by those skilled in the art that dant vitamins C and E. The individual components of this many Substances including food, therapeutics, agricultural System are utilised in various physiological and protective chemicals including pesticides, herbicides, and other indus processes and therefore require replenishment from the diet. trial chemicals have limited efficacy in use. This is despite Other components of the diet including carbohydrates, pro these Substances having been used, in Some instances, for teins and lipids are known to be important for maintaining thousands of years. Many foodstuffs, for example, are the levels of various enzymes required in body's defence known to be poorly digested and/or absorbed by the gas System providing protection against toxins for example trointestinal tract. Also the efficacy and/or bioavailability of therapeutics have often proven disappointing even though heavy metals. Such as lead which can contribute to loSS of these materials have proven useful in in vitro systems. More bone density (Zerwekh and Pak, 1998). concerning is that certain foodstuff and therapeutics may 0009. Accordingly, there is a need to improve a range of even have harmful effects attributed to them. Substances So that increased efficiency, efficaciousness and/ or bioavailability is produced. Also there is a need to provide 0003. In an attempt to overcome or at least alleviate some foodstuff and therapeutics that are capable of regulating the of these problems a number of researchers have worked on cytochrome Paso pathways Such that the host defence improving particular Substances or modifying the biological mechanisms are able to counteract the effects of ROS. Systems being affected. One area that has received Some attention recently has been the role of the cytochrome Pso 0010. The applicant has now surprisingly found that enzyme System and in particular the protective effects this Substances, may be enhanced with respect to efficacy and/or System provides against reactive oxygen species (ROS). bioavailability by using Specific agitation methods which produce particular harmonics. 0004. The production of ROS, including free radicals and free radical products is known to be deleterious. Further, 0011 Moreover, certain substances produced by the ROS are also produced by one-electron peroxidase oxida methods of the present invention are capable of regulating tions to cation radicals, Stabilisation of the ROS generator, the cytochrome Paso pathways allowing the effective pre CYP2E1. ROS are known to be cytotoxic and cause inflam vention and/or treatment of disorderS mediated at least in matory disease, including tissue necrosis, arthritis and defi part by free radicals. cits in energy metabolism (Manual et al., 2000). SUMMARY OF THE INVENTION 0005 Free radicals are formed in the body through unpaired electrons formed when there is no apparent enzyme 0012. A first aspect of the invention provides an active Synthesised by the liver to match the corresponding electron Substance, wherein Said Substance has been agitated Such of an atom of certain Substances in the body. These Sub that a harmonic of between 20 to 50 Hz has been produced. stances are often particles of Synthetic chemical compounds 0013 A second aspect of the invention provides a process for which the human enzyme System has not yet developed of preparing an active Substance comprising the Step of enzymes to enable complete detoxification via the liver and agitating Said Substance Such that a harmonic of between 20 excretory organs, for example the bowel, kidneys and skin. to 50 Hz is produced. The free radicals formed in this manner roam free in the body and contribute to inflammation and other harmful 0014) A third aspect of the invention provides a device cellular changes in a variety of tissues, for example in the for preparing an active Substance comprising a container and tendons, muscles, ligaments and bones (Lall et al, Indian a agitator, wherein Said device is capable of producing in a Journal of Experimental Biology. 37 (2): 109-16, February Substance a harmonic of between 20 to 50 Hz. 1999) Demineralisation is also considered to contribute to 0015. A fourth aspect of the invention provides a method free radical pathology (Lall et al., Supra); thus resulting in of treating a disease in a Subject in need of Such treatment, arthritis, inflammatory joint and Soft tissue disease and comprising the Step of administering a Substance or active Osteoporosis. agent which comprises one or more components which have US 2005/0238693 A1 Oct. 27, 2005 been agitated such that a harmonic of between 20 to 50 Hz one of ordinary skill in the art to which this invention has been produced, in an amount effective to treat Said belongs. Although any materials and methods similar or disease. equivalent to those described herein can be used to practice 0016 A fifth aspect of the invention provides a substance or test the present invention, the preferred materials and or active agent useful for treating a disease in a Subject in methods are now described. need of Such treatment, comprising ascorbic acid, magne 0025 All publications mentioned herein are cited for the sium and Selenomethionine and a pharmaceutically accept purpose of describing and disclosing the protocols, reagents able carrier, wherein at least one component has been and vectors which are reported in the publications and which agitated such that a harmonic of between 20 to 50 Hz has might be used in connection with the invention. Nothing been produced, together in an amount effective to treat Said herein is to be construed as an admission that the invention disease. is not entitled to antedate Such disclosure by Virtue of prior 0.017. A sixth aspect of the invention provides a method invention. of producing a Substance or active agent useful for treating 0026. The present invention relates to a process of acti a disease in a Subject in need of Such treatment, Said vation. The terms “active' and “activation” as used herein formulation or composition comprising Vitamins, trace ele with reference to the “substance” means the ability to ments and probiotic bacteria Said method comprising the produce a Substance that has enhanced effects.
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