Pharmanutrient Composition(s) and System(s) for Individualized, Responsive Dosing Regimens

Abstract

Individualized responsive dosing pharmanutrient systems, compositions, methods of dosing, and processes of producing the same, which allow a consumer to generate individualistic biological responses/effects. More specifically, a pharmanutrient system for generating individualized biological conditions/responses which utilizes ultra-low dosage amounts of vitamins, minerals, amino acids, co-enzymes, organics substrates, inorganic or synthetic substrates, biological components, and/or other nutrients incorporated or provided with a pharmacologically active ingredient in a bio-active delivery system which preferably avoids first pass metabolism, such that an individual may take multiple doses of the same or different pharmanutrient based on varying desired biological response within each dosing period.

1 . A process for producing a pharmanutrient system for individualized responsive dosing comprising the steps of:
 (a) providing an amount of water;   (b) adding a base composition, wherein
 i. the base composition comprises at least two vitamins or minerals and at least one pharmacologically active ingredient; 
 ii. the base composition is selected from a group of two or more base-compositions configured to generate one or more pre-determined biological effects; and 
 iii. optionally at least one nutrient group; 
   (c) adding a pre-mix composition comprising a blend of
 i. at least one vitamin; and 
 ii. at least one mineral; 
   (d) optionally diluting an intermediate mixture of water, base composition, and pre-mix composition by a dilution factor;   (e) configuring the mixture comprising the water, base composition, and pre-mix composition into a final formulation or formulations which substantially avoids first-pass metabolism, wherein
 the final formulation or formulations comprise between about 1×10 −7%  of the RDA, DV, or UL to about 10% of the RDA, DV, or UL of any vitamin, mineral, amino acid, or co-enzyme; and 
   (f) repeating steps (a)-(e) one or more times by utilizing
 i. a different base composition; or 
 ii. a different dilution factor. 
   
   
   
       2 . The process of  claim 1 , wherein the base composition contains the pre-mix. 
   
   
       3 . The process of  claim 1 , wherein the pre-mix composition components have constant weight percentages in relation to one another. 
   
   
       4 . The process of  claim 1 , further comprising the step of multiplying the amount of base mixture by a multiplication factor before adding it to the mixture. 
   
   
       5 . The process of  claim 1 , wherein the base mixture is allowed to age for a period of time from about 48 hours to about 240 hours. 
   
   
       6 . The process of  claim 1 , wherein the final formulation is delivered via an oral film, a tablet, a pill, a liquid, a capsule, a lozenge, a dragee, an oral powder, a powder for inhalation, a suppository, a nasal spray, a coating, or a troche capable of avoiding first-pass metabolism. 
   
   
       7 . The process of  claim 6 , wherein the final formulation is delivered via an oral film. 
   
   
       8 . The process of  claim 1 , wherein the pre-determined biological effect for each of the one or more base mixtures is selected from the group consisting of: stress-relief, cellular metabolism, syndrome metabolism, maintenance of vascular tissue tension, fertility enhancement, lymphatic system modulation, satiety modulation, oxygen metabolism, pyruvate/lactic acid metabolism, body weight modulation, mitochondrial function modulation, enhanced digestion, preventative anti-aging, remedial anti-aging, hormonal release, improved cardiovascular performance, energy conservation, neurochemical release, neurochemical uptake, neurochemical repair, energy utilization, glucose modulation, energy enhancement, cellular repair, enhanced memory, enhanced cognitive function, calmness, awareness, elimination of cellular by-products, elimination of tissue by-products, stimulation of the hypothalamic-pituitary-thyroid axis, fatigue relief, immune response modulation, tissue catabolic activity modulation, antioxidation, liver detoxification, and alcohol metabolism. 
   
   
       9 . The process of  claim 1 , wherein the base mixture and pre-mix composition in combination comprise an amount of between about 0.01% to about 0.30% by weight of the mixture comprising base mixture, pre-mix composition, and water. 
   
   
       10 . The process of  claim 7 , wherein the water is selected from a Shenandoah Valley water source. 
   
   
       11 . The process of  claim 1 , wherein the amount of any vitamin or mineral in the final formulation is between about 1×10 −7%  of the RDA, DV, or UL to about 1% of the RDA or UL. 
   
   
       12 . The process of  claim 1 , wherein the amount of any vitamin or mineral in the final formulation is between about 1×10 −7%  of the RDA, DV, or UL to about 0.001% of the RDA or UL. 
   
   
       13 . The process of  claim 1 , wherein the base-mixture comprises at least two of the members of the nutrient group consisting of: an amino acid, an enzyme, a co-enzyme, an organic substrate, an inorganic or synthetic substrate, a biological component, a mineral, a vitamin, a nitrate, a nitrite, a stimulant, a derivative thereof, and a combination thereof. 
   
   
       14 . The process of  claim 13 , wherein the base-mixture comprises at least five of the members of the nutrient group consisting of: magnesium chloride, sodium chloride, potassium chloride, calcium chloride, ascorbic acid, caffeine, niacin, potassium benzoate, chromium picolinate, polynicolinate, coenzyme Q10, L-Glutamine, potassium sorbate, calcium ascorbate, sodium nitrite, L-arginine, lysine, beta-glucans, methylsulfonyl methane, proteoglycan, sodium ascorbate, and combinations thereof. 
   
   
       15 . The process of  claim 3 , wherein each of the two or more pre-mixtures and base-mixtures comprises the components and relative amounts of a member from the group consisting of Series S, Series T, Series U, Series V, Series K, Series L, Series M, Series N, Series X, and Series W. 
   
   
       16 . The process of  claim 1 , wherein the pre-mix composition comprises two or more of the members of the group consisting of: vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, vitamin C, vitamin D3, vitamin E, vitamin H, folic acid, copper, iron, potassium iodide, calcium carbonate, zinc, and combinations and derivatives thereof. 
   
   
       17 . The process of  claim 16 , wherein the pre-mix composition comprises five or more of the members of the group consisting of: vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, vitamin C, vitamin D3, vitamin E, vitamin H, folic acid, copper, iron, potassium iodide, calcium carbonate, zinc, and derivatives thereof. 
   
   
       18 . The process of  claim 1 , wherein the pharmacologically active ingredient of the base composition is a member selected from the group consisting of blood modifiers, hormonal agents, diuretic agents, cardiovascular agents, respiratory agents, anti-neoplastic agents, systemic anti-infective agents, central nervous system agents, gastrointestinal agents, local anti-infective agents, combinations thereof, and derivatives thereof. 
   
   
       19 . The process of  claim 18 , wherein the dose of the pharmacologically active ingredient present in the final formulation comprises from about 0.0000001 mg or greater. 
   
   
       20 . A base mixture for producing an individualized responsive dosing pharmanutrient composition or system wherein,
 (a) the base mixture is configured to generate one or more pre-determined biological effects;   (b) the base mixture comprises two or more vitamins or minerals and at least one pharmacologically active ingredient; and   (c) the base mixture is configured to provide no more than about 10% of the RDA, DV, or UL of any vitamin or mineral in a finished formulation.   
   
   
       21 . The base mixture of  claim 20 , wherein the base mixture is configured to provide no more than about 0.01% of the RDA, DV, or UL for any vitamin or mineral in one dose of an individualized responsive dosing pharmanutrient composition or system. 
   
   
       22 . The base mixture of  claim 20 , comprising at least five of the members of the group consisting of: magnesium chloride, sodium chloride, potassium chloride, calcium chloride, ascorbic acid, caffeine, niacin, potassium benzoate, chromium picolinate, chromium, polynicolinate, coenzyme, L-glutamine, potassium sorbate, calcium ascorbate, sodium nitrite, L-arginine, sodium ascorbate, and combinations and derivatives thereof. 
   
   
       23 . The base mixture of  claim 22 , wherein the base mixture comprises the components and relative amounts of a member from the group consisting of Series S, Series T, Series U, Series V, Series K, Series L, Series M, Series N, Series X, and Series W. 
   
   
       24 . The base mixture of  claim 20 , wherein the pharmacologically active ingredient is a member selected from the group consisting of blood modifiers, hormonal agents, diuretic agents, cardiovascular agents, respiratory agents, anti-neoplastic agents, systemic anti-infective agents, central nervous system agents, gastrointestinal agents, local anti-infective agents, combinations thereof, and derivatives thereof. 
   
   
       25 . The base mixture of  claim 24 , wherein the base mixture is configured to provide 0.0000001 mg or greater of the pharmacologically active ingredient in one dose of an individualized responsive dosing pharmanutrient composition or system. 
   
   
       26 . A pre-mix composition for use in an individualized responsive dosing pharmanutrient composition, wherein
 (a) the pre-mix composition comprises two or more compounds selected from the group consisting of: vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, vitamin C, vitamin D3, vitamin E, vitamin H, folic acid, copper, iron, potassium iodide, calcium carbonate, zinc, amino acids, co-enzyme Q-10, and derivatives thereof; and   (b) the pre-mix composition is configured to provide no more than 10% of the RDA, DV, or UL of any vitamin, mineral, amino acid, or co-enzyme in each dose of a finished individualized responsive dosing pharmanutrient formulation.   
   
   
       27 . The pre-mix composition of  claim 26 , wherein the pre-mix composition is a component of an individualized responsive pharmanutrient dosing system, formulation, method, or series of compositions which allows for individualized enhancement of biological functions. 
   
   
       28 . The pre-mix composition of  claim 26 , configured to provide no more than 0.01% of the RDA, DV, or UL of any vitamin, mineral, amino acid, or co-enzyme in each dose of a finished individualized responsive dosing pharmanutrient formulation. 
   
   
       29 . The pre-mix composition of  claim 26 , comprising five or more compounds selected from the group consisting of vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, vitamin C, vitamin D3, vitamin E, vitamin H, folic acid, copper, iron, potassium iodide, calcium carbonate, zinc, amino acids, co-enzyme, combinations and derivatives thereof. 
   
   
       30 . An individualized responsive pharmanutrient dosing treatment method comprising selecting from two or more pharmanutrient formulations in delivery systems which substantially avoid first pass metabolism, wherein each member of a selection of pharmanutrient formulations comprises:
 (a) five or more vitamins, minerals, amino acids, or co-enzyme Q-10 in amounts no greater than about 10% of the RDA, DV, or UL;   (b) water containing at least one mineral, nitrate, and nitrite, each in an amount less than about 10% of the RDA, DV, or UL; and   (c) at least one pharmacologically active ingredient;   wherein, any selected pharmanutrient formulation is separately configured to generate a pre-determined biological response and   wherein, the pharmanutrient formulation may be taken by an individual two or more times within each day.   
   
   
       31 . The method of  claim 30 , wherein two or more different selections from the group of two or more pharmanutrient formulations may be taken by an individual each 24 hour period. 
   
   
       32 . The method of  claim 30 , wherein the pre-determined biological response is selected from the group consisting of: stress-relief, cellular metabolism, syndrome metabolism, maintenance of vascular tissue tension, fertility enhancement, lymphatic system modulation, satiety modulation, oxygen metabolism, pyruvate/lactic acid metabolism, body weight modulation, mitochondrial function modulation, enhanced digestion, preventative anti-aging, remedial anti-aging, hormonal release, improved cardiovascular performance, energy conservation, neurochemical release, neurochemical uptake, neurochemical repair, energy utilization, glucose modulation, energy enhancement, cellular repair, enhanced memory, enhanced cognitive function, calmness, awareness, elimination of cellular by-products, elimination of tissue by-products, stimulation of the hypothalamic-pituitary-thyroid axis, modulation tissue catabolic activity fatigue relief, immune response modulation, antioxidation, liver detoxification, and alcohol metabolism. 
   
   
       33 . The method of  claim 30 , wherein each delivery for the pharmanutrient formulations is an oral film, a tablet, a pill, a liquid, a capsule, a lozenge, a dragee, an oral powder, a powder for inhalation, a suppository, a coating, a nasal spray, or a troche capable of avoiding first-pass metabolism. 
   
   
       34 . The method of  claim 30 , wherein the water is selected from a Shenandoah Valley water source. 
   
   
       35 . The method of  claim 30 , wherein the pharmanutrient formulation comprises between about 1×10 −7%  of the RDA, DV, or UL to about 1% of the RDA, DV, or UL of at least five of the members of the group consisting of: magnesium chloride, sodium chloride, potassium chloride, calcium chloride, ascorbic acid, caffeine, niacin, potassium benzoate, chromium picolinate, chromium, polynicolinate, coenzyme, L-Glutamine, potassium sorbate, calcium ascorbate, sodium nitrite, L-Arginine, sodium ascorbate, and combinations and derivatives thereof. 
   
   
       36 . The method of  claim 30 , wherein the pharmanutrient formulation further comprises between about 0.0001% of the RDA, DV, or UL to about 1% of the RDA, DV, or UL of five or more of the members of the group consisting of: vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, vitamin C, vitamin D3, vitamin E, vitamin H, folic acid, copper, iron, potassium iodide, calcium carbonate, zinc, and combinations and derivatives thereof. 
   
   
       37 . The method of  claim 30 , wherein the pharmacologically active ingredient is a member selected from the group consisting of blood modifiers, hormonal agents, diuretic agents, cardiovascular agents, respiratory agents, anti-neoplastic agents, systemic anti-infective agents, central nervous system agents, gastrointestinal agents, local anti-infective agents, combinations thereof, and derivatives thereof. 
   
   
       38 . The method of  claim 37 , wherein dose of the pharmacologically active ingredient present in the final formulation comprises from about 0.0000001 mg or greater. 
   
   
       39 . A product produced by the process of  claim 1 . 
   
   
       40 . A method of causing stress-relief in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       41 . A method of increasing metabolism in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       42 . A method of increasing antioxidation in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       43 . A method of regulating hormonal release or uptake in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       44 . A method of increasing cardiovascular performance within cardiac tissue in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       45 . A method of regulating neurochemical release or uptake in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       46 . A method of regulating energy production in a human or an animal comprising the step of providing one or more doses a product produced by the process of  claim 1 . 
   
   
       47 . A method of regulating glucose production or consumption in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       48 . A method of increasing cellular repair in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       49 . A method of improving cognitive function in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       50 . A method of increasing the elimination of cellular or tissue by-products in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       51 . A method of regulating the hypothalamic-pituitary-thyroid axis uptake or release of neurochemicals in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       52 . A method of regulating an immune response in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       53 . A method of increasing liver detoxification in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       54 . A method of increasing alcohol metabolism in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 . 
   
   
       55 . A method of mitigating or preventing fatigue in a human or an animal comprising the step of providing one or more doses of a product produced by the process of  claim 1 .