DESC:“NUTRACEUTICAL COMPOSITION COMPRISING FULVIC ACID, FISETIN AND ONE OR MORE NUTRACEUTICALS, VITAMINS AND MINERALS”

FIELD OF THE INVENTION
The present invention relates to a nutraceutical composition comprising Fulvic acid, Fisetin and one or more nutraceuticals, vitamins and minerals its process of preparation and method of use of said nutraceutical composition.

BACKGROUND OF THE INVENTION
Fulvic acid is group of chemicals formed when plants and animals break down. It is found in the humus (organic matter) part of soil and peat and is also found in streams and lakes.
Fulvic acid has been used for the treatment of diseases related to immune suppression. It is also anti-microbial and anti-inflammatory property.
It has properties such as it enhances the absorption of nutrients, including minerals and trace elements in the digestive system, it has antioxidant properties, it has moisturizing properties to skin and it maintains gut health by maintaining microbial balance.

(Formula I)

Fisetin (7,3',4'-flavon-3-ol) is a plant flavonol from the flavonoid group of polyphenols. It is also found in many fruits and vegetables, such as strawberries, apples, persimmons, onions and cucumbers.

Fisetin has many biological effects, like antioxidant, anti-inflammatory, neuroprotective effects, anticarcinogenic, antibacterial immune-stimulating, and antiviral, anti-arthritic effects and it have cardiovascular benefits. Fisetin can also reduce factors related to aging in the body and mitigate symptoms related to aging.

(Formula II)

To date, no nutraceutical composition comprising combination of Fulvic acid, Fisetin and one or more nutraceuticals, vitamins and minerals is known. In view of this nutraceutical composition comprising combination of Fulvic acid, Fisetin and one or more nutraceuticals, vitamins and minerals is desirable over presently available dosage forms, as they would offer better and enhanced options as they provide potential health benefits beyond basic nutrition support.

The inventors of the present invention surprisingly found that a nutraceutical composition comprising combination of Fulvic acid and Fisetin and one or more nutraceuticals, vitamins and minerals can be manufactured without using costly and tedious formulation manufacturing instruments.

The inventors of the present invention surprisingly found that a nutraceutical composition comprising combination of Fulvic acid, Fisetin and one or more nutraceuticals, vitamins and minerals exhibit qualities such as but not limited to addressing nutrient deficiencies, supporting overall health, disease prevention, supporting cardiovascular, brain and gut health. Further it has advantages such as minimum side effects, storage stability, ready to use composition, easy administration, and better patient compliance and have a significant advance over the available nutraceutical dosage forms of comprising Fulvic acid or Fisetin as a sole active nutraceutical ingredient and fulfills the long felt need to provide synergistic composition.

OBJECTS OF THE INVENTION
It is an object of the present invention to provide a novel nutraceutical composition comprising Fulvic acid, Fisetin, one and more nutraceuticals and one or more suitable pharmaceutically acceptable excipient.

It is an object of the present invention to provide a novel oral nutraceutical composition comprising Fulvic acid, Fisetin, one or more nutraceutical, one or more vitamin, one or more mineral and one or more suitable pharmaceutically acceptable excipient.

It is an object of the present invention to provide a novel oral nutraceutical composition comprising:
a) Fulvic acid;
b) Fisetin;
c) One or more nutraceutical;
d) One or more vitamin;
e) One or more mineral; and
f) One or more suitable pharmaceutically acceptable excipient.

It is an object of the present invention to provide a novel oral nutraceutical composition, comprising:
a) 5 mg to 300 mg of Fulvic acid;
b) 0.5 mg to 300 mg of Fisetin;
c) 0.1 mg to 200 mg of One or more nutraceutical;
d) 0.01 mg to 50 mg of One or more vitamins;
e) 0.25 mg to 20 mg of One or more minerals; and
f) One or more pharmaceutically acceptable excipient

It is an object of the present invention to provide a novel oral nutraceutical composition comprising:
a) Fulvic acid;
b) Fisetin;
c) One or more of nutraceutical selected from group consisting of consisting of Oyster Peptide, Oyster Calcium, Calcium alpha ketoglutarate, Vitamin C, Red clover extract, Reduced glutathione, Ashwagandha, Melatonin, Soy Isoflavones, Nicotinamide Nucleotide (NMN), Theanine, Coenzyme Q10, Curcumin, Lutein, Zeaxanthin, Rosmarinic acid, Isoleucine, Berberine HCl, Carnosine, Grape seed extract, L-carnitine, L-citrulline, Rosemary extract, Thiocolchicoside and Phenyl alanine or combination thereof;
d) One or more vitamin selected from a group consisting of Vitamin A, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B7, Vitamin B9, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Vitamin K or combinations thereof;
e) One or more mineral selected from a group consisting of calcium, phosphorus, potassium, sodium, magnesium, sulfur, iron, chlorine, cobalt, copper, zinc, manganese, molybdenum, iodine, selenium, chromium or combinations thereof; and
f) One or more suitable pharmaceutically acceptable excipient.

It is another object of the present invention to provide a process of preparation of a novel oral nutraceutical composition, comprises steps of:
a) Dissolving Fulvic acid, Fisetin, nutraceuticals, vitamins and minerals into suitable solvent or vehicle to obtain solution;
b) Adding and dissolving one or more suitable pharmaceutically acceptable excipient into solution of step (a);
c) Filtering solution of step (b) through suitable filter; and
d) Filling into suitable bottle or container.

It is another object of the present invention to provide a process of preparation of a novel oral nutraceutical composition, comprises steps of:
a) Sifting Fulvic acid, Fisetin, nutraceuticals, vitamins and minerals through suitable sieve;
b) Sifting one or more suitable pharmaceutically acceptable excipient through suitable sieve;
c) pre-lubricating sifted material of step (a) and step (b) and blending into suitable blender;
d) Lubricating above material and blending it for suitable time; and
e) Compressing blend of step (d) into suitable dosage form.

It is another object of the present invention to provide a process of preparation of a novel oral nutraceutical composition, comprises steps of:
a) Sifting Fulvic acid, Fisetin, nutraceuticals, vitamins and minerals through suitable sieve;
b) Dry mixing of components of step (a);
c) Preparing binder solution;
d) Granulating mixture obtained in step (b) using binder solution obtained in step (c);
e) Drying the granules obtained in step (d);
f) Sifting, blending and lubricating the dried granules of step (e); and
g) Compressing granules of step (f) into suitable dosage form.

It is another object of the present invention to provide a method of using a novel oral nutraceutical composition, comprising Fulvic acid, Fisetin, nutraceuticals, vitamins and minerals for addressing nutrient deficiencies, supporting overall health, disease prevention, supporting cardiovascular, brain and gut health.

SUMMARY OF THE INVENTION
In one aspect, the present invention discloses a novel nutraceutical composition comprising Fulvic acid, Fisetin, nutraceuticals, vitamins, minerals and one or more suitable pharmaceutically acceptable excipient.

In one aspect, the present invention relates to a novel oral nutraceutical composition comprising Fulvic acid, Fisetin, nutraceuticals, vitamins, minerals and one or more suitable pharmaceutically acceptable excipient

In another aspect, the present invention provides a novel oral nutraceutical composition, comprising:
a) Fulvic acid;
b) Fisetin;
c) One or more nutraceutical;
d) One or more vitamin;
e) One or more mineral; and
f) One or more pharmaceutically acceptable excipient.

In another aspect, the present invention to provide a novel oral nutraceutical composition, comprising:
a) 5 mg to 300 mg of Fulvic acid;
b) 0.5 mg to 300 mg of Fisetin;
c) 0.1 mg to 200 mg of One or more nutraceutical;
d) 0.01 mg to 50 mg of One or more vitamin;
e) 0.25 mg to 20 mg of One or more mineral; and
f) One or more pharmaceutically acceptable excipient

In another aspect, the present invention also relates to a process of preparation of a novel nutraceutical composition comprising Fulvic acid, Fisetin, nutraceuticals, vitamins, minerals and one or more suitable pharmaceutically acceptable excipient.

In another aspect, the present invention to provide a novel oral nutraceutical composition comprising:
a) Fulvic acid;
b) Fisetin;
c) One or more of nutraceutical selected from group consisting of Oyster Peptide, Oyster Calcium, Calcium alpha ketoglutarate, Vitamin C, Red clover extract, Reduced glutathione, Ashwagandha, Melatonin, Soy Isoflavones, Nicotinamide Nucleotide (NMN), Theanine, Coenzyme Q10, Curcumin, Lutein, Zeaxanthin, Rosmarinic acid, Isoleucine, Berberine HCl, Carnosine, Grape seed extract, L-carnitine, L-citrulline, Rosemary extract, Thiocolchicoside and Phenyl alanine or combination thereof;
d) One or more vitamin selected from a group consisting of Vitamin A, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B7, Vitamin B9, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Vitamin K or combinations thereof;
e) One or more mineral selected from a group consisting of calcium, phosphorus, potassium, sodium, magnesium, sulfur, iron, chlorine, cobalt, copper, zinc, manganese, molybdenum, iodine, selenium, chromium or combinations thereof; and
f) One or more suitable pharmaceutically acceptable excipient.

In another aspect, the present invention to provide a process of preparation of a novel oral nutraceutical composition, comprises steps of:
a) Dissolving Fulvic acid, Fisetin, nutraceuticals, vitamins and minerals into suitable solvent or vehicle to obtain solution;
b) Adding and dissolving one or more suitable pharmaceutically acceptable excipient into solution of step (a);
c) Filtering solution of step (b) through suitable filter; and
d) Filling into suitable bottle or container.

In another aspect, the present invention to provide a process of preparation of a novel oral nutraceutical composition, comprises steps of:
a) Sifting Fulvic acid, Fisetin, nutraceuticals, vitamins and minerals through suitable sieve;
b) Sifting one or more suitable pharmaceutically acceptable excipient through suitable sieve;
c) pre-lubricating sifted material of step (a) and step (b) and blending into suitable blender;
d) Lubricating above material and blending it for suitable time; and
e) Compressing blend of step (d) into suitable dosage form.

In another aspect, the present invention to provide a process of preparation of a novel oral nutraceutical composition, comprises steps of:
a) Sifting Fulvic acid, Fisetin, nutraceuticals, vitamins and minerals through suitable sieve;
b) Dry mixing of components of step (a);
c) Preparing binder solution;
d) Granulating mixture obtained in step (b) using binder solution obtained in step (c);
e) Drying the granules obtained in step (d);
f) Sifting, blending and lubricating the dried granules of step (e); and
g) Compressing granules of step (f) into suitable dosage form.

In another aspect, the present invention to provide a method of using a novel oral nutraceutical composition, comprising Fulvic acid, Fisetin, nutraceuticals, vitamins and minerals for addressing nutrient deficiencies, supporting overall health, disease prevention, supporting cardiovascular, brain and gut health.

DETAILED DESCRIPTION OF THE INVENTION
The term "composition" or "nutraceutical composition" or as used herein synonymously include dosage forms such as a tablet, capsule, powder, granules, pellets, caplets, pills, soft gelatin capsules, mini tablets, solution, syrup, suspension, emulsion, elixir or the like.

The term “composition”, as in nutraceutical composition, is intended to encompass a nutraceutical product(s) comprising combination of Fulvic acid, Fisetin and one or more nutraceuticals and other inert ingredient(s) (pharmaceutically acceptable excipients).

The term “Fulvic acid” refers to a natural compound found in soil, plants, and organic matter. It is a type of humic substance, and it is part of humic substance known for its rich composition of minerals, trace elements, and other beneficial compounds.

The term “Fisetin” is a natural flavonoid compound found in various fruits and vegetables, such as strawberries, apples, persimmons, onions, and cucumbers. It has gained attention for its potential health benefits, and ongoing research is exploring its various uses.

"Pharmaceutically acceptable excipient(s)" are components that are added to the pharmaceutical composition other than the active ingredients Fulvic Acid, Fisetin and one or more nutraceuticals. Excipients may be added to facilitate manufacture, enhance stability, enhance product characteristics, enhance patient acceptability etc. Pharmaceutically acceptable excipient(s) includes, but not limited to, diluents or filler, disintegrants, binders, solubilizing agent, surfactant, absorption enhancer, bioadhesive agents or mucoadhesion promoting agent, polymers or release modifying agent, carriers, plasticiser, penetration enhancer, bases, lubricant, glidant, acidic agent, basic agent, chelators, sweeteners, flavoring agent, pH regulating agent, preservatives, antioxidants, coloring agents, solvents, taste masking agent, antifoaming agents, flow agents and opacifiers, antiadherent, stabilizing agent, antistatic agent, viscosity adjuster and coating agent and any other excipient known to the art for making pharmaceutical composition.

In one embodiment, an invention provides a nutraceutical composition comprising Fulvic acid, Fisetin and one or more nutraceutical.

In one embodiment, an invention provides a nutraceutical composition for novel oral administration comprising:
a) Fulvic acid;
b) Fisetin;
c) One or more nutraceutical;
d) One or more vitamin;
e) One or more mineral; and
f) One or more suitable pharmaceutically acceptable excipient.

In one embodiment, an invention provides a process of preparation of a nutraceutical composition comprising Fulvic acid, Fisetin and one or more nutraceuticals, vitamins and minerals.

In one embodiment, an invention provides a nutraceutical composition for comprising Fulvic acid, Fisetin and one or more nutraceuticals, vitamins and minerals and its process of preparation and its use for addressing nutrient deficiencies, supporting overall health, disease prevention, supporting cardiovascular, brain, gut health and works as antiaging by its antioxidative stress properties.

In one embodiment, one or more nutraceutical selected from but not limited to the group comprising of Oyster Peptide, Oyster Calcium, Calcium alpha ketoglutarate, Vitamin C, Red clover extract, Reduced glutathione, Ashwagandha, Melatonin, Soy Isoflavones, Nicotinamide Nucleotide (NMN), Theanine, Coenzyme Q10, Curcumin, Lutein, Zeaxanthin, Rosmarinic acid, Isoleucine, Berberine HCl, Carnosine, Grape seed extract, L-carnitine, L-citrulline, Rosemary extract, Thiocolchicoside and Phenyl alanine or combination thereof.

In another embodiment, the present invention comprises one or more vitamin is selected from but not limited to group comprising of Vitamin A, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B7, Vitamin B9, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Vitamin K or the like or any combination thereof.

In another embodiment, the present invention comprises one or more mineral selected from but not limited to group comprising of calcium, phosphorus, potassium, sodium, magnesium, sulfur, iron, chlorine, cobalt, copper, zinc, manganese, molybdenum, iodine, selenium, sodium selenite, chromium or the like or any combination thereof.

In another embodiment, the pharmaceutically acceptable excipients are selected from the group consisting of diluents or filler, disintegrants, binders, solubilizing agent, surfactant, absorption enhancer, bioadhesive agents or mucoadhesion promoting agent, polymers or release modifying agent, carriers, plasticiser, penetration enhancer, bases, lubricant, glidant, acidic agent, basic agent, chelators, sweeteners, flavoring agent, pH regulating agent, preservatives, antioxidants, coloring agents, solvents, taste masking agent, antifoaming agents, flow agents and opacifiers, antiadherent, stabilizing agent, antistatic agent, viscosity adjuster and coating agent and any other excipient known to the art for making pharmaceutical composition.

The examples of diluent or filler according to present invention include but not limited to group comprising of citric acid, mannitol, carboxymethyl cellulose (carmellose), calcium hydrogen phosphate, sodium carboxymethyl cellulose (carmellose sodium), hydroxypropyl cellulose, corn starch, potato starch, microcrystalline cellulose, anhydrous lactose, lactose monohydrate and the mixtures thereof.

The diluents according to present invention may be present in an amount from about 10% to about 95% by weight with respect to total weight of the pharmaceutical composition, preferably 30% to 90% w/w.

The examples of disintegrants according to present invention include but not limited to group comprising of croscarmellose sodium, croscarmellose potassium, carboxymethyl cellulose, chitosan, carboxymethyl cellulose calcium, carboxymethyl cellulose sodium, crospovidone, hydroxypropyl cellulose, microcrystalline cellulose, chitosan, colloidal silicon dioxide, pectin and tragacanth, magnesium aluminium silicate, polyvinylpyrrolidone or mixture thereof.

The disintegrants according to present invention may be present in an amount from about 1%-15% by weight with respect to total weight of the pharmaceutical composition.

The examples of binders according to present invention include but not limited to group comprising of microcrystalline cellulose, alginic acid, potato starch, corn starch, carboxymethyl cellulose sodium, hydroxymethyl cellulose, hydroxypropyl cellulose, microcrystalline cellulose, dihydroxy propylcellulose, hypromellose, hydroxypropylmethylcellulose, D-mannitol, sodium alginate, cellulose gum, polyvinyl pyrrolidone, polyacrylamides, polyvinyloxoazolidone, polyvinyl alcohols, or mixture thereof.

The binders according to present invention may be present in an amount from about 0.5%-30% by weight with respect to total weight of the pharmaceutical composition.

The examples of solubilizing agents or solubility enhancer according to present invention include but not limited to group comprising of cyclodextrin and/or its derivatives, 2-Hydroxypropyl-beta-cyclodextrin (Kleptose), polyethylene glycol, polyvinylpyrrolidone, dextran, sugars such as sucrose, lactose or dextrose, mannitol, sorbitol or lactitol, sodium chloride or mixture thereof.

The examples of surfactants according to present invention include but not limited to group comprising of cationic, anionic, nonionic or amphoteric agents, polysorbate, sodium lauryl sulphate, polyoxyethylene, polyoxypropylene glycol, the monooleate, the monolaurate, spans and tweens, ethoxylated oils, including ethoxylated castor oils, such as cremophor or mixture thereof.

The examples of absorption enhancer according to present invention include but not limited to group comprising of sodium lauryl sulphate, sodium caprate or chitosans, and also Pglycoprotein (P-gp) inhibitors, such as polysorbates, sorbitan esters, triolein PEG-6 esters, lecithin, d-alpha tocopheryl, polyethylene glycol 1000 succinate, polycarbonate, sodium glycocholate, sodium taurocholate, cyclodextrins, citric acid, sodium citrate, triacetin, combinations thereof or the like.

The examples of bioadhesive agents or mucoadhesion promoting agents according to present invention include but not limited to group comprising of carbomers, chitosan (poly-(D-glucosamine); natural polymers such as gelatin, sodium alginate, pectin; scleroglucan; xanthan gum; poly co-(methylvinyl ether/maleic anhydride); and crosscarmellose (e.g. crosscarmellose sodium) or mixture thereof.

The examples of polymers or release modifying agent include but not limited to cellulosic polymers, such as hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose (HPC), hydroxyethylcellulose (HEC), methylcellulose (MC), powdered cellulose such as microcrystalline cellulose, cellulose acetate, sodium carboxymethylcellulose, calcium salt of carboxymethylcellulose, ethylcellulose; alginates, gums such as guar and xanthan gums; crosslinked polyacrylic acid derivatives such as polyvinyl pyrrolidone and its derivatives such as crospovidone; polyethylene oxides; and polyvinyl alcohol, glyceryl monostearate, mixtures of glyceryl, styrene-maleic monoester copolymer, methyl acrylate-methacrylic acid copolymer, methacrylate-methacrylic acid-octyl acrylate copolymer or mixture thereof.

The examples of carriers according to present invention include but not limited to group comprising of mannitol, carbohydrates, e.g., sugars, such as lactose, and sugar alcohols, such as mannitol, sorbitol and xylitol, polyvinylalcohol, polyvinylpyrrolidine and croscarmellose sodium and other polymers, such as buffered saline, dextrose solution, propylene glycol, polyethylene glycols, miglyol or mixtures thereof.

The examples of plasticizers according to present invention include but not limited to group comprising of polyalkylene oxides, such as polyethylene glycols, polypropylene glycols, citric acid esters, polyvinyl alcohol, polyvinyl methyl ether, triacetin; mannitol, xylitol, and sorbitol or mixtures thereof.

The examples of penetration enhancers according to present invention include but not limited to group comprising of bile salts, such as sodium cholate, sodium glycocholate, sodium glycodeoxycholate, taurodeoxycholate, sodium deoxycholate, sodium lithocholate chenocholate, chenodeoxycholate, ursocholate, ursodeoxy-cholate, bile salt analogs, derivatives of bile salts, inclusion compounds, such as cyclodextrins and caged molecules; coloring agents; and flavors, cyclodextrin derivatives like hydroxypropyl, hydroxyethyl, glucosyl, maltosyl, ß-cyclodextrin maltotriosyl derivatives, ?-cyclodextrin maltotriosyl derivatives or mixtures thereof.

The examples of bases according to present invention include but not limited to group comprising of hydrophilic bases include, for example, polyethylene glycol,
polyvinylpyrrolidone, polyoxyethylene polyoxypropylene glycol, polyoxyethylene sorbitan higher fatty acid ester, citric acid, tartaric acid, glycine, ß-alanine, lysine hydrochloride and meglumine or mixture thereof.

The examples of lubricant according to present invention include but not limited to group comprising of calcium stearate, magnesium stearate, Sodium stearyl fumarate, fumaric acid, calcium stearate, polyethylene glycol, sodium benzoate, potassium benzoate, sodium lauryl sulphate, talc, colloidal silica, sucrose fatty acid esters, stearic acid, zinc stearate, hydrogenated vegetable oil, mineral oil, glyceryl behenate, polyoxyethylene glycols, sodium benzoate, dimethicone or liquid paraffin, or mixture thereof.

The lubricant according to present invention may be present in an amount from about 0.001% to about 10% by weight with respect to total weight of the pharmaceutical composition, preferably 0.1-5% w/w.

The examples of glidant according to present invention include but not limited to group comprising of colloidal silica, pyrogenic silica, hydrated sodium silicoaluminate, magnesium stearate, sodium stearyl fumarate, fumed silica (colloidal silicon dioxide), starch, talc, calcium phosphate tribasic, powdered cellulose, magnesium oxide; magnesium silicate, magnesium trisilicate, stearic acid, calcium stearate or mixture thereof.

The examples of basic agents according to present invention include but not limited to group comprising of potassium carbonate, sodium carbonate, sodium, anhydrous sodium perborate, effervescent perborate, sodium perborate monohydrate, sodium percarbonate, sodium dichloroisocyanurate, sodium hypochlorite, calcium hypochlorite, tris, tartrate, acetate, phosphate or mixture thereof.

The examples of chelators according to present invention include but not limited to group comprising of ethylene diamine tetra acetic acid (EDTA), proteins, polysaccharides, organic diacids, polypeptides, phytochelatin, hemoglobin, chlorophyll, humic acid, phosphonates, transferrin, desferrioxamine, and combinations thereof.

The examples of sweeteners according to present invention include but not limited to group comprising of dipotassium glycyrrhizinate, aspartame, stevia, thaumatin, saccharose, glucose, maltose, galactose, and artificial sweeteners, such as acesulfame potassium, sodium saccharin, cyclamates, sucralose, sodium saccharinate, neohesperidine dihydrochalcone, monoammonium glycyrrhizinate, Thaumatic, dextrose, invert sugar, fructose, Stevia Rebaudiana (Stevioside); sugar alcohols such as sorbitol, mannitol, xylitol, and the like. Also contemplated are sodium and calcium salts thereof, and natural intensive sweeteners, or mixture thereof.

The examples of flavoring agent according to present invention include but not limited to group comprising of fruit flavor, peppermint flavor, lemon, lemon-lime, orange, sour cherry, flavor of mint, honey lemon, vanilla, citrus oil, grapefruit grape, menthol, cranberry, vanilla berry, bubble gum, cherry, alpha-citral, beta-citral, decanal, aldehyde C-8, aldehyde C-9, aldehyde C-12, and volatile oils, synthetic flavor oils, flavoring aromatics, oils, liquids, oleoresins or extracts derived from plants, leaves, flowers, fruits, stems and combinations thereof. mint oils, cocoa, and citrus oils such as lemon, orange, grape, lime, cinnamon oil, oil of wintergreen, peppermint oils, eucalyptus, thyme oil, cedar leave oil, oil of nutmeg, oil of sage, oil of bitter almonds and cassia oil, grapefruit and fruit essences including apple, pineapple, apricot or other fruit flavors or mixture thereof.

The examples of pH regulating agent according to present invention include but not limited to group comprising of hydrochloric acid, fumarate, citrate, phosphate, carbonate, tartrate, acetate, amino acid, citric acid and sodium citrate or potassium citrate, sodium hydroxide, monoethanolamine, diethanolamine, sodium bicarbonate or potassium bicarbonate, sodium phosphate, tartaric acid, propionic acid, lactic acid, fumaric acid/sodium fumarate, monosodium phosphate/disodium phosphate, and boric acid/sodium borate and monosodium glutamate or mixture thereof.

The examples of the preservatives according to present invention include but not limited to group comprising of phenethyl alcohol, benzyl alcohol, p-hydroxybenzoate esters, chlorobutanol, methyl paraben, propyl paraben, dehydroacetic acid, sorbic acid or mixtures thereof.

The examples of the antioxidants according to present invention include but not limited to group comprising of butylated hydroxytoluene (BHT), hydrogen sulfite, ascorbic acid, sodium ascorbate, erythorbic acid, sodium nitrite, propyl gallate (PG), butylhydroxyanisol (BHA), sodium bisulfite, sodium pyrosulfite, citric acid, and edetate sodium, glutathione peroxidase or peroxidase catalase, cysteine, cystine, cystamine, thiodipropionic acid), sulphoximines (e.g., buthionine-sulphoximines, homo-cysteine-sulphoximine, buthioninesulphones, and penta-, hexa- and phenols (e.g., butylhydroxytoluene, butylhydroxyanisole, ubiquinol, nordihydroguaiaretic acid, trihydroxybutyrophenone), benzoates (e.g. coniferyl benzoate), uric acid, mannose, selenium (e.g., selenium-methionine), stilbenes (e.g. stilbene oxide and trans-stilbene oxide), superoxide dismutase (SOD) or mixtures thereof.

The examples of the coloring agents according to present invention include but not limited to group comprising of carmine, caramel, ß-carotene, titanium oxide, talc, riboflavin sodium phosphate, hydrogenated starch hydrolysate, food, drug and cosmetic colors (FD&C), drug and cosmetic colors (D&C), or external drug and cosmetic colors (Ext. D&C). These colors are dyes, their corresponding lakes, and certain natural and derived colorants, yellow aluminum lake natural pigments (examples, water-insoluble lake pigments (examples: aluminum salts of the above water-soluble edible tar pigments) natural coloring agents such as grape skin extract, beet red powder, annato, carmine, turmeric, paprika or mixtures thereof.

The examples of solvents according to present invention include but not limited to group comprising of aqueous or inert organic solvents or inorganic acids, alcohols, ketones, esters, ethers, aliphatic hydrocarbons, halogenated solvents, cycloaliphatic solvents, aromatic solvents, heterocyclic solvents, and mixtures thereof. Typical solvents include acetone, diacetone alcohol, methanol, ethanol, isopropyl alcohol, butyl alcohol, methyl acetate, ethyl acetate, isopropyl acetate, n-butyl acetate, methyl isobutyl ketone, methyl ethyl ketone, methylene chloride, methyl propyl ketone, n-hexane, cyclohexane, cyclooctane, benzene, toluene, naphtha, 1,4-dioxane, tetrahydrofuran, diglyme, water, hydrochloric acid (HCl), aqueous solvents containing inorganic salts (such as sodium chloride, calcium chloride, and the like), and mixtures thereof (such as acetone and water, acetone and methanol, acetone and ethyl alcohol, methylene dichloride and methanol, and ethylene dichloride and methanol) or mixture thereof.

The examples of taste masking agent according to present invention include but not limited to group comprising of ionic exchange resins including a water-insoluble organic or inorganic matrix material having covalently bound functional groups that are ionic or capable of being ionized under appropriate conditions..

The examples of anti-foaming agents according to present invention include but not limited to group comprising of certain alcohols (cetostearyl alcohol), insoluble oils (castor oil), stearates, polydimethylsiloxanes and other silicones derivatives, ether and glycols or mixture thereof.

The examples of flow agents and opacifiers according to present invention include but not limited to group comprising of such as the oxides of magnesium, aluminum, silicon, titanium or mixture thereof

The examples of antiadherent according to present invention include but not limited to group comprising of talc, corn starch, colloidal silica, DL-leucine, sodium lauryl sulphate, stearates or mixture thereof.

The examples of stabilizing agent according to present invention include but not limited to group comprising of tocopherol, cyclodextrin tetrasodium edetate, nicotinamide, thermosetting gels such as pectin, carageenan, and gelatin, yellow ferric oxide, red ferric oxide, black iron oxide or mixture thereof.

The examples of antistatic agents according to present invention include but not limited to group comprising of micronized or nonmicronized talc, colloidal silica, treated silica or precipitated silica or mixtures thereof.

The examples of viscosity adjusters according to present invention include but not limited to group comprising of alginate, carrageenan, hydroxypropyl methyl cellulose, locus bean gum, guar gum, xanthan gum, dextran, gum arabic, gellan gum or mixtures thereof.

The examples of coating agents according to present invention include but not limited to a film coating agent or the like. for example, an opadry film coating agents or film coating agent sknown in the prior art for pharmaceutical dosage form.

In an embodiment, a nutraceutical composition for oral administration comprises dosage forms selected from the group of tablets, capsule, powder, granules, pellets, caplets, pills, soft gelatin capsules, mini tablets, solution, syrup, suspension, emulsion, elixir or the like.

In another embodiment, the present invention provides a novel oral nutraceutical composition, comprising:
a) Fulvic acid;
b) Fisetin;
c) One or more nutraceutical;
d) One or more vitamin;
e) One or more mineral; and
f) One or more pharmaceutically acceptable excipient.

In another embodiment, the present invention to provide a novel oral nutraceutical composition, comprising:
a) 5 mg to 300 mg of Fulvic acid;
b) 0.5 mg to 300 mg of Fisetin;
c) 0.1 mg to 200 mg of One or more nutraceutical;
d) 0.01 mg to 50 mg of One or more vitamin;
e) 0.25 mg to 20 mg of One or more mineral; and
f) One or more pharmaceutically acceptable excipient

In another embodiment, the present invention also relates to a process of preparation of a novel nutraceutical composition comprising Fulvic acid, Fisetin, nutraceuticals, vitamins, minerals and one or more suitable pharmaceutically acceptable excipient.

In another embodiment, the present invention to provide a novel oral nutraceutical composition comprising:
a) Fulvic acid;
b) Fisetin;
c) One or more of nutraceutical selected from group consisting of Oyster Peptide, Oyster Calcium, Calcium alpha ketoglutarate, Vitamin C, Red clover extract, Reduced glutathione, Ashwagandha, Melatonin, Soy Isoflavones, Nicotinamide Nucleotide (NMN), Theanine, Coenzyme Q10, Curcumin, Lutein, Zeaxanthin, Rosmarinic acid, Isoleucine, Berberine HCl, Carnosine, Grape seed extract, L-carnitine, L-citrulline, Rosemary extract, Thiocolchicoside and Phenyl alanine or combination thereof;
d) One or more vitamin selected from a group consisting of Vitamin A, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B7, Vitamin B9, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Vitamin K or combinations thereof;
e) One or more mineral selected from a group consisting of calcium, phosphorus, potassium, sodium, magnesium, sulfur, iron, chlorine, cobalt, copper, zinc, manganese, molybdenum, iodine, selenium, chromium or combinations thereof; and
f) One or more suitable pharmaceutically acceptable excipient.

In another embodiment, the present invention to provide a process of preparation of a novel oral nutraceutical composition, comprises steps of:
a) Dissolving Fulvic acid, Fisetin, nutraceuticals, vitamins and minerals into suitable solvent or vehicle to obtain solution;
b) Adding and dissolving one or more suitable pharmaceutically acceptable excipient into solution of step (a);
c) Filtering solution of step (b) through suitable filter; and
d) Filling into suitable bottle or container.

In another embodiment, the present invention to provide a process of preparation of a novel oral nutraceutical composition, comprises steps of:
a) Sifting Fulvic acid, Fisetin, nutraceuticals, vitamins and minerals through suitable sieve;
b) Sifting one or more suitable pharmaceutically acceptable excipient through suitable sieve;
c) pre-lubricating sifted material of step (a) and step (b) and blending into suitable blender;
d) Lubricating above material and blending it for suitable time; and
e) Compressing blend of step (d) into suitable dosage form.

In another embodiment, the present invention to provide a process of preparation of a novel oral nutraceutical composition, comprises steps of:
a) Sifting Fulvic acid, Fisetin, nutraceuticals, vitamins and minerals through suitable sieve;
b) Dry mixing of components of step (a);
c) Preparing binder solution;
d) Granulating mixture obtained in step (b) using binder solution obtained in step (c);
e) Drying the granules obtained in step (d);
f) Sifting, blending and lubricating the dried granules of step (e); and
g) Compressing granules of step (f) into suitable dosage form.

In another embodiment, there is provided a method of using a nutraceutical composition comprising Fulvic acid, Fisetin and one or more nutraceuticals, vitamins and minerals. for the addressing nutrient deficiencies, supporting overall health, disease prevention, supporting cardiovascular, brain, gut health and works as antiaging by its antioxidative stress properties.

The following examples serve to illustrate the embodiments of the present invention. However, they do not intend to limit the scope of the present invention.

Example 1: Fulvic acid, Fisetin, Nutraceutical with Multivitamin & Multimineral Syrup:
No Ingredients mg/20mL
1 Fulvic acid 250.00
2 Fisetin 50.00
3 Calcium alpha ketoglutarate 100.00
4 Vitamin B6 (Pyridoxine hydrochloride) 10.00
5 Vitamin B9 (Folic acid) 0.35
6 Vitamin B12 (Cyanocobalamin) 0.22
7 Manganese 10.00
Inactive Ingredients
8 Orange flavor 30.00
9 Sodium Benzoate 0.50
10 Citric acid 0.01
11 Aspartame 0.01
12 Xanthan gum 10.00
13 Methyl paraben 0.34
14 Propyl paraben 0.06
15 Purified water qs
q.s.: Quantity sufficient
Manufacturing process:
1. Take the Purified water and dissolve the active and inactive materials from serial number 1-11 into vehicle or solvent and stirred for 60 minutes with 250 RPM.
2. Take the Purified water and heat up to 95°C and dissolve the Methyl paraben and propyl paraben and cool up to room temperature.
3. Step 2 added in Step -1 and mixed for 10 minutes.
4. Take the Purified water and dissolve the Xanthan gum and get the free from lumps and added to step no. 1 and mixed for 15 minutes.
5. Make up the volume and check the pH.

Example 2: Fulvic acid, Fisetin, Nutraceutical with Multivitamin & Multimineral Tablet:
No. Ingredients mg/Tablets
1 Fulvic acid 100.00
2 Fisetin 250.00
3 Thiocolchicoside 2.00
4 Vitamin B12 (Cyanocobalamin) 0.40
5 Manganese 2.00
Inactive Ingredient
6 Microcrystalline cellulose 152.00
7 Croscarmellose sodium 10.00
8 PVPK - 30 13.00
9 Purified Water q. s
10 Sodium starch glycolate 11.00
11 Colloidal Silicone Dioxide 5.60
12 Magnesium stearate 8.00
Total Tablets weight (mg) 554.00

Manufacturing process:
1. Sifting all material separately of serial number 1-7 though with #30 sieve
2. Dry mixing of above materials in RMG for 10 minutes with 12 RPM
3. Binder preparation with PVPK-30 in sufficient quantity of water and addition of binder in above dry mixed materials.
4. Drying at 40 – 50 °C to achieve the desired LOD is below 3%
5. Sifting of dry granules through #24 sieve
6. Sifting of extra material of serial number 10-11 though with #40 sieve.
7. Pre-lubrication of above dry granules along with extra material in blender for 10 min with RPM 12;
7. Sifting of Magnesium Stearate with through # 60 sieve;
8. Blending of above materials in blender for 5 minutes with suitable 10 RPM; and
9. Lubricated blend for compression with suitable punches.

Example 3: Fulvic acid, Fisetin, Nutraceutical with Multivitamin & Multimineral Capsule:
No Ingredients mg/capsule
1 Fulvic acid 250.00
2 Fisetin 5.00
3 Thiocolchicoside 3.50
4 Vitamin B12 (Cyanocobalamin) 0.50
5 Manganese 3.00
Inactive Ingredient
6 Butylated hydroxytoluene 0.20
7 Butylated hydroxy anisole 0.20
8 Lactose Anhydrous 114.00
9 Colloidal Silicone Dioxide 5.00
10 Pearlitol® 200 SD Mannitol 50.10
11 Magnesium Stearate 1.50
Total weight (mg) 433.00

Manufacturing process:
1. Sifting all material separately of serial number 1-10 through with #40 sieve
2. Dry mixing of above materials in Blender for 10 minutes with 12 RPM
3. Sifting of Magnesium Stearate with through # 60 sieve.
4. Blending of above materials in blender for 5 minutes with suitable 10 RPM; and
5. Blend filled in appropriate capsule shell.
,CLAIMS:1. An oral nutraceutical composition comprising:
a) Fulvic acid;
b) Fisetin;
c) One or more nutraceutical;
d) One or more vitamin;
e) One or more mineral; and
f) One or more pharmaceutically acceptable excipient.

2. The composition as claimed in claim 1, comprising:
a) 5 mg to 300 mg of Fulvic acid;
b) 0.5 mg to 300 mg of Fisetin;
c) 0.1 mg to 200 mg of One or more nutraceutical;
d) 0.01 mg to 50 mg of One or more vitamin;
e) 0.25 mg to 20 mg of One or more mineral; and
f) One or more suitable pharmaceutically acceptable excipient.

3. The composition as claimed in claim 1, wherein the nutraceutical is selected from a group comprising of Oyster Peptide, Oyster Calcium, Calcium alpha ketoglutarate, Vitamin C, Red clover extract, Reduced glutathione, Ashwagandha, Melatonin, Soy Isoflavones, Nicotinamide Nucleotide (NMN), Theanine, Coenzyme Q10, Curcumin, Lutein, Zeaxanthin, Rosmarinic acid, Isoleucine, Berberine HCl, Carnosine, Grape seed extract, L-carnitine, L-citrulline, Rosemary extract, Thiocolchicoside and Phenyl alanine or combination thereof.

4. The composition as claimed in claim 1, wherein the vitamin is selected from a
group comprising of Vitamin A, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin
B5, Vitamin B6, Vitamin B7, Vitamin B9, Vitamin B12, Vitamin C, Vitamin D,
Vitamin E, Vitamin K and combinations thereof.

5. The composition as claimed in claim 1, wherein the mineral is selected from a
group comprising of calcium, phosphorus, potassium, sodium, magnesium, sulfur,
iron, chlorine, cobalt, copper, zinc, manganese, molybdenum, iodine, selenium,
chromium and combinations thereof.

6. The composition as claimed in claim 1, wherein the pharmaceutically acceptable excipients are selected from the group consisting of diluents or filler, disintegrants, binders, solubilizing agent, surfactant, absorption enhancer, bioadhesive agents or mucoadhesion promoting agent, polymers or release modifying agent, carriers, plasticiser, penetration enhancer, bases, lubricant, glidant, acidic agent, basic agent, chelators, sweeteners, flavoring agent, pH regulating agent, preservatives, antioxidants, coloring agents, solvents, taste masking agent, antifoaming agents, flow agents and opacifiers, antiadherent, stabilizing agent, antistatic agent, viscosity adjuster and coating agent and any other excipient known to the art for making pharmaceutical composition.

7. The composition as claimed in claim 1, wherein the composition is formulated
into a dosage form selected from a group comprising of tablet, effervescent tablet,
chewable tablet, modified release tablet, controlled release tablet, delayed release
tablet, capsule, granules, pellets, beads or sachet, oral syrup, liquid oral solution,
solution, suspension, emulsion and combinations thereof.

8. A process for preparation of a novel oral nutraceutical composition, comprising:
a) Dissolving Fulvic acid, Fisetin, nutraceuticals, vitamins and minerals into a solvent or a vehicle to obtain a solution;
b) Adding and dissolving one or more pharmaceutically acceptable excipient into
the solution obtained in step (a);
c) Filtering the solution obtained in step (b) through suitable filter; and
d) Filling the filtered solution obtained in step (c) into a bottle or a container.

9. A process for preparation of an oral nutraceutical composition, comprising:
a) Sifting Fulvic acid, Fisetin, nutraceuticals, vitamins and minerals through a sieve;
b) Dry mixing of the components of step (a);
c) Preparing a binder solution;
d) Granulating the mixture obtained in step (b) using the binder solution obtained
in step (c);
e) Drying the granules obtained in step (d);
f) Sifting, blending and lubricating the dried granules of step (e); and
g) Compressing the granules of step (f) into a dosage form.

10. The composition as claimed in claim 1, wherein the composition is used for nutrient deficiencies, supporting overall health, disease prevention, supporting cardiovascular, brain, gut health and works as antiaging by its antioxidative stress properties.