AU2006200036B8 - Vitamin composition, methods and applications - Google Patents

Abstract

VITAMIN COMPOSITION, METHODS AND APPLICATIONS Abstract 5 The present invention relates to a composition comprising one or more vitamins and one or more herbal extracts. The composition may comprise a vitamin which is selected from the group consisting of Vitamin B I (Thiamine Hydrochloride), Vitamin B2 (Riboflavine), Vitamin B3 (Nicotinamide), Vitamin B6 (Pyridoxine Hydrochloride), Vitamin B12 (Cyanocobalamin), Vitamin C (Ascorbic acid) and Biotin. The composition 10 may comprise a herbal extract which is selected from the group consisting of ginseng, milk thistle, and green tea. The present invention also relates to a method of producing a vitamin composition and uses of the vitamin composition of the present invention.

Description

S&F Ref: 739150 AUSTRALIA PATENTS ACT 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT Name and Address Liam Patrick Ellis, of Applicants: of 3 Oswald Lane, Darlinghurst, New South Wales, 2010, Australia Michael Peter Blumberg, of 3 Oswald Lane, Darlinghurst, New South Wales, 2010, Australia Actual Inventor(s): Liam Patrick Ellis and Michael Peter Blumberg, Address for Service: Spruson & Ferguson St Martins Tower Level 35 31 Market Street Sydney NSW 2000 (CCN 3710000177) Invention Title: Vitamin composition, methods and applications The following statement is a full description of this invention, including the best method of performing it known to me/us:- 1 VITAMIN COMPOSITION, METHODS AND APPLICATIONS FIELD OF THE INVENTION 5 The present invention relates generally to a vitamin composition for dietary supplementation, and more particularly to a method and composition for dietary vitamin supplementation in order to overcome fatigue and maintain general well being. The vitamin composition is formulated for enhanced absorption and also comprises natural herb extracts. The vitamin composition may also be in a tablet form and may be in a form to which is suitable for point of sale packaging. BACKGROUND OF THE INVENTION Vitamins and minerals are an essential part of a diet and are vital for many functions such as the breaking down of food and for provision of energy for the body. is Many vitamins cannot be stored in the body and thus should be replenished daily. Minerals, which are primarily stored in bone and muscle tissue, likewise must be replenished daily. Replenishing vitamins and minerals appropriately can be a complex task and research has shown that there must be a balance of vitamins and minerals taken daily for optimal absorption. One key factor in determining a vitamin composition relates 20 to the interaction of different vitamins and minerals. For example, a large dose of one "B" vitamin may cause a deficiency in another "B" vitamin. The same is also true for minerals, which must also be taken in correct amounts and combinations to produce the synergistic effect of increasing the positive effect of each one alone. The use of herbal extracts as used in Eastern societies has also been considered 25 as providing useful alternatives to the pharmaceutical products which are commonly used in particularly Western society. Since pharmaceutical products are generally synthesized chemical compounds and mixtures thereof, it has been perceived that prolonged use of these products to overcome fatigue and maintain general well-being may not be advantageous to a person's health. Thus, there has been an increase in awareness and 30 demand for alternative vitamin and herbal products which seek to assist people in overcoming fatigue, stress and related orders in the work and home environment. Accordingly, there is a need to provide formulations and compositions which are adapted to the rigours of modern life including the stress of long hours at work, home and even socialising where often excess alcohol and food may be consumed. In this situation, 35 an inadequate diet over a period of time leads to fatigue, stress and, at least, general ill health. It would also be useful if the vitamin and herbal formulation was sold in a form which lends itself to the needs of busy individuals who wish to purchase such vitamin formulations in convenient pharmaceutical forms outside of the traditional retail sites and also to be in an easily identifiable, storable, transportable and disposable packaging. OBJECT OF THE INVENTION The present invention, at least in the preferred embodiment(s) of the invention, seeks to overcome or ameliorate the disadvantages of the above-identified multi-vitamin formulas available on the market or at least provide a useful alternative. SUMMARY OF INVENTION According to a first aspect of the invention there is provided a composition comprising one or more herbal extracts and the vitamins: Vitamin BI (Thiamine Hydrochloride), Vitamin B2 (Riboflavine), Vitamin B3 (Nicotinamide), Vitamin B6 (Pyridoxine Hydrochloride), Vitamin B12 (Cyanocobalamin) and Biotin; and wherein the herbal extract is selected from the group of 100 to 1000 mcg ginseng, milk thistle, and 50 to 200 mcg green tea leaf. According to a further aspect of the invention there is provided a method for preventing or treating fatigue or stress comprising administering a composition according to the first aspect of the invention. According to a further aspect of the invention there is provided a use of a composition according to the first aspect of the invention in the manufacture of a medicament for the prevention or treatment of fatigue or stress. According to a further aspect of the invention there is provided a method of producing a composition according to according to the first aspect of the invention comprising the steps substantially as hereinbefore described with reference to any one of the examples or the description. 2 7687304 According to a further aspect of the invention there is provided a method of treating fatigue or stress in a subject comprising administering once or twice daily a composition according to the first aspect of the invention. According to a further aspect of the invention there is provided a method of supplementing a dietary regimen comprising administering a composition according to the first aspect of the invention. According to a further aspect of the invention there is provided an anti-fatigue and nutritious tonic agent comprising the composition according to the first aspect of the invention. In an embodiment, there is provided a composition comprising one or more vitamins and one or more herbal extracts. The one or more vitamins may be selected from the group consisting of one or more of the members selected from the group consisting of Vitamin Bl (Thiamine Hydrochloride), Vitamin B2 (Riboflavine), Vitamin B3 (Nicotinamide), Vitamin B6 (Pyridoxine Hydrochloride), Vitamin B12 (Cyanocobalamin), Vitamin C (Ascorbic acid), and Biotin. The herbal extract may be selected from the group consisting of one or more members selected from the group consisting of ginseng, milk thistle, and green tea. The composition may further comprise pharmaceutically acceptable carriers and excipients. The pharmaceutically acceptable excipients may be selected from the group consisting of calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hydrogenated vegetable oil, povidone, and silica. The silica may be anhydrous colloidal silica. The composition may be in a pharmaceutical form of a tablet, a capsule, etc. The composition in an embodiment comprises: a) Vitamin BI; b) Vitamin B2; c) Vitamin B3; d) Vitamin B6; e) Vitamin B12; and f) Biotin. 2a 7687304 3 In an aspect of this embodiment, the composition comprising components a) to f) may further comprise: g) Magnesium; h) Potassium; and 5 i) Zinc. In another aspect of this embodiment, the composition comprising components a) to i) may further comprise one or more members selected from the group consisting of: j) Milk Thistle; k) Ginseng; 10 1) Green tea. In the composition of the present invention, Ginseng is selected from the group consisting of Korean Ginseng, Tianchi Ginseng and Siberian Ginseng. In one embodiment of the composition of the present invention, components a) to f) may be present in an amount as follows: is a) about 5 to about 30mcg of Vitamin B1; b) about 5 to about 30mcg of Vitamin B2; c) about 10 to about 100mcg of Vitamin B3; d) about 10 to about 50mcg of Vitamin B6; e) about 50 to about 500mcg of Vitamin B12; and 20 f) about 50 to about 500mcg of Biotin. In a particular embodiment of the composition of the present invention, components a) to f) may also be present in an amount as follows: a) about 10 to about 25 mcg of Vitamin BI; b) about 10 to about 25mcg of Vitamin B2; 25 c) about 10 to about 80mcg of Vitamin B3; d) about 10 to about 40mcg of Vitamin B6; e) about 50 to about 250mcg of Vitamin B12; and f) about 50 to about 300mcg of Biotin. In another particular embodiment of the composition of the present invention, 30 components a) to f) may also be present in an amount as follows: a) about 10 to about 20 mcg of Vitamin BI; b) about 10 to about 20mcg of Vitamin B2; c) about 20 to about 60mcg of Vitamin B3; d) about 15 to about 30mcg of Vitamin B6; 35 e) about 50 to about 150mcg of Vitamin B12; and 4 f) about 50 to about 200mcg of Biotin. In a further particular embodiment of the composition of the present invention, components a) to f) may also be present in an amount as follows: a) about 12 to about 17 mcg of Vitamin BI; s b) about 12 to about 17meg of Vitamin B2; c) about 40 to about 60mcg of Vitamin B3; d) about 15 to about 30mcg of Vitamin B6; e) about 70 to about 150mcg of Vitamin B12; and f) about 100 to about 200mcg of Biotin. 10 The composition comprising components a) to f) may further comprise: g) about 10 to about 1 00mcg magnesium; h) about 5 to about 50mcg potassium; and i) about 5 to about 40mcg zinc. In another particular embodiment of the composition comprising components a) is to f), components g) to i) are present in an amount as follows: g) about 10 to about 80mcg magnesium; h) about 5 to about 30mcg potassium; and i) about 5 to about 20mcg zinc. In another particular embodiment of the composition comprising components a) 20 to f), components g) to i) are present in an amount as follows: g) about 20 to about 70mcg magnesium; h) about 10 to about 20mcg potassium; and i) about 5 to about 15mcg zinc. The composition may further comprise: 25 j) about 100 to about 1000mcg Siberian Ginseng; k) about 100 to about 1000mcg Korean Ginseng; 1) about 100 to about 500mcg Tienchi Ginseng; and m) about 50 to about 200mcg Green Tea Leaf. In another particular embodiment, components j. to m. are present in an amount 30 as follows: j) about 100 to about 500mcg Siberian Ginseng; k) about 100 to about 500mcg Korean Ginseng; 1) about 100 to about 25Omcg Tienchi Ginseng; and m) about 75 to about 150mcg Green Tea Leaf.

5 The composition of the present invention provides a vitamin and herbal extract formulation composition which is balanced to increase absorption of vitamins and herbal extracts thereof into blood, and to increase absorption thereof so as to provide additional energy to a subject in need thereof. 5 The vitamins present in the formulation of the present invention may be selected from one or more of the members selected from the group consisting of Vitamin B1 (Thiamine Hydrochloride), Vitamin B2 (Riboflavine), Vitamin B3 (Nicotinamide), Vitamin B6 (Pyridoxine Hydrochloride), Vitamin B12 (Cyanocobalamin), Vitamin C (Ascorbic acid) and Biotin. 10 The herbal extracts present in the formulation of the present invention may be selected from one or more members selected from the group consisting of ginseng, milk thistle, and green tea. The ginseng may be wild ginseng, cultivated ginseng, and optionally in admixture with other herb medicines, or water extract of the powder. The ginseng may be Siberian ginseng, Korean ginseng, or Tienchi ginseng. is The vitamin and herbal extract formulation may also comprise magnesium amino acid chelate, potassium citrate monohydrate, zinc citrate dihydrate. Suitable pharmaceutical excipients and carriers may be added to the vitamin and herbal formulation of the present invention. The pharmaceutical excipients and carriers may comprise calcium hydrogen phosphate, microcrystalline cellulose, magnesium 20 stearate, hydrogenated vegetable oil, povidone, and silica. The coating of the tablet may comprise hypromellose, colouring agents, talc, camauba wax, Macrogol 8000, Macrogol 400, and hypromellose. The vitamin and herb composition may further comprise additional herb medicine which does not affect the efficacy of the above-mentioned compositions and 25 which are employable in the present invention. Thus, additional components may be any one conventionally used in nutritious tonic agents and for the treatment of fatigue. Examples thereof include Lycii Fructus, Cnidii Rhizoma, Angelicae gigantis Radix, Acanthopanacis Cortex, Cervi parvum Cornu, Cervi Cornu, royal jelly, honey, Radix Codonopsis, Astragali Radix, Atractylodis Rhizoma, Dioscoreae Radix, Glycyrrhizae 30 Radix, Amomi Cardamomi Fructus, Zizyphi Fructus, Paeoniae Radix, Rehmanniae Radix Preparata, Polygoni multiflori Radix, Adenophorae Radix, Liriopis Tuber, Asparagi Tuber, Polygonati Rhizoma, Testudi plastrum, Morindae Radix, Epidedii Herba, Eucommiae Cortex, Cibotii Rhizoma, Cordyceps, etc. The present composition may further contain additional vitamins or analogues 35 thereof, amino acids, grains or vegetables as auxiliaries.

6 Additional Vitamins or analogues thereof, which may be used in the present invention, include vitamin A, vitamin BI or acid addition salts (e.g. nitrate) thereof, vitamin B2, vitamin B6, vitamin B12 or acid addition salts thereof, vitamin C, vitamin D, vitamin E, choline, nicotinic amide, pantothenic acid or salts thereof, folic acid, taurine, 5 biotin, inositol, lecithin, DHA powder, fructo-oligosaccharide, casein phosphopeptide, galacto-oligosaccharide, glucosamine, foremilk protein powder, skim milk, magnesium hydroxide or ionic calcium. These vitamins or analogues there of may be in an amount of an ordinary range for the desired pharmaceutical form of the invention, e.g tablet, capsule,etc. 10 Amino acids, which may be used in the present invention, include glycine, alanine, valine, norvaline, leucine, isoleucine, phenylalanine, tyrosine, surinamine, threonine, serine, proline, hydroxyproline, tryptophane, thyroxine, methionine, cystine, cysteine, asparaginic acid, glutamic acid, lysine, arginine and histidine. These amino acids may be used at an amount of an ordinary range for the desired pharmaceutical form is of the invention, e.g tablet, capsule,etc. Grains or vegetables, which may be used in the present invention, include glutinous rice, unpolished rice, Job's-tear, barley, soy bean, pumpkin, and mung bean. In the present invention, one or more members selected from the group consisting of pectin, sodium CMC, sodium arginate, glycine, etc. may also be used as a 20 thickening agent. One or more selected members from the group consisting of sucrose, aspartame, micronized saccharide, oligosaccharide, isomerized saccharide, glucose, maltose or other saccharides may be used as a sweetener. One or more members selected from water, ethanol or glycerin may be added as a diluent. The present composition may also contain a natural organic acid such as citric acid, as an organic acid, which plays a 25 role as a pH adjuster (preservative) and vitamin C stabilizer when Vitamin C is present in the composition of the present invention. As a preservative, one or more of sodium benzoate, methyl p-oxybenzoate, ethyl p-oxybenzoate, propyl p-oxybenzoate and other conventional food preservatives may be used in the present invention. These preservatives may be used according to relevant 30 standards for use of food additives. As flavoring agents, ginseng flavor, honey flavor, herb flavor, orange flavor, lemon flavor, strawberry flavor or other edible natural or artificial flavors may be added to the composition of the present invention. The amounts of the flavoring agents may be used at an amount of an ordinary range for the desired pharmaceutical form and desired flavoring of the composition of the present invention, 35 e.g. tablet, capsule, etc.

7 The present composition may be formulated into conventional dosage forms in food engineering or pharmaceutical field, such as powder, granules, tablets, capsules, solution, suspension, solution for injection, jam, syrup, essence, or concentrated solution, by additionally including one or more engineered foods or pharmaceutically acceptable 5 carriers. The formulations can be administered via conventional routes in pharmaceutical field, such as orally or parenterally, for example, by injection or transdermal absorption. The method and multi-vitamin supplement described above may be formulated for a subject having fatigue, stress, lack of energy, as well as for the prevention of these ailments. The supplement may be provided in chewable form for facilitating absorption in 10 the subject. The present invention also relates to a method for preventing or treating fatigue or stress comprising administering a pharmaceutical composition comprising one or more vitamins and one or more herbal extracts. The one or more vitamins in the method may be selected from the group 15 consisting of one or more of the members selected from the group consisting of Vitamin BI (Thiamine Hydrochloride), Vitamin B2 (Riboflavine), Vitamin B3 (Nicotinamide), Vitamin B6 (Pyridoxine Hydrochloride), Vitamin B12 (Cyanocobalamin), Vitamin C (Ascorbic acid), and Biotin. The herbal extract used in the method may be selected from the group consisting 20 of one or more members selected from the group consisting of ginseng, milk thistle, and green tea. The pharmaceutical composition used in the method may further comprise pharmaceutically acceptable carriers and excipients. The pharmaceutically acceptable excipients may be selected from the group consisting of calcium hydrogen phosphate, 25 microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hydrogenated vegetable oil, povidone, and silica. The silica may be anhydrous colloidal silica. The composition used in the method may be in a pharmaceutical form of a tablet, a capsule, etc. The composition used in the method may in an embodiment comprise: 30 a) Vitamin B1; b) Vitamin B2; c) Vitamin B3; d) Vitamin B6; e) Vitamin B12; and 35 f) Biotin.

8 In an aspect of this embodiment, the composition comprising components a) to f) in the method may further comprise: g) Magnesium; h) Potassium; and 5 i) Zinc. In another aspect of this embodiment, the composition comprising components a. to i. in the method may further comprise one or more members selected from the group consisting of: j) Milk Thistle; 10 k) Ginseng; and I) Green tea. In the composition used in the method of the present invention, Ginseng is selected from the group consisting of Korean Ginseng, Tianchi Ginseng and Siberian Ginseng. is In one embodiment of the composition of the present invention used in the method, components a) to f) may be present in an amount as follows: a) about 5 to about 30mcg of Vitamin B1; b) about 5 to about 30mcg of Vitamin B2; c) about 10 to about 100mcg of Vitamin B3; 20 d) about 10 to about 50mcg of Vitamin B6; e) about 50 to about 500mcg of Vitamin B12; and f) about 50 to about 500mcg of Biotin. In a particular embodiment of the composition of the present invention used in the method, components a) to f) may also be present in an amount as follows: 25 a) about 10 to about 25 mcg of Vitamin B1; b) about 10 to about 25mcg of Vitamin B2; c) about 10 to about 80mcg of Vitamin B3; d) about 10 to about 40mcg of Vitamin B6; e) about 50 to about 250mcg of Vitamin B12; and 30 f) about 50 to about 300mcg of Biotin. In another particular embodiment of the composition of the present invention used in the method, components a) to f) may also be present in an amount as follows: a) about 10 to about 20 mcg of Vitamin B1; b) about 10 to about 20mcg of Vitamin B2; 35 c) about 20 to about 60mcg of Vitamin B3; 9 d) about 15 to about 30meg of Vitamin B6; e) about 50 to about 150mcg of Vitamin B12; and f) about 50 to about 200mcg of Biotin. In a further particular embodiment of the composition of the present invention s used in the method, components a) to f) may also be present in an amount as follows: a) about 12 to about 17 mcg of Vitamin B1; b) about 12 to about 17mcg of Vitamin B2; c) about 40 to about 60mcg of Vitamin B3; d) about 15 to about 30mcg of Vitamin B6; 1o e) about 70 to about 150mcg of Vitamin B12; and f) about 100 to about 200mcg of Biotin. The composition comprising components a) to f) used in the method may further comprise: g) about 10 to about 1 00mcg magnesium; is h) about 5 to about 50mcg potassium; and i) about 5 to about 40mcg zinc. In another particular embodiment, the composition comprising components g. to i. used in the method are present in an amount as follows: g) about 10 to about 80mcg magnesium; 20 h) about 5 to about 30mcg potassium; and i) about 5 to about 20mcg zinc. In another particular embodiment, the composition comprising components g) to i) used in the method are present in an amount as follows: g) about 20 to about 70meg magnesium; 25 h) about 10 to about 20mcg potassium; and i) about 5 to about 15mcg zinc. The composition comprising components g) to i) used in the method may further comprise: j) about 100 to about 1000mcg Siberian Ginseng; 30 k) about 100 to about 1000mcg Korean Ginseng; 1) about 100 to about 500mcg Tienchi Ginseng; and m) about 50 to about 200mcg Green Tea Leaf. In another particular embodiment of the composition comprising components g) to i), components j) to m) are present in an amount as follows: 35 j) about 100 to about 500mcg Siberian Ginseng; 10 k) about 100 to about 500mcg Korean Ginseng; 1) about 100 to about 250mcg Tienchi Ginseng; and m) about 75 to about 150mcg Green Tea Leaf. In another embodiment of the present invention, there is provided a use of a 5 pharmaceutical composition pharmaceutical composition comprising one or more vitamins and one or more herbal extracts in the manufacture of a medicament for the prevention or treatment of fatigue or stress. The uses of the pharmaceutical composition in the manufacture of a medicament may also be for the maintenance of general health and/or for supplementing a dietary 10 regimen. In another embodiment of the present invention, there is also provide a packaging for providing a single or twin dose of a pharmaceutical composition of the present invention as described above. The packaging may be brightly coloured and be in the form of a vacuum sealed sachet. The sachet may be shaped such that it is is substantially flat and is sized so as to fit easily within a user's pocket, wallet or other compartment of carry bags. The packaging must be durable enough to resist normal tampering in day to day use but be easily opened by way of tearing or ripping. In one embodiment, the packaging is red which matches the colour of the red tablet comprising the vitamin and herbal composition of the present invention. In another embodiment, the 20 packaging is blue which matches the colour of the blue tablet comprising the vitamin and herbal composition of the present invention. The packaging may be for providing a single or twin dose of a pharmaceutical composition of the present invention. In another embodiment, the present invention provides a method of treating 25 fatigue or stress comprising administering once or twice daily a pharmaceutical composition of the present invention. In an embodiment of the method of the present invention, the pharmaceutical composition may be in the form of a tablet is which is in a packaging designed for one or two tablets. In another embodiment, there is provided a method of supplementing a dietary 30 regimen comprising administering a pharmaceutical composition of the present invention. In another embodiment of the present invention, there is provided an anti-fatigue and nutritious tonic agent composition comprising the composition of the present invention. The herb medicine, which may be employable in the present invention, may be 35 any one conventionally used in nutritious tonic agents. Examples thereof include Lycii 11 Fructus, Cnidii Rhizoma, Angelicae gigantis Radix, cultivated ginseng, Acanthopanacis Cortex, Cervi parvum Cornu, Cervi Cormu, royal jelly, honey, Radix Codonopsis, Astragali Radix, Atractylodis Rhizoma, Dioscoreae Radix, Glycyrrhizae Radix, Amomi Cardamomi Fructus, Zizyphi Fructus, Paeoniae Radix, Rehmanniae Radix 5 Preparata, Polygoni multiflori Radix, Adenophorae Radix, Liriopis Tuber, Asparagi Tuber, Polygonati Rhizoma, Testudi plastrum, Morindae Radix, Epidedii Herba, Eucommiae Cortex, Cibotii Rhizoma, Cordyceps, etc. The present composition may further contain vitamins or its analogues, amino acids, grains or vegetables as auxiliaries as described hereinbefore. 10 Vitamins or analogues thereof, employable in the present invention, include vitamin A, vitamin BI or acid addition salts (e.g. nitrate) thereof, vitamin B2, vitamin B6, vitamin B12 or acid addition salts thereof, vitamin C, vitamin D, vitamin E, choline, nicotinic amide, pantothenic acid or salts thereof, folic acid, taurine, biotin, inositol, lecithin, DHA powder, fructo-oligosaccharide, casein phosphopeptide, galacto is oligosaccharide, glucosamine, foremilk protein powder, skim milk, magnesium hydroxide or ionic calcium. They can be used at an amount of an ordinary range. Amino acids, employable in the present invention, include glycine, alanine, valine, norvaline, leucine, isoleucine, phenylalanine, tyrosine, surinamine, threonine, seine, proline, hydroxyproline, tryptophane, thyroxine, methionine, cystine, cysteine, 20 asparaginic acid, glutamic acid, lysine, arginine and histidine. They can be used at an amount of an ordinary range. Grains or vegetables, employable in the present invention, include glutinous rice, unpolished rice, Job's-tear, barley, soy bean, pumpkin, and mung bean. In the present invention, one or more members selected from pectin, sodium 25 CMC, sodium arginate, glycine, etc. may be used as a thickening agent. One or more members selected from sucrose, aspartame, micronized saccharide, oligosaccharide, isomerized saccharide, glucose, maltose or other saccharides may be used as a sweetener. One or more selected from the group consisting of water, ethanol or glycerin may be added as a diluent. The present composition may contain a natural organic acid such as 30 citric acid, as an organic acid, which plays a role as a pH adjuster (preservative) and vitamin C stabilizer. As a preservative, one or more of sodium benzoate, methyl p oxybenzoate, ethyl p-oxybenzoate, propyl p-oxybenzoate and other conventional food preservatives may be used in the present invention. They can be used according to standards for use of food additives. As flavor, ginseng flavor, honey flavor, herb flavor, 12 orange flavor, lemon flavor, strawberry flavor or other edible natural or artificial flavors may be added. Additional features, advantages, and embodiments of the invention may be set forth or apparent from consideration of the following detailed description and claims. s Moreover, it is to be understood that both the foregoing summary of the invention and the following detailed description are exemplary and intended to provide further explanation without limiting the scope of the invention as claimed. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT (S) The components and the benefits thereof, described below, include the following 1o vitamins and minerals: magnesium, boron, zinc, phosphorus, L-lysine, potassium, manganese, copper, Vitamin A, Vitamin C, Vitamin D3, Vitamin E, Vitamin K, ipriflavone, Vitamin Bi, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B12, silicon, selenium, vanadium, bioflavonoids and isoflavonoids. Magnesium (phosphate dibasic) is necessary for calcium (citrate) and potassium is uptake (dispersion and utilization) and energy production, as well as for the correct function of osteoblast (bone building cells). Studies show that many individuals do not get the required daily amount of magnesium. Potassium (phosphate dibasic) improves cell membrane transfer of nutrients. Phosphorous is required for merging calcium into bone. Without a corresponding 20 increase in phosphorus intake, people taking calcium supplements run the risk of a phosphorus deficiency that would reduce bone mass at the end. Some studies indicate supplements should contain a 2:1 balance of calcium to phosphorus for proper balance and benefit. Manganese is an essential mineral for skeletal development. 25 Boron and L-lysine improve calcium absorption, with L-lysine further improving connective tissue strength. Boron further assists in transfer of calcium from the bloodstream to bone structure, and helps prevent loss of calcium in urine. Zinc (citrate) is important for calcium uptake, the function of the immune system and proper bone maintenance. Studies indicate that the American diet provides under 60% 30 of the required daily amount for this mineral. Silica is important for calcium uptake and the synthesis of collagen (connective bone tissue). Copper (citrate) aids in the formation of bones and skeletal mineralization.

13 Selenium (sodium selenate) is a vital antioxidant, which acts with Vitamin E for the production of antibodies and the maintenance of a healthy heart, liver and tissue elasticity. Vanadium (citrate) is beneficial in the formation of bones and teeth, and for 5 growth and reproduction. Vitamin D3 (cholecalciterol) is one of the most important factors in calcium absorption. Vitamin K (phylloquinone) is essential for the production of bone protein. It also acts as a receptor for the formation of calcium ions and reduces urinary calcium loss. 10 Vitamin E (d-alpha tocopheryl acetate) aids in the use of Vitamin A and vital antioxidants necessary for tissue repair. Vitamin C (ascorbic acid) is important for collagen and connective tissue formation, as well as for the maintenance of healthy gums. Bioflavonoids are essential for the absorption of Vitamin C. 15 Soy isoflavonoids promote bone mass and protect antioxidant vitamins from oxidate damage. Vitamin A (retinol palmitate) retards the aging process, and is essential for the maintenance and repair of epithelial tissue and bone formation. Vitamin B1 enhances circulation and is important for digestion. 20 Vitamin B2 is necessary for red blood cell formation, antibody production and cell respiration and growth. Vitamin B3 is necessary for proper circulation, the functioning of the nervous system, metabolism and for proper digestion. Vitamin B5 is an anti-stress vitamin which aids in vitamin utilization, energy 25 production and the production of neurotransmitters. Vitamin B6 (pyridoxine hydrochloride) is important for most of the bodily functions, and especially for mental and physical health. Vitamin B12 (cyanocobalamine) is needed to prevent anemia, and for proper digestion, absorption of foods, synthesis of protein and metabolism. Vitamin B12 also 30 provides strength to protein in bone tissue. The above-identified minerals and vitamins, which are useful for vitamin composition of the present invention, are essential to human life and good health. Of the above-identified vitamins and minerals, the usage of magnesium, phosphorous, boron and Vitamin BI, B2, B3, B6, B12, Biotin, magnesium, potassium, zinc are essential to the 35 benefits of the vitamin composition discussed herein. The remaining vitamins and 14 minerals enhance the effect of the essential elements to further provide benefits to the entire human body. With regard to the human body, since many of these minerals and vitamins can only be used when available, they must be constantly replenished. As discussed above, 5 during periods of absence or shortage, those vitamins and minerals stored in the bones, teeth and muscle tissue are slowly depleted. Thus, by means of a process known as "roofing," lack of essential vitamins and minerals can greatly hasten the aging process and produce poor health, lack of vitality and cause lack of energy for everyday life. In addition to the benefits discussed above, the above-identified vitamins and 10 minerals (also referred to as nutrients hereinafter) provide energy, which helps prevent fatigue and also protects the immune system against colds and flu. Nutrients also help prevent cancer, maintain good mental health, facilitate dealing with stress, and help prevent memory loss, Alzheimer's disease and insomnia. They guard against infection in organs such as the heart by helping to prevent heart disease and the build-up of bad 15 cholesterol. Vitamins and minerals further protect the human body against the toxin "homocystine," a chemical which attacks the heart and allows deposits of cholesterol around the heart. Nutrients also aid in the lubrication of joints, prevent glucose intolerance and abscesses. They aid the skin by reducing wrinkles, skin disorders, slowing the aging process, age spots, acne, and aid in the formation of skin proteins. 20 For vision, nutrients help prevent night blindness, cataracts and aid in the overall health of the eyes. For digestion, vitamins and minerals aid in the normal digestion of foods, help heal ulcers and prevent diarrhea. They also aid in the tasting of foods and the prevention of a sore tongue. 25 The above-identified nutrients also facilitate blood clotting, prevent salt retention, edema, headaches and strokes. They also aid in the synthesis of sex hormones and reproduction, regulation of muscle tone and composition of body fluids, unwanted weight loss and unhealthy weight gain. They are essential in the utilization of many other vitamins and minerals, the synergistic activity of all nutrients, and the absorption and 30 prevention of cell damage and cell permeability. They are also a vital catalyst for enzyme activity, oxidation and metabolism. Korean Ginseng is also known by the names Asian Ginseng, Asiatic Ginger, and Chinese Ginseng. Korean Ginseng is a deciduous perennial shrub whose fleshy root requires 4-6 years of cultivation to reach maturity. Its name comes from the Chinese "jen 3s shen," which means "man root," so-named because some roots have limb-like branches 15 resembling arms and legs. Because the root has a human-like shape, it is considered in Eastern societies to be an overall body tonic. Traditionally, the wild root was consumed to vitalize, strengthen, and rejuvenate the entire body. Widely cultivated, Korean Ginseng is now used as a natural preventive, restorative remedy and valued for its adaptogenic 5 properties. Used for centuries in China, Korean Ginseng was believed to be and anti aging herb. Today, Ginseng is a favorable herb because of its ability to be used long-term without toxic effects on the body. Korean Ginseng contains adaptogens that have been known to return the body's system levels back to normal. By equalizing the system levels in the body, Korean Ginseng has been used to lower cholesterol, balance the metabolism, 1o increase energy levels, and stimulate the immune system. Korean Ginseng also increases oxygenation to the cells and tissues, promoting detoxification, and stimulating the regeneration of damaged cells. For this reason, Korean Ginseng is the popular choice because it enhances the feeling of overall well being by stimulating the nervous system, brain, and heart, as well as healthy liver functions. 15 Tienchi Ginseng is also known as "Sanchi" or "Noto" Ginseng. This form of Ginseng is generally not used as an energy tonic, but more for bleeding and trauma conditions. Commonly prescribed in Asia for trauma and emergencies, the use of Tienchi ginseng provides enhanced effects when used together with other components of the vitamin composition of the present invention. 20 Siberian Ginseng has been used for centuries in China and Russia. Although a distant relative of American and Asian ginsengs (Panax sp.), with some overlap in its uses, Siberian ginseng is a distinct plant with different active chemical components. Siberian ginseng is considered to be an adaptogen, which means that it helps in stressful circumstances and also helps return the body to a normal balance. So, for example, an 25 adaptogen might lower blood pressure in someone who has high blood pressure, but raise it in another person who has low blood pressure. The active ingredients in Siberian ginseng, eleutherosides (similar to ginsenosides in the panax species), are thought to increase stamina and to stimulate the immune system. Based upon the above-identified description of the components for the vitamin 30 and herbal composition of the present invention, the preferred dosage for the vitamin composition are listed in Table 1, which specifically lists the average adult daily dose per tablet of the vitamin composition. Those skilled in the art will appreciate in view of this disclosure that the vitamin composition of the present invention may be provided in many forms, including tablets, pills, capsules, gel etc., without departing from the scope of this 35 disclosure.

16 TABLE 1 Formula Components Preferred Dosage for Vitamin Composition (1 dose/day) Vitamin B I (Thiamine Hydrochloride) 15mg Vitamin B2 (Riboflavine) 15mg Vitamin B3 (Nicotinamide) 25mg Vitamin B6 (Pyridoxine Hydrochloride) 50mg Vitamin B12 (Cyanocobalamin) 1 00mcg Biotin 150mcg Magnesium 60mg Potassium 16mg Zinc 10mg Milk Thistle 500mg Korean Ginseng 400mg Tienchi Ginseng 150mg Siberian Ginseng 450mg Green Tea 100mg In a further example of the composition of the present invention, there is provided a red 5 tablet having the formulation as set out in Table 2. TABLE 1 RED TABLET Formula Components Mass Vitamin BI (Thiamine Hydrochloride) 16.5mg Vitamin B2 (Riboflavine) 16.5mg Vitamin B3 (Nicotinamide) 55mg Vitamin B6 (Pyridoxine Hydrochloride) 27.5mg Vitamin B12 (Cyanocobalamin) 0.13mg Biotin 195mcg Magnesium 60mg Potassium 16mg Zinc 10mg 17 Milk Thistle 500mg Korean Ginseng 400mg Tienchi Ginseng 150mg Siberian Ginseng 450mg Schizandra fruit 150mg Green Tea 100mg Pharmaceutically acceptable carrier and excipients are also added together a red colouring agent. The pharmaceutically acceptable carrier and excipients may be as set out below. 5 Excipients Mass Calcium hydrogen phosphate 200mg Microcrystalline cellulose 139mg Sodium croscarmellose 30mg Magnesium stearate 25mg Hydrogenated vegetable oil 20mg Povidone 20mg Colloidal Anhydrous Silica 10mg Coating Mass Hypromellose 6.9mg Opadry Clear 10.0mg Purified talc 4.00mg Allura Red 1.0mg Macrogol 8000 2.00mg Macrogol 400 1.00mg Carnauba Wax 0.10mg In another example, the formulation for the vitamins, herbal extracts, excipients and coating are substantially the same except that a blue colouring agent is added, namely Brilliant Blue*. 10 The present composition can be formulated into conventional dosage forms in food engineering or pharmaceutical field, such as powder, granules, tablets, capsules, solution, suspension, solution for injection, jam, syrup, essence, or concentrated solution, by additionally including one or more engineered foods or pharmaceutically acceptable 18 carriers. The formulations can be administered via conventional routes in pharmaceutical field, such as orally or parenterally, for example, by injection or transdermal absorption. Wild ginseng powder or water extract thereof may be administered within a range of conventional dosage of ginseng. 5 Modifications and variations such as would be apparent to a skilled addressee are deemed to be within the scope of the present invention. It is to be understood that the invention should not be restricted to the particular embodiment(s) described above.

Claims (19)

1. A composition comprising one or more herbal extracts and the vitamins: Vitamin B 1 (Thiamine Hydrochloride), Vitamin B2 (Riboflavine), Vitamin B3 (Nicotinamide), Vitamin B6 (Pyridoxine Hydrochloride), Vitamin B12 (Cyanocobalamin) and Biotin; and wherein the herbal extract is selected from the group of 100 to 1000 mcg ginseng, milk thistle, and 50 to 200 mcg green tea leaf.

2. A composition according to claim 2, wherein the composition further comprises pharmaceutically acceptable excipients.

3. A composition according to any one of the preceding claims, wherein the composition is in a form of a tablet.

4. A composition according to any one of the preceding claims, further comprising Vitamin C.

5. A composition according to claim 4, further comprising one or more members selected from the group consisting of: g) magnesium; h) potassium; and i) zinc.

6. A composition according to any one of the preceding claims, wherein ginseng is selected from the group consisting of Korean ginseng, Tianchi ginseng and Siberian ginseng.

7. A composition according to any one of the previous claims, wherein the vitamins are present in an amount as follows: a) about 5 to about 30 mcg of Vitamin B1; b) about 5 to about 30 mcg of Vitamin B2; c) about 10 to about 100 mcg of Vitamin B3; d) about 10 to about 50 mcg of Vitamin B6; e) about 50 to about 500 mcg of Vitamin B12; and 0 about 50 to about 500 mcg of Biotin; or a) about 10 to about 25 mcg of Vitamin Bl; b) about 10 to about 25 mcg of Vitamin B2; c) about 10 to about 80 mcg of Vitamin B3; d) about 10 to about 40 mcg of Vitamin B6; e) about 50 to about 250 mcg of Vitamin B12; and 20 f) about 50 to about 300 mcg of Biotin; or a) about 10 to about 20 mcg of Vitamin B 1; b) about 10 to about 20 mcg of Vitamin B2; c) about 20 to about 60 mcg of Vitamin B3; d) about 15 to about 30 mcg of Vitamin B6; e) about 50 to about 150 mcg of Vitamin B12; and f) about 50 to about 200 mcg of Biotin; or a) about 12 to about 17 mcg of Vitamin B1; b) about 12 to about 17 meg of Vitamin B2; c) about 40 to about 60 mcg of Vitamin B3; d) about 15 to about 30 mcg of Vitamin B6; e) about 70 to about 150 meg of Vitamin B12; and f) about 100 to about 200 mcg of Biotin.

8. A composition according to claim 7, further comprising: g) about 10 to about 100 meg magnesium; h) about 5 to about 50 meg potassium; and i) about 5 to about 40 mcg zinc; or g) about 10 to about 80 mcg magnesium; h) about 5 to about 30 mcg potassium; and i) about 5 to about 20 mcg zinc; or g) about 20 to about 70 mcg magnesium; h) about 10 to about 20 mcg potassium; and i) about 5 to about 15 mcg zinc. 21

9. A composition according to claim 8, wherein the components are present in an amount as follows: * about 100 to about 1000 mcg Siberian Ginseng; e about 100 to about 1000 mcg Korean Ginseng; " about 100 to about 500 mcg Tienchi Ginseng; and " about 50 to about 200 mcg Green Tea Leaf; or " about 150 to about 500 mcg Siberian Ginseng; " about 150 to about 500 mcg Korean Ginseng; " about 100 to about 250 mcg Tienchi Ginseng; and * about 75 to about 150 mcg Green Tea Leaf; or " about 300 to about 500 mcg Siberian Ginseng; e about 300 to about 500 mcg Korean Ginseng; e about 100 to about 200 mcg Tienchi Ginseng; and e about 85 to about 125 mcg Green Tea Leaf.

10. A composition accordingly to any one of the previous claims substantially as hereinbefore described.

11. A method for preventing or treating fatigue or stress comprising administering a composition according to any one of claims I to 10.

12. Use of a composition according to any one of claims I to 10 in the manufacture of a medicament for the prevention or treatment of fatigue or stress.

13. A method for preventing or treating fatigue according to claim 11, substantially as herein before described with reference to any one of the examples or the description.

14. A method of producing a composition according to any one of claims I to 10 comprising the steps substantially as hereinbefore described with reference to any one of the examples or the description.

15. A method of treating fatigue or stress in a subject comprising administering once or twice daily a composition according to any one of claims I to 10.

16. A method according to claim 15, wherein the composition is in the form of a tablet. 22

17. A method according to claim 16, wherein the tablet is in a packaging designed for one or two tablets.

18. A method of supplementing a dietary regimen comprising administering a composition according to any one of claims I to 10.

19. An anti-fatigue and nutritious tonic agent comprising the composition of any one of claims I to 10. Michael Peter Blumberg Patent Attorneys for the Applicant/Nominated Person SPRUSON & FERGUSON