AU2018267584A1

AU2018267584A1 - Therapeutic composition

Info

Publication number: AU2018267584A1
Application number: AU2018267584A
Authority: AU
Inventors: Toni McQuinn
Original assignee: Body Armour Pty Ltd
Current assignee: Body Armour Pty Ltd
Priority date: 2018-11-20
Filing date: 2018-11-20
Publication date: 2020-06-04

Abstract

A composition suitable for therapeutic or prophylactic treatment of one or more conditions in a subject is provided, the composition comprising one or more vitamins; one or more metals; one or more amino acids; and/or one or more plant extracts. The 5 condition may be a hangover symptom. Associated methods of manufacture of compositions, and methods of treatment are also provided. S 1 AA- 1

Description

TITLE THERAPEUTIC COMPOSITION TECHNICAL FIELD THIS invention relates to a therapeutic composition. More particularly, the invention relates to a composition suitable for treating or preventing hangover symptoms. The invention also relates to methods of manufacture and use of the composition. BACKGROUND Human consumption of alcohol is common in many societies world-wide. Typically, alcohol is consumed as a recreational activity, by drinking alcohol containing beverages. Alcohol can promote feelings of relaxation and/or loss of inhibition, and is generally consumed for these psychotropic effects. However, the consumption of alcohol has a range of other physiological effects. Depending on various factors including the amount of alcohol consumed, and the age, weight, and general well being of the drinker, alcohol consumption can cause substantial short-term physiological imbalances. Such imbalances may manifest as unwanted 'hangover' effects, typically experienced after the desired psychotropic effects have subsided. Hangover effects range in severity and can include, for example, symptoms such as malaise, dehydration, fatigue, light-headedness, loss of appetite, thirst, sweating, headache, diarrhoea, and light or sound sensitivity. While some options for hangover treatment exist, typically these are of limited or variable effectiveness, or are effective in treating certain hangover symptoms but not others. New options for treatment of hangover symptoms are therefore desirable. In particular, options for prophylactic hangover treatment, to prevent or reduce hangover symptoms, are currently very limited and highly desirable. SUMMARY This invention broadly provides a composition suitable for therapeutic or prophylactic treatment of one or more conditions in a subject. A method of manufacturing a composition suitable for therapeutic or prophylactic treatment of one or more conditions is also provided, including the step of combining a plurality of active ingredients to thereby manufacture the composition. The invention further broadly provides a method of therapeutically or prophylactically treating one or more conditions in a subject in need thereof, including

S 1 AA- 1 the step of administering to the subject a composition comprising a plurality of active ingredients. In a first aspect, there is provided a composition comprising one or more vitamins; one or more metals; one or more amino acids; and/or one or more plant extracts. Preferably, the composition is suitable for, for, or when used for the prophylactic and/or therapeutic treatment of one or more hangover symptoms. Preferably, the composition comprises one or more vitamins; one or more metals; one or more amino acids; and one or more plant extracts. Preferably, the composition includes a plurality of vitamins. Preferably, the composition includes a plurality of metals. Preferably, the composition includes a plurality of plant extracts. In certain embodiments, the composition further comprises one or more sugars. In preferred said embodiments, the composition comprises a plurality of sugars. Preferably, the one or more vitamins of the composition include vitamin C and/or one or more B vitamins. Preferably, the one or more B vitamins are selected from the group consisting of vitamin BI, vitamin B2, vitamin B5, vitamin B6, and vitamin B12. In a preferred embodiment, the one or more metals of the composition include magnesium and/or potassium. In a preferred embodiment, the one or more amino acids of the composition include cysteine. In a preferred embodiment, the one or more plant extracts of the composition are of the group of plants consisting of a Puerariaspecies, a Silybum species, and a Hovenia species. Preferably, the Puerariaspecies is Puerarialobata. Preferably, the Silybum species is Silybum marianum. Preferably, the Hovenia species is Hovenia dulcis. The one or more plant extracts may be extracts from fresh, partially dry, or dry plant material. In a preferred embodiment, the one or more plant extracts are from dry plant material. Preferably, the one or more plant extracts are selected from the group consisting of a flower extract, a fruit extract, a root extract, a leaf extract, and a seed extract. In a particularly preferred embodiment the one or more plant extracts are flower extracts and/or fruit extracts.

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Preferably, the total concentration of vitamins in the composition of this aspect is between about 0.15 and about 15 w/w%. Preferably, the concentration of vitamin C in the composition is between about 0.1 and about 10 w/w%. Preferably, the total concentration of B vitamins in the composition is between about 0.005 and about 0.5 w/w%. Preferably, the concentration of each of the B vitamins in the composition is between about 0.0001 and about 0.1 w/w%. Preferably, the total concentration of metals in the composition is between about 0.003 and about 3 w/w%. Preferably, the concentration of magnesium in the composition is between about 0.005 and about 0.5 w/w%. Preferably the concentration of potassium in the composition is between about 0.02 and about 2 w/w%. Preferably, the total concentration of amino acids in the composition is between about 0.03 and about 3 w/w%. Preferably, the concentration of cysteine in the composition is between about 0.03 and about 3 w/w%. Preferably, the total concentration of plant extracts of the composition is between about 0.05 and about 5 w/w%. Preferably, the concentration of each of the plant extracts of the composition is between about 0.01 and about 1 w/w%. In embodiments wherein the composition comprises one or more sugars, preferably the total concentration of sugars is between about 0.4 and about 40 w/w%. Preferably, the concentration of each of the sugars of the composition is between about 0.2 and about 20 w/w%. In preferred embodiments, the composition of this aspect is a liquid composition. Preferably, the composition is an aqueous composition. In a second aspect, the invention provides a method of manufacturing a composition, including the step of combining one or more vitamins; one or more metal ions; one or more amino acids; and/or one or more plant extracts, to thereby manufacture the composition. In preferred embodiments of the second aspect, combining includes the step of dissolving the one or more vitamins; one or more metal ions; one or more amino acids; and/or one or more plant extracts, in a liquid. Preferably, said liquid is water. A third aspect of the invention provides a composition produced according to the method of the second aspect. Preferably, the composition of the third aspect is a composition of the first aspect.

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In a fourth aspect, the invention provides a method for prophylactically or therapeutically treating one or more hangover symptoms in a subject, including the step of administering an effective amount of a composition of the first or third aspects to the subject, to thereby prophylactically or therapeutically treat the one or more hangover symptoms in the subject. Preferably, the one or more hangover symptoms treated according to the method of the fourth aspect are selected from the group consisting of a musculoskeletal symptom, such as muscle pain; a gastrointestinal symptom, such as dry mouth, nausea, diarrhoea, or stomach cramping; a nervous or mood symptom, such as headache, dizziness, excessive sweating, anxiety, drowsiness, fatigue, cognitive difficulties, or loss of appetite; a urinary symptom, such as excessive urination; and a circulatory symptom, such as dehydration. Preferably, the method of the fourth aspect is for prophylactically treating the symptom in the subject. In an embodiment, the method of the fourth aspect is for therapeutically treating the symptom in the subject. In certain preferred embodiments of the fourth aspect, the step of administering the effective amount of the composition to the subject is performed less than about 4 hours before consumption of alcohol by the subject. Preferably, said step of administering the effective amount of the composition is performed less than about 1 hour before consumption of alcohol by the subject. In one particularly preferred embodiment, said step of administering the effective amount of the composition is performed immediately, or substantially immediately, before consumption of alcohol by the subject. Preferably, the composition is administered to the subject by ingestion. Preferably, the composition is administered by drinking of the composition by the subject. In certain preferred embodiments of the fourth aspect, the composition is administered to the subject by way of one or more individual doses. In one preferred embodiment, each dose is administered as about 10 ml to about 1000 ml of liquid, more preferably about 30 ml to about 300 ml of liquid. Preferably, each dose of the composition comprises about 150 mg to about 15 g of total vitamins, more preferably about 350 mg to about 5 g of total vitamins. Preferably, each dose of the composition comprises about 100 mg to about 10 g of vitamin C, more preferably about 300 mg to about 3 g of vitamin C.

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Preferably, each dose of the composition comprises about 0.5 mg to about 50 mg total B vitamins, more preferably about 1.5 to about 20 mg total B vitamins. Preferably, each dose of the composition comprises about 0.1 mg to about 30 mg of each B vitamin, more preferably about 0.3 to about 20 mg of each B vitamin. Preferably, each dose of the composition comprises about 30 mg to about 3 g total metals, more preferably about 100 mg to about 1 g total metals. Preferably, each dose of the composition comprises about 5 mg to about 500 mg of magnesium, more preferably about 15 mg to about 200 mg of magnesium. Preferably, each dose of the composition comprises about 20 mg to about 2 g potassium, more preferably about 60 mg to about 600 mg potassium. Preferably, each dose of the composition comprises about 30 mg to about 3 g total amino acids, more preferably about 100 mg to about 1 g total amino acids. Preferably, each dose of the composition comprises about 30 mg to about 3 g cysteine, more preferably about 100 mg to about 1 g cysteine. Preferably, each dose of the composition comprises about 50 mg to about 5 g total plant extracts, more preferably about 200 mg to about 2 g total plant extracts. Preferably, each dose of the composition comprises about 10 mg to about 2 g of each plant extract, more preferably about 30 mg to about 600 mg of each plant extract. In embodiments wherein the composition comprises one or more sugars, preferably each dose of the composition comprises about 400 mg to about 40 g total sugars, more preferably about 1 g to about 10 g total sugars. Preferably, each dose of the composition comprises about 200 mg to about 20 g of each sugar, more preferably about 600 mg to about 6 g of each sugar. In a fifth aspect, the invention provides for use of one or more vitamins; one or more metal ions; one or more amino acids; and/or one or more plant extracts, in the manufacture of a composition for therapeutic or prophylactic treatment of one or more hangover symptoms. It will be appreciated that the indefinite articles "a" and "an" are not to be read as singular indefinite articles or as otherwise excluding more than one or more than a single subject to which the indefinite article refers. For example, "a" symptom includes one symptom, one or more symptoms or a plurality of symptoms. As used herein, unless the context requires otherwise, the words "comprise", "comprises" and "comprising" will be understood to mean the inclusion of a stated

1 - -/~ A integer or group of integers but not the exclusion of any other integer or group of integers. DETAILED DESCRIPTION The present invention is at least partly predicated on the identification of combinations of agents that may be particularly effective for the therapeutic or prophylactic treatment of one or more hangover symptoms. As used herein, a "hangover symptom" broadly includes any undesirable, typically acute, symptom associated with the consumption and metabolism of alcohol. Typically, hangover symptoms are experienced after complete, or substantially complete, metabolism of consumed alcohol. Typically, hangover symptoms are experienced after the direct psychotropic effects of consumed alcohol have ended or at least substantially subsided. Typically, a hangover symptom is selected from the group consisting of a musculoskeletal symptom, such as muscle pain; a gastrointestinal symptom, such as dry mouth, nausea, diarrhoea, or stomach cramping; a nervous or mood symptom, such as headache, dizziness, excessive sweating, anxiety, drowsiness, fatigue, cognitive difficulties, or loss of appetite; a urinary symptom, such as excessive urination; and a circulatory symptom, such as dehydration. In some embodiments, a hangover symptom includes one or more pathophysiologic characteristics as described in Wiese, J. G., Shlipak, M. G., Browner, W. S. (2000). The alcohol hangover. Annals of internal medicine, 132(11), & 897-902 ('Wiese et al. 2011'), incorporated herein by reference. In some embodiments, a hangover symptom includes at least one, or at least two, of headache, poor sense of overall well-being, diarrhea, loss of appetite, tremulousness, fatigue, and nausea. Typically, a hangover symptom is at least partially causally related to the consumption of alcohol. However, it will be appreciated that the scope of "hangover symptom" in the context of the invention is not necessarily so limited. That is, in at least some embodiments, a hangover symptom may include one or more of the above symptoms, wherein the symptom is not causally related to alcohol consumption. For clarity, a hangover symptom that is at least partly causally related to alcohol consumption may be more specifically referred to herein as an "alcohol hangover". Compositions

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One aspect of the invention is directed to a composition. Typically, the composition is suitable for therapeutic or prophylactic treatment of one or more hangover symptoms. Typically, the hangover symptom is an alcohol hangover symptom. Typically, the composition is for prophylactic treatment of one or more hangover symptoms. In an embodiment, the treatment is for therapeutic treatment of one or more hangover symptoms. Although compositions of this aspect of the invention will typically be suitable for therapeutic and/or prophylactic treatment of hangover symptoms, it will be understood that the compositions are not so limited. By way of non-limiting example, in embodiments, the composition of this aspect may additionally or alternatively be suitable for one or more of: relief of headache or migraine symptoms; maintenance or support of energy levels; maintenance or support of electrolyte balance; maintenance or support of liver function; maintenance or support of overall well-being; reduction of free radical production; reduction of free radical cell damage; maintenance or support of cardiovascular system function; maintenance or support of blood vessel health; maintenance or support of haemoglobin synthesis; maintenance or support of red blood cell health and/or production; maintenance or support of bone health; maintenance or support of skin health; maintenance or support of connective tissue health and/or production; maintenance or support of wound healing; maintenance or support of healthy digestion; prevention or reduction of digestive discomfort; maintenance or support of eye health; maintenance or support of immune system function; maintenance or support of metabolism; maintenance or support of iron absorption; maintenance or support of bile flow; maintenance or support of muscle function; maintenance or support of neuromuscular function; maintenance or support of mucous membrane health; maintenance or support of nervous system function; maintenance or support of the stress response; maintenance or support of nerve conduction; maintenance or support of neurotransmitter production; maintenance or support of hair growth and/or hair health; maintenance or support of nail growth and/or health; and maintenance or support tooth health and/or development. The composition of this aspect will comprise one or more vitamins; one or more metals; one or more amino acids; and/or one or more plant extracts. As used herein, "vitamin" refers generally to organic molecules that contribute to functional metabolism in an organism and are obtained from the environment, typically through diet. Typically, the vitamin is a human vitamin.

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As used herein, "metal" refers generally to metallic elements as defined in the periodic table of elements. It will be understood that metals are inclusive of metal ions. In some embodiments as used herein, a metal may include metalloid elements or ions thereof. As used herein, "amino acid" will be understood to refer generally to organic compounds containing amine (-NH2) and carboxyl (-COOH) functional groups, along with a specific side chain (R group). The amino acid may be an essential amino acid for human metabolism as are known in the art, inclusive of histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine. The amino acid may be a nonessential amino acid for human metabolism as are known in the art, inclusive of alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, proline, serine, and tyrosine. As used herein, a "plant extract" broadly refers to any substance, chemical, or agent, or combination of substances, chemicals, or agents, that is removed from a plant cell or tissue. Plant extracts may be obtained from any suitable tissue, including structural tissues such as roots, stem, branches, and leaves; and reproductive tissues such as flowers, fruit, and seeds. A range of methods for obtaining plant extracts are known in the art. These include simple methods such as physical disruption (e.g. fruit juicing) and more involved methods that may include multiple extraction steps (e.g. solvent treatments). For a non-limiting overview of plant extraction techniques, the skilled person is directed to Phytochemical Methods A Guide to Modern Techniques of Plant Analysis, J.B. Harbome, Chapman & Hall (1998), incorporated herein by reference. The skilled person is further directed to Huie C.W. (2002) A Review of Modern Sample PreparationTechniquesfor the Extraction and Analysis of Medicinal Plants, Analytical and Bioanalytical Chemistry 373, 23-30 (incorporated herein by reference) for potentially suitable extraction techniques. Typically, the one or more plant extracts of the composition of this aspect are extracted water as a primary solvent. In embodiments, the extracts are extracted using at least about 50% water as a primary solvent, including at least about 60, 70, 80, 90, 95, and 99% water as a primary solvent. In one typical embodiment, the extracts are extracted using pure water, or substantially pure water, as a primary solvent. For clarity, in at least some embodiments, the scope of a plant extract may include synthetic or artificially produced formulations with the same, or substantially the same, composition.

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Typically, the composition of this aspect comprises one or more vitamins; one or more metals; one or more amino acids; and one or more plant extracts. Typically, the composition comprises a plurality of vitamins. Typically, the composition comprises a plurality of metals. Typically, the composition comprises a plurality of plant extracts. Typically, one or more of the one or more vitamins, one or more metals, and/or one or more amino acids of the composition of this aspect are active agents. More typically, each of the one or more vitamins, one or more metals, and the one or more amino acids are active agents. Typically, the one or more plant extracts of the composition will contain one or more active agents. As used herein, an "active agent" will be understood to include any chemical agent, such as an element, ion, molecule, or compound, that contributes to one or more therapeutic and/or prophylactic effects or activities of the composition. It will be further understood that, as used herein, an active agent of the one or more plant extracts may be referred to as a "plantactive". In embodiments, the composition of this aspect may comprise one or more sugars. In typical such embodiments, the composition comprises a plurality of sugars. As used herein, "sugar" will be understood to refer generally to soluble, crystalline carbohydrates that typically have a sweet taste to the human palate. In embodiments wherein the composition comprises one or more sugars, the one or more sugars may, but need not necessarily, be active agents. In embodiments, the composition of this aspect may comprise one or more viscosity modifiers, thickeners, and/or stabilisers. Typically, said one or more viscosity modifiers, thickeners, and/or stabilizers are selected from the group consisting of a polysaccharide, inclusive of starches, flours, vegetable gums, cellulose, and pectin, or a protein, inclusive of collagen and gelatin. In one typical embodiment, the viscosity modifier, thickener, and/or stabilizer is or includes carboxymethylcellulose sodium (carmellose sodium). The composition of this aspect may further include one or more: flavouring agents; sweetening agents; acidifiers; and/or preservatives. In one typical embodiment, the one or more flavouring agents include a fruit flavouring agent such as a peach and/or tropical fruit flavouring agent. In one typical embodiment, the sweetening agent includes an artificial sweetener such as sucralose.

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In one typical embodiment the acidifying agent includes a food acid such as citric acid. In one typical embodiment, the preservative includes sodium benzoate and/or potassium sorbate. The composition of this aspect will typically have one or more biological activities when suitably administered to a subject, typically a human subject. Typically, one or more of the biological activities will be appropriate to therapeutically or prophylactically treat one or more hangover symptoms. The one or more biological activities may be selected from the group consisting of: maintenance or support of energy levels; maintenance or support of electrolyte balance; maintenance or support of liver function; maintenance or support of overall well being; reduction of free radical production; reduction of free radical cell damage; maintenance or support of cardiovascular system function; maintenance or support of blood vessel health; maintenance or support of haemoglobin synthesis; maintenance or support of red blood cell health and/or production; maintenance or support of bone health; maintenance or support of skin health; maintenance or support of connective tissue health and/or production; maintenance or support of wound healing; maintenance or support of healthy digestion; prevention or reduction of digestive discomfort; maintenance or support of eye health; maintenance or support of immune system function; maintenance or support of metabolism; maintenance or support of iron absorption; maintenance or support of bile flow; maintenance or support of muscle function; maintenance or support of neuromuscular function; maintenance or support of mucous membrane health; maintenance or support of nervous system function; maintenance or support of stress response; maintenance or support of nerve conduction; maintenance or support of neurotransmitter production; maintenance or support of hair growth and/or hair health; maintenance or support of nail growth and/or health; and maintenance or support of tooth health and/or development. Typically, the one or more vitamins of the composition of this aspect include vitamin C (ascorbic acid). Typically, the one or more vitamins include one or more B vitamins. Typically, the one or more B vitamins are selected from the group consisting of vitamin BI (thiamine, e.g. in the form of thiamine nitrate), vitamin B2 (riboflavin, e.g. in the form of riboflavin sodium phosphate), vitamin B5 (pantothenate, e.g. in the form of calcium pantothenate), vitamin B6 (pyridoxine, e.g. in the form of pyridoxine hydrochloride), and vitamin B12 (e.g. in the form of cyanocobalamin).

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Typically, the one or more metals of the composition of this aspect are selected from magnesium and potassium. In an embodiment, the metals of the composition include magnesium and potassium. Typically, the one or more amino acids of the composition include a non essential amino acid. Typically, the non-essential amino acid is cysteine. In embodiments, the one or more plant extracts of the composition include an extract from a Faboideae plant. In embodiments, the one or more plant extracts of the composition include an extract from a Cynareae plant. In embodiments, the one or more plant extracts of the composition an extract from a Paliureae plant. Typically, the one or more plant extracts of the composition are selected from extracts of the group of plants consisting of a Puerariaspecies, a Silybum species, and a Hovenia species. Typically, the Puerariaspecies is Puerarialobata. Typically, the Silybum species is Silybum marianum. Typically, the Hovenia species is Hovenia dulcis. It will be understood that, in at least some embodiments, included within the scope of the agents or ingredients of the composition, such as vitamins; metals; amino acids; plant actives; sugars; viscosity modifiers; thickeners; stabilisers; flavouring agents; sweetening agents; acidifiers; and preservatives, are analogues and derivatives of said agents. As used herein, an "analogue" refers to a chemical, such as an element, ion, or compound, that is structurally similar to an original or 'parent' chemical, but differs slightly in composition (e.g., an atom or component thereof, or functional group is different, added, or removed). Analogues may or may not have different chemical or physical properties than the parent chemical and may or may not have altered biological and/or chemical activity. By way of non-limiting example, the analogue may be more hydrophilic or it may have altered reactivity as compared to the parent chemical. The analogue may mimic the chemical and/or biologically activity of the parent chemical (i.e., it may have similar or identical activity), or, in some cases, may have increased or decreased activity. It will be further appreciated that an analogue may be a naturally or non naturally occurring (e.g., recombinant) variant of an original chemical. Analogues include isomers (enantiomers, diasteromers, and the like) and other types of chiral variants of a compound, as well as structural isomers. The analogue may be a

S 1 AA- 1 branched or cyclic variant of a linear compound. For example, a linear compound may have an analogue that is branched or otherwise substituted to impart certain desirable properties (e.g., without limitation, improved hydrophilicity or bioavailability). As used herein, a "derivative" refers to a chemically or biologically modified version of a chemical that is structurally similar to an original or parent chemical and (actually or theoretically) derivable from that parent chemical. A "derivative" differs from an "analogue" in that a parent chemical may be the starting material to generate a derivative, whereas the parent chemical need not necessarily be used as the starting material to generate an analogue. A derivative may or may not have different chemical or physical properties than the parent. For example, the derivative may be more hydrophilic or it may have altered reactivity as compared to the parent compound. Derivatization (i.e., modification) may involve substitution of one or more moieties within the molecule (e.g., a change in functional group). By way of non-limiting example, a hydrogen may be substituted with a halogen, such as fluorine or chlorine, or a hydroxyl group (-OH) may be replaced with a carboxylic acid moiety (-COOH). As used herein, the term derivative encompasses all solvates, for example hydrates or adducts (e.g., adducts with alcohols), active metabolites, and salts of the parent chemical. The type of salt that may be prepared depends on the nature of the moieties within the parent. For example, acidic groups, for example carboxylic acid groups, can form, for example, alkali metal salts or alkaline earth metal salts (e.g., sodium salts, potassium salts, magnesium salts and calcium salts, and also salts with physiologically tolerable quaternary ammonium ions and acid addition salts with ammonia and physiologically tolerable organic amines such as, for example, triethylamine, ethanolamine or tris-(2-hydroxyethyl)amine). Basic groups can form acid addition salts, for example with inorganic acids such as hydrochloric acid, sulfuric acid or phosphoric acid, or with organic carboxylic acids and sulfonic acids such as acetic acid, citric acid, benzoic acid, maleic acid, fumaric acid, tartaric acid, methanesulfonic acid or p-toluenesulfonic acid. Compounds which simultaneously contain a basic group and an acidic group, for example a carboxyl group in addition to basic nitrogen atoms, can be present as zwitterions. Salts can be obtained by customary methods known to those skilled in the art, for example by combining a compound with an inorganic or organic acid or base in a solvent or diluent, or from other salts by cation exchange or anion exchange.

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Typically, in embodiments wherein the composition of this aspect comprises analogues or derivatives of the agents described herein, the analogue or derivative will be a biologically active analogue or derivative. As used herein a "biologically active" analogue or derivative will be understood to refer to an analogue or derivative retaining at least a portion of one or more biological activities of the parent chemical when administered to a biological subject, preferably a human. Typically, the analogue or derivative will possess at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the biological activity of the parent chemical. It will be appreciated that biological activities of agents as described herein will typically include one or more of the biological activities of the composition of this aspect, as set out above. It will further be understood that some typical biological activities of specific agents or ingredients of compositions of this aspect are set out in Table 4. Typically, the total concentration of vitamins in the composition of this aspect is between about 0.15 and about 15 w/w%, including about: 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14 w/w%. Typically, the total concentration of vitamins is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 6 0 0 %, 700 %, 8 0 0 %, and 9 0 0 %, of the total concentration of vitamins in the formulation set out in Table 1. Typically, the concentration of vitamin C (or ascorbic acid) in the composition is between about 0.1 and about 10 w/w%, including about: 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 9 w/w %. Typically, the total concentration of vitamin C is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the total concentration of vitamin C in the formulation set out in Table 1. Typically, the total concentration of B vitamins in the composition is between about 0.005 and about 0.5 w/w%, including about: 0.006, 0.007, 0.008, 0.009 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, and 0.4. Typically, the total concentration of vitamin B is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the total concentration of vitamin B in the formulation set out in Table 1.

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Typically, the concentration of each of the respective B vitamins in the composition is between about 0.0001 and about 0.1 w/w%, including about: 0.0001, 0.0002, 0.0003, 0.0004, 0.0005, 0.0006, 0.0007, 0.0008, 0.0009, 0.001, 0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, and 0.09. Typically, the concentration of each of the B vitamins is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the concentration of each of the respective B vitamins in the formulation set out in Table 1. Typically, the concentration of vitamin B1 (or thiamine) in the composition is between about 0.0002 and about 0.02 w/w%, including about: 0.0003, 0.0004, 0.0005, 0.0006, 0.0007, 0.0008, 0.0009, 0.001, 0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, 0.01, 0.011, 0.012, 0.013, 0.014, 0.015, 0.016, 0.017, 0.018, and 0.019 w/w%. Typically, the concentration of vitamin B1 is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%,100%,150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the concentration of vitamin B1 in the formulation set out in Table 1. Typically, the concentration of vitamin B2 (or riboflavin) in the composition is between about 0.0002 and about 0.02 w/w%, including about: 0.0003, 0.0004, 0.0005, 0.0006, 0.0007, 0.0008, 0.0009, 0.001, 0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, 0.01, 0.011, 0.012, 0.013, 0.014, 0.015, 0.016, 0.017, 0.018, and 0.019 w/w%. Typically, the concentration of vitamin B2 is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the concentration of vitamin B2 in the formulation set out in Table 1. Typically, the concentration of vitamin B3 (or nicotinamide) in the composition is between about 0.002 and about 0.2 w/w%, including about: 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, and 0.19 w/w%. Typically, the concentration of vitamin B3 is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 6 0 0 %, 7 0 0 %, 8 0 0 %, and 9 0 0 %, of the concentration of vitamin B3 in the formulation set out in Table 1.

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Typically, the concentration of vitamin B5 (or pantothenic acid) in the composition is between about 0.0005 and about 0.05 w/w%, including about: 0.0006, 0.0007, 0.0008, 0.0009, 0.001, 0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, 0.01, 0.02, 0.03, and 0.04 w/w%. Typically, the concentration of vitamin B5 is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the concentration of vitamin B5 in the formulation set out in Table 1. Typically, the concentration of vitamin B6 (or pyridoxine) in the composition is between about 0.0002 and about 0.02 w/w%, including about: 0.0003, 0.0004, 0.0005, 0.0006, 0.0007, 0.0008, 0.0009, 0.001, 0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, 0.01, 0.011, 0.012, 0.013, 0.014, 0.015, 0.016, 0.017, 0.018, and 0.019 w/w%. Typically, the concentration of vitamin B6 is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the concentration of vitamin B6 in the formulation set out in Table 1. Typically, the concentration of vitamin B12 (cyanocobalamin) in the composition is between about 0.00005 and about 0.005 w/w%, including about: 0.00006, 0.00007, 0.00008, 0.00009, 0.0001, 0.0002, 0.0003, 0.0004, 0.0005, 0.0006, 0.0007, 0.0008, 0.0009, 0.001, 0.002, 0.003, and 0.004 w/w%. Typically, the concentration of vitamin B12 is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 2 0 0 %, 3 0 0 %,

400% , 500%, 6 0 0 %, 7 0 0 %, 8 0 0 %, and 9 0 0 %, of the concentration of vitamin B12 in the formulation set out in Table 1. Typically, the total concentration of metals in the composition is between about 0.03 and about 3 w/w%, including about: 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, and 2.5 w/w%. Typically, the total concentration of metals is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 6 0 0 %, 7 0 0 %, 8 0 0 %, and 9 0 0 %, of the total concentration of metals in the formulation set out in Table 1. Typically, the concentration of magnesium in the composition is between about 0.005 and about 0.5 w/w%, including about 0.006, 0.007, 0.008, 0.009, 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, and 0.4 w/w%. Typically, the concentration of magnesium is between about 10% and about 1000%, including

S 1 AA- 1 about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the concentration of magnesium in the formulation set out in Table 1. Typically, the concentration of potassium in the composition is between about 0.02 and about 2 w/w%, including about: 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, and 1.9 w/w%. Typically, the concentration of potassium is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the concentration of potassium in the formulation set out in Table 1. Typically, the concentration of each of the amino acids in the composition is between about 0.03 and about 3 w/w%, including about 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, and 2.5 w/w%. Typically, the concentration of cysteine in the composition is between about 0.03 and about 3 w/w%, including about 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, and 2.5 w/w%. Typically, the concentration of about: cysteine is between about 10% and about 1000%, including 2 0 %, 3 0 %, 4 0 %, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the concentration of cysteine in the formulation set out in Table 1. Typically, the total concentration of plant extract of the composition is between about 0.1 and about 10 w/w%, including about 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, and 9 w/w%. Typically, the total concentration of plant extract is between about 10% and about 1000%, including about: 2 0 %, 3 0 %, 4 0 %, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the total concentration of plant extract in the formulation set out in Table 1. Typically, the concentration of Puerarialobata extract of the composition is between about 0.03 and about 3 w/w%, including about 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, and 2.5 w/w%. Typically, the concentration of Puerarialobata extract is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 2 0 0 %,

3 0 0 %, 4 0 0 %, 500%, 6 0 0 %, 7 0 0 %, 8 0 0 %, and 9 0 0 %, of the concentration of Pueraria lobata extract in the formulation set out in Table 1.

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Typically, the concentration of Silybum marianum extract of the composition is between about 0.02 and about 2 w/w%, including about 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, and 2 w/w%. Typically, the concentration of Silybum marianum extract is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 7 0 0 %, 800%, and 900%, of the concentration of Silybum marianum extract in the formulation set out in Table 1. Typically, the concentration of Hovenia dulcis extract of the composition is between about 0.03 and about 3 w/w%, including about 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, and 2.5 w/w%. Typically, the concentration of Hovenia dulcis extract is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 3 0 0 %, 4 0 0 %, 500%, 6 0 0 %, 7 0 0 %, 8 0 0 %, and 9 0 0 %, of the concentration of Hovenia dulcis extract in the formulation set out in Table 1. In embodiments wherein the composition comprises one or more sugars, typically, the total concentration of sugars is between about 0.4 and about 40 w/w%, including about: 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38, and 39 w/w%. Typically, the total concentration of sugars is between about 10% and about: about 1000%, including 2 0 %, 3 0 %, 4 0 %, 50%, 6 0 %, 7 0 %, 8 0 %, 9 0 %, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the total concentration of sugars in the formulation set out in Table 1. Typically, the concentration of each of the sugars of the composition is between about 0.2 and about 20 w/w%., including about: 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, and 19 w/w%. Typically, the concentration of glucose of the composition is between about 0.2 and about 20 w/w%, including about: 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, and 19 w/w%. Typically, the concentration of glucose is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 6 0 0 %, 7 0 0 %, 8 0 0 %, and 9 0 0 %, of the concentration of glucose in the formulation set out in Table 1. Typically, the concentration of fructose of the composition is between about 0.2 and about 20 w/w%., including about: 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5,

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6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, and 19 w/w%. Typically, the concentration of glucose is between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the concentration of fructose in the formulation set out in Table 1. Manufacture of compositions In another aspect, the invention provides a method of manufacturing a composition, including the step of combining one or more agents or ingredients, to thereby manufacture the composition. More specifically, the method includes the step of combining one or more vitamins; one or more metals; one or more amino acids; and/or one or more plant extracts, to thereby manufacture the composition. Typically, the method includes the step of combining one or more vitamins; one or more metals; one or more amino acids; and one or more plant extracts. In embodiments, the method includes the step of combining one or more sugars with the one or more vitamins; one or more metals; one or more amino acids; and/or one or more plant extracts, to thereby manufacture the composition. In embodiments, the method includes the step of combining one or more viscosity modifiers, thickeners, and/or stabilisers with the one or more vitamins; one or more metals; one or more amino acids; one or more plant extracts; and/or one or more sugars, to thereby manufacture the composition. In embodiments, the method includes the step of combining one or more sweetening agents; acidifiers; and/or preservatives with the one or more vitamins; one or more metals; one or more amino acids; one or more plant extracts; one or more sugars; and/or one or more viscosity modifiers, thickeners, and/or stabilisers, to thereby manufacture the composition. Suitably, the one or more vitamins; one or more metals; one or more amino acids; one or more plant extracts; one or more sugars; one or more viscosity modifiers, thickeners, and/or stabilisers; and one or more sweetening agents; acidifiers; and/or preservatives are as described for the composition of the previous aspect. Typically, the method of this aspect includes the step of controlling the concentration of the one or more vitamins; one or more metals; one or more amino acids; one or more plant extracts; one or more sugars; one or more viscosity modifiers, thickeners, and/or stabilisers; and one or more sweetening agents;

1 - A-/~ acidifiers; and/or preservatives, to thereby manufacture the composition. Typically, the concentration is controlled to a concentration as described for the composition of the previous aspect. Typically, combining the one or more agents or ingredients according to the method of this aspect includes the step of dissolving the agents or ingredients in a liquid. Typically, said liquid is water. In embodiments, the method of this aspect includes the steps of obtaining one or more extracts from one or more plants, and combining the one or more extract with one or more further agents or ingredients, to thereby manufacture the composition. Typically, the one or more extracts are obtained using pure water or substantially pure water. Therapeutic or prophylactic treatment using compositions A further aspect of the invention provides a method for prophylactically or therapeutically treating a condition in a subject, including the step of administering an effective amount of a composition comprising one or more vitamins; one or more metals; one or more amino acids; and/or one or more plant extracts to the subject, to thereby prophylactically or therapeutically treat the condition in the subject. To avoid doubt, it will be understood that administration according to this aspect may be self administration by the subject, to the subject. Suitably, the composition administered according to this aspect is a composition as described hereinabove. Typically, the condition is or includes one or more hangover symptoms. Typically, the one or more hangover symptoms are alcohol hangover symptoms. Typically, the one or more symptoms are selected from the group consisting of a musculoskeletal symptom, such as muscle pain; a gastrointestinal symptom, such as dry mouth, nausea, diarrhoea, or stomach cramping; a nervous or mood symptom, such as headache, dizziness, excessive sweating, anxiety, drowsiness, fatigue, cognitive difficulties, or loss of appetite; a urinary symptom, such as excessive urination; and a circulatory symptom, such as dehydration. Typically, the method is for prophylactically treating the one or more hangover symptoms in the subject. In embodiments wherein the method is for prophylactically treating the one or more symptoms in the subject, the step of administering the effective amount of the composition to the subject is typically performed before the consumption of alcohol by the subject.

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Typically, the step of administering the effective amount of the composition to the subject is performed less than about 4 hours before consumption of alcohol by the subject, including less than about: 3.5 hours; 3 hours; 2.5 hours; 2 hours; 1.5 hours; 1 hour; 45 minutes; 30 minutes; 25 minutes; 20 minutes; 15 minutes; 10 minutes; 5 minutes; 4 minutes; 3 minutes; 2 minutes; and 1 minute. In an embodiment the step of administering the effective amount of the composition to the subject is performed immediately or substantially immediately before consumption of alcohol by the subject. In embodiments wherein the method is for prophylactically treating the symptom in the subject, the step of administering the effective amount of the composition to the subject may additionally or alternatively be performed concurrently with the consumption of alcohol. In the context of the consumption of alcohol, "concurrently with" will be understood to be a period commencing with consumption of the first serving of alcohol in a subject with no substantial unmetabolised alcohol in the subject's system, and ending with consumption of the last serving of alcohol prior to which all or substantially all consumed alcohol is metabolised in the subject's system. In some embodiments, the method of this aspect is for therapeutically treating one or more hangover symptoms in the subject. In embodiments wherein the method is for therapeutically treating the symptom in the subject, the step of administering the effective amount of the composition to the subject is typically performed after the consumption of alcohol by the subject. Typically, the step of administering the effective amount of the composition to the subject is performed after all, or substantially all consumed alcohol is metabolised in the subject's system. Typically, the composition is administered to the subject by ingestion according to the method of this aspect. In typical embodiments of this aspect wherein the composition is a liquid composition, administration of the composition to the subject takes the form of drinking of the composition by the subject. Typically, the composition is administered to the subject according to the method of the aspect by way of one or more individual doses. The one or more doses may be between 1 and about 10 doses, including 2, 3, 4, 5, 6, 7, 8, and 9 doses. In one typical embodiment the composition is administered as a single (i.e. 1) dose. Typically, each of the one or more doses is administered as about 10 ml to about 1000 ml of liquid, including about: 20; 30; 40; 50; 60; 70; 80; 90; 100; 150;

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200;250;300;350;400;450;500;550;600;650;700;750;800;850;900;and 950 ml of liquid. More typically, each of the one or more doses is administered as about 50 ml to about 200 ml of liquid, including about: 60; 70; 80; 90; 100; 110; 120; 130; 140; 150; 160; 170; 180; and 190 ml. Typically, each does of the composition comprises about 150 mg to about 15 g of total vitamins, including about: 200 mg; 300 mg; 400 mg; 500 mg; 600 mg; 700 mg; 800 mg; 900 mg; 1g; 1.5 g; 2 g; 2.5 g; 3 g; 3.5 g; 4 g; 4.5 g; 5 g; 5.5 g; 6 g; 6.5 g; 7 g; 7.5 g; 8 g; 8.5 g; 9 g; 9.5 g; 10 g; 10.5 g; 11 g; 11.5 g; 12 g; 12.5 g; 13 g; 13.5 g; 14 g; and 14.5 g. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the amount of total vitamins per dose as set out in Table 1. Typically, each dose of the composition comprises about 100 mg to about 10 g of vitamin C, including about 200 mg; 300 mg; 400 mg; 500 mg; 600 mg; 700 mg; 800 mg; 900 mg; 1 g; 1.5 g; 2 g; 2.5 g; 3 g; 3.5 g; 4 g; 4.5 g; 5 g; 5.5 g; 6 g; 6.5 g; 7 g; 7.5 g; 8 g; 8.5 g; 9 g; and 9.5 g. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the amount of vitamin C per dose as set out in Table 1. Typically, each dose of the composition comprises about 0.5 mg to about 50 mg total B vitamins, including about: 1mg; 2 mg; 3 mg; 4 mg; 5 mg; 6 mg; 7 mg; 8 mg; 9 mg; 10 mg; 15 mg; 20 mg; 25 mg; 30 mg; 35 mg; 40 mg; and 45 mg. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the amount of total B vitamins per dose as set out in Table 1. Typically, each does of the composition comprises about 0.1 mg to about 30 mg of each B vitamin, including about: 0.1; 0.2; 0.3; 0.4; 0.5; 0.6; 0.7; 0.8; 0.9; 1; 1.1; 1.2; 1.3; 1.4; 1.5; 1.6; 1.7; 1.8; 1.9; 2; 2.1; 2.2; 2.3; 2.4; 2.5; 2.6; 2.7; 2.8; 2.9; 3; 3.1; 3.2; 3.3; 3.4; 3.5; 3.6; 3.7; 3.8; 3.9; 4; 4.1; 4.2; 4.3; 4.4; 4.5; 4.6; 4.7; 4.8; 4.9; 5; 5.5; 6; 6.5; 7; 7.5; 8; 8.5; 9; 9.5; 10; 15; 20; and 25 mg. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 2 0 %, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%,

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600%, 700%, 800%, and 900%, of the amount of each B vitamin per dose as set out in Table 1. Typically, each does of the composition comprises about 30 mg to about 3 g total metals, including about 40 mg; 50 mg; 60 mg; 70 mg; 80 mg; 90 mg; 100 mg; 200 mg; 300 mg; 400 mg; 500 mg; 600 mg; 700 mg; 800 mg; 900 mg; 1 g; 1.5 g; 2 g; and 2.5 g. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the amount of total metals per dose as set out in Table 1. Typically, each dose of the composition comprises about 3 mg to about 300 mg magnesium, including about: 5; 10; 15; 20; 25; 30; 35; 40; 45; 50; 55; 60; 65; 70; 75;80;85;90;95; 100; 110; 120; 130; 140; 150; 160; 170; 180; 190;200;220;240; 260; and 280 mg. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the amount of magnesium per dose as set out in Table 1. Typically, each dose of the composition comprises about 20 mg to about 2 g potassium, including about: 30 mg; 40 mg; 50 mg; 60 mg; 70 mg; 80 mg; 90 mg; 100 mg; 150 mg; 200 mg; 250 mg; 300 mg; 400 mg; 450 mg; 500 mg; 550 mg; 600 mg; 650 mg; 700 mg; 750 mg; 800 mg; 850 mg; 900 mg; 950 mg; 1 g; and 1.5 g. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the amount of potassium per dose as set out in Table 1. Typically, each dose of the composition comprises about 30 mg to about 3 g total amino acids, including about 40 mg; 50 mg; 60 mg; 70 mg; 80 mg; 90 mg; 100 mg; 150 mg; 200 mg; 250 mg; 300 mg; 400 mg; 450 mg; 500 mg; 550 mg; 600 mg; 650 mg; 700 mg; 750 mg; 800 mg; 850 mg; 900 mg; 950 mg; 1 g; and 1.5 g; 2 g; and 2.5 g. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the amount of total amino acids per dose as set out in Table 1. Typically, each dose of the composition comprises about 30 mg to about 3 g cysteine, including about 40 mg; 50 mg; 60 mg; 70 mg; 80 mg; 90 mg; 100 mg; 150

S 1 AA- 1 mg; 200 mg; 250 mg; 300 mg; 400 mg; 450 mg; 500 mg; 550 mg; 600 mg; 650 mg; 700 mg; 750 mg; 800 mg; 850 mg; 900 mg; 950 mg; 1 g; and 1.5 g; 2 g; and 2.5 g. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 7 0 0 %, 800%, and 900%, of the amount of cysteine per dose as set out in Table 1. Typically, each dose of the composition comprises about 100 mg to about 10 g total plant extracts, including about 150 mg; 200 mg; 250 mg; 300 mg; 350 mg; 400 mg; 450 mg; 500 mg; 550 mg; 600 mg; 650 mg; 700 mg; 750 mg; 800 mg; 850 mg; 900 mg; 950 mg; 1g; 1.5 g; 2 g; 2.5 g; 3 g; 3.5 g; 4 g; 4.5 g; 5 g; 5.5 g; 6 g; 6.5 g; 7 g; 7.5 g; 8 g; 8.5 g; 9 g; and 9.5 g. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the amount of total plant extracts per dose as set out in Table 1. Typically, each dose of the composition comprises about 10 mg to about 3 g of each plant extract, including about: 20 mg; 30 mg; 40 mg; 50 mg; 60 mg; 70 mg; 80 mg; 90 mg; 100 mg; 110 mg; 120 mg; 130 mg; 140 mg; 150 mg; 160 mg; 170 mg; 180 mg; 190 mg; 200 mg; 210 mg; 220 mg; 230 mg; 240 mg; 250 mg; 260 mg; 270 mg; 280 mg; 290 mg; 300 mg; 310 mg; 320 mg; 330 mg; 340 mg; 350 mg; 360 mg; 370 mg; 380 mg; 390 mg; 400 mg; 410 mg; 420 mg; 430 mg; 440 mg; 450 mg; 460 mg; 470 mg; 480 mg; 490 mg; 500 mg; 550 mg; 600 mg; 650 mg; 700 mg; 750 mg; 800 mg; 850 mg; 900 mg; 950 mg; 1 g; 1.1 g; 1.2 g; 1.3 g; 1.4 g; 1.5 g; 1.6 g; 1.7 g; 1.8 g; 1.9; 2.1; 2.2; 2.3; 2.4; 2.5; 2.6; 2.7; 2.8; and 2.9 g. Typically, each dose of the composition comprises about 30 mg to about 3 g of Puerarialobata extract, including about 40 mg; 50 mg; 60 mg; 70 mg; 80 mg; 90 mg; 100 mg; 110 mg; 120 mg; 130 mg; 140 mg; 150 mg; 160 mg; 170 mg; 180 mg; 190 mg; 200 mg; 210 mg; 220 mg; 230 mg; 240 mg; 250 mg; 260 mg; 270 mg; 280 mg; 290 mg; 300 mg; 310 mg; 320 mg; 330 mg; 340 mg; 350 mg; 360 mg; 370 mg; 380 mg; 390 mg; 400 mg; 410 mg; 420 mg; 430 mg; 440 mg; 450 mg; 460 mg; 470 mg; 480 mg; 490 mg; 500 mg; 550 mg; 600 mg; 650 mg; 700 mg; 750 mg; 800 mg; 850 mg; 900 mg; 950 mg; 1 g; 1.1 g; 1.2 g; 1.3 g; 1.4 g; 1.5 g; 1.6 g; 1.7 g; 1.8 g; 1.9; 2.1; 2.2 g; 2.3 g; 2.4 g; 2.5 g; 2.6 g; 2.7 g; 2.8 g; and 2.9 g. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 2 0 %, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%,

S 1 AA- 1

600%, 700%, 800%, and 900%, of the amount of Puerarialobata extract per dose as set out in Table 1. Typically, each dose of the composition comprises about 10 mg to about 2 g of Silybum marianum extract, including about 20 mg, 30 mg, 40 mg; 50 mg; 60 mg; 70 mg; 80 mg; 90 mg; 100 mg; 110 mg; 120 mg; 130 mg; 140 mg; 150 mg; 160 mg; 170 mg; 180 mg; 190 mg; 200 mg; 210 mg; 220 mg; 230 mg; 240 mg; 250 mg; 260 mg; 270 mg; 280 mg; 290 mg; 300 mg; 310 mg; 320 mg; 330 mg; 340 mg; 350 mg; 360 mg; 370 mg; 380 mg; 390 mg; 400 mg; 410 mg; 420 mg; 430 mg; 440 mg; 450 mg; 460 mg; 470 mg; 480 mg; 490 mg; 500 mg; 550 mg; 600 mg; 650 mg; 700 mg; 750 mg; 800 mg; 850 mg; 900 mg; 950 mg; 1 g; 1.1 g; 1.2 g; 1.3 g; 1.4 g; 1.5 g; 1.6 g; 1.7 g; 1.8 g; 1.9 g; 2.1 g; 2.2 g; 2.3 g; 2.4 g; 2.5 g; 2.6 g; 2.7 g; 2.8 g; and 2.9 g. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the amount of Silybum marianum extract per dose as set out in Table 1. Typically, each dose of the composition comprises about 30 mg to about 3 g of Hovenia dulcis extract, including about 40 mg; 50 mg; 60 mg; 70 mg; 80 mg; 90 mg; 100 mg; 110 mg; 120 mg; 130 mg; 140 mg; 150 mg; 160 mg; 170 mg; 180 mg; 190 mg; 200 mg; 210 mg; 220 mg; 230 mg; 240 mg; 250 mg; 260 mg; 270 mg; 280 mg; 290 mg; 300 mg; 310 mg; 320 mg; 330 mg; 340 mg; 350 mg; 360 mg; 370 mg; 380 mg; 390 mg; 400 mg; 410 mg; 420 mg; 430 mg; 440 mg; 450 mg; 460 mg; 470 mg; 480 mg; 490 mg; 500 mg; 550 mg; 600 mg; 650 mg; 700 mg; 750 mg; 800 mg; 850 mg; 900 mg; 950 mg; 1 g; 1.1 g; 1.2 g; 1.3 g; 1.4 g; 1.5 g; 1.6 g; 1.7 g; 1.8 g; 1.9; 2.1; 2.2 g; 2.3 g; 2.4 g; 2.5 g; 2.6 g; 2.7 g; 2.8 g; and 2.9 g. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the amount of Hovenia dulcis extract per dose as set out in Table 1. In embodiments wherein the composition comprises one or more sugars, typically, each dose of the composition comprises about 400 mg to about 40 g total sugars, including about: 500 mg; 600 mg; 700 mg; 800 mg; 900 mg; 1 g; 1.5 g; 2 g; 2.5 g; 3 g; 3.5 g; 4 g; 4.5 g; 5 g; 5.5 g; 6 g; 6.5 g; 7 g; 7.5 g; 8 g; 8.5 g; 9 g; 9.5 g; 10g; 15 g; 20 g; 25 g; 30 g; and 35 g. Typically, each dose of the composition comprises about: 2 0 %, 3 0 %, 4 0 %, 50%, between about 10% and about 1000%, including 6 0 %,

1 - -/~ A

70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the amount of total sugars per dose as set out in Table 1. Typically, each dose of the composition comprises about 200 mg to about 20 g of each sugar, including about: 300 mg; 400 mg; 500 mg; 600 mg; 700 mg; 800 mg; 900 mg; 1 g; 1.5 g; 2 g; 2.5 g; 3 g; 3.5 g; 4 g; 4.5 g; 5 g; 5.5 g; 6 g; 6.5 g; 7 g; 7.5 g; 8 g; 8.5 g; 9 g; 9.5 g; 10g; and 15 g. Typically, each dose of the composition comprises about 200 mg to about 20 g of glucose, including about: 300 mg; 400 mg; 500 mg; 600 mg; 700 mg; 800 mg; 900 mg; 1 g; 1.5 g; 2 g; 2.5 g; 3 g; 3.5 g; 4 g; 4.5 g; 5 g; 5.5 g; 6 g; 6.5 g; 7 g; 7.5 g; 8 g; 8.5 g; 9 g; 9.5 g; 10g; and 15 g. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the amount of glucose per dose as set out in Table 1. Typically, each dose of the composition comprises about 200 mg to about 20 g of fructose, including about: 300 mg; 400 mg; 500 mg; 600 mg; 700 mg; 800 mg; 900 mg; 1 g; 1.5 g; 2 g; 2.5 g; 3 g; 3.5 g; 4 g; 4.5 g; 5 g; 5.5 g; 6 g; 6.5 g; 7 g; 7.5 g; 8 g; 8.5 g; 9 g; 9.5 g; 10g; and 15 g. Typically, each dose of the composition comprises between about 10% and about 1000%, including about: 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, and 900%, of the amount of fructose per dose as set out in Table 1. To assist the skilled person to readily understand and work the invention, the following non-limiting examples are provided. EXAMPLES Example 1. Preferred compositions Particularly preferred formulas of the invention have been developed, referred to as Formula F and Formula D. The concentration and dose amounts of components of Formula F and Formula D are set out in Table 1. Exemplary biological activities of components of Formula F and Formula D are summarised in Table 2. Formulation details for manufacture of Formula F are set out in Table 3. Formulation details for manufacture of Formula D are set out in Table 4. It will be appreciated that the formulation details for manufacture of Formula F differ slightly from those of Formula D, as set out in Table 5. Specifically, for Formula D Silybum marianum and Hovenia dulcis extracts were produced using additional solvent (e.g. ethyl acetate) + water extraction methods, whereas for

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Formula F all plant extracts were produced using a 100% water based extraction method. Additionally, for Formula D the concentration of carmellose sodium (Cellogen) is 6%, whereas for Formula F the concentration of carmellose sodium is 3%. Example 2. Alternative composition An alternative composition of the invention has been developed, referred to herein as Formula 0. Components of Formula 0 are as follows: filtered water, granulated D-glucose (dextrose monohydrate), fructose, ascorbic acid (Vit. C), magnesium chloride, trisodium citrate, anhydrous citric acid, monopotassium orthophosphate, potassium chloride, potassium sorbate, sodium benzoate, sodium chloride, sucralose, chlorophyl powder (from Cordyline terminalis), niacinamide (Vit. B3), calcium pantothenate (Vit. B5), flavourings, pyridoxine hydrochloride (Vit. B6), riboflavin (Vit. B2), thiamine mononitrate (Vit. BI), cyanocobalamin (Vit. B12). Amounts of components of Formula 0 are set out in Table 5. Example 3. Assessment of formulas for treatment of hangover symptoms Assessment of formulas of the invention for treatment of hangover symptoms was performed in five trials (Trial 1 - Trial 5). Trial1 In Trial 1, Formula 0 was assessed. A mixture of beer, wine, and spirits was consumed during an evening by 14 subjects, such that each of the 14 subjects experienced substantial alcohol-induced psychotropic effects. Each of the subjects consumed one 60 ml portion of Formula 0 immediately prior to the commencement of alcohol consumption. The following morning, the subjects was asked to rate their hangover symptoms on a 1 to 10 scale, with 1 being no hangover symptoms and 10 being the most severe hangover symptoms. The subjects were also each asked to provide comments on efficacy of the formula. Results of Trial 1 are provided in Table 6. The average hangover symptom rating was 3.9. Comments were overall of a positive nature, indicating that the formula had helped prevent hangover symptoms. Trial 2 In Trial 2, Formula 0 was assessed. A mixture of beer, wine, and spirits was consumed during an evening by 25 subjects, such that each of the subjects experienced substantial alcohol-induced psychotropic effects. Each of the 25 subjects consumed one 60 ml portion of Formula 0. The timing of consumption was either

S 1 AA- 1 concurrently with alcohol consumption during the evening (subjects 1-8); the morning after alcohol consumption (subjects 9-18); or immediately prior to alcohol consumption (subjects 19-25). The morning after alcohol consumption, the subjects were asked to rate their hangover symptoms on a 1 to 10 scale, with 1 being no hangover symptoms and 10 being the most severe hangover symptoms. The subjects were also asked to provide comments on efficacy of the formula. Results of Trial 2 are provided in Table 7. Overall, the average hangover symptom rating was 5.4 out of 10. For subjects 1-8 who consumed Formula 0 concurrently with alcohol consumption, the average rating was 5.1. For subjects 9-18 who consumed Formula 0 the morning after alcohol consumption, the average rating was 7. For subjects 19-25, whom consumed Formula 0 immediately prior to alcohol consumption, the average rating was 3.4. Comments indicate that the formula provided at least some assistance with treating or preventing hangover symptoms when consumed prior to, concurrently with, and after alcohol consumption. However, the most positive comments were obtained from subjects who consumed the formula prior to alcohol consumption. Trial 3 In Trial 3, Formula D was assessed. The design was similar as for Trial 2. A mixture of beer, wine, and spirits was consumed during an evening by 25 subjects, such that each of the subjects experienced substantial alcohol-induced psychotropic effects. Each of the 25 subjects consumed one 100 ml portion of Formula D. The timing of consumption was either concurrently with alcohol consumption during the evening (subjects 1-8); the morning after alcohol consumption (subjects 9-14); or immediately prior to alcohol consumption (subjects 15-25). The following morning, the subjects were asked to rate their hangover symptoms on a 1 to 10 scale, with 1 being no hangover symptoms and 10 being the most severe hangover symptoms. The subjects were also asked to provide comments on efficacy of the formula. Results of Trial 3 are provided in Table 8. Overall, the average hangover symptom rating was 4.2 out of 10. For subjects 1-8 who consumed Formula D concurrently with alcohol consumption, the average rating was 4.5. For subjects 9-14 who consumed Formula D the morning after alcohol consumption, the average rating was 6. For subjects 15-25 who consumed Formula D immediately prior to alcohol consumption, the average rating was 3. Comments indicate that the formula provided at least some assistance with treating or preventing hangover symptoms when

S 1 AA- 1 consumed prior to, concurrently with, and after alcohol consumption. However, the most positive comments were obtained from subjects who consumed the formula prior to alcohol consumption. Trial 4 In Trial 4, Formula D was assessed. The design of this trial was substantially the same as for Trial 1, and the same 14 subjects as for Trial1 participated. Results of Trial 4 are provided in Table 8. The average hangover symptom rating was 2.1 and very positive comments were obtained from the subjects. Additionally, the group was asked to comment on the comparative efficacy of Formula 0 (Trial 1) and Formula D (Trial 4), and the clear consensus while Formula O was effective, Formula D was superior. Trial 5 In Trial 5, Formula F was assessed. The design of this trial was substantially the same as for trials 1 and 4. However, Trial 5 included 25 subjects. Results of Trial 5 are provided in Table 9. The average hangover symptom rating was 3.2, and very positive comments were obtained from the subjects. Of the 25 subjects, a subset also participated in Trial 1 and/or Trial 4 and were asked to comment on efficacy and consumability of Formula 0, Formula D, and Formula F. The consensus was that Formula D and Formula F were similar in efficacy, and clearly superior to Formula 0. The consensus was also that Formula F had superior texture and mouth feel as compared to Formula D. Conclusions The results of the trials conducted clearly indicate that each of Formula 0, Formula D, and Formula F have efficacy for therapeutic and prophylactic treatment of hangover symptoms. Overall, the trials suggest that administration of the formulas prior to alcohol consumption provides the most effective relief of hangover symptoms. Additionally, the trials suggest that Formulas D and F are comparatively more effective than Formula 0. The trials also suggest that Formula F is more desirable for consumption than Formula D.

Throughout the specification, the aim has been to describe the preferred embodiments of the invention without limiting the invention to any one embodiment or specific collection of features. Various changes and modifications may be made to

1 - -/~ A the embodiments described and illustrated without departing from the present invention. The disclosure of each patent and scientific document, computer program and algorithm referred to in this specification is incorporated by reference in its entirety.

S 1 AA- 1

TABLES Table 1. Concentrations and dose amounts of components of Formula D and Formula F.

Ingredient mg/ml w % Amount/ Therapeutic dosage 100 ml dose

Glucose monohydrate 18 0.18 1.8g 13.5g/L glucose anhydrous (BP) Fructose 18 0.18 1.8g N/A Potassium Chloride 3.75 0.375 375mg Equiv. Potassium 1.97 0.197 197mg Monobasic potassium phosphate 0.843 0.0843 84.3mg Equiv. Potassium 0.2422 0.02422 24.2mg TOTAL POTASSIUM 2.21 0.221 221mg AI=2.8 - 3.8g Ascorbic acid 9.9 0.99 990mg RDI= 45mg Thiamine nitrate 0.0247 0.00247 2.47mg Equiv. Thiamine 0.02 0.002 2mg RDI = 1.1-1.2mg Riboflavin sodium phosphate 0.0262 0.00262 2.62mg RDI: 1.1-1.3mg Equiv. Riboflavin 0.02 0.002 2mg Nicotinamide 0.16 0.016 16mg RDI= 14-16mg Calcium pantothenate 0.0656 0.00656 6.56mg Equiv. Pantothenic acid 0.06 0.006 6mg A1= 4 - 6mg Pyridoxine hydrochloride 0.0246 0.00246 2.46mg RDI = 1.3 - 1.7mg Equiv. Pyridoxine 0.02 0.002 2mg Cyanocobalamin 0.005 0.0005 500 pg RDI= 2.4-2.8 pg Magnesium citrate 1.85 0.185 185mg RDI = 310-420mg Equiv Magnesium 0.3 0.03 30mg Cysteine Hydrochloride 5 0.5 500mg Equiv. Cysteine 3.45 0.345 345mg Puerarialobata dry extract 3 0.3 300mg Derived from dry flower 30 3 3g Silybum marianum dry extract 1.71 0.171 171mg Standardised extract Derived from minimum dry fruit 120 0.120 12g 250-750mg Std to Flavanolignans calculated 1.368 0.1368 136mg Equiv 80% silybins as silybin 200 - 600mg Hovenia Dulcis dry extract 3 0.3 300mg Derived from dry fruit 30 3 3g

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Table 2. Formulation details for manufacture of Formula F.

_ _ Acitive I nhs _ _ _ _

RM Code AustalianApproved Nan.tAA) Label Cluimt Input UOM %OW hi..e 11FF

RM515 Glucose monciohdrate 18,00 18,010 g 0 904120 if RMQ63 lFructose 1800 18-00 MR0 Q12L RMS46 Nicatiromide 0.16 _0.208 mg 30 904150 4____ RM027 CalciUm pzrtothenate Dios 5 60 (V0 _____ Equiv. P riothel icAcid J91-6Y6 G.060 MR___ ____

RM179 Thiamine nitrate 0.0469 MR 90 90450o P - FubkThiamine (8.06%) 0.20 _____ ____

RM15 Ritoflavn sodium phosphate .00 10.0342 ing 30 90-150 #f

AM551 jPyridoxinehiydrachloride, M.3165 Mg 30 90-150 Fqulv Pyridoxine(27% 0.020 _____ 9____ RM044 Cyancobaamn 0,005 0.0098 Ma 96 D045

# RMO0B lAscorbicacid 9D 14,85 rig so q015IS RM145 Potassium chloride 3.75 mg 0 Eoiv Ptasim 5245)M,7 ____ ___ 90-125 if RM1I1 Magne siumciWrate 1.85 Mg 0 E LuivMagnesium (16.2%) 0.30 mg___ ____ 9&125 a____ RMIS63 Mcnobasic potassium phosphate 0-843 Mg 0 Equiv. Potvssium(2873%1) 0.2422 i________ 904M2 bf RM2301 Cysteine hydrochloride rrionchydrate 5.0 mg 0 Equiv. Cysteine[10%) 3.45 _____ 9.20 i RM2S34 Puerarla lobata flower eyt. dryconc. 3.00 M& 0 (10:1 in 100% Water) Ecium Pueraria lobata flowerdry 30MOD___ ____ MFA RM2621 jSiiybum marianumnfruitext~dry conc. 1.71 Mg 0 (70:1 in100O% Water) FQunv Silybummarianumnfruftdry M2COD _____g___ MFRt RM253S Hoveniadulisfruitextdry conc. 100 mg 0 10:1i n 100% Water) ____Equix.Hovenia dulcis fruit d!X 300 ___g ___ MFR Sy"tal 70.44

RM coo Austra aApprovdNme AAN) abuiCIlm ,t UOM %OVAI Nolne NOF Unltfr Amounit Uinft _ __ _ _ _ _ML U a- . _ 9911 RM209 Cellogen -Carniellase sodium NA 3.00 Mg 0 NA #f _____Contains:Sodium Chloride(N M T0. 25%).7.50 mcg _____________

RM256 Peach Powder Flavour Natural 4TP-CO6762 (PI 111605) NA 16.00 M& 0 NA MFR RM1567 Tropical Flavour IN 106481 NA 16,00 mg0 NA MFR RM4U $ucralose NA 0.1 **l 0 N~A #

RM473 Citric acid N Aj 0 NA #f RMS30 Sodium 4enzoate N~A ______ 0 NA #f RM819 Potasiumnsorbare N~A MR____~ 0 NA RM490 ROWater NA QS& MA Sub-total(exciudingwater): 33.20 M9

T !al- 1=00.00 Ml

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Table 3. Formulation details for manufacture of Formula D.

Master Formulation Active In-redients RMCode AustralanApprvedName(AAN) LabelClaim input UOM %OVR Release REF Unit/mi Amount Limks

RMS15 Glucose monohydrate 18.00 18.00 mg 0 90-120

# RM063 Fructose 18.00 1800 Mg 0 90-120

# RMS46 Nicotinamide 0.16 0.208 mg 30 90-150

# RM027 Calcium pantothenate 0.105 mg 60 90-175

# Equiv. Pantothenic acid (91.6%) 0.060 mg RM179 Thiaminenitrate 0.047 mg 90 90-150

# Equiv. Thiamine (81.06%) 0020 mg RM158 Riboflavin sodium phosphate 0.034 mg 30 90-150

# Equiv. Riboflavin (76%) 0.020 RM551 Pyridoxine hydrochloride 0-032 mg 30 90-150

# Equiv. Pyridox ine (82.27%) 0.020 mg RM044 Cyanocobalamin 0.005 0.0098 mg 96 90-150

# RM008 Ascorbicacid 9.90 14.85 mg 50 90-150 #f RM145 Potassium chloride 3175 mg 0 Equiv. Potassium (52.5%) 1.97 90-125

# RM111 Magnesium citrate 1.85 mg 0 1 Muiv.Magnesium (16.2%) 0.30 1.85 mg 0 90-125 MFR RM1563 Monobasic potassium phosphate 0843 mg 0 Equiv. Potassium (28.73%) 0.2422 mg 90-125

# RM2303 Cysteinehydrochloridemonohydrate 5.00 mg 0 Equiv. Cysteine (69%) 345 mg 90-120

# TBA Pueraria lobata flower ext. dry conc. 3.00 mg 0 (101 in100% Water) Equiv. Puerana lobata flower dry 30.00 mg _ MFR RM1953 Silybum marianum fruit ext. dry conc. Std. 1.71 mg 0 (70.1 in 95% Ethyl acetate/Water) Equiv Silybu maanumfruit dry 120.00 mg MFR Equiv. Flavanolignans (NLT 80.0%) calc. as Silybin on dried basis - 1.368 mg_ TBA Hovenia dulcis fruit ext. dry conc. 3.00 mg 0 (10:1 in 50% E/W) Equiv. Hovenia dulcis fruit dry 30.00 mg MFR Contains: Maltodextrin (maize) Sub-total: 70.44 mg

_____ ~~zEnpientngients-___ RM Code Astriahn Approved Name(AN} tabelClaim Input UOM %OVR Release REF Unit/mi Amount Limbs

RM2560 Peach Powder Flavour Natural MTP-006762 (PI 111605) NA 16.00 mg 0 NA MFR RM1567 Tropical Flavour (P110648) NA 16.00 mg 0 NA MFR RM488 Sucralose NA Mg 0 NA RM473 Citic acid NA mg 0 NA RMB30 Sodium benzoate NA mg 0 NA #

RM819 Potassium sorbate NA mg 0 NA #

RM490 RO Water NA Os g Sub-total(excludingwater): 33.20 mg

Total 1000.00 | ml

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Table 4. Known or putative activities of formulation components.

Therapeutic indications/biological activities of formulation components Exemplary active (listed in brackets and/or in adjacent column) ingredients Traditionally used in Chinese Medicine to help decrease/reduce/relieve symptoms Puerarialobata of occasional hangovers. Traditionally used in Chinese Medicine to decrease/reduce/relieve headache Puerarialobata symptoms. Maintain/support energy levels. (B3, B5, B6, B12, Magnesium) Thiamine Maintain/support energy production (B1, B2, B3, B5, B12, Magnesium) Riboflavin Helps convert (food) into energy (B3, B2, B5) Niacin Pantothenic acid Pyridoxine Cyanocobalamin Magnesium Maintain/support body electrolyte balance. Magnesium Maintain/support healthy liver function. Silybum marianum Maintain/support general health and wellbeing. (Vitamin B, B2, B3, B5, B6, B1, B2, B3, B5, B6, B12, C &Magnesium) B12, C, Helps prevent dietary Vitamin Bi, B2, Niacin, B5, B6, B12, C & Magnesium Magnesium, deficiency. Silybum marianum Helps reduce/decrease free radical damage to body cells. (B2, C, Silybum Riboflavin Ascorbic marianum) Acid Silybum Antioxidant/Reduce free radicals formed in the body. (B2,Silybum marianum) marianum

Maintain/support red blood cell health. (B2) Riboflavin Aid/assist healthy red blood cell production. (B6, B12) Pyridoxine Cyanocobalamin

Maintain/support bone health. (Vit. C, Magnesium) Ascorbic acid Magnesium Maintain/support cardiovascular system health. (Magnesium) Pantothenic acid Maintain/support healthy cardiovascular system function. (Magnesium) Pyridoxine Helps maintain/support haemoglobin formation /synthesis. (B6) Magnesium Maintain/ support blood capillary health. (VitaminC) Ascorbic acid Maintain/support blood vessel health. (Vitamin C) Maintain/support skin health. (Vitamin B2, B3,C) Riboflavin Aid/assist/helps connective tissue production/formation. (Vitamin B2) Niacin Maintain/support healthy body tissues. (B2) Vitamin C Maintain/ support collagen formation. (Vitamin C) Aid/assist/ helps connective tissue production/formation. (B2, Vitamin C) Maintain/ support connective tissue health. (Vitamin C) Maintain/support wound healing. (Vitamin C) Traditionally used in Western Herbal Medicine to maintain/support healthy Silybum marianum digestion. Traditionally used in Western Herbal Medicine to relieve digestive discomfort.

Maintain/support healthy eye function. Riboflavin Maintain/support eye health. Maintain/support healthy immune system function. (B2, B6, B12, Vit C, Pyridoxine Magnesium)

Maintain/support immune system health. (Vitamin B6, B12, C, Magnesium) Magnesium Aid/assist/helps metabolism of (Carbohydrates, Fats & Proteins). (B1, B2, B3, Thiamine B5, B6, Magnesium) Riboflavin Maintain/support absorption of dietary iron (Vitamin B2,C) Niacin Pantothenic acid Pyridoxine Ascorbic acid Magnesium Traditionally used in Western Herbal Medicine as a cholagogue/promote bile flow Silybum marianum from gallbladder. Traditionally used in Western Herbal Medicine as a choleretic/promote bile flow from liver Traditionally used in Western Herbal Medicine to help maintain/support bile secretion/flow. Maintain/support muscle function. (B1, Magnesium) Thiamine Maintain/support healthy neuromuscular system/function. (Magnesium) Magnesium Maintain/support body mucous membrane health. Niacin Maintain/support nervous system function. (Vitamin B, B3, B5, B6, B12, C, Thiamine Magnesium) Riboflavin Maintain/support nervous system health. (Vitamin B5, B6, B12, C, Magnesium) Niacin Support healthy stress response in the body. (Vitamin B5) Pantothenic acid Maintain/support nerve conduction. (Vitamin B1, Magnesium) Pyridoxine Aid/assist/helps synthesis of neurotransmitters. (Vitamin BI, B5, B6, C) Cyanocobalamin Vitamin C Magnesium Maintain/support hair growth. Riboflavin Maintain/support hair health. Maintain/support nail health Riboflavin Aid/assist nail growth Maintain/support healthy teeth. (Vitamin C Magnesium) Ascorbic acid Aids/assists teeth development (VitaminC) Magnesium

Table 5. Amounts of components of Formula 0.

NUTRITIONAL INFORMATION Portion: 1 shot or bottle (60 ml) Portions per bottle: 1 100mI 1 portion Energy (Kcal) 24 14 Proteins (g) 0.00 0.00 TotalFat(g) 0.00 0.00 Saturated fat (g) 0.00 0.00 Monounsat. fat (g) 0.00 0.00 Polysat. fat (g) 0.00 0.00 Trans. fat (g) 0.00 0.00 Cholesterol (mg) 0.00 0.00 Carbohydrates (g) 5.7 3.4 Total sugars (g) 5.7 3.4 Total dietary fibre (g) 0.00 0.00 Sodium (mg) 99 59 Potassium (mg) 140 84 Chlorophyl powder (mg) 17 10

Vitamin C (mg) 1650 1650% Niacin (mg EN) 15 50% Pantothenic acid (mg) 8.4 50% Vitamin B6 (mg) 1.7 50% Vitamin B2 (mg) 1.3 50% Vitamin B1 (mg) 1.2 50% Vitamin B12 (mcg) 0.83 50%

Magnesium (mg) 42 8%

Portion: 1 shot or bottle (60 ml) Sweetener ADI* Quantity of sweetener 100 ml 1 portion SUCRALOSE (mg) 0-15 17 10

3361441vl

Table 6. Results of Trial 1 as described in Example 3. 'Timing' is timing of consumption of the formula; 'Pre' designates immediately before consumption of alcohol.

Subject Formula Timing Alcohol Results Comments I can still feel that I was drinking last 60ml Mixture - night but I should be way worse . . 1 Formula 0 Pre Beer/wine/spirits 5 I'm usually in bed for the day 60ml Mixture - I feel great, still tired but don't feel 2 Formula 0 Pre Beer/wine/spirits 2 sick 60ml Mixture 3 Formula 0 Pre Beer/wine/spirits 4 1 feel way better than I normally feel 60ml Mixture - Definitely feel better . . still tired but 4 Formula 0 Pre Beer/wine/spirits 5 no headache 60ml Mixture - Only tired, I don't have the sick 5 Formula 0 Pre Beer/wine/spirits 4 feeling I feel good . . I don't get too bad of 60ml Mixture - hangovers but definitely feel better 6 Formula 0 Pre Beer/wine/spirits 2 than I normally do Tired and I definitely know I was drinking last night, but can actually 60ml Mixture - get up and I'm not worried about 7 Formula 0 Pre Beer/wine/spirits 5 going on with my day Still feeling a bit hungover but ... I'm 60ml Mixture - usually vomiting and can't stand up. I 8 Formula 0 Pre Beer/wine/spirits 6 can function 60ml Mixture 9 Formula 0 Pre Beer/wine/spirits 4 100% feel better than I normally do 60ml Mixture 10 Formula 0 Pre Beer/wine/spirits 3 1 feel good . . just wrecked tired 60ml Mixture - I am so surprised as to how good I 11 Formula 0 Pre Beer/wine/spirits 2 feel . . this has helped me for sure 60ml Mixture - I don't feel sick and I don't have a 12 Formula 0 Pre Beer/wine/spirits 4 headache, it worked 60ml Mixture - I feel good. I should be feeling way 13 Formula 0 Pre Beer/wine/spirits 2 worse I'm still hungover and I still have a 60ml Mixture - headache. I always get very bad 14 Formula 0 Pre Beer/wine/spirits 6 hangovers though Average result= 3.9

Table 7. Results of Trial 2 as described in Example 3. 'Timing' is timing of consumption of the formula; 'During' designates concurrently with alcohol consumption; 'Next morning' designates the morning after alcohol consumption; 'Pre' designates immediately before consumption of alcohol.

Subject Formula Timing Alcohol Results Comments 60ml Mixture - It helped, I wasn't feeling as bad as 1 Formula 0 During Beer/wine/spirits 5 normal. I would buy it for sure 60ml Mixture - I was still hungover but I was able to 2 Formula 0 During Beer/wine/spirits 6 do stuff the next day 60ml Mixture - It 100% helped me. I was not too bad 4 Formula 0 During Beer/wine/spirits 4 at all the next morning 60ml Mixture - I was pretty hungover. I don't think it 5 Formula 0 During Beer/wine/spirits 7 did anything for me 60ml Mixture 6 Formula 0 During Beer/wine/spirits 4 It helped but I was still hungover I was feeling ok. I think it helped. I 60ml Mixture - drank a lot last night so should have 7 Formula 0 During Beer/wine/spirits 5 been dying 60ml Mixture - I was only really tired. Urine was 8 Formula 0 During Beer/wine/spirits 5 yellow during the drinking session I woke up hungover. I did feel better 60ml Next Mixture - through the day after drinking it. But 9 Formula 0 morning Beer/wine/spirits 6 Maccas also usually does the trick 60ml Next Mixture - I woke up really hungover. I think it 10 Formula 0 morning Beer/wine/spirits 7 was too late 60ml Next Mixture 11 Formula 0 morning Beer/wine/spirits 7 Very hungover 60ml Next Mixture - Splitting headache. Got better during 12 Formula 0 morning Beer/wine/spirits 7 the day 60ml Next Mixture - I woke up really tired. I felt better by 13 Formula 0 morning Beer/wine/spirits 5 midday 60ml Next Mixture - I couldn't move for the day. I don't 14 Formula 0 morning Beer/wine/spirits 9 think that helped I was pretty hungover in the morning. 60ml Next Mixture - It got a little better an hour or so after 15 Formula 0 morning Beer/wine/spirits 6 drinking it 60ml Next Mixture - Only very tired. It helped me during 16 Formula 0 morning Beer/wine/spirits 5 the day for sure 60ml Next Mixture - No, I was very sick. Drank too much 17 Formula 0 morning Beer/wine/spirits 9 1 think 60ml Next Mixture - I was hungover for the entire day. It 18 Formula 0 morning Beer/wine/spirits 9 might have helped but not noticeable 60ml Mixture 19 Formula 0 Pre Beer/wine/spirits 4 Huge help. I'm normally dead 60ml Mixture - Felt great, very tired still but no 20 Formula 0 Pre Beer/wine/spirits 3 sickness 60ml Mixture 21 Formula 0 Pre Beer/wine/spirits 2 Nearly no hangover, I'm amazed 60ml Mixture 22 Formula 0 Pre Beer/wine/spirits 2 Great product - nearly no hangover 60ml Mixture - I could still feel hungover but this 23 Formula 0 Pre Beer/wine/spirits 4 helped for sure

1 - -/~ A

60ml Mixture - Still hungover, tired but it took away 24 Formula 0 Pre Beer/wine/spirits 6 all the sick feeling 60ml Mixture - Excellent, felt great. Drank a lot so Formula 0 Pre Beer/wine/spirits 3 should be worse Overall average result = 5.4 'During' average result = 5.1 'Next morning' average result= 7 'Pre' average result= 3.4

Table 8. Results of Trial 3 as described in Example 3. 'Timing' is timing of consumption of the formula; 'During' designates concurrently with alcohol consumption; 'Next morning' designates the morning after alcohol consumption; 'Pre' designates immediately before consumption of alcohol.

Subject Formula Timing Alcohol Results Comments 60ml Mixture 1 Formula D During Beer/wine/spirits 4 Helped 100%. 60ml Mixture - Really like it. Tasted good too. I 2 Formula D During Beer/wine/spirits 4 could function the next day 60ml Mixture 4 Formula D During Beer/wine/spirits 4 Good - would buy it for sure 60ml Mixture - Much better than the last one. A bit 5 Formula D During Beer/wine/spirits 5 sandy texture 60ml Mixture - Love it. I felt great. Huge 6 Formula D During Beer/wine/spirits 3 improvement 60ml Mixture 7 Formula D During Beer/wine/spirits 6 Better. This helped 60ml Mixture - Still hungover but I can feel the 8 Formula D During Beer/wine/spirits 6 difference 60ml Next Mixture 9 Formula D morning Beer/wine/spirits 6 Really good. No headache. 60ml Next Mixture - Much better but I don't think I drank 10 Formula D morning Beer/wine/spirits 6 as much 60ml Next Mixture 11 Formula D morning Beer/wine/spirits 6 Still hungover 60ml Next Mixture - Woke up dying but it got much better 12 Formula D morning Beer/wine/spirits 7 after the drink 60ml Next Mixture - 100% improvement. I felt better after 13 Formula D morning Beer/wine/spirits 4 couple of hours of drinking it 60ml Next Mixture - Dying. I don't think my hangovers 14 Formula D morning Beer/wine/spirits 7 can be fixed. Not worse though Excellent. Woke up feeling good. I'm 60ml Mixture - surprised. The texture of the drink is 15 Formula D Pre Beer/wine/spirits 4 hard to swallow. 60ml Mixture - Improvement from the last one. 16 Formula D Pre Beer/wine/spirits 4 Feeling good. 60ml Mixture 17 Formula D Pre Beer/wine/spirits 3 Love this and I'm addicted now. 60ml Mixture - Great results, much better than the 18 Formula D Pre Beer/wine/spirits 3 other one 60ml Mixture - Tired, little headache but no horrible 19 Formula D Pre Beer/wine/spirits 4 feelings 60ml Mixture - No headache, no sickness, this 20 Formula D Pre Beer/wine/spirits 2 worked 60ml Mixture - Love this product. Taste good and 21 Formula D Pre Beer/wine/spirits 2 felt great in the morning 60ml Mixture - Amazing. My hangovers are usually 22 Formula D Pre Beer/wine/spirits 5 horrible, 100% worked I don't really get bad hangovers as 60ml Mixture - you know, but this made it even less. 23 Formula D Pre Beer/wine/spirits 1 Was a bit hard to drink. Grainy

1 - A-/~

60ml Mixture - excellent. I felt great. The grainy 24 Formula D Pre Beer/wine/spirits 3 feeling is tough to drink. Overall average result = 4.2 'During' average result = 4.5 'Next morning' average result = 6 'Pre' average result = 3

Table 9. Results of Trial 4 as described in Example 3. 'Timing' is timing of consumption of the formula; 'Pre' designates immediately before consumption of alcohol.

Subject Formula Timing Alcohol Results Comments 100ml Mixture 1 Formula F Pre Beer/wine/spirits 2 So much better again. Unreal 100ml Mixture 2 Formula F Pre Beer/wine/spirits 1 Excellent, only tired 100ml Mixture - Massive improvement - bit hard to 3 Formula F Pre Beer/wine/spirits 2 drink, sandy feeling 100ml Mixture 4 Formula F Pre Beer/wine/spirits 2 Feel great 100ml Mixture 5 Formula F Pre Beer/wine/spirits 2 1 should be dying but I'm not 100ml Mixture - Much, much better again.. Feels like 6 Formula F Pre Beer/wine/spirits 2 sand in the mouth when drinking 100ml Mixture - Nail on the head. I feel great and I 7 Formula F Pre Beer/wine/spirits 2 drank a lot of wine 100ml Mixture 8 Formula F Pre Beer/wine/spirits 3 Excellent 100ml Mixture - I know I was drinking last night but I 9 Formula F Pre Beer/wine/spirits 2 can get up no worries 100ml Mixture 10 Formula F Pre Beer/wine/spirits 1 Just tired 100ml Mixture 11 Formula F Pre Beer/wine/spirits 2 Excellent.. I'm addicted 100ml Mixture - Unreal. I can't believe how good I 12 Formula F Pre Beer/wine/spirits 2 feel 100ml Mixture - Only tired. Only comment is texture 13 Formula F Pre Beer/wine/spirits 1 of the liquid I don't have a headache, I'm amazed! 100ml Mixture - Still tired and I know that I was 14 Formula F Pre Beer/wine/spirits 5 drinking last night Average result = 2.1

Table 10. Results of Trial 5 as described in Example 3. 'Timing' is timing of consumption of the formula; 'Pre' designates immediately before consumption of alcohol.

Subject Formula Timing Alcohol Results Comments 100ml Mixture 1 Formula F Pre Beer/wine/spirits 3 Love it. Texture much better 100ml Mixture - Sandy feel is no longer there. 2 Formula F Pre Beer/wine/spirits 2 Next to no hangover. Just tired 100ml Mixture - grain in the liquid is nearly 4 Formula F Pre Beer/wine/spirits 2 gone. Excellent 100ml Mixture - Love this product. I'm 5 Formula F Pre Beer/wine/spirits 4 addicted 100ml Mixture - A little headache, tired but not 6 Formula F Pre Beer/wine/spirits 5 dying. Easy to drink 100ml Mixture - Taste good, barely any 7 Formula F Pre Beer/wine/spirits 1 hangover, I love the product 100ml Mixture - No sandy feeling in my mouth. 8 Formula F Pre Beer/wine/spirits 1 No hangover 100ml Mixture 9 Formula F Pre Beer/wine/spirits 3 1 went to the gym the next day 100ml Mixture - I was very drunk. I was only 10 Formula F Pre Beer/wine/spirits 2 tired the next day 100ml Mixture - Amazing, as you know I'm 11 Formula F Pre Beer/wine/spirits 4 usually dead to the world 100ml Mixture 12 Formula F Pre Beer/wine/spirits 5 Still brilliant 100ml Mixture - A little hungover but should be 13 Formula F Pre Beer/wine/spirits 6 way worse 100ml Mixture - Still a bit dying but no way as 14 Formula F Pre Beer/wine/spirits 6 bad as without the drink 100ml Mixture 15 Formula F Pre Beer/wine/spirits 2 Amazing!! 100ml Mixture - Feel great. Tastes good. I'm 16 Formula F Pre Beer/wine/spirits 2 amazed No hangover. I was completely 100ml Mixture - fine. Didn't drink a huge 17 Formula F Pre Beer/wine/spirits 1 amount 100ml Mixture - So much better than I normally 18 Formula F Pre Beer/wine/spirits 5 feel. Easy to drink Excellent. This definitely 100ml Mixture - works. Tastes good. Easy to 19 Formula F Pre Beer/wine/spirits 4 drink 100ml Mixture - Feel great and it was a huge 20 Formula F Pre Beer/wine/spirits 2 night. I will recommend Only tired and a small 100ml Mixture - headache but only slept 4 21 Formula F Pre Beer/wine/spirits 2 hours 22 100ml Pre Mixture - 5 This works, I could function

1 - -/~ A

Formula F Beer/wine/spirits the next day 100ml Mixture 23 Formula F Pre Beer/wine/spirits 4 great product, actually works 100ml Mixture 24 Formula F Pre Beer/wine/spirits 5 Helped massively! 100ml Mixture - Love this product and tastes Formula F Pre Beer/wine/spirits 2 really good now. I'm hooked. Average result = 3.25

Claims

CLAIMS 1. A composition comprising one or more vitamins; one or more metals; one or more amino acids; and one or more plant extracts.
2. The composition of claim 1, for the prophylactic and/or therapeutic treatment of one or more hangover symptoms.
3. The composition of claim 1, when used for the prophylactic and/or therapeutic treatment of one or more hangover symptoms.
4. The composition of any preceding claim, wherein the composition comprises a plurality of vitamins.
5. The composition of any preceding claim, wherein the composition comprises a plurality of metals.
6. The composition of any preceding claim, wherein the composition comprises a plurality of plant extracts.
7. The composition of any preceding claim, wherein the composition comprises one or more sugars.
8. The composition of any preceding claim, wherein the one or more vitamins include vitamin C and/or one or more B vitamins.
9. The composition of claim 8, wherein the one or more B vitamins are selected from the group consisting of vitamin BI, vitamin B2, vitamin B5, vitamin B6, and vitamin B12.
10. The composition of any preceding claim, wherein the one or more metals include magnesium and/or potassium.
11. The composition of any preceding claim, wherein the one or more amino acids include cysteine.

S 1 AA- 1
12. The composition of any preceding claim, wherein the one or more plant extracts are of plants selected from the group consisting of a Pueraria species, a Silybum species, and a Hovenia species.
13. The composition of claim 12, wherein the one or more plant extracts include an extract of Puerarialobata.
14. The composition of claim 12 or claim 13, wherein the one or more plant extracts include an extract of Silybum marianum.
15. The composition of any one of claims 12-14, wherein the one or more plant extracts includes an extract of Hovenia dulcis.
16. The composition of any preceding claim, wherein the one or more plant extracts are from dry plant material.
17. The composition of any preceding claim, wherein the one or more plant extracts are selected from the group consisting of a flower extract; a fruit extract; a root extract; a leaf extract; and a seed extract.
18. The composition of claim 17, wherein the one or more plant extracts are flower extracts or fruit extracts.
19. The composition of any preceding claim, wherein the total concentration of vitamins is between about 0.15 and about 15 w/w%.
20. The composition of any preceding claim, wherein the concentration of vitamin C is between about 0.1 and about 10 w/w%.
21. The composition of any preceding claim, wherein the total concentration of B vitamins is between about 0.005 and about 0.5 w/w%.
22. The composition of any preceding claim, wherein the concentration of each of the B vitamins is between about 0.0001 and about 0.1 w/w%.

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23. The composition of any preceding claim, wherein the total concentration of metals is between about 0.003 and about 3 w/w%.
24. The composition of any preceding claim, wherein the concentration of magnesium is between about 0.005 and about 0.5 w/w%.
25. The composition of any preceding claim, wherein the concentration of potassium is between about 0.02 and about 2 w/w%.
26. The composition of any preceding claim, wherein the total concentration of amino acids is between about 0.03 and about 3 w/w%.
27. The composition of any preceding claim, wherein the concentration of cysteine is between about 0.03 and about 3 w/w%.
28. The composition of any preceding claim, wherein the total concentration of plant extracts is between about 0.05 and about 5 w/w%.
29. The composition of any preceding claim, wherein the concentration of each of the plant extracts is between about 0.01 and about 1 w/w%.
30. The composition of any preceding claim, wherein the composition is liquid.
31. The composition of any preceding claim, wherein the composition is aqueous.
32. A method of manufacturing a composition, including the step of combining one or more vitamins; one or more metal ions; one or more amino acids; and one or more plant extracts, to thereby manufacture the composition.
33. A composition produced according to the method of claim 32.
34. A method for prophylactically or therapeutically treating one or more hangover symptoms in a subject, including the step of administering an effective

S 1 AA- 1 amount of the composition of any one of claims 1-31 to the subject, to thereby prophylactically or therapeutically treat the one or more hangover symptoms in the subject.
35. The method of claim 34, wherein the one or more hangover symptoms treated are selected from the group consisting of a musculoskeletal symptom, such as muscle pain; a gastrointestinal symptom, such as dry mouth, nausea, diarrhoea, or stomach cramping; a nervous or mood symptom, such as headache, dizziness, excessive sweating, anxiety, drowsiness, fatigue, cognitive difficulties, or loss of appetite; a urinary symptom, such as excessive urination; and a circulatory symptom, such as dehydration.
36. The method of claim 34 or claim 35, wherein the method is for prophylactically treating the one or more hangover symptoms in the subject.
37. The method of claim 36, wherein the step of administering the effective amount of the composition to the subject is performed less than about 4 hours before consumption of alcohol by the subject.
38. The method of claim 37, wherein the step of administering the effective amount of the composition is performed less than about 1 hour before consumption of alcohol by the subject.
39. The method of claim 38, wherein the step of administering the composition includes drinking of the composition by the subject.
40. The method of any one of claims 34-39, wherein the composition is administered to the subject by way of one or more individual doses.
41. The method of claim 40, wherein the composition is a liquid composition, and each dose is administered as about 10 ml to about 1000 ml of liquid.
42. The method of claim 40 or claim 41, wherein each dose of the composition comprises about 150 mg to about 15 g of total vitamins.

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43. The method of any one of claims 40-42, wherein each dose of the composition comprises about 100 mg to about 10 g of vitamin C.
44. The method of any one of claims 40-43, wherein each dose of the composition comprises about 0.5 mg to about 50 mg total B vitamins.
45. The method of any one of claims 40-44, wherein each dose of the composition comprises about 0.1 mg to about 30 mg of each B vitamin.
46. The method of any one of claims 40-45, wherein each dose of the composition comprises about 30 mg to about 3 g total metals.
47. The method of any one of claims 40-46, wherein each dose of the composition comprises about 5 mg to about 500 mg of magnesium.
48. The method of any one of claims 40-47, wherein each dose of the composition comprises about 20 mg to about 2 g potassium.
49. The method of any one of claims 40-48, wherein each dose of the composition comprises about 30 mg to about 3 g total amino acids.
50. The method of any one of claims 40-49, wherein dose of the composition comprises about 30 mg to about 3 g cysteine.
51. The method of any one of claims 40-50, wherein each dose of the composition comprises about 50 mg to about 5 g total plant extracts.
52. The method of any one of claims 40-51, wherein each dose of the composition comprises about 10 mg to about 2 g of each plant extract.
53. Use of one or more vitamins; one or more metal ions; one or more amino acids; and one or more plant extracts, in the manufacture of a composition for therapeutic or prophylactic treatment of one or more hangover symptoms.

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