AU2018101942A4 - A sterile liquid formulation for aiding recovery from an alcohol hangover - Google Patents

Abstract

The present invention relates to a sterile liquid formulation by aiding recovery from an alcohol hangover comprising nicotinamide, pyridoxine and a source of zinc ions wherein the formulation is formulated for addition to a food or beverage prior to consumption of alcohol by a user.

Description

TECHNICAL FIELD

The present invention relates to a sterile liquid formulation for aiding recovery from an alcohol hangover by supporting the enzymatic metabolism of alcohol.

BACKGROUND ART

Alcohol hangover is caused by consumption of excessive amounts of ethanol causing dehydration, hormonal alterations, deregulated cytokine pathways and toxicity from alcohol and by-products such as acetaldehyde. The symptoms of an alcohol hangover can include headache, nausea, trembling or shaking, diarrhoea, a reduction of the quality of sleep and therefore fatigue (decreased cognitive and/or visual-spatial awareness).

As shown in the equations below, ethanol is primarily metabolised to acetaldehyde by the enzyme alcohol dehydrogenase (ADH) which transfers hydrogen from a cofactor in the form of nicotinamide adenine dinucleotide (NAD). Hydrogen is transferred from alcohol to the NAD, converting it to the reduced form (NADH), and acetaldehyde is produced. Levels of ADH in a person's liver and stomach effectively detoxify about one drink each hour. When more than one alcoholic drink per hour is consumed the excess alcohol cannot be metabolized efficiently.

The aldehyde is then metabolised by the enzyme aldehyde dehydrogenase enzymes (ALDH). These enzymes require cofactors & coenzymes to perform their reaction. Zinc holds the alcohol in it place and Nicotinamide adenine dinucleotide (NAD) which is constructed from Nicotinamide, performs the chemical reaction. The levels of these cofactors and coenzymes deplete during alcohol consumption.

NAD+ NADH

OH

Ethanol

Acetaldehyde Acetate

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Lack of these cofactors & coenzymes leads to the inefficient metabolism of alcohol and the buildup of acetaldehyde due to low activity of ADH and ALDH enzyme³ a toxic molecule that is damaging to the body's organs, and causes the symptoms commonly known as hangover. Factors effecting the severity and onset of acetaldehyde build up depend on genetic factors, gender, age, weight, fatty liver syndrome (hepatic steatosis) and the amount of alcohol consumed. The enzyme's activity is solely dependent on the level of available cofactors and coenzymes. Regardless of the enzymes level, the efficient activity of this enzyme is promoted when there are enough cofactors and coenzymes available to perform the reaction. In brief, replenishing NAD+ cofactors may assist in the management of hangover symptoms

Conversely an excess of cofactors & coenzymes involved with alcohol metabolism promotes efficient metabolism of alcohol and helps the symptomatic relief of hangover. NAD+ is a cofactor for alcohol dehydrogenase (alcohol: NAD+ oxidoreductase, ADH). In the metabolism of ethanol to ethanal (acetaldehyde), NAD+ is converted to NADH2: CH3CH2OH + NAD+ -> CH3CHO + NADH + H+. In vitamin B3 deficiency, levels of NAD and NADP in the erythrocyte are disproportionately maintained; NAD levels fall, while NADP remains stable. Again, replenishing NAD+ cofactors may assist in the management of hangover symptoms.

Most known pre-drinking and post-drinking hangover directed products contain a blend of amino acid, vitamins, mineral and herbal ingredients. The mechanism of action of the herbal ingredient in the commercially available hangover directed products are mostly unknown, however, some studies have show that the herbal ingredients used in hangover products may:

• Counteract the inflammatory response produced by alcohol consumption;

• Enhance the ADH and ALDH activities in the liver; and/or • Reduce the reported severity of nausea, vomiting and diarrhoea.

However, there is no scientific evidence for these known formulations to be effective in alleviating the symptoms of an alcohol hangover. These known formulations are administered once the symptoms are apparent by which time the person who displays the symptoms has suffered from its effects.

In addition, these known formulations are usually administered in capsule form which must be taken with water or other fluids to facilitate swallowing which can be inconvenient. Further, a

2018101942 07 Dec 2018 relatively large dose must be taken to produce a desired effect. This large dose is frequently taken in more than one dose which can be inconvenient to the user.

In fact there are no known cures for the symptoms of an alcohol hangover themselves. The best way to actually avoid a hangover is not to drink alcohol in the first place.

OBJECTOFTHE INVENTION

The present invention is directed to sterile liquid formulation for aiding recovery from an alcohol hangover by supporting the enzymatic metabolism of alcohol, which may at least partially overcome at least one of the abovementioned disadvantages or provide the consumer with a useful or commercial choice.

SUMMARY OF INVENTION

The present invention relates to a nutritional supplement substantially free of flavourings and preservatives which can be added to a food or beverage to be ingested by a user before alcohol consumption without altering the taste to aid in the recovery from a future alcohol hangover by replenishing nutrients in the form of cofactors and coenzymes of ADH and ALDH which form the enzymatic pathway of alcohol metabolism and which may be depleted when drinking alcohol. The inventor has un-expectantly discovered that the combination of ingredients in the proportions described herein when ingested before up to 4 to 5 standard alcoholic drinks can substantially prevent the symptoms of alcoholic hangover being manifested in a person by aiding the metabolism of alcohol in the user.

With the foregoing in view, a first embodiment of the present invention resides broadly in a sterile liquid formulation by aiding recovery from an alcohol hangover comprising:

• nicotinamide;

• at least one source of pyridoxine; and • zinc ions wherein the formulation is formulated for addition to a food or beverage prior to consumption of alcohol by a user.

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Keeping track of the amount of alcohol consumed can be difficult. The most common way to achieve this is to express the amount of pure alcohol in a drink as units of alcohol or standard drinks, depending on where you live. A standard drink in the USA, is any drink containing 14 grams of pure alcohol. A standard drink in Australia is any drink containing 10 grams of pure alcohol. A standard drink in the UK, is any drink containing 8 grams of pure alcohol.

Pure alcohol mass = volume x (alcohol by volume x Volumetric mass density)

0.150 X (0.12 X 789.24) = 14.2 g

For example, 0.150 litre glass of champagne with 12% alcohol has 14 grams of pure alcohol*.

*Pure alcohol has a density of 789.24 g/1 (at 20 °C).

14g of pure alcohol = 1 Standard Drink in USA

14g of pure alcohol = 1.4 Standard Drinks in Australia

14g of pure alcohol = 1.8 Standard Drinks in the UK

In the present specification and claims (if any), the word 'comprising' and its derivatives including 'comprises' and 'comprise' include each ofthe stated integers but does not exclude the inclusion of one or more further integers.

The formulation used in the present invention is in liquid form which allows for faster absorbance compared to solid forms such as tablets to be added to drinks at the time of consumption.

For the purposes of the specification, nicotinamide, also known as niacinamide or NAM, is a form of vitamin B3 found in food and is a precursor to the production of cofactor nicotinamide adenine dinucleotide (NAD) which in turn is used as a cofactor by the enzyme alcohol dehydrogenase (ADH) to accept hydrogen converting NAD to its reduced form (NADH), and producing acetaldehyde as a byproduct. It has a bitter taste when ingested in high quantities (substantially 50mg).

Zinc and nicotinamide are ADH cofactors and precursors ofthe co-enzymes NAD and NADP for the alcohol dehydrogenase enzyme.

In a second embodiment ofthe present invention resides broadly in a sterile liquid formulation by aiding recovery from an alcohol hangover comprising:

• substantially 2.5% w/v of total concentration nicotinamide;

2018101942 07 Dec 2018 • substantially 0.25% w/v of total concentration at least one source of pyridoxine; and • substantially 0.023% w/v of total concentration of zinc ions wherein the formulation is formulated for addition to a food or beverage prior to consumption of alcohol by a user.

In a third embodiment of the present invention there is provided a food or beverage for aiding recovery from an alcohol hangover comprising the sterile liquid formulation as described above.

Preferably, the at least one source of pyridoxine is pyridoxine hydrochloride.

Zinc is a mineral that aids in prevention of dehydration which can be experienced after excessive alcohol intake. Zinc ions are required by alcohol dehydrogenase (ADH) for its metabolic action on ethanol. Preferably, the at least one zinc ion source may be zinc sulphate.

The food or beverage can be cold or hot (greater than 55 °C or 85 °C). The formulation as described is stable in a broad range of temperatures.

Preferably, the food or beverage is an alcoholic food or beverage.

Any of the features described herein can be combined in any combination with any one or more of the other features described herein within the scope of the invention.

DESCRIPTION OF EMBODIMENTS

A formulation is manufactured as an aid to recovery from an alcohol hangover in the form of a sterile liquid comprising substantially 2.5% w/v of total concentration nicotinamide; substantially 0.25% w/v of total concentration source of pyridoxine in the form of pyridoxine hydrochloride; and a source of zinc ions in the form of zinc sulphate substantially 0.1% w/v of total concentration (or substantially 0.023% of zinc ions) for use by addition to a food or beverage in the form of an alcoholic beverage to be ingested by a user. In this way, the formulation is ingested before alcohol consumption. The formulation is free of flavourings and preservatives.

The formulation is manufactured under sterile conditions as a beverage for dilution in a first alcoholic drink before consumption. In 2 ml volumes in single-use containers in the form of a strip of 4 single use containers (vials) as described in Australian patent no. 2015234318.

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An example of use of the composition of the present invention is now described. A dilution of one container into 100ml of a first alcoholic beverage produces substantially 2.5% w/v of total concentration nicotinamide; substantially 0.25% w/v of total concentration pyridoxine; and substantially 0.023% of total concentration zinc ions (or 0.1% w/v of total concentration of a zinc ion source in the form of zinc sulphate). A user could use the contents of 1 or 2 containers into a standard alcoholic unit beverage. The taste is not substantially affected by the addition of the formulation of the present invention due to the absence of flavouring agents which acts as a nutritional supplement to boost the metabolism of the user to better.

Where the consumer ingests more than one unit dose of formulation, this may be at the same time or at different times (for example, morning and evening). The formulation may also be prepared in unit doses that permit different consumers to ingest a different number of unit doses, for example, taking into account the different ages, weights, or health conditions of different consumers.

CONCLUDING STATEMENTS

Therefore the present invention provides a number of advantages over the prior art such as:

• improved symptomatic relief from an alcohol hangover through promotion of alcohol metabolism; and • improved ease of use in consuming a formulation for aiding recovery from an alcohol hangover (at the time of consumption) in view of the fact can be added to beverages or food as a liquid without altering the taste.

Reference throughout this specification to 'one embodiment' or 'an embodiment' means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearance of the phrases 'in one embodiment' or 'in an embodiment' in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more combinations.

In compliance with the statute, the invention has been described in language more or less specific to structural or methodical features. It is to be understood that the invention is not limited to specific features shown or described since the means herein described comprises preferred forms of putting the invention into effect. The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims (if any) appropriately interpreted by those skilled in the art.

Claims (5)

1. A sterile liquid formulation by aiding recovery from an alcohol hangover comprising:

• nicotinamide;

• pyridoxine; and • zinc ions wherein the formulation is formulated for addition to a food or beverage prior to consumption of alcohol by a user.

2. A sterile liquid formulation by aiding recovery from an alcohol hangover comprising:

• substantially 2.5% w/v of total concentration nicotinamide;

• substantially 0.25% w/v of total concentration pyridoxine; and • substantially 0.023% w/v of total concentration of zinc ions wherein the formulation is formulated for addition to a food or beverage prior to consumption of alcohol by a user.

3. A beverage for aiding recovery from an alcohol hangover comprising the sterile liquid formulation as claimed in claim 1 or claim 2.

4. The sterile liquid formulation as claimed in any one of claims 1 to 3, wherein the at least one source of pyridoxine is pyridoxine hydrochloride.

5. The sterile liquid formulation as claimed in any one of claims 1 to 4, wherein the at least one zinc ion source is zinc sulphate.