AU2021100611A4 - A systems for aiding recovery from alcohol - Google Patents

A systems for aiding recovery from alcohol Download PDF

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Publication number
AU2021100611A4
AU2021100611A4 AU2021100611A AU2021100611A AU2021100611A4 AU 2021100611 A4 AU2021100611 A4 AU 2021100611A4 AU 2021100611 A AU2021100611 A AU 2021100611A AU 2021100611 A AU2021100611 A AU 2021100611A AU 2021100611 A4 AU2021100611 A4 AU 2021100611A4
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liquid formulation
sterile liquid
alcohol
pyridoxine
consumption
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AU2021100611A
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Arash Gol
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PLUS DAILY Ltd
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PLUS DAILY Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4415Pyridoxine, i.e. Vitamin B6
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/30Zinc; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32Alcohol-abuse
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Addiction (AREA)
  • Neurology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Psychiatry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Abstract

A system for aiding recovery from an alcohol hangover, the system comprising: a sterile liquid formulation including: 25 mg/mL nicotinamide, substantially 2.5 mg/mL pyridoxine equivalent, wherein the source of pyridoxine is pyridoxine hydrochloride, and substantially 0.36 mg/mL zinc equivalent, wherein the source of zinc is zinc sulphate monohydrate, a single-use container having a reservoir containing the sterile liquid formulation therein, wherein the single-use container is adapted to dispense the sterile liquid formulation in an aseptic manner, and wherein the sterile liquid formulation is added to a food or beverage prior to consumption of alcohol.

Description

A SYSTEM FOR AIDING RECOVERY FROM ALCOHOL TECHNICAL FIELD
[0001] The present invention relates to a system for aiding recovery from an alcohol hangover. In particular, the invention relates to a system for aiding recovery from an alcohol hangover by supporting the enzymatic metabolism of alcohol.
BACKGROUND ART
[0002] 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).
[0003] 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.
[0004] The aldehyde is then metabolised by the enzyme aldehyde dehydrogenase enzymes (ALDH). These enzymes require cofactors and coenzymes to perform their reaction. Zinc holds the alcohol in 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.
[0005] Lack of these cofactors and coenzymes leads to the inefficient metabolism of alcohol and the build-up of acetaldehyde due to low activity of ADH and ALDH enzyme, a toxic molecule that is damaging to the body's organs, and causes the symptoms commonly known as hangover.
[0006] 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 shown 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.
[0007] While there is evidence that some traditional herbal ingredients may relieve hangover symptoms, many of these studies required the participant to consume a relatively large amount of the herbal ingredient. For instance, a study conducted with Hovenia dulcis fruit extract by the Ewha Womans University, Republic of Korea and Chonbuk National University Hospital, Republic of Korea required each participate to consume 2.46g of fruit extract with 50g alcohol (-3-5 standard drinks). Commercially available supplements comprising Hovenia dulcis fruit extracts suggest a consumer take at least one or two capsules (comprising 300mg each of Hovenia dulcis extract) per three alcoholic drinks consumed before going to bed.
[0008] Thus, there would be an advantage if it were possible to provide a formulation for aiding recovery from an alcohol hangover, which was relatively convenient to take.
[0009] It will be clearly understood that, if a prior art publication is referred to herein, this reference does not constitute an admission that the publication forms part of the common general knowledge in the art in Australia or in any other country.
SUMMARY OF INVENTION
[0010] The present invention is directed to a system for aiding recovery from an alcohol hangover, which may at least partially overcome at least one of the abovementioned disadvantages or provide the consumer with a useful or commercial choice.
[0011] With the foregoing in view, the present invention in one form, resides broadly in a system for aiding recovery from an alcohol hangover, the system comprising
a sterile liquid formulation including:
25 mg/mL nicotinamide,
substantially 2.5 mg/mL pyridoxine equivalent, wherein the source of pyridoxine is pyridoxine hydrochloride and
substantially 0.36 mg/mL zinc equivalent, wherein the source of zinc is zinc sulphate monohydrate.
a single-use container having a reservoir containing the sterile liquid formulation therein, wherein the single-use container is adapted to dispense the sterile liquid formulation in an aseptic manner, and
wherein the sterile liquid formulation is added to a food or beverage prior to consumption of alcohol.
[0012] The system for aiding recovery from an alcohol hangover comprises a sterile liquid formulation. Preferably, the sterile liquid formulation may aid in recovery from an alcohol hangover. For instance, the sterile liquid formulation may aid in the treatment and/or the prophylactic treatment of hangover symptoms namely headache, vomiting, cognitive disturbance, concentration problems, mood disturbances, dehydration, excessive thirst, gastritis, diarrhea, dizziness, tremulousness, fatigue, tiredness, nausea, loss of appetite, sensitivity to light and sensitivity to sound.
[0013] The sterile liquid formulation may be prepared using any suitable technique. For instance, the sterile liquid formulation may be prepared using sterile ingredients, may be sterilised in a sterilisation apparatus before packaging, may be sterilised in a sterilisation apparatus after packaging, or any suitable combination thereof. However, it will be understood that the process of preparing the sterile liquid formulation may vary depending on a number of factors, such as the type of ingredients being sterilised, the form of the ingredients and interactions between the ingredients. In an embodiment of the invention the sterile liquid formulation may be prepared aseptically using sterile ingredients. In use, it is envisaged preparing the sterile liquid formulation aseptically using sterile ingredients reduces vitamin losses during preparation.
[0014] In a preferred embodiment of the invention, a container configured to contain a sterile liquid formulation therein may be aseptically filled. In use, it is envisaged that by aseptically filling the container, there may be a reduced need for preservatives which could affect the flavour of the formulation and consequently the flavour of the food or beverage. Preferably, the sterile liquid formulation may be maintained in a sterile environment until dispensed into an alcoholic drink.
[0015] In an embodiment of the invention, the sterile liquid formulation includes a source of nicotinamide.
[0016] In a preferred embodiment of the invention, the sterile liquid formulation includes 25 mg/mL nicotinamide. In this instance, it will be understood that 1 mL of sterile liquid formulation may comprise 25 mg nicotinamide. In use, it is envisaged that a sterile liquid formulation comprising 25 mg/mL nicotinamide may have less of an effect on the taste of the sterile liquid formulation compared to higher concentrations.
[0017] In an embodiment of the invention, the sterile liquid formulation includes a source of pyridoxine. Any suitable form of pyridoxine may be used. Preferably, however the source of pyridoxine is pyridoxine hydrochloride.
[0018] In a preferred embodiment of the invention, the sterile liquid formulation includes substantially 2.5 mg/mL pyridoxine equivalent. In this instance, it will be understood that 1 mL of sterile liquid formulation may include substantially 2.5 mg pyridoxine equivalent. Preferably, the sterile liquid formulation may include substantially 3.0 mg/mL pyridoxine hydrochloride.
[0019] In an embodiment of the invention, the sterile liquid formulation includes a source of zinc ions. Any suitable source of zinc ions may be used. Preferably, however, the source of zinc ions may be zinc sulphate. In a preferred embodiment of the invention, the source of zinc ions may be zinc sulphate monohydrate. Advantageously, it has been found that a sterile liquid formulation comprising zinc sulphate monohydrate may have less of an effect on the taste of the sterile liquid formulation compared to other sources of zinc ions.
[0020] In a preferred embodiment of the invention, the sterile liquid formulation includes substantially 0.36 mg/mL zinc equivalent. In this instance, it will be understood that 1 mL of sterile liquid formulation may include substantially 0.36 mg zinc ions. Preferably, the sterile liquid formulation may include substantially 1 mg/mL zinc sulphate monohydrate.
[0021] The system for aiding recovery from an alcohol hangover comprises a single-use container. In this instance, it will be understood that a single-use container is intended for a single use. In use, it is envisaged that by providing the sterile liquid formulation in a single-use container, a consumer may be assured that the formulation is safe and has not been tampered with.
[0022] Preferably, the single-use container may be adapted to dispense the formulation in an aseptic manner. In use, it is envisaged that by providing the sterile liquid formulation in a single-use container, the formulation may be dispensed aseptically into an alcoholic food or beverage.
[0023] Preferably, the single-use container may have a reservoir, the reservoir configured to contain a sterile liquid formulation therein. The reservoir may be configured to contain any suitable amount of sterile liquid formulation therein. Preferably, the reservoir of the single-use container may be configured to contain at least one unit dose of sterile liquid formulation therein. In use, it is envisaged that by providing a single-use container configured to contain at least one unit dose of sterile liquid formulation therein enables a consumer to conveniently dispense the required dose of sterile liquid formulation into a food or beverage.
[0024] In a preferred embodiment of the invention, one unit dose of sterile liquid formulation may be sufficient to aid recovery from an alcohol hangover based on the consumption of at least one standard alcoholic drink. Preferably, one unit dose of formulation may be sufficient to aid recovery from an alcohol hangover based on the consumption of four to five standard alcoholic drinks. However, it will be understood that the number of standard alcoholic drinks able to be consumed per unit dose of sterile liquid formulation may vary depending on a number of factors such as gender, weight and age of the consumer, the alcohol content of the alcoholic drink, and whether food has been consumed by the consumer.
[0025] The single-use container may be of any suitable size, shape and configuration. Preferably, the size, shape and configuration of the single-use container may be sufficient to contain the required volume of sterile liquid formulation therein. In an embodiment of the invention, the single-use container may be the single-use container described in Australian patent no. 2015234318, the disclosure of which is incorporated herein by reference.
[0026] In an embodiment of the invention, the system for aiding recovery from an alcohol hangover comprises adding the sterile liquid formulation to a food or beverage prior to consumption of alcohol. In an embodiment of the invention, the system for aiding recovering from an alcohol hangover further comprises dispensing a further unit dose of the sterile liquid formulation to a food or beverage during and/or after consumption of alcohol. In this instance it will be understood that the further unit dose of the sterile liquid formulation may be the contents of at least one single use container. The sterile liquid formulation may be added to any food or beverage.
[0027] In an embodiment of the invention, the system for aiding recovering from an alcohol hangover comprises an application with a user interface configured to receive inputs and provide an output to a consumer. Preferably, the application is configured to track alcohol consumption. Preferably, the application may be executable on a mobile computing device. In use, it is envisaged that a consumer may input personal details (such as gender, age, weight, percentage body fat, ethnicity, diagnosed medical conditions, or the like) and consumption information (such as food consumed, the number of non-alcoholic drinks consumed, the type of alcoholic drink being consumed, the number of alcoholic drinks consumed, time over which the drinks have been consumed, or the like) into the application. In use, it is envisaged that the application may display an output on the mobile computer device to the consumer, for instance the number of drinks consumed, the estimated time to sober, notifications to take another unit dose of sterile liquid formulation, notifications that the number of standard drinks consumed have exceeded recommended guidelines, or the like. In use, it is envisaged that the application may enable a consumer to track their alcohol consumption behaviour over a period of time.
[0028] 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 consumer 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. 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. Unexpectantly, 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 consumer.
[0029] 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.
[0030] The reference to any prior art in this specification is not, and should not be taken, as an acknowledgement or any form of suggestion that the prior art forms part of the common general knowledge.
[0031] In the present specification and claims (if any), the word 'comprising' and its derivatives including 'comprises' and 'comprise' include each of the stated integers but does not exclude the inclusion of one or more further integers.
[0032] 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.
[0033] 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.
CITATION LIST
[0034] Kim, H., Kim, Y.J., Jeong, H.Y., Kim, J.Y., Choi, E.-K., Chae, S.W. and 0. Kwon (2017). A standardized extract of the fruit of Hovenia dulcis alleviated alcohol induced hangover in healthy subjects with heterozygous ALDH2: A randomized, controlled, crossover trial. J Ethnopharmacol, 14;209:167-174. doi: 10.1016/j.jep.2017.07.028.

Claims (4)

1. A system for aiding recovery from an alcohol hangover, the system comprising
a sterile liquid formulation including:
25 mg/mL nicotinamide,
substantially 2.5 mg/mL pyridoxine equivalent, wherein the source of pyridoxine is pyridoxine hydrochloride, and
substantially 0.36 mg/mL zinc equivalent, wherein the source of zinc is zinc sulphate monohydrate,
a single-use container having a reservoir containing the sterile liquid formulation therein, wherein the single-use container is adapted to dispense the sterile liquid formulation in an aseptic manner, and
wherein the sterile liquid formulation is added to a food or beverage prior to consumption of alcohol.
2. The system according to claim 1, wherein a further unit dose of the sterile liquid formulation is added to a food or beverage during and/or after consumption of alcohol.
3. The system according to claim 1 or claim 2, further comprising an application with a user interface, wherein the application is configured to track alcohol consumption.
4. The system according to claim 3, wherein the application is configured to track alcohol consumption behaviour over a period of time.
AU2021100611A 2021-02-01 2021-02-01 A systems for aiding recovery from alcohol Ceased AU2021100611A4 (en)

Priority Applications (1)

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Application Number Priority Date Filing Date Title
AU2021100611A AU2021100611A4 (en) 2021-02-01 2021-02-01 A systems for aiding recovery from alcohol

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