CA2919586A1

CA2919586A1 - A pharmaceutical composition, use of a pharmaceutical composition and method for treating the symptoms of excess alcohol consumption

Info

Publication number: CA2919586A1
Application number: CA2919586A
Authority: CA
Inventors: Umjeet Jolly; Gilles Ethier
Original assignee: Rise&shine Global Corp
Current assignee: Rise&shine Global Corp
Priority date: 2016-02-01
Filing date: 2016-02-01
Publication date: 2017-08-01

Abstract

According to the invention, there is disclosed a pharmaceutical composition for treating hangover symptoms in a patient, a use of the pharmaceutically composition for treating hangover symptoms in a patient, and a method for treating hangover symptoms. The pharmaceutical composition preferably comprises a combination of therapeutically effective amounts of one or more of the following medicinal ingredients: an alkaloid, an analgesic, an antiemetic, electrolytes, an amidiarrheal, an anti-foaming agent, an anti-ulcer agent, Opuntia ficus-indica and/or a fructose-containing product.

Description

A PHARMACEUTICAL COMPOSITION, USE OF A PHARMACEUTICAL
COMPOSITION AND METHOD FOR TREATING THE SYMPTOMS OF EXCESS
ALCOHOL CONSUMPTION
FIELD OF THE INVENTION
10001] The present invention relates generally to pharmaceutical compositions and methods for treating the symptoms of alcohol cons-umption. More specifically, the present invention may preferably relate to compositions and methods for the treatment of the symptoms of excessive alcohol consumption with a combination of therapeutically effective arnounts of an allcaloid, an analgesic, an antiemetic, an electrolyte, an antidiantheal, an anti-foaming agent, an anti-ulcer agent, Opuntia ficus-indica and/or a fructose-containing product.
BACKGROUND OF THE' INVENTION

[0002]
Estimates of lost revenue due to reduced job productivity and absenteeism from alcohol may be as high as $148 billion a year in the U.S. alone. Much of this expense is related to what is commonly referred to as "hang-overs" (i.e., symptoms of excessive alcohol consumption) in light to moderate drinkers (1-ittp://www.hopkinsmedicine.orgineuro1ogy neurosumervicenters clinics/headache/conditions/
h2inaover headache.html). At least one report has found that 54% of all workplace alcohol issues (mainly hangover related) are caused by light drinkers and that 87% are caused by light to moderate drinkers (0 to 3 drinks / day for men; 0 to 1 drinks / day for women).

[0003]
Based on various reports, the worldwide consumption of alcohol is rising. In 2010, approximately 6.2 litres of pure alcohol was reported to be constune,c1 per person at least 15 years of age. In general, the greater the economic wealth of a country, the more alcohol is consumed.

As a rule, high-income countries have the highest alcohol per capita consumption ("APC") and the highest prevalence of heavy episodic or "binge" drinking ("HED") among alcohol thinkers (World Health Organizarion. Global status report on alcohol and health 2014, accessible at lity://vvww.who.int/substazwe abuse/publications/49hal aieohol report/an!), HED iE defined as the consumption of greater than 60 grams of pure alcohol (i.e., six or more standard drinks in most countries) on at least one single occasion at least monthly. The World Health Organization has also reported that the total APC (litres of pure alcohol) in the United States will be from 7.5 to 9.9 anct in Canacia from 10.0 to t2.4 in the next 15 years (World !Icahn Organization. Global status report on alcohol and health 2014, accessible at hup://www.who.inr/substance abuse/publicationstiobal alcohol report/en/) and the prevalence of HED among current drinkers has also been estimated by the World Health Organization (World Health Organization. Global sratus report on alcohol and health 2014, accessible at hrtn://www.who.int/substance_abuse/publications/global_alcohol reporeen/) to be between 20.0-29.9% in North America,

[0004] It has been reported that 10% of British males experience hangover-related problems at work at least monthly. It has also been estimated that 8% experience hangover-related problems at work in the United States, 4% for British females and 2% for females in the United States. The number of the population annually that experience hangovers in the United States is estimated to be half of those who experience hangovers in the United Kingdom.

[0005] Given the growing prevalence of HED and the estimates of lost revenue and job absenteeism clue to alcohol, there is a need to provide a composition that may treat the symptoms that often follow overconsumption of alcohol, By ameliorating the 'hang-over' symptoms, individuals (i.e., social drinkers, stress / self-medicating drinkers, binge drinkers, causal drinkers) will be better able to perform their activities of daily living.
[00061 Commercially available products currently available and described in the prior art may comprise herbal remedies with unsubstantiated and pseudoscientific claims of benefit.
[00071 It is an object of the present invention, therefore, to obviate and/or mitigate one or more of the aforementioned disadvantages and/or shortcomings associated with the prior art, to provide one of the aforementioned needs or advantages, and/or to achieve one or more of the aforementioned objects of the invention.
SUMMARY OF THE INVENTION
[0008] According to the present invention, there is disclosed a pharmaceutical composition for treating the symptoms associated with excess alcohol consumption in a patient. The pharmaceutical composition preferably, but need not necessarily, comprises alone or in combination, therapeutically effective amounts of one or more of an alkaloid, an analgesic, an antiemetic, an electrolyte, an antidiatTheal, an anti-foaming agent, an anti-ulcer agent, Opuntia ficus-indica and/or a fructose-containing product.
100091 AS may be known to persons skilled in the art, administering each of the foregoing medicinal ingredients separately (as is currently available) requires a large volume of various oral dosage forms (including the amount of fluids accompanying each medicinal ingredient).
The combination of the different ingredients into a single oral dosage form may preferably improve patient compliance and therapeutic outcomes.

..L4.-10010]
Based preferably on the varying absorption times of the medicinal ingredients and potential synergistic drug-drug effects between the various ingredients of the present invention, there rnay be a synergy between the different medicinal ingredients such that the cumulative therapeutic effect on the hangover symptoms is greater than with each medicinal ingredient used indi vidually.
[0011]
According to the invention, there is preferably disclosed a pharmaceutical composition for treating the symptoms associated with alcohol consuraption in a patient. The pharmaceutical composition includes a therapeutically effective amount of an alkaloid, an analgesic, an electrolyte, an antidiarrheal, an anti-foaming agent, an anti-ulcer agent, Opuntia fieus-indica, a fructose-containing product and pharmaceutically acceptable excipients.

According to the invention, the alkaloid of the pharmaceutical composition may preferably include one or more alkaloids selected front the group consisting of nicotine, caffeine, morphine, quinine, theobromine, theacrine, theophylline, ephedrine, and/or xanthine.
[00131 According to the invention, the analgesic of the pharmaceutical composition may preferably include one Or more analgesics selected from the group consisting of: acetaminophen, n n nn-qe:rni cl a 1 a nti nflammatorY drua. saliCYlates, acetic acid derivatives, eno I i c acid derivatives, anthranilic acid derivatives, select cyc1ooxyengase-2 inhibitors and/or opioids.
10014) According to the invention, the electrolyte of the pharmaceutical composition may preferably include one or more electrolytes selected from the group consisting of: a sodium salt and/or a potassium salt.

According to the invention, the antidiarrheal of the pharmaceutical composition rnay preferably include one or more antidia,nheals selected from the group consisting of: a bulking agent, an absorbent, an anti-inflammatory compound, an anticholinergic, and/or an opioid.
[00161 According to the invention, the antifoaraing agent of the pharmaceutical composition may preferably include simethicone.
1001'71 According to the invention, the anti-ulcer agent of the pharmaceutical composition may preferably include one or more anti-ulcer agents selected from the group consisting of: an H2 receptor antagonist, antacids, proton pump inhibitors and/or antibiotics.
[0018]
According to the invention, the fructose-containing product of the pharmaceutical composition may preferably include one or more fructose-containing products selected from the group consisting of: a honey extract and/or a propolis extract.
[00191 According to the invention, the pharmaceutical composition may also preferably include an antiemetic.
[0020]
According to the invention, the antiemetic of the pharmaceutical composition may preferably include one or more antiemetics selected from the group consisting of: a 5-11T3 remptor antagonist, a (1Qpaming 41-11A-gonipt, a NKl receptor antagonist, an antihistamine, a cannabinoid, a benzodiazepine, an anticholinergic, a steroid, trimethobenzamide, ginger, emetrol, propofol, peppermint, muscimol, and/or ajwain.
[0021]
According to the invention, there is preferably disclosed a use of a pharmaceutical composition. The pharmaceutical composition may include a therapeutically effective amount of an alkaloid, an analgesic, an electrolyte, an anticliarrheal, an anti-foaming agent, an anti-ulcer

- 6 -agent, Opuntia ficus-indica, a fructose-containing product. and pharmaceutically acceptable excipients for the treatment of symptoms associated with excess alcohol consumption in a patient.
10022] According to the invention, the use may preferably include a pharmaceutical composition with one or more of the following alkaloids: nicotine, caffeine, morphine, quinine, theobromine, theacrine, theophylline, ephedrine, and/or xanthine.
[00231 According to the invention, the use may preferably include a pharmaceutical composition with one or more of the following analgesics: acetaminophen, a non-steroidal anti-inflammatory drug, salicylates, acetic acid derivatives, enolic acid derivatives, anthranilie acid derivatives, select cyclooxyengase-2 inhibitors and/or apioids.
(00241 According to the invention, the use may preferably include a pharmaceutical composition with one or more of the following electrolytes: a sodiurn salt and/or a potassium salt.
[0025] According to the invention, the use may preferably include a pharmaceutical composition with one or more of the following antidiarrheals: a bulking agent, an absorbent, an anti-inflammatory compound, an anticholinergic, and/or an opioid.
[0026] According to the invention, the use may preferably include a pharmaceutical composition with the anti-foaming agent simethicone.
[0027] According to the invention, the use may preferably include a pharmaceutical composition with one or more of the following anti-ulcer agents: an 1-12 receptor antagonist, antacids, proton pump inhibitors and/or antibiotics.

- -[0028] According to the invention, the use may preferably include a pharmaceutical composition with one or more of the following fructose-containing products: a honey extract and/or a propolis extract.
[00291 According to the invention, the use may preferably include a pharmaceutical composition with an antiemetic.
[0030] According to the invention, the use may preferably include a pharmaceutical composition with one of more of the following antiemetics: a 5-HT3 receptor antagonist, a dopamine antagonist, a NKI receptor antagonist, an antihistamine, a cannabinoid, a benzodiazepine, an anticholinergic, a steroid, trimethobenzamide, ginger, emetrol, propofol, peppermint, muscimol, and/or ajwain.
[00311 According to the invention, there is preferably disclosed a method for treating the symptoms associated with excess alcohol consumption in a patient that includes administering to the patient, in one or more doses at predetermined time intervals, a pharmaceutical composition.
The pharmaceutical composition may include a therapeutically effective amount of one or more medicinal ingredients selected from the group consisting of: an alkaloid, an analgesic, an antiemetic, an electrolytes, an antidiarrheal, an anti-foaming agent, an anti-ulcer agent, Opuntia ficus-indica and/or a fructose-containing product.
[00321 According to the invention, the method may preferably include a first dose formulation and a second dose formulation. The first dose formulation comprises a first set of a therapeutically effective amount of the one or more medicinal ingredients and a second dose formulation comprises a second set of a therapeutically effective amount of the one or more medicinal ingredi ents.

100331 According to the invention, the method may preferably include administering the Second dose formulation at a predetermined time after the first dose formulation.
[0034] According to the invention, the method may preferably include a third dose formulation. The third dose formulation comprises a third set of a therapeutically effective amount of the one or more medicinal ingredients.
f00351 According to the invention, the method may preferably include administering the second dose formulation at a predetermined time after the second dose formulation arid a third dose formulation at a predetermined time after the second dose formulation.
10036] According to the invention, there is disclosed methods and uses of a pharmaceutical composition of the present invention comprising alone or in combination a therapeutically effective amount of one or more of an alkaloid, an analgesic, an antiemetic, an electrolyte, an antidiarrhcal, an anti-foaming agent, an anti-ulcer agent, Opuntia ficus-indica and/or a fructose-containing product for the treatment or amelioration of symptoms associated with excess alcohol consumption in a patient.
100371 According to the invention, there is disclosed a method for treating the symptoms associated with excess alcohol consumption in a patient comprising administering to the patient, in one or more doses at predetermined time intervals, a pharmaceutical composition comprising alone or in combination a therapeutically effective amount of one or more of an alkaloid, an analgesic, an antiernetic, an electrolyte, an antidiarrheal, an anti-foaming, an anti-ulcer agent, Opuntia ficus-indica and/or a fructose-containing product.
[0038] Other advantages, features and characteristics of the present invention, as well as methods of operation and functions of the related elements of the system, method, device and computer readable medium, and the combination of steps, pans and economics of manufacture, will becoine more apparent upon consideration of the following detailed description and the appended claims with reference to the accompanying drawings, the latter of which are briefly described hereinbel ow.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0039] The description that follows, and the embodiments described therein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present invention, These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the invention.
[0040] It should also be appreciated that the present invention can be implemented in numerous ways, including as a use of the pharmaceutical composition or a method for treating symptoms associated with the overconsumption of alcohol or alcohol containing beverages (e.g.
distilled alcoholic beverages (e.g. whiskey), brewed or fermented alcoholic beverages (e.g. beer, wine, etc.). It will be understood by a person skilled in the relevant art that the term "alcohol" as used herein refers to alcohol per se or anything containing alcohol that is typically consumed by users, In this specification, these implementations, or any other form that the invention may take, may be referred to as uses or methods, In general, the order of the steps of the disclosed methods may be altered within the scope of the invention, 100411 In this disclosure, a number of terms are used. The following definitions of such terms are provided.
[00421 As used herein, a person skilled in the relevant art may generally understand the term "comprising" to generally mean the presence of the stated features, integers, steps, or components as referred to in the claims, but that it does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.
[00431 As used herein, the skilled reader may generally understa,nd the term "hang-over" to generally mean the constellations of symptoms that typically develop following alcohol consumption. it will be understood that given variations in an individual's physiology, physical condition, etc. over time, the amount of alcohol that is required to induce the symptoms of a hangover may vary siertificantly between individuals and even for the same individual. A person skilled in the relevant art will understand that the amount of alcohol consumed that ca.n be defined as "excessive" (i.e., enough to induce a hangover) will vary between, individuals and for a given individual. The consumption of the amount of alcohol necessary for an individual to experience one or more of the symptoms associated with a hangover may be referred to as "overconsumption", overindulgence or the like.
[0044] Physiologic symptoms of a hangover may often be related to a combination of dehydration, metabolic changes, and dropping alcohol levels in the blood stream. Hang-over symptoms, may generally include, but are not limited to: fatigue, thirst and dry mouth, drowsiness and sleepiness, headache, nausea / upset stomach, diarrhea / gas /
intestinal bloating, weakness, reduced alertness and concentration problems. These symptoms were reported by at least 75% of survey responders in Penning R. et al. Alcohol hangover symptoms and their contribution to the overall hangover severity. Alcohol. 2012; 47: 248-252.
[0045] As used herein, a person skilled in the relevant art may generally understand the ten-n "treatment to generally refer to an approach for obtaining beneficial or desired results.
Beneficial ûr desired results can include, but are not limited to, prevention OT prOphyla.xis, alleviation or amelioration of one Or more symptoms or conditions, diminishment of the extent of a disease, stabilized (i.e. not worsening) state of disease, preventing spread of disease, delay or slowing of disease progression, amelioration or palliation of the disease state, and remission (whether partial or total), whether detectable or undetectable, "Treatment"
can also mean prolonging survival as compared to expected survival if not receiving treatment.
[0046] As used herein, a person skilled in the relevant art may generally understand the term "therapeutically effective amount" to be an amount sufficient to effect treatment when administered to a subject in need of treatment. In the case of the embodiments of the present invention, a therapeutically effective amount can include, but is not limited to, an amount that eliminates or reduces the effects of the hang Over.
[00471 It will be understood by a person skilled in the relevant art that the compositions of the present invention can be formulated into pharmaceutical compositions for administration in a manner customary for administration of such materials using standard pharmaceutical formulation chemistries and methodologies, all of which are readily available to a person skilled in the relevant art. It will also be understood by a person skilled in the relevant art that such phaxmaceutical compositions may include one or more excipients, carriers, stabilizers or other pharmaceutically inactive compounds, such as, but not limited to, wetting or emulsifying agents, p1-1 buffering substances and the like. Pharmaceutically acceptable salts can also be included therein. A thorough discussion of pharmaceutically acceptable excipients, vehicles ancl auxiliary substances is available in Remington's. Pharmaceutical Sciences (Mack Pub. Co.
N.J. 1991), incorporated herein by reference. Such pharmaceutical compositions can be prepared as injectable or oral preparations. The embodiments of the present invention may be administered by injection, including, but not limited to, intramuscular, intravenous, subcutaneous, peritoneal, - 1'2 -transderrnie or nasal injection. The therapeutically effective doses may vary according to body weight and the timing and duration of administration wili be determined by specific clinical research protocols.
[0048] It will be understood by a person skilled in the relevant art that the term "dose" refers to the measured quantity of an agent, preferably a therapeutic agent, to be taken at one time to have a desired therapeutic effect(s). Preferably, "dose" as used herein means a specified quantity of a pharmaceutical or therapeutic agent provided in one or more administration, It will be farther understood that a "dosage unit" or "dosage form" as used herein means a form in which the active agent is provided. It will be understood that any known dosage form may be employed with the present invpntinn Th rnay inc1iiç1. solid dosage forms. liquid domge forms, gel dosage fonns, etc. The term "effective dose" or "effective dosage"
is defined as an amount sufficient to achieve or at least partially achieve the desired effect.
The term "therapeutically effective close" is defined as an amount sufficient to cure or at least partially arrest the disease and its complications in a patient already suffering from the disease.
[00491 It will be understood by a person skilled in the relevant art that the term "administering" means providing a therapeutically active agent or composition to a subject, and includes, but is not limited to, administering by a medical professional and self-administering.
100501 It will be understood by a person skilled in the relevant art that a "pharmaceutical agent" or "therapeutic agent" as used herein means a substance that provides a therapeutic effect when administered to a subject. "Pharmaceutical composition" means a mixture of substances suitable for administering to an individual that includes one or more pharmaceutical or therapeutically effective agents. The terms "active pharmaceutical ingredient"
shall be understood to refer to a substance in a pharmaceutical composition that provides a desired effect.
[0051) The treatment of the symptoms of excess alcohol consumption in accordance with the present invention and as hereinafter defined for the purposes of this invention is directed to the relief of the symptoms associated with the overindulgence of alcohol, including but n.ot limited to: fatigue, weakness, alertness, drowsiness, dehydration, headache, diarrhea, gas / intestinal bloating, and/or heartburn. One or more of the foregoing symptoms may be caused at least in part by the production of inflammatory mediators and/or blood alcohol concentration. In a preferred embodiment of tne presem invention, an agent ur aguniz wliich can treat a range of symptoms is recommended. Since no single active ingredient is presently capable of treating the multiple symptoms of excess alcohol consumption, a composition such as is described in the present invention is recommended.
[0521 Preferred embodiments of the present invention treat the one or more symptoms of an alcohol-induced hang-over, including, headache, nausea, gastroesophageal acid reflux, and somnolence.
[0053] Preferably, the pharmaceutical compositions of the present invention may be provided with different active ingredients, different strengths and/or different formulations.
Preferably, the pharmaceutical composition of the present invention comprises a therapeutically effective amount of an alkaloid. A person skilled in the relevant art would understand the term "alkaloid" to refer to any of a class of nitrogenous organic compounds that h.ave pronounced physiological actions on humans. Alkaloids preferable include a large class of organic, nitrogen -containing ring compounds of vegetable or synthesized origin, some of which are liquid but most of which are solid, that have a bitter taste, that are usually water-insoluble and alcohol-soluble, that combine with acids without the loss of a water molecule to form water-soluble hydrochlorides, hydrobromides, or the like, and that usually exhibit pharmacological action, as nicotine, caffeine, morphine, quinine, theobromine, theacrine, theophylline, ephedrine, and xanthine. Persons skilled in the art will appreciate that alkaloids may include true alkaloids, protoalkaloids, polyarnine alkaloids, peptide and cyclopeptide alkaloids, and/or pseudoal kalkoids 10054] Preferably, the alkaloid of the present invention may have central nervous stimulating effects, preferably for the treatment of symptoms including fatigue, weakness, alertness and/or drowsiness. Persons skilled in the art will understand that alcohol, considered a depressant drug, may supress the central nervous system (causing, for example, decreased rate of breathing, decreased heart rate, loss of consciousness, etc.). Persons skilled in the art will also readily appreciate that, following consumption, alkaloids such as caffeine act as central nervous system and metabolic stimulants. In accordance with one or more preferred embodiments of the invention, the pharmaceutical composition may preferably comprise an alkaloid with a stimulant effect including at least one of caffeine, theobromine or theophylline.
Pharmaceutical compositions of the present invention may preferably comprise alkaloids such as caffeine, in amounts from about 0 to 200 mg per dose and preferably from about 0 to 120 mg per dose. In some alternate compositions of the present invention, persons skilled in the art will appreciate that sympathomirnetic drugs such as pseudoephedrine may be used for treating the symptoms of fatigue, weakness, alertness and/or drowsiness.
[00551 Preferably, the pharmaceutical composition of the present invention may also comprise a therapeutically effective amount of one or more analgesics. A
person skilled in the - -relevant art would understand the term "analgesic" to refer to any member of the group of drugs used to achieve analgesia, relief from pain, acting on the peripheral and/or central nervous systems. Analgesics include acetaminophen, non-steroidal anti-inflammatory drugs ("NSAIDs";
including propionic acid derivatives such as ibuprofen, dexibuprofen, naproxen, fenoprofen, ketoprofen, dexketoprofen, flurbiprofen, oxaprozin, and/or loxoprofen;
salicylates; acetic acid derivatives; enolic acid derivatives; anthranilic ac id derivatives; and/or selective cyclooxygenase-2 inhibitors), and opioid drugs such as morphine and oxycodone.
Preferably, acetylsalicylic Acid and other NSAIDs, including but not limited to ibuprofen and naproxen, may preferably, but need not necessarily, be included in the pharmaceutical composition for the treatment of symptoms including pain and/or headache, Persons skilled in the art will under$tand that one or more symptoms of excess alcohol consumption may be related to the increased synthesis of prostaglandins and that nonselective and/or selective inhibitors of the enzyme cyclooxygenase preferably inhibit the formation of prostaglandins -among other biologic effects. In preferred embodiments of the invention, therapeutically effective amounts of NSAIDs, such as ibuprofen, may be present in the composition preferably from about 0 to 400 mg per dose. While in a preferred embodiment of the present invention, the composition contains ibuprofen, persons skilled in the art win appreciate that alternative NSAIDs, such as naproxen or celecoxib or other short or long acting NSAIDs may be used in accordance with the present invention.
[00561 In some preferable enabodiments, a therapeutically effective amount of acetaminophen is included in the composition as an alternative, or in addition, to NSAIDs for the treatment of symptoms including pain and/or headache, Similar to NSAIDs, acetaminophen has been reported to inhibit cyclooxygenase leading to an inhibition in the formation of prostaglandins. In addition, acetaminophen provides analgesic and antipyretic properties comparable to acetylsalicylic acid and other NSAIDs. In some embodiments of the present invention, the composition may preferably comprise acetaminophen from about 0 to 500 mg per dose, Preferably, the pharmaceutical composition of the present invention comprises a therapeutically effective amount of one or more antiemetic. A person skilled in the relevant art would understand the term "antiemetic" to refer to a drug that is effective against vomiting and nausea and may include 5-1-1T3 receptor antagonists (e.g., dolasetron, granisetron, ondansetron, etc.), dopamine antagonists (e.g., domperidone, olanzapine, metoclopramide, etc.), NK1 receptor antagonists (e.g., aprepitant), antihistamines (e.g., cyclizine, diphenhydramine, dimenhydrinate, etc.), cannabinoids (e.g., cannabis, sativex, etc.), benzodiazepines (e.g., midazolam, lorazepam, etc.), a,ntichol inergies (e.g., hyosci ne), steroids (e.g., dexamethaso ne), trimethobenzami de, ginger, emetrol, propofol, peppermint, muscimol, and ajwain, In preferred embodiments, the composition may comprise a therapeutically effective amount of dimenhydrinate alone or in combination with an electrolyte (e.g., sodium chloride or other electrolytes known to persons skilled in the art) to provide an antiemetic effect in persons who have consumed excessive amounts of alcohol. Symptoms such as nausea may be treated by including one or both of dimenhydrinate and/or an electrolyte in a preferred embodiment of the composition. It will be understood by a person skilled in the relevant art that alcohol is metabolized into acetaldehyde by liver enzyme alcohol dehydrogenase and that high concentrations of acetaldehyde in the body can cause nausea and vomiting. Moreover, excess alcohol consumption may decrease antidiuretic hormone ("ADH") levels in the body leading to dehydration and potential electrolyte - J.ri -imbalances. The antiemetie effect of dimenhydrinatc may be due to antagonism of the H1-receptor in the vestibular system in the brain.
[0058] In S ome embniiimpritc nf thc.. pre.sent invention. the composition comprises dimenhydrinate from about 0 TO 100 mg per dose and preferably from about 0 to 25 mg per dose.
Persons skilled in the art will appreciate that other antierneties, such as prochlorperazine and ondansetron may be used in the composition instead of dimen.hydrinate.
[0059]
Preferably, the pharmaceutical composition of the present invention comprises a therapeutically effective amount of one or more electrolytes. A person skilled in the relevant art would understand the term "electrolyte" to refer to a substance that produces an electrically conducting solution when dissolved in a polar solvent, such as water, Dissolved electrolytes separate into cations and anions, which disperse uniformly through the solvent. An electrolyte, preferably but need not necessarily comprising soditun and potassium salts (e.g., sodium chloride), preferably replenish electrolyte levels in the body to restore balance and/or prevent imbalances. In some embodiments of the present invention, an electrolyte may be present in the composition from about 0 to 50 mg per dose and preferably from about 0 to 25 mg per dose.
[0060]
Preferably, the pharinaceutical composition of the present invention comprises a therapeutically effective amount of one or more antidiarrheal. A person skilled in the relevant art would understand the term "antidiarrheal" to refer to any medication which provides symptomatic relief for diarrhea, including but not limited to, bulking agents (e.g., methylcellulose, plant fibres, etc.), absorbents, anti-inflarnmatory compounds (e.g., bismuth subsalicylate), anticholinergics, and/or opioids (e.g., loperamide). In some preferred embodiments, the composition further comprises a therapeutically effective amount of - -loperamide for the treatment of symptoms including diarrhea. Persons .skilled in the relevant art rnay understand that excessive consumption of alcohol (acute or chronic) may alter gastrointestinal motility, including increasing colonic propulsive motility.
Such changes in gastrointestinal function may, for example, contribute to diarrhea following the acme overconsumption of alcohol and chronic alcohol consumption. In addition, the consumption of alcohol may reduce the ability of the intestinal cells to absorb water, resulting in higher volumes of fluid in the intestinal tract. Persons skilled in the relevant art may appreciate that loperamide, an opioid-receptor agonist, decreases the activity of the myenteric plexus of the large intestine which in turn decreases the tone of the longitudinal and circular smooth muscles of the intestinal wall. This may effectively increase the amount of time substances retnain in the intestine, allowing for more water to be absorbed out of fecal matter (e.g., as the body metabolizes the alcohol in the system). In some embodiments of the present inveruion, loperamide may be present in the composition from about 0 to 16 mg per dose and preferably from about 0 to 4 mg per dose.
[0061i Preferably, the pharmaceutical composition of the present invention comprises a therapeutically effective amount of one or more anti-foaming agent. A person skilled in the relevant art would understand the term "anti-foaming agent" to refer to a chemical additive that reduces and hinders the formation of foam, such as simethicone. Some embodiments of the pharmaceutical composition may preferably, but need not necessarily, further comprise a therapeutically effective amount of simethicone, an anti-foaming agent, for the treatment of symptoms including intestinal bloating and/or discomfort or pain caused by excessive gas in the stomach or intestines. Persons of skill in the relevant art may appreciate that such symptoms can be caused by excessive alcohol consumption. Simethicone may increase the rate at which formed gas exits the body by decreasing the surface tension of gaseous bubbles, causing them to combine into larger bubbles in the gastrointestinal tract and stomach that can be passed more easily. In accordance with some embodiments of the present invention, simethicone may be present in the composition from about 0 to 500 mg per dose and most preferably from about 0 to 125 mg per dose.
[0()621 Preferably, the pharmaceutical composition of the present invention comprises a therapeutically effective amount of one or more anti-ulcer agent. A person skilled in the relevant art would understand the term "anti-ulcer agent" to refer to a class of drugs used to treat ulcers in the stomach and the upper part of the small intestine and may include acid reducing medication (e.g., 1-I2 receptor antagonists such as ranitidine and farnotidine, antacids, proton pump inhibitors) and/or when H. pylori infection is present., autibiutics (e.g., clarithromycin, metronidazole). In accordance with a preferred embodiment of the present invention, the composition preferably, but need not necessarily, further comprises a therapeutically effective amount of an anti-ulcer agent, such as ranitidine, for the treatment of symptoms related to stomach acid production. Certain alcoholic beverages (e.g., beer and wine) have been reported to be strong stimulants of gastric acid secretion and gastrin release, In addition, alcohol has also been reported to be a trigger for acid reflux (i.e., stomach acid coming up from the stomach into the esophagus). Occasional reflux may cause heartburn, but chronic reflux has been reported to result in reflux esophagitis, gastroesophageal reflux disease and sometimes Barrett esophagus. Ranitidine, a competitive, reversible inhibitor of the action of histamine at the histamine H2 receptors found in gastric parietal cells, decreases gastric acid secretion and gastric volume, as well as hydrogen ion concentration. In accordance with some embodiments of the present invention, ranitidine may be present in the composition preferably =from about 0 to 150 mg per dose. Persons skilled in the art will appreciate that alternative I-12 receptor antagonists (e.g., famotidine) or the class of proton pump inhibitors (e.g., omeprazole, lansoprazole, esomeprazole, etc,) may also be used in accordance with the present invention.
[00631 In accordance with the present invention, the composition is preferably taken with water or other electrolyte containing beverage for th.e treatment of symptoms including dehydration. Alcohol has been reported to cause the body to increase urinary output (i.e., a diuretic). As aforesaid, alcohol may promote urine production by inhibiting the release of ADI-1 or vasopressin. Reduced levels of ADH may prevent the kidneys from reabsorbing water and thereby increase urine production. Dehydration in combination with sweating, vomiting and diarrhea can result in additional fluid loss and electrolyte imbalances.
Persons skilled in the art may appreciate that the ingestion of water or other electrolyte containing beverage will preferably contribute to the restoration of hydration and electrolyte balance.
Preferably, 1000 ml of water or other electrolyte containing beverage is consumed along with the composition.
0064] In preferred embodiments of the present invention, the pharmaceutical composition may preferably, but need not necessarily, contain a therapeutically effective amount of Opuntia ficus-indica to lessen the severity of the hangover symptoms. It has been reported that the symptoms of excessive constunption of alcohol may be related at least in part to inflammation.
O. ficus-indica has been observed to inhibit the production of inflammatory mediators, potentially lessening the severity of the symptoms associated with excessive alcohol consumption. In accordance with the present invention, compositions comprising O. ficus-inclica are preferably ingested prior to the first alcoholic drink. In this way, such compositions may preferably serve as a preventative to reduce hangover symptoms associated with overconsumption of alcohol. In accordance with some embodiments of the present invention, O.

ficus-indica may be present in the composition preferably from about 0 to 1600 IU per dose and most preferably from about 0 TO 1600 IU per dose.
[0065] In accordance with some embodiments o tne present invention, the composition may include a therapeutically effective amount of a fructose-containing food product (e.g., honey extract). Tt has been reported that fructose-containing foods (e.g., honey) may decrease blood alcohol concentration. In accordance with the present invention, compositions containing honey extract may preferably, but need not necessarily, be ingested during a morning application to decrease the intensity of the symptoms associated with excess alcohol consumption by reducing blood alcohol concentration. In accordance with some embodiments of -the present invention, fructose-containing foods (e.g., honey extract, propolis extract) may he present in the composition from about 0 to 1000 mg per close and most preferably from about 0 to 25 mg per dose.
[00661 The pharmaceutical composition is preferably, but need not necessarily, ingested in a multi-step or inulti-dose application. In a preferable embodiment of the present invention, formulations of the composition of the present invention may be administered in various two or three step regimens. A preferred embodiment involves a first regimen which may comprise the administration of a first dose of a formulation of the composition prior to or during the episode of alcohol consumption (e.g., before the onset of hangover symptoms) and one or more subsequent doses of a formulation of the composition following the episode of alcohol consumption (e.g., during or following the onset of hangover symptoms).¨ the "Before and After" regimen.

[00671 More preferably, a further preferred embodiment involves a second regimen which may comprise the administration of a first dose of a formulation of the composition following the episode of alcohol consumption (e.g., during or following the onset of hangover symptoms) and one or more subsequent doses of a formulation of the composition at a predetermined time after the first close ¨ including, but not limited to, 4-24 hours, 12 hours, 8 hours, 6 hours, or 4 hours after administration of the first dose. In accordance with preferred embodiments of the present invention, the formulation of the composition used for the first dose may be the same or different than the formulation of the composition used fol. the second dose.
100681 In accordance with embodiments of the present invention, the multi-step application may comprise a three step regimen. A first regimen may comprise the administration of a first dose of a formulation of the composition prior to or during the episode of alcohol consumption (e.g., before the onset of hangover symptoms), a second dose of a formulation of the composition following the episode of alcohol consumption (e.g., during or following the onset of hangover symptoms) and a third dose of a formulation of the composition at a predetermined time after the second dose ¨ including, but not limited to, 4-24 hours, 12 hours, 8 hours, 6 hours, or 4 hours after administration of the second close. ln accordance with preferred embodiments of the present invention, the formulation of the composition used for the first dose may be the same or different than the formulation of the composition used for the second and/or third dose.
Similarly, the formulation of the composition used for the second dose may be the same or different than the formulation of the composition used for the third dose.
[00691 In some embodiments of the invention, preventative treatments (e.g., Opuntia Ficus Indica, which may prevent, or reduce the severity of, hangover symptoms if administered in - 1j -advance of the episode of alcohol consumption) may be combined with symptom-directed treatments (e.gõ acetaminophen and/or ibuprofen for pain relief).
[0070] An alternative embodiment of the present invention may comprise a single-step administration of the composition before, during or after the onset of hangover symptoms.
[0071] The following examples set out various dose regimens using a variety of formulations of the pharmaceutical composition, in accordance with the present invention, for the prevention of hangover symptoms and/or the reduction or elimination of symptoms following the onset of a h angover.
[0072] Example 1 Night Before Morning After Caffeine = 0 mg 80 mg Ibuprofen 200 mg 200 mg Acetaminophen 0 mg 325 mg Dimenhydrinate 25 mg 0 mg Ranitidine 75 mg 75 mg Simethicone 0 mg 125 mg Loperamicle 2 mg 2 mg NaCl 0 mg 25 mg Honey Extract 25 mg 0 mg Opuntia Ficus Indica 1000 IU .800 IU
100731 A first regular snength 2-step dosage (e.g., night before and morning after) regimen may preferably, but need not necessarily, comprise the administration of formulations of the composition in an oral dosage form (e,gõ a soluble powder, liquid, tablet, or capsule). In the present example, the formulation used for the first dose (i.e., Night Before) preferably does not c,ornprise caffeine to reduce the probability that the user experiences insomnolence. The first dose may preferably, but need not necessarily, also comprise a higher strength of Opuntia Ficus indica to increase the probability of preventing, or reducing the severity of, hangover symptoms.
In addition, the first dose also includes dimenhydrinate for treating the symptoms of nausea, but is not included in the second dose as dimenhyclrinate may cause drowsiness.
101)741 Example 2 Night Before Morning After Caffeine 0 mg 1.00 mg ibuprofen 200 nig 200 mg Acetaminophen 0 mg 0 mg Dimenhychiliate 0 mg 0 mg Ranitidine 75 mg 75 mg Simethicone 0 mg 125 rag Loperami de 2 mg 2 mg NaC1 0 mg 25 mg Honey Extract 25 mg 0 mg Opuntia Ficus Indica 1000 ILI 800 IU .
100751 A second regular strength 2-step dosage (e.g., night before and morning after) regimen may preferably, but need not necessarily, comprise the administration of formulations of the composition in an oral dosage form (e.g., a soluble powder, liquid, LJ1t tn. 4.; apSuk). In the present example, neither formulation includes acetaminophen.
(00761 Example 3 Night Before Morning After - .4D -Caffeine = 0 mg 120 mg Ibuprofen 400 mg 400 mg Acetaminophen 0 mg 500 mg Dimenhydri nate 25 mg 0 mg Ranitidine 150 mg 150 mg Simethi cone 0 mg 125 mg Loperamide 2 mg 2 mg NaC1 0 mg 25 mg Honey Extract 25 mg 0 mg Opuntia Ficus Indica 1600 IU 1000 TU
[00771 A first extra strength 2-step dosage (e.g., night before and morning after) regimen may preferably, but need not necessarily, comprise the administration of formulations of the composition in an oral dosage form (e.g., a soluble powder, liquid, tablet or capsule). The extra strength formulations preferably, but need not necessarily, comprise greater amounts of one or more medicinal ingredients as compared to the regular strength formulations.
[0078] Example 4 Night Before Morning After Caffeine 0 mg 120 mg Ibuprofen 400 mg 400 mg Acetaminophen 0 mg 0 mg Dimenhydrinate 0 mg 0 mg Rani ti dine 150 ing 150 mg Simethicone 0 mg 125 mg Loperarnide 2 mg 2 mg NaCI 0 mg 25 mg Honey Extract 25 mg 0 mg Opuntia Ficus Indica 1600 IU 1000 IU
[00791 A second extra strength 2-step dosage (e.g., night before and morning after) regimen cotnposition may preferably, but need not necessarily, comprise the administration of formulations of the composition in an oral dosage form (e.g., a soluble powder, liquid, tablet or capsule). In the present example, neither formulation includes acetaminophen.
100801 Example 5 Morning After =Morning After +6 hrs Caffeine 80 mg 80 mg Ibuprofen 200 mg 200 mg Acetaminophen 325 mg 500 mg Dimenhydrinate 0 mg 0 mg Ranitidi ne 75 mg 75 mg Simethicone 125 mg 125 mg L op eramide 2 mg 2 mg 1\11aCI 0 mg 25 mg Honey Extract 25 mg 0 mg Opuntia Ficus Indica. 1000 IU 800 IU
[00811 A third normal strength 2-step dosage (e.g., morning oiler and morning after + 6 hours) regimen may preferably, but need not necessarily, comprise the administration of formulations of the composition in an oral dosage form (e.g., a soluble powder, liquid, tablet or capsule), In the present example, both formulations contain caffeine and the formulation used - -for the second dose contains a greater amount of acetaminophen than the formulation used for the first dose as it may provide greater pain relief.
[0082] Example 6 Morning After Morning After +6 hrs Caffeine 100 mg 80 mg Ibuprofen 200 mg 200 mg Acetaminophen 0 mg 325 mg Dimenhydrinate 0 mg .25 mg Ranitid ine 75 mg 75 mg Si methicone 125 mg 125 mg Loperamicle 2 mg 2 mg NaC1 0 mg 25 mg Honey Extract 25 mg 0 mg Opuntia Ficus Indica 1000 IU 800 ILI
[0083] A fourth normal strength 2-step dosage (e.g., morning and morning after t 6 hours) regimen may preferably, but need not necessarily, comprise the administration of formulations of the cUlnpOSitiOn in an oral dosage form (e.g., a soluble powder, liquid, tablet or capsule.), In the present example, the formulation used for the first dose contains a greater amount of caffeine than the formulation used for the second dose. In addition, the formulation for the second dose contains acetaminophen. The "Morning After" (alternately, "first dose") formulation preferably provides relief of the hangover symptoms (e.g., fatigue, weakness, alertness, drowsiness, dehydration, headache, diarrhea, gas, intestinal bloating, and heartburn), The "Morning After"
formulation also comprises an electrolyte, NaC1, to reduce nausea symptoms.
After a certain time interval (approximately 6 hours and noted as "Morning After + 6 hours", alternately, "second dose"), a second dose is administered to prolong and/or enhance the effectiveness of the composition in eliminating and/or reducing the severity of one or more hangover symptoms.
Caffeine is reduced in the second dose to preferably provide alertness while limiting potential caffeine side effects. The second dose comprises acetaminophen to preferably improve the effectiveness of headache and pain relief jointly and synergistically with ibuprofen, while being administered at a predetermined time interval to prevent and/or minimize the possible metabolism interaction between high doses of alcohol and high doses of acetaminophen. The second dose, instead of the first dose, also comprises dimenhydrinate TO
preferably reduce and/or eliminate fatigue-related symptoms and to prioritize the alertness effects from the caffeine in the first dose while reducing nausea symptoms, Opuntia Ficus Indica and honey extract are reduced and/or eliminated in the second dose preferably to maintain the consumption dose for size and mass of the patient.
[0084] Example 7 Morning After Morning After +6 hrs Caffeine 120 mg 120 mg Ibuprofen 400 ing 400 mg Acetaminophen 325 mg 500 mg Dimenhydrinate 0 mg 0 mg Raniti dine 150 mg 150 mg S imethicoae 125 mg 125 mg Loperamide 2 mg 2 mg NaCl 0 mg 25 rag Honey Extract 25 mg 0 mg - '43 -Opuntia Ficus Indica 1600 TU 1000 ILI
[00851 A third extra strength 2-step dosage (e.g., morning and morning after + 6 hours) regimen may preferably, but need not necessarily, comprise the administration of formulations of the composition in an oral dosage form (e.g., a soluble powder, liquid, tablet or capsule). The extra strength formulations preferably, but need not necessarily, comprise greater amounts of one or more medicinal ingredients as compared to the regular strength formu[ations.
[0086] Example 8 Morning After Morning After +6 hrs Caffeine 140 mg 120 mg Ibuprofen 400 mg 400 mg Acetaminophen 0 mg 500 mg Dimenhydri nate 0 mg 25 mg Ranitidine 150 mg 150 mg Simethicone = 125 mg 125 mg Loperarnide 2 rng 2 mg NaC1 0 mg 25 mg Honey Extract 25 mg 0 mg Opuntia Ficus Indica 1600 IU 1000 ILI
[00871 A fourth extra strength 2-step dosage (cg., morning anti iiiuming aft& i 6 hou1'3) regimen may preferably, but need not necessarily, comprise the administration of formulations of the composition in an oral dosage form (e.g., a soluble powder, liquid, tablet or capsule). In the present example, the formulation used for the second dose includes acetaminophen and dirnenhydrinate. The "Morning After" (a)ternately, "first dose") formulation preferably provides relief of the hangover symptoms (e.g., fatigue, weakness, alertness, drowsiness, dehydration, headache, diarrhea, gas, intestinal bloating, and heartburn). The first dose preferably comprises an electrolyte, NaCl, to reduce nausea symptoms. After the first dose, a second dose is preferably administered to enhance and/or prolong the effect of the first dose in eliminating and/or reducing the severity of the hangover symptoms. The amount. of caffeine in the second dose is reduced to preferably provide alertness while limiting caffeine side effects. The second close comprises acetaminophen to preferably improve the effectiveness of headache and pain relief jointly and synergistically with ibuprofen, while being administered at a predetermined time interval to prevent and/or minimize the possible metabolisrn interaction between 1411 doses of alcohol and high doses of acetaminophen. The second close, instead of the first dose, also comprises dirnenhydrinate to preferably reduce and/or eliminate fatigue-related symptoms and to prioritize the alertness effects from the caffeine in the first dose while reducing nausea symptoms, C.)puntia Ficus Indica and honey extract are red.uced and/or eliminated in the second dose preferably to maintain the constunption dose for size and mass of the patient.
[0088] Example 9 Night Before Morning After Morning After +6 hrs Caffeine 0 mg 80 mg 80 mg Ibuprofen 200 mg 200 mg = 200 mg Acetaminophen 0 mg 325 mg 325 mg Dimenhydrinate 25 mg 0 mg 0 mg Raniticline 75 mg 75 mg 75 mg S i me thicone 0 m.g 125 mg 125 mg Loperamide 2 mg 2 mg 2 mg NaC1 0 mg 25 mg 25 mg Honey Extract 25 mg 10 mg 0 mg Opuntia Ficus Indica 1000 IU 800 IU 0 IU
[00891 A first normal strength 3-step dosage (e.g., night, morning =and morning after -I- 6 hours) regimen may preferably, but need not necessarily, comprise the administration of formulations of the composition in an oral dosage form (e.g;., a soluble powder, liquid, tablet or capsule). In the present example, the formulation used for the first dose (i.e., Night Before) preferably does not comprise caffeine to reduce the probability that the user experiences insomnolence. The "Night Before" (alternately, "first close") formulation is preferably administered in advance of alcohol consumption to preferably prevent, reduce or eliminate hangover symptoms. For prevention, the first dose preferably comprises honey extract and Opuntia Ficus Indica to prevent or reduce inflammation and reduce blood alcohol concentrations, while dimenhydrinate is preferably included to limit or prevent the development uf iiuç. Loperamidc is preferably included to 'maintain water retention, while ranitidine is preferably included to prevent or lessen the severity of acid reflux (i.e., rather than allowing the symptom to occur in the first place and treating it afterwards). Caffeine is preferably MN
included in the first dose as this may prevent the patient from sleeping. The "Morning After"
(alternately "second dose") dosage preferably reduces the amounts of Opuntia Ficus Indica, honey extract, and dimenhydrinate as the treatment objective preferably switches from hangover prevention to hangover symptom relief. The second dose formulation targets the spectrum of hangover symptoms (e.g., fatigue, weakness, alertness, drowsiness, dehydration, headache, dieu.ihc.-,a, gas, intestinal bloating, and heartburn) to preferably provide signitioant relief of thc hangover symptoms. Caffeine is preferably included in the second dose to increase the patients' alertness and functionality. An electrolyte, NaCl, is also added in the second dose to preferably reduce nausea symptoms. The "Morning After +6hrs" (alternately "third dose") dosage is administered to preferably ensure or enhance the effectiveness of treating the hangover symptoms. Caffeine is preferably held at a consistent strength to preferably provide alertness while limiting caffeine side effects. For both the second dose and third dose, acetaminophen is added to preferably enhance the effectiveness of headache and pain relief jointly and synergistically with ibuprofen, while being administered at a preoeterrnined time Imerva Lu not impact or reduce the impact possible metabolism interaction between high dosages of alcohol and high dosages of acetaminophen. Opuntia Ficus Indica and honey extract are reduced and/or eliminated in the second dose and third dose preferably to maintain the consumption dose for size and mass of the patient.
100901 Example 10 Nipht Before Morning After = Morning After +6 hrs Caffeine 0 mg 80 mg 80 mg Ibuprofen 200 mg 200 mg 200 mg Acetaminophen 0 mg 0 mg 325 mg Dimenhydrinate 0 mg 0 mg 25 mg Rani tidine 75 mg 75 mg 75 mg Simethicone 0 mg 125 mg 125 mg Loperamide 2 mg 2 mg 2 mg NaCI 0 mg 25 mg 25 mg Honey Extract 25 mg 10 mg 0 mg Opuntia Ficus Indica 1000 IU 800 III 0 IU

[0091] A
second normal strength 3-step dosage (e.g., night, morning and morning after +6 hours) regimen may preferably, but need not necessarily, comprise the administration of formulations of the composition in an oral dosage form (e.g., a soluble powder, liquid, tablet or capsule). The "Night Before" (alternately, "first dose") formulation is preferably administered in advance of alcohol consumption to preferably prevent, reduce or eliminate hangover symptoms.
For prevention, the first dose preferably comprises honey extract and Opuntia Ficus Indica to prevent or reduce inflammation and reduce blood alcohol concentrations, while dimenhydrinate is nreferablv included to limit or prevent the development of nausea.
Loperamide is preferably included to maintain water retention, while ranitidine is preferably included to prevent or lessen the severity of acid reflux (i.e., rather than allowing the symptom to occur in the 'first place and treating it afterwards). Caffeine is preferably not included in the first dose as this may prevent the patient from sleeping. The "Morning After" (alternately "second dose") dosage preferably reduces the amounts of Opuntia Ficus Indica, honey extract, and dimenhydrinate as the treatment objective preferably switches from hangover prevention to hangover symptom relief.
The second dose formulation targets the spectrum of hangover symptoms (e.g., fatigue, weakness, alertness, drowsiness, dehydration, headache, diarrhea, gas, intestinal bloating, and heartburn) to preferably provide significant relief of the hangover symptoms.
Caffeine is preferably included in the second dose to increase the patients' alertness and functionality An electrolyte, NaCl, is also added in the second dose to preferably reduce nausea symptoms. The "Morning After +61irs" (alternately "third. dose") dosage is administered to preferably ensure or enhance the effectiveness of treating the hangover symptoms. Caffeine is preferably held at a consistent strength to preferably provide alertness while limiting caffeine side effects. For both the second dose and third dose, acetaminophen is added to preferably enhance the effectiveness of headache and pain relief jointly and synergistically with ibuprofen, while being adminigered j4 -at a predetermined time interval as to not impact or reduce the impact possible metabolism interaction between high dosages of alcohol and high dosages of acetaminophen.
Opuntia Ficus indica and honey extract are reduced and/or eliminated in the second dose and third dose preferably to maintain the consumption dose for size and mass of the patient.
[00921 Example 11 Night Before Morning After Morning After +6 hrs Caffeine 0 mg 120 mg 120 mg Ibuprofen 400 mg 400 mg 400 mg Acetaminophen 0 mg 500 mg 500 mg Dime nhydri n ate 25 mg 0 mg 0 mg Raniti di ne 150 mg 150 mg 150 mg Simethicone 0 mg 125 mg 125 mg Loperamide 2 mg 2 mg 2 mg NaCl 0 mg 25 mg 25 mg Honey Extract 25 mg 10 mg 0 mg Opuntia Ficus Indica 1600 IU 1000 IU 0 IU
10093] A first extra strength 3-step dosage (e.g., night, morning and morning after +6 hours) regimen may preferably, but need not necessarily, comprise the administration of formulations of the composition in an oral dosage form (e.g., a soluble powder, liquid, tablet or capsule). The extra strength formulations preferably, but need not necessarily, comprise greater amounts of one or more medicinal ingredients as compared to the regular strength formulations. The "Night 13efore" (alternately, "first dose") formulation is preferably administered in advance of alcohol consumption to preferably prevent, reduce or eliminate hangover symptoms. For prevention, the -first dose preferably comprises honey extract arid Opuntia Ficus Indica to prevent or reduce inflammation and reduce blood alcohol concentrations, while dimenhydrinate is preferably included to limit or prevent the development of nausea. Loperarnide is preferably included to maintain water retention, while ranitidine is preferably included to prevent or lessen the severity of acid reflux (i.e., rather than allowing the symptom to occur in the first place and treating it afterwards). uarteine is preferably not Included ill L1I ìi duw:.- as thi3 rnay prevent the patient fsrom sleeping. The "Morning After" (alternately "second dose") dosage preferably reduces the amounts of Opuntia Ficus Indica, honey extract, and climenhydrinate as the treatment objective preferably switches from hangover prevention to hangover symptom relief. The second dose formulation targets the spectrum of hangover symptoms (e.g,, fatigue, weakness, alertness, drowsiness, dehydration, headache, diarrhea, gris, inteminal bloating, and heartburn) to preferably provide significant relief of the hangover symptoms. Caffeine is preferably included in the second dose to increase the patients' alertness and. fhtictionality. An electrolyte, NaC1, is also added in the second dose to preferably reduce nausea symptoms, The "Morning After +6hrs"
(alternatoly "third cloe") dosage. 'lc adrniniqtered to preferably ensure or enhance the effectiveness of treating the hangover symptoms. Caffeine is preferably held at a consistent strength to preferably provide alertness while limiting caffeine side effects.
For both the second dose and third dose, acetaminophen is added to preferably enhance the effectiveness of headache and pain relief jointly and synergistically with ibuprofen, while being administered at a predetermined time interval as to not impact or reduce the irnpact possible metabolism interaction between high dosages of alcohol and high dosages of acetaminophen.
Opuntia Ficus Indica and honey extract are reduced and/or eliminated in the second dose and third dose preferably to maintain the consumption dose for size and mass of the patient.

[00941 Example 12 Night Before 1Viorning After Morning After +6 hrs Caffeine 0 mg 150 mg 120 mg Ibuprofen 400 mg 400 mg 400 mg Acetaminophen 0 mg 325 mg 500 mg Di rn enhydrinate 0 mg 0 mg 25 mg Ranitidi ne 150 mg 150 mg 150 mg S imethicone 0 mg 125 mg 125 mg Loperam i de 2 mg 2 mg 2 mg NaC1 0 mg 25 mg 25 mg Honey Extract 25 mg 10 mg 0 mg Opuntia Ficus Indica 1600 TU 1000 IU 0 TU
[0095] A second extra strength 3-step (e.g,, night, morning and morning after + 6 hours) regimen may preferably, but need not necessarily, comprise the administration of formulations of the composition in an oral dosage form (e.g., a soluble powder, liquid, tablet or capsule). The "Night Before" (alternately, "first close") formulation is preferably administered in advance of alcohol consumption to preferably prevent, reduce or eliminate hangover symptoms. For prevention, the first dose preferably comprises honey extract and Opuntia Ficus Indica to prevent or reduce inflammation and reduce blood alcohol concentrations, while dimenhydrinate is preferably included to limit or prevent the development of nausea.
Loperamide is preferably included to maintain water retention, while ranitidine is preferably included to prevent or lessen the everity of acid reflux (i.e., rather than allowing the symptom to occur in the first place and treating it afterwards). Caffeine is preferably not included in the first dose as this may prevent the patient from sleeping. The "Morning After" (alternately "second dose") dosage preferably reduces the amounts of Opuntia FiC14.1 Indica, honey extract, and dimenhydrinate as the treatment objective preferably switches from hangover prevention to hangover symptom relief.
The second dose formulation targets the spectrum of hangover symptoms (e.g., fatigue, weakness, alertness, drowsiness, dehydration, headache, diarrhea, gas, intestinal bloating, and heartburn) to preferably provide significant relief of the hangover symptoms.
Caffeine is preferably included in the second dose to increase the patients alertness arid functionality An electrolyte, NaC1, is also added in the second dose to preferably reduce nausea symptoms. The "Morning After -h6hrs" (alternately "third dose") dosage is administered to preferably ensure or enhance the effectiveness of treating the hangover symptoms. Caffeine is preferably held at a.
consistent strength to preferably provide alertness while limiting caffeine side effects. For both the second dose and third dose, a.cetarninophen is added to preferably enhance the effectiveness of headache and pain relief jointly and synergistically with ibuprofen, while being administered a a predetermined time interval as to not impact or reduce the impact possible metabolism interaction between high dosages of alcohol and high dosages of acetaminophen.
A smaller dosage of acetaminophen is preferably administered during the second dose, while a larger dosage of acetaminophen is preferably administered during the third dose to preferably improve hangover symptom relief, Opuntia Ficus Indica and honey extract are reduced or eliminated in the second dose and third close to preferably maintain the consumption dose for size and mass of the patient.
10096] Example 13 [0097] Background:

[0098] A test formulation comprising a combination of caffeine (30 mg), dimenhydrinate (25 mg), ibuprofen (200 mg), and ranitidine (75 mg) in was prepared in a capsule dosage form to study the effective of the combination on preventing, reducing, and/or eliminating hangover symptoms.
[0099] Objective:
[00100] To assess whether the test formulation described above is effective in preventing, reducing, and/or eliminating hangover symptoms associated with a hangover.
[00101] Methods:
[00102] Three (3) study subjects volunteered. Each subject consumed a greater volume of alcohol than each subject was accustomed to in order to increase the likelihood of developing a hang-over. The following morning, each subject was administered at least I
capsule of the test formulation and then qualitatively assessed whether the hangover symptoms improved.
[00103] Results:
[00104] All three (3) subjects participated and each consumed a larger volume of alcohol than each subject was accustomed. Each subject self-reported on the presence of at least one of the following hangover symptoms: nausea, headache, drowsiness, and/or heartburn.
Each subject ingested at least 1 capsule of the test formulation and one (l) subject ingested 2 capsules of the test formulation separated by 4 ¨ 6 hours. Each subject rated an improvement in the hangover aymptarn reported. No obviou5a adverse effertc rif the ti formulation were identified.
[00105] Conclusions:

[00106] The test formulation may be effective in ameliorating symptoms in potential hangover patients. Further studies may be needed to qualitatively and/or quantitatively assess symptom improvement and determine the preferred medicinal ingredients to include in the composition as well as the potential adverse effects associated with same.
[00107) The sthove description is ninFini to be exemplary only, ancl one skilled in the art will recognize that changes may be made to the embodiments described without departing from the scope of the invention disclosed, Modifications which fall within the scope of the scope of the present invention will be apparent to those skilled in the art, in light of a review of this disclosure, and such modifications are intended to fall within the appended claims.
[00108] This concludes the description of presently preferred embodiments of the invention.
The foregoing description has been presented for the purpose of illustration and is not intended to be exhaustive of to limit the invention to the precise form disclosed.
Other modification, variations and alterations are possible in light of the above teaching and will be apparent to those skilled in the art, and may be used in the design and manufacture of other embodiments according to the present invention without departing from the spirit and scope of the invention.
It is intended the scope of the invention be limited be limited not by this description but only by the claims forming a part hereof.

Claims

THE EMBODIMENTS FOR WHICH AN EXCLUSIVE PRIVILEGE OR PROPERTY IS
CLAIMED ARE AS FOLLOWS:

1. A pharmaceutical composition for treating the symptoms associated with alcohol consumption in a patient comprising a therapeutically effective amount of an alkaloid, an analgesic, an electrolyte, an antidiarrheal, an anti-foaming agent, an anti-ulcer agent, Opuntia .ficus-indica, a fructose-containing product and pharmaceutically acceptable excipients.

2. The pharmaceutical composition of claim 1, wherein the alkaloid comprises one or more alkaloids selected from the group consisting of: nicotine, caffeine, morphine, quinine, theobromine, theacrine, theophylline, ephedrine, and/or xanthine.

3. The pharmaceutical composition of any one of claims 1 to 2, wherein the analgesic comprises one or more analgesics selected from the group consisting of:
acetaminophen, a non-steroidal anti-inflammatory drug, salicylates, acetic acid derivatives, enolic acid derivatives, anthranilic acid derivatives, select cyclooxyengase-2 inhibitors and/or opioids.

4. The pharmaceutical composition of any one of claims 1 to 3, wherein the electrolyte comprises one or more electrolytes selected from the group consisting of: a sodium salt and/or a potassium salt.

5. The pharmaceutical composition of any one of claims 1 to 4, wherein the antidiarrheal comprises one or more anticliarreals selected from the group consisting of: a bulking agent, an absorbent, an anti-inflammatory compound, an anticholinergic, and/or an opioid.

6. The pharmaceutical composition of any one of claims 1 to 5, wherein the anti-foaming agent comprises simethicone.

7. The pharmaceutical composition of any one of claims 1 to 6, wherein the anti-ulcer agent comprises one or more anti-ulcer agents selected from the group consisting of:
an H2 receptor amagoinist, antacids, propton pump inhibitors and/or antibiotics.

8. The pharmaceutical composition of any one of claims 1 to 7, wherein the fructose-containing product comprises one or more fructose-containing products selected from the group consisting of: a honey extract and/or a propolis extract. ,

9. The pharmaceutical composition of any one of claims 1 to 8 further comprising an antiemetic.

10. The pharmaceutical composition of claim 9, wherein the antiemetic comprises one or more antiemetics selected from the group consisting of; a 5-4-1T3 receptor antagonist, a dopamine antagonist, a NK1 receptor antagonist, an antihistamine, a cannabinoid, a benzodiazepine, an anticholinergic, a steroid, trimethobenzamide, ginger, emetrol, propofol, peppermint, muscimol, and/or ajwain.

11. Use of a pharmaceutical composition comprising a therapeutically effective amount of an alkaloid, an analgesic, an electrolyte, an anticliarrheal, an anti-foaming agent, an anti-ulcer agent, Opuntia ficus-indica, a fructose-containing product and pharmaceutically acceptable excipients for the treatment of symptoms associated with excess alcohol consumption in a patient.

12. The use of the pharmaceutical composition of claim 11, wherein the alkaloid comprises one or more alkaloids selected from the group consisting of: nicotine, caffeine, morphine, quinine, theobromine, theacrine, theophylline, ephedtine, and/or xanthine.

13. The use of the pharmaceutical composition of any one of claims 11 to 12, wherein the analgesic comprises one or more analgesics selected from the group consisting of:
acetaminophen, a non-steroidal anti-inflammatory drug, salicylates, acetic acid derivatives, enolic acid derivatives, anthranilic acid derivatives, select cyclooxyengase-2 inhibitors and/or opioids.

14. The use of the pharmaceutical composition of any one of claims 1 l to 13, wherein the electrolyte comprises one or more electrolytes selected from the group consisting of: a sodium salt and/or a potassium salt.

15. The use of the pharmaceutical composition of any one of claims 11 to 14, wherein the antidiarrheal comprises one or more antidiarrheals selected from the group consisting of:
a bulking agent, an absorbent, an anti-inflammatory compound, an anticholinergic, and/or an opioid.

16. The use of the pharmaceutical composition of any one of claims 11 to 15, wherein the anti-foaming agent comprises simethicone.

17. The use of the pharmaceutical composition of any one of claims 11 to 16, wherein the anti-ulcer agent comprises one or more anti-ulcer agents selected from the group consisting of; an H2 receptor antagoinist, antacids, propton pump inhibitors and/or antibiotics.

18. The use or the pharmaceutical composition of any one of claims 11 to 17, wherein the fructose-containing product comprises one or more fructose-containing products selected from ale group consisting of: a honey extract and/or a propolis extract.

19. The use or the pharmaceutical composition of any one of claims 11 to 18 further comprising an antiemetic.

20. The use of the pharmaceutical composition of claim 19, wherein the antiemetic comprises one or more antiemetics selected from the group consisting of: a 5-HT3 receptor antagonist, a dopamine antagonist, a NK1 receptor antagonist, an antihistamine, a cannabinoid, a benzodiazepine, an anticholinergic, a steroid, trimethobenzamide, ginger, emetrol, propofol, peppermint, muscimol, and/or ajwain.

21. A method for treating the symptoms associated with excess alcohol consumption in a patient comprising administering to the patient, in one or more doses at predetermined time intervals, a pharmaceutical composition comprising a therapeutically effective amount of one or more medicinal ingredients selected from the group consisting of: an alkaloid, an analgesic, an antiemetic, an electrolytes, an antidianteal, an anti-foaming agnet, tut anti-ulcer agent, Opuntia ficus-indica and/or a fructose-containing product.

22. The method of claim 21 comprising a first dose formulation comprising a first set of a therapeutically effective amount of the one or more medicinal ingredients ana second dose formulation comprising a second set of a therapeutically effective amount of the one or more medicinal ingredients.

23. The method of claim 22 comprising administering the second dose formulation at a predetermined time after the first dose formulation.

24. The method of claim of 22 further comprising a third dose, formulation comprising a third set of a therapeutically effective amount of the one or more medicinal ingredients.

25. The method of claim 24 comprising administering the second dose formulation at a predetermined time after the second dose formulation and a third dose formulation at a predetermined time after the second dose formulation.