Drug – bio-affecting and body treating compositions – Free carbon containing
Reexamination Certificate
2002-01-11
2004-12-07
Leith, Patricia (Department: 1654)
Drug, bio-affecting and body treating compositions
Free carbon containing
C424S687000, C502S180000, C502S416000, C502S417000
Reexamination Certificate
active
06827932
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a composition which is effective in reducing the effects associated with alcohol consumption and to a method based on administering the composition to a subject in need thereof.
BACKGROUND OF THE INVENTION
As long as history has been recorded, every society has used substances that alter mood, thought and feeling. Alcohol based beverages have played a central role throughout modem history as a prominent ingredient in social and cultural gatherings. The association of alcohol based beverages with culinary enjoyment and other human celebrations have been central to the development of western culture. The role of alcohol based beverages in social human activities is increasingly spreading throughout the globe due to the adoption by populations around the world of the western lifestyle and cultural standards.
However, while consumption of alcohol based beverages in moderation has been associated with refined and sophisticated western lifestyle, abuse of alcohol and alcohol dependency (i.e., alcoholism) are increasingly a public health problem for the modern western society, and now worldwide. In the United States alone, an estimated 13 million adults exhibit symptoms of alcohol dependency due to excessive alcohol intake, and an additional 7 million abuse alcohol without showing symptoms of dependency.
Alcohol dependency and abuse are very expensive in economic and medical terms. It is estimated that alcohol abuse related expenditures will cost the U.S. well over 2 hundred billion dollars in the next year with no prospect of falling or leveling off. The social and psychological damages inflicted on individuals as consequence of alcohol abuse, for example, as more children are born with fetal alcohol syndrome and more victims fall to alcohol related accidents, homicides, suicides, etc. are immense. In view of the staggering statistics associated with alcohol abuse, most, if not all efforts concerned with the effects of alcohol focused on the treatment of alcohol abuse and alcoholism. While those efforts are important and should be pursued, they should not overshadow the importance of the positive effects of moderate consumption of alcohol within ancestral social and cultural norms.
The less dramatic effects of alcohol when consumed in moderation have received little or no interest. There have been very few remedies rationally developed for addressing the effects of moderate alcohol consumption. Those effects include alcohol related “hangover” which is generally characterized by a headache, tremulousness, nausea, sour stomach, diarrhea, fatigue and decreased cognitive or visual-spatial skills.
The symptoms referred to as hangover are believed to be connected to dehydration, hormonal alterations, de-regulation of cytokine pathways and other toxic effects of alcohol. Dehydration is believed to be one of the primary causes of hangover. As alcohol is ingested, ethanol is introduced into the blood stream. In the body, alcohol and its metabolites are identified as toxins and are therefore broken down to less harmful chemical entities. In the body, the liver and kidneys are the organs where most of toxin processing takes place. In order for toxins to be processed adequately by the liver and kidneys, they must be dissolved in water. When the amount of toxins generated by alcohol consumption is higher than the amount of water available in the stomach, water is drawn from other areas of the body where water may be available. In order to process excessive amounts of toxins associated with alcohol consumption, water is generally drawn from the blood, the lymphnodes and the brain. Intensive use of the water available in the body in the processing of toxins results in dehydration, which in turn may result in effects ranging from mere headaches to serious harm to the brain, kidneys, liver, lymphnodes and other vital parts of the human body.
Other effects of alcohol consumption are associated with the presence of congeners generated during the preparation of alcohol beverages, particularly in fermentation processes. Another source for the effects of alcohol consumption is associated with the build up of acetaldehyde during the metabolism of alcohol by the liver kidneys. Alcohol breakdown in the liver involves two steps which are catalyzed by two different enzymes. In the first step, the enzyme alcohol dehyrogenase (ADH) converts alcohol into extremely toxic acetaldehyde. In the second step, the enzyme dehyrogenease (ALDH) converts the acetaldehyde into harmless acetate.
When acetaldehyde is produced at a faster rate than it is converted to acetate, excess acetaldehyde accumulates in the liver which produces an extreme visible reaction. The visible violent effects of acetaldehyde accumulation on the body has resulted in particular attention to the treatment of symptoms associated with acetaldehyde accumulation in the liver. Most studies have focused on using vitamin B6 to help reduce the amount of acetaldehyde accumulated in the liver due to alcohol ingestion as vitamin B6 is believed to be a co-factor that facilitates the conversion of acetaldehyde by ALDH into acetate. However, it has been shown that vitamin B6 is generally available in sufficient amounts in the body upon consumption of alcohol and therefore the administration of high doses of B6 have not resulted in significant reduction of the side effects of alcohol consumption. However, studies have shown that vitamin B1 required for (ADH) is potentially available in insufficient amounts to both supply the required Thiamine (B1) for the essential oxygen-dependent part of the metabolism of alcohol and supply the required vitamin B I to the body. The net affect is in addition to making it harder to breakdown the alcohol into the harmless acetate for efficient removal from the body, high blood alcohol levels can potentially reduce the vitamin B1 supply to the brain. Long term effects of vitamin B1 deficiency in the brain can cause severe health problems.
Another approach for reducing the undesirable effects of alcohol consumption has focused on the removal of alcohol and its metabolites from the blood stream through absorption by alcohol absorbing materials. Specifically, U.S. Pat. No. 4,594,249, the contents of which are hereby incorporated by referenced in their entirety, discloses the use of activated charcoal in alleviating the effects of consumption of alcohol containing beverages. The '249 patent discloses that the effects of alcohol consumption may be reduced by administering to a subject activated charcoal in amounts varying between 5 and 15 milligrams per kilogram of weight of the subject. However, administration of activated charcoal alone has provided only limited reduction of the hangover symptoms associated with alcohol consumption. More effective reduction of those effects would necessitate the injection of substantially larger quantities of activated charcoal.
The effective use of activated charcoal in the treatment of the effects of alcohol consumption may require the administration of high doses in the range of 50 grams or more which must be provided in water suspension form. However, charcoal suspension adheres to the mucosal surfaces of the throat, and gives a chalk like taste which is objectionable and may reduce the desirability of intake of activated charcoal. The limited effectiveness of activated charcoal at doses that are adequate for administration in tablet or capsule form essentially has resulted in a halt in the efforts to develop methods of reducing the effects of alcohol consumption based on activated charcoal.
Thus, there remains a need for compositions and methods based on activated charcoal, yet presenting a significantly enhanced effect in reducing the hangover symptoms associated with alcohol consumption without the need for increased doses of activated charcoal to be administered to a subject beyond the quantities adequate for capsule and tablet packaging. It is therefore an object of the present invention to provide a composition which is based on a
Bhargava Manoj
Crippen Raymond
Morse Thomas F.
Leith Patricia
Pillsbury & Winthrop LLP
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