Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid
Reexamination Certificate
2002-02-28
2003-11-11
Hartley, Michael G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
Organic pressurized fluid
C424S489000, C424S499000, C514S023000, C514S029000, C514S054000, C514S062000
Reexamination Certificate
active
06645469
ABSTRACT:
This application claims the benefit of and priority to European Patent Application No. EP 01125055.2, filed Mar. 1, 2001.
DESCRIPTION
1. Technical Field
The present invention relates generally to the technical sector of chemistry and pharmacology and particularly to a new method for dispensing a medicine. It doesn't consist of a therapeutic treatment, since the therapeutic function of the S-Adenosilmetionina (SAMe) is already known, but it discloses a new use, by means of a method for dispensing it through the respiratory tract.
2. Background Art
The assimilation of an adequate quantity of physiologically important S-Adenosylmethionine is essential to the health of people. Failure of the body to assimilate the necessary amount of such SAMe which acts as a methyl donor in over 35 methylation reactions involving DNA, proteins, phospholipids and catechol and indole amines, that can lead to the improvement of the biochemical reactions of the body functions and the metabolic processes as well as to the prevention or cure of variety of diseases and associated symptoms. SAMe=S-Adenosyl-L-methionine, S-(
5
′-deoxyadenosine-
5
′)-methionine, active methionine, active methyl, abbreviated as S-Ado-Met, SAM: a reactive sulfonium compound which is the most important methylating agent in cellular metabolism (transmethylation). It is formed by activation of L-methionine with ATP: Met+ATP−SAM+PP
1
+P
1
. The adenosine residue of the ATP is transformed to the methionine.
The transmethylation reaction produces, in addition to the methylated product, S-adenosyl-L-homocysteine: systematic name S-(
5
′deoxyadenosine-
5
′)-homocysteine. It may be reconverted to SAM after cleavage into adenosine and L-homocysteine. L-Homocysteine is the substrate of dimethylthetin-homocysteine methyltransferase. SAMe controls virtually all body functions in man beginning with sugar metabolism and fatty acid metabolism and extending to the immune system and even mental stability, through SAMe mediated modification of a number of critical neurotransmitters and hormones. Not surprisingly, SAMe also controls aging of the organism. Hence, virtually all diseases and/or disorders associated with aging, such as diabetes, atherosclerosis, arthritis and Alzheimer's disease, are caused by abnormal perturbations of the SAMe pathways.
SAMe has been clinically proven to promote joint health and support emotional wellbeing.
SAMe is one of the most vital links to health known today in maintaining not only health but in preventing diseases. SAMe most significant claims include efficacy in treating depression, osteoarthritis, cirrhosis of the liver, fibromyalgia, cancer, cystic fibrosis, ALZHEIMER's and PARKINSON's diseases.
The importance of this reaction in maintaining health cannot be overemphasized. Everything from activating or deactivating enzymes to converting the coded messages in our DNA to actual proteins involves methylation reactions, and therefore SAMe.
Many scientists have known for years that most of us don't get all the vitamins we need from our food and that the RDA levels of many vitamins are absurdly low. We also know that the levels of folate and SAMe in the blood of many people are too low for their optimum health, mental and physical. Likewise, we know that homocysteine levels in the upper half of the normal range are a risk factor for many diseases, including hearth attack.
Unfortunately today is considered normal to have a heart attack even at a young age, but today thank to SAMe many, if not most heart attacks and strokes are almost entirely preventable! In fact, the basic process of vascular disease, arteriosclerosis and athrosclerosis is largely preventable.
SAMe is a naturally occurring molecule that is part of all living cells, and affect so many different aspects of human biology and pathology being a metabolic helper that is produced during methylation and facilitates nearly all methylation reactions in your body.
As one of the primary methyl group donors, SAMe is extremely important and historically unappreciated. One of its many roles is methylating DNA. When DNA is properly laced with methyl groups, your cells are protected form the abnormal expression of DNA, a behavior associated with disease and aging. Aside from this sole in DNA methylation, SAMe also acts as a natural antidepressant, possibly through its role in creating the neurotransmitter melatonin.
Clinical studies have long shown oral intake of SAMe to have antidepressant effects. Recent clinical studies have also shown it to be very effective in maintaining a healthy liver, and it is even effective in people who already have alcoholic liver cirrhosis. However, perhaps its greatest potential in preventing or delaying serious age-related disease lies in its ability to regulate plasma homocysteine metabolism. High levels of homocysteine, a sulfur-containing amino acid, have been highly correlated with the onset of cardiovascular and cerebrovascular disease. One very important way your body gets rid of homocysteine is to put a methyl group on it and form methionine, which is not harmful. SAMe is a major contributor to this process, and it does this by methylating a substance called tetrahydrofolate, which in turn methylates homocysteine to methionine, SAMe taken orally has been shown to increase levels of methylated tetrahydrofolate in humans, thus potentially decreasing their risk of cerebrovascular (stroke) and cardiovascular disease. This seems logical, when considered with the fact that patients with coronary artery disease have been shown to have significantly lower levels of SAMe than similar individuals without coronary artery disease.
SAMe may also have a role in cancer prevention. In certain types of cancer, reduced methylation of DNA may contribute to loss of the control on genes that control normal cell division. In human, low methylation of DNA has been observed in colorectal cancers and in their adenomatous polyp precursors. Low dietary folate and methionine and high intake of alcohol may reduce levels of SAMe, which as noted previously is required for DNA methylation. Therefore, oral supplementation of SAMe may be prophylactic in individuals at risk for these types of cancers.
Improving the methylation process in the body, SAMe will:
reduce the risk of hearth disease
reduce the risk of cancer
slow or reduce the risk of age-related diseases, including Alzheimer's disease, Parkinson's and Arthritis
reduce the risk of a host of other diseases and conditions including birth defects, liver disease
improve the mood
improve existing ailments such as herpes, diabetes, depression, poor digestion and fatigue
control the weight and increase mass.
SAMe may be administered by different methods. The various methods include oral, rectal, sublingual or buccal, parental inhalation, topical, etc. The choice of method depends upon both convenience and necessity. Obviously, drug substances are most frequently administered orally for access to the systematic circulation by means of solid dosage forms, such as tablets and capsules. Oral administration does not always give rise to sufficiently high plasma concentrations to be effective. Some drugs are absorbed unpredictably or erratically. Patients occasionally have an absorption malfunction.
Fillers and binders comprise the bulk of the contents in SAMe tablets to which most people exhibit adverse side effects, such as headaches, rashes, hives, itching, and upset stomach, while the same vitamin doses when taken as the pure vitamin by injection without fillers or binders does not produce these side effects.
Several doctors who use in their practice, drugs via oral administration have observed many such undesirable reactions, including headache, arthritis, joint pain, chronic fatigue, depression, personality changes, gout attacks, and even chronic earaches and infection in children. It has been discovered that the allergic reactions are generally to table fillers and binders, not to the drugs themselves (though i
Haghighatian Mina
Hartley Michael G.
Malin Haley & DiMaggio, P.A.
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