Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2001-03-29
2003-01-28
Reamer, James H. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
Reexamination Certificate
active
06511964
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to compositions and methods for treating acute mountain sickness.
BACKGROUND OF THE INVENTION
It is well known that the energy coinage of the cell is adenosine triphosphate (ATP). During anabolism, the energy derived from the metabolism of nutrients is transferred to high energy phosphate bonds of ATP. The energy in these bonds is expended during the energy consumption phase. An important and “costly” expenditure, in which ATP is rapidly cycled, is that required for muscular contraction.
The energy buildup steps occur within the muscle cell during two basic processes. Oxidative phosphorylation replenishes ATP by the breakdown of circulating fatty acids, glucose and intramuscular glycogen and triglycerides. Anaerobic phosphorylation provides ATP from creatine phosphate, circulating glucose and intramuscular glycogen via kinase reactions such as the myokinase reaction.
In the synthesis of ATP via the nucleotide salvage pathway, the nucleotide precursors that may be present in the tissue are converted to AMP and further phosphorylated to ATP. Adenosine is directly phosphorylated to AMP, while xanthine and inosine are first ribosylated by 5-phosphoribosyl-1-pyrophosphate (PRPP) and then converted to AMP. Ribose is found in the normal diet only in very low amounts, and is synthesized within the body by the pentose phosphate pathway. In the de novo synthetic pathway, ribose is phosphorylated to PRPP, and condensed with adenine to form the intermediate adenosine monophosphate (AMP.) AMP is further phosphorylated via high energy bonds to form adenosine diphosphate (ADP) and ATP. During energy consumption, ATP loses one high energy bond to form ADP, which can be hydrolyzed to AMP. AMP and its metabolites adenine, hypoxanthine and inosine are freely diffusible from the muscle cell and may not be available for resynthesis to ATP via the salvage pathway.
In U.S. Pat. No. 4,719,201, it is disclosed that when ATP is hydrolyzed to AMP in cardiac muscle during ischemia, the AMP is further metabolized to adenosine, inosine and hypoxanthine, which are lost from the cell upon reperfusion. In the absence of AMP, rephosphorylation to ADP and ATP cannot take place. Since the precursors were washed from the cell, the nucleotide salvage pathway is not available to replenish ATP levels. It is disclosed that when ribose is administered via intravenous perfusion into a heart recovering from ischemia, recovery of ATP levels is enhanced.
The availability of PRPP appears to control the activity of both the salvage and de novo pathways, as well as the direct conversion of adenine to ATP. Production of PRPP from glucose via the pentose phosphate pathway appears to be limited by the enzyme glucose-6-phosphate dehydrogenase (G6PDH). Glucose is converted by enzymes such as G6PDH to ribose-5-phosphate and further phosphorylated to PRPP, which augments the de novo and salvage pathways, as well as the utilization of adenine. The addition of ribose bypasses this rate limiting enzymatic step.
Many conditions produce hypoxia. Such conditions include acute or chronic ischemia when blood flow to the tissue is reduced due to coronary artery disease or peripheral vascular disease where the artery is partially blocked by atherosclerotic plaques. Transient hypoxia frequently occurs in individuals undergoing anesthesia and/or surgical procedures in which blood flow to a tissue is temporarily interrupted. Peripheral vascular disease can be mimicked in intermittent claudication where temporary arterial spasm causes similar symptoms.
Persons encountering high altitudes or the effective high altitude conditions of air travel, may become hypoxic. They are additionally subjected to low atmospheric pressure. The combination of these two conditions results in Acute Mountain Sickness (AMS). Headache is perhaps the most common symptom of AMS. Headache may be accompanied by lethargy and in extreme cases, potentially fatal cerebral edema. Lung tissue is also affected. Shortness of breath is common and potentially fatal pulmonary edema can occur. Many subject experience nausea. If the symptoms are severe, the person must be taken immediately to lower altitudes and may require hospitalization. If the symptoms are mild, the person may choose to tolerate the discomfort.
A continuing need exists for compositions and methods to alleviate or prevent the symptoms of acute mountain sickness.
SUMMARY OF THE INVENTION
The present invention provides compositions for, and methods to, alleviate or prevent the symptoms of acute mountain sickness, which include headache, nausea, lethargy and pulmonary edema with associated shortness of breath and cough. It is believed that the present compositions and methods allow mammals to tolerate situations in which, absent the present compositions and methods, the mammal would experience the onset of symptoms of AMS. The preferred compositions include D-Ribose alone or, optionally, in combination with other energy pathway intermediates, oxygenating substances or pharmaceuticals in pharmaceutically acceptable carriers.
It is here shown that the administration of ribose will alleviate or prevent the symptoms of AMS. Ribose is preferably administered before and during exposure to high altitudes or simulated high altitudes. Preferably, ribose is administered fifteen minutes before exposure to high altitude and two or three times a day until the subject is acclimated to high altitudes. The usual subject becomes acclimated in about five days and ribose can be discontinued at that time. If symptoms re-occur, ribose administration should be re-instituted. Many subjects may choose to take ribose throughout their stay at high altitudes. Ribose is administered in single doses of 0.5 to 30 grams, preferably in doses of three to ten grams, and most preferably in a dose of five grams. The ribose can be administered in any convenient form, such as dissolved in water, added to a soft drink, sprinkled on dry food or incorporated into bars.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides a method of alleviating the symptoms of acute mountain sickness (AMS) of a human, by the oral, intravenous or peritoneal administration of and effective amount of ribose to said human. AMS commonly occurs in persons going abruptly from near sea level to a higher elevation. Depending on individual susceptibility, AMS can occur at relatively low altitudes. Persons who are exposed to, for example, carbon monoxide from smoking, or persons with preexisting conditions such as asthma are among those groups that are particularly susceptible to AMS. Altitudes above about 1,000 meters are at significantly lower oxygen tension and atmospheric pressure than at sea level and such more susceptible persons may begin experiencing AMS at this altitude. At altitudes between 1,500 and 3,000 meters, up to 25% of unacclimatized travelers experience AMS. At higher altitudes, both the incidence and severity of AMS increase.
AMS is characterized by a constellation of symptoms. Headache is the main symptom. Nausea, vomiting, dyspnea, insomnia, lethargy, loss of energy, impaired cognition and balance. The onset of symptoms typically occurs within hours to three days after arrival at the high altitude. These symptoms may resolve after several days, but can lead to fatal conditions of cerebral edema and pulmonary edema. Even those experiencing no or minimal symptoms at rest will be more affected if they attempt to exercise.
Travelers who are able to acclimatize gradually, preferably at several stages of increasing altitude, are less affected by AMS. If slow acclimatization is not possible, several medications have been used for the prevention or amelioration of AMS. Acetazolamide is a carbonic anhydrase inhibitor, which creates a metabolic acidosis due to a renal loss of bicarbonate and an inhibition of red blood cell enzymes with a retention of carbon dioxide. If acetazoamide is taken daily, starting three days before reaching altitude, sleep is improved, exercise performance is improved and higher
Butler Terri L.
Cyr John St.
Johnson Clarence A.
Bioenergy Inc.
Reamer James H.
Schwegman Lundberg Woessner & Kluth P.A.
LandOfFree
Method for treating acute mountain sickness does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method for treating acute mountain sickness, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method for treating acute mountain sickness will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3007441