Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2000-03-27
2002-06-18
Raymond, Richard L. (Department: 1624)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S547000
Reexamination Certificate
active
06407141
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention is directed to oxalic acid or oxalate compositions and methods of producing such compositions and for the utilization of oxalic acid or oxalate compositions, including solutions, mixtures, products, rinses, and carriers in the treatment, control, remedy, and prevention of vascular disorders, diseases, and calcerous conditions in patients.
Conventional medicine treats vascular disorders, diseases, and calcerous conditions with cholesterol lowering drugs, diet, and exercise programs, as well as life style changes such as quitting smoking. Coronary artery bypass surgery is preformed when conditions are not suited to artery angioplasty. Angiography is used to determine which invasive treatment may be feasible. There has recently been developed a new procedure involving the placement of stints in restricted arteries.
The cause of Alzheimer's disease is currently not known, and treatment is limited to drugs that may slow the progression of the disease.
In the case of vascular disease, artherosclerosis plaque develops in the arteries causing blockage. Plaque results when calcification takes place in the cholesterol developed gummy substances in the inner lining of the arteries.
Recent news articles reveal researchers suspect that formation of plaque in the brain interferes with normal activity.
In the early stages of research and development of the parent patent, U.S. application Ser. No. 08/629,538, filed Apr. 9, 1996, now U.S. Pat. No. 6,133,317, the inventor became aware of the decalcifying effect of oxalic acid on calcerous matter.
Oxalic acid or ethanedioic acid (C
2
H
2
O
4
) is a dicarboxylic acid and is present in many plants and vegetables, notably in those of the Oxalis and Rumex families, where it often occurs in the cell sap of the plants as the potassium or calcium salt (oxalate, Tables I-IV). Oxalic acid is also a product of the metabolism of many molds. Several species of Penicillum and Aspergillus convert sugar into calcium oxalate with a 90 percent yield under optimum conditions. Oxalic acid is also made by passing carbon monoxide into concentrated NaOH or heating sodium formate in the presence of NaOH.
Oxalic acid dihydrate, monoclinic tablets, prisms, and granules are considered poisonous. Anhydrous oxalic acid is crystallized from glacial acetic acid and is orthorhombic with the crystals being pyramidal or elongated octahedral.
Oxalic acid is listed as being caustic and corrosive to the skin and mucous membranes. Ingestion may cause severe gastroenteritis, with vomiting, diarrhea, or melena. Renal damage can occur as a result of formation of excessive calcium oxalate crystals. Convulsions, coma, or death from cardiovascular collapse can also occur.
Conventional uses of oxalic acid include as an analytical reagent, in calico printing and dying, for bleaching straw and leather, removing paint or varnish, rust or ink stains, cleaning wood, and manufacturing oxalates, blue ink, celluloid, intermediates and dyes, in metal polishes, in purifying methanol, for decolorizing crude gycerol, for stabilizing hydrocyanic acid, as a general reducing agent, in ceramics and pigments, in metallurgy as a cleanser, in the paper industry, in photography, in process engraving, in rubber manufacturing, in making glucose from starch, as a condensing agent in organic chemistry, and a veterinary hemostatic agent when mixed in 5 percent solution with 5 percent malonic acid.
As described in “Oxalic Acid in Biology and Medicine” by A. Hodgkinson, 1977, oxalic acid was formerly used intravenously as a hemostatic agent and topically as an antiseptic in man and other animals but this was discontinued because of its toxicity and the danger of precipitating insoluble calcium oxalate in the tissues. Oxalic acid is a relatively strong acid having a first dissociation constant being exceeded by that of only a few halogen-substituted carboxylic acids. Oxalic acid forms neutral and acid salts with monovalent metals and ammonia. Oxalic acid forms a number of oxalates or salts including calcium oxalate, potassium oxalate, sodium oxalate, strontium oxalate, magnesium oxalate, and the like. Oxalic acid also inhibits the activity of a number of enzymes possibly due to the competition between oxalate and a structurally similar substrate of the enzyme. Precipitation as the calcium salt is the classical method of separating oxalic acid from other substances. Although calcium oxalate is generally considered to be an insoluble salt this is a relative term and its solubility in water is actually 6-7 mg/l at room temperature. Biological fluids contain many substances that affect the solubility or rate of crystallization of calcium oxalate or co-precipitate with the salt For example, magnesium, polyphosphates and other polyelectrolytes affect the solubility or rate of crystallization of calcium oxalate while phosphate and sulphate ions, uric acid and citric acid co-precipitate with the salt.
Further, as reported in a literature including “Oxalic Acid in Biology and Medicine”, poisoning from oxalic acid in animals and man has been recognized since the beginning of the 19
th
Century. The death rate from oxalate poisoning has declined supposedly because of a decreased use of oxalic acid in domestic cleaning fluids. Examples of chronic poisoning by absorption of oxalic acid through the skin and by inhalation have been reported. The range of lethal doses in acute poisoning is wide, varying between 2 and 30 g and depending upon a variety of factors such as the form in which the acid or its salt is taken and the amount of food, particularly calcium, which is present in the stomach and intestine. Death has occurred as early as 3 minutes and as late as 14 days after ingestion. Symptoms of acute oxalic acid toxicity in man can be divided into those caused by a local corrosive action and those resulting from absorption and excretion of the soluble oxalate. If a high concentration or the solid form is taken, the local effects may be predominant and death may result from acute hemorrhagic gastroenteritis without development of symptoms depending on absorption. If death does not result from local corrosive action then symptoms develop from the systemic effects and from renal insufficiency. The cardiovascular, neuromuscular and central nervous systems are markedly affected. The skin is pale, cold and clammy, the pulse is weak and the blood pressure and temperature are low. Numbness and tingling may develop in the extremities and cramp-like muscular and abdominal pain may be extremely severe. Local or generalized muscular twitching occur and may progress to marked tetany and convulsive seizures. The central nervous system may show evidence of excitation or depression, varying from an acute maniacal state to stupor and coma. Death results from cardiovascular collapse or depression of the central nervous system. Renal involvement is frequent and even if the patient survives the severe local or systemic effects, death may ultimately occur from renal insufficiency, which dominates the picture from the second day. Oliguria develops and may progress to anuria. Hence, there is a need for oxalic acid or oxalate compositions and methods of producing such compositions and for treating, preventing, impeding, retarding, delaying, and controlling vascular disorders, diseases, and calcerous conditions in patients.
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