Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
1999-03-11
2001-06-12
Prats, Francisco (Department: 1651)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
C514S263370, C514S264110, C514S629000
Reexamination Certificate
active
06245336
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates generally to a method and composition for preventing and/or treating acetaminophen toxicity in a person who has received or is receiving an excessive amount of acetaminophen.
Acetaminophen, or N-acetyl-p-amino phenol,
is a well-known and reliable analgesic commonly used and available without prescription in the United States. Acetaminophen can cause serious damage to liver cells and tissues when an excessive amount is taken. The amount that can lead to this damage varies for individuals based on various factors; for example, lower body weight, past alcoholism, ingestion of acetaminophen with alcohol, or other special sensitivity all can lead to damage from ingestion of amounts of acetaminophen normally not excessive. According to the United States Poison Control Center, thousands of cases of acetaminophen toxicity are reported in the U.S. each year.
Acetaminophen is thought to be metabolized in the liver by cytochrome P-450 enzymes, resulting in highly reactive oxygen free radicals and toxic metabolites, e.g., N-acetyl-&rgr;-benzoquinone imine. These metabolites interact with cellular lipids, protein, DNA, and biological macromolecules, causing cell injury and death. When acetaminophen is taken in a non-excessive amount, these metabolites are cleared by hepatic glutathione stores. Excessive amounts of acetaminophen are thought to deplete these glutathione stores, resulting in hepatic necrosis.
Present methods of treating acetaminophen overdose include induction of vomiting, stomach lavage, and/or administration of acetylcysteine to replenish hepatic glutathione. These methods, while somewhat effective in preventing injury if performed within 24 hours of ingestion of the excess amount, are not preventative measures that can inhibit toxicity from the initial time of ingestion. These methods also usually require assistance of medical personnel, which might not be immediately available, particularly because acetaminophen is available for use without a prescription.
There remains a need for an effective method to prevent and/or reduce acetaminophen toxicity in a convenient manner, without need for medical supervision or assistance. The present invention fulfills this need and provides further related advantages.
SUMMARY OF THE INVENTION
The present invention resides in a method to prevent and/or reduce the effects of acetaminophen toxicity by administering grape seed proanthocyanidin extract (GSPE) to a person in an amount effective to counteract the toxic effects of the acetaminophen, preferably from about 0.1 to about 3 mg of GSPE per kg of body weight. The invention also allows for regular supplementation with GSPE as a prophylactic to protect against acetaminophen toxicity. The GSPE may be administered by various methods, such as orally, intravenously, and intramuscularly, and may be administered before, during, and/or after ingestion of acetaminophen. The present invention is also embodied in a composition comprising acetaminophen and GSPE in sufficient quantity to inhibit acetaminophen toxicity for the amount present in the composition is provided.
Other features and advantages of the present invention should become apparent from the following detailed description of the invention, taken with the illustrative drawings, which illustrate the principles of the invention.
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patent: 5260340 (1993-11-01), Baranowitz
patent: 5474757 (1995-12-01), Yang
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patent: 5670549 (1997-09-01), Baranowitz
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Ray et al., FASEB Journal, vol. 12, No. 5, pp. A779, Mar. 20, 1998.*
I.A. Donatus, Cytotoxic and Cytoprotective Activities Curcumin; Effects on Paracetamol-Induced Cytotoxicity, Lipid Peroxidation and Glutathione Depletion in Rat Hepatocytes, Biochemical Pharmacology, Jun. 15, 1990.
Bagchi Debasis
Ray Siddhartha D.
Coe Susan D.
Dry Creek Nutrition, Inc.
Marshall O'Toole Gerstein Murray & Borun
Prats Francisco
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