Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2002-04-19
2004-04-13
Fay, Zohreh (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S561000, C514S578000, C424S449000
Reexamination Certificate
active
06720356
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a composition containing a chelating agent, more particularly to an EDTA complex to be administered in suppository form.
BACKGROUND OF THE INVENTION
Chelating agents are well known organic compounds that are capable of forming complexes of multivalent metal ions. Chelation therapy, involving the administration of EDTA (ethylene diamine tetraacetic acid) complexes for removing arterial calcium plaque, or for removing heavy metals such as lead has been extensively employed. For example, EDTA has been used to remove high levels of lead from the bloodstream of those who have been exposed to lead paint. Intravenous injection of chelators has been widely used for the treatment of atherosclerosis. Intravenous administration may take several hours per session, and several sessions per month for many months. Such a treatment schedule is inconvenient to the patient and health care provider.
Oral chelation therapy is also well known as a more convenient method. However, when administered orally, a very low percentage of the EDTA complex is actually absorbed by the bloodstream.
It is known that EDTA may be administered in a suppository form. Bennett U.S. Pat. No. 5,602,180 relates to a method of administering a disodium EDTA complex in the form of a controlled release suppository. U.S. Pat. No. 5,602,180 is hereby incorporated into this specification by reference.
Disodium EDTA has the disadvantage of raising sodium levels. Sodium stimulates the sympathetic system, causing, among other effects, an increase in blood pressure, pulse pressure, and heart rate. These affects are undesirable in the patient suffering from atherosclerosis, a condition for which EDTA therapy is often prescribed. As sodium increases pulse pressure, the amplitude of the cyclic changes in lumen size and shape are increased. These cyclic changes may lead to the disruption of plaque and subsequent myocardial infarction. See Valentin Fuster, MD, “The Vulnerable Atherosclerotic Plaque” (American Heart Association).
SUMMARY OF THE INVENTION
The present invention provides an alternative to the intravenous injection or oral formulation of EDTA chelating agents. A method of administering EDTA complexes includes forming a suppository containing a magnesium di-potassium EDTA complex. The suppository may also contain a controlled-release agent, which, when used, will release the complex over a period of several hours.
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patent: 5602180 (1997-02-01), Bennett
patent: 6114387 (2000-09-01), Cutler
“Oral Chelation and Nutritional Replacement Therapy for Chemical & Heavy Toxicity and Cardiovascular Disease”, Maile Pouls Townsend Letter, 1999.
Fay Zohreh
Kwon Brian Yong S
LandOfFree
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