US20040143019A1 - Magnesium di-potassium EDTA complex and method of administration - Google Patents

Magnesium di-potassium EDTA complex and method of administration Download PDF

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Publication number
US20040143019A1
US20040143019A1 US10754063 US75406304A US2004143019A1 US 20040143019 A1 US20040143019 A1 US 20040143019A1 US 10754063 US10754063 US 10754063 US 75406304 A US75406304 A US 75406304A US 2004143019 A1 US2004143019 A1 US 2004143019A1
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Prior art keywords
suppository
magnesium di
potassium edta
edta complex
edta
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Abandoned
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US10754063
Inventor
Spencer Feldman
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Spencer Feldman
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic, hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic, hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
    • A61K31/198Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0031Rectum, anus

Abstract

A composition containing an EDTA complex in the form of a suppository is provided. More specifically, the EDTA complex is a magnesium di-potassium EDTA complex. The suppository may contain a controlled release agent which will release the EDTA complex over a period of several hours.

Description

  • This application claims priority under 35 U.S.C. §119 from provisional patent application serial No. 60/285,546, filed Apr. 20, 2001, which is hereby incorporated by reference in its entirety.[0001]
  • FIELD OF THE INVETION
  • The present invention relates to a composition containing a chelating agent, more particularly to an EDTA complex to be administered in suppository form. [0002]
  • 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. [0003]
  • 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. [0004]
  • 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. [0005]
  • 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). [0006]
  • 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.[0007]
  • DETAILED DESCRIPTION OF THE INVENTION
  • According to this invention, a suppository is formed of magnesium di-potassium EDTA complex and a matrix, which may or may not contain a time release agent. The magnesium di-potassium EDTA complex may be obtained from Fluka of Switzerland as EDTA dipotassium magnesium salt monohydrate or EDTA dipotassium magnesium salt (product No. 40694). It can also be in the anhydrous form. The suppository is molded in a common shape from a waxy material in which the active ingredients have been dissolved or suspended. The base material may comprise cocoa butter, glycerin, glyceryl, monopalmitate, glyceryl monostearate, hydrogenated coconut oil fatty acids and hydrogenated palm kernel oil fatty acids or polyethylene glycol. The choice of base material is a matter of ordinary skill. [0008]
  • Methods of making controlled release suppositories are well known. Choosing suitable carrier materials, and suitable matrix ingredients, are within the skill of the artisan in this field. Representative prior U.S. patents include U.S. Pat. Nos. 4,265,875, 4,292,300, 4,406,883, 5,151,434, 5,188,840, 5,215,758, 5,352,455, and 5,393,528. The foregoing patents are hereby incorporated into this specification by reference. The release-controlling agents, and their concentrations, should be chosen so that release occurs within the body over a one to four hour period after the suppository is administered. [0009]
  • In addition to avoiding the above mentioned disadvantages of disodium EDTA, the invention provides other advantages as well. Magnesium suppresses the sympathetic system and potassium stimulates the parasympathetic system. Thus the complex of the present invention may lower blood pressure, pulse and coronary blood flow. The magnesium di-potassium EDTA complex can also be used as a form of magnesium or potassium supplementation. [0010]
  • A magnesium di-potassium EDTA complex as described can also be administered orally to supplement magnesium and potassium levels. The complex also can be administered orally to treat arterial plaque and heavy metal toxicity. [0011]

Claims (4)

    I claim:
  1. 1. A method of administering a magnesium di-potassium EDTA complex to a patient, comprising the steps of:
    (a) forming a suppository containing magnesium di-potassium EDTA and
    (b) administering said suppository to the patient.
  2. 2. The method of claim 1, wherein the suppository contains controlled release agents which release the magnesium di-potassium EDTA over a period of about one to four hours after placement in the anus.
  3. 3. A suppository for chelation therapy, said suppository comprising an inert meltable carrier containing dissolved or suspended magnesium di-potassium EDTA.
  4. 4. The suppository of claim 3, wherein the magnesium di-potassium EDTA is dissolved or suspended in a controlled release matrix for releasing the complexes in the body over a period of about one to four hours after anal administration of the suppository.
US10754063 2001-04-20 2004-01-07 Magnesium di-potassium EDTA complex and method of administration Abandoned US20040143019A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US28554601 true 2001-04-20 2001-04-20
US10124763 US6720356B2 (en) 2001-04-20 2002-04-19 Magnesium di-potassium EDTA complex and method of administration
US10754063 US20040143019A1 (en) 2001-04-20 2004-01-07 Magnesium di-potassium EDTA complex and method of administration

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US10754063 US20040143019A1 (en) 2001-04-20 2004-01-07 Magnesium di-potassium EDTA complex and method of administration

Related Parent Applications (1)

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US10124763 Division US6720356B2 (en) 2001-04-20 2002-04-19 Magnesium di-potassium EDTA complex and method of administration

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US20040143019A1 true true US20040143019A1 (en) 2004-07-22

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US10124763 Active US6720356B2 (en) 2001-04-20 2002-04-19 Magnesium di-potassium EDTA complex and method of administration
US10754063 Abandoned US20040143019A1 (en) 2001-04-20 2004-01-07 Magnesium di-potassium EDTA complex and method of administration

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WO (1) WO2002085789A3 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6720356B2 (en) * 2001-04-20 2004-04-13 Spencer Feldman Magnesium di-potassium EDTA complex and method of administration
US7563460B2 (en) * 2004-02-26 2009-07-21 Med Five, Inc. Enteric coated oral pharmaceutical to erode kidney stones

Citations (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2781291A (en) * 1953-08-21 1957-02-12 Dow Chemical Co Magnesium chelate of ethylenediaminetetraacetic acid for treatment of hypertension
US3184381A (en) * 1961-02-28 1965-05-18 Ashmead Harvey Urinary calculi treating compositions and methods of using same
US3838196A (en) * 1972-09-25 1974-09-24 J Mercer Method of treating arteriosclerosis
US4191196A (en) * 1976-06-15 1980-03-04 American Medical Systems, Inc. Profilometry method and apparatus
US4196196A (en) * 1978-06-19 1980-04-01 Tiholiz Ivan C Divalen/monovalent bipolar cation therapy for enhancement of tissue perfusion and reperfusion in disease states
US4265875A (en) * 1976-07-23 1981-05-05 Inveresk Research International Controlled release suppositories
US4344940A (en) * 1981-11-30 1982-08-17 E. R. Squibb & Sons, Inc. Steroid formulation containing dipotassium EDTA
US4372858A (en) * 1979-08-29 1983-02-08 Tetra Werke Dr. Rer. Nat. Ulrich Baensch Gesellschaft Mit Beschrankter Haftung Method of regenerating ion exchangers
US4406883A (en) * 1976-07-23 1983-09-27 Merrell Dow Pharmaceuticals Inc. Controlled release suppositories consisting essentially of a linear polymer particularly, polyvinyl pyrrolidones
US5114974A (en) * 1991-01-30 1992-05-19 Martin Rubin Treatment of atherosclerosis with MgNa2 EDTA
US5151434A (en) * 1984-03-14 1992-09-29 Kyorin Seiyaku Kabushiki Kaisha Controlled-release composition and the preparation thereof
US5155096A (en) * 1987-06-15 1992-10-13 Garcia Y Bellon Donato P Method for potentiation of a therapeutic agent
US5188840A (en) * 1985-09-26 1993-02-23 Chugai Seiyaku Kabushiki Kaisha Slow-release pharmaceutical agent
US5215758A (en) * 1991-09-11 1993-06-01 Euroceltique, S.A. Controlled release matrix suppository for pharmaceuticals
US5352455A (en) * 1991-01-23 1994-10-04 British Technology Group Ltd. Controlled release compositions
US5393528A (en) * 1992-05-07 1995-02-28 Staab; Robert J. Dissolvable device for contraception or delivery of medication
US5602180A (en) * 1995-03-31 1997-02-11 World Health Group Method of administering EDTA complexes
US5602196A (en) * 1994-12-05 1997-02-11 Ciba-Geigy Corporation Bisphenol ester derivatives
US6144387A (en) * 1998-04-03 2000-11-07 Liu; Mei-Chi Guard region and hither plane vertex modification for graphics rendering
US6720356B2 (en) * 2001-04-20 2004-04-13 Spencer Feldman Magnesium di-potassium EDTA complex and method of administration

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6114387A (en) 2000-02-16 2000-09-05 Cutler; Paul Pharmaceutical composition for oral administration of chelating agents

Patent Citations (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2781291A (en) * 1953-08-21 1957-02-12 Dow Chemical Co Magnesium chelate of ethylenediaminetetraacetic acid for treatment of hypertension
US3184381A (en) * 1961-02-28 1965-05-18 Ashmead Harvey Urinary calculi treating compositions and methods of using same
US3838196A (en) * 1972-09-25 1974-09-24 J Mercer Method of treating arteriosclerosis
US4191196A (en) * 1976-06-15 1980-03-04 American Medical Systems, Inc. Profilometry method and apparatus
US4292300A (en) * 1976-07-23 1981-09-29 Inveresk Research International Controlled release suppositories
US4265875A (en) * 1976-07-23 1981-05-05 Inveresk Research International Controlled release suppositories
US4406883A (en) * 1976-07-23 1983-09-27 Merrell Dow Pharmaceuticals Inc. Controlled release suppositories consisting essentially of a linear polymer particularly, polyvinyl pyrrolidones
US4196196A (en) * 1978-06-19 1980-04-01 Tiholiz Ivan C Divalen/monovalent bipolar cation therapy for enhancement of tissue perfusion and reperfusion in disease states
US4372858A (en) * 1979-08-29 1983-02-08 Tetra Werke Dr. Rer. Nat. Ulrich Baensch Gesellschaft Mit Beschrankter Haftung Method of regenerating ion exchangers
US4344940A (en) * 1981-11-30 1982-08-17 E. R. Squibb & Sons, Inc. Steroid formulation containing dipotassium EDTA
US5151434A (en) * 1984-03-14 1992-09-29 Kyorin Seiyaku Kabushiki Kaisha Controlled-release composition and the preparation thereof
US5188840A (en) * 1985-09-26 1993-02-23 Chugai Seiyaku Kabushiki Kaisha Slow-release pharmaceutical agent
US5155096A (en) * 1987-06-15 1992-10-13 Garcia Y Bellon Donato P Method for potentiation of a therapeutic agent
US5352455A (en) * 1991-01-23 1994-10-04 British Technology Group Ltd. Controlled release compositions
US5114974A (en) * 1991-01-30 1992-05-19 Martin Rubin Treatment of atherosclerosis with MgNa2 EDTA
US5215758A (en) * 1991-09-11 1993-06-01 Euroceltique, S.A. Controlled release matrix suppository for pharmaceuticals
US5393528A (en) * 1992-05-07 1995-02-28 Staab; Robert J. Dissolvable device for contraception or delivery of medication
US5602196A (en) * 1994-12-05 1997-02-11 Ciba-Geigy Corporation Bisphenol ester derivatives
US5602180A (en) * 1995-03-31 1997-02-11 World Health Group Method of administering EDTA complexes
US6144387A (en) * 1998-04-03 2000-11-07 Liu; Mei-Chi Guard region and hither plane vertex modification for graphics rendering
US6720356B2 (en) * 2001-04-20 2004-04-13 Spencer Feldman Magnesium di-potassium EDTA complex and method of administration

Also Published As

Publication number Publication date Type
WO2002085789A3 (en) 2003-02-20 application
WO2002085789A2 (en) 2002-10-31 application
US6720356B2 (en) 2004-04-13 grant
US20020169211A1 (en) 2002-11-14 application

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