US Patent On EDTA Suppositories
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| United States Patent | 5,602,180 |
| Bennett | February 11, 1997 |
Method of administering EDTA
complexes
Abstract
A method of administering EDTA complexes includes steps of forming a suppository containing an EDTA complex and controlled-release agents which release the EDTA complex over a period of about three to four hours after placement, and then administering the suppository to a patient in lieu of an intravenous drip.
| Inventors: | Bennett; Ronald (Laughlin, NV) |
| Assignee: | World Health Group (Laughlin, NV) |
| Appl. No.: | 416038 |
| Filed: | March 31, 1995 |
| Current U.S. Class: | 514/578; 424/457; 424/DIG15; 514/964 |
| Intern'l Class: | A01N 037/00; A01J 025/12 |
| Field of Search: | 514/578,667,964 424/DIG. 15,457 562/566 |
References Cited [Referenced By]
U.S. Patent Documents
| 4107331 | Aug., 1978 | Rosenberg | 424/319. |
| 5208324 | May., 1993 | Klaveness et al. | 534/16. |
| 5281704 | Jan., 1994 | Love et al. | 540/465. |
Primary Examiner: Nutter; Nathan M.
Attorney, Agent or Firm: Shoemaker and Mattare, Ltd.
Claims
I claim:
1. A method of administering EDTA complexes to a patient, said
method comprising steps of
forming a suppository containing disodium EDTA and
controlled-release agents which release the disodium EDTA over a
period of about three to four hours after placement in the anus, and
then
administering the suppository to the patient.
2. A suppository for chelation therapy, said
suppository comprising an inert meltable carrier containing
dissolved or suspended disodium EDTA and a controlled-release matrix
for releasing the complexes into the body over a period of three to
four hours after anal administration of the suppository.
Description
BACKGROUND OF THE INVENTION
This invention relates to the art of medicine and more particularly
to a method of administering EDTA complexes.
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 and mercury, has
been practiced for many years. It is normally administered
intravenously to a patient, who must remain relatively immobile for
about three and a half to four hours each session. The normal
schedule is three sessions a week for three months. Such frequent
immobilization inconveniences the patient, and requires considerable
dedicated floor space at the administration facility. An alternative
method of administration would be preferred by many doctors and
patients.
Oral ingestion of EDTA is impractical, inasmuch as stomach acids
destroy its effectiveness.
[Karl Note:
Notice this completely false claim in the Patent!]
I have discovered that EDTA can be administered in other ways,
especially rectally, in suppository form, provided
that the EDTA is bound in a container, matrix or vehicle which
releases it slowly, over a period of hours.
Prior inventors have developed suppositories with time-release
capability for other medications. The materials employed vary.
Usually, the bulk of the suppository is an inert waxy
carrier in which the medication is dissolved or suspended. Early
suppositories used a material, such as gelatin, which dissolved
slowly in the intestine. More recently, synthetic polymers have been
used, as have metal salts in a matrix which regulates the release of
medication. 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. All the patents identified in the preceding
sentence are hereby incorporated in this specfication by reference.
SUMMARY OF THE INVENTION
An object of the invention is to reduce the amount of time that a
patient must remain in a physician's office to receive chelation
therapy.
Another object of the invention is to make it possible for a patient
to administer EDTA complexes to himself at any convenient time, such
as before retiring.
A further object of the invention is to increase the efficiency of
chelation therapy practice.
These and other objects are attained by a method of administering
EDTA complexes comprising steps of forming a suppository
containing EDTA complexes and controlled-release agents which
release the EDTA complexes over a period of about three to four
hours after placement, and then administering the suppository
to a patient in lieu of an intravenous drip.
Alternatively, the invention can be practiced transdermally, for
example in patch form.
[Karl Note: Notice that the entire effectiveness of this product is based on the claim that an EDTA suppository will allow about 100% absorption into the blood stream. Yet, this patent makes no claim for such an absorption rate, and the idea that a "patch" would also allow absorption of the EDTA through the skin is not logical -- since the promoters claim that the EDTA cannot be absorbed through the mouth!]
[Karl note: Also, note this result from a study of absorption of EDTA from HERE:
The metabolism of EDTA labeled with 14CaC-EDTA spreads rapidly from the vascular system and is not concentrated in any tissue. The compound is rapidly and totally excreted through the kidneys, and after six house 95% to 98% of the dose ids found in the urine. The compound is poorly absorbed by the gastrointestinal tract (in the rat a maximum of 18%; in man a maximum of 5%) and not at all through the skin. The low intestinal absorption of CaNa2EDTA has been confirmed by Srbová and Teisinger (1957), who found only 16.6% and 2.6% was absorbed in the rat and in man respectively. (source) ]
It is expected that either dosage form will greatly reduce the number of office visits for patients, who may need to visit a facility only once a month for blood and urine chemistry and perhaps thermography or Doppler tests to evaluate vessel occlusion. I anticipate also that daily dosages can be reduced from their current level, as it will be convenient to extend the treatment session duration from three to six months.
DESCRIPTION OF THE PREFERRED EMBODIMENT
A therpeutic method according to the invention comprises steps of forming an EDTA complex containing suppository with a controlled release matrix. The presently preferred complex is disodium EDTA. 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 glycerin, glyceryl monopalmitate, glyceryl monostearate, hydrogenated coconut oil fatty acids and hydrogenated palm kernel oil fatty acids. The choice of base materials is a matter of ordinary skill.
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, making reference to the patents mentioned above, and others. The release-controlling agents, and their concentrations, should be chosen so that release occurs within the body over a three to four hour period after the suppository is administered.
Since the invention is subject to modifications and variations, it is intended that the foregoing description and the accompanying drawings shall be interpreted as only illustrative of the invention defined by the following claims.
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