Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2000-09-12
2003-06-24
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S400000, C426S072000, C426S074000
Reexamination Certificate
active
06582722
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to unique calcium, magnesium and potassium chelates and a method and use of such chelates for the supplementation of essential minerals in the human diet.
BACKGROUND OF THE INVENTION
The public is becoming increasingly aware of the role of nutrition in the maintenance of health. The science of nutrition deals with the processes by which food and its components are made available to and assimilated within the human system to help it meet the energy requirements needed to keep the body in an optimum functional state. Although overall nutrition is important, the levels of bioavailable calcium, magnesium and potassium in the daily diet affects healthy bone growth, muscle function, cardiac function, blood clotting, blood pressure, heart rhythm, permeability of cell membranes, acid-base balance and CO2 transport. The following summary illustrates the importance of having proper levels of these essential minerals to maintain human health:
Element &
Manifest-
Total Amt In
Absorption &
Metabolic
ation of
Human Body
RDA
Metabolism
Functions
Deficiency
CALCIUM
1000 mg
Poorly ab-
Formation of
Rickets
(22 gm/Kg)
sorbed from
bones, teeth
(children),
foods
blood clot-
Osteo-
(20%-40%)
ting, cardiac
porosis,
Absorption
function,
High
from milk en-
neuro-
Blood
hanced by Vit
muscular
Pressure
D, lactose &
irritability.
acidity. Ab-
sorption
hindered by
excessive fats,
phytates,
oxalates
MAGNESIUM
350 mg
Absorbed
Decrease
Muscular
(male)
readily from
neuro-
Tremor,
390 mg
some foods.
muscular
Con-
(female)
Needed by
irrit-
fusion,
Calcium to en-
ability.
Vaso-
hance transport
Co-factor
irritability.
for
PO
4
trans-
ferring
enzymes.
POTASSIUM
1.9-5.6 gm
Readily ab-
Acid-base
Acidosis,
sorbed from
balance
Renal
some foods.
Water
Damage,
balance. CO
2
Cardiac
Transport
Arrest
Neuro-
muscular
irritability.
Unless expressly stated otherwise, as used herein, all liquid components are measured in liters or fractions thereof and all solid components are measured in grams or fractions thereof.
A major problem exists in North America for adults and youth eat increasingly routine amounts of fast foods that contain high amounts of fats, sodium and phosphates. These compete and interfere with calcium, magnesium and potassium absorption and create deficiencies in the daily amounts of these minerals that are bioavailable for essential use by the human body.
What is needed and what we have invented is a chelate formed between calcium and picolinic acid and/or between magnesium and picolinic acid and/or a complex formed between potassium and picolinic acid.
SUMMARY OF THE INVENTION
In its broadest aspect, the calcium, magnesium and potassium chelates of the invention have a selective rate of absorption and provide calcium, magnesium and potassium supplements which have a high bioavailability in the human system.
Picolinic acid is a mono-carboxylic acid formed naturally during the metabolism of tryptophan by what is known as the Kynurenine pathway. The Kynurenine pathway is comprised of two major degradation pathways as is well known in the art. Each pathway produces different intermediate and end products.
Tryptophan is an essential amino acid in the human system. During metabolism it forms many intermediates depending on which of the two major degradation pathways it follows in the Kynurenine pathway. One of the intermediates produced is picolinic acid.
Picolinic acid from animal source may be used to form an amino acid chelate with calcium, magnesium or potassium. In the case of calcium or magnesium, one or more donor atoms from picolinic acid (the ligand) combines with the metal ion through the process of coordinate covalent bonding to form a ring-like molecule (metal ion chelate). In the case of potassium, instead of a chelate, a metal complex is formed. In this case a heterocyclic ring is not created but the same coordinate bond exists. The difference between the calcium or magnesium picolinic acid chelate and the potassium picolinic acid complex is that in the case of the complex, two donor atoms within the ligand molecules do not bond potassium.
When the disclosed chelate between calcium, magnesium or potassium and picolinic acid is ingested and passes through the stomach and intestines (the ionic absorption sites are in the intestines), the calcium, magnesium or potassium is protected from entering into the multitude of chemical reactions which are normal for minerals derived from the ingestion of soluble salts. The result is a much higher absorption of the calcium, magnesium or potassium that has been chelated to picolinic acid.
DESCRIPTION OF THE ILLUSTRATED EMBODIMENT
The calcium picolinate composition of this invention is designed to be added to a food per 2 oz. serving of from about 0.001 mg. to about 10,000 mg. and/or added to a beverage per 2 oz. serving of from about 0.001 mg. to about 10,000 mg. and/or added to a pharmaceutical preparation per mg. of from about 0.001 mg. to about 10,000 mg. and/or taken as a dietary supplement from about 0.001 mg. to about 10,000 mg. This calcium picolinate preparation will therefore provide a source of nutritional calcium with high bioavailability.
The magnesium picolinate composition of this invention is designed to be added to a food per 2 oz. serving of from about 0.001 mg. to about 10,000 mg. and/or added to a beverage per 2 oz. serving of from about 0.001 mg. to about 10,000 mg. and/or added to a pharmaceutical preparation per mg. of from about 0.001 mg. to about 10,000 mg. and/or taken as a dietary supplement from about 0.001 mg. to about 10,000 mg. This magnesium picolinate preparation will therefore provide a source of nutritional magnesium with high bioavailability.
The potassium picolinate composition of this invention is designed to be added to a food per 2 oz. serving of from about 0.001 mg. to about 10,000 mg. and/or added to a beverage per 2 oz. serving of from about 0.001 mg. to about 10,000 mg. and/or added to a pharmaceutical preparation per mg. of from about 0.001 mg. to about 10,000 mg. and/or taken as a dietary supplement from about 0.001 mg. to about 10,000 mg. This potassium picolinate preparation will therefore provide a source of nutritional potassium with high bioavailability.
These particular chelates or in the case of potassium, a complex, are non-toxic, tightly bound, non-irritating to the buccal cavity, alimentary canal, gastric mucosa or intestinal tract. These particular chelates, or in the case of potassium, the complex, do not impede the absorption of water from the intestinal tract. They are easily absorbed and are quickly transferred to the tissues whereupon any released calcium ions, magnesium ions and/or potassium ions, enter the cells to replace calcium, magnesium and/or potassium, respectively, which may have been depleted. The amino acid (picolinic acid) is then excreted in the urine. These chelate and complex substances are physiologically compatible with the systems of humans.
Our invention will be illustrated by the following suggested examples that are given by way of illustration only. All parameters submitted in these examples are not to be construed to unduly limit the scope of this invention.
It is to be appreciated that some tests applicable to human beings yield results which at best give merely qualitative results due to the subjective sensations of the human subjects. It is further to be appreciated that subjective sensations may vary so substantially from individual to individual that it is difficult to delineate well defined, quantitative results. Nevertheless, though test results are evidence of subjective sensations, it is believed they are of objective value it unanimously elicited from a large number (e.g. 100 or more) of human subjects from different ethnic backgrounds and age groups.
REFERENCES:
patent: 4212893 (1980-07-01), Takahata
patent: 4264638 (1981-04-01), Sirett et al.
patent: 4460616 (1984-07-01), Rialland et al.
patent: 4737375 (1988-04-01), Nakel et al.
patent: 4738856 (1988-04-01), Clark
patent: 4804552 (1989-02-01), Ahmed
patent: 4842884
Clark George H.
Clark Mary Ann
Evans Charesse
Lorusso Loud & Kelly LLP
Mac Farms Inc.
Page Thurman K.
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