Dimetalhydroxy malates

Details Dimetalhydroxy malates Dimetalhydroxy malates

2002-12-04

2004-03-16

Nazario-Gonzalez, Porifirio (Department: 1621)

Organic compounds -- part of the class 532-570 series

Organic compounds

Heavy metal containing

C556S114000, C556S138000, C556S147000, C556S028000, C562S582000, C426S074000

Reexamination Certificate

active

06706904

ABSTRACT:

FIELD OF THE INVENTION
The present invention is drawn to compositions, and methods of making and administering compositions, that can be used for mineral supplementation. More specifically, the present invention is drawn to dimetalhydroxy malates.
BACKGROUND OF THE INVENTION
Magnesium is a mineral that is needed in humans and other warm-blooded animals for bone, protein, and fatty acid formation. Magnesium is also involved in the formation of new cells, activating certain vitamins, relaxing muscles, clotting blood, and forming ATP. People with diabetes often have magnesium levels that are lower than normal compared with those who have normal glucose tolerance. Supplementation of magnesium can help maintain health in some of these areas, as well as help in overcoming some of these problems. Typically, many people do not consume enough magnesium in their diets.
Calcium, on the other hand, is the most abundant mineral in the human body. Of the calcium contained in the average body, about 99% is located in the bones, including the teeth. Calcium is needed to form bones and teeth and is also required for blood clotting, transmission of signals in nerve cells, and muscle contraction. Calcium supplementation is believed to reduce the incidence of osteoporosis.
Choosing a form of magnesium and/or calcium for supplementation has been a source of some confusion in the industry. Calcium carbonate is one form of calcium that is widely used, but is not believed to be absorbed as well as some other forms. Calcium citrate provides a form that is believed to be better absorbed than calcium carbonate. Calcium citrate/malate (CCM) is believed to be absorbed more fully than carbonate as well.
Other divalent minerals, such as zinc, copper, iron, and manganese, are also known to be important to the human diet, and can be administered in a supplemental form. For example, the trace mineral zinc is known to be involved in the transport of vitamin A, taste, wound healing, and fetal development. Zinc also plays a part in the correct functioning of many enzymes, hormones including insulin, genetic material, and proteins. Copper, on the other hand, plays a role in the absorption of iron, and is part of many enzymes. Additionally, iron is necessary for production or hemoglobin and oxygenation of red blood cells, builds up blood quality, and increases resistance as well as increasing energy production. Benefits of manganese include improvement of memory and reflexes, reducing of fatigue, and promoting proper development of thyroid hormones, skeletal, reproductive, and central nervous systems.
Malic acid is a dicarboxylic acid that is naturally occurring. Malic acid plays a role in the complex process of deriving ATP (the energy currency that runs the body) from food. Malic acid is found in a wide variety of fruits (including richly in apples) and vegetables. As malic acid is already found abundantly in humans and other warm-blooded animals, it can be administered without adverse affects. Further, there is some evidence that malic acid supplementation can be helpful to human nutrition.
SUMMARY OF THE INVENTION
It has been recognized that the use of certain complexes can provide a quantity of a bioavailable form of certain nutritionally relevant metals. Specifically, a composition meeting this criterion can have the structure:
wherein M and M′ are each independently a nutritionally relevant divalent metal.
Additionally, a method of administering a high content of a divalent essential metal in a bioavailable form to a warm-blooded animal is also provided. The method comprises the step of administering the composition of Formula 1 to a warm-blooded animal.
In another embodiment, a method of making a bioavailable divalent metal-containing complex, such as that shown in Formula 1, can comprise the step of reacting malic acid with a divalent metal-containing composition at a 1:2 molar ratio, wherein the divalent metal of the divalent metal-containing composition is a nutritionally relevant divalent metal.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)
Before the present invention is disclosed and described, it is to be understood that this invention is not limited to the particular process steps and materials disclosed herein because such process steps and materials may vary somewhat. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only. The terms are not intended to be limiting because the scope of the present invention is intended to be limited only by the appended claims and equivalents thereof.
It is to be noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.
The term “nutritionally relevant metal” or “nutritionally relevant divalent metal” means any divalent metal that can be used as part of a nutritional supplement, is known to be beneficial to humans and other warm-blooded animals, and is substantially non-toxic when administered in traditional amounts, as is known in the art. Examples of such metals include copper, zinc, manganese, iron, magnesium, calcium, and the like.
When referring to a dimetalhydroxy malate (such as dicalciumhydroxy malate, dimagnesium malate, etc.), the “di” portion of the name refers to two
+
M(OH) or metalhydroxy groups, one being complexed to a first carboxyl group of the malate ion, and the other being complexed to a second carboxyl group of the malate ion. Thus, each metal is complexed to the malate ion and is also complexed to its own hydroxy group to charge balance the metal. The metals that can be used include divalent nutritionally relevant metals, and two of the same metal or two different metals can be present at each carboxyl group of the malate ion.
The term “divalent metal-containing composition” shall mean compositions used to react with malic acid to form a dimetalhydroxy malate in accordance with embodiments of the present invention, wherein the metal can be two of the same metal, or two different metals. Elemental divalent metals, divalent metal hydroxides, divalent metal oxides, and divalent metal carbonates are included.
In one embodiment of the present invention, a composition having the structure:
is provided, wherein M and M′ are each independently a nutritionally relevant divalent metal. In other words, M and M′ can be the same divalent metal, or can be different divalent metals. Though any nutritionally relevant divalent metal can be used, calcium, magnesium, copper, zinc, manganese, and iron provide examples of desired metals for use.
The present invention is also drawn toward a method of administering a high content of a metal in a bioavailable form to a warm-blooded animal. In one embodiment, the composition of Formula 1 above can be administered to the warm-blooded animal, such as a human. The administration can be by one of many known administration routes, including oral administration. If formulated for oral delivery or consumption, such a composition can be incorporated into many delivery vehicles, including tablets, capsules, foods, drinks, dry drink mixes, or other substances acceptable for oral consumption. Tablets may be chewable or non-chewable. A food delivery vehicle may be, for example, in the form of food bars or incorporated into dairy products. Drinks may be in the form of sports drinks, fruit drinks, citrus drinks, carbonated drinks, and other suitable drink mediums. Dry drink mixes may be in the form of a fruit mix and/or citrus mix or other particulate drink mixes. No matter what the vehicle of delivery, the compositions of the present invention are very stable, and thus, can be coadministered with many other supplements known in the art. For example, the compositions of the present invention can be coadministered with mineral salts and/or mineral amino acid chelates in drink mixes, supplement tablets or capsules, or food items.
In another embodiment, a method of making a bioavailable divalent metal-containing

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