Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Heavy metal or compound thereof
Reexamination Certificate
2002-12-10
2004-11-09
Page, Thurman K. (Department: 1616)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Heavy metal or compound thereof
C424S641000, C424S643000, C424S646000, C424S682000, C514S052000, C514S167000, C514S249000, C514S251000, C514S276000, C514S351000, C514S355000, C514S458000, C514S474000, C514S566000, C514S567000, C514S725000, C514S904000, C514S905000
Reexamination Certificate
active
06814983
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to compositions comprising various vitamins and minerals and methods for using these compositions for nutritional supplementation in, for example, subjects in physiologically stressful states.
BACKGROUND OF THE INVENTION
Nutrition plays a critical role in maintaining good health. Proper nutrition prevents dietary deficiencies, and also protects against the development of disease. Proper nutrition plays an increasingly important role as the body faces physiological stress. For example, pregnancy and lactation are among the most nutritionally volatile and physiologically stressful periods and processes in the lifetimes of women. Specifically, vitamin and mineral needs are almost universally increased during these natural processes. These increased needs are almost always due to elevated metabolic demand, increased plasma volume, increased levels of blood cells, decreased concentrations of nutrients, and decreased concentrations of nutrient-binding proteins.
Thus, nutritional supplementation serves a vital role in protecting against poor nutrition and disease. More specifically, research has suggested that optimizing specific nutrients before, during, and after the physiological processes of pregnancy or lactation can have a profound, positive, and comprehensive impact upon the overall wellness of the developing and newborn child as well as the safety and health of the mother. The present inventions provide compositions and methods designed to supplement the nutritional needs of individuals within physiologically stressful states.
SUMMARY OF THE INVENTION
The present invention provides compositions and methods of using these compositions for both prophylactic and therapeutic nutritional supplementation, specifically throughout physiologically stressful states.
Specifically, for example, the present invention relates to novel compositions of vitamins and minerals that can be used to supplement the nutritional deficiencies observed in patients throughout physiologically stressful states such as, for example, pregnancy, lactation, and any disease state.
In one embodiment, the compositions of the present invention may comprise less than about 160 mg calcium, more than about 20 mg iron, and copper in either chelated or non-chelated form.
In another embodiment, the compositions of the present invention may comprise one or more of about 2430 IU to about 2970 IU of Vitamin A, about 360 IU to about 440 IU of Vitamin D, about 63 mg to about 77 mg of Vitamin C, about 27 IU to about 33 IU of Vitamin E, about 0.9 mg to about 1.1 mg of folic acid, about 1.44 mg to about 1.76 mg of Vitamin B
1
, about 1.62 mg to about 1.98 mg of Vitamin B
2
, about 2.25 mg to about 2.75 mg of Vitamin B
6
, about 10.8 mcg to about 13.2 mcg of Vitamin B
12
, about 16.2 mg to about 19.8 mg of niacin, about 90 mg to about 110 mg of calcium, about 58.5 mg to about 71.5 mg of iron, about 22.5 mg to about 27.5 mg of magnesium, about 22.5 mg to about 27.5 mg of zinc, and about 1.8 mg to about 2.2 mg of copper.
In yet another embodiment, the compositions of the present invention may comprise one or more of 2700 IU of Vitamin A, 400 IU of Vitamin D, 70 mg of Vitamin C, 30 IU of Vitamin E, 1 mg of folic acid, 1.6 mg of Vitamin B
1
, 1.8 mg of Vitamin B
2
, 2.5 mg of Vitamin B
6
, 12 mcg of Vitamin B
12
, 18 mg of niacin, 100 mg of calcium, 65 mg of iron, 25 mg of magnesium, 25 mg of zinc, and 2 mg of copper.
In an embodiment, the compositions of the present invention may be suitable for administration to subjects in physiologically stressful states. Such compositions may be suitable for treating nutritional deficiencies resulting from such physiologically stressful states, which may result from, for example, elevated metabolic demand, increased plasma volume, or decreased concentrations of nutrient-binding proteins such as serum-ferritin, maltose-binding protein, lactoferrin, calmodulin, tocopheryl binding protein, riboflavin binding protein, retinol binding protein, transthyretin, high density lipoprotein-apolipoprotein A1, folic acid binding protein, and 25-hydroxyvitamin D binding protein. The compositions of the present invention may comprise one or more compounds that serve as pharmaceutical carriers such as water, oil, alcohol, any flavoring agent, any preservative, any coloring agent, starch, any sugar, any diluent, any granulating agent, any lubricant, any binder, and any disintegrating agent.
In one embodiment, the compositions of the present invention may comprise one or more of Vitamin A in the form of beta carotene, Vitamin D in the form of cholecalciferol, Vitamin C in the form of ascorbic acid, Vitamin E in the form of dl-alpha-tocopheryl acetate, a B-complex vitamin in the form of folic acid, Vitamin B
1
in the form of thiamine mononitrate, Vitamin B
2
in the form of riboflavin, Vitamin B
6
in the form of pyridoxine hydrochloride, Vitamin B
12
in the form of cyanocobalamin, niacin in the form of niacinamide, calcium in the form of calcium carbonate, iron in the form of ferrous fumarate, magnesium in the form of magnesium oxide, zinc in the form of zinc oxide, and/or copper in the form of copper oxide.
The present invention also relates to methods for supplementing nutritional deficiencies in a patient or person throughout physiologically stressful states such as, for example, pregnancy, lactation, and any disease state.
In an embodiment, the methods of the present invention may comprise the step of administering to a patient a composition comprising less than about 160 mg calcium, more than about 20 mg iron, and copper in either chelated or non-chelated form.
In another embodiment, the methods of the present invention may utilize compositions comprising one or more of about 2430 IU to about 2970 IU of Vitamin A, about 360 IU to about 440 IU of Vitamin D, about 63 mg to about 77 mg of Vitamin C, about 27 IU to about 33 IU of Vitamin E, about 0.9 mg to about 1.1 mg of folic acid, about 1.44 mg to about 1.76 mg of Vitamin B
1
, about 1.62 mg to about 1.98 mg of Vitamin B
2
, about 2.25 mg to about 2.75 mg of Vitamin B
6
, about 10.8 mcg to about 13.2 mcg of Vitamin B
12
, about 16.2 mg to about 19.8 mg of niacin, about 90 mg to about 110 mg of calcium, about 58.5 mg to about 71.5 mg of iron, about 22.5 mg to about 27.5 mg of magnesium, about 22.5 mg to about 27.5 mg of zinc, and about 1.8 mg to about 2.2 mg of copper.
In yet another embodiment, the methods of the present invention may utilize compositions comprising one or more of 2700 IU of Vitamin A, 400 IU of Vitamin D, 70 mg of Vitamin C, 30 IU of Vitamin E, 1 mg of folic acid, 1.6 mg of Vitamin B
1
, 1.8 mg of Vitamin B
2
, 2.5 mg of Vitamin B
6
, 12 mcg of Vitamin B12, 18 mg of niacin, 100 mg of calcium, 65 mg of iron, 25 mg of magnesium, 25 mg of zinc, and 2 mg of copper.
In an embodiment, the methods of the present invention utilize the compositions of the present invention suitable for administration to subjects in physiologically stressful states. The methods of the present invention may be directed to the alleviation of nutritional deficiencies resulting from such physiologically stressful states, which may result from, for example, elevated metabolic demand, increased plasma volume, or decreased concentrations of nutrient-binding proteins such as serum-ferritin, maltose-binding protein, lactoferrin, calmodulin, tocopheryl binding protein, riboflavin binding protein, retinol binding protein, transthyretin, high density lipoprotein-apolipoprotein A1, folic acid binding protein, and 25-hydroxyvitamin D binding protein. The methods of the present invention may utilize one or more compounds that serve as pharmaceutical carriers such as water, oil, alcohol, any flavoring agent, any preservative, any coloring agent, starch, any sugar, any diluent, any granulating agent, any lubricant, any binder, and any disintegrating agent.
In one embodiment, the methods of the present invention may utilize compositions comprising one or more of Vitamin A in the form of beta carotene, Vitamin D in the form of cho
Balzer Charles
Giordano John A.
Choi Frank
Everett Laboratories, Inc.
Page Thurman K.
Preston Gates Ellis & Rouvelas Meeds LLP
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