Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2001-10-19
2003-12-09
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, C424S451000, C424S464000, C424S489000
Reexamination Certificate
active
06660293
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to compositions comprising various vitamins and minerals, and without added iron, and methods for using these compositions for prophylactic nutritional supplementation and therapeutic nutritional supplementation in, for example, physiologically stressful conditions and to minimize the effect of exogenous iron supplementation.
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, as the body ages it suffers significant physiological stresses. Specifically, as the body metabolism shifts to accumulating larger fat stores and decreasing lean body mass, this increase in body weight may lead to obesity and associated conditions such as diabetes, cardiovascular disease, hypertension, osteoarthritis, and cancer. Other conditions, such as anorexia, malnutrition, gastrointestinal disorders, chronic alcoholism, chronic infections, acute infections, congestive heart failure, hyperthyroidism, poorly controlled diabetes, cheilosis, gingivitis, stomatitis and dietary restrictions, often result in physiological stresses that may be exacerbated by poor nutrition. In particular, these disease states may result in increased oxidative stress or elevated homocysteine levels that further compromise health.
Thus, nutritional supplementation serves a vital role in protecting against poor nutrition and disease. More specifically, nutritional supplementation may provide the necessary vitamins, minerals, and other nutrients that might otherwise be lacking in the diet, and provide the nutritional defense against disease development. The invention herein provides for compositions and methods, specifically using an iron-free multi-vitamin/mineral/antioxidant formulation, designed to optimize health and wellness, minimize oxidative stress, and normalize homocysteine levels.
SUMMARY OF THE INVENTION
The present invention provides nutritional compositions without iron and methods of using these compositions for both prophylactic and therapeutic nutritional supplementation, specifically in physiologically stressful conditions. Specifically, the present invention relates to novel compositions of vitamins and minerals, without exogenous iron, that can be used to supplement the nutritional deficiencies observed in patients with anorexia, malnutrition, gastrointestinal disorders, chronic alcoholism, chronic infections, acute infections, congestive heart failure, hyperthyroidism, poorly controlled diabetes, cheilosis, gingivitis, stomatitis, and/or dietary restrictions. In addition, the compositions may be used to treat the nutritional deficiencies of patients suffering from a disease state that results in increased oxidative stress or elevated homocysteine levels.
The compositions of the present invention include various vitamins and minerals that improve the nutritional state of a patient; these compositions preferably may be used therapeutically or prophylacticly. The vitamins of the present invention may preferably comprise one or more of carotenoids, vitamin E, vitamin D
3
, vitamin C, thiamine, riboflavin, niacin, folic acid, pyridoxine, biotin, pantothenic acid, and cyanocobalamin. The minerals of the present invention may preferably include one or more of magnesium, manganese, zinc, selenium, chromium, and copper. In addition, the present invention may preferably comprise other nutritional elements, such as alpha lipoic acid, and/or lutein. The compositions of the present invention preferably do not include exogenous iron as an added component.
In a preferred embodiment, the compositions of the present invention comprise carotenoids in a range of about 2400 IU to about 3600 IU, vitamin E in a range of about 80 IU to 120 IU, vitamin D in a range of about 320 IU to about 480 IU, vitamin C in a range of about 240 mg to 360 mg, thiamine in a range of about 16 mg to 24 mg, riboflavin in a range of about 4 mg to about 6 mg, niacin in a range of about 20 mg to about 30 mg, folic acid in a range of about 0.8 mg to 1 mg, pyridoxine provided in a range of about 20 mg to 30 mg, biotin in a range of about 80 &mgr;g to about 120 &mgr;g, pantothenic acid in a range of about 12 mg to about 18 mg, cobalamin in a range of about 40 &mgr;g to about 60 &mgr;g, magnesium in a range of about 40 mg to about 60 mg, manganese in a range of about 1.2 mg to about 1.8 mg, zinc in a range of about 20 mg to about 30 mg, selenium in a range of about 80 &mgr;g to 120 &mgr;g, chromium in a range of about 40 &mgr;g to about 60 &mgr;g, copper in a range of about 1.2 mg to about 1.8 mg copper, lipoic acid in a range of about 12 mg to about 18 mg, and lutein in a range from about 4 mg to 6 mg, wherein these compositions are free of added iron.
In another embodiment of the compositions of the present invention, vitamin E is present as d-alpha tocopheryl succinate, vitamin D is vitamin D
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, niacin is niacinamide, chromium is chromium chloride, selenium is present as sodium selenate, zinc is zinc oxide, carotenoids consist of alpha-carotene, beta-carotene, cryptoxanthin, lutein and zeaxanthin, magnesium is magnesium oxide, manganese is present as manganese sulfate, and copper is cupric sulfate.
In a further preferred embodiment of the present invention, the composition includes about 3000 IU carotenoids, about 100 IU d-alpha tocopheryl succinate, about 400 IU vitamin D
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, about 300 mg vitamin C, about 20 mg thiamine, about 5 mg riboflavin, about 25 mg niacinamide, about 1.0 mg folic acid, about 25 mg pyridoxine HCl, about 100 &mgr;g biotin, about 15 mg calcium pantothenate, about 50 &mgr;g cyanocobalamin, about 50 mg magnesium oxide, about 1.5 mg manganese sulfate, about 25 mg zinc oxide, about 100 &mgr;g selenium, about 50 &mgr;g chromium chloride, about 1.5 mg cupric sulfate, about 15 mg alpha lipoic acid, and about 5 mg lutein, wherein this composition is free of added iron.
In addition, the compositions of the present invention may be administered to an individual on a daily basis and the composition may be administered orally. Furthermore, the compositions of the present invention may include a pharmaceutically acceptable carrier.
The present invention also relates to methods for supplementing nutritional deficiencies in a patient or person by administering a composition comprising carotenoids, vitamin E, vitamin D, vitamin C, thiamine, riboflavin, niacin, folic acid, pyridoxine, biotin, pantothenic acid, cobalamin, magnesium, manganese, zinc, selenium, chromium, copper, alpha lipoic acid, and lutein, wherein this composition is free of added iron.
The methods of the present invention may be used to treat patients suffering from anorexia, malnutrition, gastrointestinal disorders, chronic alcoholism, chronic infections, acute infections, congestive heart failure, hyperthyroidism, poorly controlled diabetes, cheilosis, gingivitis, stomatitis, and dietary restrictions. In addition, these methods may be used to treat the nutritional deficiencies in patients suffering from a disease state that results in increased oxidative stress or elevated homocysteine levels.
In a preferred embodiment, the methods of the present invention utilize compositions comprising carotenoids in a range of about 2400 IU to about 3600 IU, vitamin E in a range of about 80 IU to about 120 IU, vitamin D in a range of about 320 IU to about 480 IU, vitamin C in a range of about 240 mg to 360 mg, thiamine in a range of about 16 mg to about 24 mg, riboflavin in a range of about 4 mg to about 6 mg, niacin in a range of about 20 mg to about 30 mg, folic acid in a range of about 0.8 mg to about 1 mg, pyridoxine provided in a range of about 20 mg to about 30 mg, biotin in a range of about 80 &mgr;g to about 120 &mgr;g, pantothenic acid in a range of about 12 mg to about 18 mg, cobalamin in a range of about 40 &mgr;g to about 60 &mgr;g, magnesium in a range of about 40 mg to about 60 mg, m
Balzer Charles
Giordano John A.
Evans Charesse
Everett Laboratories, Inc.
Page Thurman K.
Preston Gates Ellis & Rouvelas Meeds LLP
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