Abstract:
An oral formulation that is a combination of three mineral ascorbates and metabolites for antioxidant protection against free radical damage, healthy skin maintenance, support for vision health, healthy joint support, cardiovascular support, and maintenance of the immune system.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    The present invention relates to a novel therapeutic use of a combination of three mineral ascorbates and metabolites for antioxidant protection against free radical damage, healthy skin maintenance, support for vision health, healthy joint support, cardiovascular support, and maintenance of the immune system. 
         [0002]    More specifically, the present invention relates to the coordinated use of calcium ascorbate, magnesium ascorbate and zinc ascorbate in a formulation. In addition to the ascorbate components there is present calcium threonate, calcium xylonate, and calcium lyxonate. 
       SUMMARY OF THE INVENTION 
       [0003]    Therefore, the present invention also relates to orally administrable pharmaceutical compositions suitable for preventing oxygen and free radicals from damaging body tissue. The formulation is necessary for the production of proteins, collagen and elastin, which strengthen arteries, bones, teeth, cartilage, and other tissues. It helps the body absorb iron, helps lower blood pressure and blood cholesterol, and reduces the effects of some allergy-producing substances. 
         [0004]    The invention described herein is based on the surprising synergistic effect occurring between the combination of the three ascorbates, calcium, magnesium and zinc. The addition of the three calcium component compounds provides for a uniques and superior oral formulation. This synergistic effect is particularly surprising. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0005]    It has now been found that the combined unique ascorbate tri formulation of calcium ascorbate, magnesium ascorbate not only prevents cell damage but also enhances the process of cell repair, thus allowing remarkable therapeutic results to be achieved. 
         [0006]    Further, there is added to the unique ascorbate tri formulation calcium threonate, calcium xylonite, and calcium lyxonate. 
         [0007]    The unique ascorbate tri formulation is an excellent reducing agent, and it acts as a cofactor in various biochemical reactions to reduce the transition metals, iron and copper. 
         [0008]    Ascorbate can be oxidized by most reactive oxygen and nitrogen species thought to play roles in tissue injury associated with various diseases. These species include superoxide, hydroxyl, peroxyl and nitroxide radicals, as well as such non-radical reactive species as singlet oxygen, peroxynitrite and hypochlorite. By virtue of this scavenging activity, ascorbate inhibits lipid peroxidation, oxidative DNA damage and oxidative protein damage. 
         [0009]    Ascorbate is oxidized by reactive oxygen and nitrogen species to the semidehydroascorbate radical that is either reconverted to ascorbate via the enzyme NADH semidehydroascorbate reductase or is converted to dehydroascorbate 
         [0010]    Dehydroascorbate in turn can be converted back to ascorbate via glutathione-dependent enzymes or catabolized. 
         [0011]    Ascorbate can act as a secondary antioxidant. At least in vitro, ascorbate regenerates the major lipid antioxidant alpha-tocopherol from the alpha-tocopheroxyl radical form. Ascorbate may also participate in regenerating and sparing alpha-tocopherol in vivo, though this has not been clearly demonstrated. The unique ascorbate tri formulation does preserve intracellular reduced glutathione concentrations. 
         [0012]    As noted above, Unique ascorbate tri formulation helps preserve intracellular reduced glutathione concentrations. This activity likely helps maintain nitric oxide levels and potentiates its vasoactive effects. Oral Unique ascorbate tri formulation can reach high enough concentrations intracellularly to scavenge superoxide radicals. Thus, intracellular sources of superoxide that impair nitric oxide may be scavenged by oral Unique ascorbate tri formulation. Recently, it has been found that ascorbic acid enhances nitric oxide synthase activity by increasing intracellular tetrahydrobiopterin. 
         [0013]    The unique ascorbate tri formulation may modulate prostaglandin synthesis to favor the production of eicosanoids with antithrombotic and vasodilatory activity. The possible sparing and regeneration of alpha-tocopherol by the unique ascorbate tri formulation could be yet another factor in the vitamin&#39;s possible anti-atherogenic action. 
         [0014]    Evidence appears to suggest that the unique ascorbate tri formulation may have cancer-preventive activity, at least for certain types of cancer. A recent cell-culture study of human breast carcinoma lines may suggest the unique ascorbate tri formulation to improve the antineoplastic activity of doxorubicin, cisplatin and paclitaxel. The mechanism of the effect may be pro-oxidant, not antioxidant, activity of the vitamin in potentiating the effects of these chemotherapeutic agents. Another study suggests that the pro-oxidant form of the unique ascorbate tri formulation may upregulate some of the enzymes involved in DNA repair. This possible activity may play some anticarcinogenic role. 
         [0015]    The unique ascorbate tri formulation may have anti-hypertensive activity in some. The mechanism of this possible effect is a matter of speculation. As observed above, the unique ascorbate tri formulation may help maintain nitric oxide levels and potentiate its vasoactive effects. There is an indication that the unique ascorbate tri formulation may improve endothelial-dependent vasodilation in those with essential hypertension, as well as in those with hypercholesterolemia, and may help restore nitric oxide-mediated flow-dependent vasodilation in those with congestive heart failure. 
         [0016]    There is some evidence that the unique ascorbate tri formulation supplementation decreases the incidence, severity and duration of common cold symptoms in some. It is thought that this is due, at least in part, to antihistaminic activity of the unique ascorbate tri formulation. 
         [0017]    Some studies suggest a protective effect of the unique ascorbate tri formulation supplementation against cataracts. Age-related lens opacities are thought to be due to oxidative stress. 
         [0018]    The unique ascorbate tri formulation may protect against asthma and other obstructive pulmonary diseases, as well as protect the airways against the effects of allergens, viral infections and irritants in some. Allergens, viruses and irritants, including ozone, nitrogen oxides and sulfur oxides, subject the airways to increased oxidative stress, which can lead to bronchoconstriction. The possible protective action of the unique ascorbate tri formulation appears clearly due to its antioxidant properties. 
         [0019]    The antioxidant properties of the unique ascorbate tri formulation can also account for its role in protecting against the tissue-damaging effect of some toxic chemicals and heavy metals. High serum levels of ascorbic acid have been reported to be associated with a decreased prevalence of elevated blood lead levels. One study compared the chelating properties of ascorbic acid and the known lead-chelating agent EDTA and found them to have equivalent activity with respect to lead. 
         [0000]    The formulation comprises: 
         [0000]                                                                                    Tri Formulation Blend   10-100,000   mg           Calcium (as Calcium Ascorbate and   1-10,000   mg           Calcium Threonate))           Citrus Bioflavanoids Complex   2-20,000   mg           Rosehips Extract   0.25-2,500   mg           Rutin   0.25-2,500   mg           Acerola Cherry Extract   0.19-1,900   mg                            Tri Formulation Blend   Dosage Range                            Calcium Ascorbate   9.20-920,000   mg           Magnesium Ascorbate   0.4925-49,250   mg           Zinc Ascorbate   0.0075-7.5   mg           Calcium Threonate   0.10-10,000   mg           Calcium Xylonate   0.10-10,000   mg           Calcium Lyxonate   0.10-10,000   mg                        
The preferred formulation comprises:
 
         [0000]    
       
         
               
               
               
               
               
             
               
               
               
               
               
               
             
           
               
                   
               
               
                   
                   
                 % Concentration of 
                   
                   
               
               
                   
                   
                 Ascorbic Acid/ 
                 Amount of Ascorbic 
                 Amount of 
               
               
                 Tri Formulation Blend 
                 Dosage 
                 Mineral 
                 Acid 
                 Mineral 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 Calcium Ascorbate 
                 920 
                 mg. 
                 80%/9%  
                  736 mg. 
                 82.8 mg. 
               
               
                 Magnesium Ascorbate 
                 49.25 
                 mg. 
                  80%/6.5% 
                 39.4 mg. 
                 3.20 mg. 
               
               
                 Zinc Ascorbate 
                 0.75 
                 mg. 
                 80%/8%  
                  0.6 mg. 
                 0.06 mg. 
               
               
                 Calcium Threonate 
                 10 
                 mg. 
                 50%/50% 
                   5 mg. of L-Threonate 
                   5 mg. of Calcium 
               
               
                 Calcium Xylonate 
                 10 
                 mg. 
                 50%/50% 
                  2.5 mg. of L-Xylonate 
                  2.5 mg. of Calcium 
               
               
                 Calcium Lyxonate 
                 10 
                 mg. 
                 50%/50% 
                  2.5 mg. of L-Lyxonate 
                  2.5 mg. of Calcium 
               
               
                   
               
             
          
         
       
     
         [0000]                                                                    Tri Ascorbate Formulation Complex 1000 mg. Tablets       Supplement Facts       Serving Size: 1 Tablet       Servings per Bottle: 300 servings                        Raw Mat.               %   (mg.) 2%       Amount Per Serving   Dosage   Concentration   overage                    Tri Formulation Blend   1000   mg.   78%   1275.0 mgs.        Calcium (as Calcium   100   mg.   9%       Ascorbate and Calcium       Threonate))       Citrus Bioflavanoids   200   mg.   100%   204.0 mgs.        Complex       Rosehips Extract   25   mg.   100%   25.5 mgs.       Rutin   25   mg.   100%   25.5 mgs.       Acerola Cherry Extract   19   mg.   100%   19.4 mgs.                       1549.4 mg.                Weight of Active Ingredients per Tablet: 1,549.40 mgs.       Approximate Weight of Finished Tablet: 1700.00 mgs.       Other Ingredients: Di-Calcium Phophate, Cellulose, Stearic Acid, Magnesium Stearate, Silica, Pharmaceutical Glaze            
Calcium Ascorbate is an optimal combination of Ascorbic Acid (Vitamin C) with Calcium Carbonate
 
Magnesium Ascorbate is an optimal combination of Ascorbic Acid (Vitamin C) with Magnesium Carbonate
 
Zinc Ascorbate is an optimal combination of Ascorbic Acid (Vitamin C) with Zinc Carbonate
 
Calcium threonate, calcium xylonite and calcium lyxonate are metabolites that are natural components that exist in plants and animals.