Nutritional composition

Abstract

The present inventive subject matter is directed to novel chewable prenatal nutritional supplements which contain vitamin C, as well as novel methods for providing optimal vitamin C supplementation to pregnant women. The present invention is also directed to novel compositions and methods for providing nutritional supplementation to individuals planning to conceive a child.

We claim:  
     
         1 . A substantially non-acidic chewable prenatal nutritional composition, which comprises: 
 a vitamin C derivative;    a folic acid compound present in an amount ranging from about 0.1 mg to about 5.0 mg; and    wherein the vitamin C derivative and the folic acid compound are contained together within a stable chewable dosage form having a pH ranging from about 5.5 to about 9.5.    
     
     
         2 . The composition of  claim 1 , wherein the vitamin C derivative is a mineral ascorbate or a multi-mineral ascorbate.  
     
     
         3 . The composition of  claim 1 , wherein the vitamin C derivative is selected from the group consisting of calcium ascorbate, magnesium ascorbate, zinc ascorbate, potassium ascorbate, sodium ascorbate and combinations thereof.  
     
     
         4 . The composition of  claim 1 , wherein the vitamin C derivative is present in the composition in an amount ranging from about 10 mg to about 1000 mg.  
     
     
         5 . The composition of  claim 1 , wherein the dosage form has a pH ranging from about 6.5 to about 9.0.  
     
     
         6 . The composition of  claim 1 , wherein the dosage form has a pH ranging from about 7.0 to about 8.5.  
     
     
         7 . The composition of  claim 1 , wherein the dosage form is pH neutral.  
     
     
         8 . The composition of  claim 1 , wherein the vitamin C derivative is alkaline.  
     
     
         9 . The composition of  claim 1 , wherein the stable chewable dosage form is selected from the group consisting of a chewable tablet, a chewable lozenge, a particulate matrix, a cereal, a health bar, a confection, a nutritive food, a quick chew, a quick dissolve and combinations thereof.  
     
     
         10 . The composition of  claim 1 , wherein the composition is contained in a single dosage unit.  
     
     
         11 . The composition of  claim 1 , wherein the composition is divided into portions and contained in multiple dosage units.  
     
     
         12 . The composition of  claim 11 , wherein at least one portion is administered during the daytime and at least one portion is administered during the evening or nighttime.  
     
     
         13 . The composition of  claim 11 , wherein the portions are uneven portions.  
     
     
         14 . The composition of  claim 13 , wherein at least one uneven portion is administered during the daytime and at least one uneven portion is administered during the evening or nighttime.  
     
     
         15 . The composition of  claim 1 , further comprising a mineral compound.  
     
     
         16 . The composition of  claim 15 , wherein said mineral compound is selected from the group consisting of calcium carbonate, calcium citrate, calcium hydroxide, aluminum hydroxide and combinations thereof.  
     
     
         17 . The composition of  claim 16 , wherein the calcium carbonate is present in said composition in an amount ranging from about 20 mg to about 2,000 mg.  
     
     
         18 . The composition of  claim 1 , further comprising a mineral selected from the group consisting of calcium, magnesium, zinc, copper and mixtures thereof.  
     
     
         19 . The composition of  claim 1 , further comprising a pharmaceutically acceptable iron compound.  
     
     
         20 . The composition of  claim 19 , wherein said pharmaceutically acceptable iron compound is selected from the group consisting of ferrous fumarate, ferrous sulfate, ferric chloride, ferrous gluconate, ferrous lactate, ferrous tartrate, iron-sugar-carboxylate complexes, ferrous succinate, ferrous glutamate, ferrous citrate, ferrous pyrophosphate, ferrous cholinisocitrate, ferrous carbonate, carbonyl iron and mixtures thereof.  
     
     
         21 . The composition of  claim 19 , wherein the pharmaceutically acceptable iron compound is present in said composition in an amount ranging from about 10 mg to 200 mg.  
     
     
         22 . The composition of  claim 1 , further comprising a B vitamin.  
     
     
         23 . The composition of  claim 22 , wherein the B vitamin is pyridoxine and is present in said composition in an amount ranging from about 0.1 mg to about 200 mg.  
     
     
         24 . The composition of  claim 1 , further comprising vitamin D in amount ranging from about 100 IU to about 600 IU.  
     
     
         25 . The composition of  claim 1 , further comprising vitamin E in an amount ranging from about 1 IU to about 50 IU.  
     
     
         26 . The composition of  claim 1 , further comprising an aldono-lactone compound.  
     
     
         27 . The composition of  claim 1 , further comprising an edible salt of an aldonic acid.  
     
     
         28 . The composition of  claim 27 , wherein said aldonic acid is selected from the group consisting of L-threonic acid, L-xylonic acid, L-lyxonic acid and combinations thereof.  
     
     
         29 . The composition of  claim 1 , further comprising a flavor, a sweetener, or combinations thereof.  
     
     
         30 . The composition of  claim 29 , wherein said flavor is vanilla.  
     
     
         31 . The composition of  claim 29 , wherein said sweetener is glycyrrizin and pharmaceutical salts thereof.  
     
     
         32 . The composition of  claim 1 , further comprising an alkaline pH buffering agent.  
     
     
         33 . The composition of  claim 1 , further comprising an anti-nausea agent.  
     
     
         34 . The composition of  claim 1 , further comprising an herbal agent.  
     
     
         35 . The composition of  claim 1 , further comprising ascorbic acid.  
     
     
         36 . A substantially non-acidic chewable prenatal nutritional composition, which comprises: 
 ascorbic acid in an amount ranging from about 25 mg to about 2,000 mg;    a non-toxic acid neutralizing alkaline compound in an amount sufficient to substantially neutralize the acidity of the composition;    a folic acid compound present in an amount ranging from about 0.1 mg to about 5.0 mg; and    wherein the ascorbic acid, the non-toxic acid neutralizing alkaline compound and the folic acid compound are contained together within a stable chewable dosage form.    
     
     
         37 . The composition of  claim 36 , wherein said composition has a pH ranging from about 5.5 to about 9.5.  
     
     
         38 . The composition of  claim 36 , wherein said composition has a pH ranging from about 7.0 to about 8.5.  
     
     
         39 . The composition of  claim 36 , wherein the non-toxic acid neutralizing alkaline compound has a total daily dosage of at least the amount required to substantially neutralize the acidity of the composition.  
     
     
         40 . The composition of  claim 36 , wherein the non-toxic acid neutralizing alkaline compound is a mineral compound.  
     
     
         41 . The composition of  claim 40 , wherein the mineral compound is selected from the group consisting of aluminum carbonate, aluminum hydroxide, aluminum phosphate, aluminum hydroxy carbonate, aluminum citrate, dihydroxyaluminum sodium carbonate, aluminum magnesium glycinate, dihydroxyaluminum aminoacetate, dihydroxyaluminum aminoacetic acid, bismuth aluminate, bismuth carbonate, bismuth subcarbonate, bismuth subgallate, bismuth subnitrate, calcium carbonate, calcium hydroxide, calcium phosphate, calcium citrate, calcium citrate malate, hydrated magnesium aluminate, activated sulfate, magnesium aluminate, magnesium aluminosilicates, magnesium carbonate, magnesium glycinate, magnesium hydroxide, magnesium oxide, magnesium trisilicate, potassium carbonate, potassium phosphate, potassium citrate, sodium carbonate, sodium bicarbonate, sodium phosphate, sodium citrate, oyster shell calcium and mixtures thereof.  
     
     
         42 . The composition of  claim 36 , wherein the non-toxic acid neutralizing alkaline compound is selected from the group consisting of calcium-based compounds, antacids, aluminum-based compounds, magnesium-based compounds, sodium-based compounds, potassium-based compounds, and mixtures thereof.  
     
     
         43 . The composition of  claim 36 , further comprising a vitamin C derivative.  
     
     
         44 . The composition of  claim 43 , wherein the vitamin C derivative is a mineral ascorbate or a multi-mineral ascorbate.  
     
     
         45 . The composition of  claim 43 , wherein the vitamin C derivative is selected from the group consisting of calcium ascorbate, magnesium ascorbate, zinc ascorbate, potassium ascorbate, sodium ascorbate and combinations thereof.  
     
     
         46 . The composition of  claim 43 , wherein the dosage form has a pH ranging from about 6.0 to about 7.2.  
     
     
         47 . The composition of  claim 43 , wherein the dosage form has a pH ranging from about 6.5 to about 7.0.  
     
     
         48 . The composition of  claim 43 , wherein the dosage form is pH neutral.  
     
     
         49 . The composition of  claim 43 , wherein the vitamin C derivative is alkaline.  
     
     
         50 . The composition of  claim 36 , wherein the stable chewable dosage form is selected from the group consisting of a chewable tablet, a chewable lozenge, a particulate matrix, a cereal, a health bar, a confection, a nutritive food, a quick chew, a quick dissolve and combinations thereof.  
     
     
         51 . The composition of  claim 36 , wherein the composition is contained in a single dosage unit.  
     
     
         52 . The composition of  claim 36 , wherein the composition is divided into portions and contained in multiple dosage units.  
     
     
         53 . The composition of  claim 52 , wherein at least one portion is administered during the daytime and at least one portion is administered during the evening or nighttime.  
     
     
         54 . The composition of  claim 52 , wherein the portions are uneven portions.  
     
     
         55 . The composition of  claim 54 , wherein at least one uneven portion is administered during the daytime and at least one uneven portion is administered during the evening or nighttime.  
     
     
         56 . The composition of  claim 36 , further comprising a pharmaceutically acceptable iron compound.  
     
     
         57 . The composition of  claim 56 , wherein said pharmaceutically acceptable iron compound is selected from the group consisting of ferrous fumarate, ferrous sulfate, ferric chloride, ferrous gluconate, ferrous lactate, ferrous tartrate, iron-sugar-carboxylate complexes, ferrous succinate, ferrous glutamate, ferrous citrate, ferrous pyrophosphate, ferrous cholinisocitrate, ferrous carbonate, carbonyl iron and mixtures thereof.  
     
     
         58 . The composition of  claim 56 , wherein the pharmaceutically acceptable iron compound is present in said composition in an amount ranging from about 10 mg to 200 mg.  
     
     
         59 . The composition of  claim 36 , further comprising a B vitamin.  
     
     
         60 . The composition of  claim 59 , wherein the B vitamin is pyridoxine and is present in said composition in an amount ranging from about 0.1 mg to about 200 mg.  
     
     
         61 . The composition of  claim 36 , further comprising vitamin D in amount ranging from about 100 IU to about 600 IU.  
     
     
         62 . The composition of  claim 36 , further comprising vitamin E in an amount ranging from about 1 IU to about 50 IU.  
     
     
         63 . The composition of  claim 36 , further comprising an aldono-lactone compound.  
     
     
         64 . The composition of  claim 36 , further comprising an edible salt of an aldonic acid.  
     
     
         65 . The composition of  claim 64 , wherein said aldonic acid is selected from the group consisting of L-threonic acid, L-xylonic acid, L-lyxonic acid and combinations thereof.  
     
     
         66 . The composition of  claim 36 , wherein the stable chewable dosage form is a prenatal dietary supplement.  
     
     
         67 . The composition of  claim 36 , further comprising an alkaline pH buffering agent.  
     
     
         68 . A substantially non-acidic chewable prenatal nutritional composition, which comprises: 
 ascorbic acid;    at least one vitamin C derivative;    a folic acid compound present in an amount ranging from about 0.1 mg to about 5.0 mg; and    wherein the composition is in a stable chewable dosage form having a pH ranging from about 5.5 to about 9.5.    
     
     
         69 . The composition of  claim 68 , further comprising a non-toxic acid neutralizing alkaline compound.  
     
     
         70 . A substantially non-acidic chewable nutritional composition for males or females planning to conceive a child, which comprises: 
 a vitamin C derivative;    a folic acid compound present in an amount ranging from about 0.1 mg to about 5.0 mg; and    wherein the vitamin C derivative and the folic acid compound are contained together within a stable chewable dosage form having a pH ranging from about 5.5 to about 9.5.    
     
     
         71 . A substantially non-acidic chewable prenatal nutritional composition, which comprises: 
 a vitamin C derivative;    a folic acid compound present in an amount ranging from about 0.1 mg to about 5.0 mg; and    wherein the vitamin C derivative and the folic acid compound are contained together within a stable chewable extended release dosage form having a pH ranging from about 5.5 to about 9.5.    
     
     
         72 . A method of administering vitamin C to a pregnant woman without causing irritation to the esophagus or pharynx or gastrointestinal upset, which comprises: 
 administering to the pregnant woman a vitamin C derivative in an amount ranging from about 10 mg to about 1,000 mg; said vitamin C derivative being contained in a stable chewable dosage form having a pH ranging from about 5.5 to about 9.5;    wherein the vitamin C derivative provides vitamin C without causing gastrointestinal upset.    
     
     
         73 . The method of  claim 72 , further comprising administering a folic acid compound simultaneously with said vitamin C derivative.  
     
     
         74 . The method of  claim 73 , wherein said folic acid is administered in an amount ranging from about 0.1 mg to about 5.0 mg.  
     
     
         75 . The method of  claim 73 , wherein said folic acid is contained together with the vitamin C derivative in said stable chewable dosage form.  
     
     
         76 . The method of  claim 72 , wherein the vitamin C derivative is a mineral ascorbate or a multi-mineral ascorbate.  
     
     
         77 . The method of  claim 72 , wherein the vitamin C derivative is selected from the group consisting of calcium ascorbate, magnesium ascorbate, zinc ascorbate, potassium ascorbate, sodium ascorbate and combinations thereof.  
     
     
         78 . The method of  claim 72 , wherein the vitamin C derivative is administered to the pregnant woman in an amount ranging from about 10 mg to about 1000 mg.  
     
     
         79 . The method of  claim 72 , wherein the vitamin C derivative has a pH ranging from about 6.5 to about 9.0.  
     
     
         80 . The method of  claim 72 , wherein the vitamin C derivative has a pH ranging from about 7.0 to about 8.5.  
     
     
         81 . The method of  claim 72 , wherein the vitamin C derivative is pH neutral.  
     
     
         82 . The method of  claim 72 , wherein the stable chewable dosage form is selected from the group consisting of a chewable tablet, a chewable lozenge, a particulate matrix, a cereal, a health bar, a confection, a nutritive food, a quick chew, a quick dissolve and combinations thereof.  
     
     
         83 . The method of  claim 72 , further comprising administering a mineral compound to the pregnant woman.  
     
     
         84 . The method of  claim 72 , wherein said mineral compound is selected from the group consisting of calcium carbonate, calcium citrate, calcium hydroxide, aluminum hydroxide, oyster shell calcium and combinations thereof.  
     
     
         85 . The method of  claim 72 , wherein the calcium carbonate is administered to the pregnant woman in an amount ranging from about 20 mg to about 2,000 mg.  
     
     
         86 . The method of  claim 72 , further comprising administering a mineral selected from the group consisting of calcium, magnesium, zinc, copper or combinations thereof to the pregnant woman.  
     
     
         87 . The method of  claim 72 , further comprising administering a pharmaceutically acceptable iron compound to the pregnant woman.  
     
     
         88 . The method of  claim 87 , wherein said pharmaceutically acceptable iron compound is selected from the group consisting of of ferrous fumarate, ferrous sulfate, ferric chloride, ferrous gluconate, ferrous lactate, ferrous tartrate, iron-sugar-carboxylate complexes, ferrous succinate, ferrous glutamate, ferrous citrate, ferrous pyrophosphate, ferrous cholinisocitrate, ferrous carbonate, carbonyl iron and mixtures thereof.  
     
     
         89 . The method of  claim 87 , wherein the pharmaceutically acceptable iron compound is administered in an amount ranging from about 10 mg to 200 mg.  
     
     
         90 . The method of  claim 72 , further comprising administering a B vitamin to the pregnant woman.  
     
     
         91 . The method of  claim 90 , wherein the B vitamin is pyridoxine and is administering in an amount ranging from about 0.1 mg to about 50 mg.  
     
     
         92 . The method of  claim 72 , further comprising administering vitamin D in amount ranging from about 100 IU to about 600 IU to the pregnant woman.  
     
     
         93 . The method of  claim 72 , further comprising administering vitamin E in an amount ranging from about 1 IU to about 50 IU to the pregnant woman.  
     
     
         94 . The method of  claim 72 , further comprising administering an aldono-lactone compound to the pregnant woman.  
     
     
         95 . The method of  claim 72 , further comprising administering an edible salt of an aldonic acid to the pregnant woman.  
     
     
         96 . The method of  claim 95 , wherein said aldonic acid is selected from the group consisting of L-threonic acid, L-xylonic acid, L-lyxonic acid and combinations thereof.  
     
     
         97 . The method of  claim 72 , wherein the stable chewable dosage form is a prenatal dietary supplement.  
     
     
         98 . The method of  claim 72 , further comprising administering a pH buffering agent.  
     
     
         99 . The method of  claim 72 , wherein the solubility of folic acid administered simultaneously with the vitamin C derivative is increased in the body of the pregnant woman.  
     
     
         100 . The method of  claim 72 , further comprising administration of a dietary supplement to the pregnant woman.  
     
     
         101 . The method of  claim 72 , further comprising a therapeutic or nutritional regimen for the pregnant woman.  
     
     
         102 . The method of  claim 72 , wherein said vitamin C derivative is provided in a blister pack.  
     
     
         103 . The method of  claim 72 , wherein said vitamin C derivative is dosed for nighttime administration.  
     
     
         104 . The method of  claim 72 , wherein the pregnant woman has low ascorbic acid tolerance.  
     
     
         105 . The method of  claim 72 , wherein the pregnant woman has a tendency to form kidney stones.  
     
     
         106 . The method of  claim 72 , wherein the pregnant woman has enhanced vitamin C requirements.  
     
     
         107 . The method of  claim 72 , wherein the pregnant woman has high blood pressure or cardiovascular disease.  
     
     
         108 . The method of  claim 72 , wherein pregnancy presents a high risk for the pregnant woman.  
     
     
         109 . The method of  claim 72 , wherein the pregnant woman is immuno-compromised.  
     
     
         110 . The method of  claim 72 , wherein said method provides vitamin C without causing diarrhea or gastric inflammation.  
     
     
         111 . The method of  claim 72 , wherein normal or above-normal levels of vitamin C are established and maintained in the body of the pregnant woman.  
     
     
         112 . The method of  claim 72 , wherein said method increases the pregnant woman's tolerance to vitamin C.  
     
     
         113 . A method of administering vitamin C to a pregnant woman without causing gastrointestinal upset or tooth enamel erosion, which comprises: 
 administering to the pregnant woman an amount of ascorbic acid ranging from about 25 mg to about 2,000 mg; a non-toxic acid neutralizing alkaline compound in an amount sufficient to neutralize the acidity of the ascorbic acid; and a folic acid compound in an amount ranging from about 0.1 mg to about 5.0 mg; and    wherein the ascorbic acid, the non-toxic acid neutralizing alkaline compound and the folic acid compound are each contained in a stable chewable dosage form having a pH ranging from about 5.5 to about 9.5.    
     
     
         114 . The method of  claim 113 , wherein the non-toxic acid neutralizing alkaline compound has a total daily dosage of at least the amount required to substantially neutralize the ascorbic acid present in the stable chewable dosage form.  
     
     
         115 . The method of  claim 113 , wherein the non-toxic acid neutralizing alkaline compound is a mineral compound.  
     
     
         116 . The method of  claim 115 , wherein the mineral compound is selected from the group consisting of aluminum carbonate, aluminum hydroxide, aluminum phosphate, aluminum hydroxy carbonate, aluminum citrate, dihydroxyaluminum sodium carbonate, aluminum magnesium glycinate, dihydroxyaluminum aminoacetate, dihydroxyaluminum aminoacetic acid, bismuth aluminate, bismuth carbonate, bismuth subcarbonate, bismuth subgallate, bismuth subnitrate, calcium carbonate, calcium hydroxide, calcium phosphate, calcium citrate, calcium citrate malate, hydrated magnesium aluminate, activated sulfate, magnesium aluminate, magnesium aluminosilicates, magnesium carbonate, magnesium glycinate, magnesium hydroxide, magnesium oxide, magnesium trisilicate, potassium carbonate, potassium phosphate, potassium citrate, sodium carbonate, sodium bicarbonate, sodium phosphate, sodium citrate, oyster shell calcium and mixtures thereof.  
     
     
         117 . The method of  claim 113 , wherein the non-toxic acid neutralizing alkaline compound is selected from the group consisting of calcium-based compounds, antacids, aluminum-based compounds, magnesium-based compounds, sodium-based compounds, potassium-based compounds and mixtures thereof.  
     
     
         118 . The method of  claim 113 , further comprising a vitamin C derivative.  
     
     
         119 . The method of  claim 113 , wherein the stable chewable dosage form is selected from the group consisting of a chewable tablet, a chewable lozenge, a particulate matrix, a cereal, a health bar, a confection, a nutritive food, a quick chew, a quick dissolve and combinations thereof.  
     
     
         120 . A method of administering vitamin C to a pregnant woman without causing tooth enamel erosion, which comprises: 
 administering to the pregnant woman a vitamin C derivative in an amount ranging from about 10 mg to about 1,000 mg; said vitamin C derivative being contained in a stable chewable dosage form having a pH ranging from about 5.5 to about 9.5;    wherein the vitamin C derivative provides vitamin C without causing tooth enamel erosion.