ESSENTIAL NUTRIENTS AND RELATED METHODS
The present disclosure relates to pharmaceutical compositions for mammalian consumption containing essential fatty acids, protein, vitamins and choline, or combinations thereof, so constituted to optimize absorption and/or transport and/or efficiency of the co-ingredients of the composition. The pharmaceutical compositions are useful as supplements to provide nutrients to nutritionally deficient patients. The composition can contain essential fatty acids, such as EPA, DHA and/or ALA, cobalamin binding protein, such as Intrinsic Factor, vitamin B12 or a synthetic form thereof, choline, such as choline bitartrate, or combinations thereof.
1 . A composition comprising:
about 10 to about 1500 mg of an essential fatty acid selected from the group consisting of EPA, DHA and ALA; and
about 10 to about 33,000 μg of a cobalamin binding protein.
2 . The composition of claim 1 , wherein the essential fatty acid is DHA.
3 . The composition of claim 2 , wherein the source of DHA is animal, fish, plant, algae or microorganism produced.
4 . The composition of claim 2 , wherein the source of DHA is a phosphatidylcholine containing DHA, a lysophosphatidylcholine containing DHA, or combination thereof.
5 . The composition of claim 1 , wherein the cobalamin binding protein is Intrinsic Factor.
6 . The composition of claim 1 , wherein the cobalamin binding protein is recombinant human Intrinsic Factor.
7 . The composition of claim 1 , wherein the molar ratio of essential fatty acid to cobalamin binding protein is about 1:0.025 to about 1:0.00000005.
8 . The composition of claim 1 , further comprising about 0.25 to about 9,000 μg of vitamin B12 or a synthetic form of vitamin B12.
9 . The composition of claim 8 , wherein the vitamin B12 or synthetic form of vitamin B12 is selected from the group consisting of cyanocobalamin, methylcobalamin, hydroxocobalamin and adenosylcobalamin.
10 . The composition of claim 8 , wherein the molar ratio of the cobalamin binding protein to the vitamin B12 or a synthetic form of vitamin B12 is about 1:25,000 to about 1:0.00025.
11 . The composition of claim 8 , further comprising about 10 to about 3500 mg of choline, a biologically compatible salt thereof, or a phospholipid bound form and intermediates or derivatives thereof.
12 . The composition of claim 11 , wherein the molar ratio of choline to the essential fatty acid is about 1:0.0005 to about 1:50.
13 . The composition of claim 11 , wherein the molar ratio of the vitamin B12 or a synthetic form of vitamin B12 to choline is about 1:14 to about 1:200,000,000.
14 . The composition of claim 11 , wherein the choline is in the form of a salt.
15 . The composition of claim 11 , wherein the choline is in the form of choline chloride, choline bitartrate, choline hydroxide, choline citrate and choline carbonate or combinations thereof.
16 . The composition of claim 11 ,
wherein the molar ratio of essential fatty acid to cobalamin binding protein is about 1:0.025 to about 1:0.00000005,
wherein the molar ratio of the cobalamin binding protein to the vitamin B12 or a synthetic form of vitamin B12 is about 1:25,000 to about 1:0.00025,
wherein the molar ratio of the vitamin B12 or a synthetic form of vitamin B12 to choline is about 1:14 to about 1:200,000,000, and
wherein the molar ratio of choline to the essential fatty acid is about 1:0.0005 to about 1:50.
17 . A method of providing supplemental nutrition to a mammal comprising administering to the mammal the composition of claim 1 .
18 . The method of claim 17 , wherein the nutrition reduces the occurrence of a neural tube defect, low birth weight, premature birth, an allergic disease, a neurodevelopmental defect, a neurodegenerative defect, a neuropsychiatric defect, pervasive development disorder, autism, ADD, ADHD, schizophrenia, bipolar depression, Alzheimer's disease, Parkinson's disease, Huntington's disease, Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis (NASH), Metabolic Syndrome, cardiovascular disease or combinations thereof.
19 . The method of claim 17 , wherein the nutrition improves cognitive ability, a neurodevelopmental condition, neurodegenerative condition, a neuropsychiatric condition, brain development and ocular health.