Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2000-04-14
2001-07-24
Davis, Zinna Northington (Department: 1625)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S399000, C536S026400
Reexamination Certificate
active
06265391
ABSTRACT:
Homocystinuria is characterized by high serum homocysteine levels and leads to blood vessel damage, excretion of homocysteine in the urine, mental retardation, ectopia lentis, sparse blonde hair, convulsive tendency, thromboembolic episodes, and fatty changes of liver and is associated with defective formation of cystathionine synthetase.
Homocysteine is a homolog of cysteine and is produced by the demethylation of methionine, and is an intermediate in the biosynthesis of cysteine from methionine via cystathionine by cystathioninase.
High serum homocysteine-related blood vessel damage may account for up to 20% of U.S. heart attacks, 40% of strokes and 60% of peripheral venous occlusions, in addition to those in the placenta associated with neural tube defects in about 2,000 infants a year.
It has recently been disclosed that the B vitamins, folic acid and vitamin B
12
, by converting homocysteine to methionine, lower high serum homocysteine and thereby protect against high serum homocysteine-related blood vessel damage and nerve damage. The major sources of folic acid are foods that are often not ingested in sufficient amount, namely fresh fruits and vegetables, particularly the dark green leafy vegetables and orange juice. However, while vitamin B
12
is in all animal protein, including meat, fish, poultry, eggs, milk and milk products, there is none in anything that grows out of the ground.
Folic acid and vitamin B
12
are members of the vitamin B complex necessary for the normal production of red blood cells and nerve cells. Folic acid is present in peptide linkages in high quantities in liver, green vegetables and yeast. Vitamin B
12
is present in high quantities in liver and other animal products.
Many plant and animal tissues contain folic acid as reduced methyl or formyl polyglutamates. Folates act as co-enzymes for processes in which there is transfer of a 1-carbon unit, as in purine and pyrimidine nucleotide biosynthesis, amino acid conversions such as histidine to glutamic acid and generation and use of formate. Absorption takes place in the small intestine. In the gut epithelial cells, polyglutamates are reduced to dihydro- and tetrahydra-folates, and absorbed bound to protein and transported in blood serum as methyl tetrahydrafolate. Some absorbed folate is excreted in the bile and re-absorbed, together with an amount not absorbed and excreted in the stool.
Vitamin B
12
is necessary for taking a one-carbon unit from folic acid and delivering it to homocysteine to convert homocysteine to methionine. Vitamin B
12
and folic acid are necessary for normal nerve function as well as for blood formation.
Vitamin B
6
is involved in a different pathway for getting rid of excess homocysteine, which pathway is usually less important than the B
12
-folate dependent pathway.
Vitamin supplements containing Folic Acid and/or vitamin B
12
and or Vitamin B
6
are known, however, such supplements contain other vitamins, phytochemicals and minerals such as iron and copper, or other antioxidant substances, including antioxidants, which destroy some of Vitamin B
12
and also some of the folic acid.
In accordance with an aspect of the present invention there is provided a multiple vitamin supplement composition comprising folic acid and vitamin B
12
that is essentially free of antioxidants.
In accordance with another aspect of the present invention there is provided a multiple vitamin supplement composition comprising folic acid, vitamin B
12
and vitamin B
6
that is essentially free of antioxidants.
In accordance with another aspect of the present invention there is provided a method of administering a multiple vitamin supplement composition for lowering high serum homocysteine levels to protect against the incidence of heart attack and other blood vessel related disorders.
In accordance with another aspect of the present invention there is provided a method of preparing a multiple vitamin supplement composition comprising folic acid and vitamin B
12
that is essentially free of antioxidants.
In accordance with another aspect of the present invention there is provided a method of preparing a multiple vitamin supplement composition comprising folic acid, vitamin B
12
and vitamin B
6
that is essentially free of antioxidants.
In accordance with the primary aspect of the present invention there is provided a multiple vitamin supplement composition comprising folic acid and vitamin B
12
. The composition may also contain vitamin B
6
, wherein the composition is essentially free of antioxidants.
It has been shown that folic acid and vitamin B
12
each have the ability to protect against high serum homocysteine-related blood vessel damage, as in some circumstances, does vitamin B
6
.
One problem with previous attempts at using vitamin supplements to prevent such cardiovascular problems from developing is that folic acid supplements taken alone are unsafe since they allow unrecognized genetically predisposed vitamin B
12
deficiency to produce irreversible nerve damage in susceptible populations. Susceptible populations include the elderly (those at least about 50 years of age) and women of African American descent in their child-bearing years.
Accordingly, the multiple vitamin supplement composition of the present invention comprises folic acid and vitamin B
12
, and may also contain vitamin B
6
. The addition of vitamin B
12
lowers to normal the vitamin B
12
-deficiency-produced high serum homocysteine found in millions of the elderly.
Vitamin B
6
, the other B vitamin involved in homocysteine metabolism is also added to the multiple vitamin supplement of the present invention. The addition of vitamin B
12
and vitamin B
6
further metabolizes homocysteine and lowers serum homocysteine levels.
REFERENCES:
Wighton et al, Medical Journal of Australia, vol. 2, No. 1, pp. 1-3, Abstract Only, Jul. 1979.
Davis Zinna Northington
Upsher-Smith Laboratories, Inc.
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