Pharmaceutical delivery system for vitamin C and vitamin E and use of a combination of vitamin C and E for preventing or treating conditions involving oxidative stress
AssigneeFerrosan A/S
InventorsBent Højgaard, Henrik Enghusen Poulsen, Jukka Salonen
Life of this patent
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Abstract
A pharmaceutical delivery system comprising a slow-release formulation of vitamin C (ascorbic acid) and a plain-release formulation of vitamin E (tocopherol) has been found to raise and maintain the concentrations of these vitamins in the blood plasma to a ratio of approximately 2.2:1. The steady-state concentration and ratio of these antioxidants has been found to be critical in the prevention and treatment of oxidative stress related disorders such as arteriosclerosis and diabetes and neural degenerative disorders such as Alzheimer's Disease.
Claims15
A delivery system for oral delivery of the antioxidants vitamin C and vitamin E to obtain high concentrations thereof and a controlled ratio between vitamin C and vitamin E in blood plasma in humans or animals, characterized in that it has a slow release of vitamin C and a plain release of vitamin E;
- wherein vitamin C is present in an amount in the delivery system so as to deliver a daily dose corresponding to 60 mg-2 g of vitamin C, and vitamin E is present in an amount in the delivery system so as to deliver a daily dose corresponding to 50 mg-500 mg of α-tocopherol, and the antioxidants are present in amounts so as to obtain vitamin C and vitamin E in a ratio in the blood plasma of 1:1 to 3:1;
- wherein the solubility of vitamin E is such that at least 90% of vitamin E is dissolved in less than 30 minutes under the conditions of Test B;
- and
- wherein the solubility of vitamin C is such that less than 40% of vitamin C is dissolved after 1 hour under the conditions of Test A;
- and
- wherein said delivery system achieves a concentration of vitamin E in the blood plasma of at least 20 μmol/liter and a concentration of vitamin C in the blood plasma of at least 40 μmol/liter.
A method of treating oxidative stress disorders, said method comprising administering to an individual a combination of vitamin C and vitamin E in sufficient amounts to raise the concentration of said vitamins in blood plasma to a ratio of approximately 1:1 to 3:1, in not more than 8 weeks from the first administration,
- wherein vitamin C is released by a slow release formulation and vitamin E is released by a plain release formulation;
- and
- wherein the concentration of vitamin E in the blood plasma is at least 20 μmol/liter and the concentration of vitamin C in the blood plasma is at least 40 μmol/liter;
- and
- wherein the administering is in amounts corresponding to a daily dose of 60 mg-2 g of vitamin C and corresponding to a daily dose of 50 mg-500 mg of α-tocopherol.
A method of treating oxidative stress disorders, said method comprising daily administering to an individual at least one dosage unit comprising a combination of vitamin C and vitamin E in sufficient amounts to raise the concentration of said vitamins in blood plasma to a controlled ratio;
- wherein said vitamin C is formulated in a slow-release preparation and vitamin E is formulated only in plain-release formulation;
- wherein the concentration of vitamin E in the blood plasma is at least 20 μmol/liter, and the concentration of vitamin C in the blood plasma is at least 40 μmol/liter;
- wherein the antioxidants are present in amounts so as to obtain vitamin C and vitamin E in a in the blood plasma of 1:1 to 3:1;
- wherein the at least one dosage units delivers a daily dose corresponding to 60 mg-2 g of vitamin C and a daily dose corresponding to 50 mg-500 mg of α-tocopherol;
- and
- wherein the formulation of vitamin E is such that at least 90% of vitamin E is dissolved in less than 30 minutes under the conditions of Test B, and the formulation of vitamin C is such that less than 40% of vitamin C is dissolved after 1 hour under the conditions of Test A.
Dependencies are inferred from the claim text.