ONCE-A-WEEK ADMINISTRATION OF 25-HYDROXY VITAMIN D3 TO SUSTAIN ELEVATED STEADY-STATE PHARMACOKINETIC BLOOD CONCENTRATION
An oral dosage form comprising a single dose of 25-hydroxy-vitamin D 3 sufficient to elevate the serum level in a human to a concentration in the range of 30 ng/ml to 200 ng/ml for at least 7 days and a pharmaceutically suitable oral carrier system, wherein subsequent single doses at least every 7 days are sufficient to sustain the serum level in a human to a concentration in the range of 30 ng/ml to 200 ng/ml at steady-state pharmacokinetics is disclosed. A method of elevating and sustaining the blood level concentration of 25-hydroxy-vitamin D 3 in a human in need thereof comprising orally administering or parenterally administering by injection or infusion, at least once every 7 days, a single dose of 25-hydroxy-vitamin D 3 sufficient to elevate the serum level in a human to a concentration in the range of 30 ng/ml to 200 ng/ml for at least 7 days, wherein the single doses orally administered at least every 7 days are sufficient to sustain the serum level in a human to a concentration in the range of 30 ng/ml to 200 ng/ml at steady-state pharmacokinetics is disclosed. The human in need thereof may be a human deficient in vitamin D having a serum level concentration of 25-hydroxy-vitamin D 3 less than 30 ng/ml.
1 . An oral dosage form comprising:
a single dose of 25-hydroxy-vitamin D 3 , or the monohydrate thereof, sufficient to sustain the serum level in a human in need thereof to a concentration in the range of 30 ng/ml to 200 ng/ml for at least 7 days at steady-state pharmacokinetics, and,
a pharmaceutically suitable oral carrier system.
2 . The oral dosage form of claim 1 , wherein each single dose administered weekly is sufficient to sustain the serum level in the human to a concentration in the range of 30 ng/ml to 200 ng/ml at steady-state pharmacokinetics.
3 . The oral dosage form of claim 1 , wherein the concentration is in the range of 30 ng/ml to 100 ng/ml.
4 . The oral dosage form of claim 1 in the form of a soft gel capsule.
5 . The oral dosage form of claim 1 , wherein the pharmaceutically suitable carrier system comprises one or more digestible oils.
6 . The oral dosage form of claim 1 in the form of a tablet.
7 . The oral dosage form of claim 1 , wherein the single dose is in the range of 10-100 μg/kg body weight of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
8 . The oral dosage form of claim 1 , wherein the single dose is in the range of 3-100 μg/kg body weight of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
9 . The oral dosage form of claim 1 , wherein the single dose is in the range of 1-50 μg/kg body weight of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
10 . The oral dosage form of claim 1 , wherein the single dose is in the range of 30-50 μg/kg body weight of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
11 . The oral dosage form of claim 1 , wherein the single dose is in the range of 0.6 mg-6 mg of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
12 . A dosage form comprising:
a single dose of 25-hydroxy-vitamin D 3 , or the monohydrate thereof, sufficient to sustain the serum level in a human in need thereof to a concentration in the range of 30 ng/ml to 200 ng/ml for at least 7 days at steady-state pharmacokinetics, and,
a pharmaceutically suitable carrier system.