Once-a-week administration of 25-hydroxy vitamin D
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 maintain the serum level in a human in need thereof to a therapeutic 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 maintain the serum level in the human to a therapeutic 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 therapeutic 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 30-50 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 0.6 mg-6 mg of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
10. An parenteral dosage form comprising:
a single dose of 25-hydroxy-vitamin D 3 , or the monohydrate thereof, sufficient to maintain the serum level in a human in need thereof to a therapeutic 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 parenteral carrier system,
wherein the parenteral dosage form is an injectable dosage form or an infusion dosage form.
11. The parenteral dosage form of claim 10 , wherein each single dose is administered weekly and is sufficient to maintain the serum level in the human to a therapeutic concentration in the range of 30 ng/ml to 200 ng/ml at steady-state pharmacokinetics.
12. The parenteral dosage form of claim 10 , wherein the therapeutic concentration is in the range of 30 ng/ml to 100 ng/ml.
13. The parenteral dosage form of claim 10 , wherein the single dose is in the range of 10-100 μg/kg of body weight of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
14. The parenteral dosage form of claim 10 , wherein the single dose is in the range of 30-50 μg/kg of body weight of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
15. The parenteral dosage form of claim 10 , wherein the single dose is in the range of 0.6 mg-6 mg of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
16. A method of maintaining the blood level therapeutic concentration of 25-hydroxy-vitamin D 3 at steady-state pharmacokinetics in a human in need thereof comprising orally administering, at least once every 7 days, a single dose of 25-hydroxy-vitamin D 3 , or the monohydrate thereof, sufficient to maintain the serum level in a human to a therapeutic concentration in the range of 30 ng/ml to 200 ng/ml for at least 7 days at steady-state pharmacokinetics.
17. The method of claim 16 , wherein each single dose is administered weekly and is sufficient to maintain the serum level in the human to a therapeutic concentration in the range of 30 ng/ml to 200 ng/ml at steady-state pharmacokinetics.
18. The method of claim 16 , wherein the therapeutic concentration is in the range of 30 ng/ml to 100 ng/ml.
19. The method of claim 16 , wherein the single dose is in the range of 10-100 μg/kg of body weight of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
20. The method of claim 16 , wherein the single dose is in the range of 30-50 μg/kg of body weight of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
21. The method of claim 16 , wherein the single dose is in the range of 35-45 μg/kg of body weight of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
22. The method of claim 16 , wherein the single dose is in the form of a soft gel capsule or a tablet.
23. The method of claim 16 , wherein the human in need thereof is a human deficient in vitamin D having a serum level therapeutic concentration of 25-hydroxy-vitamin D 3 less than 30 ng/ml.
24. The method of claim 16 , wherein the human in need thereof is a human deficient in vitamin D having a serum level therapeutic concentration of 25-hydroxy-vitamin D 3 in the range of 10 ng/ml to 20 ng/ml.
25. A method of maintaining the blood level therapeutic concentration of 25-hydroxy-vitamin D 3 at steady-state pharmacokinetics in a human in need thereof comprising parenterally administering by injection or infusion, at least once every 7 days, a single dose of 25-hydroxy-vitamin D 3 , or the monohydrate thereof, sufficient to maintain the serum level in the human to a therapeutic concentration in the range of 30 ng/ml to 200 ng/ml for at least 7 days at steady-state pharmacokinetics.
26. The method of claim 25 , wherein each single dose is administered weekly and is sufficient to maintain the serum level in the human to a therapeutic concentration in the range of 30 ng/ml to 200 ng/ml at steady-state pharmacokinetics.
27. The method of claim 25 , wherein the therapeutic concentration is in the range of 30 ng/ml to 100 ng/ml.
28. The method of claim 25 , wherein the single dose is in the range of 10-100 μg/kg of body weight of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
29. The method of claim 25 , wherein the single dose is in the range of 30-50 μg/kg of body weight of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
30. The method of claim 25 , wherein the single dose is in the range of 35-45 μg/kg of body weight of 25-hydroxy-vitamin D 3 or the monohydrate thereof.
31. The method of claim 25 , wherein the human in need thereof is deficient in vitamin D having a serum level therapeutic concentration of 25-hydroxy-vitamin D 3 less than 30 ng/ml.
32. The method of claim 25 , wherein the human in need thereof is deficient in vitamin D having a serum level therapeutic concentration of 25-hydroxy-vitamin D 3 in the range of 10 ng/ml to 20 ng/ml.
33. A method of maintaining the blood level therapeutic concentration of 25-hydroxy-vitamin D 3 at steady-state pharmacokinetics in a human in need thereof comprising transdermally administering, at least once every 7 days, a single dose of 25-hydroxy-vitamin D 3 , or the monohydrate thereof, in a transdermal dosage form, sufficient to maintain the serum level in the human to a therapeutic concentration in the range of 30 ng/ml to 200 ng/ml for at least 7 days at steady-state pharmacokinetics.
34. A method of maintaining the blood level therapeutic concentration of 25-hydroxy-vitamin D 3 at steady-state pharmacokinetics in a human in need thereof comprising administering by inhalation, at least once every 7 days, a single dose of 25-hydroxy-vitamin D 3 , or the monohydrate thereof, in an inhalation dosage form, sufficient to maintaining the serum level in the human to a therapeutic concentration in the range of 30 ng/ml to 200 ng/ml for at least 7 days at steady-state pharmacokinetics.
35. A method of maintaining the blood level therapeutic concentration of 25-hydroxy-vitamin D 3 at steady-state pharmacokinetics in a human in need thereof comprising administering at least once every 7 days, a single dose of 25-hydroxy-vitamin D 2 , or the monohydrate thereof, sufficient to maintain the serum level in the human to a therapeutic concentration in the range of 30 ng/ml to 200 ng/ml for at least 7 days at steady-state pharmacokinetics.
36. A dosage form comprising:
a single dose of 25-hydroxy-vitamin D 2 , or the monohydrate thereof, sufficient to maintain the serum level in a human in need thereof to a therapeutic 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.
37. An inhalation dosage form comprising:
a single dose of 25-hydroxy-vitamin D 3 , or the monohydrate thereof, sufficient to maintain the serum level in a human in need thereof to a therapeutic 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 inhalation carrier system.
38. A topical dosage form comprising:
a single dose of 25-hydroxy-vitamin D 3 , or the monohydrate thereof, sufficient to maintain the serum level in a human in need thereof to a therapeutic 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 topical carrier system.
39. The topical dosage form of claim 38 , wherein the dosage is delivered transdermally.
40. The oral dosage form of claim 1 , wherein the single dose can elevate the serum level within one day.
41. The oral dosage form of claim 1 , wherein the pharmaceutically suitable oral carrier is 5% ethanol in Neobee oil.