Once-a-Week Administration of 25-Hydroxy Vitamin D3 to Sustain Elevated Steady-State Pharmacokinetic Blood Concentration

Abstract

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.

We claim: 
     
         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.