Formulation for lipophilic agents

Abstract

The invention relates to pharmaceutical formulations of lipophilic therapeutic agents in which such agents are solubilized in largely aqueous vehicles, and processes for preparing and using the same.

1 - 45 . (canceled) 
     
     
         46 . A parenteral formulation of doxercalciferol comprising doxercalciferol, polysorbate 20, butylated hydroxytoluene, ethanol, and water. 
     
     
         47 . The parenteral formulation of doxercalciferol of  claim 46 , wherein the doxercalciferol is present in an amount ranging from about 2-10 μg/mL. 
     
     
         48 . The parenteral formulation of doxercalciferol of  claim 47 , wherein the polysorbate 20 is present in an amount ranging from about 0.5% to about 5% w/w. 
     
     
         49 . The parenteral formulation of doxercalciferol of  claim 48 , wherein the butylated hydroxytoluene is present in an amount ranging from about 20 to about 2000 ppm. 
     
     
         50 . The parenteral formulation of doxercalciferol of  claim 49 , wherein the ethanol is present in an amount ranging from about 1% to about 10% w/w. 
     
     
         51 . The parenteral formulation, of doxercalciferol of  claim 50 , wherein water is present in an amount of about 50% to about 99% w/w of the formulation. 
     
     
         52 . The parenteral formulation of doxercalciferol of  claim 51 , wherein the formulation has been terminally sterilized. 
     
     
         53 . The parenteral formulation of doxercalciferol of  claim 52 , for use in the treatment of secondary hyperparathyroidism. 
     
     
         54 . A method of treating secondary hyperparathyroidism comprising the parenteral administration of a formulation of doxercalciferol further comprising polysorbate 20, butylated hydroxytoluene, ethanol, and water. 
     
     
         55 . The method of  claim 54 , wherein the formulation of doxercalciferol comprises doxercalciferol in an amount ranging from about 2-10 μg/mL. 
     
     
         56 . The method of  claim 55  wherein the formulation of doxercalciferol comprises polysorbate 20 in an amount ranging from about 0.5% to about 5% w/w. 
     
     
         57 . The method of  claim 56 , wherein the formulation of doxercalciferol comprises butylated hydroxytoluene in an amount ranging from about 20 to about 2000 ppm. 
     
     
         58 . The method of  claim 57 , wherein the formulation of doxercalciferol comprises ethanol in an amount ranging from about 1% to about 10% w/w. 
     
     
         59 . The method of  claim 58 , wherein the formulation of doxercalciferol comprises water in an amount of about 50% to, about 99% w/w of the formulation. 
     
     
         60 . The method of  claim 59 , wherein the formulation of doxercalciferol has been terminally sterilized.