Steroidal Compositions

Abstract

Provided herein are steroid containing compositions suitable for providing therapeutically effective amounts of at least one steroid to individuals. Also provided herein are compositions comprising testosterone and/or testosterone derivatives suitable for providing therapeutically effective and safe amounts of testosterone over periods of time. Further provided are methods of treating andro- and/or testosterone deficiency in individuals by administering to the individuals compositions described herein.

What is claimed is: 
     
         1 . A pharmaceutical composition comprising (i) a therapeutically effective amount of one or more testosterone C 2 -C 13  alkyl ester; and (ii) at least one pharmaceutically acceptable carrier; the pharmaceutical composition releasing about 80% or less of the testosterone C 2 -C 13  alkyl ester after 30 minutes in an aqueous medium. 
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the testosterone C 2 -C 13  alkyl ester is testosterone undecanoate. 
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition comprises about 10 mg to about 1000 mg of testosterone C 2 -C 13  alkyl ester. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein a single dose of the pharmaceutical composition provides a mean plasma C max  of testosterone that is about 19 ng/mL or less upon oral administration. 
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein a single dose of the pharmaceutical composition provides a mean plasma C max  of dihydrotestosterone that is about 4.5 ng/mL or less upon oral administration. 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition provides a testosterone mean plasma C max  at steady state of about 1300 ng/dL or less. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition provides a testosterone mean plasma C min  at steady state of about 200 ng/dL or more. 
     
     
         8 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition provides with administration to an individual a ratio of a testosterone equivalent dose to a mean steady state testosterone C max , the ratio being about 500×10 6  mL or less. 
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition provides, with oral administration to an individual, a difference between a mean plasma C max  of testosterone at steady state and a mean plasma C min  of testosterone at steady state that is about 16 ng/mL or less. 
     
     
         10 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition provides, with oral administration to an individual, a difference between a mean plasma C max  at steady state and a mean plasma C min  at steady state of testosterone C 2 -C 13  alkyl ester that is about 275 ng/mL or less. 
     
     
         11 . The pharmaceutical composition of  claim 1 , wherein a single dose of the pharmaceutical composition provides a mean plasma concentration of testosterone after 1 hour that is about 150 ng/dL or less upon oral administration. 
     
     
         12 . The pharmaceutical composition of  claim 1 , wherein a single dose of the pharmaceutical composition provides a mean plasma concentration of testosterone after 2 hours that is about 500 ng/dL or less upon oral administration. 
     
     
         13 . The pharmaceutical composition of  claim 1 , wherein the at least one pharmaceutically acceptable carrier comprises at least one hydrophilic carrier. 
     
     
         14 . The pharmaceutical composition of  claim 13 , wherein the hydrophilic carrier is a hydrophilic triglyceride. 
     
     
         15 . The pharmaceutical composition of  claim 14 , wherein the hydrophilic triglyceride is a polyoxylated castor oil, or a polyoxylated hydrogenated castor oil. 
     
     
         16 . The pharmaceutical composition of  claim 1 , wherein the at least one pharmaceutically acceptable carrier comprises at least one lipophilic carrier. 
     
     
         17 . The pharmaceutical composition of  claim 1 , wherein the at least one lipophilic carrier is selected from the group consisting of a monoglyceride, a diglyceride, a Vitamin E compound, a trigliceride, a fatty acid, polyoxylated fatty acid, polyoxylated triglyceride, polyoxylated vegetable oil, and a combination thereof. 
     
     
         18 . A delayed release oral dosage form comprising (i) a therapeutically effective amount of one or more testosterone C 2 -C 13  alkyl ester; and (ii) at least one pharmaceutically acceptable carrier; wherein a single dose of the delayed release oral dosage form provides a mean plasma C max  of testosterone that is at least 5% lower than the mean plasma C max  of testosterone that is provided by a single dose of an immediate release oral dosage form having an identical amount of the testosterone C 2 -C 13  alkyl ester. 
     
     
         19 . The delayed release oral dosage form of  claim 18 , wherein the testosterone C 2 -C 13  alkyl ester is testosterone undecanoate. 
     
     
         20 . The delayed release oral dosage form of  claim 18 , wherein the pharmaceutical composition comprises about 10 mg to about 1000 mg of testosterone C 2 -C 13  alkyl ester. 
     
     
         21 - 44 . (canceled)