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 . An oral pharmaceutical composition comprising testosterone undecanoate in a range of greater than 20% w/w to 25% w/w; 10-21% w/w of a hydrophilic surfactant carrier; a solidifying agent comprising no more than 20% w/w of said composition, and 40-70% w/w of a lipophilic surfactant carrier, wherein said lipophilic surfactant carrier comprises at least one of a fatty acid, a fatty acid ester, and a combination thereof, and wherein said pharmaceutical composition comprises from about 70 mg to about 150 mg testosterone undecanoate and is of a predetermined viscosity. 
     
     
         2 . The composition of  claim 1 , wherein said fatty acid ester comprises at least one of a glycerol fatty acid ester, a propylene glycol fatty acid ester, and a combination thereof. 
     
     
         3 . The composition of  claim 1 , wherein said composition includes at least one additive comprising at least one of a solid, a liquid, and a semi-solid. 
     
     
         4 . The composition of  claim 1 , wherein said composition comprises a phytosterol or ester thereof. 
     
     
         5 . The composition of  claim 1 , wherein said composition comprises at least one of propylene glycol laurate and polyoxyl 40 hydrogenated castor oil. 
     
     
         6 . The composition of  claim 1 , wherein when said composition is orally administered as at least one unit dosage form with a meal twice daily to a hypogonadal male, said administration results in a plasma C max  of testosterone of less than 2500 ng/dL in said hypogonadal male. 
     
     
         7 . The composition of  claim 1 , wherein when said composition is orally administered as at least one unit dosage form twice daily with a meal to a hypogonadal male, said administration results in a steady state plasma testosterone concentration in the range of about 250 ng/dL to about 1200 ng/dL in said hypogonadal male. 
     
     
         8 . The composition of  claim 1 , wherein said lipophilic surfactant carrier comprises at least one of a glycerol palmitostearate and a glyceryl monolinoleate, and wherein said composition comprises testosterone undecanoate in an amount of at least one of about 8 mg to about 140 mg, about 90 mg to about 140 mg, about 100 mg to about 130 mg, about 110 mg to about 130 mg, and about 120 mg. 
     
     
         9 . The composition of  claim 1 , wherein said composition comprises 25% w/w of testosterone undecanoate.