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 5-30% w/w of testosterone undecanoate; 10-40% w/w of a hydrophilic surfactant carrier; no more than 20% w/w of a solidifying agent, 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 said composition provides a plasma C max  of testosterone of less than 2500 ng/dL when orally administered as at least one unit dosage form with a meal twice daily to a hypogonadal male. 
     
     
         7 . The composition of  claim 1 , wherein said composition provides a plasma testosterone concentration in the range of about 250 ng/dL to about 1200 ng/dL at steady state when orally administered as at least one unit dosage form twice daily with a meal to a hypogonadal male. 
     
     
         8 . The composition of  claim 1 , wherein said lipophilic surfactant carrier comprises a at least one of a glycerol palmitostearate and a glyceryl monooleate. 
     
     
         9 . The composition of  claim 1 , wherein said composition comprises testosterone undecanoate in an amount of at least one of about 80 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. 
     
     
         10 . The composition of  claim 1 , wherein said composition comprises 10-20% w/w of testosterone undecanoate. 
     
     
         11 . An oral pharmaceutical composition comprising 5-30% w/w of testosterone undecanoate;
 10-40% w/w of a hydrophilic surfactant carrier; 40-70% w/w of a lipophilic surfactant carrier, and at least one additive, wherein said lipophilic surfactant carrier comprises at least one of a fatty acid, a fatty acid ester, and a combination thereof, and wherein said at least one additive comprises at least one of a solid, a liquid, and a semi-solid, and wherein said pharmaceutical composition comprises from about 70 mg to about 150 mg testosterone undecanoate and a phytosterol or ester thereof.   
     
     
         12 . The composition of  claim 11 , 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. 
     
     
         13 . The composition of  claim 11 , wherein said composition comprises at least one of propylene glycol laurate and polyoxyl 40 hydrogenated castor oil. 
     
     
         14 . The composition of  claim 11 , wherein said composition provides a plasma C max  of testosterone of less than 2500 ng/dL when orally administered as at least one unit dosage form with a meal twice daily to a hypogonadal male. 
     
     
         15 . The composition of  claim 11 , wherein said composition provides a plasma testosterone concentration in the range of about 250 ng/dL to about 1200 ng/dL at steady state when orally administered as at least one unit dosage form twice daily with a meal to a hypogonadal male. 
     
     
         16 . The composition of  claim 11 , wherein said lipophilic surfactant carrier comprises at least one of a glycerol palmitostearate and a glyceryl monooleate. 
     
     
         17 . The composition of  claim 11 , wherein said composition comprises testosterone undecanoate in an amount of at least one of about 80 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. 
     
     
         18 . The composition of  claim 11 , wherein said composition comprises 10-20% w/w of testosterone undecanoate. 
     
     
         19 . An oral dosage form of testosterone undecanoate in a carrier comprising 5-30% w/w testosterone undecanoate; 5-30% w/w of polyoxyl 40 hydrogenated castor oil; and 50-90% w/w of at least one of a fatty acid, a fatty acid ester, and a combination thereof; wherein said carrier comprises at least one of a solid, a liquid, and a semi-solid. 
     
     
         20 . The oral dosage form of  claim 19 , 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. 
     
     
         21 . The oral dosage form of  claim 19 , wherein said oral dosage form comprises at least one of a jelly, a solid, a semi-solid, and a glassy or paste-like composition. 
     
     
         22 . The oral dosage form of  claim 19 , wherein said oral dosage form provides a plasma C max  of testosterone of less than 2500 ng/dL when orally administered as at least one unit dosage form with a meal twice daily to a hypogonadal male. 
     
     
         23 . The oral dosage form of  claim 19 , wherein said oral dosage form provides a plasma testosterone concentration in the range of about 250 ng/dL to about 1200 ng/dL at steady state when orally administered as at least one unit dosage form twice daily with a meal to a hypogonadal male. 
     
     
         24 . The oral dosage form of  claim 19 , wherein said carrier comprises a at least one of a glycerol palmitostearate and a glyceryl monooleate. 
     
     
         25 . The oral dosage form of  claim 19 , wherein said oral dosage form comprises testosterone undecanoate in an amount of at least one of about 70 mg to about 150 mg, about 80 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. 
     
     
         26 . The oral dosage form of  claim 19 , wherein said oral dosage form comprises 10-20% w/w of testosterone undecanoate. 
     
     
         27 . A method of treating a mammal having testosterone deficiency comprising orally administering to said mammal at least one of:
 an oral pharmaceutical composition comprising 5-30% w/w of testosterone undecanoate; 10-40% w/w of a hydrophilic surfactant carrier; no more than 20% w/w of a solidifying agent, 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,   an oral pharmaceutical composition comprising 5-30% w/w of testosterone undecanoate; 10-40% w/w of a hydrophilic surfactant carrier; 40-70% w/w of a lipophilic surfactant carrier, and at least one additive, wherein said lipophilic surfactant carrier comprises at least one of a fatty acid, a fatty acid ester, and a combination thereof, and wherein said at least one additive comprises at least one of a solid, a liquid, and a semi-solid, and wherein said pharmaceutical composition comprises from about 70 mg to about 150 mg testosterone undecanoate and a phytosterol or ester thereof, and   an oral dosage form of testosterone undecanoate in a carrier comprising 5-30% w/w testosterone undecanoate; 5-30% w/w of polyoxyl 40 hydrogenated castor oil; and 50-90% w/w of at least one of a fatty acid, a fatty acid ester, and a combination thereof; wherein said carrier comprises at least one of a solid, a liquid, and a semi-solid.   
     
     
         28 . The method of  claim 27 , wherein said administration provides a plasma C max  of testosterone of less than 2500 ng/dL when orally administered as at least one unit dosage form with a meal twice daily to said mammal. 
     
     
         29 . The method of  claim 27 , wherein said administration provides a plasma testosterone concentration in the range of about 250 ng/dL to about 1200 ng/dL at steady state when orally administered as at least one unit dosage form twice daily with a meal to said mammal. 
     
     
         30 . The method of  claim 27 , wherein said administration is performed with a meal or within at least one of 30 minutes of a meal, 1 hour of a meal, or 2 hours of a meal. 
     
     
         31 . The method of  claim 27 , wherein said mammal is in at least one of a fasting state and a fed state. 
     
     
         32 . The method of  claim 27 , wherein said administration comprises at least one of a once-a-day administration and a plurality-of-times-a-day administration. 
     
     
         33 . The method of  claim 27 , wherein said method provides said subject about 240 mg to about 800 mg of testosterone undecanoate per day. 
     
     
         34 . The method of  claim 33 , wherein said method provides said subject about 120 mg to about 400 mg of testosterone undecanoate twice per day. 
     
     
         35 . The method of  claim 27 , wherein said 5-30% w/w of testosterone undecanoate comprises 10-20% w/w of testosterone undecanoate.