Steroidal compositions and method of making and use

Abstract

Disclosed herein are compositions suitable for use in increasing the energy level, memory function and cognitive focus, and lowering the feeling of lethargy in men and women. Further disclosed are methods of use and processes for preparing the disclosed compositions.

What is claimed is: 
     
         1 . An implantable pharmaceutical composition, comprising:
 a) from about 90% to about 99% by weight of testosterone:   b) from about 0.005% to about 0.05% by weight of triamcinolone; and   c) the balance carriers and adjunct ingredients.   
     
     
         2 . The composition according to  claim 1 , wherein the composition comprises from about 92% to about 99% by weight of testosterone. 
     
     
         3 . The composition according to  claim 1 , wherein the composition comprises from about 90% to about 97% by weight of testosterone. 
     
     
         4 . The composition according to  claim 1 , wherein the composition comprises from about 93% to about 99% by weight of testosterone. 
     
     
         5 . The composition according to  claim 1 , wherein the composition comprises from about 90% to about 96% by weight of testosterone. 
     
     
         6 . The composition according to  claim 1 , wherein the composition comprises from about 93% to about 97% by weight of testosterone. 
     
     
         7 . The composition according to  claim 1 , wherein the composition comprises 95% by weight of testosterone. 
     
     
         8 . The composition according to  claim 1 , wherein the composition comprises from about 0.0075% to about 0.05% by weight of triamcinolone. 
     
     
         9 . The composition according to  claim 1 , wherein the composition comprises from about 0.005% to about 0.04% by weight of triamcinolone. 
     
     
         10 . The composition according to  claim 1 , wherein the composition comprises from about 0.01% to about 0.04% by weight of triamcinolone. 
     
     
         11 . The composition according to  claim 1 , wherein the composition comprises from about 0.015% to about 00.3% by weight of triamcinolone. 
     
     
         12 . The composition according to  claim 1 , wherein the composition comprises 0.02% by weight of triamcinolone. 
     
     
         13 . The composition according to  claim 1 , further comprising from about 1% to about 8% by weight of a coating agent. 
     
     
         14 . The composition according to  claim 13 , comprising about 4% by weight of a coating agent. 
     
     
         15 . The composition according to  claim 13 , wherein the coating agent is chose from dextran, poly(ε-caprolactone), poly(1,4-dioxan-2-one), poly(sebacic anhydride), poly(dodecanoic anhydride), poly(ethylene glycol), polyoxyethylene, stearic acid, stearyl alcohol, ethylene glycol palmitostearate, cetyl esters wax, poly(1,3-bis(carboxyphenoxy)propane-co-sebacic acid), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) or a combination thereof. 
     
     
         16 . The composition according to  claim 13 , wherein the coating agent is stearic acid or stearyl alcohol. 
     
     
         17 . The composition according to  claim 13 , wherein the coating agent is stearic acid. 
     
     
         18 . The composition according to  claim 1 , further comprising a binding agent. 
     
     
         19 . The composition according to  claim 18 , wherein the binding agent is chosen from polyethylene glycol 1500, polyethylene glycol 2000, polyethylene glycol 3000, polyethylene glycol 4000, polyethylene glycol 6000, polyethylene glycol 8000, polyethylene glycol 10000, methylcellulose, ethylcellulose, hydroxymethyl cellulose, hydroxyethylcellulose, hydroxypropyl methylcellulose, polyoxyethylene, copolymers of polyoxyethylene-polyoxypropylene and mixtures thereof. 
     
     
         20 . The composition according to  claim 19 , wherein the binding agent is methylcellulose, ethylcellulose, hydroxymethyl cellulose, or hydroxyethylcellulose. 
     
     
         21 . The composition according to  claim 19 , wherein the binding agent is ethylcellulose. 
     
     
         22 . An implantable pharmaceutical composition, comprising:
 a) from about 10 mg to about 250 mg by weight of testosterone;   b) from about 1 μg to about 50 μg by weight of triamcinolone; and   c) the balance one or more adjunct ingredients or carriers.   
     
     
         23 . The composition according to  claim 22 , wherein the one or more adjunct ingredients are chosen from a coating agent, a binding agent or mixtures thereof. 
     
     
         24 . The composition according to  claim 23 , wherein the composition comprises from about 0.5 mg to about 12.5 mg by weight of a coating agent, a binding agent or mixtures thereof. 
     
     
         25 . A method for treating a subject in need of an increased testosterone level, comprising contacting the subject with a composition comprising:
 a) from about 90% to about 99% by weight of testosterone;   b) from about 0.005% to about 0.05% by weight of triamcinolone;   c) the balance carriers and adjunct ingredients.   
     
     
         26 . The method according to  claim 25 , wherein the one or more adjunct ingredients are chosen from a coating agent, a binding agent or mixtures thereof. 
     
     
         27 . The method according to  claim 26 , wherein the composition comprises from about 0.5 mg to about 12.5 mg by weight of a coating agent, a binding agent, or mixtures thereof. 
     
     
         28 . The method according to  claim 27 , wherein the coating agent is stearic acid 1. 
     
     
         29 . The method according to  claim 27 , wherein the coating agent is stearyl alcohol. 
     
     
         30 . The method according to  claim 27 , wherein the binding agent is ethylcellulose.