Abiraterone acetate lipid formulations

Abstract

Abiraterone acetate lipid formulations.

1 . A dosage form, comprising:
 a capsule; and   a lipid fill composition, comprising
 abiraterone acetate; 
 a lipid matrix comprising (i) a fatty acid ester of glycerol, or a mixture thereof in an amount ranging from 10 wt % to 60 wt % of the lipid fill composition; and (ii) a propylene glycol fatty acid ester, or a polyoxylglyceride, or a combination thereof, wherein the propylene glycol fatty acid ester and/or the polyoxylglyceride is present in an amount ranging from 20 wt % to 60 wt % of the lipid fill composition; and 
 an optional antioxidant; wherein the abiraterone acetate is solubilized in the lipid matrix. 
   
     
     
         2 . The dosage form of  claim 1 , wherein the abiraterone acetate is present in an amount ranging from 5 wt % to 20 wt %. 
     
     
         3 . The dosage form of  claim 1 , wherein at least 60 wt % of the abiraterone acetate in the lipid fill composition is crystalline. 
     
     
         4 . The dosage form of  claim 1 , wherein the fatty acid ester of glycerol is glycerol monolinoleate, glycerol monooleate, glycerol monostearate, glycerol monocaprylate, glycerol monocaprate, or mixtures thereof. 
     
     
         5 . The dosage form of  claim 1 , wherein the propylene glycol fatty acid ester is selected from propylene glycol monocaprylate, a propylene glycol dicaprate/dicaprylate ester, propylene glycol heptanoate, propylene glycol monolaurate, propylene glycol monostearate, propylene glycol monooleate, propylene glycol monopalmitate, propylene glycol monomyristate, or a mixture thereof. 
     
     
         6 . The dosage form of  claim 1 , wherein the polyoxylglyceride is selected from an oleoyl macrogol-6 glyceride, a linoleoyl macrogol-6 glyceride, a lauroyl macrogol-6 glyceride or a mixture thereof. 
     
     
         7 . The dosage form of  claim 1 , wherein the lipid fill composition further comprises a surfactant. 
     
     
         8 . The dosage form of  claim 7 , wherein the surfactant is present in an amount ranging from 15 wt % to 60 wt %. 
     
     
         9 . The dosage form of  claim 7 , wherein the surfactant is polyoxyl 40 hydrogenated castor oil, polyoxyl 35 castor oil, polyethoxylated 12-hydroxteric acid, vitamin E, tocopheryl polyethylene glycol succinate, a caprylocaproyl macrogol-8 glyceride, a lauroyl macrogol-32 glyceride, a macrogol stearate, a polysorbate, or a mixture thereof. 
     
     
         10 . The dosage form of  claim 1 , wherein the antioxidant is present and is selected from vitamin E, tocopheryl polyethylene glycol succinate, rosemary extract, ascorbic acid, ascorbyl palmitate, butylated hydroxyanisole, butylated hydroxytoluene, or a mixture thereof. 
     
     
         11 . The dosage form of  claim 1 , wherein the lipid fill composition comprises the abiraterone acetate; the fatty acid ester of glycerol in an amount ranging from 25 wt % to 35 wt %; and the propylene glycol fatty acid ester or the polyoxylglyceride in an amount ranging from 30 wt % to 50 wt %. 
     
     
         12 . The dosage form of  claim 11 , wherein the lipid fill composition further comprises a surfactant, an antioxidant, or a combination thereof. 
     
     
         13 . The dosage form of  claim 12 , wherein the surfactant is polyoxyl 40 hydrogenated castor oil. 
     
     
         14 . The dosage form of  claim 1 , wherein the fatty acid ester of glycerol is glycerol monooleate; and the propylene glycol fatty acid is propylene glycol monolaurate, propylene glycol monocaprylate, or a mixture thereof. 
     
     
         15 . The dosage form of  claim 1 , wherein the capsule is a hard capsule or a soft capsule.