Liquid-filled hard gel capsule pharmaceutical formulations

Abstract

Embodiments of liquid-filled hard gel capsule pharmaceutical formulations comprise a non-emulsified mixture, wherein the non-emulsified mixture comprises about 0.1 to about 5% by weight of at least one active pharmaceutical ingredient, about 50 to about 95% by weight long chain triglycerides, and about 5 to about 25% by weight medium chain mono/diglycerides, wherein the long chain triglycerides and medium chain mono/diglycerides are present at a ratio by weight of from about 10:1 to about 5:1.

What is claimed is: 
     
         1 . A liquid-filled hard gel capsule pharmaceutical formulation comprising a non-emulsified mixture disposed in a hard capsule shell, wherein the non-emulsified mixture comprises:
 about 0.1 to about 5% by weight of at least one active pharmaceutical ingredient;   about 50 to about 95% by weight long chain triglycerides; and   about 5 to about 25% by weight medium chain mono/diglycerides, wherein the long chain triglycerides and medium chain mono/diglycerides are present at a ratio by weight of from about 10:1 to about 5:1.   
     
     
         2 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 1  wherein the active pharmaceutical ingredient comprises dutasteride. 
     
     
         3 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 1  wherein the long chain triglyceride comprises corn oil. 
     
     
         4 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 1  wherein the medium chain mono/diglycerides comprise mono/diglycerides of caprylic/capric acid. 
     
     
         5 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 1  wherein the long chain triglyceride comprises vegetable oils. 
     
     
         6 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 5  wherein the vegetable oils are selected from the group consisting of corn oil, canola oil, safflower oil, arachis oil, almond oil, peanut oil, palm oil, palm kernel oil, blackcurrent seed oil, rice bran oil, soybean oil, canola oil, corn oil, coconut oil, cotton seed oil, castor oil, olive oil, Linn oils (Neem), sesame oil, primrose oil, wheat germ oil, fish oil, rapeseed oil, sunflower oil, safflower oil, and combinations thereof. 
     
     
         7 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 1  wherein the at least one active pharmaceutical ingredient comprises dutasteride and tamsulosin. 
     
     
         8 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 1  wherein the medium chain mono/diglycerides comprise mono/diglycerides of caprylic/capric acid. 
     
     
         9 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 1  wherein the non-emulsified mixture is disposed inside a gelatin capsule shell. 
     
     
         10 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 1  wherein the non-emulsified mixture is a substantially homogenous mixture. 
     
     
         11 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 1  wherein the pharmaceutical formulation is substantially free of surfactants. 
     
     
         12 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 1  wherein the pharmaceutical formulation is substantially free of surfactants having a hydrophilic-lipophilic balance (HLB) of greater than or equal to 8. 
     
     
         13 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 1  wherein the non-emulsified mixture further comprises about 0.1 to about 1% by weight of at least one antioxidant. 
     
     
         14 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 13  wherein the at least one antioxidant comprises butylated hydroxytoluene (BHT). 
     
     
         15 . The liquid-filled hard gel capsule pharmaceutical formulation of  claim 1  further comprising medium chain triglycerides.