Novel formulations comprising lipid-regulating agents

Abstract

The present invention is directed to a formulation comprising a lipid-regulating agent dissolved in at least one monoglyceride as the primary solvent medium for said agent. One or more emulsifiers may be added to the formulation.

1 . A composition comprising a lipid-regulating agent dissolved in at least one monoglyceride.  
     
     
         2 . A composition of  claim 1  wherein the lipid-regulating agent is a fibrate.  
     
     
         3 . A composition of  claim 2  wherein the fibrate is fenofibrate.  
     
     
         4 . A composition of  claim 1  wherein at least one or more of the monoglycerides is selected from glyceryl oleate, glyceryl caprylate/caprate, glyceryl caprylate, and glyceryl caprate.  
     
     
         5 . A composition of  claim 4  wherein the monoglyceride is glyceryl oleate.  
     
     
         6 . A composition as in  claim 1  further comprising at least one emulsifier.  
     
     
         7 . A composition of  claim 6  wherein at least one emulsifier is selected from castor oil or hydrogenated castor oil ethoxylates.  
     
     
         8 . A composition of  claim 7  wherein the castor oil or hydrogenated castor oil ethoxylates is a polyoxyl 35 castor oil.  
     
     
         9 . A composition of  claim 1  that contains a therapeutically-effective amount of a lipid-regulating agent.  
     
     
         10 . A composition of  claim 9  wherein the lipid-regulating agent is a fibrate.  
     
     
         11 . A composition of  claim 10  wherein the fibrate is fenofibrate.  
     
     
         12 . A capsule comprising a composition of  claim 1 .  
     
     
         13 . A capsule of  claim 12  wherein the lipid-regulating agent is a fibrate.  
     
     
         14 . A capsule of  claim 13  wherein the fibrate is fenofibrate.  
     
     
         15 . A method of treating hyperlipidemia comprising the administration of a composition of  claim 1  to a patient.  
     
     
         16 . A method of treating hyperlipidemia comprising the administration of a composition of  claim 9  to a patient.  
     
     
         17 . A method of  claim 16  wherein the lipid-regulating agent is a fibrate.  
     
     
         18 . A method of  claim 17  wherein the fibrate is fenofibrate.  
     
     
         19 . A composition of  claim 1  further comprising at least one co-solvent.  
     
     
         20 . A composition of  claim 19  wherein at least one co-solvent is selected from ethanol, propylene glycol, and dimethyl isosorbide.