Formulation and manufacturing process for Coenzyme Q10 soft gel capsules

Abstract

A soft gelatine capsule formulation improved manufacturing of Coenzyme Q10, comprising Coenzyme Q10 in a thixotropic gelatine carrier capable of admixing without heating with Coenzyme Q10, and capable of keeping Coenzyme Q10 in suspension at ambient temperature.

1 . A composition comprising Coenzyme Q10 in combination with an antioxidant in a thixatropic gelatine carrier for manufacturing soft gel capsules at a temperature of about 27° C. to about 30° C. containing a stable uniform suspension of Coenzyme Q10.  
     
     
         2 . A composition comprising Coenzyme Q10 and a thixatropic gelatine carrier.  
     
     
         3 . The composition of  claim 2 , wherein the thixatropic gelatine carrier is a semi-solid at a temperature of about 23° C. to about 28° C. and becomes fluid when stirred.  
     
     
         4 . The composition of  claim 2 , wherein the thixatropic gelatine carrier comprises: 
 from about 84% to about 95% vegetable oil selected from the group consisting of soybean oil, rapeseed oil, palm oil, and cotton seed oil;    from about 1% to about 9% of a viscosity modifier selected from the group consisting of a glyceryl palmito stearate and glyceryl behenate; and    from about 1% to about 15% of a surface active agent comprising polyglyceryl oleate.    
     
     
         5 . The composition of  claim 2 , wherein the amount of Coenzyme Q10 in the composition ranges from 8 to 40% by weight.  
     
     
         6 . A process of manufacturing a composition comprising Coenzyme Q 10, said process comprising the steps of: 
 (a) stirring a thixatropic gelatine carrier until the thixatropic gelatine carrier is liquefied; and    (b) adding Coenzyme Q10 to the liquefied carrier to form a mixture.    
     
     
         7 . The process of  claim 6 , wherein the thixatropic gelatine carrier comprises: 
 from about 84% to about 95% vegetable oil selected from the group consisting of soybean oil, rapeseed oil, palm oil, and cotton seed oil;    from about 1% to about 9% of a viscosity modifier selected from the group consisting of a glyceryl palmito stearate and glyceryl behenate; and    from about 1% to about 15% of a surface active agent comprising polyglyceryl oleate.    
     
     
         8 . The process of  claim 6 , further comprising the step of heating the thixatropic gelatine carrier from about 27° C. to about 30° C. prior to the addition of the Coenzyme Q10.  
     
     
         9 . The process of  claim 6 , wherein 30 to 100 mg of the Coenzyme Q10 are in each capsule.  
     
     
         10 . The process of  claim 6 , wherein the mixture is cooled from about 23° C. to 28° C.  
     
     
         11 . The process of  claim 6 , wherein 50 to 500 mg of the thixatropic gelatine carrier is in each capsule.  
     
     
         12 . A composition, prepared by a process comprising the steps of: 
 (a) heating a thixatropic gelatine carrier to a temperature that liquefies the carrier;    (b) blending the heated thixatropic gelatine carrier and Coenzyme Q10; and    (c) cooling the blended mixture to a temperature, thereby causing the mixture to form a viscous semi-solid.    
     
     
         13 . The composition prepared by the process of  claim 12 , wherein the thixatropic gelatine carrier comprises: 
 from about 84% to about 95% vegetable oil selected from the group consisting of soybean oil, rapeseed oil, palm oil, and cotton seed oil;    from about 1% to about 9% of a viscosity modifier selected from the group consisting of a glyceryl palmito stearate and glyceryl behenate; and    from about 1% to about 15% of a surface active agent comprising polyglyceryl oleate.    
     
     
         14 . The composition prepared by the process of  claim 12 , wherein the thixatropic gelatine carrier is heated from about 27° C. to about 30° C.  
     
     
         15 . The composition prepared by the process of  claim 12 , wherein 30 to 100 mg of the Coenzyme Q10 are in each capsule.  
     
     
         16 . The composition prepared by the process of  claim 12 , wherein the mixture is cooled from about 23° C. to 28° C.  
     
     
         17 . The composition prepared by the process of  claim 12 , wherein 50 to 500 mg of the thixatropic gelatine carrier is in each capsule.  
     
     
         18 . A process of manufacturing a composition comprising Coenzyme Q 10, said process comprising the step of: 
 (a) mixing a thixatropic gelatine carrier and Coenzyme Q10 to form a mixture.    
     
     
         19 . The process of  claim 18 , wherein the thixatropic gelatine carrier comprises: 
 from about 84% to about 95% vegetable oil selected from the group consisting of soybean oil, rapeseed oil, palm oil, and cotton seed oil;    from about 1% to about 9% of a viscosity modifier selected from the group consisting of a glyceryl palmito stearate and glyceryl behenate; and    from about 1% to about 15% of a surface active agent comprising polyglyceryl oleate.    
     
     
         20 . The process of  claim 18 , further comprising the step of heating the mixture from about 27° C. to about 30° C.  
     
     
         21 . The process of  claim 18 , wherein 30 to 100 mg of the Coenzyme Q10 are in each capsule.  
     
     
         22 . The process of  claim 18 , wherein the mixture is cooled from about 23° C. to 28° C.  
     
     
         23 . The process of  claim 18 , wherein 50 to 500 mg of the thixatropic gelatine carrier is in each capsule.