Water dispersible policosanol cyclodextrin complex and method of its production

Abstract

Disclosed is a formulation of policosanol with natural cyclodextrins resulting in a water dispersible form of policosanol. The disclosed process provides an economical commercial method for making the policosanol complex. The complex is suitable for incorporation into oral dosage forms and also in functional foods. One aspect of the present disclosure is a process for making a water dispersible policosanol cyclodextrin complex for animal ingestion. This method includes preparing a policosanol cyclodextrin complex and administering said complex to an animal. The preferred animal is a human with the route of administration being oral ingestion. The form of the complex for ingestion can be a hard gelatin capsule, tablet or wafers, which may contain other ingredients, both active and inactive. The complex also can be further formulated with excipients suitable for soft gelatin capsules, such as, for example, vegetable oils, waxes, lecithin, and surfactants such as Tween-80.

1 . A water dispersible complex, which comprises:
 water dispersible policosanol cyclodextrin complex in a molar ratio of cyclodextrin to policosanol ranging from about 0.5:1 to about 10:1.   
     
     
         2 . The water dispersible complex of  claim 1 , wherein said cyclodextrin is one or more of α-cyclodextrin, β-cyclodextrin, or γ-cyclodextrin. 
     
     
         3 . The water dispersible complex of  claim 1 , wherein policosanol is an isolate from one or more of sugarcane was, rice bran wax, or beeswax. 
     
     
         4 . The water dispersible complex of  claim 1 , wherein said molar ratio of cyclodextrin to policosanol ranges from between about 1:1 and about 2:1. 
     
     
         5 . The water dispersible complex of  claim 1 , which additionally comprises between about 0.1 wt-% and about 15 wt-% of a surfactant. 
     
     
         6 . The water dispersible complex of  claim 5 , which additionally comprises between about 10 wt-% and about 15 wt-% of said surfactant. 
     
     
         7 . The water dispersible complex of  claim 5 , wherein said surfactant comprises a non-ionic surfactant. 
     
     
         8 . The water dispersible complex of  claim 7 , wherein said surfactant is Tween-80. 
     
     
         9 . The water dispersible complex of  claim 1 , which has been dried to recover said complex as a powder. 
     
     
         10 . The water dispersible complex of  claim 9 , which has been dried by one or more of freeze-drying, spray-drying, or vacuum-drying. 
     
     
         11 . A method for making a water dispersible complex, which comprises the steps of:
 (a) forming a heated oily solution of policosanol and a surfactant;   (b) forming a heated aqueous solution of a cyclodextrin;   (c) mixing said oily solution under agitation to aqueous cyclodextrin solution to form a mixture; and   (d) cooling said mixture to form a complex precipitate.   
     
     
         12 . The method of  claim 11 , wherein said cooled mixture is dried to recover a complex precipitate powder. 
     
     
         13 . The method of  claim 11 , wherein the molar ratio of cyclodextrin to policosanol ranges from about 0.5:1 to about 10:1. 
     
     
         14 . The method of  claim 11 , wherein said cyclodextrin is one or more of α-cyclodextrin, β-cyclodextrin, or γ-cyclodextrin. 
     
     
         15 . The method of  claim 11 , wherein policosanol is an isolate from one or more of sugarcane was, rice bran wax, or beeswax. 
     
     
         16 . The method of  claim 11 , wherein said surfactant in step (a) ranges from between about 0.1 wt-% and about 15 wt-%. 
     
     
         17 . The method of  claim 16 , wherein said surfactant comprises a non-ionic surfactant. 
     
     
         18 . The method of  claim 17 , wherein said surfactant is Tween-80. 
     
     
         19 . The method of  claim 11 , wherein said complex precipitate is recovered as a powder by drying. 
     
     
         20 . The method of  claim 19 , wherein said drying comprises one or more of freeze-drying, spray-drying, or vacuum-drying.