Stable cannabinoid formulations

Abstract

The present invention is generally directed to substantially pure cannabidiol, stable cannabinoid pharmaceutical formulations, and methods of their use.

1 - 27 . (canceled) 
     
     
         28 . An oral composition consisting of:
 10 to 17% w/w cannabidiol (CBD);   60 to 85% w/w sesame oil;   5 to 15% w/w ethanol;   a sweetener;   a flavoring agent, and   optionally a preservative,   wherein the CBD has a purity of greater than 98% w/w, and wherein the composition is a liquid composition for oral administration.   
     
     
         29 . The composition of  claim 28 , comprising about 10% w/w CBD. 
     
     
         30 . The composition of  claim 28 , comprising about 80% w/w of sesame oil. 
     
     
         31 . The composition of  claim 28 , wherein the sweetener is sucralose. 
     
     
         32 . The composition of  claim 28 , comprising about 0.1 to about 2% w/w of sweetener. 
     
     
         33 . The composition of  claim 28 , wherein the flavoring agent is strawberry flavor. 
     
     
         34 . The composition of  claim 28 , comprising about 0.01 to about 1% w/w of flavoring agent. 
     
     
         35 . The composition of  claim 28 , comprising about 0.30% w/w of flavoring agent. 
     
     
         36 . The composition of  claim 28 , wherein the preservative is benzyl alcohol. 
     
     
         37 . The composition of  claim 28  wherein the pH of the formulation is from about 6 to about 7. 
     
     
         38 . A method for treating a disease or disorder, or a symptom of a disease or disorder, comprising administering the composition of  claim 28  to a patient in need thereof, wherein the disease or disorder is selected from the group consisting of Dravet Syndrome, Lennox Gastaut Syndrome, myoclonic seizures, juvenile myoclonic epilepsy, refractory epilepsy, juvenile spasms, West syndrome, infantile spasms, refractory infantile spasms, and tubular sclerosis complex. 
     
     
         39 . The method of  claim 38 , wherein the disease or disorder is Dravet Syndrome. 
     
     
         40 . The method of  claim 38 , wherein the disease or disorder is Lennox Gastaut Syndrome. 
     
     
         41 . The method of  claim 38 , wherein the disease or disorder is tubular sclerosis complex. 
     
     
         42 . The method of  claim 38 , wherein the disease or disorder is infantile spasms and/or West Syndrome. 
     
     
         43 . The method of  claim 38 , wherein the disease or disorder involves myoclonic seizures.