Stable cannabinoid formulations

Abstract

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

1 - 23 . (canceled) 
     
     
         24 . A method of treating a disease or disorder caused by aberrant expression of chromosome 15q11-q13, comprising administering to a subject in need of treatment a composition comprising cannabidiol, wherein the cannabidiol has a purity of greater than 98% w/w, and wherein the dose of the cannabidiol is about 10 to about 40 milligrams of cannabidiol per kilogram body weight of the subject per day. 
     
     
         25 . The method of  claim 24 , wherein the disease or disorder is Prader-Willi syndrome. 
     
     
         26 . The method of  claim 24 , wherein the disease or disorder is an epilepsy disorder. 
     
     
         27 . The method of  claim 26 , wherein the epilepsy disorder is a refractory epilepsy. 
     
     
         28 . The method of  claim 24 , wherein the disease or disorder is characterized by tonic-clonic seizures. 
     
     
         29 . The method of  claim 28 , wherein the tonic-clonic seizures are generalized tonic-clonic seizures. 
     
     
         30 . The method of  claim 24 , wherein the disease or disorder is characterized by myoclonic seizures. 
     
     
         31 . The method of  claim 30 , wherein the myoclonic seizures are generalized myoclonic seizures. 
     
     
         32 . The method of  claim 24 , wherein the disease or disorder is characterized by absence seizures. 
     
     
         33 . The method of  claim 24 , wherein the disease or disorder is characterized by more than one type of seizure. 
     
     
         34 . The method of  claim 33 , wherein the type of seizure is selected from refractory, tonic-clonic, myoclonic, or absence seizures. 
     
     
         35 . The method of  claim 24 , wherein the subject is a pediatric patient. 
     
     
         36 . The method of  claim 24 , wherein the dose of cannabidiol is about 30 to about 40 mg of cannabidiol per kg of body weight of the subject per day. 
     
     
         37 . The method of  claim 24 , wherein the dose of cannabidiol is about 40 mg of cannabidiol per kg of body weight of the subject per day. 
     
     
         38 . The method of  claim 24 , wherein the composition is a liquid solution. 
     
     
         39 . The method of  claim 24 , wherein the composition does not contain alcohol. 
     
     
         40 . The method of  claim 24 , wherein the composition comprises about 10 to about 32% w/w of cannabidiol. 
     
     
         41 . The method of  claim 24 , wherein the composition comprises:
 about 10 to about 32% w/w of cannabidiol;   about 60 to about 95% of a lipid; and   an antioxidant.   
     
     
         42 . The method of  claim 41 , wherein the lipid comprises caprylic/capric triglycerides. 
     
     
         43 . The method of  claim 41 , wherein the composition comprises about 0.01 to about w/w of an antioxidant, and wherein the antioxidant is alpha-tocopherol. 
     
     
         44 . The method of  claim 24 , wherein the composition comprises:
 about 10% to about 32% w/w cannabidiol;   caprylic/capric triglycerides at a concentration of about 58 to about 90% w/w;   alpha tocopherol at a concentration of about 0.01 to about 1% w/w;   a sweetener at a concentration of about 0.01 to about 2% w/w; and   a flavoring agent at a concentration of about 0.01 to about 1% w/w.   
     
     
         45 . The method of  claim 24 , wherein the formulation comprises:
 about 10.53% w/w of cannabidiol;   about 0.2% w/w alpha-tocopherol;   about 0.3% w/w of a flavoring agent;   about 0.025 w/w of a sweetener; and   about 88.945 of caprylic/capric triglycerides.   
     
     
         46 . The method of  claim 24 , wherein the formulation comprises:
 about 31.09% w/w of cannabidiol;   about 0.2% w/w alpha-tocopherol;   about 0.3% w/w of a flavoring agent;   about 0.025 w/w of a sweetener; and   about 68.385 of caprylic/capric triglycerides.   
     
     
         47 . A method of treating a disease or disorder in a subject, comprising administering to the subject a composition comprising cannabidiol, wherein the cannabidiol has a purity of greater than 98% w/w, and wherein the disease or disorder is characterized by absence seizures. 
     
     
         48 . The method of  claim 47 , wherein the disease or disorder is substantially characterized by absence seizures. 
     
     
         49 . The method of  claim 47 , wherein the disease or disorder is an epilepsy disorder. 
     
     
         50 . The method of  claim 47 , wherein the disease or disorder is a refractory epilepsy. 
     
     
         51 . The method of  claim 47 , wherein the disease or disorder is Dravet syndrome. 
     
     
         52 . The method of  claim 47 , wherein the disease or disorder is Lennox-Gastaut syndrome. 
     
     
         53 . The method of  claim 47 , wherein the disease or disorder further comprises tonic-clonic seizures. 
     
     
         54 . The method of  claim 53 , wherein the tonic-clonic seizures are generalized tonic-clonic seizures. 
     
     
         55 . The method of  claim 47 , wherein the disease or disorder further comprises myoclonic seizures. 
     
     
         56 . The method of  claim 55 , wherein the myoclonic seizures are generalized myoclonic seizures. 
     
     
         57 . The method of  claim 47 , wherein the subject is a pediatric patient. 
     
     
         58 . The method of  claim 47 , wherein the dose of cannabidiol is about 10 to about 40 mg of cannabidiol per kg of body weight of the subject per day. 
     
     
         59 . The method of  claim 47 , wherein the dose of cannabidiol is about 30 to about 40 mg of cannabidiol per kg of body weight of the subject per day. 
     
     
         60 . The method of  claim 47 , wherein the dose of cannabidiol is about 40 mg of cannabidiol per kg of body weight of the subject per day. 
     
     
         61 . The method of  claim 47 , wherein the composition is a liquid solution. 
     
     
         62 . The method of  claim 47 , wherein the composition does not contain alcohol. 
     
     
         63 . The method of  claim 47 , wherein the composition comprises about 10 to about 32% w/w of cannabidiol. 
     
     
         64 . The method of  claim 47  wherein the composition comprises:
 about 10 to about 32% w/w of cannabidiol; 
 about 60 to about 95% of a lipid; and 
 an antioxidant. 
 
     
     
         65 . The method of  claim 64 , wherein the lipid comprises caprylic/capric triglycerides. 
     
     
         66 . The method of  claim 64 , wherein the composition comprises about 0.01 to about 1% w/w of an antioxidant, and wherein the antioxidant is alpha-tocopherol. 
     
     
         67 . The method of  claim 47 , wherein the composition comprises:
 about 10% to about 32% w/w cannabidiol;   caprylic/capric triglycerides at a concentration of about 58 to about 90% w/w;   alpha tocopherol at a concentration of about 0.01 to about 1% w/w;   a sweetener at a concentration of about 0.01 to about 2% w/w; and   a flavoring agent at a concentration of about 0.01 to about 1% w/w.   
     
     
         68 . The method of  claim 47 , wherein the formulation comprises:
 about 10.53% w/w of cannabidiol;   about 0.2% w/w alpha-tocopherol;   about 0.3% w/w of a flavoring agent;   about 0.025 w/w of a sweetener; and   about 88.945 of caprylic/capric triglycerides.   
     
     
         69 . The method of  claim 47 , wherein the formulation comprises:
 about 31.09% w/w of cannabidiol;   about 0.2% w/w alpha-tocopherol;   about 0.3% w/w of a flavoring agent;   about 0.025 w/w of a sweetener; and   about 68.385 of caprylic/capric triglycerides.