Stable cannabinoid formulations

Abstract

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

1 - 20 . (canceled) 
     
     
         21 . A method for treating a disease or disorder, or a symptom of a disease or disorder, comprising administering to a subject in need of treatment a formulation comprising:
 from about 0.1 to about 40% of cannabidiol; and   from about 10 to about 95% of a lipid,   wherein the disease or disorder is selected from the group consisting of Dravet Syndrome, Lennox Gastaut Syndrome, myoclonic seizures, juvenile, myoclonic epilepsy, refractory epilepsy, schizophrenia, juvenile spasms, West syndrome, infantile spasms, refractory infantile spasms, tubular sclerosis complex, brain tumors, neuropathic pain, cannabis use disorder, post-traumatic stress disorder, anxiety, early psychosis, Alzheimer's Disease, and autism.   
     
     
         22 . (canceled) 
     
     
         23 . The method of  claim 21 , wherein the lipid is selected from the group consisting of sesame oil, olive oil, corn oil, sunflower oil, safflower oil, flaxseed oil, almond oil, peanut oil, walnut oil, cashew oil, castor oil, coconut oil, palm oil, soybean oil, canola oil, vegetable oil, rice bran oil, medium chain glycerides, decanoyl glycerides, octanoyl glycerides, caprylic/capric triglyceride, oleoyl polyoxyl-6 glycerides, linoleoyl polyoxyl-6 glycerides, polyglyceryl-3 dioleate, glyceryl monolinoleate, glyceryl monocaprylate, oleic acid, and a combination thereof. 
     
     
         24 . The method of  claim 21 , wherein the lipid is a medium-chain triglyceride whose fatty acids have an aliphatic tail of from 6 to 12 carbon atoms. 
     
     
         25 . The method of  claim 24 , wherein the medium-chain triglyceride is caprylic/capric triglyceride. 
     
     
         26 . The method of  claim 21 , wherein the cannabidiol is substantially pure, synthetically synthesized, cannabidiol which has a purity greater than 98%. 
     
     
         27 . The method of  claim 21 , wherein the dose of cannabidiol is about 20 to about 100 mg of cannabidiol per kg weight of the subject per day. 
     
     
         28 . The method of  claim 21 , wherein the dose of the cannabidiol is about 20 to about 30 mg of cannabidiol per kg weight of the subject per day. 
     
     
         29 . The method of  claim 21 , wherein the dose of the cannabidiol is about 30 mg of cannabidiol per kg weight of the subject per day. 
     
     
         30 . The method of  claim 21 , wherein the formulation is free of alcohol. 
     
     
         31 . The method of  claim 21 , wherein the formulation further comprises from about 1% to about 15% ethanol. 
     
     
         32 . The method of  claim 31 , wherein the ethanol is at a concentration from about 1% to about 10%. 
     
     
         33 . The method of  claim 21 , wherein the formulation comprises from about 0.001% to about 1% of an antioxidant. 
     
     
         34 . The method of  claim 33 , wherein the antioxidant is selected from the group consisting of butylated hydroxyltoluene, butylated hydroxyl anisole, alpha-tocopherol (Vitamin E), ascorbyl palmitate, ascorbic acid, sodium ascorbate, ethylenediamino tetraacetic acid, cysteine hydrochloride, citric acid, sodium citrate, sodium bisulfate, sodium metabisulfite, lecithin, propyl gallate, sodium sulfate, monothioglycerol, and combinations thereof. 
     
     
         35 . The method of  claim 33 , wherein the antioxidant is selected from the group consisting of alpha tocopherol (Vitamin E), ascorbyl palmitate and a combination thereof. 
     
     
         36 . The method of  claim 21 , wherein the formulation further comprises from about 0.1% to about 1.0% of an antioxidant selected from the group consisting of alpha-tocopherol (Vitamin E), ascorbyl palmitate and a combination thereof. 
     
     
         37 . The method of  claim 21 , wherein the formulation comprises:
 cannabidiol at a concentration of from about 28% to about 32%; and   caprylic/capric triglyceride at a concentration from about 66% to about 74%.   
     
     
         38 . The method of  claim 21 , wherein the formulation comprises
 cannabidiol at a concentration of about 31.09%; and   caprylic/capric triglyceride at a concentration of about 68.385%.   
     
     
         39 . The method of  claim 38 , wherein the formulation further comprises about 0.20% alpha-tocopherol (Vitamin E). 
     
     
         40 . The method of  claim 21 , 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. 
     
     
         41 . The method of  claim 21 , wherein the disease or disorder is West syndrome and/or infantile spasms. 
     
     
         42 . The method of  claim 38 , wherein the infantile spasms are refractory infantile spasms. 
     
     
         43 . The method of  claim 21 , wherein the disease or disorder is a refractory epilepsy. 
     
     
         44 . The method of  claim 21 , wherein the disease or disorder is a myoclonic epilepsy. 
     
     
         45 . The method of  claim 21 , wherein the disease or disorder is schizophrenia.