US2022125932A1PendingUtilityA1

Stable cannabinoid formulations

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Assignee: RADIUS PHARMACEUTICALS INCPriority: May 29, 2014Filed: Nov 5, 2021Published: Apr 28, 2022
Est. expiryMay 29, 2034(~7.9 yrs left)· nominal 20-yr term from priority
Inventors:Kiran Kumar VangaraHuaguang LiNingxin YanHung Q. NguyenVenkat R. Goskonda
A61K 31/658A61P 35/00A61P 25/36A61P 25/34A61P 25/22A61P 25/18A61P 25/08A61P 25/04A61K 47/22A61P 25/00A61K 47/10A61K 9/08A61K 47/14A61P 25/30A61K 9/0053A61K 47/44A61K 31/352A61K 31/05
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Claims

Abstract

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

Claims

exact text as granted — not AI-modified
1 - 25 . (canceled) 
     
     
         26 . A method of reducing seizure frequency in a subject with a refractory epilepsy, comprising administering to the subject a composition comprising cannabidiol, wherein the cannabidiol has a purity of greater than 98% w/w. 
     
     
         27 . (canceled) 
     
     
         28 . The method of  claim 26 , wherein the refractory epilepsy is West syndrome. 
     
     
         29 . The method of  claim 26 , wherein the refractory epilepsy is Dravet syndrome. 
     
     
         30 . The method of  claim 26 , wherein the refractory epilepsy is Lennox-Gastaut syndrome. 
     
     
         31 . The method of  claim 26 , wherein the refractory epilepsy comprises tonic-clonic seizures. 
     
     
         32 . The method of  claim 31 , wherein the tonic-clonic seizures are generalized tonic-clonic seizures. 
     
     
         33 . The method of  claim 26 , wherein the refractory epilepsy comprises myoclonic seizures. 
     
     
         34 . The method of  claim 33 , wherein the myoclonic seizures are generalized myoclonic seizures. 
     
     
         35 . The method of  claim 26 , wherein the refractory epilepsy comprises tonic-clonic and myoclonic seizures. 
     
     
         36 . The method of  claim 26 , wherein the subject is a pediatric patient. 
     
     
         37 . The method of  claim 26 , wherein the composition is a liquid solution. 
     
     
         38 . The method of  claim 26 , wherein the composition does not contain alcohol. 
     
     
         39 . The method of  claim 26 , wherein the cannabidiol is a synthetically prepared cannabidiol. 
     
     
         40 . The method of  claim 26 , wherein the composition comprises about 10 to about 32% w/w of cannabidiol. 
     
     
         41 . The method of  claim 26 , 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 1% w/w of an antioxidant, and wherein the antioxidant is alpha-tocopherol. 
     
     
         44 . 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 tonic-clonic seizures. 
     
     
         45 . The method of  claim 44 , wherein the disease or disorder is substantially characterized by tonic-clonic seizures. 
     
     
         46 . The method of  claim 44 , wherein the tonic-clonic seizures are generalized tonic-clonic seizures. 
     
     
         47 . The method of  claim 44 , wherein the disease or disorder is an epilepsy disorder. 
     
     
         48 . The method of  claim 44 , wherein the disease or disorder is a refractory epilepsy. 
     
     
         49 . The method of  claim 44 , wherein the disease or disorder is Dravet syndrome. 
     
     
         50 . The method of  claim 44 , wherein the disease or disorder is Lennox-Gastaut syndrome. 
     
     
         51 . The method of  claim 44 , wherein the disease or disorder further comprises myoclonic seizures. 
     
     
         52 . The method of  claim 51 , wherein the myoclonic seizures are generalized myoclonic seizures. 
     
     
         53 . The method of  claim 44 , wherein the subject is a pediatric patient. 
     
     
         54 . The method of  claim 44 , wherein the composition is a liquid solution. 
     
     
         55 . The method of  claim 44 , wherein the composition does not contain alcohol. 
     
     
         56 . The method of  claim 44 , wherein the cannabidiol is a synthetically prepared cannabidiol. 
     
     
         57 . The method of  claim 44 , wherein the composition comprises about 10 to about 32% w/w of cannabidiol. 
     
     
         58 . The method of  claim 44 , wherein the composition comprises:
 about 10 to about 32% w/w of cannabidiol;   about 60 to about 95% of a lipid; and   an antioxidant.   
     
     
         59 . The method of  claim 58 , wherein the lipid comprises caprylic/capric triglycerides. 
     
     
         60 . The method of  claim 58 , wherein the composition comprises about 0.01 to about 1% w/w of an antioxidant, and wherein the antioxidant is alpha-tocopherol. 
     
     
         61 . 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 myoclonic seizures. 
     
     
         62 . The method of  claim 61 , wherein the disease or disorder is substantially characterized by myoclonic seizures. 
     
     
         63 . The method of  claim 61 , wherein the myoclonic seizures are generalized myoclonic seizures. 
     
     
         64 . The method of  claim 61 , wherein the disease or disorder is an epilepsy disorder. 
     
     
         65 . The method of  claim 61 , wherein the disease or disorder is a refractory epilepsy. 
     
     
         66 . The method of  claim 61 , wherein the disease or disorder is Dravet syndrome. 
     
     
         67 . The method of  claim 61 , wherein the disease or disorder is Lennox-Gastaut syndrome. 
     
     
         68 . The method of  claim 61 , wherein the disease or disorder further comprises tonic-clonic seizures. 
     
     
         69 . The method of  claim 68 , wherein the tonic-clonic seizures are generalized tonic-clonic seizures. 
     
     
         70 . The method of  claim 61 , wherein the subject is a pediatric patient. 
     
     
         71 . The method of  claim 61 , wherein the composition is a liquid solution. 
     
     
         72 . The method of  claim 61 , wherein the composition does not contain alcohol. 
     
     
         73 . The method of  claim 61 , wherein the cannabidiol is a synthetically prepared cannabidiol. 
     
     
         74 . The method of  claim 61 , wherein the composition comprises about 10 to about 32% w/w of cannabidiol. 
     
     
         75 . The method of  claim 61 , wherein the composition comprises:
 about 10 to about 32% w/w of cannabidiol;   about 60 to about 95% of a lipid; and   an antioxidant.   
     
     
         76 . The method of  claim 75 , wherein the lipid comprises caprylic/capric triglycerides. 
     
     
         77 . The method of  claim 75 , wherein the composition comprises about 0.01 to about 1% w/w of an antioxidant, and wherein the antioxidant is alpha-tocopherol.

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