Methods of treating autoimmune or inflammatory conditions with cannabidiol or its derivatives/analogs

Abstract

A method of treating an autoimmune disease and/or inflammatory condition in a subject, whereby the subject in need thereof is administered, via the oral mucosa, a rapidly infusing composition that includes (a) a pharmaceutically acceptable binder and/or excipient system containing gelatin and a sugar alcohol, and (b) a therapeutically effective amount of cannabidiol (CBD) or a derivative/analog thereof. The autoimmune disease and/or inflammatory condition may include, inter alia, rheumatoid arthritis, psoriasis, systemic lupus erythematosus, type-I diabetes, multiple sclerosis, Guillain-Barre syndrome, Crohn's disease, and ulcerative colitis, including refractory diseases/conditions thereof.

1 . A method of treating an autoimmune disease and/or inflammatory condition in a subject, comprising:
 administering to the subject in need thereof, via the oral mucosa, a rapidly infusing composition comprising (a) a pharmaceutically acceptable binder and/or excipient system comprising gelatin and a sugar alcohol, and (b) a therapeutically effective amount of cannabidiol (CBD) or a derivative/analog thereof.   
     
     
         2 . The method of  claim 1 , wherein the rapidly infusing composition is lyophilized. 
     
     
         3 . The method of  claim 1 , wherein the rapidly infusing composition has a disintegration time of approximately 1 to 30 seconds in deionized water maintained at 37° C.±2° C. 
     
     
         4 . The method of  claim 1 , wherein the rapidly infusing composition has a disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37° C.±2° C. 
     
     
         5 . The method of  claim 1 , wherein the gelatin is present in the rapidly infusing composition in an amount of 10 to 35 wt. %, based on a total weight of the rapidly infusing composition on a dry basis. 
     
     
         6 . The method of  claim 1 , wherein the gelatin is bovine gelatin. 
     
     
         7 . The method of  claim 1 , wherein the sugar alcohol is present in the rapidly infusing composition in an amount of 5 to 35 wt. %, based on a total weight of the rapidly infusing composition on a dry basis. 
     
     
         8 . The method of  claim 1 , wherein the sugar alcohol comprises mannitol. 
     
     
         9 . The method of  claim 1 , wherein the CBD or derivative/analog thereof is present in the rapidly infusing composition in an amount of 20 to 70 wt. %, based on a total weight of the rapidly infusing composition on a dry basis. 
     
     
         10 . The method of  claim 1 , wherein the rapidly infusing composition is formulated with a solid form of the CBD. 
     
     
         11 . The method of  claim 1 , wherein the rapidly infusing composition is formulated with a solid form of the CBD having a purity between 95 and 99.9 wt. %. 
     
     
         12 . The method of  claim 1 , wherein the rapidly infusing composition is formulated with a solid form of the CBD that has been micronized to have a D50 diameter between 1 and 50 μm. 
     
     
         13 . The method of  claim 1 , wherein the rapidly infusing composition is formulated with a CBD derivative/analog. 
     
     
         14 . The method of  claim 13 , wherein the CBD derivative/analog is cannabidiolic acid methyl ester. 
     
     
         15 . The method of  claim 1 , wherein the rapidly infusing composition further comprises at least one selected from the group consisting of a sweetener, a flavorant, and a colorant. 
     
     
         16 . The method of  claim 15 , wherein the rapidly infusing composition comprises the flavorant, and the flavorant comprises lemon-lime flavor. 
     
     
         17 . The method of  claim 15 , wherein the rapidly infusing composition comprises the colorant, and the colorant comprises FD&C Yellow #5. 
     
     
         18 . The method of  claim 15 , wherein the rapidly infusing composition comprises the sweetener, and the sweetener comprises a mixture of sucralose and acesulfame-K. 
     
     
         19 . The method of  claim 1 , wherein the rapidly infusing composition is administered to the subject via the buccal mucosa. 
     
     
         20 . The method of  claim 1 , wherein the therapeutically effective amount of CBD or derivative/analog thereof is from 10 to 100 mg of CBD per dose. 
     
     
         21 . The method of  claim 1 , wherein the rapidly infusing composition is administered to the subject 1 to 10 times per day. 
     
     
         22 . The method of  claim 1 , wherein the autoimmune disease and/or inflammatory condition is a systemic autoimmune disease. 
     
     
         23 . The method of  claim 22 , wherein the systemic autoimmune disease is rheumatoid arthritis. 
     
     
         24 . The method of  claim 22 , wherein the systemic autoimmune disease is psoriasis. 
     
     
         25 . The method of  claim 22 , wherein the systemic autoimmune disease is systemic lupus erythematosus. 
     
     
         26 . The method of  claim 1 , wherein the autoimmune disease and/or inflammatory condition is an endocrine disease. 
     
     
         27 . The method of  claim 26 , wherein the endocrine disease is type-I diabetes. 
     
     
         28 . The method of  claim 1 , wherein the autoimmune disease and/or inflammatory condition is a neuronal disease. 
     
     
         29 . The method of  claim 28 , wherein the neuronal disease is multiple sclerosis. 
     
     
         30 . The method of  claim 28 , wherein the neuronal disease is Guillain-Barre syndrome. 
     
     
         31 . The method of  claim 1 , wherein the autoimmune disease and/or inflammatory condition is an inflammatory bowel disease. 
     
     
         32 . The method of  claim 31 , wherein the inflammatory bowel disease is Crohn's disease. 
     
     
         33 . The method of  claim 31 , wherein the inflammatory bowel disease is ulcerative colitis. 
     
     
         34 . The method of  claim 1 , wherein the autoimmune disease and/or inflammatory condition is a refractory autoimmune disease and/or inflammatory condition. 
     
     
         35 . The method of  claim 1 , wherein the autoimmune disease and/or inflammatory condition is Post-Treatment Lyme Disease Syndrome (PTLDS).