Rapidly infusing platform and compositions for therapeutic treatment in humans

Abstract

A composition and method of treatment in a subject, whereby the subject is administered via the oral mucosa a rapidly infusing composition that includes (a) a pharmaceutically acceptable binder and/or excipient system containing gelatin and mannitol, and (b) a therapeutically effective amount of an active therapeutic ingredient (ATI). Preferably, a composition and method of treating pain in a subject, whereby the subject is administered via the oral mucosa a rapidly infusing composition that includes (a) a pharmaceutically acceptable binder and/or excipient system containing gelatin and mannitol, and (b) a therapeutically effective amount cannabidiol (CBD).

1 . A method of treating pain in a subject, comprising:
 administering to the subject in need thereof, via the oral mucosa, a lyophilized 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 cannabidiol (CBD) or a derivative/analog thereof, wherein the rapidly infusing composition has a disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37° C.±2° C.   
     
     
         2 . 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. 
     
     
         3 . 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. 
     
     
         4 . 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. 
     
     
         5 . The method of  claim 1 , wherein the rapidly infusing composition is formulated with a solid form of the CBD. 
     
     
         6 . The method of  claim 5 , wherein the rapidly infusing composition is formulated with a solid form of the CBD having a purity between 95 and 99.9 wt. %. 
     
     
         7 . The method of  claim 5 , 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. 
     
     
         8 . 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. 
     
     
         9 . The method of  claim 1 , wherein the rapidly infusing composition is administered to the subject via the buccal mucosa. 
     
     
         10 . 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. 
     
     
         11 . The method of  claim 1 , wherein the rapidly infusing composition is administered to the subject 1 to 10 times per day. 
     
     
         12 . The method of  claim 1 , wherein the subject is a human. 
     
     
         13 . The method of  claim 1 , wherein the pain is neuropathic pain. 
     
     
         14 . The method of  claim 1 , wherein the pain is acute neuropathic pain. 
     
     
         15 . The method of  claim 1 , wherein the pain is postsurgical pain and the rapidly infusing composition is administered post-operatively to the subject who has undergone a surgical procedure. 
     
     
         16 . The method of  claim 15 , wherein the surgical procedure is knee arthroplasty. 
     
     
         17 . The method of  claim 15 , wherein surgical procedure is shoulder arthroscopy. 
     
     
         18 . The method of  claim 1 , wherein the subject has cancer and the pain is cancer-associated pain. 
     
     
         19 . The method of  claim 1 , wherein the rapidly infusing composition is formulated with a CBD derivative/analog. 
     
     
         20 . The method of  claim 19 , wherein the CBD derivative/analog is cannabidiolic acid methyl ester. 
     
     
         21 . A rapidly infusing composition, comprising:
 gelatin, in an amount of 10 to 35 wt. %, based on a total weight of the rapidly infusing composition on a dry basis;   a sugar alcohol, in an amount of 5 to 35 wt. %, based on a total weight of the rapidly infusing composition on a dry basis;   cannabidiol (CBD) or a derivative/analog thereof, in an amount of 20 to 70 wt. %, based on a total weight of the rapidly infusing composition on a dry basis;   wherein the rapidly infusing composition is lyophilized and has a disintegration tune of approximately 1 to 5 seconds in deionized water maintained at 37° C.±2° C.   
     
     
         22 . The rapidly infusing composition of  claim 21 , wherein the rapidly infusing composition further comprises at least one selected from the group consisting of a sweetener, a flavorant, and a colorant. 
     
     
         23 . The rapidly infusing composition of  claim 22 , wherein the rapidly infusing composition comprises the flavorant, and the flavorant comprises lemon-lime flavor. 
     
     
         24 . The rapidly infusing composition of  claim 22 , wherein the rapidly infusing composition comprises the colorant, and the colorant comprises FD&C Yellow #5. 
     
     
         25 . The rapidly infusing composition of  claim 21 , wherein the rapidly infusing composition is formulated with a solid form of the CBD. 
     
     
         26 . The rapidly infusing composition of  claim 25 , wherein the rapidly infusing composition is formulated with a solid form of the CBD having a purity between 95 and 99.9 wt %. 
     
     
         27 . The rapidly infusing composition of  claim 25 , 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. 
     
     
         28 . The rapidly infusing composition of  claim 21 , further comprising melatonin. 
     
     
         29 . The rapidly infusing composition of  claim 21 , wherein the rapidly infusing composition is formulated with a CBD derivative/analog. 
     
     
         30 . The rapidly infusing composition of  claim 29 , wherein the CBD derivative/analog is cannabidiolic acid methyl ester.