Rapidly infusing platform and compositions for therapeutic treatment in humans
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, by placement in a buccal cavity, a lyophilized rapidly infusing composition comprising (a) a pharmaceutically acceptable binder and/or excipient system comprising bovine gelatin and a sugar alcohol, and (b) a therapeutically effective amount of cannabidiol (CBD) via buccal mucosa,
wherein the rapidly infusing composition is formulated with a solid form of the CBD having a purity between 95 and 99.9 wt. %, and 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 bovine 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 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 solid form of the CBD has been micronized to have a D50 diameter between 1 and 50 μm.
6. 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.
7. The method of claim 1 , wherein the therapeutically effective amount of CBD is from 10 to 100 mg of CBD per dose.
8. The method of claim 1 , wherein the rapidly infusing composition is administered to the subject 1 to 10 times per day.
9. The method of claim 1 , wherein the subject is a human.
10. The method of claim 1 , wherein the pain is neuropathic pain.
11. The method of claim 1 , wherein the pain is acute neuropathic pain.
12. 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.
13. The method of claim 12 , wherein the surgical procedure is knee arthroplasty.
14. The method of claim 12 , wherein surgical procedure is shoulder arthroscopy.
15. The method of claim 1 , wherein the subject has cancer and the pain is cancer-associated pain.
16. A rapidly infusing buccal composition, comprising:
bovine gelatin, in an amount of 10 to 35 wt. %, based on a total weight of the rapidly infusing buccal 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 buccal composition on a dry basis;
a therapeutically effective amount of cannabidiol (CBD), in an amount of 20 to 70 wt. %, based on a total weight of the rapidly infusing buccal composition on a dry basis;
wherein the rapidly infusing buccal composition is formulated with a solid form of the CBD having a purity between 95 and 99.9 wt. %, and wherein the rapidly infusing buccal composition is lyophilized and has a rapid disintegration time in a buccal cavity as demonstrated by a disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37° C.±2° C.
17. The rapidly infusing buccal composition of claim 16 , wherein the rapidly infusing buccal composition further comprises at least one selected from the group consisting of a sweetener, a flavorant, and a colorant.
18. The rapidly infusing buccal composition of claim 17 , wherein the rapidly infusing buccal composition comprises the flavorant, and the flavorant comprises lemon-lime flavor.
19. The rapidly infusing buccal composition of claim 17 , wherein the rapidly infusing buccal composition comprises the colorant, and the colorant comprises FD&C Yellow #5.
20. The rapidly infusing buccal composition of claim 16 , wherein the solid form of the CBD has been micronized to have a D50 diameter between 1 and 50 μm.
21. The rapidly infusing buccal composition of claim 16 , further comprising melatonin.
22. The rapidly infusing buccal composition of claim 16 , wherein the CBD has a purity between 99 and 99.9 wt. %.
23. The rapidly infusing buccal composition of claim 16 , wherein the bovine gelatin is present in an amount of 10 to 28 wt. %, based on a total weight of the rapidly infusing composition on a dry basis.
24. The rapidly infusing buccal composition of claim 16 , wherein the bovine gelatin is present in an amount of 20 to 24 wt. %, based on a total weight of the rapidly infusing composition on a dry basis.
25. The method of claim 1 , wherein the CBD has a purity between 99 and 99.9 wt. %.
26. A method of treating pain in a subject, comprising:
administering to the subject in need thereof via buccal mucosa, by placement in a buccal cavity, a lyophilized rapidly infusing composition comprising (a) a pharmaceutically acceptable binder and/or excipient system comprising 20 to 24 wt. % of bovine gelatin based on a total weight of the rapidly infusing composition on a dry basis, and a sugar alcohol, and (b) 20 to 55 mg of cannabidiol (CBD),
wherein the rapidly infusing composition is formulated with a solid form of the CBD having a purity between 99 and 99.9 wt. %, and wherein the rapidly infusing composition has a disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37° C.±2° C.
27. The method of claim 1 , wherein the subject is administered a total of from 75 to 150 mg of CBD per day in one or more doses comprising the rapidly infusing composition.
28. The method of claim 27 , wherein the total of from 75 to 150 mg of CBD per day represents a dosage per weight of the subject of less than or equal to 1.875 mg/kg/day.
29. The method of claim 26 , wherein the subject is administered a total daily dosage per weight of the subject that is less than or equal to 1.875 mg/kg/day.
30. The method of claim 1 , wherein the rapidly infusing composition comprises less than 0.5 wt. % of surfactants and lubricants, based on a total weight of the rapidly infusing composition on a dry basis.
31. The rapidly infusing buccal composition of claim 16 , wherein the rapidly infusing buccal composition comprises less than 0.5 wt. % of surfactants and lubricants, based on a total weight of the rapidly infusing composition on a dry basis.
32. The method of claim 26 , wherein the rapidly infusing composition comprises less than 0.5 wt. % of surfactants and lubricants, based on a total weight of the rapidly infusing composition on a dry basis.
33. The method of claim 26 , 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.