Oral cannabinoid formulations
The present invention relates to a cannabinoid containing oral solution. Preferably the oral solution comprises a cannabinoid, a lipid solvent, a sweetener and ethanol, characterised in that the sweetener is an ultrahigh potency sweetener.
1. A pharmaceutical formulation for oral administration comprising:
cannabidiol (CBD);
a lipid solvent;
an ultrahigh potency sweetener; and
ethanol, wherein ethanol has a concentration of less than about 3% v/v.
2. The pharmaceutical formulation of claim 1 , wherein the ultrahigh potency sweetener has a sweetness intensity that is 1000x greater than sucrose.
3. The pharmaceutical formulation of claim 1 , wherein the ultrahigh potency sweetener has a sweetness intensity that is 5000x greater than sucrose.
4. The pharmaceutical formulation of claim 1 , wherein the ultrahigh potency sweetener is (N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1- methyl ester) (Neotame).
5. The pharmaceutical formulation of claim 1 , wherein the ultrahigh potency sweetener is N-[n-3-(3-hydroxy-4methoxyphenyl)propyl-α-L-aspartyl] -L-phenylalanine 1-methyl ester) (Advantame).
6. The pharmaceutical formulation of claim 1 , further comprising a flavorant.
7. The pharmaceutical formulation of claim 1 , wherein the CBD is present in an amount of from 5 to 40% (w/v), ethanol is present in an amount of less than 2% (v/v), ultrahigh potency sweetener is present in less than 0.05% (w/v), flavorant is present in an amount of less 0.2% (w/v) and lipid solvent is q.s. to 100%.
8. The pharmaceutical formulation of claim 7 , wherein the ultrahigh potency sweetener is Neotame, the flavorant is strawberry flavor and the lipid solvent is sesame oil.
9. The pharmaceutical formulation of claim 1 , wherein the formulation is stable in climatic zones I and II for up to 24 months at 25° C.
10. The pharmaceutical formulation of claim 1 , wherein the formulation is stable in climatic zones III and IV for up to 18 months at 30° C.
11. The pharmaceutical formulation of claim 1 , wherein the solution lacks a stabilizing agent.
12. The pharmaceutical formulation of claim 8 , wherein the formulation is stable in climatic zones I and II for up to 24 months at 25° C.
13. The pharmaceutical formulation of claim 8 , wherein the formulation is stable in climatic zones III and IV for up to 18 months at 30° C.
14. The pharmaceutical formulation of claim 8 , wherein the solution lacks a stabilizing agent.
15. The pharmaceutical formulation of claim 1 , the ultrahigh potency sweetener is Neotame, and the lipid solvent is sesame oil.
16. The pharmaceutical formulation of claim 1 , wherein the concentration of ethanol is less than about 2% (v/v).
17. The pharmaceutical formulation of claim 1 , wherein the concentration of ethanol ranges from about 0.5% (v/v) to 3% (v/v).
18. The pharmaceutical formulation of claim 1 , wherein the lipid solvent is sesame oil.
19. The pharmaceutical formulation of claim 1 , wherein:
the CBD is present in an amount ranging from 5 to 40% (w/v);
the ethanol is present in an amount ranging from 0.5% (v/v) to 2% (v/v);
the ultrahigh potency sweetener is present in an amount ranging from 0.01% (w/v) to 0.0025% about;
flavorant is present in an amount of less 0.2% (w/v); and
sesame oil is q.s. to 100%.
20. The pharmaceutical formulation of claim 1 , wherein the CBD is present in an extract.