Granted Patent B2

US 12,213,985 · App. 17/689,245 · Granted Feb 4, 2025

Inventor: Harshit Shah (Cambridge, GB)

Assignee: Jazz Pharmaceuticals Research UK Limited

A61K31/658A61K9/0095A61K9/08A61K31/05A61K47/10A61K47/14A61K47/44A61P25/08

Abstract

Claims (37)

1. A method of treating a disease or disorder, the method comprising orally administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical formulation comprising:

cannabidiol (CBD);

a lipid solvent;

an ultrahigh potency sweetener; and

ethanol, wherein ethanol has a concentration of less than about 3% v/v, and

wherein the disease or disorder is epilepsy or a syndrome associated therewith, schizophrenia, tuberous sclerosis complex, brain tumors, neuropathic pain, cannabis use disorder. post-traumatic stress disorder, anxiety, early psychosis, Alzheimer's Disease, or autism.

2. The method of claim 1 , wherein the ultrahigh potency sweetener has a sweetness intensity that is 1000× greater than a sweetness intensity of sucrose.

3. The method of claim 1 , wherein the ultrahigh potency sweetener has a sweetness intensity that is 5000× greater than a sweetness intensity of sucrose.

4. The method 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 method 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 method of claim 1 , further comprising a flavorant.

7. The method of claim 6 , wherein the CBD is present in an amount of from 5 to 40% (w/v), the ethanol is present in an amount of less than 2% (v/v), the ultrahigh potency sweetener is present in an amount of less than 0.05% (w/v), the flavorant is present in an amount of less 0.2% (w/v) and the lipid solvent is q.s. to 100%.

8. The method of claim 7 , wherein the ultrahigh potency sweetener is Neotame, the flavorant is strawberry flavor and the lipid solvent is sesame oil.

9. The method of claim 1 , wherein the formulation is stable in climatic zones I and II for up to 24 months at 25° C.

10. The method of claim 1 , wherein the formulation is stable in climatic zones III and IV for up to 18 months at 30° C.

11. The method of claim 1 , wherein the solution lacks a stabilizing agent.

12. The method of claim 8 , wherein the formulation is stable in climatic zones I and II for up to 24 months at 25° C.

13. The method of claim 8 , wherein the formulation is stable in climatic zones III and IV for up to 18 months at 30° C.

14. The method of claim 8 , wherein the solution lacks a stabilizing agent.

15. The method of claim 1 , the ultrahigh potency sweetener is Neotame, and the lipid solvent is sesame oil.

16. The method of claim 1 , wherein the concentration of ethanol is less than about 2% (v/v).

17. The method of claim 1 , wherein the concentration of ethanol ranges from about 0.5% (v/v) to 3% (v/v).

18. The method of claim 1 , wherein the lipid solvent is sesame oil.

19. The method 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%;

flavorant is present in an amount of less 0.2% (w/v); and

sesame oil is q.s. to 100%.

20. The method of claim 1 , wherein the CBD is present in an extract.

21. The method of claim 1 , wherein the subject is a human.

22. The method of claim 1 , wherein the disease or disorder is epilepsy or a syndrome associated therewith.

23. The method of claim 22 , wherein the syndrome associated with epilepsy is Dravet Syndrome, Lennox Gastaut Syndrome, myoclonic seizures, juvenile myoclonic epilepsy, refractory epilepsy, juvenile spasms, West syndrome, infantile spasms, or refractory infantile spasms.

24. The method of claim 23 , wherein the syndrome is associated with epilepsy is Dravet Syndrome.

25. The method of claim 23 , wherein the syndrome is associated with epilepsy is Lennox Gastaut Syndrome.

26. The method of claim 23 , wherein the syndrome is associated with epilepsy is tuberous sclerosis complex.

27. The method of claim 23 , wherein the syndrome is associated with epilepsy is myoclonic seizures.

Assignments (3)

Priority Claims (1)

Continuity (2)

References Cited (400)

Cited By (3)

US 12,427,160 US 12,569,505 US 12,661,365