Use of cannabinoids in the treatment of epilepsy

Patent metadata

Field	Value
Publication number	US-10966939-B2
Application number	US-202016911914-A
Country	US
Kind code	B2
Filing date	Jun 25, 2020
Priority date	Oct 14, 2014
Publication date	Apr 6, 2021
Grant date	Apr 6, 2021

Abstract

The present disclosure relates to the use of cannabidiol (CBD) for the treatment of atonic seizures. In particular the CBD appears particularly effective in reducing atonic seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Aicardi syndrome; CDKL5 and Dup15q in comparison to other seizure types. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).

First claim

The invention claimed is:

1. A method of treating seizures in a patient with Lennox-Gastaut syndrome or Dravet syndrome, comprising orally administering to the patient in need thereof cannabidiol (CBD), wherein the CBD has a purity of at least 95% (w/w), and wherein the CBD is administered in a composition, comprising:
(i) CBD at a concentration ranging from about 22.5 mg/mL and about 110 mg/mL;
(ii) ethanol at a concentration ranging from about 71.1 mg/mL to about 86.9 mg/mL;
(iii) a sweetener at a concentration ranging from about 0.45 mg/mL to about 0.55 mg/mL;
(iv) flavoring at a concentration ranging from about 0.18 mg/mL to about 0.22 mg/mL;
and (v) a solvent.

2. The method according to claim 1 , wherein the sweetener is sucralose.

3. The method according to claim 1 , wherein the flavoring is strawberry flavor.

4. The method according to claim 1 , wherein the composition comprises from about 25 mg/mL to about 100 mg/mL of CBD.

5. The method of claim 1 , wherein the composition comprises about 79 mg/mL of ethanol.

6. The method of claim 2 , wherein the composition comprises about 0.5 mg/mL of sucralose.

7. The method of claim 3 , wherein the composition comprises about 0.2 mg/mL of strawberry flavoring.

8. The method of claim 1 , wherein the composition comprises about 100 mg/mL of CBD that has a purity of at least 98% (w/w).

9. The method of claim 1 , wherein the composition comprises:
(i) about 90 mg /mL to about 110 mg/mL of CBD that has a purity of at least 98% (w/w);
(ii) about 71.1 mg/mL to about 86.9 mg/mL of ethanol;
(iii) about 0.45 mg/mL to about 0.55 mg/mL of sucralose;
(iv) about 0.18 mg/mL to about 0.22 mg/mL of strawberry flavoring; and
(v) sesame oil q.s. to about 1.0 ml.

10. An oral pharmaceutical composition comprising: (i) cannabidiol (CBD) at a concentration of between about 22.5 mg/ml and about 110 mg/ml, (ii) ethanol at a concentration of about 71.1 mg/ml to about 86.9 mg/ml, (iii) sweetener at a concentration of about 0.45 mg/ml to about 0.55 mg/ml, (iv) flavoring at a concentration of about 0.18 mg/ml to about 0.22 mg/ml, and (v) sesame oil.

11. The oral pharmaceutical composition of claim 10 , wherein the CBD is at a concentration of about 100 mg/mL±10%.

12. The oral pharmaceutical composition of claim 10 , wherein the CBD has a purity of at least about 95% (w/w).

13. The oral pharmaceutical composition of claim 10 , wherein the CBD has a purity of at least about 98% (w/w).

14. The oral pharmaceutical composition of claim 10 , wherein the sweetener is sucralose.

15. The oral pharmaceutical composition of claim 10 , wherein the flavoring is strawberry flavoring.

16. The oral pharmaceutical composition of claim 10 , wherein: (i) the CBD is at a concentration of between about 90 mg/ml and about 110 mg/ml; (ii) ethanol is at a concentration of about 71.1 mg/ml to about 86.9 mg/mL; (iii) the sweetener is at a concentration of about 0.45 mg/ml to about 0.55 mg/ml; (iv) the flavoring is at a concentration of about 0.18 mg/ml to about 0.22 mg/ml; and (v) the sesame oil, q.s. to about 1.0 ml.

17. The composition of claim 16 , wherein the CBD has a purity of at least about 95% (w/w).

18. The composition of claim 16 , wherein the CBD has a purity of at least about 98% (w/w).

19. The method according to claim 1 , wherein the solvent is sesame oil.

20. An oral pharmaceutical composition, comprising: (i) CBD at a concentration of between about 22.5 mg/ml and about 110 mg/ml, wherein the CBD has a purity of at least about 95% (w/w); (ii) ethanol is at a concentration of about 71.1 mg/ml to about 86.9 mg/mL; (iii) the sweetener is at a concentration of about 0.45 mg/ml to about 0.55 mg/ml; (iv) the flavoring is at a concentration of about 0.18 mg/ml to about 0.22 mg/ml; and (v) sesame oil.

21. The oral pharmaceutical composition of claim 19 , wherein the composition comprises:
(i) about 90 mg /mL to about 110 mg/mL of CBD that has a purity of at least 98% (w/w);
(ii) about 71.1 mg/mL to about 86.9 mg/mL of ethanol;
(iii) about 0.45 mg/mL to about 0.55 mg/mL of sucralose; and
(iv) about 0.18 mg/mL to about 0.22 mg/mL of strawberry flavoring.

Assignees

• Gw Res Ltd

Inventors

• Guy Geoffrey
• Wright Stephen
• Devinsky Orrin

Classifications

• A61K36/185

  Magnoliopsida (dicotyledons) · CPC title

• A61K31/658 Primary

  o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol · CPC title

• A61K2300/00

  Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00 · CPC title

• A61P25/08

  Antiepileptics; Anticonvulsants · CPC title

• A61P25/00

  Drugs for disorders of the nervous system · CPC title