Cannabidiol preparations and its uses

Patent metadata

Field	Value
Publication number	US-11865102-B2
Application number	US-202117529005-A
Country	US
Kind code	B2
Filing date	Nov 17, 2021
Priority date	Apr 27, 2018
Publication date	Jan 9, 2024
Grant date	Jan 9, 2024

Abstract

Cannabidiol (CBD) is a cannabinoid designated chemically as 2-[(IR,6R)-3-Methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol. Its empirical formula is C 21 H 30 O 2 and its molecular weight is 314.46. CBD is a cannabinoid that naturally occurs in the Cannabis sativa L. plant. CBD is a white to pale yellow crystalline solid which is insoluble in water and soluble in organic solvents. The present invention encompasses the surprising recognition that certain CBD preparations which are prepared from a botanical origin are more effective in treating diseases or disorders than preparations of CBD which are synthetic or purified to the extent no other impurities in the form of other cannabinoids are present. Prior CBD compositions have been prepared such that no psychoactive components, e.g., tetrahydrocannabinol (THC), remain in the final CBD preparation. Surprisingly, the absence of such minor impurities reduces the efficacy of CBD treatment. Such CBD preparations are characterized by chemical components and/or functional properties that distinguish them from prior CBD compositions. One or more components of the preparations described herein provide an unexpectedly synergistic effect when utilized in combination.

First claim

The invention claimed is:

1. A cannabidiol (CBD) preparation comprising greater than or equal to 90% (w/w) CBD based on total amount of cannabinoid in the preparation and the remainder comprises other cannabinoids, wherein the other cannabinoids comprise tetrahydrocannabinol (THC), wherein the THC is present as a mixture of trans-THC and cis-THC, and wherein the ratio of trans-THC to cis-THC is about 0.7:1.0 to about 5.0:1.0.

2. The CBD preparation of claim 1 , comprising not more than 1.5% (w/w) THC based on total amount of cannabinoid in the preparation.

3. The CBD preparation of claim 1 , comprising about 0.01% to about 0.1% (w/w) THC based on total amount of cannabinoid in the preparation.

4. The CBD preparation of claim 1 , comprising about 0.02% to about 0.05% (w/w) THC based on total amount of cannabinoid in the preparation.

5. The CBD preparation of claim 1 , wherein the ratio of trans-THC to cis-THC is about 0.7:1.0 to about 3.6:1.0.

6. The CBD preparation of claim 1 , comprising about 0.1% to about 0.15% (w/w) CBD-C1 based on total amount of cannabinoid in the preparation.

7. The CBD preparation of claim 1 , comprising about 0.2% to about 0.8% (w/w) CBDV based on total amount of cannabinoid in the preparation.

8. The CBD preparation of claim 1 , comprising about 0.3% to about 0.4% (w/w) CBD-C4 based on total amount of cannabinoid in the preparation.

9. The CBD preparation of claim 1 , wherein at least a portion of at least one of the cannabinoids present in the CBD preparation is isolated from cannabis plant material.

10. The CBD preparation as claimed in claim 1 , wherein at least a portion of the CBD present in the CBD preparation is isolated from cannabis plant material.

11. The CBD preparation as claimed in claim 1 , wherein at least a portion of the THC present in the CBD preparation is isolated from cannabis plant material.

12. The CBD preparation of claim 1 , wherein the cannabinoids present in the CBD preparation are isolated from cannabis plant material.

13. The CBD preparation of claim 12 , wherein the cannabis plant material is from a Cannabis sativa, Cannabis indica , or Cannabis ruderalis plant.

14. The CBD preparation of claim 13 , wherein the cannabis plant is a high-CBD containing cannabis chemotype.

15. The CBD preparation of claim 1 , wherein at least a portion of at least one of the cannabinoids present in the CBD preparation is prepared synthetically.

16. The CBD preparation of claim 1 , wherein substantially all of at least one of the cannabinoids present in the CBD preparation is prepared synthetically.

17. The CBD preparation of claim 1 , wherein the cannabinoids present in the CBD preparation are prepared synthetically.

18. A pharmaceutical composition comprising the CBD preparation of claim 1 and at least one pharmaceutically acceptable excipient.

19. The pharmaceutical composition of claim 18 , wherein the pharmaceutical composition is a liquid dosage form.

20. The pharmaceutical composition of claim 18 , wherein the ratio of trans-THC to cis-THC is about 0.7:1.0 to about 2.0:1.0.

21. A method of treating epilepsy in a subject in need thereof, comprising administering a therapeutically effective amount of the CBD preparation of claim 1 , wherein the epilepsy is Dravet syndrome, Lennox Gastaut syndrome, Doose syndrome, or tuberous sclerosis complex (TSC).

22. The method of treating epilepsy of claim 21 , wherein the therapeutically effective amount of the CBD preparation provides a dose of CBD ranging from about 5 mg/kg/day to about 50 mg/kg/day.

23. The method of treating epilepsy of claim 21 , wherein the epilepsy is Dravet syndrome.

24. The method of claim 23 , wherein the wherein the therapeutically effective amount of the CBD preparation provides a dose of CBD of 10 mg/kg/day or 20 mg/kg/day.

25. The method of treating epilepsy of claim 21 , wherein the epilepsy is Lennox Gastaut syndrome.

26. The method of claim 25 , wherein the wherein the therapeutically effective amount of the CBD preparation provides a dose of CBD of 10 mg/kg/day or 20 mg/kg/day.

27. The method of treating epilepsy of claim 21 , wherein the epilepsy is Doose syndrome.

28. The method of treating epilepsy of claim 21 , wherein the epilepsy is TSC.

29. The method of claim 28 , wherein the wherein the therapeutically effective amount of the CBD preparation provides a dose of CBD of about 25 mg/kg/day.

30. The method of claim 27 , wherein the wherein the therapeutically effective amount of the CBD preparation provides a dose of CBD of 10 mg/kg/day, 20 mg/kg/day, or 25 mg/kg/day.

Assignees

• Gw Res Ltd

Inventors

• Guy Geoffrey
• Knappertz Volker
• Whalley Benjamin
• Woolley-Roberts Marie
• Brodie James
• Lach-Falcone Katarzyna
• Sutton Alan
• Gray Royston
• Rana Rohini Rajyalaxmi

Classifications

• A61K36/3482

  Cannabis · CPC title

• A61K31/658 Primary

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

• A61K2236/51

  Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying · CPC title

• A61K2236/33

  involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones · CPC title

• A61K9/7023

  Transdermal patches and similar drug-containing composite devices, e.g. cataplasms (galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006) · CPC title