Pharmaceutical composition comprising the phytocannabinoids cannabidivarin (CBDV) and cannabidiol (CBD)

Patent metadata

Field	Value
Publication number	US-11318109-B2
Application number	US-201916709401-A
Country	US
Kind code	B2
Filing date	Dec 10, 2019
Priority date	Sep 29, 2011
Publication date	May 3, 2022
Grant date	May 3, 2022

Abstract

This invention relates to a pharmaceutical composition comprising or consisting essentially of the phytocannabinoids cannabidivarin (CBDV) and cannabidiol (CBD). The composition is particularly safe and efficacious for use in the treatment of neurological conditions, characterized by hyper-excitability of the central nervous system, convulsions or seizures such as occur in epilepsy. Preferably the CBDV and the CBD are present with at least one non-cannabinoid component of cannabis such as one or more terpenes or a terpene fraction. More particularly the composition further comprises one or more cannabichromene type compounds. Particularly cannabichromene propyl variant (CBCV) and/or cannabichromene (CBC). More particularly still the composition is absent or substantially absent of other cannabinoids, including in particular tetrahydrocannabinol (THC) and tetrahydrocannabivarin (THCV), which would normally be present in significant amounts in cannabis chemotypes bred to contain a significant amount of CBDV and/or CBD.

First claim

The invention claimed is:

1. A composition comprising or consisting essentially of cannabidivarin (CBDV) and cannabidiol (CBD), wherein the CBDV and CBD are present in a ratio of from 5:1 to 1:1 (CBDV:CBD).

2. The composition as claimed in claim 1 , further comprising one or more excipients.

3. The composition as claimed in claim 1 , further comprising at least one non-cannabinoid component of cannabis.

4. The composition as claimed in claim 3 , wherein at least one non-cannabinoid component of cannabis comprises a terpene.

5. The composition as claimed in claim 1 , wherein the composition further comprises, or consists essentially of CBDV, CBD and one or more cannabichromene type compounds.

6. The composition as claimed in claim 5 , wherein the one or more cannabichromene type compounds is cannabichromene propyl variant (CBCV) and/or cannabichromene (CBC).

7. The composition as claimed in claim 1 , which is absent or substantially absent of any other cannabinoids.

8. The composition as claimed in claim 7 , wherein the any other cannabinoids are tetrahydrocannabivarin (THCV) and/or tetrahydrocannabinol (THC).

9. The composition as claimed in claim 1 , wherein the CBDV and CBD are present in a ratio of 4.5:1 to 2:1 (CBDV:CBD).

10. The composition as claimed in claim 1 , wherein a unit dosage form of the composition comprises from 500 to 2000 mg CBDV.

11. The composition as claimed in claim 1 , wherein a unit dosage form of the composition comprises from 100 to 600 mg CBD.

12. The composition as claimed in claim 1 , wherein the composition is an extract or botanical drug substance (BDS), and wherein the composition is substantially absent of tetrahydrocannabivarin (THCV) and tetrahydrocannabinol (THC).

13. A composition as claimed in claim 12 , wherein the composition further comprises one or more non-cannabinoid component(s).

14. The combination, comprising:
a composition as claimed in claim 1 , and
a standard anti-epileptic drug (SAED),
wherein the combination is configured for use in the treatment of neurological conditions that involve hyper-excitability of the central nervous system, convulsions or seizures.

15. The combination as claimed in claim 14 , wherein the neurological condition is epilepsy.

16. The combination as claimed in claim 15 , wherein the type of epilepsy to be treated is generalised seizure.

17. A method, comprising using a composition as claimed in claim 1 in the manufacture of a medicament for use in the treatment of neurological conditions that involve hyper-excitability of the central nervous system, convulsions or seizures.

18. A method for treating a neurological condition that involves hyper-excitability of the central nervous system, convulsions or seizures in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a composition as claimed in claim 1 .

19. The method as claimed in claim 18 , wherein the neurological condition is epilepsy.

20. The method as claimed in claim 19 , wherein the type of epilepsy is generalised seizure.

21. The method as claimed in claim 18 , wherein the composition further comprises at least one non-cannabinoid component of cannabis.

22. The method as claimed in claim 21 , wherein at least one non-cannabinoid component of cannabis comprises a terpene.

23. The method as claimed in claim 18 , wherein the composition further comprises one or more cannabichromene type compounds.

24. The method as claimed in claim 18 , wherein the composition further comprises cannabichromene propyl variant (CBCV) and/or cannabichromene (CBC).

25. The method as claimed in claim 18 , wherein the composition is absent or substantially absent of any other cannabinoids.

26. The method as claimed in claim 18 , wherein the composition is absent or substantially absent of tetrahydrocannabivarin (THCV) and/or tetrahydrocannabinol (THC).

27. The method as claimed in claim 18 , wherein the CBDV and CBD are present in the composition in a ratio of 4.5:1 to 2:1 (CBDV:CBD).

28. The method as claimed in claim 18 , wherein a unit dosage form of the composition comprises from 500 to 2000 mg CBDV.

29. The method as claimed in claim 18 , wherein a unit dosage form of the composition comprises from 100 to 600 mg CBD.

30. The method as claimed in claim 18 , wherein a unit dosage form of the composition comprises: (i) from 100 to 600 mg CBD and (ii) from 500 to 2000 mg CBDV.

31. The method as claimed in claim 18 , further comprising administering to the subject a standard anti-epileptic drug (SAED).

32. The composition as claimed in claim 1 , wherein a unit dosage form of the composition comprises: (i) from 100 to 600 mg CBD and (ii) from 500 to 2000 mg CBDV.

33. The composition as claimed in claim 1 , wherein the composition consists essentially of cannabidivarin (CBDV) and cannabidiol (CBD), and wherein the CBDV and CBD are present in a ratio of from 5:1 to 1:1 (CBDV:CBD).

34. The composition as claimed in claim 1 , wherein the composition comprises:
cannabidivarin (CBDV) and cannabidiol (CBD), wherein the CBDV and CBD are present in a ratio of from 5:1 to 1:1 (CBDV:CBD);
one or more cannabichromene type compounds;
at least one non-cannabinoid component of cannabis ; and
one or more excipients, wherein the composition is absent or substantially absent of any other cannabinoids.

35. The method for treating a neurological condition that involves hyper-excitability of the central nervous system, convulsions or seizures in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a composition as claimed in claim 33 .

36. The method as claimed in claim 35 , wherein the neurological condition is epilepsy.

37. The method as claimed in claim 36 , wherein the type of epilepsy is generalised seizure.

38. The method as claimed in claim 35 , further comprising administering to the subject a standard anti-epileptic drug (SAED).

39. The method for treating a neurological condition that involves hyper-excitability of the central nervous system, convulsions or seizures in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a composition as claimed in claim 34 .

40. The method as claimed in claim 39 , wherein the neurological condition is epilepsy.

41. The method as claimed in claim 40 , wherein the type of epilepsy is generalised seizure.

42. The method as claimed in claim 39 , further comprising administering to the subject a standard anti-epileptic drug (SAED).

Assignees

• Gw Pharma Ltd
• Otsuka Pharma Co Ltd

Inventors

• Whalley Benjamin
• Williams Claire
• Stephens Gary
• Hill Thomas

Classifications

• A61K36/3482

  Cannabis · 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

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title