Pharmaceutical Compositions For the Treatment of Disease and/or Symptoms in Arthritis

• US 20080139667A1
• Filed: 06/07/2005
• Published: 06/12/2008
• Est. Priority Date: 06/08/2004
• Status: Abandoned Application

• Current Assignee: GW Pharmaceuticals Limited (Jazz Pharmaceuticals Plc)
• Original Assignee: GW Pharmaceuticals Limited (Jazz Pharmaceuticals Plc)
• Inventors: Robson, Philip, Guy, Geoffrey
• Application Number:
  US11/628,814
• Publication Number:
  US 20080139667A1
• Time in Patent Office: Days
• US Class Current: 514/733
• CPC Class Codes: A61K 2236/15 involving mechanical treatment, e.g. chopping up, cutting or grinding
• CPC Class Codes: A61K 2236/39 Complex extraction schemes, e.g. fractionation or repeated extraction steps
• CPC Class Codes: A61K 2236/51 Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
• CPC Class Codes: A61K 2236/55 Liquid-liquid separation; Phase separation
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/047 having two or more hydroxy groups, e.g. sorbitol
• CPC Class Codes: A61K 31/05 Phenols cannabinoids A61K31/658
• CPC Class Codes: A61K 31/352 condensed with carbocyclic rings, e.g. methantheline cannabinoids A61K31/658
• CPC Class Codes: A61K 36/185 Magnoliopsida (dicotyledons)
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The invention relates to the use of a combination of cannabinoids for the treatment of pain, inflammation and/or disease modification in arthritis. Preferably the cannabinoids are selected from cannabidiol (CBD) or cannabidivarin (CBDV) and delta-9-tetrahydrocannabinol (THC) or tetrahydrocannabinovarin (THCV). More preferably the cannabinoids are in a predefined ratio by weight of less than or equal to 19:1 of CBD or CBDV to THC or THCV.

Claims

1. A method of treating a subject with arthritis comprising:

administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical formulation comprising a combination of cannabinoids x and y;

wherein x is selected from the group consisting of;

cannabidiol (CBD) and cannabidivarin (CBDV);

y is selected from the group consisting of;

delta-9-tetrahydrocannabinol (THC) and tetrahydrocannabinovarin (THCV); and

the ratio of x;

y by weight is less than or equal to 2.5;

1.

2. A method according to claim 1 for the treatment of osteoarthritis.

3. A method according to claim 1 for the treatment of rheumatoid arthritis.

4. A method according to claim 1 for the treatment of pain in arthritis.

5. A method according to claim 1 for the treatment of inflammation in arthritis.

6. A method according to claim 1 for improvement in quality of sleep in arthritis.

7. A method according to claim 1 for disease modification of arthritis.

8. A method according to claim 1 for the treatment of one or more symptoms of arthritis and in disease modification in arthritis.

9. A method according to claim 8, wherein the one or more symptoms of arthritis are selected from the group consisting of pain, inflammation and lack of sleep.

13. A method according to claim 1, wherein the ratio of cannabinoids x:

y is less than or equal to 2;

1.

14. A method according to claim 1, wherein the ratio of cannabinoids x:

y is less than or equal to 1.5;

1.

15. A method according to claim 1, wherein the ratio of cannabinoids x:

y is substantially 1;

1.

16. A method according to claim 1, wherein the ratio of cannabinoids x:

y is 0.93;

1.

17. A method according to claim 1 wherein cannabinoid x is CBD and cannabinoid y is THC.

18. A method according to claim 1 wherein cannabinoid x is CBDV and cannabinoid y is THCV.

19. A method according to claim 1 wherein cannabinoid x is CBDV and cannabinoid y is THC.

20. A method according to claim 1 where wherein cannabinoid x is CBD and cannabinoid y is THCV.

21. A method according to claim 1, wherein the pharmaceutical formulation is packaged for delivery sublingually or buccally.

22. A method according to claim 1, wherein the pharmaceutical formulation is in the form of a gel or gel spray, a tablet, a liquid, a capsule or for vaporisation.

23. A method according to claim 1, wherein the formulation further comprises one or more carrier solvent/s.

24. A method according to claim 23, wherein the carrier solvent/s are ethanol and/or propylene glycol.

25. A method according to claim 24, wherein the formulation comprises ethanol and propylene glycol in a ratio of ethanol to propylene glycol of between 4:

1 and 1;

4.

26. A method according to claim 24, wherein the ratio of ethanol to propylene glycol is 1:

1.

27. A method according to claim 1, wherein the formulation is in a titratable dosage form.

28. A method according to claim 1, wherein the dose taken by a patient is in the range of 5-25 mg of each cannabinoid per day.

29. A method according to claim 1, wherein cannabinoid x is administered separately, simultaneously or sequentially to cannabinoid y.

30. A method according to claim 1, wherein the cannabinoids are present as a cannabis based medicine extract (CBME).

31. A method according to claim 1, wherein the cannabinoids are derived from one or more CBME/s.

32. A method according to claim 31, wherein the formulation comprises a combination of:

a) a cannabis based medicinal extract which comprises THC at more than 90% of the total cannabinoid content in the extract; and

b) a cannabis based medicinal extract which comprises CBD at more than 90% of the total cannabinoid content in the extract.

33. A method according to claim 31, wherein the CBME/s are produced by extraction with supercritical or subcritical CO₂.

34. A method according to claim 30, wherein the CBME/s are produced by contacting plant material with a heated gas at a temperature which is greater than 100°

C., sufficient to volatilise one or more of the cannabinoids in the plant material to form a vapour, and condensing the vapour to form an extract.

35. A method according to claim 30, wherein the CBME/s comprise all the naturally occurring cannabinoids in one or more cannabis plant/s.

36. A method according to claim 1, wherein the cannabinoids are substantially pure.

37. A method according to claim 1, wherein the cannabinoids are synthetic.

38. A method according to claim 30, wherein the formulation comprises a CBD-containing CBME characterised by a chromatographic profile as illustrated below, where the retention time of the CBD is between 5.4 and 6.4 minutes.

39. A method according to claim 30, wherein the formulation comprises a THC-containing CBME characterised by a chromatographic profile as illustrated below, where the retention time of the THC is between 9.6 and 10.6 minutes.

40. A method according to claim 30, wherein the formulation comprises a CBME containing THC and CBD characterised by a chromatographic profile as illustrated below.

10-12. -12. (canceled)

41-42. -42. (canceled)