IP Library Granted Patent US 8,603,515
Granted Patent B2
US 8,603,515 · App. 13/486,227 · Granted Dec 10, 2013

Pharmaceutical formulation

View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 8,603,515
App. No.
13/486,227
Granted
Dec 10, 2013
Kind
B2
Abstract

The invention relates to pharmaceutical formulations, and more particularly to formulations containing cannabinoids for administration via a pump action spray. In particular, the invention relates to pharmaceutical formulations, for use in administration of lipophilic medicaments via mucosal surfaces, comprising: at least one lipophilic medicament, a solvent and a co-solvent, wherein the total amount of solvent and co-solvent present in the formulation is greater than 55% wt/wt of the formulation and the formulation is absent of a self emulsifying agent and/or a fluorinated propellant.

Claims (36)

1. A method of cannabis delivery comprising:

administering a liquid pharmaceutical formulation via buccal route to a patient, wherein the formulation comprises one or more cannabinoids, a solvent and a co-solvent, wherein the total amount of solvent and co-solvent present in the formulation is greater than 55% wt/wt of the formulation, the formulation is absent of a self-emulsifying agent and a fluorinated propellant and the one or more cannabinoids are present in the formulation in an amount at least 10 mg/ml.

2. The method of claim 1 , wherein the one or more cannabinoids are present in the formulation in an amount of at least 25 mg/ml.

3. The method of claim 1 , wherein the solvent is selected from C1-C4 alcohols.

4. The method of claim 3 , wherein the solvent is ethanol.

5. The method of claim 1 , wherein the co-solvent is selected from glycols, sugar alcohols, carbonate esters and chlorinated hydrocarbons.

6. The method of claim 5 , wherein the glycols are selected from propylene glycol and glycerol, and the carbonate ester is propylene carbonate.

7. The method of claim 1 , wherein the co-solvent is propylene glycol.

8. The method of claim 1 , wherein the solvent is ethanol and the co-solvent is propylene glycol.

9. The method of claim 8 , wherein the ethanol/propylene glycol are present in relative proportions by weight in the range 60/40 to 40/60.

10. The method of claim 8 , wherein the ethanol/propylene glycol are present in relative proportions by weight in the range 55/45 to 45/55.

11. The method of claim 8 , wherein the ethanol/propylene glycol are present in the relative proportions by weight of about 50/50.

12. The method of claim 1 , wherein the formulation further comprises a flavouring.

13. The method of claim 12 , wherein the flavouring is peppermint oil.

14. The method of claim 12 , wherein the flavouring is present in an amount up to 0.1% v/v.

15. The method of claim 1 , wherein the one or more cannabinoids are present in the formulation in an amount of at least 50 mg/ml.

16. The method of claim 1 , wherein the cannabinoids medicament is at least one extract from at least one cannabis plant.

17. The method of claim 16 , wherein the extract from at least one cannabis plant is a botanical drug substance.

18. The method of claim 16 , wherein the extract, which is a botanical drug substance, has undergone an extraction step to remove a substantial proportion of waxes and other solvent insoluble materials present in extract.

19. The method of claim 16 , wherein the extract, which is a botanical drug substance, is a CO2 extract of one or more cannabis plants.

20. The method of claim 1 , wherein the cannabinoid medicament comprises one or more of: tetrahydrocannabinol (THC), including Δ9-tetrahydrocannabinol, Δ9-tetrahydrocannabinol propyl analogue, cannabidiol (CBD), cannabidiol propyl analogue, cannabinol, cannabichromene, cannabichromene propyl analogue, cannabigerol or any mixture thereof.

21. The method of claim 20 , wherein the cannabinoids include tetrahydrocannabinol (THC) and cannabidiol (CBD).

22. The method of claim 20 , wherein THC and CBD are present in a ratio (w/w) of from 0.9:1.1 to 1.1:0.9.

23. The method of claim 20 , wherein the formulation includes from 22.5 to 27.5 mg/ml tetrahydrocannabinol (THC) and from 22.5 to 27.5 mg/ml cannabidiol (CBD).

24. The method of claim 1 , wherein the formulation comprises both the cannabinoids cannabidiol (CBD) and tetrahydrocannabinol (THC), or the cannabinoids tetrahydrocannabinovarin (THCV) and cannabidivarin (CBDV), in a pre-defined ratio by weight.

25. The method of claim 16 , wherein the at least one extract is prepared by supercritical or sub-critical fluid extraction of dried Cannabis plant.

26. The method of claim 1 , wherein the formulation is packaged for delivery as a pump-action spray, and wherein, in use, a dose is discharged through a break-up button.

27. The method of claim 1 , wherein the formulation comprises an extract from a high tetrahydrocannabinol (THC) yielding cannabis plant and an extract from a high cannabidiol (CBD) yielding cannabis plant and wherein said extracts each comprise all naturally occurring cannabinoids in said plants.

28. A method of cannabis delivery comprising:

administering a liquid pharmaceutical formulation via buccal route to a patient, wherein the formulation comprises in a 1 ml vol: THC 25-50 mg/ml based on amount of cannabinoid in a botanical drug substance, CBD 25-50 mg/ml based on amount of cannabinoid in a botanical drug substance, propylene glycol 0.5 ml/ml, peppermint oil 0.0005 ml/ml, and anhydrous ethanol qs to 1 ml.

29. A method of cannabis delivery comprising:

administering a liquid pharmaceutical formulation via buccal route to a patient, wherein the formulation comprises in a 1 ml vol: THC 25-50 mg/ml based on amount of cannabinoid in a botanical drug substance, propylene glycol 0.5 ml/ml, peppermint oil 0.0005 ml/ml, and anhydrous ethanol qs to 1 ml.

30. A method of cannabis delivery comprising:

administering a liquid pharmaceutical formulation via buccal route to a patient, wherein the formulation comprises in a 1 ml vol: CBD 25-50 mg/ml based on amount of cannabinoid in a botanical drug substance, propylene glycol 0.5 ml/ml, peppermint oil 0.0005 ml/ml, and anhydrous ethanol qs to 1 ml.

31. A method of cannabis delivery comprising:

administering a liquid pharmaceutical formulation via buccal route to a patient, wherein the formulation comprises in a 1 ml volume: THC 22.5-27.5 mg/ml based on amount of cannabinoid in a botanical drug substance, CBD 22.5-27.5 mg/ml based on amount of cannabinoid in a botanical drug substance, propylene glycol 0.5 ml/ml, peppermint oil 0.0005 ml/ml, and anhydrous ethanol qs to 1 ml.

Assignments (4)
CHANGE OF NAME Recorded May 13, 2025
From: GW RESEARCH LIMITED
To: JAZZ PHARMACEUTICALS RESEARCH UK LIMITED
Reel/Frame 071097/0142 →
SECURITY AGREEMENT Recorded Jul 22, 2021
From: GW PHARMA LIMITED; GW RESEARCH LIMITED
To: U.S. BANK NATIONAL ASSOCIATION
Reel/Frame 056958/0493 →
DEED OF ASSIGNMENT OF INTELLECTUAL PROPERTY RIGHTS Recorded Feb 4, 2021
From: GW PHARMA LIMITED
To: GW RESEARCH LIMITED
Reel/Frame 055222/0457 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 6, 2012
From: WHITTLE, BRIAN
To: GW PHARMA LIMITED
Reel/Frame 028500/0594 →