Pharmaceutical formulation
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.
1. A method of treating multiple sclerosis in a patient in need thereof, wherein the method comprises administering to the patient a liquid pharmaceutical formulation comprising in a 1 mL volume: 22.5-27.5 mg/mL of delta-9-tetrahydrocannabinol (THC) based on amount of cannabinoid in a botanical drug substance, 22.5-27.5 mg/mL of cannabidiol (CBD) based on amount of cannabinoid in a botanical drug substance, 0.5 mL/mL of propylene glycol, 0.0005 mL/mL of peppermint oil, and anhydrous ethanol to 1 mL.
2. The method of claim 1 , wherein the liquid pharmaceutical formulation comprises 22.5-27.5 mg/mL of THC based on amount of cannabinoid in a botanical drug substance, 25 mg/mL of CBD based on amount of cannabinoid in a botanical drug substance, 0.5 mL/mL of propylene glycol, 0.0005 mL/mL of peppermint oil, and anhydrous ethanol to 1 mL.
3. The method of claim 2 , wherein the liquid pharmaceutical formulation is administered to the patient by sub-lingual application.
4. The method of claim 2 , wherein the liquid pharmaceutical formulation is administered to the patient by buccal application.
5. The method of claim 2 , wherein the liquid pharmaceutical formulation is administered via a pump-action spray.
6. A method of treating spasms associated with multiple sclerosis in a patient in need thereof, wherein the method comprises administering to the patient a liquid pharmaceutical formulation, comprising in a 1 mL volume: 22.5-27.5 mg/mL of delta-9-tetrahydrocannabinol (THC) based on amount of cannabinoid in a botanical drug substance, 22.5-27.5 mg/mL of cannabidiol (CBD) based on amount of cannabinoid in a botanical drug substance, 0.5 mL/mL of propylene glycol, 0.0005 mL/mL of peppermint oil, and anhydrous ethanol to 1 mL.
7. The method of claim 6 , wherein the liquid pharmaceutical formulation comprises 22.5-27.5 mg/mL of THC based on amount of cannabinoid in a botanical drug substance, 25 mg/mL of CBD based on amount of cannabinoid in a botanical drug substance, 0.5 mL/mL of propylene glycol, 0.0005 mL/mL of peppermint oil, and anhydrous ethanol to 1 mL.
8. The method of claim 7 , wherein the liquid pharmaceutical formulation is administered to the patient by sub-lingual application.
9. The method of claim 7 , wherein the liquid pharmaceutical formulation is administered to the patient by buccal application.
10. The method of claim 7 , wherein the liquid pharmaceutical formulation is administered via a pump-action spray.
11. A method of treating multiple sclerosis or spasms associated with multiple sclerosis in a patient in need thereof, wherein the method comprises administering to the patient a liquid pharmaceutical formulation comprising 22.5-27.5 mg/mL of delta-9-tetrahydrocannabinol (THC) based on amount of cannabinoid in a botanical drug substance, 22.5-27.5 mg/mL of CBD cannabidiol (CBD) based on amount of cannabinoid in a botanical drug substance, propylene glycol, peppermint oil, and anhydrous ethanol, wherein the THC and CBD are present at a weight ratio of from 0.9:1.1 to 1.1:0.9.
12. The method of claim 11 , wherein the liquid pharmaceutical formulation comprises in a 1 mL volume: 22.5-27.5 mg/mL of THC based on amount of cannabinoid in a botanical drug substance, 22.5-27.5 mg/mL of CBD based on amount of cannabinoid in a botanical drug substance, 0.5 mL/mL of propylene glycol, 0.0005 mL/mL of peppermint oil, and anhydrous ethanol to 1 mL.
13. The method of claim 11 , wherein the liquid pharmaceutical formulation comprises in a 1 mL volume: 22.5-27.5 mg/mL of THC based on amount of cannabinoid in a botanical drug substance, 25 mg/mL of CBD based on amount of cannabinoid in a botanical drug substance, 0.5 mL/mL of propylene glycol, 0.0005 mL/mL of peppermint oil, and anhydrous ethanol to 1 mL.
14. The method of claim 11 , wherein the patient has multiple sclerosis.
15. The method of claim 11 , wherein the patient has spasms associated with multiple sclerosis.
16. The method of claim 11 , wherein the liquid pharmaceutical formulation is administered to the patient by sub-lingual application.
17. The method of claim 11 , wherein the liquid pharmaceutical formulation is administered to the patient by buccal application.
18. The method of claim 11 , wherein the liquid pharmaceutical formulation is administered via a pump-action spray.
19. The method of claim 18 , wherein the pump-action spray produces a spray in which the particles have a mean aerodynamic particle size of between 15 and 45 microns.
20. The method of claim 18 , wherein the pump-action spray produces a spray in which the particles have a mean aerodynamic particle size of between 20 and 40 microns.