Pharmaceutical formulation

Patent metadata

Field	Value
Publication number	US-2019270563-A1
Application number	US-201916417860-A
Country	US
Kind code	A1
Filing date	May 21, 2019
Priority date	Aug 14, 2002
Publication date	Sep 5, 2019
Grant date	—

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.

First claim

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), 22.5-27.5 mg/mL of cannabidiol (CBD), 0.5 mL/mL of propylene glycol, 0.0005 mL/mL of peppermint oil, and anhydrous ethanol qs to 1 mL.

2 . The method of claim 1 , wherein the liquid pharmaceutical formulation comprises 22.5-27.5 mg/mL of THC, and 25 mg/mL of CBD, 0.5 mL/mL of propylene glycol, 0.0005 mL/mL of peppermint oil, and anhydrous ethanol qs 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), 22.5-27.5 mg/mL of cannabidiol (CBD), 0.5 mL/mL of propylene glycol, 0.0005 mL/mL of peppermint oil, and anhydrous ethanol qs to 1 mL.

7 . The method of claim 6 , wherein the liquid pharmaceutical formulation comprises 22.5-27.5 mg/mL of THC, 25 mg/mL of CBD, 0.5 mL/mL of propylene glycol, 0.0005 mL/mL of peppermint oil, and anhydrous ethanol qs 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 delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), 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, 22.5-27.5 mg/mL of cannabidiol (CBD), 0.5 mL/mL of propylene glycol, 0.0005 mL/mL of peppermint oil, and anhydrous ethanol qs 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, 25 mg/mL of cannabidiol (CBD), 0.5 mL/mL of propylene glycol, 0.0005 mL/mL of peppermint oil, and anhydrous ethanol qs 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.

Assignees

• Gw Pharma Ltd

Inventors

• Whittle Brian Anthony

Classifications

• B65B3/003

  Filling medical containers such as ampoules, vials, syringes or the like · CPC title

• A61P25/28 Primary

  for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia · CPC title

• A61K36/534

  Mentha (mint) · CPC title

• B65B31/003

  Adding propellants in fluid form to aerosol containers (in solid form B65B31/10) · CPC title

• A61K9/006

  Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays · CPC title