Delta9 tetrahydrocannabinol (delta9 THC) solution metered dose inhalers and methods of use

Abstract

The present invention provides therapeutic formulations for solutions of Δ 9 -tetrahydrocannabinol (Δ 9 THC) to be delivered by metered dose inhalers. The formulations, which use non-CFC propellants, provide a stable aerosol-deliverable source of Δ 9 THC for the treatment of various medical conditions, such as: nausea and vomiting associated with chemotherapy-muscle spasticity; pain; anorexia associated with AIDS wasting syndrome, epilepsy; glaucoma; bronchial asthma; and mood disorders.

1 - 22 . (Cancelled).  
     
     
         23 . A method of administering a pharmaceutically effective dose of aerosolized tetrahydrocannabinol to a patient, comprising the steps of: 
 providing a solution comprising a pharmaceutically acceptable form of said tetrahydrocannabinol in a hydrofluoroalkane, said solution having not more than 15% of a pharmaceutically acceptable solvent;    aerosolizing said solution to provide respirable droplets comprising said tetrahydrocannabinol, wherein at least 20% of the mass of said respirable droplets comprise droplets having an aerodynamic diameter of less than 5.8 μm;    administering a pharmaceutically effective dose of said respirable droplets to said patient's lungs.    
     
     
         24 . The method of  claim 23  wherein said tetrahydrocannabinol is present in pharmaceutically pure form.  
     
     
         25 . The method of  claim 23  wherein said tetrahydrocannabinol is a pharmaceutically acceptable salt of said tetrahydrocannabinol.  
     
     
         26 . The method of  claim 23  wherein said pharmaceutically acceptable solvent comprises ethanol.  
     
     
         27 . The method of  claim 23  wherein said solution consists essentially of said hydrofluoroalkane and said tetrahydrocannabinol.  
     
     
         28 . The method of  claim 23  wherein said solution is surfactant free.  
     
     
         29 . The method of  claim 23  wherein said tetrahydrocannabinol is present in said solution at a concentration sufficient to achieve serum concentration levels in said patient of 10-100 ng/ml fifteen minutes following inhalation.  
     
     
         30 . The method of  claim 23  wherein said pharmaceutically effective dose is sufficient to treat nausea.  
     
     
         31 . The method of  claim 23  wherein said pharmaceutically effective dose is sufficient to treat vomiting.  
     
     
         32 . The method of  claim 23  wherein said pharmaceutically effective dose is sufficient to reduce pain.  
     
     
         33 . The method of  claim 23  wherein said pharmaceutically effective dose is sufficient to relieve muscle spasticity.  
     
     
         34 . The method of  claim 23  wherein said pharmaceutically effective dose is sufficient to relieve migraine headaches.  
     
     
         35 . The method of  claim 23  wherein said pharmaceutically effective dose is sufficient to relieve movement disorders.  
     
     
         36 . The method of  claim 23  wherein said pharmaceutically effective dose is sufficient to increase appetite in patients suffering from cachexia.  
     
     
         37 . A method of administering a pharmaceutically effective dose of medical marijuana to a patient, comprising the steps of: 
 providing a solution comprising a pharmaceutically acceptable form of said medical marijuana in a hydrofluoroalkane, said solution having not more than 15% of a pharmaceutically acceptable solvent;    aerosolizing said solution to provide respirable droplets comprising said medical marijuana, wherein at least 20% of the mass of the respirable droplets comprise droplets having an aerodynamic diameter of less than 5.8 μm;    administering a pharmaceutically effective dose of said respirable droplets to said patient's lungs.    
     
     
         38 . The method of  claim 37  wherein said pharmaceutically acceptable solvent comprises ethanol.  
     
     
         39 . The method of  claim 37  wherein said solution consists essentially of said hydrofluoroalkane and said medical marijuana.  
     
     
         40 . The method of  claim 37  wherein said solution is surfactant free.  
     
     
         41 . The method of  claim 37  wherein said medical marijuana is present in said solution at a concentration sufficient to achieve serum concentration levels in said patient of 10-100 ng/ml fifteen minutes following inhalation.  
     
     
         42 . The method of  claim 37  wherein said pharmaceutically effective dose is sufficient to treat a condition selected from the group consisting of nausea, vomiting, pain, muscle spasticity, migraine headaches, movement disorders, and loss of appetite due to cachexia.  
     
     
         43 . A pharmaceutical composition comprising a hydrofluoroalkane, Δ 9 -tetrahydrocannabinol, and up to 15 percent by weight of an organic solvent, said A9-tetrahydrocannabinol and said organic solvent being dissolved in said hydrofluoroalkane to form a stable composition, wherein said Δ 9 -tetrahydrocannabinol is present in said composition in concentrations ranging from 0.147% w/w (±0.008) to 5.940% w/w (±0.191).  
     
     
         44 . The pharmaceutical composition of  claim 43  wherein said Δ 9 -tetrahydrocannabinol is present in pharmaceutically pure form.  
     
     
         45 . The method of  claim 43  wherein said Δ 9 -tetrahydrocannabinol is a pharmaceutically acceptable salt of said Δ 9 -tetrahydrocannabinol.  
     
     
         46 . The pharmaceutical composition of  claim 43  wherein said organic solvent comprises ethanol.  
     
     
         47 . The pharmaceutical composition of  claim 43  wherein said solution consists essentially of said hydrofluoroalkane and said Δ 9 -tetrahydrocannabinol.  
     
     
         48 . The pharmaceutical composition of  claim 43  wherein said stable composition is surfactant free.  
     
     
         49 . The pharmaceutical composition of  claim 43  wherein said Δ 9 -tetrahydrocannabniol is present in said stable composition at a concentration sufficient to achieve serum concentration levels in a patient of 10-100 ng/ml fifteen minutes following inhalation.  
     
     
         50 . A pharmaceutical composition comprising a hydrofluoroalkane, a tetrahydrocannabinol, and up to 15 percent by weight of an organic solvent, said tetrahydrocannabinol and said organic solvent being dissolved in said hydrofluoroalkane to form a stable composition, wherein said tetrahydrocannabinol is present in said composition in concentrations ranging from 0.147% w/w (±0.008) to 5.940% w/w (±0.191).  
     
     
         51 . The pharmaceutical composition of  claim 50  wherein said tetrahydrocannabinol is present in pharmaceutically pure form.  
     
     
         52 . The method of  claim 50  wherein said tetrahydrocannabinol is a pharmaceutically acceptable salt of said tetrahydrocannabinol.  
     
     
         53 . The pharmaceutical composition of  claim 50  wherein said organic solvent comprises ethanol.  
     
     
         54 . The pharmaceutical composition of  claim 50  wherein said solution consists essentially of said hydrofluoroalkane and said tetrahydrocannabinol.  
     
     
         55 . The pharmaceutical composition of  claim 50  wherein said stable composition is surfactant free.  
     
     
         56 . The pharmaceutical composition of  claim 50  wherein said tetrahydrocannabinol is present in said stable composition at a concentration sufficient to achieve serum concentration levels in a patient of 10-100 ng/ml fifteen minutes following inhalation.