Pharmaceutical compositions

Abstract

The present invention relates to an improved mode of administration for cannabis and its natural and synthetic derivatives. A pharmaceutical composition suitable for sublingual aerosol or spray delivery of cannabis is provided. The formulation may be dispensed using a pump spray or the formulation may include a propellant, such as butane, 1,1,1,2-tetrafuorethane (HFC-134a) or 1,1,1,2,3,3,3-heptafluropropane (HFC-227). The term cannabis is used herein to refer to all physiologically active substances derived from the cannabis family of plants and synthetic cannabis analogues and derivatives, precursors, metabolites etc., or related substances having cannabis-like physiological effects.

1 . A pharmaceutical composition formulated for sublingual aerosol delivery comprising a pharmaceutically active agent which is cannabis.  
     
     
         2 . A composition as claimed in  claim 1 , which further comprises a propellant.  
     
     
         3 . A composition as claimed in  claim 1  or  claim 2  wherein the cannabis is a liquid extract derived from the cannabis plant.  
     
     
         4 . A composition as claimed in any of the preceding claims, further comprising at least one carrier.  
     
     
         5 . A composition as claimed in  claim 4 , wherein the at least one carrier is ethanol.  
     
     
         6 . A composition as claimed in  claim 4 , wherein the at least one carrier is propylene glycol.  
     
     
         7 . A composition as claimed in  claim 4 , wherein the at least one carrier is a polyoxyethylene caster oil derivative.  
     
     
         8 . A composition as claimed in any of  claims 4  to  7 , wherein the composition comprises a plurality of carriers.  
     
     
         9 . A composition as claimed in  claim 8  wherein the plurality of carriers comprise ethanol and propylene glycol.  
     
     
         10 . A composition as claimed in any of the preceding claims, wherein the composition further comprises an organic surfactant.  
     
     
         11 . A composition as claimed in  claim 10 , wherein the organic surfactant is oleyl alcohol, sorbitan trioleate, sorbitan mono-oleate, sorbitan monolaurate, polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan mono-oleate, natural lecithin, oleyl polyoxyethylene (2) ether, stearyl polyoxyethylene (2) ether, lauryl polyoxyethylene (4) ether, block copolymers of oxyethylene and , oxypropylene, oleic acid, synthetic lecithin, diethylene glycol dioleate, tetrahydrofurfuryl oleate, ethyl oleate, isopropyl myristate, glyceryl mono-oleate, glyceryl monostearate, glyceryl monoricinoleate, cetyl alcohol, stearyl alcohol, cetyl pyridinium chloride, olive oil, glyceryl monolaurate, corn oil, cotton seed oil or sunflower seed oil.  
     
     
         12 . A composition as claimed in  claim 11 , wherein the surfactant is oleyl alcohol.  
     
     
         13 . A composition as claimed in any of the preceding claims, wherein the pharmaceutically active agent is delta-9-tetrahydrocannabinol or a pharmaceutically acceptable salt thereof.  
     
     
         14 . A composition as claimed in  claim 13 , wherein the delta-9-tetrahydrocannabinol is in an anhydrous, hydrated, or solvated state, preferably, in any anhydrous state.  
     
     
         15 . A composition as claimed in any of the preceding claims substantially free of weak organic or strong inorganic acid.  
     
     
         16 . A composition as claimed in any of the preceding claims, further comprising a flavouring oil, preferably peppermint oil.  
     
     
         17 . A composition as claimed in any of the preceding claims, comprising a further pharmaceutically active agent.  
     
     
         18 . Use of cannabis in the preparation of an aerosol pharmaceutical formulation for administration to a patient via the sub-lingual route.  
     
     
         19 . The use as claimed in  claim 18  wherein said pharmaceutical formulation has a composition as claimed in any one of  claims 1  to  17 .  
     
     
         20 . A device for providing pharmaceutical doses comprising a container filled with a pharmaceutical composition according to any of  claims 1  to  17  and valve means arranged for delivering aerosol doses of said pharmaceutical composition to the exterior of the container.  
     
     
         21 . A pump spray device comprising a pharmaceutical composition formulated for sublingual aerosol delivery wherein the pharmaceutically active agent is cannabis.  
     
     
         22 . A device as claimed in  claim 21  wherein the cannabis is a liquid extract derived from the cannabis plant.  
     
     
         23 . A device as claimed in  claim 21  or  22  wherein the composition further comprises at least one carrier.  
     
     
         24 . A device as claimed in  claim 23  wherein the at least one carrier is ethanol.  
     
     
         25 . A device as claimed in  claim 23  wherein the at least one carrier is polyethylene glycol.  
     
     
         26 . A device as claimed in  claim 23  wherein the at least one carrier is a polyoxyethylate caster oil derivative.  
     
     
         27 . A device as claimed in any one of  claims 21  to  26  wherein the composition comprises a plurality of different carriers.  
     
     
         28 . A device as claimed in  claim 27  wherein the plurality of carriers comprise ethanol and propylene glycol.  
     
     
         29 . A device as claimed in any one of  claims 21  to  28  wherein a valve or mouthpiece is adapted to spray a dose towards a patient's sub-lingual mucosa.  
     
     
         30 . A device as claimed in any one of  claims 21  to  29  wherein the device is adapted to dispense particles of a particular size, thereby optimising the sub-lingual uptake.  
     
     
         31 . A device as claimed in any one of  claims 21  to  30  further comprising a metered valve.  
     
     
         32 . A device as claimed in any of  claims 21  to  31  in which the device comprises a canister or cap formed from stainless steel or glass.  
     
     
         33 . A pump action spray device for delivery of a pharmaceutical composition having a valve or mouthpiece adapted to spray a dose of said composition towards a patient's sub-lingual mucosa wherein the device comprises a canister or cap formed from stainless steel or glass.  
     
     
         34 . A device as claimed in  claim 33  which is adapted to dispense particles of a particular size, thereby optimising the sub-lingual uptake.  
     
     
         35 . A device as claimed in  claim 33  or  34  further comprising a metered valve.