Cannabinoid compositions and uses

Abstract

An inhalable composition for use as a medicament in the treatment of a subject wherein said composition comprises: one or more cannabinoids or a pharmaceutically acceptable derivative or salt thereof; a propellant; a monohydric or polyhydric alcohol; and a glycol and/or glycol ether, characterised in that the ratio of monohydric or polyhydric alcohol to glycol or glycol ether by weight is from 6:1 to 1:1, wherein the composition is administered in the form of an aerosol having a fine particle fraction of 60% or more.

1 .- 44 . (canceled) 
     
     
         45 . An inhalable composition for use as a medicament in the treatment of a subject wherein said composition comprises:
 one or more cannabinoids or a pharmaceutically acceptable derivative or salt thereof;   at least 92% w/w of a propellant based on the total weight of the composition, wherein the propellant is a hydrofluorocarbon;   from 0.5 to 4% w/w ethanol based on the total weight of the composition; and   from 0.3 to 2% w/w propylene glycol based on the total weight of the composition,   characterized in that the ratio of ethanol to propylene glycol by weight is from 6:1 to 1.2:1,   wherein the composition is to be administered in the form of an aerosol having a fine particle fraction of 60% or more.   
     
     
         46 . The composition according to  claim 45 , wherein the fine particle fraction is 70% or more. 
     
     
         47 . The composition according to  claim 45 , wherein the fine particle fraction is 75% or more. 
     
     
         48 . The composition according to  claim 45 , wherein the one or more cannabinoids is selected from tetrahydrocannabinol (THC), dronabinol, cannabidiol (CBD), cannabinol (CBN), tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabidivarin (CBDV) and cannabichromene (CBC). 
     
     
         49 . The composition according to  claim 45 , comprising from 0.01 to 15% w/w of the one or more cannabinoids or pharmaceutically acceptable derivatives or salts thereof based on the total weight of the composition. 
     
     
         50 . The composition according to  claim 45 , wherein the alcohol is a monohydric alcohol, and the ratio of monohydric alcohol to glycol or glycol ether by weight is from 5:1 to 1.2:1. 
     
     
         51 . The composition according to  claim 45  wherein the composition comprises from 0.1 to 2% w/w propylene glycol, based on the total weight of the composition. 
     
     
         52 . The composition according to  claim 45  wherein the composition further comprises a human TAS2R bitter taste receptor agonist. 
     
     
         53 . The composition according to  claim 52  wherein the human TAS2R bitter taste receptor agonist is saccharin, and wherein the saccharin is present in the composition in an amount by weight from 0.001% w/w to 0.1% w/w based on the total weight of the composition. 
     
     
         54 . The composition according to  claim 45  further comprising a flavor component. 
     
     
         55 . The composition according to  claim 54  wherein the flavor component is menthol, and wherein the menthol is present in the composition in an amount up to 0.1% w/w, based on the total weight of the composition. 
     
     
         56 . The composition according to  claim 54  wherein the flavor component is selected from at least one of peppermint oil, aniseed, chocolate, coco, and vanillin. 
     
     
         57 . A cannabinoid inhaler comprising:
 a housing;   a reservoir within the housing containing an inhalable composition comprising a cannabinoid or a pharmaceutically acceptable derivative or salt thereof, and an alcohol;   a composition flow path from the reservoir and out of a composition outlet at an inhaling end of the housing; and   a non-metered breath operated outlet valve for controlling the flow of inhalable composition through the composition flow path.   
     
     
         58 . The inhaler according to  claim 57 , wherein the breath operated inhaler further comprises an air flow path from an inlet spaced from the inhaling end of the inhaler to an air outlet at the inhaling end, the air flow path being configured such that suction on the inhaling end causes flow through the air flow path which causes the breath operated valve to open, the air outlet being positioned adjacent to the composition outlet, such that air from the air outlet impinges on the composition leaving the composition outlet. 
     
     
         59 . The inhaler according to  claim 58 , wherein there is a respective air flow outlet on either side of the inhalable composition outlet. 
     
     
         60 . The inhaler according to  claim 59 , wherein the air flow outlets are directed towards a composition plume emitted, in use, from the inhaler to break up the particle size of the composition plume. 
     
     
         61 . The inhaler according to  claim 57 , wherein the outlet valve comprises:
 a flexible diaphragm within the housing and being positioned so as to be influenced by the air flowing through the air flow path;   a valve element movable with the diaphragm and biased by a biasing force into a position in which it closes the composition flow path;   wherein suction on the inhaling end causes a flow through the air flow path providing a pressure differential across the diaphragm thereby lifting the valve element against the biasing force to open the composition flow path; and   wherein the biasing force is arranged to close the composition flow path once the suction ceases.   
     
     
         62 . The inhaler according to  claim 61 , further comprising a first air flow path partly defined by one side of the diaphragm, a second air flow path partly defined by the opposite side of the diaphragm, each flow path having an opening at the outlet end, wherein the air flow paths are arranged such that suction at the outlet end results in a pressure differential across the diaphragm that moves the diaphragm and hence moves the valve element against the biasing force to open the composition flow path. 
     
     
         63 . The inhaler according to  claim 57 , wherein at least a portion of the flow path is a deformable tube, and the outlet valve is provided by a clamping member which pinches the deformable tube closed when no suction force is applied to the inhaling end to close the composition flow path and releases the tube to open the composition flow path when suction is applied at the inhaling end. 
     
     
         64 . The inhaler according to  claim 57 , wherein there is a single diaphragm and valve element. 
     
     
         65 . The inhaler according to  claim 57 , further comprising tube having an internal bore leading from an inlet on a main axis of the housing a reservoir outlet.