Compositions comprising cannabinoids for treatment of nausea, vomiting, emesis, motion sickness or like conditions

Abstract

Cannabinoids, in particular CBD and CBDA and their acid derivatives are provided for use as an active pharmaceutical substance in the treatment of nausea, vomiting, emesis, motion sickness. In particular extracts of cannabis plants are presented which are rich in these substances and suitable for pharmaceutical use.

We claim: 
     
         1 .- 30 . (canceled) 
     
     
         31 . A botanical drug substance (BDS) in the form of a subcritical CO 2  extract obtained from a high cannabidiol (CBD) containing cannabis plant, wherein said BDS comprises cannabinoid constituents and other chemical entities, wherein the cannabinoid constituents comprise at least 90% CBD and the other chemical entities include terpene or carotene rich volatile oils, said BDS having been purified by winterisation in ethanol and cold filtration to remove waxes and other non-specific lipid-soluble material, and any water and ethanol have been removed by evaporation. 
     
     
         32 . A crystalline cannabidiol (CBD) obtained by re-dissolving a BDS as claimed in  claim 31  in a suitable solvent, filtering to remove insoluble material and then removing the solvent, such that the crystalline CBD has a chromatographic purity of greater than 99% by area normalization and contains less than 0.1% each of tetrahydrocannabinol (THC) and cannabinol (CBN). 
     
     
         33 . The crystalline cannabidiol (CBD) as claimed in  claim 32 , wherein the suitable solvent is pentane. 
     
     
         34 . A process of preparing a botanical drug substance (BDS) in the form of a subcritical CO 2  extract obtained from a high cannabidiol (CBD) containing cannabis plant comprising the following steps:
 i) Decarboxylate dry high CBD plant material by heating for a sufficient time and temperature to decarboxylate CBDA to CBD;   ii) Extract with liquid carbon dioxide under subcritical conditions of 50 to 70 bar and 5 to 15° C. for up to 10 hours;   iii) Removal of carbon dioxide by depressurization to recover crude extract;   iv) Winterization in ethanol and cold filtration to remove waxes and other non-specific lipid-soluble material; and   v) Removal of ethanol and water by evaporation to produce BDS.   
     
     
         35 . The process as claimed in  claim 34 , wherein the dry high CBD plant material is chopped to 2 to 3 mm prior to decarboxylation. 
     
     
         36 . The process as claimed in  claim 34 , wherein the plant material is decarboxylated by heating at 100 to 150° C. 
     
     
         37 . The process as claimed in  claim 34 , wherein the winterization step (iv) comprises chilling at −20° C. ±5° C. for up to 52 hours. 
     
     
         38 . The process as claimed in  claim 34 , wherein the ethanol and water in step (v) is removed by evaporation under reduced pressure. 
     
     
         39 . A process of preparing crystalline cannabidiol (CBD) such that the crystalline CBD has a chromatographic purity of greater than 99% by area normalization and contains less than 0.1% each of tetrahydrocannabinol (THC) and cannabinol (CBN) from the BDS obtained from  claim 34 , further comprising the additional steps of:
 i) Re-dissolving the BDS obtained in a suitable solvent;   ii) Filtering to remove insoluble material; and   iii) Removing the solvent.   
     
     
         40 . The process as claimed in  claim 39 , wherein the suitable solvent is pentane.