Extraction of pharmaceutically active components from plant materials

Abstract

The invention relates to the extraction of pharmaceutically active components from plant materials, and more particularly to the preparation of a botanical drug substance (BDS) for incorporation in to a medicament. It also relates to a BDS of given purity, for use in pharmaceutical formulations. In particular it relates to BDS comprising cannabinoids obtained by extraction from cannabis.

1 . (canceled) 
     
     
         2 . A botanical drug substance obtained under subcritical conditions from botanical raw material from a high CBD containing  cannabis  plant, wherein said botanical drug substance is an extract derived from the high CBD  cannabis  plant by extracting with liquid CO2 and comprising at least 60% cannabinoid constituents together with non-cannabinoid constituents, wherein the cannabinoid constituents comprise at least 90% CBD and the non-cannabinoid constituents comprise terpenes, and reduced levels of hydrocarbon and triglyceride waxes and plant pigments, and wherein the extraction with liquid CO2 is conducted under subcritical conditions at a temperature in the range of from 5 to 15° C. and a pressure in the range of from 50 to 70 bar. 
     
     
         3 . The botanical drug substance as claimed in  claim 2  comprising no more than 4 ppb aflatoxin. 
     
     
         4 . The botanical drug substance as claimed in  claim 2  comprising no more than 20 ppm total heavy metals. 
     
     
         5 . The botanical drug substance as claimed in  claim 2  comprising no more than 15% w/w residual solvents. 
     
     
         6 . The botanical drug substance as claimed in  claim 5  wherein the residual solvent is ethanol. 
     
     
         7 . The botanical drug substance as claimed in  claim 2  comprising no more than 10 5  cfu/g Total Viable Count (TVC), no more than 10 4  cfu/g fungi, no more than 10 3  cfu/g enterobacteria and other non gram negative organisms, and no detectable  E. coli, Salmonella  or  S. aureus.    
     
     
         8 . (canceled) 
     
     
         9 . A botanical drug substance obtained from  cannabis  comprising at least 60% cannabinoids of which at least 85% is CBD, about 3% is THC and the remainder comprises other minor cannabinoids. 
     
     
         10 . The botanical drug substance as claimed in  claim 9 , further mixed with a botanical drug substance obtained from  cannabis  comprising at least 60% cannabinoids of which at least 90% is THC, about 1.5% is CBD and the remainder comprises other minor cannabinoids. 
     
     
         11 . A pharmaceutical formulation comprising the botanical drug substance of  claim 2 . 
     
     
         12 . A pharmaceutical formulation comprising the botanical drug substance of  claim 3 . 
     
     
         13 . A pharmaceutical formulation comprising the botanical drug substance of  claim 4 . 
     
     
         14 . A pharmaceutical formulation comprising the botanical drug substance of  claim 5 . 
     
     
         15 . A pharmaceutical formulation comprising the botanical drug substance of  claim 6 . 
     
     
         16 . A pharmaceutical formulation comprising the botanical drug substance of  claim 7 .