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 . A botanical drug substance obtainable from botanical raw material from a high THC containing  cannabis  plant having a THC content, wherein said botanical drug substance is an extract derived from the high THC  cannabis  plant comprising at least 50% THC w/w of extract, no more than 5% CBD as % w/w of the THC content, and no more than 5% cannabinoids other than THC and CBD as % w/w of the THC content. 
     
     
         2 . A botanical drug substance obtainable from botanical raw material from a high CBD containing  cannabis  plant having a CBD content, wherein said botanical drug substance is an extract derived from the high CBD  cannabis  plant comprising 50% CBD w/w of extract, no more than 7.5% THC as % w/w of the CBD content, and no more than 5% cannabinoids other than CBD and THC as % w/w of the CBD content. 
     
     
         3 . A botanical drug substance as claimed in  claim 1  or  claim 2  comprising no more than 4 ppb aflatoxin. 
     
     
         4 . A botanical drug substance as claimed in  claim 1  or  claim 2  comprising no more than 20 ppm total heavy metals. 
     
     
         5 . A botanical drug substance as claimed in  claim 1  or  claim 2  comprising no more than 15% w/w residual solvents. 
     
     
         6 . A botanical drug substance as claimed in  claim 5  wherein the residual solvent is ethanol. 
     
     
         7 . A botanical drug substance as claimed in  claim 1  or  claim 2  comprising no more than 10 5  cfu/g 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 . 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. 
     
     
         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 . A botanical drug substance resulting from the mixing of a botanical drug substance as claimed in  claim 8  and  9 .