EXTRACTION OF PHARMACEUTICALLY ACTIVE COMPONENTS FROM PLANT MATERIALS
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 .