Objectives: Knowledge of the exact concentration of active compounds in galenic preparations is crucial to be able to ensure their quality and to properly administer the prescribed dose. Currently, the need for titration of extracts is still debated. Considering this, together with the absence of a standard preparation method, the aim of this study was to evaluate cannabinoids concentrations variability in galenic olive oil extracts, to evaluate the interlot and interlaboratory variability in the extraction yield and in the preparation composition.
Methods: Two hundred and one extracts (123 (61.2%) from Bedrocan® , 54 (26.9%) from Bediol® , 11 (5.5%) from Bedrolite® , and 13 (6.5%) from mixed preparations) were analysed by liquid chromatography coupled with tandem mass spectrometry, quantifying cannabinoids (THC, CBD, THCA, CBDA and CBN) concentrations.
Key findings: The RSD% of THC and CBD concentrations resulted higher than 50%. Specifically for Bedrocan® , Bediol® , Bedrolite® (5 g/50 ml), these were THC 82%, THC 53% and CBD 91%, THC 58% and CBD 59%, respectively. The median extraction yields were greater than 75% for all preparations.
Conclusions: Our results highlighted a wide variability in THC and CBD concentrations that justify the need for titration and opens further questions about other pharmaceutical preparations without regulatory indication for this procedure.
Keywords: Bediol®; Bedrocan®; Bedrolite®; LC-MS; cannabis; cannabis olive oil.
© 2017 Royal Pharmaceutical Society.