Cannabis-based products : analytical implications and impact on regulation

Abstract

The human use of cannabis for medicinal and recreational purposes dates back centuries. Research advances and changes in legislation led to the widespread availability of Cannabis based products from a variety of sources. This project investigated the quality parameters applicable to Cannabis from an analytical perspective and their impact on the regulation of Cannabis. The research question being addressed is to determine the relevance of quality parameters to Cannabis-based products and identify how these parameters inform regulatory sciences in this area. The objectives of this study involved the development, validation, and implementation of analytical techniques relevant to Cannabis-based products, intended for Cannabis testing and comparing properties of Cannabis in different dosage forms and from different sources, alongside assessment of how the outcomes of this research impact on the establishment of official standards and their adoption in regulatory frameworks. The initial phase of the study was based on the development and validation of methods for detection and quantification of Cannabinoids (THC, CBD, and CBN) and major terpene compounds in different dosage forms of Cannabis products. The developed analytical procedure based on a rapid liquid extraction and analysis on GC-MS was shown to provide accurate and reliable results by satisfying all the quality criteria included in the extensive validation process conducted. In the second phase of the study, the validated procedures were applied to analyse Cannabis inflorescence, Cannabis extracts and other dosage forms available on the market. The analytical data indicated a significant difference in the quality traits of cannabis products available on the local market, that included deviations from labelled content exceeding 10% in 28.3% of the products tested, deviations from the 0.2% THC limit enacted in Maltese legislation, inconsistency or absence of Terpene compounds and the presence of adulterants such as semi-synthetic cannabinoids in cannabis based products available on the local market. The final phase was focused on data analysis and the interplay between analytical data and regulatory sciences. The research presented provides pivotal analytical data and regulatory aspects to develop a harmonised regulatory framework for cannabis based products focused on product quality and safety. These are mainly related to the introduction of limits for degradation compounds, enhancing manufacturing quality, product consistency, adherence to legal limits of THC and the regulation of semi-synthetic cannabinoids.