Tilray Medical has published new research comparing the pharmacokinetic profiles of two different cannabis formulations, providing insights that could influence therapeutic dosing strategies for medical cannabis patients. The pilot crossover study examined the bioavailability differences between oral and oromucosal delivery methods in twelve healthy volunteers.
Study Design and Methodology
The research assessed pharmacokinetic parameters and relative bioavailability of two THC:CBD formulations: an orally administered Tilray THC:CBD extract and an oromucosally administered nabiximols formulation. The study employed a counterbalanced crossover design with participants receiving both treatments under fasting conditions.
Participants received either 1 mL of orally administered Tilray THC:CBD extract (10 mg/mL each of THC and CBD) or oromucosally administered nabiximols (four sprays of 2.7 mg THC and 2.5 mg CBD per spray, totaling 10.8 mg THC and 10 mg CBD). Blood samples were collected pre-dose and at 16 post-dose time points over 24 hours, with pharmacokinetic parameters calculated for THC, 11-hydroxy-tetrahydrocannabinol (11-OH-THC), and CBD.
Key Findings
The results revealed significant differences between the two formulations. The Cmax for both THC and CBD was significantly higher for the Tilray THC:CBD extract compared to nabiximols, while neither Tmax nor AUC showed significant differences between treatments. The study demonstrated that oral administration of Tilray THC:CBD extract achieved higher THC and CBD concentrations within a shorter timeframe compared to oromucosal delivery of nabiximols.
An interesting gender-related finding emerged, showing that the Cmax for nabiximols was significantly higher in males compared to females. Under both treatment conditions, THC and CBD became undetectable 24 hours post-dose, and 11-OH-THC was markedly reduced from its peak levels.
Safety Profile
The study reported no serious adverse events across all participants, supporting the safety profile of both formulations under the tested conditions.
Clinical Implications
José Tempero, Tilray's Medical Director, emphasized the significance of the findings: "By advancing our understanding of cannabinoid pharmacokinetics, we are better equipped to develop formulations that can significantly enhance therapeutic outcomes. We extend our heartfelt thanks to our partners in this study for their invaluable contributions and collaboration."
Denise Faltishchek, Chief Strategy Officer and Head of International at Tilray, added: "This pioneering research exemplifies our commitment to advancing the science of medical cannabis. By deepening our understanding of cannabinoid pharmacokinetics, we strive to enhance the therapeutic potential of our products, ultimately improving the quality of life for patients globally."
Broader Research Context
Tilray Medical has established itself as a leading provider of EU-GMP certified and pharmaceutical-grade medical cannabis products, supplying over 20 countries with THC and CBD products. The company has supported medical trials globally across Europe, Canada, the United States, Australia, and Latin America, investigating medical cannabis efficacy for various indications including pediatric epilepsy, refractory pediatric epilepsy, cancer-induced nausea and vomiting, HIV, essential tremor, breast cancer disorders, post-traumatic stress disorder, and alcohol use disorders.
The research findings may have significant implications for clinical populations using these formulations therapeutically, potentially informing dosing strategies and formulation selection for different patient populations and therapeutic applications.
