Tilray Medical, a division of Tilray Brands, Inc., today announced the publication of a study that focuses on comparing the bioavailability of different cannabinoid formulations, “taking a step forward in our understanding of medical cannabis.”
The study aimed to assess the pharmacokinetic parameters and relative bioavailability of two D9-tetrahydrocannabinol: cannabidiol (THC:CBD) formulations. (A) An orally administered: Tilray THC:CBD extract and (B) an oromucosally administered nabiximols formulation.
This pilot crossover study counterbalanced (1) 1 mL of orally administered Tilray THC:CBD extract (10 mg/mL each of THC and CBD) and (2) oromucosally administered nabiximols (four sprays of 2.7 mg THC and 2.5 mg CBD per spray, for a total dose of 10.8 mg THC and 10 mg CBD). Blood samples were obtained pre-dose and at 16 post-dose time points over 24 hours. Pharmacokinetic parameters were calculated for THC, 11-hydroxy-tetrahydrocannabinol (11-OH-THC), and CBD.
Conducted with twelve healthy volunteers (6 male, 6 female) under fasting conditions, the results revealed that the Cmax for THC and CBD was significantly higher for the Tilray THC:CBD extract compared to nabiximols and neither Tmax nor AUC was significantly different for the two treatments. Interestingly, the Cmax for nabiximols was significantly higher in males compared to females. Under both treatment conditions, THC and CBD were undetectable 24 hours post-dose, and 11-OH-THC was markedly reduced from its peak. Notably, no serious adverse events were reported.
This pilot study shows that oral administration of Tilray THC:CBD extract formulation achieved higher THC and CBD concentrations within a shorter timeframe compared to the oromucosal delivery of nabiximols. These findings may have significant implications for clinical populations using these formulations therapeutically.
José Tempero, Tilray’s Medical Director, remarked, “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. Our goal is to continue driving innovation and providing patients with safe, effective, consistent and reliable medical cannabis solutions for patients around the world.”
Tilray Medical is a leading provider of EU-GMP certified and pharmaceutical-grade medical cannabis products, having supplied over 20 countries with a comprehensive portfolio of THC and CBD products. Tilray has supported medical trials globally, across Europe, Canada, the United States, Australia, and Latin America, studying the efficacy of medical cannabis as a treatment for 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.
