The safety and effectiveness of Lexaria’s DehydraTECH™ technology has been studied in a series of controlled and well designed in vitro and in vivo human focus studies, examining factors such as total bioabsorption directly and indirectly through surrogate biomarkers, time to onset of effectiveness, flavor appeal and quality of effectiveness. Studies to-date have focused on cannabinoid applications where Lexaria is most advanced commercially, although research is underway for the other bioactive compounds named in Lexaria’s patent portfolio and described under Commercial Applications.
Pre-Clinical Research into Lexaria’s DehydraTECH™
An in vitro absorption study was performed to assess unidirectional CBD permeability using a human epi-intestinal tissue model with various formulations in the presence of simulated intestinal fluid. The study was designed to, as closely as possible, mimic intestinal absorption as it would occur in a live subject. Samples of Lexaria’s commercially available CBD-fortified ViPova™ black tea were administered in the model compared with concentration-matched CBD control preparations that lacked Lexaria’s patented formulation and process enhancements. The study showed as much as a 499% improvement, on average, in intestinal tissue permeability with the ViPova™ black tea formulation relative to a concentration-matched CBD control preparation without any Lexaria technology enhancements. The study also showed a 325% improvement, on average, in intestinal tissue permeability comparing the ViPova™ black tea preparation to a concentration-matched CBD control preparation that utilized Lexaria`s dehydration synthesis processing methodology but lacked its fatty acid ingredient incorporation, demonstrating the power of the Lexaria technology as a whole (see Figure 1).
Following this study, a series of independent, well designed, well controlled human focus studies were undertaken corroborating Lexaria’s in vitro performance findings. A study in healthy volunteers (n=6) suggested as much as a 5-10X increase in CBD absorption, which was assessed indirectly through measurement of the increase in salivary nitric oxide as a directly proportional surrogate biomarker, with onset of action in as little as 15-30 minutes. In all cases, the maximum increased level of salivary nitric oxide remained evident at the 60-minute end period of this particular test. Further testing is required to determine the full duration of elevated nitric oxide levels.
Thereafter, a blinded human focus study was conducted to evaluate the performance of THC-infused chocolates formulated using Lexaria’s DehydraTECH™ technology. This study compared the performance of the THC-infused chocolates powered by Lexaria’s technology to concentration matched THC-infused chocolates formulated using a commercial dextrin absorption enhancer. The subjects (n=12) that participated in this study indicated a clear preference on taste and overall effectiveness with the chocolates formulated using Lexaria’s technology, and onset of effectiveness was again observed very quickly, in as little as 15-20 minutes.
The degree and speed of CBD absorption into blood plasma was tested in a randomized, placebo-controlled, double-blind clinical study in 12 healthy human volunteers comparing a 90 mg CBD dose of Lexaria’s TurboCBD™ powered by its patented DehydraTECH™ absorption and palatability enhancing technology to a concentration-matched control formulation without DehydraTECH™ incorporation.
Key study highlights were as follows:
Results from this study were compared to the findings from a Mount Sinai study* previously conducted with orally administered CBD furnished by market leader GW Pharmaceuticals LLC (maker of FDA-approved Epidiolex), suggesting that Lexaria’s DehydraTECH™ delivered over 900% more CBD to the blood in the first 30 min than the GW formulation on a concentration-adjusted basis.
Lexaria is pleased to be working with Canada’s National Research Council to further investigate characteristics of the DehydraTECH™ technology in what is one of the few active research collaborations in the world with government organizations in the field of cannabinoid related research. Several studies are planned or underway designed to investigate and optimize the ability of Lexaria’s patented technology to enable delivery of lipophilic active agents including cannabinoids, vitamins, NSAIDs, and nicotine. Advanced analytical techniques, including mass spectrometry and nuclear magnetic resonance testing, are being employed to evaluate the chemical nature of the molecular association that Lexaria`s DehydraTECH™ technology is believed to form between lipophilic active agents and the flavor and delivery enabling fatty acid agents that are integral to Lexaria’s formulation methodologies. Practical applications of this work could include further broadening or strengthening of Lexaria’s intellectual property portfolio and may also provide the foundation for new commercial arrangements.