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Lexaria Bioscience Corp. (CSE:LXX; OTCQX:LXRP) has developed and out-licenses its disruptive and cost-effective DehydraTECH™ technology that promotes healthier administration methods, lower overall dosing and higher effectiveness of ingestible drugs and other beneficial molecules.
Lexaria’s DehydraTECHTM delivery technology is protected by a robust suite of patents granted or pending worldwide and is proven effective in multiple international studies in greatly assisting rapidity and quantity of absorption of a range of lipophilic (i.e., fat-soluble), bioactive molecules. By significantly enhancing the performance and experience with oral ingestion, Lexaria’s DehydraTECH delivery technology offers a viable and often healthier alternative to other delivery methods for bioactive substances in widespread use today such as inhalational delivery through smoking.
Lexaria’s patented technology, DehydraTECH™ delivers these important benefits:
Eliminates the strong tastes/odors of lipophilic compounds, without the need for unwanted sugar or sweeteners
Effects are felt within 15-20 min vs. 60-120 min.
Initial testing indirectly evidences DehydraTECH may deliver ingested molecules through the lymphatic system instead of being subject to immediate “first pass” liver exposure, potentially mitigating unwanted side effects and reducing liver biotransformation.
Bio-absorption increases up to 3 – 10X, to equate or exceed that of other routes of administration like inhalational delivery.
Lexaria’s DehydraTECH™ is designed specifically for formulating and delivering lipophilic (i.e. fat-soluble) drug payloads. It is patented or patent-pending for use with a broad range of bioactive molecules, including but not limited to:
Lexaria Bioscience Corp. (“Lexaria”) has formed the Lexaria Nicotine Corp. as its exclusive worldwide nicotine business unit. More than 89% of all nicotine that is consumed worldwide is delivered through smoking cigarettes. Approximately 6,000,000 deaths per year around the world are attributed primarily to the delivery of nicotine through the act of smoking according to the Centers for Disease Control and Prevention. Of note: “…it is primarily the toxins and carcinogens in tobacco smoke – not the nicotine – that cause illness and death.” (U.K. National Institute for Health and Care Excellence [NICE]). As many as 69% of U.S. adult smokers want to quit smoking and 43% of US adult smokers have attempted to quit in any twelve-month period. Lexaria postulates that delivery of nicotine to satisfy current demand, utilizing our patented DehydraTECH technology in common food and consumer product formats, could shift demand away from smoking cigarettes. However, ingestion of nicotine is challenging because it is poorly tolerated by the human gastrointestinal system and then significantly metabolized by the liver, thereby diminishing its overall effectiveness through edibles. Lexaria’s DehydraTECH technology offers a means to formulate ingestible product formats of nicotine and/or its analogs with higher bioavailability performance possibilities due to the benefits of our technology.
Lexaria is developing a patent suite with supporting intellectual property in the pharmaceutical sector that will supply significant long-term strategic growth potential. Lexaria Pharmaceutical Corp. is the 100%-owned subsidiary that has obtained exclusive worldwide rights to Lexaria’s patent portfolio related to pharmaceutical applications. Currently within this business unit resides the IP for Non-Steroidal Anti-Inflammatories (NSAIDs), Vitamins, hormone treatments utilizing estrogen or testosterone, phosphodiesterase inhibitors (PDE5). Additional molecules of interest could be added to this unit over time.
According to Statista.com, the global pharma industry was worth $1,105 billion in 2016, and the US pharma industry alone spent over $71 billion in 2017 on R&D: a larger R&D expenditure than the entire gross revenues of many other business sectors.. Lexaria Pharmaceutical Corp. is implementing a strategy of reinforcing its IP-suite to sufficient degree to begin partnering within this dynamic industry.
The Lexaria Hemp Co. holds exclusive global rights to the Lexaria patent portfolio related to hemp-based applications. Lexaria’s DehydraTECH technology is designed to deliver functional ingredients within hemp in oral product formats with significantly enhanced palatability, speed of effectiveness and potency as a viable and healthier alternative to conventional inhalational (i.e. smoking or vaping) administration practices. Extensively evaluated through invivo, invitro, and human clinical studies, one of the most extensive databases in the world has been collected by Lexaria related to hemp-based ingredients empowered with our DehydraTECH technology. In 2018, the World Anti Doping Agency (WADA) for the first time ever exempted cannabidiol from hemp from its list of restricted substances on its International Standards Prohibited List of substances.
Lexaria CanPharm Corp, a Canadian corporation, owns exclusive global rights to Lexaria’s intellectual property as it is applied to psychotropic bioactive molecules that act upon human CB1 and CB2 receptors in those areas of the world where it is permissible to do so. Substances that act upon these receptors and systems in the human body that affect pain, inflammation, anxiety and depression, and have also been shown to have utility against cancer and neurodegenerative conditions. Lexaria’s ground-breaking 2018 research that proved many-fold improvements in delivering an active ingredient across the blood-brain-barrier could have disruptive potential within this business sector as well as all others where Lexaria is active.
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.
Lexaria Bioscience Corp’s disruptive new patented technology DehydraTECH™ is available to be licensed.
DehydraTECH can be used to improve existing products or to create new products. It is suitable for use with a wide range of consumer product formats including:
DehydraTECH is designed to be effective in delivering most fat-soluble molecules through the human gastrointestinal system and has also demonstrated affinity for transdermal applications and even effectiveness in crossing the blood-brain-barrier once within blood plasma. Lexaria has, or is conducting, in vitro, in vivo and human clinical testing, including pharmacokinetic data gathering, for the delivery of API’s through ingestible means. Test data has consistently pointed to reduced time required to enter the bloodstream, increased absorption rate, and reported improvements in taste and smell of edible products.
Contact us today to speak about your licensing needs at ablanchard@lexariabioscience.com
Terms and rights associated with our licensing opportunities are discussed on an individual basis.
Lexaria’s typical approach to working with a new prospective licensee is to effect confidentiality terms and then collaborate with the license prospect under a non-binding letter of intent to evaluate the feasibility and applicability of the Lexaria DehydraTECH technology for the license prospect`s needs. Following this, if the license prospect is satisfied with the performance enhancements delivered by the DehydraTECH technology, Lexaria then seeks to transition to a definitive fee bearing agreement structure between it and the new licensee.
We will license our technology in any of the more than 40 countries around the world where the DehydraTECH is patented or patent-pending. Licensees can feel confident that Lexaria’s extensive IP portfolio – constantly expanding – will help to provide a competitive edge and protection against inferior methodologies or older, outdated technology.
If your company works in a different but related field, please contact us if you’d like to conduct research on applicability for your specific application.
Licensees should also always remember that DehydraTECH costs less than a penny per serving to implement – sometimes a bare fraction of a penny. Licensees may experience an increase in market share or an increase in pricing power as a result of offering their customers superior delivery characteristics. Customers are loyal to the improved performance of DehydraTECH based products.
DehydraTECH is one of the world’s ONLY delivery technologies that does not require the addition of chemicals or intimidating, complex ingredients requiring disclosure on a food label. DehydraTECH works with commons GRAS ingredients that can be organic, gluten-free, and dairy free.
If your company works in a different but related field, please contact us if you’d like to conduct research on applicability for your specific application.
Masks taste/odor
Eliminates the strong tastes/odors of lipophilic compounds, without the need for unwanted sugar or sweeteners.
Reduces time of onset
Effects are felt within 15-20 min vs. 60-120 min.
Increases bio-absorption
Increases bio-absorption by 2 – 10x, to equate or exceed that of other routes of administration like inhalational delivery.
Avoids first-pass liver metabolism
Testing has evidenced that DehydraTECH may deliver molecules through the lymphatic system instead of being subject to immediate “first pass” liver exposure, potentially mitigating unwanted side effects. More recent testing in animals even demonstrated an ability to cross the blood-brain-barrier to a degree previously thought not possible.
Interview with CEO Chris Bunka
https://youtu.be/9bRSWYKIEL8
New Enhanced DehydraTECHTM formulation delivers 8X more CBD into blood and over 19X more CBD into brain tissue than standard industry formulations.
Kelowna, British Columbia – June 4, 2019 – Lexaria Bioscience Corp. (OTCQX: LXRP) (CSE: LXX) (the “Company” or “Lexaria”), a drug delivery platform innovator, has discovered improved performance characteristics of a new version of the DehydraTECHTM delivery platform initially suitable for use in solid oral dosage forms like capsules, tablets and pills for the pharmaceutical, medical, and supplement markets. Lexaria’s innovative use of a naturally sourced formulation enhancement more than doubles DehydraTECH’s absorption performance compared to previous DehydraTECH results demonstrated to-date. The Company has filed new patent applications related to the recent innovations.
BACKGROUND
On March 20, 2019 Lexaria announced it was beginning a series of animal studies with multiple objectives, including evaluating enhanced DehydraTECH formulations that might offer improved performance. Copious data streams have been generated from these tests and continue to be analyzed.
In this arm of animal study, Lexaria tested its DehydraTECH delivery technology with compounds postulated to behave in a synergistic fashion for enhancement of gastro-intestinal absorption, which resulted in significantly enhanced DehydraTECH performance (“Enhanced DehydraTECH”).
Of note, the new Enhanced DehydraTECH and its improved performance is separate and distinct from the nanotech improvement techniques recently announced by the Company.
TEST RESULTS
In each arm of the Lexaria animal studies, 10 male Sprague-Dawley rats were administered an identically sourced CBD at a rate of 25mg per kg of bodyweight. Delivery of CBD into the bloodstream was measured at 2; 4; 6; 8; 12; 15; 30; 45; and 60 minutes after dosing. DehydraTECH-enabled CBD was measurable in animal blood within 2 to 4 minutes after dosing.
On May 15, 2019 the Company reported that DehydraTECH achieved a CBD blood concentration level that was 475% more than a generic industry medium chain triglyceride (“MCT”) coconut-oil formulation 15 minutes after dosing. Today, the Company reports that Enhanced DehydraTECH led to 811% more CBD delivery into blood than generic industry MCT coconut-oil formulations (p=0.00008); and 110% more CBD into blood than DehydraTECH in its traditional format (p=0.02).
Also of note is that both traditional DehydraTECH and Enhanced DehyraTECH delivered maximum blood concentration levels prior to the 60-minute end-of-test, with levels tapering off thereafter. The DehydraTECH technology therefore demonstrates both fast onset and fast offset as tested which is of interest for dose titration purposes when repeated dosing is desired.
CONCLUSION
DehydraTECH’s in its traditional format has been used commercially by the Company since 2014; and by the Company’s technology licensees since 2016. Lexaria has consistently introduced leading innovation for oral cannabis formats such as capsules, beverages and edibles, with a focus on the consumer experience as measured by qualities such as taste, rapidity of onset and offset, and reliability of effect. Unique among the cannabis industry, DehydraTECH has proven itself equally transformative in other sectors such as the nicotine industry where Lexaria has licensed its technology to one of the largest nicotine products companies in the world.
Enhanced DehydraTECH seems particularly adept at delivering previously unreachable quantities of CBD across the blood brain barrier and into brain tissue; more so than even the most advanced nanotech as previously reported utilized in these studies. Since most human receptor cells of the CB1 variety and otherwise that are associated with the psychotropic effects of cannabinoids are located within the brain these findings significantly expand upon the power of Lexaria’s technology to reach the target site of action for these purposes.
With this new innovation, Lexaria is establishing new performance thresholds for drug delivery technology, with tested performance of 8x (blood plasma) and more than 19x (brain tissue) of generic industry formulations. The Company intends to perform further studies to fully characterize Enhanced DehydraTECH and will work throughout 2019 to optimize implementation into the best product applications for use by its licensees.
The animal test results announced to date have led to additional new patent applications based on the positive performance results achieved. The specific nature of enhanced DehydraTECH shall remain undisclosed for proprietary reasons until the new patent filings are published. Although the current tests were limited to CBD absorption, Lexaria expects knowledge from the current innovation to apply equally to tetrahydrocannabinol (THC) as well to enhance formulation innovation for nicotine and various pharmaceutical compounds already named within the Lexaria patent suite.
