Technology

Overview

Lexaria has patented and commercialized its unique and powerful drug delivery technology, DehydraTECH™, that has been both laboratory and market proven to enhance the performance of several categories of fat-soluble active molecules and drugs, across oral and/or topical product formats:

PATENT GRANTED:

Cannabinoids including for Hypertension and Central Nervous System disorders

Nicotine

NSAIDs

Vitamins

PATENT PENDING:

Phosphodiesterase Inhibitors

Estrogen, Testosterone

Anti-viral drugs

and more…

Lexaria’s technology is easily applied through incorporation of an intermediate step in the formulation and manufacturing of existing or new orally-ingestible and topical products.  This step involves mixing the active ingredient as a delivery “payload” together with certain fatty acids, infusing the mixture into a substrate material, and then using controlled dehydration synthesis processing to associate the payload and fatty acids together at a molecular level before integrating the newly-combined molecules into end product production across a range of dosage form factors.

 

Click image to view our DehyraTECH Information Sheet to learn more:

Click on the video above to view a video explaining Lexaria’s DehydraTECH™ technology and illustrating how it is used to formulate and manufacture high performance ingestible consumer products.

A Versatile Solution to Improve Bioabsorption, Taste, and Efficacy

Compounds processed using Lexaria’s DehydraTECH™ system become masked to oral and olfactory receptors, rendering them essentially flavorless and odorless.  This can be a notable benefit in both non-pharmaceutical and certain pharmaceutical applications of the technology since  DehydraTECH™ formulations do not require unwanted sweeteners or chemical masking agents for flavor and odor blocking,allowing manufacturers to create low-sugar products with fewer calories, while also avoiding the use of excessive artificial sweeteners.

After being swallowed, the fatty acids are believed to protect the conjugated payload from hostile stomach conditions and expedite its transit to the small intestine where nutrient bioabsorption occurs.  Once in the small intestine, the fatty acids are believed to enable rapid and more significant permeation of the intestinal wall for the active payload, then transport it to the systemic circulation by one of two pathways depending on the type of fatty acid(s) chosen for each specific formulation:

1. Hepatic Transport

In cases where liver metabolism is desirable for biotransformation of the payload before access to the general circulation, Lexaria’s methodology uses medium chain fatty acids for formulation purposes since they are absorbed via the portal vein and transported to the liver for processing prior to entering the general circulation. This would be applicable, for instance, with prodrug compounds that rely on metabolism by liver enzymes to become pharmacologically active within the human body.

2. Lymphatic Transport

Conversely, in cases where faster onset of action and/or maximizing action of the originally formulated payload without biotransformation is desirable, Lexaria’s methodology uses long chain fatty acids, which are absorbed via the lymphatic lacteals thereby diverting away from the liver and entering the general circulation very quickly. For payloads that deliver pain relief or meet other immediate needs, this rapidity of onset is a vital benefit.

For Non Steroidal Anti-Inflammatory Drugs (“NSAIDs”) such as Ibuprofen and similar, this is a crucial distinction in offering protection to the kidneys from known harmful effects otherwise associated with first-pass liver metabolism of those NSAID products.

DehydraTECH™ formulations can instead permit formulation with a combination of long and medium chain fatty acids in a single formulation for purposes of engineering products with both fast and sustained release profiles. Such timed-release formulations can be sought to deliver beneficial payloads both quickly, as well as over a sustained duration for several hours.

DehydraTECH™ formulations have been shown through in vitro and in vivo studies to increase intestinal bioabsorption of bioactive compounds by as much as 5-10X and demonstrate effectiveness in as little as 1.5 minutes after administration (see:  Research).

Lexaria’s DehydraTECH™ process has the added benefit of being very cost-effective to implement; requiring micro quantities of fatty acid (GRAS ingredients) incorporation into drugs, consumer packaged goods (“CPG”) , and capsule products at a fraction of a penny per serving, together with the use of processing equipment that is readily found in most commercial kitchen/production facilities and is highly scalable.

Commercial Applications

Lexaria’s DehydraTECH™ is designed specifically for formulating and delivering lipophilic (i.e. fat-soluble) drugs and active ingredients.  DehydraTECH is protected by a robust suite of patents-pending or patents granted around the world covering its use with a broad range of bioactive molecules, including Nicotine, common NSAID pain-relievers, and much more.

Lexaria’s technology is best thought of as an additional layer that companies offering consumer supplements, prescription and non-prescription based drugs, and nicotine products can utilize to improve the effectiveness of their existing or planned new products. Lexaria Bioscience Corp. has no plans to create and sell Lexaria-branded products containing controlled substances. Instead, Lexaria licenses its advanced technology to other companies around the world to offer consumers the best performance possible across an array of product formats.

Lexaria’s ongoing R&D is mainly focused on development of product candidates across three key segments, summarized and explained as follows:

Pharmaceuticals: Heart Disease

The current global market size for drugs used to treat various heart diseases is $47.29 billion(1), and anticoagulants, antihypertensive, and antihyperlipidemic drugs comprise roughly 90% of these. Broad trends including aging populations and obesity are expected to contribute to growth in demand for heart disease-related drugs, where demand is expected to reach $63.96 billion by 2026 (2).

Cardiovascular disease caused 840,678 deaths in the US during 2016 and more than one-third of all Americans suffer from some form of cardiovascular disease. Lexaria has already demonstrated in a pilot human clinical study, published in a peer-reviewed medical journal in 2019, that its DehydraTECH processed cannabidiol (CBD) effected a statistically significant decrease in human blood pressure, theorized to have occurred as a result of the known vasodilatory potential of CBD. As a complex fat-soluble molecule, generic CBD is known to have poor absorption characteristics, such that typically only about 6% of what is orally ingested actually finds its way into blood circulation. Lexaria’s technology has been shown to increase this delivery by between 100% to 500%.Lexaria expects results in 2021 of a confirmatory pilot human clinical study to determine if Dehydratech processed CBD might have application within the hypertension market. Lexaria’s DehydraTECH is patent granted in the European Union and Australia for treatment of heart disease utilizing CBD.

Reduced Risk Non Combusted Nicotine

Lexaria Bioscience Corp. (“Lexaria”) owns 83.3% Lexaria Nicotine Corp. as its exclusive worldwide nicotine business unit, and Altria Ventures Inc owns 16.7%. More than 89% of all nicotine that is consumed worldwide is delivered through smoking cigarettes, causing over 6,000,000 deaths per year around the world 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]).

The global tobacco market is expected to be valued at $1.08 trillion by 2027 (3), making it one of the largest industries in the world. Combustible tobacco demand is shrinking by 2% per year, while demand for non-combusted alternative is growing at approximately 10% per year. The nicotine replacement therapy market size in 2019 was $2.55 billion and is expected to reach $3.54 billion by 2027(4).

There are an increasing number of alternatives to combustible tobacco experiencing dramatic growth in demand as consumers search for reduced risk method nicotine options, including the e-cig market, currently valued at $12.41 billion and projected to reach $68.48 billion by 2027; as well as the nicotine oral pouch market, currently valued at $2.37 billion and expected to reach $32.77 billion by 2026.(5) Products in the oral pouch category were the first nicotine products in the history of the Food and Drug Administration (the “FDA”) to be authorized through the Modified Risk Tobacco Product pathway approved for claims of a lower risk of mouth cancer, stoke, lung disease, heart disease, emphysema and chronic bronchitis than cigarettes.

However, oral forms of nicotine are challenging because it is poorly tolerated by the human gastrointestinal system and then significantly metabolized by the liver, thereby diminishing its overall effectiveness. Lexaria’s DehydraTECH technology offers a means to formulate oral product formats of nicotine and/or its analogs with higher bioavailability performance possibilities due to the benefits of our technology whereby the associated fatty acids confer bioabsorption benefits both within the oral cavity and upon ingestion. Lexaria has collaborated with two of the world’s largest tobacco companies related to nicotine oral delivery.

Lexaria’s DehydraTECH is patent granted in the USA, the European Union and Australia for oral delivery of nicotine

Pharmaceuticals: Antiviral Drugs

Lexaria Pharmaceutical Corp. is the 100%-owned subsidiary that has obtained exclusive worldwide rights to Lexaria’s patent portfolio related to pharmaceutical applications including a broad range of active molecules such as anti-viral drugs, Non-Steroidal Anti-Inflammatories (NSAIDs), vitamins, hormone treatments utilizing estrogen or testosterone and phosphodiesterase inhibitors (PDE5). Lexaria’s technology is undergoing early-stage examination for the delivery of anti-viral drugs with potential applications against COVID-19 or other viral disease conditions.

Viral-caused diseases such as HIV, hepatitis, influenza, and coronavirus remain common and at times reach pandemic proportions. Hepatitis caused 1.3 million deaths in 2015(6); influenza had  13 million cases reported in 2019 in the US alone; Covid-19 has infected over 48 million people worldwide during 2020 and is currently infecting more than one-half million people per day. Additionally, there are currently 37.9 million people worldwide infected with HIV/AIDS.

Vaccines help prevent the transmission of, – but do not treat – viral diseases and generally have effectiveness rates of between 50% and 80%. Antiviral drugs will always be needed to treat people who become infected and are at risk of serious health consequences with viral diseases, and in many cases are the difference between life and death. The antiviral drug market is currently $52.2 billion and expected to grow to $75.3 billion by 2027(7).

Many antiviral drugs are currently administered via injection, a process usually requiring a health care professional that introduces expense and complication for mass dosing. Lexaria believes it is possible that DehydraTECH could improve delivery performance such that some of these drugs could be dosed via oral tablet or capsule which is less expensive and makes it easier and less expensive to treat more patients in less 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 is also pursuing or investigating a number of pharmaceutical related applications of DehydraTECH with bioactive molecules that act upon human CB1 and CB2 receptors. Substances that act upon these receptors in the human body that affect pain, inflammation, anxiety and depression have also been shown to have utility against cancer and neurodegenerative conditions.

Hemp-Derived CBD Applications

Lexaria Hemp Corp. holds exclusive global rights to the Lexaria patent portfolio related to hemp-based applications. Extensively evaluated through in vivo, in vitro, 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 Hemp Corp. licenses the industry-proven DehydraTECH process on a business-to-business basis to companies to empower their creation of best-in-class products. Through the end of 2020, Lexaria Hemp Corp. took steps to discontinue direct-to-consumer sales of any products that contain CBD. Lexaria Hemp Corp. is currently the fastest growing division of the Lexaria group of companies responsible for the majority of the Company’s revenues in 2020.

The global CBD market was estimated at $4.6 billion in 2018, growing rapidly and expected to reach $23.6 billion in 2025(8). Although the CBD market size is smaller than the other opportunities under pursuit by the Company, the Company’s technology was first developed to enhance the delivery of CBD and the Company has an established business presence within the sector that is experiencing revenue growth. Lexaria’s methodology can be applied to many different ingestible product formats including foods, beverages, oral suspensions, tablets, capsules and more. This is accomplished through choosing an appropriate substrate compound for infusion during performance of the Lexaria formulation and manufacturing process, which can range from a foodstuff like cocoa powder or tapioca starch used in many confectionary products, or an emulsifier like gum arabic used in many beverage products. Many of the most common base ingredients used in modern processing of foods, beverages and supplements are effective to use with DehydraTECH™.

Videos

Lexaria’s DehydraTECH

Lexaria’s Nicotine Patents and Summer/2018 Update

Interview with CEO Chris Bunka of Lexaria BioScience

Research

The safety and effectiveness of Lexaria’s DehydraTECH technology has been studied in a series of controlled and well designed in vitro, in vivo studies, examining factors such as total bioabsorption directly and indirectly through surrogate biomarkers, time to onset of effectiveness, flavor appeal and quality of effectiveness.  In 2018 Lexaria completed one of the world’s first human clinical, double-blinded, placebo-controlled investigations into hemp extracts treated with DehydraTECH processes. Studies also include two 2018 animal studies that delivered ground-breaking results showcasing the improvements of nicotine delivery both to blood plasma as well as across the blood-brain-barrier. Extensive and repeated work conducted in the National Research Council of Canada laboratories in 2019 and 2020 confirmed that DehydraTECH does not create a covalently linked molecular entity construct and is therefore not believed to be preclusive of a Premarket Tobacco Product Application applicability.

DehydraTECH-processed nicotine was well tolerated in a 7-day, repeat-dose acute toxicology study in rats with no test article-related effects on survival, macroscopic findings, or organ weights and no test article-related histopathological tissue findings.

Patent Portfolio

Lexaria’s DehydraTECH technology is covered by a robust suite of issued and pending patents in over 40 countries around the world.  Lexaria`s patent suite commenced with two initial 2014 US provisional patent applications.  Since then, Lexaria has broadened the patent suite considerably by refining the patent claims via further US provisional and utility patent filings, extending the breadth of the claims considerably to name other compounds including but not limited to vitamins and NSAIDs, that the technology can be applied to and many other consumer product formats in which they can be formulated.  Under US patent law, a patent upon issuance provides for 20 years of patent protection from the date of filing.

In addition to the US patent filings, Lexaria has also pursued international patent protection through filings under the Patent Cooperation Treaty, followed by national filings in 40+ jurisdictions of highest commercial potential thereunder. As of Fall, 2020, Lexaria has 18 patents granted in the US, Australia and the European Union, expectations of additional patents to be granted, and roughly 60 additional patents pending. Links to our very first US and Australian patents are provided for your convenience, below.