Technology

Overview

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

PATENTS GRANTED:

  • Antiviral drugs
  • Cannabinoids – including those for Hypertension and Central Nervous System disorders
  • Nicotine
  • NSAIDs
  • Vitamins

PATENT PENDING:

  • Phosphodiesterase Inhibitors
  • Estrogen, Testosterone
  • And Other drugs and formulations!

Technology

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Lexaria’s technology is an additional step easily incorporated into the formulation and manufacturing process 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.

How does DehydraTECH work?

DehydraTECH works symbiotically with existing physiological systems to enable improved and more rapid absorption of drugs into the bloodstream and brain tissues.

Compounds processed using Lexaria’s DehydraTECH system become masked to oral and olfactory receptors, rendering them mostly flavorless and odorless.  Since DehydraTECH formulations do not require unwanted sweeteners or chemical masking agents for flavor and odor blocking, manufacturers can create low-sugar products with fewer calories, while also avoiding the use of excessive artificial sweeteners.

After oral ingestion, fatty acids expedite transit to the small intestine where nutrient bioabsorption occurs. Once in the small intestine, the fatty acids 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.

  1. 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. These 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.

DehydraTECH formulations can permit formulation with a combination of long and medium chain fatty acids in a single formulation. Such timed-release formulations are useful in delivering beneficial payloads both quickly, as well as sustained duration over several hours.

In vitro and in vivo studies have shown that DehydraTECH formulations increase intestinal bioabsorption of bioactive compounds by as much as 27x, and that they demonstrate effectiveness in as little as 1.5 minutes after administration.

Lexaria’s DehydraTECH process is very cost-effective. Micro quantities of fatty acid (Generally Recognized as Safe, or GRAS, ingredients) are incorporated into drugs, consumer packaged goods (“CPG”), and capsule products at a fraction of a penny per serving. DehydraTECH technology works with process equipment readily found in most commercial kitchen/production facilities, is easily utilized under GMP certification as needed, 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 pending patents or patents already granted around the world that cover its use with a broad range of bioactive molecules, including CBD, nicotine, common NSAID pain-relievers, and much more.

Lexaria’s technology is best thought of as an additional layer that improves the effectiveness of existing or planned new products for companies that offer consumer supplements, prescription and non-prescription-based drugs, and nicotine 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 four key segments.

Pharmaceuticals: CBD for Hypertension and Heart Disease

The current global market size for drugs used to treat various heart diseases is $96.1 billion1, and anticoagulants, antihypertensive, and antihyperlipidemic drugs comprise roughly 90% of these. The impact of COVID-19 on corporate operations led to recent growth in the market, which is expected to reach $107.77 billion by 20252.

Cardiovascular disease caused an estimated 17.9 million deaths around the world during 20193, and in the U.S., nearly one-half of all Americans suffer from some form of cardiovascular disease4. Lexaria has already demonstrated in a pilot human clinical study, that DehydraTECH-processed cannabidiol (CBD) led to 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. Research has shown that Lexaria’s technology increases absorption by 100% to 500%. Lexaria’s DehydraTECH is currently patented in the European Union and Australia for treatment of heart disease utilizing CBD.

1 https://www.researchandmarkets.com/reports/5292751/cardiovascular-drugs-global-market-report-2021?utm_source=GNOM&utm_medium=PressRelease&utm_code=hbl8p5&utm_campaign=1537264+-+Insights+on+the+%2487%2b+Billion+Cardiovascular+Drugs+Global+Market+to+2030+-+Identify+Growth+Segments+for+Investment&utm_exec=jamu273prd

2https://www.globenewswire.com/en/news-release/2021/05/17/2230401/28124/en/Insights-on-the-87-Billion-Cardiovascular-Drugs-Global-Market-to-2030-Identify-Growth-Segments-for-Investment.html

3https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)

4https://www.heart.org/en/news/2019/01/31/cardiovascular-diseases-affect-nearly-half-of-american-adults-statistics-show

Reduced Risk Non-Combusted Nicotine

Lexaria Nicotine LLC is our worldwide nicotine business unit devoted to ending smoking. More than 89% of all nicotine that is consumed worldwide is delivered through smoking cigarettes, causing more than 7,000,000 deaths per year around the world according to the Centers for Disease Control and Prevention5. 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 $908 billion by 20266, making it one of the largest industries in the world. Combustible tobacco demand is shrinking according to the World Health Organization7. Meanwhile, demand for “heat-not-burn” tobacco alternatives is growing at approximately 33% per year8. The nicotine replacement therapy market size in 2022 was $59.8 billion and is expected to reach $147.9 billion by 20289.

There are an increasing number of alternatives to combustible tobacco experiencing dramatic growth in demand as consumers search for reduced risk nicotine options, including the e-cig and vape market, currently valued at $24.68 billion and projected to reach $109.05 billion by 202810; as well as the nicotine oral pouch market, currently valued at $3.98 billion and expected to reach $21.84 billion by 202711. 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 to make claims of presenting a lower risk than traditional cigarettes of mouth cancer, stoke, lung disease, heart disease, emphysema and chronic bronchitis.

However, oral forms of nicotine are challenging because the nicotine 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 patented in the USA, the European Union and Australia for oral delivery of nicotine.

5https://www.grandviewresearch.com/industry-analysis/e-cigarette-vaping-market

6https://www.marketresearch.com/QYResearch-Group-v3531/Global-Nicotine-Pouches-Research-14261122/

7 https://www.who.int/news/item/16-11-2021-tobacco-use-falling-who-urges-countries-to-invest-in-helping-more-people-to-quit-tobacco

8 https://www.grandviewresearch.com/industry-analysis/heat-not-burn-market

9 https://www.researchandmarkets.com/reports/5265095/nicotine-replacement-therapy-market-size-share?utm_source=GNOM&utm_medium=PressRelease&utm_code=dkr7kz&utm_campaign=1505120+-+Worldwide+Nicotine+Replacement+Therapy+Industry+to+2028+-+Rise+in+Awareness+A

10 https://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/index.htm#:~:text=Worldwide%2C%20tobacco%20use%20causes%20more%20than%207%20million%20deaths%20per%20year.&text=If%20the%20pattern%20of%20smoking,to%20tobacco%20use%20by%202030.

11 https://www.researchandmarkets.com/reports/5472936/global-tobacco-market-by-product-type?utm_source=GNOM&utm_medium=PressRelease&utm_code=s4wbmf&utm_campaign=1636614+-+Global+Tobacco+Market+(2021+to+2026)+-+by+Product+Type%2c+Distribution+Channel+and+Reg

Pharmaceuticals: Other Pharmaceutical Areas of Focus

Our Lexaria Pharmaceutical Corp. subsidiary has worldwide rights to our patent portfolio related to pharmaceutical applications, including a broad range of active molecules such as antiviral drugs, Non-Steroidal Anti-Inflammatories (NSAIDs), vitamins, hormone treatments utilizing estrogen or testosterone, treatments for dementia, rheumatoid disease, and phosphodiesterase inhibitors (PDE5).

Lexaria’s technology significantly enhances oral delivery of antiviral drugs. To date we have evidenced that DehydraTECH improves the delivery of each of the following drugs into animal bloodstreams: darunavir, efavirenz, remdesivir, ebastine, and cholchicine; all of which are known to possess various antiviral properties.

Meanwhile, an in vitro screening assay determined that DehydraTECH- enabled remdesevir and ebastine were effective in inhibiting the COVID-19 SARS-CoV-2 virus.

Viral-caused diseases such as HIV, hepatitis, influenza, and coronavirus remain common and at times reach pandemic proportions. Hepatitis causes 1.5 million deaths each year12; 35 million cases of influenza were reported in the 2019-2020 flu season in the US alone13; and nearly 203 million cases of COVID-19 were recorded through 202114.  Additionally, there are currently 37.7 million people worldwide infected with HIV/AIDS.15

Vaccines help prevent the transmission of – but do not treat – viral diseases and generally have effectiveness rates that range between 50% and 90%. Antiviral drugs will always be needed to treat people who become infected and are at risk of serious health consequences with viral diseases. In many cases, these drugs are the difference between life and death. The antiviral drug market is expected to experience compound annual growth of 4.6% to reach $77.07 billion by 2028.16

Many antiviral drugs are currently administered via injection, a process usually requiring a healthcare professional that introduces expense and complication for mass dosing. Lexaria believes it is possible for DehydraTECH to 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 cheaper to treat more patients in less time.

According to market research, the global pharma industry was worth $1.5 trillion in 202217, and over $200 billion was spent on R&D in 202018. This is a larger R&D expenditure than the entire gross revenues of many other business sectors. Lexaria is pursuing or investigating multiple 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 been shown to have effect against cancer and neurodegenerative conditions.

12https://www.euro.who.int/en/health-topics/communicable-diseases/hepatitis/data-and-statistics#:~:text=Worldwide%2C%20500%20million%20people%20are,it%20due%20to%20dormant%20symptoms

13https://www.statista.com/statistics/861113/estimated-number-of-flu-cases-us/

14https://www.worldometers.info/coronavirus/

15https://www.unaids.org/en/resources/fact-sheet#:~:text=GLOBAL%20HIV%20STATISTICS&text=37.7%20million%20%5B30.2%20million%E2%80%9345.1,infected%20with%20HIV%20in%202020

16https://www.biospace.com/article/antiviral-drugs-market-size-to-reach-usd-77-07-billion-in-2028-reports-and-data/

17https://www.fortunebusinessinsights.com/impact-of-covid-19-on-pharmaceuticals-market-102685

18https://www.statista.com/statistics/309466/global-r-and-d-expenditure-for-pharmaceuticals/

Hemp-Derived CBD Applications for CPG

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, Lexaria has collected one of the most extensive databases in the world related to hemp-based ingredients empowered with our DehydraTECH technology. In 2018 for the first time ever, the World Anti-Doping Agency (WADA) 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. 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 2021.

The global CBD consumer products market is currently estimated at $4.1 billion, growing rapidly and expected to reach $111.8 billion in 203019. Although the CBD market size is currently 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 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.

19 https://www.quincemarketinsights.com/industry-analysis/cannabidiol-market

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