Zelira Has Developed a Technology to Make Consistent Cannabinoid-Based Oral Medications a Reality.
One of the most exciting aspects of covering the cannabis industry is the exponentially increasing innovation within the sector. In the medical field, studies are consistently being conducted to validate anecdotal evidence of the benefits cannabinoids offer.
Manufacturers of cannabis accessories are using AI to more precisely weigh and distribute flower, and cultivators are using novel and increasingly sustainable technologies to grow larger and more consistent yields.
It is a uniquely intriguing industry with some of the greatest minds of our generation on board for the ride.
Add to the pot the rollercoaster of emotion felt by business leaders and you have a lively ecosystem that offers almost infinite opportunity.
Of course, there is one sector that is conspicuously missing from the equation: the pharmaceutical industry.
The complicated nature of legality surrounding cannabis has left the behemoths of the pharmaceutical world largely out in the cold. I know, cue the world’s smallest violin for America’s biggest lobbyist network.
Medical cannabis is big business, but prescribers merely allow patients to access THC and its derivatives. The FDA does not currently have federal approval to test THC-containing products, giving start-ups a considerable head start in an economy that — for the time being — is being held up by state laws.
However, the opening of markets worldwide has allowed pharmaceutical companies to begin testing novel technologies, bringing cannabis into the government-regulated prescription game. This, in turn, is fueling innovation in the sector.
A New Vehicle for Cannabinoid Delivery
Zelira Therapeutics Ltd is a global leader in the research, development, and commercialization of clinically validated cannabinoid medicines.
The company is focused on developing branded cannabinoid-based medicines for the treatment of a variety of medical conditions, including insomnia, autism, and chronic non-cancer pain. It is also a technology platform development company working to enhance cannabinoid delivery or application.
Zelira’s research and development have yielded several products geared toward the regulated pharmaceutical markets worldwide, including Australia and Germany.. In the U.S., Zelira licenses its products through partnerships in Pennsylvania, Washington, D.C., and Louisiana.
Zelira’s latest breakthrough is a product called Zyraydi — a proprietary enhanced distillate capture and dissolution matrix (EDCDM) technology that substantially traps the distillate in a free-flow powder matrix and increases the rate of dissolution.
Distillate is a cannabis extract in which the final product has been systematically stripped of all materials and compounds except one specific cannabinoid.
The most common forms of distillate on the market are THC oil and cannabidiol (CBD) oil.
There are different lanes in the cannabis market. Some patients prefer to use only flower, whereas others look for tinctures, gummies, concentrates, or powders. Zelira wants to provide an option for patients that is consistent, validated, and comes in a traditional pill or capsule form.
Many patients shy away from the use of cannabis as a viable medication due to its somewhat mi xed reputation. Think hippies sprawled out on a grass lawn at a Phish concert.
Until now, powders and capsules have been unreliable, lacking the same bioavailability as other ingestion methods.
Under the Hood
Zelira uses extracted cannabinoids to formulate medicines that target needs in many therapeutic areas through a traditional pharmacetical drug development path.
Drugs are validated clinically and as regulation allows, are moved through clinical programs.
The ingredient matrix in Zyraydi achieves three things:
As a cannabinoid capture technology, it allows producers to take the honey-like extract and create a consistent free-flow powder that does not separate.
It is 100% pharmaceutical grade, meaning it is 100% consistent.
It enhances the dissolution of cannabinoids. Cannabinoids are inherently difficult to isolate. The traditional way of separating cannabinoids from flower is by binding it to a lipid such as butter or oil. Zyraydi is a novel technology that increases dissolution of cannabinoids in biorelevant fed and fasted states.
“I believe that what we have with cannabinoids and cannabinoid-based pharmacology, is that it gives us access to a natural compound with the longest documented history of safety and efficacy among natural compounds at any point in time,” said Zelira CEO Oludare Odumosu. “With that, we already have half a drug.”
The question is, because cannabis and the cannabinoid safety profile have stood the test of time, how does it translate to a pharmaceutical-grade drug?
“Whatever the traditional rigors of clinical validation are, when you make a cannabinoid-based medicine, it must be able to stand and walk through those doors,” Odumosu said.
Drugs developed for diabetic neuropathy, insomnia, autism spectrum disorder, or any specific indication, must be able to go through the regulatory and clinical validations that other medicines in that space have gone through.
According to Odumosu, the cannabis medical space will only evolve or be taken seriously when solid oral dosage forms the pharmaceutical industry recognizes can be made; a format that patients and prescribers recognize.
“The reason cannabinoids are captured in a tincture of another liquid suspension right now is that that is the most efficient format,” said Odumosu.
“But when we can now translate that to solid oral dosage forms such as capsules and tablets and be pharma-grade then we are one step closer to approaching regulatory bodies such as the FDA.”
Opening the Road
President Biden recently announced he will pardon federal simple cannabis possession charges and convictions and called on governors to follow his example.
The historic move could signal a shift in Congress toward federal legalization. If and when that happens, according to Odumosu, Zelira is situated perfectly to advance its portfolio of cannabinoid drugs through the regulatory process.
Local start-ups have had time during prohibition to upscale to multi-state operators, but the time may soon be approaching when the pharmaceutical industry comes into play on a national level.
Zelira is poised and ready for that eventuality.