Lexaria said an in vitro test employing cultured lines of human intestinal cells shows that the new delivery technology boosts the bioavailability of orally ingested CBD by as much as 499%. According to the company, only 5% of raw CBD that enters the GI tract is absorbed, as opposed to 30% of the molecule that finds its way into the blood stream if the cannabis is smoked. That boost is of critical importance for moving CBD out of the medical marijuana realm and isolating it for its individual benefits, said Lexaria CEO Chris Bunka.
Bunka said patents on the technology were filed in June of last year, and Lexaria subsequently purchased the technology and further refined it. The approach can be used to boost the bioavailability of other cannabinoids and similar molecules, he said.
'Fooling your mouth and your stomach'
“We add a lipid or in some cases more than one lipid to a the payload molecule. THC and CBD molecules are almost identical. Either of those is mostly destroyed by the human GI system before it can be absorbed. Absorption of the typical cannabinoid is only about 5% in that case,” Bunka told NutraIngredients-USA.
“We have developed a novel method of manipulating the molecule to fool both your mouth and your stomach that it is a fat,” he said.
The technology was employed by its original developers to apply CBD in a bioavailable, dispersible form into tea, which is the form Lexaria offers it in today. The company, which is based in Kelowna, BC, has a distribution center in Phoenix, AZ, where it sends out orders direct to consumers that come in through its website. It also has distribution through a number of medical marijuana dispensaries, Bunka said.
The company is expanding beyond beverages into functional foods, Bunka said. A nutrition bar with added protein featuring the liposomal CBD is slated to hit the market in October, he said.
Lexaria is relying on the status of hemp as a legal food and food ingredient, Bunka said. The company’s products are currently on the market in all 50 states under that thinking. But, while legal, it does dampen somewhat the bang Lexaria is able to derive from the CBD bioavailability boost. Bunka said the company is careful to avoid making any sort of claims for the molecule and its effects in the company’s teas and future other foods, relying on the general health halo that CBD sees to have acquired. Another issue that clouds what can be said about CBD is FDA’s recent statement that the molecule cannot be used as a supplement ingredient based on a British pharmaceutical company’s filing of an Investigational New Drug application on it.
The most researched effects of CBD is in seizure prevention, a claim that would in any case appear to lie wholly within the drug realm. Research and anecdotal evidence shows that CBD can be as or more effective as anti seizure medications in some intractable cases of childhood epilepsy, and this is the indication on which the British company, GW Pharmaceuticals, filed its IND in 2014.
Status still a gray area
But a big loophole exists in FDA’s regulatory determination, that being whether CBD was marketed as a legal supplement ingredient prior to the IND filing. A number of observers of the rapidly developing CBD picture believe that FDA got this wrong, and expect more clarity within a year to 18 months.
In any case, while Lexaria might be open to licensing the technology for use in supplements at some time in the future, Bunka said for the moment the plan is to market the foods and to further develop the delivery approach.
“We used human intestinal cells in a lab environment. They are live, but not ‘alive;’ they are not supplied with nerve connections and blood vessels,” Bunka said. “In the normal GI tract there are a number of different systems at work. We didn’t have the benefit of those feedback mechanisms in our model. It is an attempt to mimic some of the most basic fluid environments. But we do have reason to believe that the actual results may be even higher that what we achieved in the lab dish.”