Lack of attention to nanoemulsion standards could hurt cannabis manufacturers

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Susan Audino

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Cannabinoid nanoemulsions have gained in popularity.

But are they safe, and have they slipped through the regulatory cracks? Is this another example of a lesson (not) learned?

Nanoemulsions are delivery mechanisms for compounds such as CBD, designed to enhance their bioavailability.

Bioavailability means “the extent a substance or drug becomes completely available to its intended biological destination(s),” according to Gary Price and Deven Patel, two researchers who published a paper on drug bioavailability last fall.

Price and Patel point out that “the dose of a drug is indirectly proportional to its bioavailability” and that, “for a drug with relatively low bioavailability, a larger dose is required to reach the minimum effective concentration threshold.”

Cannabinoids such as CBD are lipophilic, which means they do not mix well with water and rather dissolve in fats and oil.

That, in turn, lowers the bioavailability of edible CBD products.

Nanoemulsions are encapsulations of tiny droplet sizes of specific cannabinoids (such as CBD) that are then infused in common products such as beverages.

The nanoemulsions become the delivery mechanism and appears to increase the bioavailability of its ingredient.

In 2018, a group of researchers in Japan and Thailand studied a CBD nanoemulsion formulation that was administered to rats.

The nanoemulsion formulation enhanced CBD absorption and increased bioavailability without compromising integral physiological processes.

It was an important and positive contribution to the empirical studies of cannabinoid nanoemulsions.

But the proliferation of CBD and other cannabinoid nanoemulsions has brought to the surface the potential of exploitation by product manufacturers who might not be familiar with the physiochemical and other functional attributes that could compromise the product.

For example, particle size might affect thermodynamic stability and chemical reactivity that could lower or raise bioavailability.

By their very nature, nanoemulsions are thermodynamically unstable, which means they will eventually break down over time.

Constituents of nanoemulsion products include surfactants and other chemicals, some of which could be harmful or perhaps ineffective in combination with the cannabinoid(s) of interest.

All components must coalesce to ensure appropriate physiological response and reported bioavailability.

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As with any other product, the choice of fabrication depends on the properties of the ingredients and on the desired function of the finished or final product.

The decision on fabrication process should not be taken lightly, and sound knowledge of nanoemulsion product fabrication is essential to ensure a safe and well-characterized finished product.

Because each U.S. cannabis market varies, no uniform requirements exist for product manufacturing and testing.

This creates a void with respect to essential information consumers rely on to make informed and educated decisions.

The absence of regulatory requirements for cannabinoid nanoemulsions also speaks to the limited breadth of requirements presumably established to ensure consumer safety.

Susan Audino, who holds a doctorate in chemistry, is a chemistry consultant and instructor for the American Association for Laboratory Accreditation. She is based in Delaware.