There has been much hype lately around the recently legalized Cannabidiol (CBD) isolate or full-spectrum hemp oil and its potential medicinal benefits. CBD, a non-psychoactive compound, is extracted from the hemp plant in oil form, which is subsequently used topically or ingested.
As with any oil-based product, it is difficult for the body to break the hemp oil down to gain access to the CBD. This results in poor absorption of CBD, which in turn results in low and variable bioavailability of the CBD molecule in the body. Understanding and addressing the difficulties in ensuring accurate dosing and maximum absorption is a hurdle for the CBD industry as it progresses onward, especially on the heels of the recent, not too positive, FDA guidelines.
Poor absorption of CBD oil into the body adversely affects the potential benefits of many CBD products on the market today. Because oils (including CBD Oil) are not well-absorbed by humans and other animals, most CBD delivered by ingestion is flushed from the body, leaving very little to provide its expected beneficial effects.
Unfortunately, consumers are rapidly rushing to use CBD-based products without realizing that the CBD in the product ingested may not be bioavailable to them unless it is in a water-soluble form.
According to Jason Ellis, President of Vegas CBD Factory, and a recognized expert in the manufacture of cannabinoid-based products, “My colleagues in the cannabis market are beginning to realize that high-quality CBD products will only come about by using high-quality water-soluble nanoemulsions of CBD oil.”
Why Nanoemulsions are Important
Studies1 have shown that water-soluble nanoemulsions are the most effective vehicles for introducing oil-based substances into the body, enabling the highest absorption rates**. Creating nanoemulsions of CBD oil with full preservation of CBD throughout the process, while not generating impurities, remains a significant challenge in the industry at large today.
Nanoemulsions mix oil-based nutritional and therapeutic products like CBD oil into water, for effective oral or topical delivery and absorption. Nanoemulsions reduce the size of the oil drops to such a level that they seemingly “vanish” into the water, becoming “water-soluble”. These exceedingly small, nanometer-scale droplets are so tiny that it becomes very easy for oil-based nutrients (like CBD) or drugs to be absorbed into the body directly from the inner surface of the oil droplet.
Testing Methods Required
The effectiveness of a nanoemulsion can be ascertained by looking at the size of its oil droplets. The size of oil droplets in a nanoemulsion can be measured using a universally accepted sizing method called Dynamic Light Scattering (DLS). CBD oil drops need to be reduced to approximately 20-200 nm range targeted for truly effective nanoemulsion delivery and absorption of nutrients and therapeutics, such as CBD (Nano- and Microscale Drug Delivery Systems, 2017).
In order to develop effective nanoemulsions, it is critically important to demonstrate that CBD from hemp-derived CBD oil is not lost or modified during processing. For the best results, testing should be conducted in an FDA-inspected, highly qualified analytical testing laboratory with state-of-the-art equipment and well-trained chemists with years of experience in laboratory testing, such as NutraFuels, Inc. (OTCQB: NTFU).
High-Performance Liquid Chromatography (HPLC) is a powerful laboratory technique that uses high pressure to identify, quantify and separate components of a mixture. This technique can be used to measure the concentrations of CBD and potential impurities at the start of the nano emulsification process and at the end, to determine how much CBD was lost or modified during processing. It is important that no appreciable amount of CBD be lost/changed.
The ability to control the heating and cooling that occurs in the production of nanoemulsions offers a valid alternative to thermal and non-thermal pasteurization methods that are common today and reduces the risk of harmful microbes in products such as edibles and topicals. To be successful, it is imperative that topicals and ingestibles be composed of highly stable, safe, bioavailable, and readily absorbent nanoemulsions.
Traditional processing methods struggle mightily with the challenge of producing water-soluble nanoemulsions. Ultrasonication is the main methodology in use today for producing nanoemulsions of CBD and other oils. Ultrasonication, which uses thermal and nonthermal pasteurization methods, does not produce the best results because it can carry a risk of significant loss of CBD, and it can create the appearance of impurities if not performed properly. Furthermore, Ultrasonication often uses materials such as detergents, surfactants and other chemicals that could be harmful to the body.
Breakthrough Solves Critical Issue of Poor CBD Absorption in the Body
The safest and effective way to process oil and water into high quality, long-term stable, water-soluble nanoemulsions is through the use of pressure. The utilization of the natural force of pressure has helped result in a breakthrough in creating water-soluble nanoemulsions. This new methodology (Ultra Shear Technology™, or UST™) uses ultra-high pressure and controlled shearing to make nanometer-scale droplets of fluids that become highly stable, homogenized “nanoemulsions” of materials that normally do not mix (e.g., CBD oil and water). Not only can these stable, water-soluble nanoemulsions help with proper dosing and effective bioavailability, they also offer:
- Superior aesthetics, texture, stability, and overall quality when used in creams, food, beverages, etc.
- Increased CBD absorption, resulting in significantly improved bioavailability.
- Safer and more accurate dosing of all CBD-infused products.
- Significant cost savings for both manufacturers and consumers.
- A tool for researchers interested in improving their understanding of the effect of Cannabinoids on the body, e.g., the brain and other organs.
In addition, these water-soluble nanoemulsions usually require smaller amounts of FDA-approved food-grade stabilizers rather than harsher detergents, surfactants and other chemicals. This new method compares well to the current methods of ultrasonication, many of which require larger amounts of food-grade stabilizers, non-food grade chemicals, and/or alcohol. In addition, ultrasonication methods generally do not produce water-soluble nanoemulsions of oil, including CBD oil. Consequently, manufacturers of CBD-infused products are aggressively looking for better methods to process their CBD oil emulsions.
Ultra Shear Technology™ (UST™) is a significant leap forward towards better optimization of CBD-infused products. Pressure BioSciences, Inc. (OTCQB: PBIO) has developed a proprietary UST platform that uses ultra-high pressure and intense shear forces to break oil drops into millions of ultra-small (nano) oil droplets that are highly water-soluble (nanoemulsions of oil and water).
The image below shows how stable, water-soluble, nanoemulsions can be made using Ultra Shear Technology™. The top row of beakers below show a nanoemulsion produced from commercially obtained materials, and the bottom row far right image shows a nanoemulsion produced using Ultra Shear Technology™
True Nanoemulsions Dissolve Completely in Liquids
Hemp seed oil was used as the model system
Creating nanoemulsions of reproducible size makes absorption consistent and dosing predictable, enabling greater bioavailability of the CBD containing compound. PBI’s UST platform has confirmed through independent laboratory testing that UST processing uniquely achieves the challenging criteria for creating highly effective “nanoemulsions” of CBD oil in water, without loss or modification of CBD throughout the entire UST process (> 99% recovery).
Mr Ellis concluded: “High-quality CBD products will only come about by using high-quality water-soluble nanoemulsions of CBD oil, such as those generated from processing CBD oil with PBI’s UST platform, the quality of which I have observed first-hand.”
Ken Micciche, Director UST Program, Advanced Technology for Cosmetic, Food & Beverage, Nutraceutical, Pharmaceutical Nanoemulsion Research & Production, Pressure BioSciences, Inc.
1 Solubility study: An Effective Tool For Formulation Of Successful Drug Delivery System For BCS Class II Drug, 29th August 2018, British Journal of Pharmaceutical and Medical Research Vol.03, Issue 04, Pg.1141-1146, July-August 201
Nirmal M.Kasekar*, Shilpa C.Godiyal, Sarabjit Singh, Dr.Kisan. R.Jadhav, Dr.Vilasrao. J. Kadam Bharati Vidyapeeth’s College of Pharmacy, Sector-8, C.B.D Belapur, Navi- Mumbai: 400614