Copyright © 2020 Elsevier B.V. All rights reserved.
Recent advances in the research of medicinal cannabis has placed the non-intoxicating cannabinoid cannabidiol (CBD) at the front of scientific research. The reasons behind this popularity is the compound’s therapeutic properties, alongside a safe profile of administration lacking addictive properties such as euphoric state of mind and a wide dosing range. Oral administration of CBD is challenging due to poor solubility in the gastro-intestinal system and susceptibility to extensive first pass metabolism. As a result, the practice in clinic and investigational trials is to administer cannabinoids in edible oils or oil-based solutions. Nonetheless, reported pharmacokinetics of cannabinoids and CBD in particular are not uniform among research groups and are affected by the vehicle of administration. The purpose of the work presented here is to investigate oral absorption processes of synthetic CBD when given in different oral formulations in healthy volunteers. The study design was a three way, blind, cross-over single administration study of 12 healthy male volunteers. CBD was administered in powder form, dissolved in sesame oil and in self-nano-emulsifying drug delivery system (SNEDDS). Administration of CBD in lipid-based vehicles resulted in a significant increase in Cmax and AUC of CBD, as compared to powder form. Overall plasma exposure of CBD did not differ between sesame oil vehicle and the SNEDDS formulation. However, administration of CBD in pure oil resulted in two absorption behaviors of early and delayed absorption among subjects, as opposed to SNEDDS platform that resulted in a uniform early absorption profile. Results of this trial demonstrate the importance of solubilization process of lipophilic drugs such as CBD and demonstrated the ability of the nano formulation to achieve a reliable, predictable PK profile of the drug. These findings offer a standardized oral formulation for the delivery of cannabinoids and contribute data for the growing field of cannabinoid pharmacokinetics.
Keywords: Cannabidiol; Clinical trial; Oral bioavailability; Pharmacokinetic study; SNEDDS; Sesame oil.
Conflict of interest statement
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Anyone who wants to try CBD oil or other products may get cold feet after hearing about the presence of THC in hemp-derived products. But CBD isolate provides a way to enjoy the benefits of this cannabinoid without other unwanted plant parts.
For starters, true CBD isolates consist of nothing but pure CBD, so there’s no need to worry about THC possibly entering your system and showing up on a potential drug test. Although it’s highly unlikely, trace amounts of THC found in hemp-derived CBD oil can theoretically cause a positive drug screening result.
Benefits of CBD isolate
CBD isolate is a crystalline solid or powder that contains 99% pure CBD. A traditional extraction process removes all the active compounds from the cannabis plant. Then, a refining process that strips away all other phytocannabinoids, including THC, and any plant matter. What remains is the CBD chemical compound in its purest form.
For topicals, mix the CBD isolate with moisturizing oils or lotions and apply it to the area of your skin you’d like to treat. Photo by: Gina Coleman/Weedmaps
CBD isolate can be mixed with terpenes to create homemade CBD concentrates that can be vaped or dabbed. The isolate can also be made into crystal slabs that can be dabbed using a traditional oil rig.
When it comes to using hemp extracts in their native oil-based format, typically in soft gel or liquid tincture applications, the stability of the formulas seems pretty good. But with powder forms of hemp extract, there are many variables that can impact the stability of the finished product. Technical knowledge and experience are critical in developing shelf-stable hemp products, and each manufacturer or brand should conduct its own stability study specific to its particular formula.
To read related content, check out the “Hemp/CBD: Market evolution” digital magazine and check out the livestream.for the Hemp and CBD Summit at Expo West 2020.
Formulating and product development
Most manufacturers will work with either crude or refined hemp extracts from CBD suppliers. Some suppliers have taken the extracted CBD material and complexed them with polysaccharides or other carriers to make them water-dispersible so they can be used in powder applications, like in powder blends, tablets and hard-shell capsules.
There is a learning curve suppliers, manufacturers and laboratories are all undergoing as it relates to CBD formulas, products and testing. Because CBD is relatively new, raw material suppliers are still understanding how to extract it. Manufacturers are learning how to formulate and handle it. And laboratories are figuring out how to test it. Because of this learning curve, it’s not uncommon to see variation in raw material supply and laboratory testing results. The key is to work with suppliers, manufacturers and laboratories that have experience with cannabinoid products and can speak openly about the variations they are seeing.
CBD has created a frenzy in our industry. While for some this represents a dot-com like opportunity, other industry veterans are taking a wait-and-see approach, as this industry has been littered with fleeting raw material trends. In the meantime, there’s no doubt that every company in the dietary supplement industry has made some sort of decision on CBD – whether to actively participate, not participate, or participate silently. It’s a business decision where there’s no clear black or white. At this point, there is no magic formula for success as it relates to hemp extracts. The key is to work with experienced, reputable companies who can openly discuss the good, bad and ugly.