Erva Biosciences - The Technology
ERVA Bioscience CBD Powder was developed based on the principle of S-SEDDS (Solid, Self-Emulsifying Drug Delivery System), a system designed to increase the bioavailability and thus therapeutic effectiveness of hydrophobic drugs, particularly those administered orally. S-SEDDS is firmly established as a platform technology for the formulation of poorly-soluble compounds and applies directly the CBD oil as hemp extracts naturally exhibit extremely low aqueous solubility and poor vesicular delivery via the gastrointestinal tract.
The United States Pharmacopeia requires that a compound disintegrate (breakdown) in water in 45 minutes, while being agitated in laboratory equipment designed to simulate peristalsis, to simulate the muscular action of the stomach and gastrointestinal tract. The basic science is that, if it can breakdown in water which has a neutral pH of about 7, then it should have no problem breaking down in acidic pH of gastric juices which have a pH of 1.5 to 3.5.
ERVA Bioscience CBD Powder meets and exceeds this criteria. When introduced to an aqueous phase and after gentle agitation at temperatures as low as 37° C (human body temperature), ERVA Bioscience CBD Powder forms a stable a hydrocolloid dispersion (a stable o/w suspension or emulsion), that will not physically separate.
While cannabidiol has not been specifically classified by the FDA under the Biopharmaceutics Classification System (BCS), hemp extract best fits BCS Class II, meaning CBD is highly permeable (across human intestinal membrane) but has low (water) solubility. These are the class of drugs best suited to self-emulsifying delivery systems. Active ingredients in self-emulsifying delivery systems similar to ERVA Bioscience CBD Powder, have been clinically proven to dramatically increase gastrointestinal absorption of active ingredients at rates of up to 100% absorption. Even 50% absorption would represent a 500-fold increase in CBD potency compared to non-soluble oil-based dose of CBD of the same size.
Taken in solid (powder) form, such as in a capsule or pill, ERVA Bioscience’s self-emulsifying formulation is readily dispersed in the gastrointestinal tract, the same as it is in a glass of water, where the motility of the stomach and small intestine provide the agitation necessary for emulsification.
S-SEDDS has gained attention due to enhanced oral bioavailability enabling reduction in dose, more consistent temporal profiles of active absorption, selective targeting of active ingredients toward specific absorption window in the gastrointestinal tract, and protection of active ingredients from the hostile environment in the gut.
The advantages and potential advantages of the self-emulsifying systems include 100% drug entrapment capacity, physically stable formulation and formation of submicron droplet sizes, thus increasing absorption surface area, increase in rate and extent of absorption, and increased bioavailability of active ingredient. The pharmacokinetic properties achieved by S-SEDDS advance the rate of absorption and reduce, or eliminate, hepatic first-pass metabolism. This means that the active ingredient, in this case cannabidiol, is expected to enter the blood stream in far greater quantities compared to an oil based form.