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Simulated Digestion

In vivo studies are the most accurate methods of determining the impact of specific colloidal delivery systems on the bioavailability of food and beverages infused with cannabis. In these studies, the levels of cannabinoids and their metabolites are measured in the bloodstream, urine, and/or feces over time. Despite their accuracy, animal and human studies are rarely used to test bioavailability of cannabinoids because of their high cost, lengthy timelines, government oversight, potential safety issues, and ethical concerns. Most of the pharmacokinetic (PK) studies are conducted by university and cost approximately $50,000 for animal studies and $150,000 for human studies in USA. You will have to wait 6 months (animal) to 1 1/2 years (human) for the results, but the majority of PK studies do not provide any insights into the physicochemical and structural mechanisms of functional product formulations including but not limited to:

  • Lipid Type
  • Lipid Concentration
  • Emulsifier Type
  • Emulsifier Concentration
  • Emulsifier / Lipid Ratio
  • Particle Shape
  • Particle Size Distribution
  • Mean Particle Diameter
  • Polydispersity Index
  • Zeta Potential

Le Herbe prefers to focus on physicochemical and structural mechanism in vitro and so should you. It is our opinion that the current in vivo approach in USA is not worth the price and frankly a waste of time. Small businesses like Le Herbe have hundreds of formulations. If we tested the traditional route, in vivo, on each one of our formulations then we would be out of business. Plus, formulations change over time so the current study you have a few years ago is not relevant today.

Decades of research have considerably advanced understanding of the critical anatomical, physiological, and formulation factors that control oral bioavailability. This insight enables the whole digestive process to be mathematically modeled. The main outcome of this kind of mathematical model would be the ability to simulate digestion in vitro and thus defer in vivo. The most widely used in vitro digestion method for monitoring the gastrointestinal fate of foods is the standardized INFOGEST method, which is the result of the harmonization of different methods by an international consortium [1]. This method is based on passing a sample through mouth, stomach, and small intestine conditions designed to simulate the human gut. The data is analyzed and the formulation can be adjusted quickly... in as little as 1 day.