What is SEDDS Technology?…..
SEDDS (Super Effective Dietary Delivery System) is an innovative and versatile API (Active Principal Ingredient) delivery technology designed to overcome the challenges posed by poorly water-soluble compounds. Poorly soluble APIs are a significant challenge in dietary supplement product development, leading to low absorption and efficacy of products on the market.
For example, Vitamin E bioavailability has been widely studied and research shows that Vitamin E absorption rates ranges between 10%-79%, depending on a variety of dietary factors including food matrix, fat, and fat-soluble micronutrients. With the application of SEDDS®, absorption rates are expected to improve significantly and with greater consistency. In clinical studies of actives with similar molecular structures, we’ve seen absorption rates improve 3x using SEDDS® technology.
How does it works?
At the core of SEDDS® technology is its ability to create stable emulsions or microemulsions upon contact with an aqueous medium, such as gastrointestinal fluids. This self-emulsifying behavior is achieved through the use of carefully selected excipients, including a solvent, surfactant, lipid, and often a polymeric precipitation inhibitor1.
SEDDS® specifically targets quadrants II, III, and IV.
Active Principal Ingredients fall into 4 categories.
The formulation process begins by dissolving the poorly water-soluble API within the SEDDS® vehicle. Once administered orally, the API containing SEDDS® interacts with the gastrointestinal fluids, resulting in spontaneous emulsification or micro-emulsification. This process significantly reduces the particle size of the API, leading to the formation of a solubilized state. As a consequence, the API is present at a higher concentration in the aqueous environment, facilitating its enhanced absorption across biological membranes.
Case Study
SEDDS® CoQPure (Coenzyme Q10) Liquid Softgel
SEDDS® CoQPure is a clinically studied and patented formulation that utilizes SEDDS technology to enhance CoQ10’s absorption and bioavailability.
A double-blind clinical study was performed comparing the relative bioavailability between SEDDS® CoQPure vs. a market brand of CoQ10.
Results show the immediate impact of SEDDS® is 3x higher absorption and bioavailability.
SEDDS technology comprises a vehicle of solvents, surfactants, and lipids, where the API (CoQ10) dissolves and emulsifies upon contact with water. This unique formulation with both polar and non-polar properties enhances CoQ10's cell absorption, penetrating semi-permeable cell membranes effectively. Consequently, SEDDS® CoQ10 exhibits 3x higher bioavailability in humans compared to currently marketed CoQ10 products. The use of high-quality GRAS (Generally Recognized as Safe) excipients and antioxidants contributes to the product's stability.
Furthermore, the study compared the physical & chemical stability of the SEDDS formulation vs. a market brand of CoQ10 over time in an In Vivo pK study.
Results show the long-term impact of SEDDS® becomes even more significant at 2x higher steady state concentration by Day 5.