SEDDS and SMEDDS

Self Emulsifying Drug Delivery Systems (SEDDS)

Oral administration offers a non-invasive, cost-effective, and convenient administration route. However, as API’s become more complex, so does the delivery of these drugs. Issues like product stability, degradation upon ingestion, and drug uptake can hinder product efficacy, and can sometimes mean the difference between having to take one capsule versus multiple. As a formulations solution provider, we have responded to the challenges involved in the oral delivery of complex APIs with our Oral Lipid Delivery platform. With a wide breadth of ingredients to choose from, you can have the ability to improve the bioavailability of a poorly water soluble and difficult to deliver API via selecting the right ingredient or ingredients, or by formulating a self emulsifying or self microemulsifying drug delivery system (SEDDS or SMEDDS).

What is a SEDDS or SMEDDS formulation?

Self emulsifying (or self microemulsifying) drug delivery systems are mixtures of oils, surfactants, solvents, and drug substance that rapidly and spontaneously form fine oil-in-water emulsions or microemulsions when introduced into aqueous phases under gentle agitation. Upon emulsification, the lipophilic components disperse to form small lipid cores surrounding by surfactant in an aqueous continuous phase. Depending on the exact characteristics of the drug, it may be incorporated into the core, surfactant layer, of a combination of the two.

From the perspective of oral formulations, these mixtures are typically loaded into softgel capsules. Upon ingestion and digestion, the formulation readily disperses in the stomach and forms a stable emulsion or microemulsion with the drug evenly dispersed throughout via the small lipid cores. These, in turn, can be readily absorbed either through the gastric or hepatic pathways.

What are some of the benefits of using a SEDDS or SMEDDS formulation?

There are a number of benefits that come from the use of self emulsifying drug delivery systems, including:

• Improvement in oral bioavailability
• Ease of manufacture
• Reduction of inter/intra subject variability and food effects
• Ability to deliver a wide range of molecules, including peptides
• Decrease in the influence of lipid digestion effects on the drug
• Increase in drug loading capacity.

What products are part of the oral lipid delivery platform?

The list encompasses a wide variety of chemistries, from oils to various ester mixtures, ethoxylates to fatty acids, oil derivatives and more. A number of these ingredients are available as Super Refined™ products, which add an extra element of purity so as to ensure the stability and integrity of the drug and formulation throughout its shelf life.