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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).
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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 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 get 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. 

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Formulation finder

Browse our range of fully developed formulations for inspiration and guidance.

Phase Diagrams

Phase Diagrams

Phase diagrams are useful to determine the properties of multicomponent systems:

  • Apexes represent single-components
  • The perimeter represents two-component systems
  • The body represents three-component systems

Phase behaviours of formulations can be characterised by investigating different ratios of the same excipients. Speak to one of our technical experts on the methodology, product support, and potential customer collaborations.

SEDDS and SMEDDS product portfolio

Croda offers a breadth of high purity ingredients that lend themselves well to solubilising a poorly water soluble drug, stabilising it once it’s in solution, and creating SEDDS and SMEDDS formulations. The list is constantly growing, and we strive to work with our customers to provide them with a solution they need!

Crodamol™ EO pharma

Crodamol™ EO pharma

Low viscosity solvent for lipophilic actives. Rapidly absorbed by body tissues. Dermal penetration enhancer. Required HLB value of 11. Recommended topical usage levels of 0.5-5%.

Super Refined™ Cottonseed

Super Refined™ Cottonseed

Cottonseed-derived triglyceride that has been Super Refined™ to remove impurities.

Super Refined™ Olive Oil

Super Refined™ Olive Oil

Olive-derived triglyceride that has been Super Refined™ to remove impurities Purified to yield a water-white odourless neutral non-polar lipid with a low peroxide value Can be used topically as.....

Super Refined™  Sesame Oil

Super Refined™ Sesame Oil

Sesame-derived triglyceride that has been Super Refined™ to remove impurities Purified to yield a water-white odourless neutral non-polar lipid with a low peroxide value Its major use is as a.....

Super Refined™  Soybean Oil

Super Refined™ Soybean Oil

Soy-derived triglyceride that has been Super Refined™ to remove impurities Purified to yield a water-white odourless neutral non-polar lipid with a low peroxide value Used in pharmaceutical.....

Super Refined™ Peanut Oil

Super Refined™ Peanut Oil

Peanut-derived triglyceride that has been Super Refined™ to remove impurities Purified to yield a water-white odourless neutral non-polar lipid with a low peroxide value Used as an excipient in.....

Super Refined™ Castor Oil

Super Refined™ Castor Oil

Super Refined Castor Oil is a highly purified version of naturally derived castor oil which has a high degree of functionality making it an extremely useful excipient However this increased.....

Super Refined™ Oleic Acid

Super Refined™ Oleic Acid

Highly purified oleic acid is used as a co-emulsifier in topical pharmaceutical formulations Ideal for nasal drug delivery and as a penetration enhancer in transdermal formulations In addition it.....

Would you like to talk to our experts about lipid-based drug delivery technology