SEDDS/SNEDDS – A Self Emulsifying Technology for Delivery of an Array of Small and Large Molecules

More new chemical entities (NCEs) are being discovered with fewer options to find the appropriate excipients and solubilizers for Class II and IV drugs. To address this market condition, the pharma industry is evaluating liquid Self-Emulsifying Drug Delivery Systems (SEDDS) to expedite drugs to market. Ascendia Pharmaceutical Solutions is well positioned for use of SEDDS in drug development because of its nanotechnologies, specifically EmulSol^®.

EmulSol nano-emulsion technology – one of four Ascendia proprietary technology platforms that address the three major tenets for robust formulation development: solubility, bioavailability, stability – is playing a crucial role in bringing these molecules to clinic faster. Designed by selection of FDA-approved excipients, such as lipids, solubilizers and surfactants, EmulSol can offer solutions for enhancing solubility and bioavailability of challenging molecules across all modalities.

Self-emulsifying and nanoemulsifying (SEDSS/SNEDDS) is a cocktail of homogenized pre-concentrate isotropic comprised of drug solubilized and encapsulated in mixtures of oils, surfactants/cosurfactants and co-solvents. In contrast to oral tablets and pellets, SEDDS/SNEDDS allows immediate release of drug from the cocktail, resulting in formation of tiny oil droplets from larger droplets in aqueous solutions. More specifically, once dispersed fully in gastrointestinal (GI) fluids, the preconcentrate rapidly self-emulsifies to tiny oil droplets ranging 10-500 nm o/w emulsions, as shown in the figure on the right. ¹

SEDDS for Small and Large Molecules

SEDDS finds a range of utilities for delivery of small molecules and large molecules including peptides and proteins. Thus, SEDDS offers a promising platform for enhancing solubility, stability and permeability of those molecules across the epithelial membrane in GI tract. SEDDS encapsulating peptides and proteins, and biologics for unmet medical needs, can minimize enzymatic degradation and improve permeability across the intestinal membrane by selecting the appropriate permeation enhancers.²

In a recent issue of American Pharmaceutical Review (March 2025), Ascendia Founder and CEO Jim Huang, Ph.D. and Shaukat Ali, Ph.D., Senior Director of Scientific Affairs and Technical Marketing, describe Ascendia’s expertise in this area. The Partner Perspective column outlines the CDMO’s capabilities in development and manufacturing of SEDDS/SNEDDS formulation for challenging molecules to improve their solubility and oral bioavailability.

GMP Manufacturing Capabilities

Ascendia’s GMP manufacturing capabilities with state-of-the-art nano-milling and liquid fill capsule equipment for formulation development and GMP manufacturing offer a range of choices for our clients to expedite the development of new molecules to save time and cost.

Citing an example among other equipment, Ascendia has invested in the ShearJet^® HP1200-20 Series electric-hydraulic processor, a hydraulic high shear homogenizer (shown on the left). It is used for GMP manufacturing of emulsions/nanoemulsions and lipid nanoparticles at pilot and production scale.

To learn more about our full suite of CDMO services, contact us today.

References

1. J. Huang and S. Ali, Lipid nanoparticles – enablers for efficient delivery of drug molecules, J. Anal. Pharm. Res. 2022, 11, 126‒129.
2. A. T. Zizzari, D. Pliatsika, F. M. Gall, T. Fischer, and R. Riedl, New Perspectives in Oral Peptide Delivery. Drug Discovery Today 2021, 26, 1097–1105.