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Introduction: Drug administration via feeding tubes to pediatric oncology patients is often associated with manipulating solid oral dosage forms. Tablets and capsules are crushed or opened and dispersed in a limited volume of liquid before administration. Moreover, many of the drugs used are poorly soluble, and the risk for decreased drug effectiveness upon dosage form alteration is high. It will therefore be beneficial to develop drug formulations appropriate for this route of administration. The development of self-emulsifying drug delivery systems (SEDDSs) for poorly soluble drugs, intended for administration via a feeding tube is considered a promising formulation option.

Aim: To identify and evaluate different prototypes of SEDDSs, intended to be administrated via a feeding tube, suitable for several clinically relevant poorly soluble drugs.

Methods: Formulations consisting of different types of oils, surfactants, and co-surfactants/solvents in different compositions were prepared. The mixtures were dispersed in water at 20°C and were inspected visually for emulsion formation. Final SEDDSs with an optimal range of excipients were formulated, incorporating a suitable active pharmaceutical ingredient (API). The API-incorporated SEDDSs were further characterized by emulsion droplet size analysis, rheological, and Fourier-transform infrared spectroscopy (FT-IR) analysis. 

Results: A SEDDS of type III lipid-based formulation (LBF) for lipophilic APIs and a SEDDS of type IV LBF for hydrophilic APIs were developed. The formulation characterization results demonstrated the successful incorporation of the APIs into the identified SEDDSs. A droplet size of < 200 nm was obtained, and the developed formulations had high fluidity (<2 mPa-s). The compatibility between the drug and the formulation could not be assessed by FT-IR, and LC-MS/MS analysis is required. 

Conclusion: In conclusion, several clinically relevant poorly soluble APIs can be incorporated into the identified SEDDSs, which are aimed for administration via a feeding tube. However, each API-SEDDS should still be characterized.