Lipid emulsions in clinical nutrition: Enteral and parenteral nutrition.

Clinical nutrition emulsions are important products that can be life-saving for many patients suffering from gastrointestinal tract disorders, swallowing impairment, cancer, liver diseases, and many other clinical conditions. The transfer of lipids to the human body can be either intravenously (Parenteral Nutrition, PN) or through the gastrointestinal tract (Enteral Nutrition, EN). PN emulsions are considered pharmaceuticals and thus regulated accordingly. On the other hand, EN emulsions are classified as Food for Specific Medical Purposes (FSMP) and do not follow pharmaceutical regulations. Regarding product design, PN emulsions must follow theoretical emulsion formulation and production aspects, but special requirements regarding droplet size distribution must be followed to comply with national pharmacopeia monographs. Furthermore, a full clinical program on clinical evidence to prove safety and efficacy must be provided for marketing approval. On the contrary, EN emulsions require limited clinical evidence to substantiate health or clinical benefits. A short introduction to clinical nutrition with a focus on lipid emulsions is presented in this chapter. Furthermore, a general overview of the composition and main ingredients of clinical nutrition lipid emulsions is reviewed. Main clinical aspects are also mentioned here, highlighting the difficulties of clinically proving the efficacy of these products. The manufacturing and control of clinical nutrition emulsions are also reviewed, focusing on PN products and the main regulatory requirements related to the safety of these intravenous emulsions. Finally, stability and physicochemical properties are reviewed, and examples of commercially available products are used to illustrate these properties linked to the stability of these products. Lipids in clinical nutrition is a moving field and we do hope this chapter may remain a valuable source to understand newly emerging research on this topic.