OliClinomel N4-550E/OliClinomel N7-1000E Mechanism of Action

Pharmacotherapeutic group: Solutions for parenteral/mixed nutrition. ATC code: B05BA10.
Pharmacology: Pharmacodynamics: This is a ternary mixture enabling the nitrogen/energy balance to be maintained from the nitrogen source (L series amino acids) and energy in the form of glucose and essential fatty acids. In addition, this formulation contains electrolytes.
The amino acid solution contains 15 L series amino acids (including 8 essential amino acids), which are essential for protein synthesis.
The amino acids also represent an energy source, their oxidation resulting in excretion of nitrogen in the form of urea.
The amino acid profile is as follows: essential amino acids/total amino acids 40.5%; essential amino acids (g)/total nitrogen (g) 2.5; branched-chain amino acids/total amino acids 19%.
The carbohydrate source is glucose (80 g/l for OliClinomel N4-550E) and (160 g/l for OliClinomel N7-1000E).
The lipid emulsion is an association of refined olive oil and refined soya bean oil (ratio 80/20), with the following approximate distribution of fatty acids: 15% saturated fatty acids (SFA); 65% monounsaturated fatty acids (MUFA); 20% polyunsaturated essential fatty acids (PUFA).
The phospholipid/triglyceride ratio is 0.06.
The moderate essential fatty acid (EFA) content improves the status of their higher derivatives while correcting EFA deficiency.
Olive oil contains a significant amount of alpha tocopherol which, combined with a moderate intake of polyunsaturated essential fatty acids, contributes to improving vitamin E status and reducing lipid peroxidation.
Pharmacokinetics: The ingredients (amino acids, electrolytes, glucose, lipids) are distributed, metabolised and eliminated in the same way as if they were administered individually.
The pharmacokinetic properties of the amino acids administered intravenously are principally the same as those of amino acids supplied by oral feeding. Amino acids from food proteins, however, first pass through the portal vein before reaching the systemic circulation.
The elimination rate of lipid emulsions depends on particle size. Small lipid particles appear to delay elimination clearance whereas they increase lipolysis by lipoprotein lipase.
The size of the lipid particles in the emulsion contained in OliClinomel is close to the size of chylomicrons so that this emulsion therefore has a similar elimination rate.
Toxicology: Preclinical safety data: No preclinical studies have been performed on the finished product, OliClinomel.
Preclinical studies performed using the solutions of amino acids and glucose contained in OliClinomel of various composition and concentration have not, however, revealed any specific toxicity.
Preclinical toxicity studies performed using the lipid emulsion contained in OliClinomel have identified the changes usually found with a high intake of a lipid emulsion: fatty liver, thrombocytopenia and elevated cholesterol.