An innovative lipid emulsion designed to provide complete & balanced lipid parenteral nutrition for neonates

An innovative lipid emulsion that provides in a single lipid all the necessary fatty acids in correct amounts and ratios, specifically tailored to the neonate's needs. By providing a balanced and complete parenteral nutrition for neonates, it will reduce the risks of complications.

The proposed project, with duration of two years, focuses on the development of a lipid emulsion specifically designed for parenteral nutrition of neonates. The gastro intestinal apparatus of pre-term neonates is usually unable to tolerate enteral nutrition, and an initial treatment with parenteral nutrition is required. On average, parenteral nutrition is administered to neonates during 18 days, but it may be required for longer periods, depending on the neonate's age, size and medical condition. Additionally, all neonates with prematurity complications and/or undergoing surgical interventions require a period of parenteral nutrition. The collaboration between CHIESI and HTL is aimed at developing NANOLIP, a lipid emulsion specifically designed for parenteral nutrition of neonates. NANOLIP will provide a balanced and complete lipid formulation, enabling optimal growth of the treated neonates. Additionally, it will reduce possible clinical and metabolic complications of parenteral nutrition, such as neurological disorders and liver failure, and ideally improve the clinical outcome in the long term. NANOLIP’s unique fatty acid profile will greatly support the highly important processes of brain and immune system development in the neonate. One of the main challenges in achieving a lipid emulsion of known and controlled content lies in the difficulty to control the structuring process of triglycerides. Consequently, most lipid emulsions are derived from mixing available non-optimal natural lipids. HTL has developed a set of enzymatic reactions that enables structuring triglycerides in a highly controlled manner. This technological breakthrough enables creation of a lipid emulsion that contains a tailor-made composition of fatty acids. During the proposed project the companies will jointly develop NANOLIP, as follows: HTL will develop the procedures required for NANOLIP's production, including optimisation of the triglycerides’ structuring processes. HTL will develop all production procedures, including up-scaling to a semi-industrial level, required for obtaining the necessary amounts for pre-clinical studies. HTL will assess the optimal composition of NANOLIP, taking into account the specific needs of the neonate according to updated literature. HTL and CHIESI will design preclinical and clinical experiments. CHIESI will develop an emulsification process and perform pre-clinical experiments to assess NANOLIP's safety and efficacy as follows: * Safety pharmacology experiments - in rats and mice; assessment of the treatment's effect on nerve system, respiratory, liver and renal functions, liver and lung histology. * Mutagenesis experiments. * Efficacy experiment - in rats and mice; examination of doses and treatment regimens; evaluation of the treatment's effect on multiple clinical, histopathological and biochemical parameters. * Teratogenesis in two animal species. * PK/PD studies and in-vitro metabolism. CHIESI will conduct toxicological PK/PD (Pharmacokinetics/Pharmacodynamics) studies in cooperation with selected CROs (Clinical Research Organisations). As most pharmaceutical companies of its size, CHIESI does not have in-house facilities to perform these studies. Thus the studies are committed at specialised CROs. CHIESI's and HTL's employees will work closely with the CROs to develop the protocols and will monitor the studies throughout their conduct. Upon project completion a lipid emulsion that has been proven in pre-clinical studies as non-toxic and effective will be derived. In addition, NANOLIP's production procedures for semi-industrial quantities will be optimised. The companies expect that by this time the product will be ready to be tested in clinical studies.
Project ID: 
4 919
Start date: 
Project Duration: 
Project costs: 
4 200 000.00€
Technological Area: 
Medical technology
Market Area: 

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