The NANOLIPID research project entitled Nanoemulsion for parenteral nutrition – an innovative pharmaceutical formulation with hepatoprotective properties implemented under the Lider XII program aims to develop an innovative hepatoprotective intravenous lipid. It is a response to the current market and clinical need since the long-term administration of parenteral nutrition is often associated with complications, namely intestinal failure associated with liver disease. The project assumes both modifications of qualitative and quantitative composition along with the most current clinical data as well as physicochemical properties of currently available intravenous lipid emulsion. During the implementation of the project, the elements of Design of Experiments (DoE) are adopted.  

The NANOLIPID project is carried out at the Department of Pharmaceutical Chemistry and the Department of Pharmaceutical Biochemistry at the Poznan University of Medical Sciences in cooperation with the Wielkopolska Center for Advanced Technologies (in vivo studies) and it is divided into four stages:

1. Development and optimization of the composition and method of preparation of nanoemulsions for parenteral nutrition.
2. Assessment of physicochemical properties, in vitro cytotoxicity, and compatibility with remaining components of parenteral nutrition admixtures in various concentrations
3. Development of the sterilization method, determining the effectiveness of the sterilization process by testing the sterility of the product, and determining the impact of this process on the properties and stability of the components of the developed formulation. The sterilized formulation will be then the subject of the stability testing in accordance with the ICH Q1A-Q1F guidelines.
4. Assessment of the developed formulation’s safety profile and hepatoprotective properties in an in vivo model. To confirm the achievement of the assumed goals of the project concept in vivo tests on an animal model will be carried out. Evaluation of the effectiveness, safety, and hepatoprotective properties will be made on the basis of the results of biochemical blood tests (lipogram, liver enzyme levels) and liver homogenates (confirmation of hepatoprotective properties), histological evaluation of liver sections (evaluation of the degree of toxicity) and a comparison of the obtained results with the results obtained for the control groups.

The main goal of the project is to obtain a stable, sterile nanoemulsion with hepatoprotective properties. These properties will result from both the physicochemical properties of the pharmaceutical formulation itself and the biological properties of the substances added. The methods and analytical techniques used in the research allow both to characterize the physicochemical properties of the lipid emulsion, confirm the effectiveness of the sterilization process, and determine the biological effect.

Due to the financial limitations of the LIDER XII program (1 500 000 PLN), the research project will end at the pre-clinical stage. After their completion, Aleksandra Gostyńska (Project Manager/ Principal Scientist) will begin to prepare patent documentation, which will include the method of obtaining and the composition of the obtained pharmaceutical formulation. By implementing the assumed goal of the NANOLIPID project, Aleksandra Gostyńska and her research team will also acquire skills and develop analytical methods enabling the provision of services within the spin-off company in the field of determining the stability of lipid emulsions, including parenteral nutrition admixtures in accordance with the pharmacopeial requirements.