Participations in ARRS research projects
1.Development of highly concentrated protein formulations and evaluation of absorption kinetics after subcutaneous administration (L1-3160; 1.10.2021 - 30.9.2024)
Over the past several decades, protein therapeutics, and monoclonal antibodies (MAbs) have contributed to improved therapeutic success in a variety of diseases. In particular, formulations for subcutaneous administration are gaining in importance and represent one of the most significant areas in the field of pharmaceutical industry. Subcutaneous administration offers many advantages over intravenous administration, however, 1there are still many technological challenges in terms of preparation of highly concentrated protein formulations intended for subcutaneous use. In particular, protein stability and appropriate formulation viscosity should not be overlooked, considering it may otherwise result in a limited syringeability.
This will be a collaborative applicative research project, including University of Ljubljana, Faculty of Pharmacy and Lek d.d.; Novartis Global Drug Development/Technical Research and Development as a Beneficiary/Co-funding organisation. The Department of Pharmaceutical Technology will participate in the project by identifying novel excipients to reduce the viscosity of formulations for subcutaneous administration, preparing highly concentrated mAb formulations, and evaluating formulation stability and viscosity. Additionaly, new depot systems for controlled release of proteins with limited duration of action will be established and characterized for physico-chemical properties and biological acceptability.
2. Development of biologically active and chemically stable xanthophylls, based on sustainable esterification of xanthophylls from renewable natural sources (J4-3092; 01.10.2021 - 30.09.2024)
Xanthophylls are oxygenated carotenoids, who play a role in numerous biological processes (e.g., photosynthesis) and have characteristic yellow, orange or red color. They face numerous challenges in terms of poor stability and degradation, low bioavailability and difficulty to obtain from sustainable sources. Within this project we will look for sustainable, natural sources of xanthophylls, we will develop a flexible platform for synthesis of xanthophyllic esters, which we will carefully evaluate their properties (oxidative activity, safety, chemical stability, etc.) and develop a food supplement prototype formulation with which xanthophylls could be ingested.
This project is a collaboration of Chemical institute and UL FFA, where the role of UL FFA is mostly related to development and final food supplement formulation for oral application. Here, two options will be explored: i) formulating simple oil drops, where xanthophyllic esters will be dissolved in oily vehicle and ii) development of tablet or capsule, where xanthophillyc esters, dissolved in appropriate vehicle will be filled into mesoporous carrier. The development of solid oral form is preferred because solid dosage forms show better patient compliance.