Submitted Abstract
The rise of Nanotechnology offers the pharmaceutical industry not only a better understanding of living biosystems, but also the synthesis of new drugs and their targeted delivery using smart nanocarriers. Despite the considerable interest and research in the development of nanoparticles based drug delivery systems, only few have been commercialised, mainly protein based nanoparticles (e.g. abraxane) , liposomes (e.g. doxil), and drug nanocrystals. Although there are many advantages of using mesoporous silica nanoparticles (MSNs) and nanostructured lipid carriers (NLC) for parenteral drug delivery, their use in pharmaceutical products is strongly limited by the challenges to fabricate them at industrial scale with GMPs reliable processes, and the assessment of their toxicity. The standard processes, namely sol-gel growth in batch (MSNs) and high pressure homogenising (NLC) respectively, lead to either highly diluted dispersions or excesses in stabilisers to prevent any aggregation and coalescence. A new synthetic approach is therefore required.Wet stirred media milling is a standard process in the pharmaceutical industry, mainly used as a comminution method to get drug nanocrystals. The 1008 project proposes to first couple a highly performing wet bead mill qualified for pharmaceutical applications developed by Frewitt, with a chemical reactor designed to produce smart nanocarriers such as mesoporous silica nanoparticles and nanostructured lipid carriers following recipes developed by LIST researchers. This new mechano-chemical coupling is expected to overcome the limitations of the synthesis processes of these nanocarriers, thus enabling the preparation of concentrated stable dispersions with a mean size in the nanoscale (< 100 nm). A first scale-up up to 1 L dispersion while maintaining the demonstrated process performances will be evaluated. The effectiveness of the solutions developed in the 1008 project will be shared with a panel of pharmaceutical stakeholders active in the nanocarrier developments. In parallel, the assessment of the business implementation potential will be carried out throughout the 1008 project in order to develop future opportunities both for LIST, Frewitt, and potential future industrial partners in the pharmaceutical, cosmetics, and biotechnology markets just to name a few.