The development of innovative production processes for asymmetric nanocapsules was performed by encapsulation of API into W/O nanoemulsions with lipid monolayers Mi
The selection of API focused primarily on biopharmaceuticals like :
- RNA for targeted immune vaccination therapies
- Cytotoxic proteins and other degradation sensitive API with high tumour selectivity,
to cover a large spectrum of relevant API properties for which no suitable encapsulation techniques exist without toxic side effects or existing techniques cause degradation of API or inefficient encapsulation.
Asymmetric nanocapsules were first produced in batch centrifugation processes and later transferred to continuous production
Encapsulation efficiencies were determined for different API and leaflet asymmetry of nanocapsule bilayers was studied using different fluorescent markers for the inner and outer leaflet, respectively. Comparative studies of different compounds for oil phase and nanocapsule lipids were performed. Different oil phases approved for parenteral use were tested as pharmaceutical excipients of the nanocapsule production process. A wide spectrum of compound mixture for the nanocapsule bilayer shell (consisting of pharmaceutically approved phospholipids, sterols and/or polymers) was employed for the formation of nanoemulsions and nanocapsules.
A variety of suitable compound mixtures was established for a selection process taking into account the demand of the other work packages: robustness in the continuous process (WP2 and WP3), in vitro stability when incubated in human blood components (WP4), and functional properties for in vitro (WP5).