Development of micro- and nanosystems as carriers for drugs with anti-inflammatory effect and methods for their characterization

Functional excipients critically determine stability, efficacy, safety and risk/benefit ratio of micro- and nanocarriers for generic drugs. Most anti-inflammatory drugs (e.g. non-steroid (NSAID), corticosteroids, immunosuppressives) have either poor water solubility and consequently low intestinal absorption or inadequate safety profiles. These drugs are suitable candidates for encapsulation into micro- and nanocarrier formulations. The aim of this project is to develop oral and topical micro- and nanocarriers for anti-inflammatory drugs. The project comprises two major steps: 1) The use of novel excipients with the aim to achieve physical stability of carriers, efficient drug encapsulation, optimal in vitro/in vivo bioavailability and adequate safety. 2) The development of analytical methods for formulation stability assessment and standardisation of methods for investigations on dermal bioavailability of topical formulations. Comparative dermal and oral delivery investigations using model drugs (ketoprofen, hydrocortisone, tacrolimus) will be carried out for (i) emulsions and nanocarriers based on natural surfactants; (ii) microcarriers formulations based on alginates, chitosans with varying Mw and lipid excipients and (iii) aluminosilicate and novel natural mesoporous diatomite silica materials modified by cationic surfactants, aminoacids or polymers (e.g. alginates and chitosans) in order to achieve controlled release of model anti-inflammatory drugs.