Pharmaceutical Technology & Regulatory Affairs
The activities carried out in the Section refer to the design, development and production of:
- pharmaceutical dosage forms for drug administration;
- dosage forms for nutrients or other substances (food supplements);
- medical devices;
Proper formulation of bioactive compounds is of the utmost importance for the outcome of any pharmacological treatment. The dosage form is indeed expected to make the drug available for absorption as most advantageous from the therapeutic point of view, while presenting adequate physical, chemical and microbial stability profiles. These goals are pursued through a variety of formulation and preformulation activities that are primarily aimed at an in-depth physico-chemical characterization of the active pharmaceutical ingredient, evaluation of the inherent compatibility with selected excipients, design of the dosage form, either for immediate or modified release, setup of the relevant manufacturing process and assessment of product stability, technological and biopharmaceutical properties.
Formulation development is closely related to drafting of the documentation required by the regulatory agencies for marketing of drug products and of all health products as well. Therefore, an integral part of the research activities of the Section is the study of issued guidelines and analysis of national and EU regulations in these particular areas.
In addition, special attention is given to pharmacist profession and its role in the various areas of health care in collaboration with public and private institutions.