Pharmaceutical Technology & Regulatory Affairs
A proper formulation of bioactive compounds is of the utmost importance for the outcome of any pharmacological treatment. The dosage form is indeed expected to ensure that the drug is made available for absorption as 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, which would primarily be aimed at i) an in-depth physico-chemical characterization of the active pharmaceutical ingredient, ii) the evaluation of the inherent compatibility with selected ecxipients, iii) the design of the dosage form, for either an immediate or a modified release, iv) a setup of the concerned manufacturing process and v) assessment of the relevant stability, technological and biopharmaceutical properties. These are all fields of expertise of the components of the Pharmaceutical Technology & Regulatory Affairs "Maria Edvige Sangalli" Unit, Department of Pharmaceutical Sciences. The main research topics are the study of the solid-state properties of bioactive compounds, the development of conventional formulations and delivery systems intended for differing routes of administration.
The technological development of a medicinal product is strictly connected to the preparation of the Common Technical Document (CTD) required to obtain the Marketing Authorization (MA) and the documents necessary to apply for variations of a granted MA. Hence, necessary and important as a part of the activity is the study of the regulatory framework and the doctrinal analysis of national and EU laws in medical and health products.