To provide the theoretical and practical bases of the conventional pharmaceutical technology, useful to the student to understand the relevance of the knowledges and operations that enable, for a therapeutic substance, the development of the dosage forms more suitable for a given treatment and administration route. To give to the student the reading keys of the complex legislative apparatus, both national and supranational, which regulates the pharmaceutical activity in Italy: in particular let the student know, from the normative point of view, the types of medicines and the relative dispensing discipline.
Course Prerequisites
Basics of organic chemistry (in particular functional groups and carbohydrates); basics of general chemistry (in particular pH, acid-base balances); basics of analytical chemistry (in particular solubility, units of measurement and dilutions)
Teaching Methods
Frontal theoretical lessons. Group exercises are planned
Assessment Methods
A written test on ongoing legislation is foreseen. The exam in the official sessions will be carried out in oral form
Texts
P.Colombo e coll. ” Principi di Tecnologie Farmaceutiche”, Casa Editrice Ambrosiana, Milano; M.Amorosa “Principi di tecnica farmaceutica” libreria Universitaria L.Tinarelli, Bologna; Medicamenta VII Ed., Ed. Cooperativa farmaceutica, Milano; "Aulton's Pharmaceutics- The science of dosage form design” Churchill Livingstone, P.Minghetti, M.Marchetti “ Legislazione farmaceutica - Esami di farmacia” Casa Editrice Ambrosiana; Farmacopea Ufficiale Italiana; Farmacopea Europea. Modifiche ed aggiornamenti legislativi pubblicati sulle Gazzette Ufficiali della Repubblica Italiana.
Contents
Introduction about the pharmaceutical technology. Medicines and drug delivery systems. Standard pharmaceutical manufacturing processes: milling, mixing, drying, filtering, sterilization. Disperse systems. Rheology basics. Conventional drug delivery systems as liquids, semi-solid and solid (excluding the solid dosage forms for oral administration): main characteristics, excipients, preparation methods, packaging . Basic elements about public law. Brief introduction about the historical evolution of the pharmaceutical Italian legislation. Organization of the Italian health system. European Committees for medicines and European legislation. Legal classification of medicines. Italian and European Pharmacopoeias. Rules regulating the medicines supplying. Legal regulation for psychoactive drugs. Criminal and civil liability of the pharmacist. National rate for medicines. Professional orders and health ethics.
