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
Bases of organic chemistry (in particular functional groups); bases of general chemistry (in particular pH, acid-base equilibria and buffer systems); bases of analytical chemistry (in particular solubility, units of measurement and dilutions)
Teaching Methods
Lectures; Group Work Classroom exercises.
"For students with specific needs, who are unable to attend educational activities in person and who have applied for Inclusive Educational Methods, appropriate study materials will be made available for effective self-study. If requested, self-learning can be supported by tutoring activities or supplementary teaching, and by dedicated meetings, including online ones, with flexible scheduling according to the students' needs."
Assessment Methods
The exam consists of a written test concerning the Legislation part and Technological Operations. The written test will be supplemented with an oral examination regarding Dosage Forms.
Written Test: Legislation (eight multiple-choice questions, three open-ended questions, and two exercises). Time allotted: 60 minutes. Technology (ten multiple-choice questions, ten open-ended questions, and five exercises). Time allotted: 75 minutes.
Oral Examination - four open-ended questions
In addition, appropriate examination procedures are provided for students who fall into the categories of Specific Learning Disorders (SDA) and Special Educational Needs (SHD).
Exam dates will be published on the DDS website.
Texts
P Caliceti Tecnologia farmaceutica, Casa Editrice Zanichelli, 2025P.Colombo e coll. ” Principi di Tecnologie Farmaceutiche”, Casa Editrice Ambrosiana, Milano, 2004; M.Amorosa “Principi di tecnica farmaceutica” libreria Universitaria L.Tinarelli, Bologna, 2004; Medicamenta VII Ed., Ed. Cooperativa farmaceutica, Milano; "Aulton's Pharmaceutics- The science of dosage form design” Churchill Livingstone, Fourth Edition 2013 P.Minghetti, M.Marchetti “ Legislazione farmaceutica - Esami di farmacia” Casa Editrice Ambrosiana, VIII Ed.; Farmacopea Ufficiale Italiana, XII Ed.; 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 and quality controls. Concepts of quality assurance and validation, brief basics about Good Manufacturing Practice and Good Formulation Practice for medicines. 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. Rules about homeopatic and herbal formulations. Professional orders and health ethics.
Course Language
Italian
More information
All teaching materials are uploaded to the Kiro platform