PRODUZIONE INDUSTRIALE DEI MEDICINALI
Academic Year 2024/2025 - Teacher: MARIA GRAZIA SARPIETROExpected Learning Outcomes
The training objective of the course is to provide students with knowledge on industrial plant engineering, production processes and drug control, on Good Manufacturing Practise, on the control of pharmaceutical forms, and on pharmaceutical technologies used in the production and packaging of medicines. .
At the end of the course the student knows the aspects related to the development and industrial manufacture of medicines; acquires knowledge related to other aspects characteristic of industrial practice such as validation of a production process and European legislation on the manufacture and marketing of medicinal products.
Course Structure
lectures (powerpoint presentation)
Required Prerequisites
Detailed Course Content
Overview of the pharmaceutical industry, the industrial production of medicines and related problems.
The Italian pharmaceutical industry.
Overview of market research and the fundamental economic problems of a pharmaceutical industry.
Organization, structure and organization of production units of different potential.
Good manufacturing practices.
Work premises, safety regulations.
Organization of the general services of a pharmaceutical industry.
Water: supply, treatment, use of water in the pharmaceutical industry.
Steam: thermal power stations, basic principles of the appliances.
Cold production: refrigeration systems.
Vacuum, compressed air, dust suppression systems.
Unit operations: industrial theory and application of grinding, sieving, mixing, drying, lyophilization, filtration, centrifugation, sterilization.
Production technology and quality control of pharmaceutical forms.
Liquid pharmaceutical forms: injectable preparations.
Solid pharmaceutical forms: tablets, capsules.
Packaging materials: glass for pharmaceutical use, closures in elastomer material, plastics for pharmaceutical use
Pilot studies for the development of large-scale processes, development and "scale up" of the drug.
Textbook Information
- L. Fabris, A. Rigamonti, La fabbricazione industriale dei medicinali, Società Editrice Esculapio
- Notes in PDF format
Course Planning
| Subjects | Text References | |
|---|---|---|
| 1 | Cenni generali sull’industria farmaceutica, la produzione industriale dei farmaci ed i problemi connessi. L’industria farmaceutica italiana.Cenni sulla ricerca di mercato e sui problemi economici fondamentali di un’industria farmaceutica. | 2 |
| 2 | Organizzazione, struttura ed articolazione d’unità produttive di diversa potenzialità. | 2 |
| 3 | Norme di buona fabbricazione. | 2 |
| 4 | Locali di lavoro, norme di sicurezza. | 1 (capitolo 5), 2 |
| 5 | Organizzazione dei servizi generali di un’industria farmaceutica. | 2 |
| 6 | Acqua: approvvigionamento, trattamenti, impiego | 1 (capitoli 3 e 7), 2 |
| 7 | Vapore: centrali termiche, principi di base degli apparecchi | 1 (capitolo 3), 2 |
| 8 | Produzione del freddo: impianti frigoriferi. | 2 |
| 9 | Vuoto, aria compressa, sistemi d’abbattimento delle polveri. | 1 (capitolo 3), 2 |
| 10 | Operazioni unitarie: teoria ed applicazione a livello industriale di macinazione, setacciatura, miscelazione, essiccamento, liofilizzazione, filtrazione, centrifugazione, sterilizzazione (argomenti trattati dal Prof. F. Castelli) | 1 (capitoli 11, 12 e 13), 2 |
| 11 | Forme farmaceutiche liquide | 1 (capitoli 9 e 10), 2 |
| 12 | Forme farmaceutiche solide: compresse, capsule. | 1 (capitolo 14), 2 |
| 13 | Materiali di confezionamento: il vetro per uso farmaceutico, le chiusure in materiale elastomero, le plastiche per uso farmaceutico | 1 (capitolo 6) |
| 14 | Studi pilota per la messa a punto di processi su larga scala, sviluppo e “scale up” del farmaco | 2 |