PRODUZIONE INDUSTRIALE DEI MEDICINALI
Academic Year 2026/2027 - Teacher: MARIA GRAZIA SARPIETROExpected Learning Outcomes
Knowledge and understanding:
Understand the principles of industrial pharmaceutical manufacturing, key unit operations, GMP, support facilities and services, as well as quality control and production process scale-up.
Ability to apply knowledge and understanding:
Apply the principles of industrial pharmaceutical technology to the production and control of key pharmaceutical forms, identifying appropriate operations, equipment, and process conditions.
Making judgments:
Critically evaluate production processes and issues in relation to quality, safety, efficacy, and GMP compliance.
Problem-solving skills:
Analyze technological and production issues and identify appropriate solutions at various stages of the pharmaceutical process, including development and scale-up.
Learning skills:
Integrate technological and production knowledge and develop the ability to independently stay abreast of innovations in the pharmaceutical industry
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 |