INDUSTRIAL PHARMACY AND DRUG LAWS
Academic year and teacher
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- Versione italiana
- Academic year
- 2022/2023
- Teacher
- ALESSANDRO DALPIAZ
- Credits
- 9
- Didactic period
- Secondo Semestre
- SSD
- CHIM/09
Training objectives
- The course brings the student to know the technologies that allow to separate and to purify a drug, to obtain its appropriate formulation and packaging. Moreover the regulations and guidelines will be considered about the development and commerce of medicinal products. Finally the legislative aspects related to the profession of pharmacist in Italy will be considered.
The main knowledge gained will be:
• theoretical aspects underlying the functioning of the machines used in the pharmaceutical industry;
• functioning of industrial machines used in the purification and assembly of the components of the pharmaceutical formulations;
• packaging procedures;
• industrial procedures for obtaining sterile pharmaceutical formulations and sterile devices;
• national, and European Community legislation concerning the marketing of industrial pharmaceutical products;
• the legal aspects related to the profession of pharmacist in Italy.
At the end of the course the student will be able
• to understand the working of the machines used to process active ingredients and excipients and to package finished pharmaceutical products;
• to plan and control industrial production lines by identifying the specific machines;
• to apply the rules necessary for the production and marketing of industrial pharmaceutical products;
• to identify and evaluate the rules for the management of a public or private pharmacy in Italy. Prerequisites
- Derivatives and integrals; physics, physical chemistry;
Pharmaceutical Technology Course programme
- The course includes 72 hours of lessons during which the following topics will be addressed.
• Factory services and heat transfer (3 hours).
• Preparation and purification of the components of the pharmaceutical formulations: distillation, liquid-solid extraction, sedimentation by centrifugation, filtration, centrifugation, filtration, concentration, crystallization, drying and freeze-drying, grinding and sieving (25 hours).
• Treatments for adapting the industrial water to the characteristics required by the users (5 hours).
• Mixing of solid forms, liquid forms of low viscosity and high viscosity, and their split into final containers (6 hours).
• microbiological control technologies and sterilization: sterile filtration, beta and gamma radiation, ethylene oxide, formaldehyde, production areas and sterile environments, the importance of the operators and the way they operate (11 hours).
• Legislative aspects: Sanitary organization in Italy, the profession of pharmacist, articulation of pharmaceutical services, rules on the production and marketing of medicinal products for human use, the price of medicines, governing the dispensing of medicines to the public, the regulation of narcotic drugs and psychotropic substances, medicines veterinary use (22 hours). Didactic methods
- The teaching method is based on lectures in the classroom, as an indispensable tool for synthesis and development of the formative objectives: relies on slides projected, diagrams and mathematical demonstrations that facilitate the study of the subject shown on the board to guide the training course. The lectures are set to an interactive dialogue student-teacher.
Learning assessment procedures
- The aim of the examination is to test the level of achievement of learning objectives previously indicated. An oral examination will investigate on the knowledge of the students, in particular they will be stimulate to connect and compare different aspects covered during the course in order to optimize the costs of pharmaceutical preparations in industry, their marketing and their management in pharmacy. To pass the exam, students must acquire a minimum overall score of 18/30.
Reference texts
- "La fabbricazione industriale dei medicinali", L. Fabris, A.Rigamonti, ed. Società Editrice Esculapio.
"The theory and practice of industrial pharmacy", L.Lachman, H.A.Lieberman, J.L.Craig; ed. Lea & Febiger.
"Impianti per l'industria farmaceutica", G.C.Ceschel, L.Fabris, E.Lencioni, S.Rigamonti; ed. Società Editrice Esculapio.
P. Minghetti, M. Marchetti. "Legislazione Farmaceutica". Casa Editrice Ambrosiana.
M. Cini, P. Rampinelli. "Compendio di Legislazione Farmaceutica". Edizioni Minerva Medica.
Nicoletta Loliscio. La Farmacia: un campo minato. Società Editrice Esculapio.
Massimo Frongia, Luca Casettari. "Il galenista e il laboratorio", EDRA.
