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  1. Courses

501325 - Pharmaceutical Technology and Legislation (M-Z)

courses
ID:
501325
Duration (hours):
80
CFU:
9
SSD:
FARMACEUTICO TECNOLOGICO APPLICATIVO
Year:
2025
  • Overview
  • Syllabus
  • Degrees
  • People

Overview

Date/time interval

Secondo Semestre (02/03/2026 - 19/06/2026)

Syllabus

Course Objectives

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

Degrees

Degrees

PHARMACY 
Single-cycle Master’s Degree
5 years
No Results Found

People

People

DORATI ROSSELLA
Settore CHEM-08/A - Tecnologia, socioeconomia e normativa dei medicinali e dei prodotti per il benessere e per la salute
Gruppo 03/CHEM-08 - TECNOLOGIA, SOCIOECONOMIA E NORMATIVA DEI MEDICINALI E DEI PRODOTTI PER IL BENESSERE E PER LA SALUTE
AREA MIN. 03 - Scienze chimiche
Professore associato
No Results Found
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