B2830 - Medicinal Products Customization with Laboratory of Galenic Preparations

Course contents

Part 1. Personalization of medicinal products and galenic laboratory (2CFU)

Introduction. European Pharmacopoeia and Official Pharmacopoeia of the Italian Republic. NBP. DM 16/11/2003.Organization and management of the galenic laboratory. Medicinal products prepared in the galenic laboratory. Labelling and price of galenic products.

Part 2 and 3. Personalization of medicinal products and galenic laboratory- Galenic laboratory (4 CFU)

Preparation of the following galenic formulations: capsules, tablets, syrups, suspensions, emulsions, creams, ointments, pastes, suppositories and pessaries. Calculation of price, packaging and labeling.

Readings/Bibliography

M. Frongia, L. Casettari, Il galenista e il laboratorio, EDRA, 2018.

F. Baratta et al., Manuale di galenica a uso umano e veterinario, CEA–Zanichelli, 2019.

F. Bettiol, Manuale delle preparazioni galeniche, Tecniche Nuove, 2022.

E. Ragazzi, Galenica pratica - Formulazione e tecnologia, Libreria Internazionale Cortina, 2006.

Italian and European Pharmacopoeias.

Slides presented in class are not a substitute for the reference texts.

Teaching methods

Lectures (2 CFU, 16 hours) and practical experience in the Galenic laboratory (4CFU, 60 hours).

The attendance requirement is considered fulfilled by attending at least 80% of practical experience in the Galenic laboratory and 60% of lectures. Attendance is recorded using the student attendance application.

As concerns the teaching methods of this course unit, all students must attend Module 1, 2 [https://www.unibo.it/en/services-and-opportunities/health-and-assistance/health-and-safety/online-course-on-health-and-safety-in-study-and-internship-areas] online, while Module 3 on health and safety is to be attended in class. Information about Module 3 attendance schedule is available on the website of your degree programme.

Assessment methods

The final exam is divided into 2 tests (one practical and one oral).

Practical test: Preparation of a galenic formulation, calculation of price, packaging and labelling.

Oral exam will focus on Part 1 and 2.

 

Students with Specific Learning Disorders (SLD) or temporary/permanent disabilities: It is strongly recommended to contact the relevant University Office in advance (https://site.unibo.it/studenti-con-disabilita-e-dsa/en). The office will be responsible for proposing any necessary accommodations to the interested students, which must be submitted for the instructor's approval at least 15 days in advance. The instructor will evaluate their suitability in relation to the course's learning objectives.

Teaching tools

Video-projector and PC.

Office hours

See the website of Teresa Cerchiara

See the website of Valentina Sallustio