TECNOLOGIA FARMACEUTICA - LABORATORIO GALENICO - TECNOLOGIA COSMETICA CON ESERCITAZIONI A - L

Module LABORATORIO GALENICO

The goal of the course is to provide the fundamental knowledge on the dosage forms, with particular emphasis on the role of the different components and quality controls on the final pharmaceutical form. The student will learn the nature and the classification of the excipients in order to understand the their role in the different dosage forms and administration ways. At the end of the coarse the student should be able to understand and describe the various approaches for optimizing the therapeutic efficacy of an active ingredient.

EXPECTED LEARNING RESULTS

At the end of the course the student will be able to:

- Acquire awareness of the pharmacist's responsibilities within the galenic laboratory;
- Understand the correct way to complete the documentation supplied with the shipment of a galenico;
- Apply the current legislation for the correct pricing of a galenic;
- Recognize the mandatory formal aspects in a masterly prescription for the purposes of its acceptance;
- Evaluate the checks to be carried out when shipping a magistral galenic prescription;
- Establish the main galenic pharmaceutical forms in the solid, liquid and semisolid state;
- Organize the activity within the galenic laboratory in compliance with the NBP.

The GALENIC LABORATORY A-L module will be divided into lectures (1 CFU), practical laboratory exercises in single place (3 CFU) and group laboratory exercises dedicated to quality controls (2 CFU) shared and cooperative, during which the students will be invited to participate in feedback evaluation activities.

If the teaching is given in a mixed or remote mode, the necessary changes with respect to what was previously stated may be introduced, in order to respect the program envisaged and reported in the syllabus.

- Mathematic, Statistic and Informatic;

-General and Analitical Chemistry;

- Anatomy;

- Microbiology, Pharmacology and Physiology;

- Basic knowdledge of excipients for pharmaceutical use.

The GALENICO LABORATORY course will be divided into lectures (1 CFU), participated and cooperatives, during which students will be invited to participate in feedback evaluation activities. The course includes practical exercises in single-place laboratory (3 CFU) and group laboratory exercises dedicated to quality controls (2 CFU).

Attendance at the course is compulsory and is acquired by attending at least 70% of the practical laboratory exercises.

The attendance at the FIRST PRACTICAL LABORATORY LESSON is MANDATORY (expected in mid-October), as students will be trained / informed about the minimum safety procedures related to the Galenic Laboratory. 

The schedule and start date of the practical exercises (which will take place from October to December) will be communicated by the instructor both in class and online on the Farmacia/DSFS website.

Given the limited number of places available in the laboratory, in order to allow for adequate organization of the exercises, it is mandatory to reserve a place in the laboratory according to the methods illustrated by the instructor via a notice on the DSFS starting from September 15th.

Galenic and industrial medicine, masterly and officinal Galenic. Rules of good preparation. National Tariff of Medicines. Italian F.U. in force and related updates, with focus on Tables. Customized packaging (deblistering). 

Single-place laboratory exercises with ongoing evaluation on feedback related to the shipping of a masterly galenic recipe: techniques for the preparation of the most common galenical pharmaceutical forms, receipe and preparation checks, documentation. Group laboratory exercises will be dedicated to quality controls.

The GALENICO LABORATORY course will be divided into lectures (1 CFU), participated and cooperatives, during which students will be invited to participate in feedback evaluation activities. The course includes practical exercises in single-place laboratory (3 CFU) and group laboratory exercises dedicated to quality controls (2 CFU).

Attendance at the course is compulsory and is acquired by attending at least 70% of the practical laboratory exercises.

The attendance at the FIRST PRACTICAL LABORATORY LESSON is MANDATORY, as students will be trained / informed about the minimum safety procedures related to the Galenic Laboratory. At the end of the first lesson, a writing text will be proposed to verify the acquisition of the competence.

The practical laboratory lessons will take place from October to December on a weekly basis. The calendar of practical laboratory lessons will be showed in class. The starting date of practical exercises will be communicated by the teacher (in the classroom and by means of an online notice on the Pharmacy / DSFS website). Considering the limited number of places available in the laboratory, in order to allow an adequate organization of the exercises, it is mandatory to enroll each student in the Studium platform for the Galenico Laboratory module and the simultaneous online booking for practical exercises.

1. Farmacopea Ufficiale Italiana in vigore e relativi supplementi e aggiornamenti.
2. Decreto Ministero della Sanità del 22 settembre 2017 (Tariffa Nazionale dei Medicinali),
Allegati A e B, secondo aggiornamento del 30.01.2018
3. Farmacopea Europea in vigore.
4. P. Caliceti. Tecnologia Farmaceutica - prima edizione – Casa Editrice Ambrosiana, 2025.

5. P. Colombo et al. - PRINCIPI DI TECNOLOGIA FARMACEUTICA – seconda edizione – Casa Editrice Ambrosiana, 2015.

6. Enrico Ragazzi “Galenica Pratica” Formulazione e Tecnologia. – Ed. 2006 – Libreria
Internazionale Cortina Padova.
7. Minghetti Paola. Legislazione Farmaceutica, Casa Editrice Ambrosiana. Ed. 2018.
8. Francesca Baratta, Irene De Pellegrini, Maria Beatrice Iozzino, Paola Brusa. Manuale di
galenica a uso umano e veterinario. Casa Editrice Ambrosiana (Ed. 2019).

Support material will be shared online on the teacher's Studium page during the year.

Ongoing feedback assessments will be conducted both in the classroom and during practical laboratory exercises.

A written exam, at the end of the first practical laboratory lesson, will assess knowledge and compliance with the rules of conduct and safety regulations for working in a pharmaceutical laboratory.

To earn the 6 credits: a theoretical and practical exam on the shipment of a master's prescription will be held in mid-December. Written exam (multiple-choice and/or open-ended questions).

Specifically, the final exam will cover:

- Pharmaceutical form prepared (quality, quantity, controls)

- Final report (content, technical language skills, and overall student expressive ability)

- Pricing (application of current regulations, National Tariff for Medicines)

- Worksheet and label (content, language skills, application of current regulations).

- Galenic and Industrial Medicine

- Magistral and Officinal Galenic

- Current Italian and European Pharmacopoeia

- Good Preparation Standards

- Control tests on pharmaceutical forms.

The exam will focus on the shipment of a master's prescription, such as those shown in the following example:

Example 1:

A) Shipment of 30 g of lidocaine-based gel. B) Freeze-drying: describe the process steps. C) Pulverization mechanisms.

Example 2:

A) Shipment of 50 g of syrup containing codeine. B) Dry heat sterilization. C) Purified water: characteristics and production methods.

Example 3:

A) Shipment of 20 senna capsules. B) Main drying techniques. C) Water for injections: characteristics and production methods.