Pharmaceutical Technology - Galenic Laboratory A - L

Module Galenic Laboratory

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 (2 CFU), practical laboratory exercises in single place (2 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.

The GALENICO LABORATORY course will be divided into lectures (2 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 (2 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. The practical laboratory lessons will take place from November to January on a weekly basis. The calendar of practical laboratory lessons will be published on the Studium page of the course. 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 / DSF 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.

Galenic and industrial medicine, masterly and officinal Galenic. Rules of good preparation. National Tariff of Medicines. Italian F.U. in force and related updates, European Pharmacopoeia in force.

Basic operations in pharmaceutical technology: dissolution, filtration, drying, freeze-drying, sterilization, pulverization.

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.

Due to COVID-19 emergency, the laboratory excecises may be modified.

The GALENICO LABORATORY course will be divided into lectures (2 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 (2 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 January on a weekly basis. The calendar of practical laboratory lessons will be published on the Studium page of the course. 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 / DSF 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. Colombo et al. - PRINCIPI DI TECNOLOGIA FARMACEUTICA – seconda edizione – Casa Editrice Ambrosiana, 2015.

5. Enrico Ragazzi “Galenica Pratica” Formulazione e Tecnologia. – Ed. 2006 – Libreria Internazionale Cortina Padova.

6. Manuale di galenica a uso umano e veterinario di Francesca Baratta, Irene De Pellegrini, Maria Beatrice Iozzino, Paola Brusa - Zanichelli editore, 2019.

7. Minghetti Paola. Legislazione Farmaceutica, Casa Editrice Ambrosiana. Ed. 2018.

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

Evaluation tests with ongoing feedback both in the classroom and during practical laboratory exercises.

Written examination, at the end of the first lesson of practical laboratory exercises, on the knowledge and compliance with the rules of conduct and the rules for the protection of work in the galenic laboratory.
2CFU ELS (single-seat laboratory exercise): Theoretical-practical verification on the shipment of a magisterial galenic recipe, which will be held at the end of the practical laboratory exercises (end of January).
In particular, the following will be subject to the final verification:
- pharmaceutical form prepared (quality, quantity, controls)
- final report (contents, technical language properties and overall expressive ability of the student)
- pricing (application of current legislation)
- worksheet and label (contents, language properties, application of current legislation).
2CFU ELG (group laboratory exercises): theoretical-practical test that will be proposed at the end of each group exercise.
2 CFU LT (theoretical lessons): written test (multiple choice and / or open questions), in conjunction with the written test of the Pharmaceutical Technology module, on the topics of the program listed below:
- Galenic and industrial medicine
- Magistral and officinal Galenician
- Rules of good preparation
- National Medicines Tariff
- Fundamental operations in pharmaceutical technology: solutions, filtration, concentration, drying, freeze-drying, sterilization, pulverization, granulation.
Verification of learning can also be carried out electronically, should the conditions require it.
Information for students with disabilities

To guarantee equal opportunities and in compliance with the laws in force, interested students can ask for a personal interview in order to plan any compensatory and / or dispensatory measures, based on the didactic objectives and specific needs.
It is also possible to contact Prof. Teresa Musumeci as a lecturer at CInAP (Center for Active and Participatory Integration - Services for Disabilities and / or SLD) of the Department of Pharmaceutical and Health Sciences.

The exam will focus on the delivery of a masterful recipe, such as those shown in the example:

Example 1:

Shipping of 30 g of lidocaine-based gel. B) Lyophilization: describe the steps of the process. C) Pulverization mechanisms.

Example 2:

Shipping of 50 grams of syrup containing codeine. B) Dry heat sterilization. C) Purified water: characteristics and production methods.

Example 3:

Delivery of 20 capsules to the seine. B) Main drying techniques. C) Water for injections: characteristics and production methods.