Pharmaceutical Technology - Galenic Laboratory M - Z

Module Galenic Laboratory

The main objective of the course is to provide students with the basic knowledge for the shipment of a galenic recipe and to deepen their knowledge on galenic preparations, main pharmaceutical operations and current legislation.

The course is organized in lectures and laboratory exercises, both single and group.

During the laboratory exercises the student will have the opportunity to face in itinere tests (evaluation to feedback) on the shipment of a galenic recipe, in order to facilitate the learning process.

EXPECTED LEARNING OUTCOMES - GALENIC LABORATORY M-Z

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 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, which will be held during the first semester.

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 at the end of October 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) by the end of October. 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 (to be carried out at starting from the first frontal lesson).

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.

During the first practical exercise, a test will be carried out, following the information and training activity provided by the teacher, in order to verify the acquisition of knowledge and compliance with the rules of conduct and the protection rules in the laboratory.

1. Farmacopea Ufficiale Italiana XII Edizione 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. Paola Minghetti “Legislazione farmaceutica”. Casa Editrice Ambrosiana. Ed. 2018.
7. Francesca Baratta, Irene De Pellegrini, Maria Beatrice Iozzino, Paola Brusa. Manuale di galenica a uso umano e veterinario. Casa Editrice Ambrosiana (Ed. 2019).

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

The sudents must do a test at the end of the first practical exercise lesson in the laboratory regarding the knowledge of the rules of conduct and the protection of work in the galenic laboratory.

2CFU ELS (single-seat laboratory exercise): Theoretical-practical verification of galenic preparation, which will be held at the end of the practical laboratory exercises (end of January).

In particular, the subjects of the final verification: - pharmaceutical form prepared (quality, quantity, controls) - final report (contents, properties of linguaggiotecnico and overall expressive ability of the student) - pricing (application of current legislation) - worksheet and label (contents, language properties, current regulatory application).

 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 the same test of the Pharmaceutical Technology module, on the topics of the program listed below: - galenic product - Good preparation procedure - 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, interested students can ask for a personal interview in order to plan any compensatory measures, based on the didactic objectives and specific needs. It is also possible to contact Prof. Teresa Musumeci as a representant at CInAP (Center for Active and Participatory Integration - Services for Disabilities and / or SLD) for the Department of Pharmaceutical and Health Sciences.