Learning objectives
The objective of the course is to give to the student the practical notions about the preparations, controls and technological properties of most common immediate release dosage forms.
The expected learning outcomes are:
1) Knowledge and understanding: knowledge of excipients, fabrication methods, of controls, of technological properties of immediate release dosage forms.
2) Applying knowledge and understanding: ability to apply, in an independent way, the knowledge acquired for the preparation of a given dosage form.
3) Communication skills: ability to use the specific language for this specialistic discipline.
4) Making judgements: the capability to face the professional responsibilities of the galenical pharmacist
5) Learning skills: capability of using the knowledge and the basic elements acquired in the conduction of the work as galenical pharmacist. Capability of upgrade, through the scientific publications in the field of pharmaceutical technology.
Prerequisites
In order to take the final exam, the following exams must have been passed: Organic Chemistry I (Chimica Organica I) and General Physiology (Fisiologia Generale).
Course unit content
The course contents are related to the practical learning of pharmaceutical technology, from basic technological processes to compounding and assessment of dosage forms, with focus on galenical development and the professional responsibility of the pharmacist. The first part of the course will focus on learning the fundamentals of metrology, pharmaceutical calculation, and unitary pharmaceutical operations. In the second part the student will learn how to compound and assess the different dosage forms, in agreement with the Pharmacopoeia requirements.
Full programme
• Legal issues concerning the preparation, packaging and pricing of galenical preparation according to the Italian Pharmacopeia
• Metrology
• Preparation and characterization of conventional dosage forms:
o Oral powders
o Topical powders
o Tablets
o Capsules
o Liquid preparations for oral use
o Liquid preparation for topical use
o Topical semisolid dosage forms
o Vaginal preparations
o Rectal preparations
Bibliography
ENRICO RAGAZZI, «Galenica pratica, formulazione e tecnologia», Libreria Internazionale Cortina Padova
FRANCO BETTIOL, «Manuale delle preparazioni galeniche», Tecniche Nuove
Farmacopea Ufficiale XII Ed.
PAOLO COLOMBO, et al. Principi di Tecnologia Farmaceutica, Seconda Ed.Casa Editrice Ambrosiana, Milano (2015)
H. ANSEL, S. STOCKTON PRINCIPI DI CALCOLO FARMACEUTICO A cura di Gaia Colombo, Alessandra Rossi, Paola Russo, Fabio Sonvico Casa Editrice EDRA
It i salso advised the reading of:
Farmacopea Ufficiale XII Ed.
US Pharmacopoeia
-Medicamenta, Cooperativa Farmaceutica Milano, VII ED. 1992
Teaching methods
The course will be carried out through frontal lessons (2CFU) during which the fundamentals, the theoretical and practical aspects of the compounding, included principles of pharmaceutical calculations, will be presented, and discussed.
Frontal lessons are preparatory to laboratory practice (3 CFU) in which the student will learn how to prepare the different dosage forms with focus on the chemical-physical aspects of the processes and the regulatory aspects. The practical exercises will be carried out individually by the student. To support frontal lessons, the slides used during lessons, as well as additional audio-video material, will be uploaded to the Elly platform.
Assessment methods and criteria
To acquire the final grade of the exam, the student must show to be have learned and to be able to use the basic concepts of each subject. In particular he/she should:
a) pass a practical exam at the end of practical works (Module of Laboratorio di Tecnologia Farmaceutica, weight 40% of the overall grade);
b) pass an exam (either oral and written), during the official dates established by the Dipartimento di Farmacia (both modules, weight 60% of the overall grade).
The grade, expressed in thirtieths, will be based on the following criteria:
1. knowledge and comprehension (theoretical and practical) capability of the subjects studied;
2. making judgements ability
3. communication skills and appropriate use of the technical language;
4. ability to learn.
Other information
To attend the laboratory, it is mandatory the certificate of attendance for Module 3 (formazione specifica rischio medio - specific medium risk training) of the online course "Sicurezza nei luoghi di lavoro - Safety in the workplace".
