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: to know the excipients, the production and control methods, the technological properties of the immediate release dosage forms.
2) Applying knowledge and understanding: to independently apply the acquired knowledge to make a dosage form.
3) Communication skills: to use the specific language for this specialistic discipline.
4) Making judgements: to know and to deal with the professional responsibilities of galenical pharmacist.
5) Learning skills: to use the knowledge and basic elements for practicing the profession of pharmaceutical technologist.
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
• Basic technological processes (e.g. mixing, granulation)
• Principles of pharmaceutical calculations
• Metrology
• Preparation and characterization, according to Italian Pharmacopeia, 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
• Legal issues concerning the preparation, packaging and pricing of galenical preparation according to the Italian Pharmacopeia
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 Pharmaceutical Calculation, Wolters Kluver.
It is also advised the reading of:
• Farmacopea Ufficiale XII Ed. (Italian Pharmacopea);
• European Pharmacopoeia;
• US Pharmacopoeia;
• Medicamenta, Cooperativa Farmaceutica Milano, VII ED. 1992.
Insights:
• International Journal of Pharmaceutical compounding
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 demonstrate to have understood, and to be able to apply, the fundamental concepts of each topic. In particular, the student must, in sequential order:
i) take a practical test, which consists of compounding a galenic dosage form and filling in the related processing sheet (Laboratory of Pharmaceutical Technology);
ii) take a written exam, which focuses on verifying the knowledge of pharmaceutical calculations (iia, Laboratory of Pharmaceutical Technology) and on the recognition of the a dosage form starting from the excipients (iib, Pharmaceutical Technology) and iii) oral exam (Pharmaceutical Technology), in the sessions of the official exam calendar of the Department of Food and Drug(registration through the ESSE3 platform).
The final grade, expressed out of thirty, is calculated as follows: average between i and iia (weight 40% of the overall grade) + average between iib and iii (weight 60% of the overall grade). The evaluation will be carried out on the basis of the following criteria:
1. knowledge and comprehension (theoretical and practical) capability of the topics 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".
