Learning outcomes of the course unit
The goal of the course is to provide the fundamental knowledge and the tools to understand the basic the dosage forms, with particular emphasis on the role of the different components. The student will learn the nature and the classification of the excipients in order to be able to understand and make an independent judgement about the role of the different their role in the different dosage forms and administration ways. At the end of the course the student should be able to understand and describe the various approaches for optimizing the therapeutic efficacy of an active ingredient.
In order to take the final exam Pharmaceutics/Galenic Preparations Laboratory the student have to be already passed both the exams of Organic Chemistry and General Physiology.
Course contents summary
The course deals with the modern approach at the preparation of medicines, at the comprehension of the characteristics of the different dosage forms and of the peculiarity of some administration routes
• Drugs, dosage forms and medicines.
• Pharmacopoeia and Formulary
• Administration way and pharmacokinetics.
•Biopharmaceutical Classification System
• Unit Operation: Crystallisation, Distillation; Drying; Lyophilisation Sterilization; granulation.
• Pharmaceutical excipients.
• Dosage forms: powders; granules; capsules, tablets, suppositories drops, syrups: suspensions; emulsions; ointments; eyewash; injectables; aerosols; herbal remedies.
P. Colombo, F. Alhaique, C. Caramella, B. Conti, A. Gazzaniga, E. Vidale. Principi di Tecnologie Farmaceutiche, Seconda Edizione, 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 (2017)
M. Amorosa, Principi di Tecnica Farmaceutica, Libreria Universitaria L. Tinarelli, Bologna (1998).
Farmacopea Ufficiale della Repubblica Italiana, XII Edizione, Istituto Poligrafico e Zecca dello Stato, Roma (2008).
Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins (2011).
Aulton's Pharmaceutics. The design and manufacturing of medicines, 4th Edition, Churchill Livingstone (2013).
The course will be carried out through frontal lessons during which the biopharmaceutical and pharmacokinetic aspects of the drug administration will be presented and discussed.
The most critical unit operations will be presented as well as the detailed description of the various classes of excipients and their role in the formulation.
Finally, to pursue the course goals the various dosage forms will be presented and discussed in agreement with the Pharmacopoeia classification.
Assessment methods and criteria
Oral exam with questions aiming at ascertain the knowledge, the comprehension capability and the competences acquired by the student. The student will be asked to make a judgement related to the role of various excipients inside commercial medicinal products (making judgements) and to explain his conclusions and the knowledge underline them in a clear and concise manner (communication skills). The results will be evaluated as a fraction of 30.
The exam evaluation will be obtained by the average of the notes obtained in the two modules.