Pharmaceutical Technology and Legislation II

A.Y. 2021/2022
Overall hours
Learning objectives
The course aims to introduce the principles underlying the design, preparation and control of the main conventional and modified release pharmaceutical dosage forms. In particular, the course enables the students to acquire the necessary knowledge to understand the relationships between technological, biopharmaceutical and pharmacokinetic properties of medicinal products intended for a parenteral or cutaneous administration. Moreover, regulatory aspects relevant to production and marketing of drug and health products, including cosmetics, medical devices, biocides and food supplements are addressed. Finally, fundamentals of pharmacist practice ethics are also covered.
Expected learning outcomes
The student gains fundamental skills in the design, production and control of the main dosage forms intended for parenteral or cutaneous administration. Thanks to the knowledge acquired, she/he will be able to correlate the formulation characteristics with their biopharmaceutical and pharmacokinetic properties. In addition, she/he will manage to understand regulations relevant to the production and marketing of medicinal and health products as well as to pharmacist practice ethics.
Course syllabus and organization

Linea Unica

Lesson period
Second semester
Lesson will be delivered according to the Athen indications. Remote lessons will be delivered synchronously through the MS Teams platform according to the scheduled time.
Course syllabus
1] L.A.D.M.E of non-enteral dosage forms.
2] Disperse systems. Interfacial phenomena, colloids, emulsion and suspensions.
3] Parenteral dosage forms.
4] Eye drops.
5] Semisolid dosage forms.
6] Definition of the validity period.
7] Drug delivery systems intended for transdermal and parenteral routes.
8] Regulation of medicinal, medical devices, in vitro diagnostic, biocides, cosmetics and food supplements.
9] The ethic and the role of the Pharmacy Board.
Prerequisites for admission
Due to the multi-disciplinarily of the course, the students are required to be familiar with the basic concepts of :
1. Statistics: arithmetic mean, geometric mean, standard deviation, limit of confidence, Student T test;
2. General chemistry: stoichiometry, pH and pKa; van der Waals forces, hydrogen bonds, etc.;
3. Physics: Stokes' law, Poiseuille's law;
4. General pharmacology: basic aspects of pharmacokinetics;
5. Physical chemistry: basic concepts of thermodynamics;
6. Organic chemistry;
7. Drug analysis: basic knowledge of chromatographic methods for the quantification of an active pharmaceutical ingredient and methods for its identification.
Teaching methods
Lectures. The learning progress will be evaluated using Kahoot! software
Teaching Resources
1. Principi di tecnologie farmaceutiche. P Colombo, F Alhaique, C Caramella, B Conti, A Gazzaniga, E Vidale. C.E.A. Casa Editrice Ambrosiana Ed. 2015.
2. Aulton's Pharmaceutics, The Design and Manufacture of Medicines, 5th Edition, edited by . ME Aulton, KMG Taylor. Elsevier.
3. Legislazione Farmaceutica. P Minghetti, M Marchetti, C.E.A. Casa Editrice Ambrosiana.
Handouts of slides and other supplementary materials will be available on the ARIEL website.
Assessment methods and Criteria
The course exam consists of an written and oral test. The former is based on quiz and open-ended questions. The passing of the written test is subject to the achievement of a grade of at least 18/33.
The oral exam is articulated in at least one questions regarding pharmaceutical technology and one on regulatory aspects. The candidate has to achieve a grade of 18/30 in each answer.
Lessons: 72 hours
Professor: Cilurzo Francesco
by appointment
Via G. Colombo 71