Pharmaceutical Technology and Legislation I

A.Y. 2019/2020
9
Max ECTS
72
Overall hours
SSD
CHIM/09
Language
Italian
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 LZ

Course currently not available
Lesson period
First semester
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 9
Lessons: 72 hours

Linea Unica

Responsible
Lesson period
First semester
Course syllabus
1] Biofarmaceutics. Definition of dosage forms; Bioavailability. 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.
4] Semisolid dosage forms.
5] Definition of the validity period.
6] 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
The knowledge of the following topics is required:
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, Poiseville 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 with a non formal learning of fundamental concepts by the help of the 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. Tecnologie Farmaceutiche. ME Aulton, KMG Taylor. IV Edizione Edra Ed. 2015.
3. Legislazione Farmaceutica. P Minghetti, M Marchetti, C.E.A. Casa Editrice Ambrosiana.

Slides and other supplementary materials are available on ARIEL.
Assessment methods and Criteria
The final exam includes a written test followed by an oral test. The written test is based on open-ended questions (4 regarding pharmaceutical technology topics and 1 focused on regulatory aspects). To be admitted to the oral test, the student must answer positively to at least four of the five questions.
The oral exam is made of at least 2 questions regarding pharmaceutical technology and regulatory aspects. The passing of the oral test is subject to the achievement of a vote of at least 18/30 for all the answers.
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 9
Lessons: 72 hours
Professor: Cilurzo Francesco
Professor(s)
Reception:
by appointment
Via G. Colombo 71