Pharmaceutical Technology and Legislation of Biotechnological Medicinal Products

A.Y. 2021/2022
6
Max ECTS
56
Overall hours
SSD
CHIM/09
Language
Italian
Learning objectives
The purpose of the course is to introduce the students to the principles required for the design, preparation and control of dosage forms with a principal interest in the formulation strategies and production processes of biotechnological medicinal products. The national and EU rules governing their production will be dealt with.
Expected learning outcomes
The student will acquire the knowledge enabling to study problems on medicines for human use with particular reference to biotechnological medicinal products. Training in the lab will allow to consolidate theoretical concepts.
Course syllabus and organization

Single session

Responsible
Lesson period
Second semester
More specific information on the delivery modes of training activities for academic year 2021/22 will be provided over the coming months, based on the evolution of the public health situation.
Course syllabus
Contents
General principles of biopharmaceutics and pharmacokinetics: L.A.D.M.E. Bioavailability and bioequivalence. Classification of dosage form.
Physicochemical principles: solution; interfacial phenomena; disperse systems: colloids, emulsions, and suspensions.
Preformulation. Formulation, preparation and quality control of conventional dosage forms: oral, cutaneous, transdermal, parenteral and ophthalmic.
Sterilization methods and application in the manufacturing of parenteral dosage forms. Principle of lyophilization.
The Pharmacopoeia with particular interest for Quality aspects of medicinal products.
Introduction to Italian and UE forms of law. The rules governing the production and the dispensing of the biotechnological medicinal products.

Laboratory course of Pharmaceutical Technology
Technological characterization of podwers: flowability, apparent volume and density, size and size distribution.
Preparation and quality controls on:
- oral dosage forms: powders, capsules, tablets;
- semisolid dosage forms: ointments, creams, gels and pastes;
- liquid dosage forms: solutions and suspensions.
Prerequisites for admission
Fundamentals on general and inorganic chemistry, organic chemistry, physics and physiological.
Teaching methods
Lectures in classes and practical laboratory session
Teaching Resources
- Aulton's Pharmaceutics: The Design and Manufacture of Medicines (lastest edition)
- Lecture handouts will be available on the ARIEL website.
Assessment methods and Criteria
Oral exams: 2 questions on Pharmaceutica Techologies + 1 question on Legislation. The exam will be finalized only if the answers are considered sufficient (18/30).
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 6
Single bench laboratory practical: 16 hours
Lessons: 40 hours
Shifts:
Turno 1
Professor: Selmin Francesca
Turno 2
Professor: Musazzi Umberto Maria
Professor(s)
Reception:
by appointment.
Dept. Pharmaceutica Sciences - via G. Colombo, 71