Pharmaceutical Technology and Legislation of Biotechnological Medicinal Products

A.Y. 2018/2019
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.
Course syllabus and organization

Unique edition

Responsible
Lesson period
Second semester
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 the raw materials: flowability, apparent volume and density, size and size distribution.
Preparation and quality control, according to Good Compounding Practices of:
- oral dosage forms: powders, capsules, tablets;
- semisolid dosage forms: ointments, creams, gels and pastes;
- liquid dosage forms: solutions and suspensions.
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 6
Single bench laboratory practical: 16 hours
Lessons: 40 hours
Professor: Selmin Francesca
Shifts:
Professor: Selmin Francesca
Turno 1
Professor: Selmin Francesca
Turno 2
Professor: Selmin Francesca