Pharmaceutical Technology and Legislation Ii and Lab of Pharmaceutical Technology Ii Medical Devices and Cosmetic Prod

The objective of this course is to provide basic principles of the design, production and testing of the main dosage forms, either for immediate or modified release, with special reference to injectable and topical ones. The course aims to help students gain knowledge and comprehension of the relationships linking technological, biopharmaceutical and pharmacokinetic properties of drug formulations. Regulatory aspects relevant to production and marketing of drug and health products, including cosmetics and medical devices, are addressed. Fundamentals of pharmaceutical legislation and of pharmacist practice ethics are also covered. Single-bench laboratory practicals are aimed at strengthening the knowledge acquired through preparation and control of magistral and officinal formulae intended for the concerned routes of administration and drafting of the relevant documentation in compliance with current laws.

Through this course, the student gains fundamental skills in the design, preparation/production and control of the main dosage forms, either for immediate or modified release, with special reference to injectable and topical ones. Thanks to the knowledge acquired, he will be able to correlate formulation characteristics of the covered drug preparations/products with their biopharmaceutical and pharmacokinetic properties, and to critically evaluate how to modulate the latter through purposely implemented technological activities. In addition, he will manage to understand and apply regulations relevant to the production and marketing of medicinal and health products for professional practice purposes, particularly within a pharmacy.