Regulatory aspects of medicinal products in EU. Biopharmaceutic, bioavailability and bioequivalence aspects. Formulations for inhalation
Medicated foams Drug delivery systems with modified release and site specific drug delivery systems Implants Transdermal drug delivery systems
Micro and nanocarriers Formulation of biotech and radiopharmaceutical drugs. Stability of drugs, stabilization and preservation Medical devices Orphan drugs Pharmacovigilance, socio-economy and governance systems
Colombo et al.“Principi di tecnologie farmaceutiche”Ambrosiana Ed.
Aulton M.E. “Pharmaceutics”Churchill Livingstone Ed.
FlorenceA.T. Attwood D. “Physicochemical Principles of Pharmacy”Macmillan Press Ed.
Amorosa M. “Principi di Tecnica Farmaceutica”
Farmacopea Ufficiale Italiana XI ed
European Pharmacopoeia 7° ed.
Vincieri, Cirinei e Cervini “La gestione normativa dei medicinali” Il pensiero Scientifico Ed.
Learning Objectives
The aim is to introduce the students to the understanding of socio-economy and governance systems and to have a deeper knowledge of the basic tools of pharmaceutical technology with special attention to the innovative formulations already on the market or under clinical studies.
Prerequisites
Pharmaceutical technology and legislation
Teaching Methods
Lesson using ppt presentation
Type of Assessment
Oral examination
Course program
Regulatory aspects of medicinal products in EU. Biopharmaceutic, bioavailability and bioequivalence aspects.
Formulations for inhalation
Medicated foams
Drug delivery systems with modified release and site specific drug delivery systems
Implants
Transdermal drug delivery systems
Micro and nanocarriers
Formulation of biotech and radiopharmaceutical drugs.
Stability of drugs, stabilization and preservation
Medical devices
Orphan drugs
Pharmacovigilance, socio-economy and governance systems