CODE 67522 ACADEMIC YEAR 2016/2017 CREDITS 10 cfu anno 5 FARMACIA 8452 (LM-13) - SCIENTIFIC DISCIPLINARY SECTOR CHIM/09 LANGUAGE Italiano TEACHING LOCATION SEMESTER 1° Semester PREREQUISITES Propedeuticità in ingresso Per sostenere l'esame di questo insegnamento è necessario aver sostenuto i seguenti esami: Pharmacy 8452 (coorte 2012/2013) PHARMACEUTICAL TECHNOLOGY SOCIOECONOMY AND LAW I (WITH PRACTICE) 67449 2012 TEACHING MATERIALS AULAWEB OVERVIEW The class intends to complete the overview on pharmaceutical technology, by introducing aersols as pharmaceutical forms, and with sections relevant to all the formulations developed at industrial level (i.e. stability studies, packaging). Also the legislation applied to the industrial medicinal products is addressed, in comparison to the laws disciplining other products of interest for the pharmacy profession. A brief outline of pharmacoeconomy completes the course. AIMS AND CONTENT LEARNING OUTCOMES Objectives of this discipline are: to provide notions of biopharmaceutics, drug formulation and stability; to deal with pharmaceutical formulations for controlled or modified release; to impart good knowledge of the legislation disciplining production, control and monitoring of drugs; to compare regulation of pharmaceuticals with the one of other product groups in the healthcare or medical fields; to describe the Italian National Health Service and convey the basics of socioeconomics. LEARNING OUTCOMES (FURTHER INFO) Objectives of this discipline are: to provide notions of biopharmaceutics, with specific reference to the parameters involved in determination of absolute and relative bioavailability and in bioequivalence studies; drug formulation (characterization of formulation rheology; specific focus on inhalation dosage forms, in particular pressurized formulations) and drug storage (active principle degradation kinetics; analysis of the main causes, both chemical and physical, of dosage form instability, with detailed study of the basics of hygrometry; dosage form stabilization, and role of pharmaceutical packaging); to deal with pharmaceutical formulations for modified or non-conventional release (sustained, controlled and targeted release) ; to impart good knowledge of the legislation disciplining production, control and monitoring of drugs, both for human and veterinary use; to compare regulation of pharmaceuticals with the one of other product groups in the healthcare or medical fields (medical devices, in-vitro diagnostics, medical supplies, cosmetics, food for special medical purposes, herbal supplements); to describe the Italian National Health Service (structure and functions); to convey the basics of socioeconomics (notions on the main pharmacoeconomic analysis methods). TEACHING METHODS The class is organized in 80 hours of frontal lesson, and educational material is made available to the students by Aulaweb. SYLLABUS/CONTENT Pharmaceutical technology - Introduction to rheology and the rheological characteristics of pharmaceuticals - Drug stability and storage: technological and normative aspects - Pharmaceutical packaging: technological and normative aspects - Hygrometry - Pressurized dosage forms - Fundamentals of preformulation and biopharmaceutics - Pharmaceutical formulations and therapeutics for modified release Legislation - Definition of medicinal product - Normative and administrative classification of medicines - Presentation of medicines: Product Information Leaflet and labeling - Organogram of EMA and functions within the European system for control of medicines - EU normative for Manufacturing and Marketing Authorization of active principles and medicines for human use - Generic products - Pharmacovigilance: functions and system implementation in Italy within the EU. Mentions on "WHO International Drug Monitoring Programme". - Medical scientific information and advertising of drugs - Legislation on veterinary products - Legislation on homoeopathic products - Medical devices - In-vitro diagnostics - Biocides and medical supplies - Legislation regarding the commercial activity of pharmacies: dietary products, mineral waters, herbal remedies obtained from non-medicinal plants, sweeteners, alcohols and cosmetics - Legislation on environment protection: waste classification, deposit and disposal with specific reference to the pharmaceutical and sanitary aspects - Professional ethics Socioeconomics - Health assurances - The National Health Service with specific reference to the pharmaceutical system: structure and functions. - Composition of public health expenditure: fiscal costs and public role of health expenses - Pharmaceutical market characteristics in comparison with the competitive one. - Drug price: general aspects of cost analysis - The pharma industry and investment strategies: orphan drugs - Review of the main methodologies for pharmacoeconomic analysis RECOMMENDED READING/BIBLIOGRAPHY The Theory and Practice of Industrial Pharmacy, III Ed., Lachman L. et coll., Lea & Febiger ed., 1993. Physical Pharmacy, IV Ed., Martin A. et coll., Lea & Febiger ed., 1993. Remington: the Science and Practice of Pharmacy, XXII Ed., Allen Loyd V. ed., 2000. Tecnologie farmaceutiche, I Ed., Aulton M. et coll., Edra ed., 2015. TEACHERS AND EXAM BOARD SARA BALDASSARI Ricevimento: Appointments with students and graduands can be arranged by phone call or email. Exam Board SARA BALDASSARI (President) GABRIELE CAVIGLIOLI BRUNELLA PARODI ELEONORA RUSSO GUENDALINA ZUCCARI LESSONS Class schedule The timetable for this course is available here: Portale EasyAcademy EXAMS EXAM DESCRIPTION The assessment is based on a written examination aiming at evaluating the knowledge of the theoretical aspects and the capacity of applying the acquired concepts. The exam consists of 2 problems and 16 multiple choice quizzes relevant to technology and legislation topics. The assigned grades are: 9 for one correct problem; 15 for two correct problems; 1 for each correct answer to the quizzes; -1 for each wrong answer (the first wrong answer will not be considered). The exam is carried out in two hours. After blind correction, the exams are publicly discussed with the students. ASSESSMENT METHODS One mid-term and one final examinations are normally scheduled for those students who have regularly signed in for the first time to the course. Exam schedule Data appello Orario Luogo Degree type Note 21/04/2017 14:00 GENOVA Scritto 13/06/2017 14:00 GENOVA Scritto 04/07/2017 09:00 GENOVA Scritto 18/07/2017 14:00 GENOVA Scritto 15/09/2017 14:00 GENOVA Scritto 23/01/2018 14:00 GENOVA Scritto 05/02/2018 14:00 GENOVA Scritto