CODE 67615 ACADEMIC YEAR 2020/2021 CREDITS 10 cfu anno 5 CHIMICA E TECNOLOGIA FARMACEUTICHE 8451 (LM-13) - GENOVA SCIENTIFIC DISCIPLINARY SECTOR CHIM/09 LANGUAGE Italian TEACHING LOCATION GENOVA SEMESTER 1° Semester PREREQUISITES Propedeuticità in ingresso Per sostenere l'esame di questo insegnamento è necessario aver sostenuto i seguenti esami: Pharmaceutical chemistry and technology 8451 (coorte 2016/2017) GENERAL AND INORGANIC CHEMISTRY (PCT)(MD) 55401 2016 MATHEMATICS (PCT)(MD) 55402 2016 PHYSICS (PCT)(MD) 55404 2016 PHYSICAL CHEMISTRY (MD) 60821 2016 ORGANIC CHEMISTRY I (PCT)(MD) 60822 2016 ORGANIC CHEMISTRY II (PCT)(MD) 60828 2016 PHARMACEUTICAL TECHNOLOGY AND LAW I (PCT MD) 67569 2016 MEDICINAL AND TOXICOLOGICAL CHEMISTRY I 80446 2016 TEACHING MATERIALS AULAWEB OVERVIEW The course of Pharmaceutical Technology and Legislation II is a professional teaching oriented to the formation of the CTF that intends to carry out its activity in the industrial field both in the functions of production worker and control of the preparation of active ingredients and medicines as well as those employed to preclinical and clinical research in GMP system. AIMS AND CONTENT LEARNING OUTCOMES The learning outcomes is the study of the organization of pharmaceutical industry, through the in-depth understanding of the processes and equipment used in the industrial manufacturing of active ingredients and medicinal products. The regulatory aspects of the production and vigilance of the drugs and of other products having medical or healthy significance are also presented and discussed. Furthermore, a large number of individual practice exercises for the preparation of main dosage forms involving the use of laboratory instrumentation are provided. TEACHING METHODS The course takes place in 120 hours of frontal teaching activities and individual laboratory exercises. These tutorials are guided and assisted by the teacher. In the classroom during the lectures the teacher carries out the whole teaching program. On Aulaweb, the lecturer notes of the course are provided on request to the students attending, divided into the different chapters of the program and updated annually by the teacher, where all the topics dealt with in the classroom are widely reported. SYLLABUS/CONTENT Pharmaceutical Technology The pharmaceutical industry Organization: local, working environment and centralized technical services Equipment and plants of pharmaceutical industry Process and production water Drying Grinding of solids, sieving and mixing of the powders Hard capsule filling process and equipment Compaction, Mixing and Granulation Tablet compression machines Coating process and equipment Semisolid production and filling equipment Suppository process and equipment Dosage liquid form production and filling equipment Sterilization and sterile dosage form production Pressurized dosage form production Biotechnological equipment and processes Packaging Pharmaceutical Law Sources of law. Organization of national health service (SSN) and basics of Pharmacoeconomy. Supranational bodies and organizations for the protection of health. Juridical definition of medicinal product Regulatory and administrative classification of medicines AIFA and EMA and their functions within the European Medicines Control System EU rules for authorizing the production and marketing of the Api and medicinal products for human use Patents Clinical trials Orphan Medicinal and compassionate use Generic name medicinal products. EU Regulation of homeopathic medicines. Presentation of medicines: label and leaflet. Pharmacovigilance. The medical-scientific information and advertising in the pharmaceutical field. Discipline of veterinary medicines. Medical devices. In vitro diagnostic medical devices. Biocides, ECA and Plant protection products. Regulatory issues concerning: special foods, mineral water, herbal products from non-medicinal plants, sweeteners, alcohol, cosmetics. Standards concerning environmental protection: classification, storage and disposal of waste with particular reference to the pharmaceutical and health aspects. Laboratory of Galenic dosage form preparation and industrial microscale production: the course includes a series of individual laboratory session for the preparation of classical dosage forms and for use of lab equipment for the pharmaceutical R&D. RECOMMENDED READING/BIBLIOGRAPHY Remington: The Science and Practice of Pharmacy. Edited by Allen, Loyd V., Jr Pharmaceutical Press; 22th edition (Septmber 2012). The Theory and Practice of Industrial Pharmacy, III Ed. - Lachman L. e coll.- Lea & Febiger, Philadelphia 1986. Suggested consultation textbooks are: Aulton Tecnologie farmaceutiche [Aulton's pharmaceutics] Aulton, Michael E. ; Taylor, Kevin M. G. ; Milano : Edra, 2015. La Fabbricazione Industriale Dei Medicinali- L. Fabris, A. Rigamonti- Società Editrice Esculapio-2008. Legislazione Farmaceutica - P.Minghetti – nona edizione CEA, Milano 2018. TEACHERS AND EXAM BOARD GABRIELE CAVIGLIOLI Ricevimento: Students can meet with Prof. Caviglioli at Di.FAR. - Department of Pharmacy (Viale Cembrano, 4) on Fridays, except for public holidays and when exams, lessons, laboratory sessions or meetings are scheduled. It is recommended to arrange an appointment by phone (0103532635). Exam Board GABRIELE CAVIGLIOLI (President) SARA BALDASSARI GIANCARLO GROSSI ELEONORA RUSSO GUENDALINA ZUCCARI LESSONS Class schedule The timetable for this course is available here: Portale EasyAcademy EXAMS Exam schedule Data appello Orario Luogo Degree type Note 01/04/2021 15:00 GENOVA Scritto + Orale 21/06/2021 15:00 GENOVA Scritto + Orale 01/07/2021 15:00 GENOVA Scritto + Orale 21/07/2021 15:00 GENOVA Scritto + Orale 09/09/2021 15:00 GENOVA Scritto + Orale 26/01/2022 15:00 GENOVA Scritto + Orale 11/02/2022 15:00 GENOVA Scritto + Orale