B016587 - SOCIO-ECONOMIC LEGISLATION AND PHARMACEUTICAL TECHNOLOGY

Italian

Main solid, liquid and semisolid pharmaceutical dosage forms. Pharmaceutical materials and operations necessary for production, control and packaging. Basic principles of pharmaceutical socio-economy. Legislative rules in performing pharmaceutical service. The course consists of theoretic and practical lessons.

Principi di tecnologie farmaceutiche, Colombo P.,Catellani P.L., Gazzaniga A., Menegatti E., Vidale E., C.E.A. , Milano 2015Aulton. Tecnologie farmaceutiche. Progettazione e allestimento dei medicinali. Michael E. Aulton, Kevin M. Taylor Edra 4ed.Principi di Tecnica Farmaceutica, Amorosa M., Lib Universitaria Tinarelli, Bologna last ed. Principi di Tecnica Farmaceutica, Ragazzi E., Libreria Cortina, Padova last ed. Principi di calcolo farmaceutico H. Ansel, S. Stockton, EDRA 15th ed, Milano 2017La gestione normativa dei medicinali , Vincieri F.F., Cirenei C., Cervini D., IV edizione Il Pensiero Scientifico Editore, Roma 2006. Manuale delle preparazioni galeniche, Bettiol F., II Ed. Tecniche nuove, MilanoLegislazione farmaceutica, Minghetti P., Marchetti M., C.E.A. ,Milano last ed.La Farmacia: un campo minato. Il manuale del farmacista Loliscio Nicoletta Esculaprio last ed.

The course provides a general knowledge of all the major pharmaceutical forms and the operations necessary for their formulation, production, control, packaging and storage. The course introduces the basic principles of socio-economic analysis techniques in the pharmaceutical field and the legislative norms that compose the basic skills for the pharmaceutical service from drug production to distribution. The course consists of two parts: one of theoretical lessons in which to acquire the necessary skills and one in laboratory of individual practical exercises, in which to acquire the skills and autonomy necessary for the preparation of pharmaceutical forms and their labeling.

As by study plan

Theoretical frontal lessons and solving problems exercises related to pharmaceutical operations or formulations. Individual practical exercitation in laboratory, consisting in the practical shipment of recipes about the various types of pharmaceutical forms (preparation, packaging, labeling, charging) Students are required to submit a written report at the end of each laboratory exercise.

All teaching material is in the e-Learning platform (http://e-l.unifi.it/). The password is given at the first lesson of the course. This material, supplemented by the notes taken directly during the lessons, is quite sufficient for the preparation of the exam. However, some texts are recommended to deep specific topics.

There are 5 official calls, 2 in the winter session (January-February), and 3 in the summer session, June-September. In addition, there are 2 calls, one in November and one in April, during periods of didactic silence. In case of failure, students can apply for the next first useful call. Passing the exams of the first year is a mandatory requirement to take the examination of Technology, Socioeconomics and Pharmaceutical Legislation. The final exam is oral about 20-40 minutes, during which the student is asked to describe and apply the topics and concepts covered in class.
Examinations are scheduled during laboratory practices that consist of a written report at the end of each exercise. The average of the votes obtained corresponds to the lab vote that averages with the final vote. At the end of the course is possible to take a written test open to attending students and not, consisting of an exercise and a recipe (5 + 5 points); Socio-Economy and Legislation 7 closed questions (3 points each). The test score is valid for 1 year and allow that the above-mentioned topics are not part of the oral exams. The final exam consists of an oral exam aimed at acquiring the knowledge of the all the topics.
The understanding of the technological processes that underlie the drug formulation is verified, for example, through the choice of a formulation methodology for the preparation of a pharmaceutical form and the assessment of the controls required to guarantee security and stability. The ability to solve formulation problems is verified through the application of formulas studied during the course. In any case, the ability to identify the biopharmaceutical implications and consequences of the described properties and procedures is verified.

General operations in pharmaceutical technology (separation of solids, extraction, pulverization, evaporation, drying, lyophilization, sterilization). Surface tension, surfactants and HLB. Rheology elements. Solutions. Isotonic. Dispersed systems, colloids. Pharmaceutical Forms: Liquid Pharmaceutical Forms, Syrups, Extracts and Distillates Injection. Preparations for ophthalmic, nasal and pulmonary administration. Pressurized pharmaceutical forms. Suspensions and emulsions. Semisolid pharmaceutical forms. The suppositories. Solid pharmaceutical forms: capsules, tablets, coated tablets. Microencapsulation. Excipients and additives in the preparation of pharmaceutical forms. The containers of pharmaceutical forms. Medical materials. Socio-economics: Social and economic evaluations in the design, development and production of pharmaceuticals and pharmaceutical forms. Socio-economic analysis techniques in the pharmaceutical field. Orphan drugs. Pharmaceutical legislation: Italian health organization; Pharmacists' Order and Exercise of Pharmacist Profession. Pharmacy Classification; Registers and mandatory or useful materials in Pharmacy. Requirements for production, presentation and sale of drug medicines. Medical and Veterinary Recipes: requirements and obligations. Provision of medicines under SSN. Special regulations: herbal products, dietary products, food supplements, homeopaths, medical devices and doping. Narcotics: prescribing, supplying, managing and shipping recipes; Poison Management; Pharmacy supervision. Practical tutorials The recipe: compilation and shipping rules. Incompatibilities and interactions. Exercises and individual practical exercises: preparation of pharmaceutical forms, controls, and labeling.