B016587 - SOCIO-ECONOMIC LEGISLATION AND PHARMACEUTICAL TECHNOLOGY

Italian

Italian

Italian

Practical single-place exercises on pharmaceutical preparations.

Practical single-place exercises on pharmaceutical preparations.

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 lessons and practical exercises about pharmaceuticals calculations.

La 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 ultima edLa Farmacia: un campo minato. Il manuale del farmacista Loliscio Nicoletta Esculaprio ultima ed

La 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 ultima edLa Farmacia: un campo minato. Il manuale del farmacista Loliscio Nicoletta Esculaprio ultima ed

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 ultima ed. Principi di Tecnica Farmaceutica, Ragazzi E., Libreria Cortina, Padova ultima ed. Principi di calcolo farmaceutico H. Ansel, S. Stockton, EDRA 15 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 ultima edLa Farmacia: un campo minato. Il manuale del farmacista Loliscio Nicoletta Esculaprio ultima ed.

Knowledge and understanding of the technological processes underlying the formulation and stabilization of drugs in form and dose of drug.
Knowledge and understanding of the formulas studied during the course in the preparation of formulations
Ability to solve formulation and stabilization problems of pharmaceutical forms.
Ability to identify the biopharmaceutical implications and consequences of the properties and procedures described.

Knowledge and understanding of the technological processes underlying the formulation and stabilization of drugs in form and dose of drug.
Knowledge and understanding of the formulas studied during the course in the preparation of formulations
Ability to solve formulation and stabilization problems of pharmaceutical forms.
Ability to identify the biopharmaceutical implications and consequences of the properties and procedures described.

Knowledge and understanding of the fundamental legislative norms that regulate the disengagement of the pharmaceutical service from production to dispensing of the drug
Knowledge and understanding of the basic principles of socio-economic analysis techniques in the pharmaceutical field
Knowledge and understanding of all the main pharmaceutical forms and the operations necessary for their formulation, production, control, packaging and storage.
Ability to apply knowledge and understanding of the legislative regulations of the pharmaceutical service, for example, through the choice of the delivery method of a recipe.
Ability to apply knowledge and understanding of socio-economic analysis in the pharmaceutical field, for example, evaluating the choice of a therapy from a socio-economic point of view.
Ability to apply knowledge and understanding of the technological processes underlying the formulation of drugs in form and dose of drug, for example, through the provision of the choice of a formulation methodology for the preparation of a pharmaceutical form and the evaluation of the required controls to ensure safety and stability.
Ability to apply knowledge and understanding by solving formulation problems through the application of formulas studied during the course to the preparation and control of formulation processes and formulations.
Ability to apply knowledge and understanding in identifying the biopharmaceutical implications and consequences of the properties and procedures described.

Knowledge of General Chemistry, Mathematics, Physics, Human Anatomy and Physics.

Knowledge of General Chemistry, Mathematics, Physics, Human Anatomy and Physics.

Knowledge of General Chemistry, Mathematics, Physics, Human Anatomy and Physics.

Individual practical exercises, in which to acquire the skills and autonomy necessary for the preparation of pharmaceutical forms and their labeling.
Practical shipment of recipes about the various types of pharmaceutical forms: solid, semisolid and liquid (formulation, packaging, labeling, charging) Students are required to submit a written report at the end of each laboratory exercise

Individual practical exercises, in which to acquire the skills and autonomy necessary for the preparation of pharmaceutical forms and their labeling.
Practical shipment of recipes about the various types of pharmaceutical forms: solid, semisolid and liquid (formulation, packaging, labeling, charging) Students are required to submit a written report at the end of each laboratory exercise

Frontal theoretical lessons
Theoretical exercises in the classroom and practical exercises in a single place in the laboratory.
Teaching materials:
Pdf files of the lessons
Lecture notes
Tools to support teaching:
Projector, PC
At the beginning of the course, students are provided with files with the slides of the topics that will be gradually covered by the e-Learning platform (http://e-l.unifi.it/), the password is given at the first lesson of the course. This material, supplemented by notes taken directly during the lessons, is completely sufficient for the preparation of the exam. Some texts are also recommended that students can consult if they wish to deepen specific topics

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.

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.

Student reception every day, by appointment.

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. At the end of the course is possible to take a written test 2 open question (15 point each) regarding the exercises and laboratory practices. Each test is passed if a grade greater than or equal to 18 is reported. 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.

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. At the end of the course is possible to take a written test 2 open question (15 point each) regarding the exercises and laboratory practices. Each test is passed if a grade greater than or equal to 18 is reported. 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 exam consists in passing an oral test which concerns the entire programme. The oral exam can be taken during any exam session, listed on the University Exam Booking Service web page. There are 5 official exam sessions, 2 in the January-February winter session, and 3 in the June-September summer session. In addition, 2 exam sessions are planned, one in November and one in April, during the teaching silence periods. In the event of failure to pass, students can enroll in the next first useful session. Passing the first-year exams is a mandatory requirement in order to take the exam in Pharmaceutical Technology, Socioeconomics and Legislation. The final exam is an oral exam lasting an average of 20-40 minutes, during which the student is asked to describe and apply the topics and concepts covered in class. Accuracy (40%), completeness (40%), language properties (20%) in the answers contribute to the determination of the final mark. The test is considered passed if a grade greater than or equal to 18 is obtained.
2) During the course there are two optional written exams, open to both attending and non-attending students. The first concerns topics of Socioeconomics and Legislation 10 closed questions (3 points each) and is proposed with the "Quiz" mode of Moodle. 100% accuracy in the answers contributes to the determination of the final grade, being a single-answer test. The second test is proposed at the end of the course and concerns the pharmaceutical calculation exercises carried out during the course and the sending of the prescription through two open questions (15 points each) in Moodle "Task" mode. Accuracy (40%), completeness (40%), use of correct terminology (20%) in the answers contribute to the determination of the final grade. Passing the written tests (mark greater than or equal to 18/30) is valid for one year and makes a non-arithmetic average with the final mark.
3) For those who pass the two written tests, an oral test is scheduled on the topics of the program not included in the written tests: i.e. the theoretical part indicated on the Moodle course as: general, special and pharmaceutical forms. The final grade is the weighted average of the three grades (20% Legislation Quiz, 20% Laboratory assignment 60% Oral). Accuracy (40%), completeness (40%), use of correct terminology (20%) in the answers contribute to the determination of the final grade. The exam is considered passed with a vote greater than or equal to 18/30.

Rules of conduct in the laboratory. Guide to the use of PPE and waste disposal. Preparation, labeling and control of solid pharmaceutical forms: mixtures of powders, capsules, papers and tablets; liquids: solutions, elixirs, tinctures, syrups, suspensions and emulsions; semi-solid: ointments and suppositories. I LABORATORY: LIQUORICE and VITAMIN C powders, CAPSULES of acetylsalicylic or liquorice with various excipients II LABORATORY: PIPERAZINE SYRUP, ELIXIR, HYDROALCOHOLIC ORANGE, LUGOL SOLUTION, CAMPHOR OIL. III LABORATORY: SULPHATIAZOL SUSPENSION, CASTOR OIL AND VASELINE OIL EMULSION IV LABORATORY METHYL SALICYLATE OINTMENT SULPHO-ALKALINE OINTMENT HELMERICH POMATE BENZOCAINE POMATE PEG OINTMENT LASSAR PASTE ZN PASTE ZN WATER PASTE COLD CREAM ANTIRHEUMATIC CREAM HYDROPHILIC CREAM SEPIGEL CREAM GLYCEROLATE STARCH SOFT PASTE OF UNNA HYDROXYETHYL CELLULOSE GEL Salicylic Acid GEL TOOTHPASTE VI LABORATORY ACETYLSYLICYLIC ACID AND HENBANE SUPPOSITORIES PARACETAMOL SUPPOSITORIES LACTIC ACID PESSARIES AMMONIUM SOLPHOITTHYIOLATE PESSARIES.

Rules of conduct in the laboratory. Guide to the use of PPE and waste disposal. Preparation, labeling and control of solid pharmaceutical forms: mixtures of powders, capsules, papers and tablets; liquids: solutions, elixirs, tinctures, syrups, suspensions and emulsions; semi-solid: ointments and suppositories. I LABORATORY: LIQUORICE and VITAMIN C powders, CAPSULES of acetylsalicylic or liquorice with various excipients II LABORATORY: PIPERAZINE SYRUP, ELIXIR, HYDROALCOHOLIC ORANGE, LUGOL SOLUTION, CAMPHOR OIL. III LABORATORY: SULPHATIAZOL SUSPENSION, CASTOR OIL AND VASELINE OIL EMULSION IV LABORATORY METHYL SALICYLATE OINTMENT SULPHO-ALKALINE OINTMENT HELMERICH POMATE BENZOCAINE POMATE PEG OINTMENT LASSAR PASTE ZN PASTE ZN WATER PASTE COLD CREAM ANTIRHEUMATIC CREAM HYDROPHILIC CREAM SEPIGEL CREAM GLYCEROLATE STARCH SOFT PASTE OF UNNA HYDROXYETHYL CELLULOSE GEL Salicylic Acid GEL TOOTHPASTE VI LABORATORY ACETYLSYLICYLIC ACID AND HENBANE SUPPOSITORIES PARACETAMOL SUPPOSITORIES LACTIC ACID PESSARIES AMMONIUM SOLPHOITTHYIOLATE PESSARIES.

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. Demonstration of management software in the computer room. Incompatibilities and interactions. Exercises and individual practical exercises: preparation of pharmaceutical forms, controls, and labeling. Review exercises on percentages and units of measurement. Exercises on weight and volume measurements. Error calculation and dilution. Density and specific weight exercises. Exercises on powders: apparent volume, porosity and particle size. Stokes equation. Exercises on solutions, alcoholic strength, viscosity, isotonia and extractable volume. Exercises on emulsions and suspensions: HLB, creaming and sedimentation. Exercise on the preparation and characterization of tablets - semi-manual tablet press, hardness test, friability test, disintegration test and dissolution test according to FUI.

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