Francesca SANSONE | TECNOLOGIA SOCIOECONOMIA E LEGISLAZIONE FARMACEUTICA
Francesca SANSONE TECNOLOGIA SOCIOECONOMIA E LEGISLAZIONE FARMACEUTICA
cod. 0760100065
TECNOLOGIA SOCIOECONOMIA E LEGISLAZIONE FARMACEUTICA
0760100065 | |
DIPARTIMENTO DI FARMACIA | |
EQF7 | |
PHARMACY | |
2020/2021 |
OBBLIGATORIO | |
YEAR OF COURSE 5 | |
YEAR OF DIDACTIC SYSTEM 2016 | |
PRIMO SEMESTRE |
SSD | CFU | HOURS | ACTIVITY | |
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CHIM/09 | 10 | 80 | LESSONS |
Objectives | |
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The main aim of this teaching is to provide the knowledge of the basilar approaches used to prepare pharmaceutical formulations and drug delivery systems, taking into account the methods of administration and drug stability and bio-availability problems. Moreover, the pharmaceutical legislation will be discussed. The student applying the acquired skills will have to be able to identify, formulate, prepare, control and dispense different pharmaceutical formulations, also describing the specific role played by each bulking agent |
Prerequisites | |
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KNOWLEDGE FROM THE PREPARATORY COURSES (SUCCESSFUL PASSED). IN PARTICULAR, BASIC MATHEMATICAL KNOWLEDGE IS REQUIRED: ALGEBRA, PROPORTIONS, EQUIVALENCES (UNIT OF MEASUREMENT OF THE INTERNATIONAL SYSTEMS OF UNITS (SI), MASS AND VOLUME), BASIC CONCEPTS OF STATISTICS (MEAN, STANDARD DEVIATION); “GENERAL AND ANALYTICAL CHEMISTRY": CONCEPTS OF ATOM, MOLECULE, ION, ACID, BASE, SALT, ELEMENTARY INORGANIC CHEMICAL REACTIONS, ACID-BASE DISSOCIATION EQUILIBRIA, PH, PKA, PHYSICAL STATES OF MATTER AND STATE TRANSITIONS, DENSITY, SOLUBILITY, CONCEPT OF CONCENTRATION AND RELATED EXPRESSIONS AND UNITS OF MEASUREMENT; "ORGANIC CHEMISTRY" AND "BIOCHEMISTRY": FUNCTIONAL GROUPS, BASIC ORGANIC REACTIONS (I.E. ESTERIFICATION, HYDROGENATION, ETC.), NATURAL AND SYNTHETIC POLYMERS; "GENERAL PHARMACOLOGY": CONCEPT OF DOSE, PLASMA CONCENTRATION CURVE, PHARMACOKINETICS. |
Contents | |
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1. INTRODUCTION DEFINITION OF MEDICINAL PRODUCT, EXCIPIENT AND PHARMACEUTICAL DOSAGE FORM. PHARMACOPOEIAS, GOOD MANUFACTURING PRACTICE. TRADITIONAL PHARMACEUTICAL COMPOUNDING AND INDUSTRIAL PRODUCTS WITH MARKETING AUTHORIZATION (AIC); PRIMARY CONTAINER (OR DEVICE) IN RELATION TO THE ROUTE OF ADMINISTRATION; SECONDARY CONTAINER; PACKAGE INSERT AND LABEL. 2. PHARMACEUTICAL TECHNOLOGY BIOPHARMACEUTICAL BASICS: LADME SYSTEM, BIOAVAILABILITY, BIOEQUIVALENCE, BASICS OF PHARMACOKINETICS. POWDERS: DEFINITION, FUNDAMENTAL AND DERIVED PROPERTIES, AND RELATED MEASUREMENT METHODS PRODUCTION BY MILLING AND MIXING. MEDICINAL POWDERS: ADVANTAGES, ROUTES OF ADMINISTRATION, CONTROLS AND PHARMACOPOEIA TESTS GRANULATES: DEFINITION, GRANULATION METHODS AND EQUIPMENT, EXCIPIENTS, CONTROLS AND PHARMACOPOEIA TESTS. HARD AND SOFT CAPSULES: DEFINITION, DESIGN, CAPACITY, COMPOSITION OF THE PACKAGING, EXCIPIENTS, SOLID AND LIQUID FORMULATIONS, AND INDUSTRIAL FILLING. CONTROLS AND PHARMACOPOEIA TESTS TABLETS: DEFINITION, CLASSIFICATION, PRODUCTION, EXCIPIENTS, CONTROLS AND PHARMACOPOEIA TESTS. OROMUCOSAL SOLID PREPARATIONS, MEDICATED CHEWING GUMS. COATING OF SOLID ORAL FORMS: SUGARING, FILMING MODIFIED DRUG RELEASE: DEFINITION, OBJECTIVES AND TECHNOLOGIES RESERVOIR AND MATRIX SYSTEMS. LIQUID PREPARATIONS: SOLUTIONS, DISPERSED SYSTEMS, COLLOIDAL DISPERSIONS, SURFACE AND INTERFACE PHENOMENA, CLASSIFICATION AND PROPERTIES OF SURFACTANTS AND EMULSIFIERS; SUSPENSIONS: PHYSICAL-CHEMICAL CHARACTERISTICS, PREPARATION, EXCIPIENTS, STABILITY FORMULATIONS FOR SKIN APPLICATION: OINTMENTS, GELS AND EMULSIONS, RHEOLOGY, PHYSICAL-CHEMICAL CHARACTERISTICS, PREPARATION, EXCIPIENTS, STABILITY STERILE PREPARATIONS: GMP, ANNEX I, PARENTERAL AND OPHTHALMIC PREPARATIONS TRANSDERMAL AND OPHTHALMIC DELIVERY SYSTEMS: OBJECTIVES AND ADVANTAGES, RESERVOIR AND MATRIX TRANSDERMAL PATCHES; INSERTS AND OPHTHALMIC IMPLANTS. INNOVATIVE FORMULATIONS: LIPOSOMES, NANO SYSTEMS, BIOLOGICAL DRUGS PRESSURIZED PREPARATIONS: PROPELLANTS AND CONTAINERS WITH THEIR COMPONENTS. FILLING, CONTROLS, USES ADMINISTRATION OF DRUGS IN THE RESPIRATORY SYSTEM: GENERAL CONCEPTS ON AEROSOLIZATION AND DEPOSITION. AERODYNAMIC DIAMETER; NASAL ADMINISTRATION: LIQUID AND SOLID NASAL PREPARATIONS (FORMULATION, DEVICES, CONTROLS); DRUG PRODUCTS FOR INHALATION: DEPOSITION, SAFETY, BIOPHARMACEUTICAL MECHANISMS. LIQUID PREPARATIONS FOR NEBULIZATION (FORMULATION, NEBULIZERS). PRESSURIZED PREPARATIONS FOR INHALATION. POWDERS FOR INHALATION. PHARMACOPOEIA CONTROLS: UNIFORMITY OF DELIVERED DOSE AND FINE DOSE. RECTAL AND VAGINAL PREPARATIONS: CHARACTERISTICS OF THE ROUTES OF ADMINISTRATION AND DRUG PRODUCTS SUPPOSITORIES: BASES (LIPOPHILIC AND HYDROPHILIC), OTHER VAGINAL PREPARATIONS (TABLETS, INSERTS) COMMERCIAL EXAMPLES OF DRUG PRODUCTS WILL BE DISCUSSED FOR THE PHARMACEUTICAL DOSAGE FORMS STUDIED 3. MANAGEMENT OF THE INDUSTRIAL DRUG PRODUCTS IN THE PHARMACY CHEMIST’S DUTIES IN THE DRUG PRODUCT SUPPLY CHAIN, PURCHASE, STORAGE AND DISPOSAL, VERIFICATION OF THE APPROPRIATENESS OF A PRESCRIPTION; PHARMACEUTICAL CALCULATIONS, PATIENT ASSISTANCE TO IMPROVE ADHERENCE TO THE THERAPY (I.E. PREPARATION OF AN EXTEMPORANEOUS SUSPENSION, WITHDRAWAL OF A DOSE OF SYRUP FROM A MULTIDOSE PREPARATION) 4. SOCIOECONOMICS AND PHARMACEUTICAL LEGISLATION: INTERNATIONAL LEGISLATION AND MAIN REFERENCE REGULATIONS. ADMINISTRATIVE CLASSIFICATION OF PHARMACIES, MEDICINAL PRODUCTS FOR HUMAN AND VETERINARY USE, DISPENSING DISCIPLINE TO THE PUBLIC, MEDICAL PRESCRIPTION, NON-PRESCRIPTION MEDICINES, ONLINE SALE, DRUGS AND POISONS, CHEMIST'S OBLIGATIONS IN THE REGISTRATION, STORAGE AND DISPOSAL OF THE MEDICINE (REGISTERS, PRESCRIPTIONS, RECORDS) |
Teaching Methods | |
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LECTURES; EXERCISES WITH THE DIRECT PARTICIPATION OF THE STUDENT; SEMINARS OF CHEMISTS AND SPEAKERS FROM PHARMACEUTICAL INDUSTRIES OR OTHER UNIVERSITIES / RESEARCH INSTITUTES |
Verification of learning | |
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LECTURES; EXERCISES WITH THE DIRECT PARTICIPATION OF THE STUDENT; SEMINARS OF CHEMISTS AND SPEAKERS FROM PHARMACEUTICAL INDUSTRIES OR OTHER UNIVERSITIES / RESEARCH INSTITUTES VERIFICATION OF LEARNING THE EFFECTIVE ACQUISITION OF THE KNOWLEDGE AND SKILLS PROVIDED WILL BE ASSESSED THROUGH TWO TESTS: - WRITTEN TEST (OPEN QUESTIONS, MULTIPLE CHOICE AND CALCULATION EXERCISES) ON ALL THE COURSE TOPICS. THE EXPECTED TIME FOR THE TEST IS 1 HOUR AND A HALF. IT IS NOT ALLOWED TO CONSULT TEXTS OR USE PC, SMART PHONES. CALCULATOR IS ALLOWED. - ORAL TEST ON THE ASSESSMENT OF KNOWLEDGE AND THE ABILITY TO LINK AND COMPARE CROSS-CUTTING ASPECTS OF THE PHARMACEUTICAL TECHNOLOGY FIELD, ANALYZING PRACTICAL CASES OF DISPENSING A DRUG PRODUCT, TO BE ANALYZED ACCORDING TO THE METHODS USED DURING THE COURSE. THE TWO TESTS WILL TAKE PLACE AT A DISTANCE OF 2 DAYS UP TO 1 WEEK FROM EACH OTHER. THE TIME BETWEEN THE TWO TESTS IS NEEDED FOR THE REVISION OF THE WRITTEN TEST AND DEPENDS ON THE NUMBER OF STUDENTS. TO PASS THE EXAM IT IS NECESSARY TO ACQUIRE A MINIMUM SCORE OF 18 OUT OF 30. IF THE SECOND TEST SCORE IS LESS THAN 18, IT MAY BE NECESSARY TO REPEAT BOTH TESTS. THE FINAL MARK WILL BE OBTAINED THROUGH A CAREFUL ANALYSIS OF THE STUDENT'S REPLIES CONSIDERING BOTH THE TECHNICAL-NOTIONAL ASPECTS AND THE STUDENT'S ORAL EXPOSURE CAPACITY. THE FINAL MARK IS NORMALLY FORMULATED CONSIDERING THE OUTCOME OF BOTH TESTS, EVEN IF THE SCORE OF THE FIRST IS NOT BINDING ON THE FINAL MARK NOR DOES IT NECESSARILY CONSTITUTE A STARTING SCORE. THE ORAL EVALUATION SERVES TO DETERMINE THE LEVEL OF KNOWLEDGE AND COMPREHENSION AS WELL AS COMMUNICATION SKILLS ACHIEVED BY THE STUDENT. |
Texts | |
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1.P. COLOMBO, F. ALHAIQUE, C. CARAMELLA, B. CONTI, A. GAZZANIGA, E. VIDALE, PRINCIPI DI TECNOLOGIA FARMACEUTICA. CASA EDITRICE AMBROSIANA, MILANO, 2015. 2.FARMACOPEA UFFICIALE ITALIANA (FUI), EUROPEAN PHARMACOPOEIA (EP), UNITED STATES PHARMACOPOEIA (USP): EDIZIONI CORRENTI. 3.3. AULTON M.E., KEVIN M.G.T., TECNOLOGIE FARMACEUTICA. EDRA, 2015. 4.HOWARD C. ANSEL, SHELLY J STOCKTON, PRINCIPI DI CALCOLO FARMACEUTICO. A CURA DI: G. COLOMBO ET AL. EDRA, 2017. 5.P. MINGHETTI, LEGISLAZIONE FARMACEUTICA NONA EDIZIONE, CON AGGIORNAMENTI DISPONIBILI ONLINE CASA EDITRICE AMBROSIANA, 2018 6.HANDBOOK OF PHARMACEUTICAL EXCIPIENTS, 7TH ED. EDITED BY RAYMOND C. ROWE, PAUL J. SHESKEY, SIAN C. OWEN, PHARMACEUTICAL PRESS AND AMERICAN PHARMACISTS ASSOCIATION, CHICAGO, 2012. |
More Information | |
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THE STUDENT WILL BE PROVIDED WITH NOTES ON THE LECTURES AND IN-DEPTH DIDACTIC MATERIAL |
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