PHARMACEUTICAL TECHNOLOGY AND LEGISLATION

Paola RUSSO PHARMACEUTICAL TECHNOLOGY AND LEGISLATION

0760300023
DIPARTIMENTO DI FARMACIA
EQF7
PHARMACY
2024/2025

OBBLIGATORIO
YEAR OF COURSE 4
YEAR OF DIDACTIC SYSTEM 2023
AUTUMN SEMESTER
CFUHOURSACTIVITY
1TECNOLOGIA FARMACEUTICA E FARMACOECONOMIA MODULO DI TECNOLOGIA SOCIOECONOMIA E LEGISLAZIONE FARMACEUTICA
648LESSONS
2LEGISLAZIONE FARMACEUTICA E FORME FARMACEUTICHE INNOVATIVE MODULO DI TECNOLOGIA SOCIOECONOMIA E LEGISLAZIONE FARMACEUTICA
648LESSONS
Objectives
THE COURSE PROVIDES KNOWLEDGE AND UNDERSTANDING OF THE DIFFERENT PHARMACEUTICAL DOSAGE FORMS AND THE PRINCIPLES AND METHODS FOR THEIR FORMULATION AND MANUFACTURING, TAKING INTO ACCOUNT THE DIFFERENT ROUTES OF ADMINISTRATION, STABILITY AND BIOAVAILABILITY OF THE ACTIVE PHARMACEUTICAL INGREDIENTS (API). MOREOVER, THE COURSE AIMS TO PROVIDE COMPETENCE IN PHARMACY LEGISLATION AND REGULATION FOR THE PROFESSION OF PHARMACIST IN NHS (NATIONAL HEALTHCARE SYSTEM), AS WELL AS PHARMACOECONOMIC BASIS.

AT THE END OF THE COURSE THE STUDENTS WILL KNOW:
- THE MAIN EXCIPIENTS USED FOR THE PRODUCTION OF MEDICINAL PRODUCTS
- THE TRADITIONAL AND INNOVATIVE DRUG DOSAGE FORMS
- THE PHARMACEUTICAL MARKET, PHARMACEUTICAL SPENDING AND CONTAINMENT POLICIES
- FULFILMENTS OF THE PHARMACIST FOR: PURCHASE, STORAGE, POSSESSION, SALE AND DISPOSAL OF A MEDICINAL PRODUCT
-ORGANIZATION AND CONTENT OF THE OFFICIAL PHARMACOPOEIA
AT THE END OF THE COURSE THE STUDENTS WILL BE ABLE TO:
- RECOGNIZE DRUG FORMULATIONS, UNDERSTAND THE ROLE AND UTILITY OF EACH COMPONENT,
- CORRECTLY MANAGE A MEDICAL PRESCRIPTION IN THE PHARMACY
- PROVIDE CITIZENS WITH INFORMATION ON THE CORRECT USE OF MEDICINES AND MEDICAL DEVICES
- CONSULT THE OFFICIAL PHARMACOPOEIA
Prerequisites
KNOWLEDGE FROM THE PREPARATORY COURSES I -II years
Contents
THE COURSE IS DIVIDED INTO TWO MODULES OF 6 CFU AND 48H EACH:
MODULE 1 (48H, 6CFU):
PHARMACEUTICAL TECHNOLOGY AND PHARMACOECONOMICS:
PHARMACEUTICAL TECHNOLOGY
INTRODUCTION
COURSE PROGRAM, EXAM PROCEDURES. IMPORTANCE AND ROLE OF PHARMACEUTICAL TECHNOLOGY (2H)
TECHNOLOGICAL OPERATIONS: MIXING, MILLING, DRYING, STERILIZATION (6H)
POWDERS (2H): DEFINITION, FUNDAMENTAL AND DERIVED PROPERTIES, AND RELATED MEASUREMENT METHODS.
POWDERS AS A PHARMACEUTICAL FORM: ADVANTAGES, ROUTES OF ADMINISTRATION, PHARMACOPEIAL CONTROLS/TESTS (2H)
GRANULES (4H): DEFINITION, METHODS AND EQUIPMENT, EXCIPIENTS, PHARMACOPEIAL CONTROLS/TESTS
HARD AND SOFT CAPSULES (4H): DEFINITION, DESIGN, CAPACITY, SHELL COMPOSITION, EXCIPIENTS, SOLID AND LIQUID FORMULATIONS, INDUSTRIAL FILLING. PHARMACOPEIAL CONTROLS/TESTS
TABLETS (4H): DEFINITION, CLASSIFICATION, PRODUCTION TECHNIQUES, EXCIPIENTS, PHARMACOPEIAL CONTROLS/TESTS.

LIQUID PREPARATIONS (6H): SOLUTIONS, DISPERSION SYSTEMS, COLLOIDAL DISPERSIONS, SUSPENSIONS; CLASSIFICATION/PROPERTIES, PHYSICOCHEMICAL CHARACTERISTICS, PREPARATION, EXCIPIENTS, EMULSIFIERS, SURFACTANTS; STABILITY
PREPARATIONS FOR TOPICAL APPLICATION (2H): OINTMENTS, GELS, EMULSIONS, INTRODUCTION TO RHEOLOGY, PHYSICOCHEMICAL CHARACTERISTICS, PREPARATION, EXCIPIENTS, STABILITY
STERILE PREPARATIONS (4H): BP, ANNEX I, PARENTERAL AND OPHTHALMIC PREPARATIONS
PREPARATIONS FROM HERBAL DRUGS(2H)
DRUG ADMINISTRATION IN THE RESPIRATORY SYSTEM (4H): AEROSOLIZATION AND DEPOSITION, INHALATION BIOAVAILABILITY; AERODYNAMIC DIAMETER; NASAL ADMINISTRATION: LIQUID AND SOLID NASAL PREPARATIONS, FORMULATORY ASPECTS, DEVICES, CONTROLS; PULMONARY ADMINISTRATION: DEPOSITION MECHANISMS, SAFETY, LIQUID PREPARATIONS FOR NEBULIZATION, PRESSURIZED INHALERS, INHALATION POWDERS, PHARMACOPEIAL CONTROLS/TESTS.
RECTAL AND VAGINAL PREPARATIONS (2H): CHARACTERISTICS OF ADMINISTRATION ROUTES AND TYPES OF SUPPOSITORY PRODUCTS: BASES (LIPOPHILIC AND HYDROPHILIC), OTHER VAGINAL PREPARATIONS (TABLETS, INSERTS).
FOR ALL STUDIED PHARMACEUTICAL FORMS, THE ANALYSIS OF COMMERCIAL PRODUCTS IS PROVIDED.
THE PHARMACEUTICAL MARKET, PHARMACEUTICAL SPENDING AND CONTAINMENT POLICIES (4H)
MODULE DRUG REGULATION AND INNOVATIVE DRUG DOSAGE (48H, 6CFU):
-INNOVATIVE FORMULATIONS (24H) DIVIDED AS FOLLOWS
BASIC PRINCIPLES OF BIOPHARMACEUTICS (6H): LADME SYSTEM, BIOAVAILABILITY, BIOEQUIVALENCE, ALTERNATIVE ADMINISTRATION ROUTES;
INTRODUCTION TO PHARMACOKINETICS
CONTROLLED DRUG RELEASE (2H); COATING OF SOLID ORAL FORMS (2H): SUGAR COATING, FILM COATING: DEFINITION, OBJECTIVES, AND TECHNOLOGIES.
LIPOSOMES, NANOSYSTEMS (6H)
TRANSDERMAL AND OPHTHALMIC DELIVERY SYSTEMS (4H): OBJECTIVES AND ADVANTAGES, RESERVOIR AND MATRIX TRANSDERMAL PATCHES; INSERTS AND OPHTHALMIC IMPLANTS
BIOTECHNOLOGICAL AND BIOSIMILAR DRUGS (4H)
-PHARMACEUTICAL LEGISLATION (24H) DIVIDED AS FOLLOWS
SUPRANATIONAL AND NATIONAL REGULATIONS AND LEGISLATION, STRUCTURE OF PHARMACEUTICAL SERVICES, ADMINISTRATIVE CLASSIFICATION OF PHARMACIES, THE ROLE OF THE PHARMACIST, TECHNICAL-LEGAL ASPECTS OF COMMERCIAL OPERATION AND PROFESSIONAL SERVICE, PHARMACEUTICAL ESTABLISHMENT, ORGANIZATIONAL CHART, OWNERSHIP, NETWORKS AND CONSORTIA, PROFESSIONAL ORDERS, PROFESSIONAL LIABILITY, CODE OF ETHICS, CONTINUOUS MEDICAL EDUCATION (CME) (4H)
LEGISLATIVE DECREE 219/06, AIC, ORPHAN DRUGS, OFF-LABEL USE, PHARMACEUTICAL PATENT, GENERIC DRUGS, BIOLOGICAL AND BIOSIMILAR MEDICINAL PRODUCTS, TRADITIONAL HERBAL MEDICINES, OFFICINAL AND MAGISTRAL GALENICALS, BP, RISK ASSESSMENT, PHARMACOPOEIAS AND OTHER TEXTS, MEDICINAL PRODUCT TRACEABILITY (4H)
THE PHARMACY AND THE AGREEMENT WITH THE NATIONAL AND REGIONAL HEALTH SERVICE, DIGITAL HEALTH, MEDICAL PRESCRIPTION, CORRECT DISPENSING OF MEDICINES, TEXTS, MANDATORY LISTS AND REGISTERS (6H)
NARCOTICS: REGULATIONS, CLASSIFICATION, AND PHARMACOPOEIAL TABLES WITH FORMATION CRITERIA, ACQUISITION, POSSESSION, HANDLING, DISPENSING, DISPOSAL, INSPECTIONS (6H)
VETERINARY DRUGS, MEDICAL DEVICES, BIOCIDES, THERAPEUTIC OXYGEN, AND OTHER MEDICAL GASES (4H)
Teaching Methods
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 KNOWLEDGE AND SKILLS COVERED IN THE COURSE FOR BOTH MODULES WILL BE ASSESSED THROUGH TWO EXAMINATIONS:

WRITTEN EXAM: THE WRITTEN EXAM WILL COVER TOPICS FROM BOTH MODULES AND INCLUDE OPEN-ENDED QUESTIONS, MULTIPLE-CHOICE QUESTIONS, AND CALCULATION EXERCISES. THE ALLOTTED TIME FOR THE EXAM IS 1.5 HOURS. DURING THE EXAM, YOU ARE NOT ALLOWED TO CONSULT ANY TEXTS OR USE PCS OR SMARTPHONES. HOWEVER, A CALCULATOR IS PERMITTED.

ORAL EXAM: THE ORAL EXAM WILL FOCUS ON TOPICS FROM BOTH MODULES AND EVALUATE YOUR UNDERSTANDING AND ABILITY TO CONNECT AND COMPARE DIFFERENT ASPECTS DISCUSSED DURING THE COURSE. IT WILL INVOLVE ANALYZING PRACTICAL CASES OF DISPENSING A COMMERCIAL MEDICATION, FOLLOWING THE METHODS USED IN THE COURSE.

THE TWO EXAMS WILL TAKE PLACE WITHIN A RANGE OF 2 DAYS UP TO A MAXIMUM OF 1 WEEK APART. THE TIME BETWEEN THE EXAMS DEPENDS ON THE NUMBER OF REGISTERED PARTICIPANTS (EXCLUDING THOSE WHO WITHDRAW OR ARE ABSENT) AND IS NECESSARY FOR THE CORRECTION OF THE WRITTEN TASK. TO PASS THE EXAM, YOU NEED TO ACHIEVE A MINIMUM SCORE OF 18 OUT OF 30. IF THE SECOND EXAM IS INSUFFICIENT, IT MAY BE NECESSARY TO RETAKE BOTH EXAMS.

THE FINAL EVALUATION (GRADE) WILL BE DETERMINED THROUGH A CAREFUL ANALYSIS OF THE STUDENT'S ANSWERS, CONSIDERING BOTH THE TECHNICAL-KNOWLEDGE ASPECTS AND THE STUDENT'S ABILITY TO COMMUNICATE. THE FINAL GRADE IS USUALLY FORMULATED BY TAKING INTO ACCOUNT THE RESULTS OF BOTH EXAMS, ALTHOUGH THE SCORE OF THE FIRST EXAM IS NOT BINDING FOR THE FINAL GRADE AND DOES NOT NECESSARILY SERVE AS A STARTING SCORE. THE ORAL EVALUATION AIMS TO ASSESS THE STUDENT'S LEVEL OF KNOWLEDGE, COMPREHENSION, AND COMMUNICATION SKILLS.
Texts
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.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.NICOLETTA LOLISCIO “LA FARMACIA UN CAMPO MINATO”, IL MANUALE DEL FARMACISTA, GUIDA PRATICA EDIZIONE CORRENTE (2021) SOCIETÀ EDITRICE ESCULAPIO
7.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.
8. PRINCIPI DI TECNICA FARMACEUTICA. SESTA EDIZIONE A CURA DI FRANCESCO BARBATO. PICCIN EDITRICE.



More Information
THE STUDENT WILL BE PROVIDED WITH NOTES ON THE LECTURES AND IN-DEPTH DIDACTIC MATERIAL
Lessons Timetable

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