Rita Patrizia AQUINO | PHARMACEUTICAL TECHNOLOGY AND LEGISLATION II
Rita Patrizia AQUINO PHARMACEUTICAL TECHNOLOGY AND LEGISLATION II
cod. 0760400025
PHARMACEUTICAL TECHNOLOGY AND LEGISLATION II
| 0760400025 | |
| DIPARTIMENTO DI FARMACIA | |
| EQF7 | |
| PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY | |
| 2024/2025 |
| OBBLIGATORIO | |
| YEAR OF COURSE 5 | |
| YEAR OF DIDACTIC SYSTEM 2023 | |
| AUTUMN SEMESTER |
| SSD | CFU | HOURS | ACTIVITY | |
|---|---|---|---|---|
| CHIM/09 | 6 | 48 | LESSONS |
| Objectives | |
|---|---|
| THE COURSE AIMS TO PROVIDE STUDENTS WITH THE PROFESSIONAL ELEMENTS OF THE PHARMACEUTICAL TECHNOLOGIST, FROM THE DESIGN OF THE MEDICINE TO ITS MARKETING. KNOWLEDGE AND UNDERSTANDING. AT THE END OF THE COURSE, THE STUDENT WILL KNOW: - THE REGULATIONS GOVERNING THE INDUSTRIAL PHARMACEUTICAL SECTOR, THE PRODUCTION AND MARKETING OF MEDICINES; THE PHARMACOPOEIAS; THE PHARMACEUTICAL GRADE EXCIPIENTS, PRODUCTION METHODS, CONTROLS, AND ESSENTIAL EQUIPMENT TO PRODUCE PHARMACEUTICAL FORMS. MAKING JUDGMENTS AT THE END OF THE COURSE, THE STUDENT WILL BE ABLE TO: - - UNDERSTAND THE DYNAMICS OF THE PHARMACEUTICAL MARKET AND THE AUTHORIZATION PROCESS OF A NEW DRUG FOR THE PLACEMENT ON THE MARKET. - UNDERSTAND THE RELEVANT PROCESS STAGES IN THE INDUSTRIAL PRODUCTION OF DRUGS FOR ORAL, TOPICAL, RESPIRATORY, INJECTABLE, OPHTHALMIC, SUPPOSITORY ADMINISTRATION, ABOUT CONVENTIONAL PHARMACEUTICAL FORMS. - INDEPENDENTLY APPLY THE ACQUIRED KNOWLEDGE TO IDENTIFY THE MOST APPROPRIATE EXCIPIENTS AND PREPARATION METHODS FOR THE DEVELOPMENT OF A GIVEN DOSAGE FORM. - ADDRESS THE PROFESSIONAL RESPONSIBILITIES OF A PHARMACEUTICAL TECHNOLOGIST |
| Prerequisites | |
|---|---|
| KNOWLEDGE ACQUISITION AND SUCCESSFUL COMPLETION OF YEARS I-II COURSES, ACHIEVEMENT OF PHARMACEUTICAL TECHNOLOGIES I, IV YEAR OF COURSE, IS DUE. |
| Contents | |
|---|---|
| BRIEF INTRODUCTION ON PHARMACEUTICAL MARKET AND INDUSTRY AND NATIONAL HEALTH SYSTEMS; GENERAL PRINCIPLES OF NATIONAL AND EU LAW – THE EU REGULATION SYSTEM FOR MEDICINES; DRUG REGULATION AND APPROVEMENT; AUTHORIZATION FOR DRUG PRODUCTION, DISTRIBUTION AND COMMERCE, PHARMACOVIGILANCE, SOCIAL ECONOMY, PHARMACEUTICAL MARKET AND PATIENTS, PHARMACEUTICAL SPENDING AND POLICIES OF CONTAINMENT; ELEMENTS OF PATENT RELEASE PROCEDURES. II PART PHARMACEUTICAL DOSAGE FORMS AND ROUTE OF ADMINISTRATION OF HUMAN MEDICINES (4H) CONVENTIONAL PHARMACEUITICAL DOSAGE FORMS, FORMULATION FOR CONTROLLED DRUG RELEASE; PRINCIPLES OF DRUG FORMULATION; ACTIVE PHARMACEUTICAL INGREDIENT (API); ROLE AND CHARACTERISTICS OF THE EXCIPIENTS OF PHARMACEUTICA GRADE AND ADJUVANTS MATETRILS; PHARMACEUTICAL PROCESSING AND EQUIPMENTS, GRINDING, MILLING, MIXING, GRANULATION, PELLETTISATION, DRYING, COMPRESSION, COATING. III PART DRUG FORMULATION, MANUFACTURING AND QUALITY CONTROL (32H) FOCUS ON: - PHARMACEUTICAL DOSAGE FORMS FOR ORAL ADMINISTRATION: POWDERS, GRANULES, CAPSULES, TABLETS, COATED TABLETS, PILLS AND SOLUTIONS; - POLYPHASIC SYSTEMS: SUSPENSION AND COLLOIDAL DISPERSIONS, EMULSIONS; - SEMISOLID PREPARATIONS FOR TOPICAL APPLICATION: OINTMENTS, PASTES, CREAMS, GELS; - PRESSURIZED PREPARATIONS AND RESPIRATORY ADMINISTRATION. - SUPPOSITORIES. - INJECTABLE STERILE PREPARATIONS. - OPHTHALMIC PREPARATIONS: EYE DROPS, EYE BATHS, OPHTHALMIC INSERTS. FOR EACH DOSAGE FORM: PHYSICO-CHEMICAL AND BIOPHARMACEUTIC CHARACTERISTICS, MEDICINAL MANUFACTURING, INDUSTRIAL PLANTS, SPACES, EQUIPMENTS AND PROCEDURES IN PHARMACEUTICAL INDUSTRY, GOOD MANUFACTURING PRACTISE (GMP), CLEAN ROOMS. PHARMACOPOEIA AND QUALITY CONTROLS (QC). PARTE IV (4H) MODIFIED RELEASE MEDICINES – CONTROLLED DRUG DELIVERY SYSTEMS, TAILORED CONTROLLED RELEASE; TECHNIQUES TO CONTROL THE DRUG RELEASE FROM PHARMACEUTICAL FORMS, POLYMERS AND PLATFORMS FOR CONTROLLED DRUG DELIVERY, |
| Teaching Methods | |
|---|---|
| TEACHING METHODS: - LECTURES ON ALL COURSE SUBJECTS; - TUTORIALS AND EXERCISES ON SELECTED SUBJECTS; COURSE ATTENDANCE IS COMPULSORY (AT LEAST 80%). THE FREQUENCY WILL BE VERIFIED BY SIGNATURE OR BY UNISA EASYBADGE. |
| Verification of learning | |
|---|---|
| STUDENTS HAVE TO DEMONSTRATE THAT THEY HAVE ACHIEVED THE LEARNING OUTCOME(S) AND MUST PROVIDE FEEDBACK THAT IDENTIFIES THEIR PROGRESS THROUGH A WRITTEN FINAL TEST. THE TEST (90 MIN) COMPRISES OPEN-ENDED OR EXTENDED RESPONSE EXERCISES AND MULTIPLE-CHOISE QUESTIONS. IN OPEN-ENDED QUESTIONS THE STUDENT MUST DEMONSTRATE, IN ADDITION TO A GOOD KNOWLEDGE OF THE TOPICS COVERED, ALSO TO HAVE SUFFICIENT EXPOSURE SKILLS AND TO POSSESS A SPECIALIZED LEXICON AT LEAST SUFFICIENT. THE ORAL INTERVIEW, IF DEEMED NECESSARY BY THE TEACHER, HAS THE AIM TO VERIFY THE PRESENTATION SKILLS AND THE ABILITY TO DISPLAY INDEPENDENT JUDGMENT. THE VOTE WILL REFLECT THE LEVEL OF DISCIPLINARY COMPETENCE ACHIEVED AND THE DEGREE OF CRITICAL AUTONOMY DEMONSTRATED. |
| Texts | |
|---|---|
| P. COLOMBO, F. ALHAIQUE, C. CARAMELLA, B. CONTI, A. GAZZANIGA, E. VIDALE PRINCIPI DI TECNOLOGIA FARMACEUTICA LAST EDITION - CASA EDITRICE AMBROSIANA. MILANO. M. AMOROSA PRINCIPI DI TECNICA FARMACEUTICA PICCIN ED 2021 EU PHARMACOPOEIA (EU PH.) AND ITALIAN PHARMACOPOEIA (F.U.I.). WEB SITE EU PH. |
| More Information | |
|---|---|
| THE TOPICS ARE EXTENSIVELY COVERED BY TEXT BOOKS. SUPPORTED MATERIALS FOR FEW LECTURES MAY BE DOWNLOADED FROM THE TEACHER PERSONAL SITE, SUPPLIED DURING THE LESSONS OR AVAILABLE ON-LINE ON TEACHING PLATFORMS USED AT UNISA. PLEASE, CONTACT PROF. RITA AQUINO FOR FURTHER INFORMATION: AQUINORP@UNISA.IT |
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