Unit TECHNOLOGY AND REGULATION OF MEDICINAL PRODUCTS
- Course
- Industrial pharmacy
- Study-unit Code
- A003598
- Location
- PERUGIA
- Curriculum
- In all curricula
- Teacher
- Luana Perioli
- Teachers
-
- Luana Perioli
- Matteo Puccetti (Codocenza)
- Hours
- 86 ore - Luana Perioli
- 30 ore (Codocenza) - Matteo Puccetti
- CFU
- 9
- Course Regulation
- Coorte 2024
- Offered
- 2025/26
- Learning activities
- Caratterizzante
- Area
- Discipline tecnologiche normative e economico-aziendali
- Sector
- CHIM/09
- Type of study-unit
- Obbligatorio (Required)
- Type of learning activities
- Attività formativa monodisciplinare
- Language of instruction
- Italian
- Contents
- Regulatory and law: international rules (UN, EU, WHO). Pharmaceutical technology: drugs and pharmaceutical formulations (industrial and galenic medicines). Laboratory: preparation of galenic formulations for internal and topical use.
- Reference texts
- Principi di Tecnologia Farmaceutica. P. Caliceti I edizione, Casa editrice Ambosiana. Legislazione Farmaceutica. P. Minghetti. Casa editrice Ambrosiana. X edizione.
- Educational objectives
- Knowledge of drug formulation features and performances. Knowledge of industrial drug manifacture and preparation of galenic drugs. Knowledge of medicinal regulatory and laws (italian, european).
- Prerequisites
- In order to be able to understand how to tackle the course and apply the majority of formulation technology, student must know the notion of API, pharmaceutical classification, dosage form administration. The student must possess complete knoledge of general chemistry, inorganic and organic chemistry, physical chemistry.
- Teaching methods
- Oral lessons and laboratory experiences (single place)
- Learning verification modality
- The exam consists of two parts: written exam and oral exam.
- Extended program
- Pharmaceutical Technology
1. Introduction to the Course: Historical background, definitions, role of the pharmacist and community pharmacy, pharmaceutical care. Classification of medicinal products. Homeopathy and allopathy, health economics, pharmacoeconomics, Health Technology Assessment (HTA), pharmaceutical technology and industry. 2. Definitions and Excipients: Medicinal products and drugs: definitions and regulatory framework. Excipients: role and regulatory references. 3. Dosage Forms and Routes of Administration: Pharmacodynamics, pharmacokinetics, LADME, biopharmaceutics, pharmaceutical phase, absorption, Fick's First Law, parameters affecting absorption, solubility, Biopharmaceutics Classification System (BCS), permeability studies (models and in silico studies), bioavailability (absolute and relative), bioequivalence, bioequivalent drugs, bioequivalence criteria and studies, ATC classification system. 4. Powders: Pharmaceutical powders, pharmacopoeial classification and uses. Hygroscopicity, deliquescence, efflorescence, eutectic mixtures, quality controls. Particle size and powder classification. Powder production methods: crystallization, precipitation, sublimation; milling and grinding (Hooke’s law), material properties affecting grinding (hardness, resistance, adhesiveness, softening temperature, plasticity); trituration, pulverization by intervention, levigation, porphyrization. Powder properties, particle size and size distribution, particle diameters, particle-size analysis: microscopy, sieving, sedimentation, Andreasen pipette, Coulter counter, laser diffraction, holography and DLS. Surface area (BET analysis), particle shape, flow properties, angle of repose, density, compressibility index, tapped density, packing, porosity. Mixing, convective and diffusive mechanisms. 5. Granules: Definition, classification, components, dry granulation, wet granulation (mechanical and pneumatic methods). Pharmacopoeial tests. Pellets and beads. 6. Hard and Soft Capsules: Definitions, versatility and advantages. Capsule preparation, gelatin and alternative polymers, capsule sizes, closure systems, coloring, quality control of empty capsules. Filling procedures and pharmacopoeial tests on filled capsules. Compounding of capsules. Soft capsules. 7. Tablets and Sugar-Coated Tablets: Definitions, types, shapes and presentation. Oral route and gastrointestinal tract characteristics. Preparation methods, excipients (diluents, binders, disintegrants, glidants, lubricants, anti-adherents, polymers). Tablet coating and quality controls: dry coating, sugar coating, film coating, materials and polymers. Disintegration, dissolution, hardness and friability testing. 8. Liquid Formulations: Solutions, water, solubilization, colligative properties, syrups. 9. Medicinal Preparations from Herbal Drugs: Phytotherapy, powders and milling, cryogenic grinding, sieving, mixing and applications. Extraction techniques: maceration, digestion, infusion, decoction, herbal teas, liquid extracts, soft extracts, dry extracts, tinctures, mother tinctures, alcoholates, medicated wines, oleolites, glyceric macerates and gemmotherapy derivatives. Essential oils, steam distillation, mechanical extraction and expression. Applications of essential oils. Herbal and flavored syrups. 10. Injectable Dosage Forms: intramuscular, subcutaneous and intravenous administration. Glass containers and glass properties. Oily liquids. Water for injections: pH, isotonicity and isotonic adjustment, sterility, apyrogenicity. Sterile preparation techniques. Visual inspection, pyrogen testing, Limulus Amebocyte Lysate (LAL) test. 11. Ophthalmic Preparations: Eye physiology, lacrimal pathway, glaucoma. Uses of ocular formulations. Topical administration and absorption pathways, corneal absorption, systemic absorption. Eye drops, eye baths, powders, semisolid preparations. Sterility, pH and its influence on absorption, isotonicity and abrasiveness. Ocular inserts. 12. Surfactants: Interfacial phenomena, surface tension, surfactants and their activity, micelles, critical micelle concentration (CMC), aggregates, packing parameter. Classification of surfactants. Hydrophilic-Lipophilic Balance (HLB), Griffin scale, surfactant properties, wetting, detergency and spreading. 13. Dispersed Systems: Emulsions: Dispersed systems, emulsions, emulsion types and applications, emulsion-type identification. Emulsifying agents: types, mechanisms of action, factors affecting emulsion type, HLB calculation, Bancroft rule. Emulsion stability and instability: creaming, coalescence, breaking, phase inversion, Ostwald ripening. 14. Dispersed Systems: Suspensions: Suspensions, applications, advantages and disadvantages, essential requirements. Particle-size control, wettability, sedimentation, factors affecting sedimentation, flocculation, deflocculation, DLVO theory, zeta potential, controlled flocculation. 15. Semisolid Preparations for Skin Application: Skin as a route of administration, pharmacopoeial definitions. Principles of rheology, lipophilic and hydrophilic excipients. Ointments and suitable excipients. Hydrophobic ointments, occlusive effect, water-emulsifying ointments, hydrophilic ointments. Creams, gels, emulgels, pastes, poultices and medicated plasters. Quality controls. 16. Suppositories: Pharmacopoeial definitions, rectal and vaginal preparations. Suppositories: uses, excipient selection, excipient types, preparation and packaging. Vaginal ovules: definitions, uses and excipient types.
Pharmaceutical Legislation 1. Introduction: Pharmaceutical legislation, pharmacy system, issues related to medicinal product management, health economics, pharmacoeconomics and HTA. 2. Medicinal Products Prepared in Pharmacies: Good Preparation Practices (GPP), comprehensive and simplified procedures, pharmacy quality management systems, responsibilities of the pharmacy owner/director, personnel, laboratory facilities, premises, equipment and utensils, Pharmacopoeia Table 6, pharmacy documentation, certificates of analysis, raw material procurement and documentation, preparation records, cleaning procedures. 3. Official Tariff and Compounded Medicines: Official pharmaceutical tariff, pricing of compounded medicines, pharmaceutical compounding legislation. Magistral prescriptions, pharmacist obligations, pharmacopoeial tables. Anorectic substances and doping, medicinal products containing doping substances, prescription types. Magistral and officinal galenic preparations. Consolidated Health Laws (TULS), Pharmaceutical Service Regulations. 4. OTC and Non-Prescription Medicines: Classification of SOP medicines, Legislative Decree 219/2006 (Title V). Non-prescription medicines, labeling, advertising, package leaflets, price-control measures, sale of medicines outside pharmacies, Bersani Decree, para-pharmacies, online sale of medicines. 5. Pharmacopoeias: Definition of Pharmacopoeia. International Pharmacopoeia, European Pharmacopoeia and Italian Pharmacopoeia: general chapters, analytical methods, monographs and tables. 6. Product Categories for Health Care: Medical devices, dietary supplements, nutraceuticals, foods for special medical purposes (FSMPs), cosmetics, cosmeceuticals, nutricosmetics and medicinal products. Characteristics of the Italian pharmaceutical market. 7. Evolution of Healthcare in Italy: Historical development of the Italian healthcare system, National Health Service reforms, decentralization, State-Regions agreements, direct distribution of medicines (DD and DPC), establishment and role of the Italian Medicines Agency (AIFA), integrated home care, pharmaceutical services in the Umbria Region, Pharmaceutical Hospital-Territory Formulary (PHT). 8. Management of Narcotic and Psychotropic Medicines: Narcotic drugs, psychotropic substances, drug dependence. Italian legislation on narcotics (Presidential Decree No. 309/1990 and subsequent amendments). Procurement, storage and dispensing of narcotic and psychotropic medicines. Prescription examples and inventory registers. 9. Territorial Organization of Pharmaceutical Services: Historical legislation governing community pharmacies. Pharmacy distribution planning, relocation, public competitions, classification and territorial distribution of pharmacies. Branch pharmacies, pharmaceutical dispensaries, seasonal dispensaries. Pharmacy ownership, private pharmacies, temporary management, and reforms including the 2012 Monti Law.
Laboratory Practice. 1. Pharmaceutical Compounding in Pharmacy: Professional activities permitted to European pharmacists, definition of galenic preparations, magistral and officinal formulations, rationale for compounding medicines in pharmacies. Compounding in hospital pharmacies and para-pharmacies. Restrictions on magistral prescriptions. Herbal and cosmetic products prepared in pharmacies. 2. Procedures for Pharmaceutical Compounding: Consultation of the Pharmacopoeia and Medicamenta, labeling, preparation reports and pricing. Pharmacy safety, safety data sheets, waste management and European Waste Catalogue (EWC/CER) codes. 3. Pharmaceutical Formulations: Powders for internal and external use. Preparation of divided powders and hard capsules, including weight-uniformity and disintegration testing. Solutions for internal and external use, suspensions and emulsions for internal use. Semisolid preparations for external use: ointments, pastes, O/W and W/O creams, gels, emulgels, hot- and cold-process preparations. Legal requirements concerning dispensing and supply. Language of instruction: Italian. Laboratory activities: Preparation of galenic formulations for internal and topical use. - Obiettivi Agenda 2030 per lo sviluppo sostenibile
- health and wellness/wellbeing