Study-unit SOCIO-ECONOMICS TECHNOLOGY AND PHARMACEUTICAL LAW
| Course name | Chemistry and technology of drugs |
|---|---|
| Study-unit Code | 65012609 |
| Curriculum | Comune a tutti i curricula |
| Lecturer | Luana Perioli |
| Lecturers |
|
| Hours |
|
| CFU | 9 |
| Course Regulation | Coorte 2020 |
| Supplied | 2023/24 |
| Supplied other course regulation | |
| Learning activities | Caratterizzante |
| Area | Discipline chimiche, farmaceutiche e tecnologiche |
| 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.Colombo et al, Casa editrice Ambosiana. II edizione 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 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. Written exam is divided in two sections: 1) technical report on galenic formulation (galenic formulations prepared during the laboratory sessions); 2) solution of 5 test multiple choice tests and short compositions, designed to evaluate the theoretical knoledge (pharmaceutical technology and law). Written exam has a duration of 60 minutes. The aim of oral exam is to verify the theoretical knoledge of drug formulations and drug law about dispensing, distribution (supply chain) pharmacy organization, national sanitary service organization and pharmacist responsabilities. |
| Extended program | Pharmaceutical Technology. Introduction. Definitions, role of pharmacist and pharmacy, territorial pharmacy, pharmaceutical care. Classification of medicines. Homeopathy and allopathy. Socioeconomics, drug economics, Health Technology Assessment (HTA), technology and industry. Medicines and drugs: definitions and normative references. Excipients; role and normative references. Pharmaceutical forms and administration routes. Pharmacodynamics, pharmacokinetics, LADME, biopharmaceutical, pharmaceutical phase, absorption, Fick's first law, absorption parameters, solubility, BCS, bioavailability (absolute and relative) bioequivalence, bioequivalent drugs, bioequivalence criteria and studies, ATC classification, ATC classification, Formulations: powder, granulates, capsule, tablets, liquid formulations, herbal drugs and preparations, injectable formulations, ophthalmic preparations. Surfactants. Interfacial phenomena, surface tension, surfactants and their activities, micelles, CMCs, aggregates, packing parameter. Classification of surfactants. Dispersed systems: emulsions. Dispersed systems, emulsions, types of emulsions and their uses, recognition of the type of emulsion, suspensions. Semi-solid preparations for skin application. The skin as a route of administration, FU definitions. Lipophilic and hydrophilic excipients. Ointments and excipients suitable for their preparation. Hydrophobic agents, occlusive effect, ointments that emulsify water, hydrophilic ointments. Creams, emulgels, pastes, poultices, medicated plasters. Suppositories. Definitions FU, rectal and vaginal preparations. Law. 1. Introduction. 2. Medicines prepared in the pharmacy and good preparation rules (NBP) 3. Official price of medicines, price of medicines prepared in the pharmacy. Preparation and legislation of medicines prepared in the pharmacy. Pharmaceutical Service Regulations. 4. Legislative and management aspects of SOP drugs 5. Pharmacopoeias. 6. Product categories of health products: 7. Evolution of healthcare in Italy: 8. The management of narcotics and psychotropic drugs in pharmacies. 9. Public pharmaceutical service. Galenic laboratory. Powders for oral and topic use, suspensions and emulsions for oral use. Semi-solid preparations for external use: ointments, pastes, O / W and W / O creams, gels, emulgels, Regulations for galenic laboratory production |
| Obiettivi Agenda 2030 per lo sviluppo sostenibile | 3. Health and wellness |