Course Details

Tecnologia, legislazione e deontologia farmaceutiche I

FA0017

Course
Tecnologia, legislazione e deontologia farmaceutiche I
Code
FA0017
Academic Year
2025/2026
Curriculum Year
2022/2023
Degree Programme
PHARMACY
Curriculum
000 - CORSO GENERICO
Course coordinator
Lecturers
Credits
15
Lecture Hours
120
Scientific Disciplinary Sector (SSD)
CHIM/09 - Applied Technological Pharmaceutics
Course Type
Single-subject learning activity
Course Delivery
OBB - Obbligatoria
Year
4
Teaching period
Annuale
Campus
NOVARA
Teaching language
Italian
Course Contents
The course provide the basis about the design, the formulation and the control of pharmaceutical dosage forms in accordance with current regulation. The fundamentals of legislation in the field of medicine, in the distribution to the public of medicinal products for human use, veterinary and "parafarmaco", are given. Regulatory aspects relating to the responsibility of the pharmacist in the pharmacy as well as the social function of the pharmacy on the territory are provided. Some aspects of professional ethic are given.
Reference Texts
- P. Colombo et al. Principi di Tecnologia Farmaceutica. - C.E.A. - Milano. - M. Amorosa - Principi di Tecnica Farmaceutica - Piccin – Padova. - A.T. Florence, D. Attwood – Physicochemical Principles of Pharmacy – Macmillan, LTD - M.Aulton, K. Taylor – Aulton’s Pharmaceutics – Churchill Livingstone - L.Lachman, H.A. Liebermann, J.L. Kanig – The Theory and Practice of Industrial Pharmacy Lea Febiger. Philadelphia - A.N. Martin, J Swarbrick, A.Cammarata, Physical Pharmacy- Lea & Febiger – Philadelphia - Ph.Eur. 11th Edition - EDQM - F.U. XII Edition - IPZS - E. Ragazzi - Lezioni di Tecnica Farmaceutica - Ed. Cortina – Padova. - Medicamenta - Cooperativa farmaceutica - Milano - S. Morel, G. Grosa - Preparazioni galeniche Esercizi di tariffazione secondo la nuova TNM – Ed. Libreria Rescalli - Novara. - P. Minghetti, Legislazione Farmaceutica - C.E. A. – Milano - V. Tortorella, E. Novellino, V. Iadevaia, Tirocinio professionale in farmacia – Ed. Merqurio - Napoli - R.Cipollone, Dizionario giuridico della farmacia - Edittoriale Giornaleidea - G.D’Agostini, Manuale del cosmetologo – Tecniche Nuove – Milano - G.C. Pacenti, G.Nadin, W.Salemme, La farmacia dei servizi - Tecniche nuove – Milano - Q. Lombardo e coll., La nuova farmacia del decreto Monti - Tecniche nuove – Milano
Learning Outcomes
The course aims to provide students the knowledge and the understanding of the basics regarding the design, formulation and control of pharmaceutical dosage forms in accordance with local regulations. In addition, the fundamentals of the legislation in the field of medicine, the public distribution of medicinal products for human and veterinary use and some professional ethic concepts are provided.
Prerequisites
We recommend a good knowledge of previous year courses, in particular general inorganic and organic chemistry, anatomy and physiology.
Teaching Methods
The course is throughout the year with lectures lessons. The teachings will be delivered in such a way as to encourage students to take an active role, helping to stimulate a critical spirit, autonomy and involving them in learning processes, also with exercises in class.
Additional Information
External specialists can supplement lessons with seminars.
It is not allowed to record, video-record and photograph the lectures
Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities.
Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.
Assessment Methods
Oral with questions throughout the program, according to the schedule established annually.
During the course some exercises will be carried out that can contribute to the final evaluation.
The level of difficulty of the questions corresponds to the program and the reference texts. During the oral exam the student is asked some questions on the main topics covered during the course with the dual purpose of verifying the level of knowledge and understanding of the course contents and to evaluate the autonomy of judgment, the learning ability and the communication skills. To pass the exam, the student must demonstrate knowledge and understanding at least of the fundamental concepts and the most important results relating to them. A wider knowledge and understanding of the contents of the program, which in particular allows the student to establish the connections between topics covered in different chapters of the program and greater autonomy in identifying errors and their correction, lead to an evaluation above sufficiency; to achieve a high grade, the student must be able to independently use their knowledge and understanding of the teaching contents to face an in-depth discussion on critical aspects relating to the topics covered and to be able to present their conclusions in a clear and logical.
Detailed Syllabus
Basic definitions: Dlvo 219/06 and glossary F.U. Italian Pharmacopoeia. European Pharmacopoeia. International Pharmacopoeia. American Pharmacopoeia. LADME. Main pharmaceutical dosage forms and controls F.U. Excipients, vehicles, additives used in the preparation of pharmaceutical dosage forms. Metrology. Drug stability. Gas for medicinal use. Foams. Sprays. Pressurized pharmaceutical preparations. Inhalation dosage forms. Liquid solutions. Colloidal dispersions. Emulsions. Suspensions. Microemulsions. LCD. Syrups and use of sweeteners. Drops. Preparations obtained from herbal drugs. Parenteral preparations. Semi-solid preparations for cutaneous application. Nasal, ear, eye preparations. Rectal and vaginal preparations. Oromucosal preparations. Powders. Preparation of homeopathic medicines. Veterinary medicines. Main pharmaceutical operations. Glass and plastic material containers.
Basic legislative notions. Notices about Italian, international and European legislation. Pharmacist ethics code. Good galenic preparation law (NBP e DM 18/11/2003, successively modified). Italian health organization. L.833/78. Health professions. Professional associations. Licensed to practice. Responsibility of the pharmacist. Pharmaceutical services. Administrative classification of pharmacies. Distribution of pharmacies on the territory. Supervision of pharmaceutical services. Inspections at the pharmacy. Texts, registers and documents required. Medicinal products for human use (Dlgs 219/2006, successively modified). Purchase, storage and sell out of narcotic drugs (DPR309/90 and successively modified). Pain therapy (L.12/2001 and successively modified). Storage and sell out of toxic substances. Veterinary medicinal products. REV. Medicinal products delivery: medical prescription. SOP, OTC. Generics. Biosimilars. Anti-doping law. Homeopathic medicines. Herbal products. Orphan drugs. Drugs off-label. Medical devices. Biocide. L. 69/2009. Cosmetic products (regulation 1223/2009/EU). Food in pharmacy: HACCP. Oxygen. Expired medicines, failures, imperfect. Supervision of all products.
Expected Learning Outcomes
In order to achieve the knowledge and skills corresponding to the minimum level of sufficiency, the student is asked to demonstrate knowledge of the topics presented in class. The student is asked to demonstrate that they are able to apply the knowledge acquired relating to the different FF for human and veterinary use, understanding the importance of the different excipients that can change the characteristics and bioavailability of drugs. The student must demonstrate that he has understood the importance of the pharmacy, services and dispensing of medicines, taking into account the Italian and EU legislation.
Last update:09-09-2026 00:14:31