Catalogo dei Corsi di studio

General expected learning outcomes
Aim of this course is to provide the basic knowledge on pharmaceutical technology, especially concerning the most important conventional drug delivery systems, taking into account the industrial fabrication.
Another aim of the course is to provide the fundamentals on pharmaceutical laws in Italy and in Europe, including drug dispensing in the Pharmacy. In particular, during the practical lab experiences, carried out by each student, the course will provide the basic skills for the most common dosage forms compounding and the corresponding controls, according to the Pharmacopeia. The student will also verify and check the legal requirements of medical prescriptions. Furthermore, the student will acquire the fundamentals for medicine pricing according to law and for the evaluation of the safety related to the preparations.

Specific expected learning outcomes
1. Knowledge and understanding
The student, at the end of the course, will acquire the fundamentals of pharmaceutical technology concerning the formulation, compounding and control of the main conventional dosage forms. Furthermore, the student will know the basic information concerning the regulatory affairs needed to obtain the marketing authorization, by applying the national or European procedure, together with the national laws for dispensing the dosage forms in the Pharmacy.

2. Applying knowledge and understanding
At the end of the course the student will be capable to understand and monitor the main productive steps of industrial fabrication of medicines, taking into account the regulatory and safety assessments. The student will be also aware of the regulatory requirements for the marketing authorization according to the current law.
The student will also acquire the capability to compound the most common dosage forms (by applying the correct calculations when needed), according to the current law and safety requirements.
He will be able to verify the prescription and dispensing requirements of medicines according to the current laws.

3. Making judgements
The lessons, carried out in order to interact as much as possible with the students, together with the practical laboratory experiences, aim to develop in the student the capability to make judgements and to solve problems. On the basis of a strong background, the student will be able to assess the technological requirements, together with the regulatory requirements, of industrial medicinal drugs. At the same time the student will be capable to evaluate the technological and practical activities related to dosage form formulations and dispensing.

4. Communication skills
The teacher will support the class discussion in order to improve the communication skills. This aspect is fundamental to prepare the student for the future working experiences, whether he will join a team (capability to work together), whether he will have the responsibility to coordinate other colleagues (capability to give orders and to be respected).
Furthermore, good communication skills are fundamental for a pharmacist, in his everyday contact with people which will gain benefit only when the high level of preparation and competence will be translated in suitable and easy advices to the patient (e.g. how to use the drug correctly, how to avoid interactions among different active compounds, etc).

5. Learning skills
The student, thanks also to the suggested books and web sites, will be able to update continuously, both in the industrial field and for the pharmacist job. Actually, during the lessons and during the preparation of the exam, the student will be aware of how important is to learn what is going on in its future working field. Nowadays, regulatory affairs, together with the pharmaceutical technology, are changing very fast and the “new” professionist will be able to follow and to understand the evolutions with time.

Programme

Introduction (2 ore)

European Directives. Definition and classification of medicines. AIC (autorizzazione immissione in commercio(.
Patents. Generics. Good Manufactoring Procedures (Norme di Buona Fabbricazione) and Good Manufactoring Procedures in Farmacia (NBP). The organization of the pharmaceutical service.
The medical recipe: ricetta ripetibile (RR), ricetta non ripetibile (RNR), ricetta limitativa. (12 ore)

Medicinali con AIC, galenici, SOP e OTC. Metodologia di formazione del prezzo delle preparazioni magistrali: la nuova Tariffa Nazionale dei Medicinali. Regime di autoregolamentazione per i multipli. (6 ore)

Le Tabelle della Farmacopea. La Tabella n.2. La Tabella n.3: i “veleni” e loro dispensazione. La Tabella n.4. La Tabella n.5. La Tabella n. 6. La Tabella n.7: Disciplina relativa alla produzione, acquisto e dispensazione di sostanze stupefacenti e psicotrope. Il DPR 309/90 e suoi aggiornamenti. La terapia del dolore. Ricetta medica a ricalco (RMR). Progetto pilota e dispensazione della cannabis. (12 ore)

Normativa relativa alle sostanze il cui impiego e' considerato doping. (2 ore)

Pharmaceutical dosage forms: classification. Powders: features and analysis. Tablets. Capsules. Suppository. Hydroalcoholic solutions. Ophtalmic reparations. (16 ore)

Interfacial phoenomena. Emulsions and Suspensions. Solutions. Rheology. Expiry date: t10%. (10 ore)

Tests and procedures provided by F.U. for the pharmaceutical dosage forms. (4 ore)

Lab preparations of the most common dosage forms. Numerical excercises. (40 ore)

Adopted texts

1. P.Colombo, F.Alhaique, C.Caramella, B.Conti A.Gazzaniga, E.Vidale, "Principi di tecnologia farmaceutica", Casa Editrice Ambrosiana, 2015.
2. Aulton, “Tecnologie Farmaceutiche - Progettazione e allestimento dei medicinali”, Edra,Italia, 2015.
3. P.Minghetti, "Legislazione Farmaceutica", Casa Editrice Ambrosiana, ultima edizione.
4. Nicoletta Loliscio, “La Farmacia. Un campo minato. Il manuale del farmacista”, Società editrice Esculapio, 2021.
5. Fotocopie degli appunti di lezione e materiale messo a disposizione sul sito del docente.

Bibliography

1. M. Cini, P Rampinelli, “Principi di legislazione farmaceutica”, Edizioni Minerva Medica, 2019. 2. F.U. XII Edizione, Istituto Poligrafico dello Stato, e successivi aggiornamenti. 3. "Manuale delle preparazioni galeniche", IV ediz., F. Bettiol, Tecniche Nuove ed., 2017. 4. G.C.Ceschel, L.Fabris, E.Lencioni, S.Rigamonti, “Impianti per l'industria farmaceutica", Società Editrice Esculapio,1996. 5. http://www.ministerosalute.it 6. https://www.aifa.gov.it/ 7. http://www.ema.europa.eu 8. https://ec.europa.eu/health/documents/eudralex_it 9. http://www.galenotech.org 10. Aggiornamenti normativi presenti in G.U.

Prerequisites

Necessary: Basic knowledge of Inorganic and Organic Chemistry, Mathematic, Physic, Medicinal Chemistry. Important: Farmacology and Toxicology Useful: Medicinal Chemistry Analysis

Frequency modes

Lesson attendance is not mandatory but deeply suggested for a better and easier understanding of the topics of the course. The attendance to the practical laboratory experiences is mandatory

Exam modes

For the evaluation of the students there are six session exams per year: two in summer, after the end of the lessons, two in autumn and two in winter.
The exam is divided in two parts: a preliminary written examination (which lasts 90 minutes) followed by an oral exam. The written exam contains four open questions:
- in the first question a medical prescription for a galenic preparation is proposed and the student must comment in detail the legal aspects, including the prescription law, the duties of the physician and those of the pharmacist.
- two questions deal with numerical calculations concerning subjects discussed during the lessons (e.g., calculations for the preparation of isotonic solutions, calculations for the shelf-life of market drug, calculations for the preparation of hydroalcoholic solutions, calculations for the preparation of dosage forms, etc.)
- the last question asks the student to briefly describe, in correct Italian language, one of the topics of the course, concerning pharmaceutical technology or pharmaceutical law.

The oral exam has no exact duration, depending obviously on the many variables. The student is asked to comment and to explain the errors present in the written composition, if any. Questions, in pharmaceutical technology and law, are also proposed. One question on the practical laboratory experiences carried out during the course is also proposed.
The capability to appropriately express the topics of the course, the way of thinking, that mainly infer from the execution of the written test, the capability to independently make judgements represent the parameters taken into account in order to give an evaluation of the overall exam.
In order to pass the exam with the minimum the student is asked to show a sufficient competence of the course topics and sufficient speech skills together with a sufficient capability to independently make judgements.
To reach 30 cum laude the student must demonstrate a particularly excellent preparation in all topics of the course, showing an understanding beyond the factual knowledge.

It has to be underlined that, being the course strictly connected with the future professional life, the knowledge acquired during the mandatory internship spent for six months (full time) in the Pharmacy, represents the best complement for the final preparation of the exam.

Exam reservation date start	Exam reservation date end	Exam date
20/01/2022	13/02/2022	15/02/2022
01/04/2022	19/04/2022	21/04/2022
20/05/2022	14/06/2022	17/06/2022
20/06/2022	08/07/2022	12/07/2022
20/08/2022	19/09/2022	22/09/2022
20/10/2022	08/11/2022	11/11/2022
20/12/2022	16/01/2023	18/01/2023

Programme

Introduction (2 hours)

European Directives. Definition and classification of medicines. AIC (autorizzazione immissione in commercio).
Patents. Generics. Good Manufactoring Procedures (Norme di Buona Fabbricazione) and Good Manufactoring Procedures in Farmacia (NBP). The organization of the pharmaceutical service.
The medical recipe: ricetta ripetibile (RR), ricetta non ripetibile (RNR), ricetta limitativa. (12 hours)

Medicinali con AIC, galenici, SOP e OTC. Metodologia di formazione del prezzo delle preparazioni magistrali: la nuova Tariffa Nazionale dei Medicinali. Regime di autoregolamentazione per i multipli. (6 hours)

Le Tabelle della Farmacopea. La Tabella n.2. La Tabella n.3: i “veleni” e loro dispensazione. La Tabella n.4. La Tabella n.5. La Tabella n. 6. La Tabella n.7: Disciplina relativa alla produzione, acquisto e dispensazione di sostanze stupefacenti e psicotrope. Il DPR 309/90 e suoi aggiornamenti. La terapia del dolore. Ricetta medica a ricalco (RMR). Progetto pilota e dispensazione della cannabis. (12 hours)

Normativa relativa alle sostanze il cui impiego e' considerato doping. (2 hours)

Pharmaceutical dosage forms: classification. Powders: features and analysis. Tablets. Capsules. Suppository. Hydroalcoholic solutions. Ophtalmic reparations. (16 hours)

Interfacial phoenomena. Emulsions and Suspensions. Solutions. Rheology. Expiry date: t10%. (10 hours)

Tests and procedures provided by F.U. for the pharmaceutical dosage forms. (4 hours)

Lab preparations of the most common dosage forms. Numerical excercises. (40 hours)

Adopted texts

1. P.Colombo, F.Alhaique, C.Caramella, B.Conti A.Gazzaniga, E.Vidale, "Principi di tecnologia farmaceutica", Casa Editrice Ambrosiana, 2015.
2. Aulton, “Tecnologie Farmaceutiche - Progettazione e allestimento dei medicinali”, Edra,Italia, 2015.
3. P.Minghetti, "Legislazione Farmaceutica", Casa Editrice Ambrosiana, ultima edizione.
4. Nicoletta Loliscio, “La Farmacia. Un campo minato. Il manuale del farmacista”, Società editrice Esculapio, 2021.
5. Fotocopie degli appunti di lezione e materiale messo a disposizione sul sito del docente.

Bibliography

1. M. Cini, P Rampinelli, “Principi di legislazione farmaceutica”, Edizioni Minerva Medica, 2019. 2. F.U. XII Edizione, Istituto Poligrafico dello Stato, e successivi aggiornamenti. 3. "Manuale delle preparazioni galeniche", IV ediz., F. Bettiol, Tecniche Nuove ed., 2017. 4. G.C.Ceschel, L.Fabris, E.Lencioni, S.Rigamonti, “Impianti per l'industria farmaceutica", Società Editrice Esculapio,1996. 5. http://www.ministerosalute.it 6. https://www.aifa.gov.it/ 7. http://www.ema.europa.eu 8. https://ec.europa.eu/health/documents/eudralex_it 9. http://www.galenotech.org 10. Aggiornamenti normativi presenti in G.U.

Prerequisites

Necessary: Basic knowledge of Inorganic and Organic Chemistry, Mathematic, Physic, Medicinal Chemistry. Important: Farmacology and Toxicology Useful: Medicinal Chemistry Analysis

Frequency modes

Lesson attendance is not mandatory but deeply recommended for a better and easier understanding of the topics of the course. The attendance to the practical laboratory experiences is mandatory.

Exam modes

For the evaluation of the students there are six session exams per year: two in summer, after the end of the lessons, two in autumn and two in winter.
The exam is divided in two parts: a preliminary written examination (which lasts 90 minutes) followed by an oral exam. The written exam contains four open questions:
- in the first question a medical prescription for a galenic preparation is proposed and the student must comment in detail the legal aspects, including the prescription law, the duties of the physician and those of the pharmacist.
- two questions deal with numerical calculations concerning subjects discussed during the lessons (e.g., calculations for the preparation of isotonic solutions, calculations for the shelf-life of market drug, calculations for the preparation of hydroalcoholic solutions, calculations for the preparation of dosage forms, etc.)
- the last question asks the student to briefly describe, in correct Italian language, one of the topics of the course, concerning pharmaceutical technology or pharmaceutical law.

The oral exam has no exact duration, depending obviously on the many variables. The student is asked to comment and to explain the errors present in the written composition, if any. Questions, in pharmaceutical technology and law, are also proposed. One question on the practical laboratory experiences carried out during the course is also proposed.
The capability to appropriately express the topics of the course, the way of thinking, that mainly infer from the execution of the written test, the capability to independently make judgements represent the parameters taken into account in order to give an evaluation of the overall exam.
In order to pass the exam with the minimum the student is asked to show a sufficient competence of the course topics and sufficient speech skills together with a sufficient capability to independently make judgements.
To reach 30 cum laude the student must demonstrate a particularly excellent preparation in all topics of the course, showing an understanding beyond the factual knowledge.

It has to be underlined that, being the course strictly connected with the future professional life, the knowledge acquired during the mandatory internship spent for six months (full time) in the Pharmacy, represents the best complement for the final preparation of the exam.

Exam reservation date start	Exam reservation date end	Exam date
01/01/2022	14/01/2022	18/01/2022
01/02/2022	11/02/2022	15/02/2022
21/03/2022	14/04/2022	21/04/2022
01/06/2022	12/06/2022	17/06/2022
01/07/2022	08/07/2022	12/07/2022
01/09/2022	18/09/2022	22/09/2022
24/09/2022	08/11/2022	11/11/2022
01/01/2023	16/01/2023	18/01/2023