Course program
Definition, characteristics and preparation of solid dosage form containing drugs: tablets (uncoated, coated, dispersible, effervescent, gastro-resistant, modified-release, soluble), capsules (hard and soft), powders. Definition, characteristics and preparation of liquid preparations containing drugs: (for oral use, for cutaneous application), syrups, emulsions, suspensions, extracts, tinctures. Definition, characteristics and preparation of semi-solid preparations for cutaneous application containing drugs: creams, ointments and gels.
Pharmaceutical and technical procedures from Pharmacopoeia. Pharmacopeias: Italian and European Pharmacopoeia. (24 h)
Legislation of pharma products, herbal products, dietary supplements, cosmetic products. Legislation of homeopathic products. (4 h)
Herbal drug preparation. Definition and characteristics of: herbal teas, extracts (liquid, soft and dry), tinctures and vegetable fatty oils. Powder milling. Classification of drugs with dimensions. Mills, sieves and mixer. Drug extraction methods: maceration, percolation, infusion and decoction preparation. Extracts drying methods and storage. Freeze-drying. (20 h)
Prerequisites
Necessary for the understanding of the lessons the concepts of: General and Inorganic Chemistry, Applied Pharmaceutical Botany, Nutraceuticals and Dietary Products, Drug Research and Development and Regulatory Aspects, Marketing and Pharmaceutical Market Access, Pharmaceutical Botany, Pharmacognosy, Food supplements of plant origin, Extraction of natural compounds and analysis of the active ingredients of medicinal and aromatic plants.
Important: the acquisition of knowledge on: Phytotherapy and phytovigilance, General pharmacology and Pharmacotherapy Pharmacovigilance and toxicology, Pharmacognosy applied Phytotherapeutic chemistry, Organic chemistry and chemistry of natural organic substances.
Useful: it is useful to have acquired notions of Mathematics and Statistics, Computer Science, Microbiology, Pharmaceutical chemistry and toxicology.
Books
TESTI ADOTTATI
Franco Bettiol, Franco Francesco Vincieri, "Manuale delle preparazioni erboristiche”, II Edizione, Tecniche Nuove
Colombo et al. "Principi di Tecnologia Farmaceutica", Casa Editrice Ambrosiana II Edizione
Maurizio Cini, Patrizia Rampinelli, “Principi di legislazione farmaceutica“, Edizioni Minerva Italica
Siti internet: Ministero Salute, AIFA
BIBLIOGRAFIA
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.
Frequency
The teaching consists of lectures and one or two specific seminars. The lessons are interactive; the teacher stimulates the students with questions to which they, by virtue of the courses already followed, can give an answer. This allows the teacher to make evident the links between the current course and some previous courses, whose notions play a key role in understanding what is proposed in class. Continuous references to concepts of previous courses stimulate the students studying the proposed subject as a multidisciplinary study. This is important for a student of the third year, now almost at the end of his training. The student will find on the e-learning platform the slides and the teaching material (exam program, recommended texts) useful for the preparation of the exam. It is to be underlined that the slides are a guide to the exam topics, never replacing the recommended texts and lectures given by the teacher.
Attendance to the course is optional but recommended.
Exam mode
The assessment method of the course is characterized by an oral exam according to a calendar proposed at the beginning of the academic year. The teacher is also available to postpone the scheduled exam up to 15 days. Who does not successfully pass the exam can come back to the next date. The oral exam lasts an average of one hour; during this timespan the teacher examines the candidate on his knowledge of all the subjects. Topics must be displayed in a appropriate language, using appropriate terms.
The elements taken into consideration for the evaluation are: knowledge of the subjects, the use of an appropriate language, the active participation during the lectures, the ability of reasoning demonstrated during the trial, the ability to study autonomously on the texts.
Sufficient knowledge of the topics is required for passing the exam with minimum grades. To achieve a score of 30/30 cum laude, the student must demonstrate have acquired excellent knowledge of all the topics covered during the course, being able to link them in a logical and consistent way. The student must also be able to draw up original results based on the knowledge acquired.
Lesson mode
The teaching consists of lectures and one or two specific seminars. The lessons are interactive; the teacher stimulates the students with questions to which they, by virtue of the courses already followed, can give an answer. This allows the teacher to make evident the links between the current course and some previous courses, whose notions play a key role in understanding what is proposed in class. Continuous references to concepts of previous courses stimulate the students studying the proposed subject as a multidisciplinary study. This is important for a student of the third year, now almost at the end of his training. The student will find on the e-learning platform the slides and the teaching material (exam program, recommended texts) useful for the preparation of the exam. It is to be underlined that the slides are a guide to the exam topics, never replacing the recommended texts and lectures given by the teacher.
Attendance to the course is optional but recommended.