Pharmaceutical Technology and Legislation II and Lab of Pharmaceutical Technology II Medical Devices and Cosmetic prod

A.Y. 2019/2020
12
Max ECTS
120
Overall hours
SSD
CHIM/09
Language
Italian
Learning objectives
The objective of this course is to provide basic principles of the design, production and testing of the main dosage forms, either for immediate or modified release, with special reference to injectable and topical ones. The course aims to help students gain knowledge and comprehension of the relationships linking technological, biopharmaceutical and pharmacokinetic properties of drug formulations. Regulatory aspects relevant to production and marketing of drug and health products, including cosmetics and medical devices, are addressed. Fundamentals of pharmaceutical legislation and of pharmacist practice ethics are also covered. Single-bench laboratory practicals are aimed at strengthening the knowledge acquired through preparation and control of magistral and officinal formulae intended for the concerned routes of administration and drafting of the relevant documentation in compliance with current laws.
Expected learning outcomes
Through this course, the student gains fundamental skills in the design, preparation/production and control of the main dosage forms, either for immediate or modified release, with special reference to injectable and topical ones. Thanks to the knowledge acquired, he will be able to correlate formulation characteristics of the covered drug preparations/products with their biopharmaceutical and pharmacokinetic properties, and to critically evaluate how to modulate the latter through purposely implemented technological activities. In addition, he will manage to understand and apply regulations relevant to the production and marketing of medicinal and health products for professional practice purposes, particularly within a pharmacy.
Course syllabus and organization

Linea MZ

Course currently not available
Syllabus
The syllabus is shared with the following courses:
- [E24-46](https://www.unimi.it/en/ugov/of/af20200000e24-46)
Laboratory of Pharmaceutical Technology II
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 3
Single bench laboratory practical: 48 hours
Medical Devices and Cosmetic Products
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 3
Lessons: 24 hours
Pharmaceutical Technology and Legislation II
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 6
Lessons: 48 hours

Linea Unica

Responsible
Lesson period
year
Course syllabus
Physicochemical principles: interfacial phenomena; disperse systems: colloids, emulsions, and suspensions; rheology. The sterilization.
Biopharmaceutical aspects, formulation, preparation and control of immediate and modified release dosage forms: parenteral, topical and transdermal, ocular, rectal and vaginal drug delivery.
Introduction to homoeopathic preparations.
Italian and UE forms of law. National Health Service. The rules governing the production and the marketing of the medicinal products. The case of generics, OTC, veterinary and homeopathic products. The regulation of the controlled substances. Prescription requirements. The ethic and the role of the Pharmacy Board. The organization of the pharmacy system. The law of health foods.
Prerequisites for admission
To access the exam it will be necessary to have acquired knowledge of the topics covered in Pharmaceutical Technology I and Pharmaceutical Chemistry II exams and to have attended Pharmaceutical Technology Laboratory II.
Teaching methods
Classes and single-bench practicals.
Bibliography
1. Principi Di Tecnologie Farmaceutiche. P Colombo, F Alhaique, C Caramella, B Conti, A Gazzaniga, E Vidale. C.E.A. Casa Editrice Ambrosiana Ed. 2015.
2. Tecnologie Farmaceutiche. ME Aulton, KMG Taylor. IV Edizione Edra Ed. 2015.
3. Legislazione Farmaceutica. P. Minghetti. CEA, 2018.
Lessons slides and supplementary material available on ARIEL website.
Lessons slides and additional material available on ARIEL
Assessement methods and criteria
The exam is divided into three parts. 1) Preparation of a magistral formula and related regulatory aspects inherent in its dispensing. 2) Three-hour written test (technology topics), with recognition and comment of a pharmaceutical formulation and open questions. The written test includes five queries, and it is considered passed if the candidate answers positively to at least four of these. 3) Oral test (legislation: dispensing of a recipe and three open questions) to be taken within 12 months after passing the written test.
For attending students, the written test can be replaced by an oral test to be taken within the summer exam session of the academic year of attendance.
Laboratory of Pharmaceutical Technology II
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 3
Single bench laboratory practical: 48 hours
Shifts:
Turno 1 (ed. unica AZ)
Professor: Maroni Alessandra
Turno 2 (ed. unica AZ)
Professors: Foppoli Anastasia Anna, Maroni Alessandra
Turno 3 (ed. unica AZ)
Professor: Musazzi Umberto Maria
Turno 4 (ed. unica AZ)
Professors: Franze' Silvia, Minghetti Paola
Medical Devices and Cosmetic Products
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 3
Lessons: 24 hours
Professor: Minghetti Paola
Pharmaceutical Technology and Legislation II
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 6
Lessons: 48 hours
Professor(s)
Reception:
by appointment
via G. Colombo 71
Reception:
By appointment
Dipartimento di Scienze Farmaceutiche, Sezione di Tecnlogia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71