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

A.Y. 2020/2021
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 (non attiva nel 20/21)

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
Teaching methods
The lessons will be delivered through the Microsoft Teams platform and can be followed both in synchronous according to the established schedule and asynchronously through the Ariel platform.

Program and reference material
The teaching material will be available on the Ariel platform. The program and the reference didactic material will not change.

Learning assessment procedures and assessment criteria
The exam of the Pharmaceutical Technology 2 module will take place orally using Microsoft Teams platform and will consist of four questions on the topics covered during the course. After passing this test, the oral exam of the Pharmaceutical Legislation module follows (dispension of a recipe and three questions on the topics covered during the course), to be taken within 12 months, using Microsoft Teams platform. The exams will be aimed at ascertaining the achievement of the objectives in terms of knowledge and understanding and verifying the student's autonomy of judgment. The mastery of language and the ability to exhibit will be also evaluated.
The final evaluation will be the weighted average of the evaluations achieved in the two modules.

TEACHING UNIT: Pharmaceutical Technology Laboratory II

Teaching methods
Each turn laboratory provides a portion into a remote mode on MS TEAMS platform (2 European Credit Transfer and Accumulation System (ECTS)) and a part by doing in-person practicals in labs (1 ECTS). The introductory lessons about the legislation that governs the practice of pharmacy in Italy will be delivered on MS TEAMS and can be attended by students in synchronous according to the scheduled timetable. The practicals will be organized in 2 whole days in the laboratory activities prepared in accordance with the Athens's rules. Please note that, regardless of the mode of delivery, all exercises are compulsory.

Program and reference material
The program and reference material will not change. All supporting educational material will be made available through the Ariel platform.

Learning assessment procedures and assessment criteria
The exam will take place in written form using the MS Teams platform. In this case, the test will focus on the dispension of a recipe and all the necessary material (tables, safety data sheets, TNM and doping list) will be made available to students on the Ariel platform.
Course syllabus
CLASSES
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.

SINGLE-BENCH PRACTICALS (TEACHING UNIT: Pharmaceutical Technology Laboratory II)
· Dispersed systems and surfactants (HLB system).
· Compounding in pharmacy and the compilation of labels.
· Medicines dispensing regime. Legislation relating to medical prescription. Dispension of a recipe.
· Preparation of a suspension.
· Semi-solid preparations for cutaneous use and relative controls (recognition of the emulsion type; measurement of consistency by penetrometry).
· Preparation of powders for skin application.
· Liquid preparations for skin application and control of the alcohol content.
· Rectal preparations.
· Sterile preparations. Compilation of setup procedures for sterile preparations.
· Good preparation Rules in Pharmacy.
· Preparation of oral divided powders (wrapped in parchment paper)
· Cosmetic preparations.
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.
Teaching Resources
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
Assessment 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
Professor: Gennari Chiara Grazia Milena
Turno 2
Professor: Maroni Alessandra
Turno 3
Professors: Franze' Silvia, Gazzaniga Andrea
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
Professor: Minghetti Paola
Professor(s)
Reception:
By appointment
Dipartimento di Scienze Farmaceutiche, Sezione di Tecnlogia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71