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Professor
BIANCA MARIA BAROLI (Tit.)
Period
Second Semester 
Teaching style
Convenzionale 
Lingua Insegnamento
 



Informazioni aggiuntive

Course Curriculum CFU Length(h)
[50/24]  TOXICOLOGICAL SCIENCES AND QUALITY ASSURANCE [20/00 - Ord. 2017]  PERCORSO COMUNE 10 92

Objectives

KNOWLEDGE AND UNDERSTANDING.

Student has to get strong normative and applicative knowledge on production and quality control of (i) innovative and traditional medicaments, whose active molecule(s) may be naturally, synthetically, and/or biotechnologically originated/produced, (ii) medical devices and related products, and (iii) cosmetics, without forgetting all the raw materials listed as ingredients of the mentioned products. With regards to normative aspects, a great emphasis is given to good manufacturing practices, all the analyses requested prior to their commercialization, and to the vigilance performed after their commercialization.

APPLYING KNOWLEDGE AND UNDERSTANDING.

Student has to get applicative know-how in the quality control of medicines, medical devices, and cosmetics. Student will be able to use this knowledge in professional and working environments, and will be able to evaluate the quality, effectiveness, and safeness of different products by using dedicated quality control assays.

CRITICAL OPINION.

Student will acquire a conscious independent and critical opinion on data evaluation, analysis and interpretation, as well as on the comprehension ability and evaluation of ethical, social, and environmental impact of same data. He/she will also start to learn his/her own ethical and professional responsibilities, and to learn using the base equipment needed to carry out quality control assays.
Communicative skills. Student has to acquire appropriate communicative skills to manage the information of toxicological data/issues when this is directed toward a specialist or common audience. In addition, he/she has to develop the ability to work in a team, by acquiring or simply polishing his/her communicative, relational, and/or organization skills, which are all of primary importance in the real work environment.

LEARNING ABILITIES.

In addition to all that was mentioned above, student will mould his/her own ability to autonomously search and find in books and/or web-site/database (which may be written/displayed in English or Italian) needed information. Students will be pushed toward these abilities through the home-works and group-project.

Prerequisites

To attend and pass this exam with profit, chemical, biological, and instrumental knowledges are basilar, since the major focus of this class is the pre- and post-commercialization quality control of products (medicaments, cosmetic, medical devices) that will be administered or implanted in human beings. Therefore, previous exams that have to be intended as propaedeutic are physiology, and Fundamentals of Quality Control. It is furthermore important that student has acquired instrumental (e.g., UV, HPLC, GC, MS, etc), pharmacological (e.g., pharmacokinetics e pharmacodynamics), microbiological (for those products that are administered as sterile ones), and pathological (how body respond to a non-welcome molecule or event) knowledges. Finally, to be acquainted with internet surfing, office package programs, and English will be useful resources for the home- or class-works.

Contents

Course is given for ca. 3 months starting in March, and accounts for 8 hours/week (92 hours total; 56 F + 36 L) of regular (F) and practical (L) classes and online classes.
Topics of regular classes are the followings:
Pharmaceutical and cosmetic vehicles: powders, tablets, capsules; extractive solutions; vegetable drugs and derived vehicles; injectables and other injective systems; short accounts on controlled release systems; skin and related vehicles/devices (e.g., ointments, emulsions, suspensions, other dispersed systems, patches); skin penetration enhancers: applications and toxicological issues. Quality control assays of each above-mentioned products.
Laws and regulations: good manufacture practices; analyses on raw materials, pharmaceutical and cosmetic formulations, toxicological analyses; pharmaceutical and cosmetic formulation production and marketing; cosmetics; narcotic and psychotropic drugs; poisons; and vegetable medicaments. Italian, European and American Pharmacopoeia.
Cosmetics: classification and function, general information. Laws related with cosmetic quality: raw material quality control; impurity assessment; stability, and other analyses.
Alongside with regular classes, students will receive home-works to familiarize with government websites where one can find legislations and quality control protocols. Students, as individuals or as group, will have to prepare a report in word/pdf format where he/she or the group will synthetically describe what was found. Assigned deadlines will have to be respected.
In laboratory classes students will learn how to use the Zetasizer nano (ZSP red badge).
Finally, the group project will be carried out along the semester and it will put together all the theorical and practical information acquired in this exam.

Teaching Methods

As already mentioned, course is given for ca. 3 months starting in March, and accounts for 8 hours/week (92 hours total; 56F+36L) of regular and practical classes and online classes. During regular classes, students are encouraged to take part of the discussion. By doing so, student critical skills are reinforced, relationship between knowledge form this and other courses is shown, and a positive loop on student memory of previous and new data should be established. Group discussion, when chaired by professors, may also give the correct space to timid and extroverted students. The rational beyond legislation home-works is (i) to make appealing a non-scientific topic, (ii) to encourage student in finding data/methods/regulations useful for the real work in the web-sites of Italian/European agencies/institutions, and (iii) to push students to search for job/trainee opportunities/applications in the same agencies/institutions. Generally, two in-itinere examinations are performed to guide students on their studying activity and consequently to pass the exam within a few weeks from the end of the course. In addition, students will be grouped and they will have to work as a team for a common project. The latter regards with the theoretical/practical analysis of a cosmetic. The rational beyond this project is (i) to expose students to real-working-life mimicking situation (when they will have to collaborate with colleagues), (ii) to apply all the knowledges acquired in this course regarding (a) all the different types of vehicles, raw materials, final products and containers, (b) normative, technological, toxicological, pharmacological issues, (c) assay and assay limit specifications, and (d) analysis methodology, to name some of the most important purposes.

Verification of learning

Acquired knowledges will be evaluated with a written and/or oral examination. Final score will be calculated with a dedicated Excel file, which will account of the following scores: written examination, home-works, activities performed in class, practice exercises, and participation (e.g., presence and to be active in class discussion). It is emphasized that students have to be present in class/laboratory any time that they will be required to work as a team; in this case, presence has not to be lower than 65%. Since program can be divided in three portions, final score is taking into account how many hours will be dedicated to each program module. For the examination students have to answer to three questions on legislation, pharmaceutical technology, and quality control assays; score of each answer has to be equal/superior to 18/30. For the portion of the program related with the cosmetics analyses, students will be grouped in teams, and will have to work together along the semester for a common project; even in this case the evaluation has to be equal/superior to 18/30. Knowledge evaluation will be very positive (e.g., 30/30 cum laude) when student will show to be able to integrate the different modules of the course program (and also some other knowledges previously acquired in other courses) in an organic discussion. For a future work independency, it is necessary that student will show to have understood the rationale beyond each quality control analyses of medicaments and cosmetics, as well as all the toxicological, technological, pharmacological, and legislative issues associated to each studied product.

Texts

Amorosa, Principi di tecnica farmaceutica, Ed. Tinarelli;
Ragazzi, Lezioni di tecnica Farmaceutica, Ed. Cortina;
Marchetti e Minghetti, Legislazione Farmaceutica, Ed. Ambrosiana;
Colombo et al., Principi di tecnologia farmaceutica, Casa Editrice Ambrosiana.
In addition, a detailed document describing each single lesson (i.e., content, books to be used, web sites to be visited, propaedeutic knowledges, etc.) will be given to students at the beginning of the course.
Other suggested books:
G. Proserpio Chimica e Tecnica Cosmetica 2000 Ed. Sinergia, Milano; G. Proserpio Gli ingredienti cosmetici BCM Editrice, Milano; M. Giuliani Manuale di Scienze e Tecnologie Cosmetiche, Aracne Ed., Roma; D.A. Skoog Chimica Analitica e Strumentale Ed. EdiSES.

More Information

Selected didactic materials will be uploaded on the dedicated Moodle page (e.g., exercises for auto-evaluating the comprehension of the exam, home-work specifics, video tutorials, etc).
The Official Italian Pharmacopeia as well as pubmed and other online resources will be used to develop the cosmetic project (e.g., www.Eur-lex.Europa.Eu/it ; www.ministerosalute.it ; Italian, European and American Pharmacopeias).
For some in-class exercitations, students should be provided with an electronic device connectable to internet.
In laboratory classes students will learn how to use the Zetasizer nano (ZSP red badge).

Questionnaire and social

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