First cycle
degree courses
Second cycle
degree courses
Single cycle
degree courses
School of Medicine
PHARMACY
Course unit
PHARMACEUTICAL TECHNOLOGY AND LEGISLATION
FAO2043797, A.A. 2019/20

Information concerning the students who enrolled in A.Y. 2016/17

Information on the course unit
Degree course 5 years single cycle degree in
PHARMACY (Ord. 2009)
FA1732, Degree course structure A.Y. 2009/10, A.Y. 2019/20
N0
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Number of ECTS credits allocated 7.0
Type of assessment Mark
Course unit English denomination PHARMACEUTICAL TECHNOLOGY AND LEGISLATION
Department of reference Department of Pharmaceutical and Pharmacological Sciences
Mandatory attendance No
Language of instruction Italian
Branch PADOVA
Single Course unit The Course unit can be attended under the option Single Course unit attendance
Optional Course unit The Course unit can be chosen as Optional Course unit

Lecturers
Teacher in charge NICOLA REALDON CHIM/09

ECTS: details
Type Scientific-Disciplinary Sector Credits allocated
Core courses CHIM/09 Applied Technological Pharmaceutics 7.0

Course unit organization
Period Second semester
Year 4th Year
Teaching method frontal

Type of hours Credits Teaching
hours
Hours of
Individual study
Shifts
Lecture 7.0 56 119.0 No turn

Calendar
Start of activities 02/03/2020
End of activities 12/06/2020
Show course schedule 2019/20 Reg.2018 course timetable

Syllabus
Prerequisites: The course is attended after having attended that of Pharmaceutical Technology. The exam can be taken after taking the Pharmaceutical Technology exam.
Target skills and knowledge: The course aims to acquire knowledge on medicinal products of high-tech industrial production and pharmaceutical legislation, with particular reference to the practice of pharmacy and regulations on Medicines, Medical Devices and Foods.
At the end of the course the student, as far as the technological field, must have acquired the ability to resolve the problems of the development of high-tech pharmaceutical forms in relation to production processes, in particular as regards the modified release pharmaceutical forms.
At the end of the course the student, as far as pharmaceutical legislation is concerned, must have acquired the ability to resolve specific professional problems in the regulatory field of the medicines, the medical devices, the organization of the pharmaceutical service.
Examination methods: The exam takes place with an oral interview that focuses on the two areas of the program carried out: the technological and pharmaceutical regulatory fields.
As for the technology, during the interview, the student is invited to address a general topic that is progressively deepened in specific aspects. In particular, it is required to frame, using strictly appropriate technical terms, the general aspects that characterize a pharmaceutical / dosage form, the composition, the manufacturing methods; from the general aspects it moves towards the deepening of specific aspects such as the specificity and the characterization of the components, their compatibility, the synergy of action for the purpose of the consequences on the kinetics of release and absorption of the active ingredient.
As for the pharmaceutical regulatory framework, during the interview, the student is invited to deal with a general topic that is progressively requested to be related to specific competing standards; the student is therefore urged to develop with critical spirit and autonomy of judgment the application of the rules dealt with on specific professional problems in the regulatory field of the medicines, the medical devices, the organization and the disengagement of the pharmaceutical service.
The final result is defined by the ability of the student to discuss any question about the practical test and the knowledge argued about other topics.
Assessment criteria: The assessment of the examination is carried out on the basis of the following criteria:
a) knowledge and ability for theoretical and applicative understanding of the topics studied; examples are:
- the ability to translate general knowledge on pharmaceutical polymers used in the formulation and production of modified-release pharmaceutical forms;
- demonstration of the ability to coordinate theoretical knowledge on medicinal products of industrial origin and of galenic origin in the release of prescription and in the management of poisonous substances, of substances with narcotic and psychotropic action, of the doping substances and the medicines containing them;
-the demonstration of the ability to coordinate theoretical knowledge on medical devices, in vitro diagnostics and food supplements for the purpose of their diversified technical location with respect to the medicinal product.

b) autonomy of judgment and ability to link the themes studied; example is the demonstration of the ability to address the release of medicines in emergencies, the substitutability of medicines in the context of the classification of medicinal products for the purposes of dispensation, defined in the regulatory setting of the marketing authorisation or the decision-making ability to give or not to the magistral galenic preparation following the medical prescription.

c) appropriateness in the use of technical-scientific language as unequivocal professional communication tool.

Furthermore, the expressive / communicative capacity is taken into account in the correct form of the Italian language.
Course unit contents: The course of Pharmaceutical Technology and Legislation deals with:
- pharmaceutical forms for oral use of industrial origin of advanced technology such as those with modified release (prolonged, delayed, pulsatile), with reference to production processes (coatings) and release kinetics;
- the use of polymers in modified release oral forms;
- matrix systems (inert, swellable, erodible) for oral use
- osmotic pump systems (push pull, Oros-CT, L-oros, ...)
- transdermal systems
- the national health organization
- the profession of pharmacist and professional association
- the practice of pharmacy
- the hospital pharmacy and the local pharmaceutical organization
- the disengagement of the pharmaceutical service
- the public dispensation of medicines
- The medicinal product of industrial origin
- the galenic medicine
- in vitro medical devices and diagnostics, PMCs
- Foods
- medicines containing narcotic and psychotropic substances
Planned learning activities and teaching methods: Course includes lectures (56 hours.) During the lessons, learning is encouraged through a continuous involvement of students discussing the consequences in the professional practice of the topics and concepts proposed.
Classroom exercises are planned for the application of the theoretical bases to practical examples of evaluation and delivery of medical prescriptions.
Additional notes about suggested reading: The slides shown during the lectures, are the basic material for the effective learning of the subject.
Textbooks (and optional supplementary readings)
  • P. Colombo et al., Principi di Tecnologie Farmaceutiche. Milano: Ambrosiana, --. Cerca nel catalogo
  • --, Farmacopea Ufficiale, Farmacopea Ufficiale Italiana, XII Edizione Istituto Poligrafico e Zecca dello Stato. --: Zecca dello Stato, --. Cerca nel catalogo
  • --, Farmacopea europea IX ed.. --: --, --. Cerca nel catalogo
  • P. Minghetti-M. Marchetti, Legislazione Farmaceutica IX Ed.. Milano: Ambrosiana, 2018. Cerca nel catalogo
  • B. R. Nicoloso, Il sistema Farmacia. --: Puntoeffe, --. 2012 Cerca nel catalogo
  • M.E. Aulton, Tecnologie farmaceutiche-Progettazione e allestimento dei medicinali. --: Casa editrice EDRA, 2015. Cerca nel catalogo
  • M. Cini – P. Rampinelli, Principi di Legislazione farmaceutica. --: Minerva medica, --. seconda edizione Cerca nel catalogo

Innovative teaching methods: Teaching and learning strategies
  • Lecturing
  • Problem based learning
  • Questioning
  • Problem solving
  • Use of online videos
  • Loading of files and pages (web pages, Moodle, ...)

Sustainable Development Goals (SDGs)
Good Health and Well-Being