Unit BIOMATERIALS: ADVANCED APPLICATIONS AND REGULATORY ISSUES

Course
Pharmaceutical biotechnologies
Study-unit Code
55107008
Location
PERUGIA
Curriculum
In all curricula
Teacher
Aurelie Marie Madeleine Schoubben
Teachers
  • Aurelie Marie Madeleine Schoubben
  • Aurelie Marie Madeleine Schoubben
Hours
  • 90 ore - Aurelie Marie Madeleine Schoubben
  • 4 ore - Aurelie Marie Madeleine Schoubben
CFU
8
Course Regulation
Coorte 2021
Offered
2022/23
Learning activities
Affine/integrativa
Area
Attività formative affini o integrative
Academic discipline
CHIM/09
Type of study-unit
Obbligatorio (Required)
Type of learning activities
Attività formativa monodisciplinare
Language of instruction
Italian
Contents
Applications of biomaterials in different fields: cardiovascular, nephrology, pharmaceutics, articular, and tissue engineering. Regulatory aspects of biomaterials in biological field. Laboratory of preparation methods of carriers for pharmaceutical applications.
Reference texts
Polymeric biomaterials edited by Severian Dumitriu, 2nd edition, 2002, Marcel Dekker, NY, USA.
Microencapsulation: Methods and industrial applications edited by Simon Benita, 1996, Marcel Dekker, NY, USA.
R. Pietrabissa, Biomateriali per protesi e organi artificiali, Pàtron Editore, Bologna.
C. Di Bello, Biomateriali, Pàtron Editore, Bologna.
Educational objectives
The main aim of this teaching is to provide students to the bases to understand how are designedmedical devices, bioengineered tissue and innovative pharmaceutical forms.

Main knowledge acquired will be:

- characteristics/properties of the four classes of biomaterials and their potential applications in biomedical field.

- regulatory aspects of medical devices.

- knowledge of the different preparation methods and of the strategies used to formulate different innovative carriers for pharmaceutical applications.

The main competences will be:

- to individuate the best material to use for a specific application according to the properties of this material.

- to classify a medical device according to its biomedical application following the Regulation (EU) 2017/745 of the European Parliament on medical device.

- to be able to produce innovative pharmaceutical formulations thanks to the laboratory exercises.
Prerequisites
To understand the topics of the classes, it may be usefull to have knowledge on human anatomy and pathology and knowledge on polymer, ceramic and metal materials. There are no mandatory prerequisites for students planning to follow this course with profit.
Teaching methods
The course is organized as follows:

- Face-to-face lectures on all the topics of the course;

- Laboratory exercises on the pharmaceutical applications of biomaterials.
Learning verification modality
The final exam consists of an oral test to evaluate the effective aquisition by the student of the knowledge concerning both the theoretical and practical classes. The oral exam consists on an interview of about 30-45 minutes long aiming to ascertain the knowledge level and the understanding capability acquired by the student on theoretical and practical contents as indicated in the program. The oral exam will also test the student communication skills and his autonomy in the organization and exposition of the theoretical and practical topics. The examination, as a whole, allows to verify the ability of the student to link the different topics when necessary.
Extended program
Introduction: biomaterials and biocompatibility definitions, Biomaterial applications, biomaterials and biological environment, biomaterial classification, Biomaterial problems: degradation (corrosion and wear), Causes and consequences of biodegradation, Metals as biomaterial: steel, cobalt alloy, platin, titanium alloy, shape memory alloys.

Sutures

Cardiovascular applications: hemocompatibility, hemolysis, coagulation, hearth anatomy. The mechanical heart valves and the amterials used to produce them (silastic, turbostratic carbon). The biological heart valves. Causes and consequences of heart valve prothesis failure. Comparison between biological and mechanical heart valves. Vascular prothesis and materials used (PET, PTFE, polyurethane. Stents and drug eluting stents.

Nephrology: forces and materials used in dialysis.

Biomaterials and articular prothesis: hip prothesis, UHMWPE, metalic alloys, ceramics.

Tissue engineering: introduction, skin substitutes, scaffolds, polymer and molecular imprinting, hyaluronic acid scaffolds, scaffold applications

Pharmaceutical applications: polymeric particle preparation methods (spray-drying, emulsion evaporation, freeze-drying, coacervation), liposomes, solid lipid nanoparticles

Surface modification techniques, Surface analysis techniques: IR, FTIR, ATR, SEM, ESEM, STM, AFM.

Regulatory aspects of biomaterials in biological field. Laboratory of preparation methods of carriers for pharmaceutical applications, es. liposomes, polymeric microparticles, solid lipid nanoparticles.
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