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
- 66 ore - Aurelie Marie Madeleine Schoubben
- 4 ore - Aurelie Marie Madeleine Schoubben
- CFU
- 8
- Course Regulation
- Coorte 2022
- Offered
- 2023/24
- 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. - Other information
- 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 to the course: definitions of biomaterials and biocompatibility. Applications of biomaterials. Biomaterials and biological environment, classification of biomaterials. Problems of biomaterials: the various forms of degradation: functional degradation, environmental degradation and programmed degradation. The causes of degradation and in particular fatigue. Degradation of biomaterials: corrosion. Metals as biomaterials: stainless steels, cobalt alloys, platinum, titanium alloys. Shape memory alloys.
The forms of degradation: usury. The causes and consequences of biodegradation.
The sutures. Introduction on applications in the cardiovascular field: haemocompatibility, haemolysis, coagulation, heart anatomy, mechanical valve prostheses. The various types of prosthetic valves and the materials used to produce them: silicone rubber, Co-Cr-Mo alloys, Ti alloys, PTFE, PET, acetal resin, pyrolytic turbostratic carbon and PVD. Mechanical valve prostheses (types, properties). Biological valve prostheses, causes and consequences of prosthesis failure, comparison between mechanical and biological prostheses, checks on valve prostheses.
Vascular prostheses: introduction, properties of synthetic vascular prostheses. Materials used in vascular prostheses: PET, PTFE, expanded PTFE, silicones and polyurethanes. Stents: properties of stents, coating materials, restenosis and drug eluting stents. BIS stents. The Amplatzer medical device.
Tissue engineering: Temporary and permanent skin substitutes: Transcyte, Hydrocolloids, Integra. Scaffolds: scaffold preparation methods (conventional, selective laser sintering, soft lithography). Scaffolds: scaffold preparation methods (electrospinning). Methods of dipolymer preparations for molecular recognition: synthesis in bulk or by precipitation. Applications of polymers for molecular recognition. Hyaluronic acid for the preparation of scaffolds. Properties and functions of hyaluronic acid. Bio-engineered hyaluronic acid for the dermis and epidermis. Cartilage and bioengineered bone. Evolution of tissue engineering: towards the co-culture of different cell types and references to regenerative medicine, ABAT case study for the regeneration of small arterial tracts.
Joint prostheses: total hip prosthesis, materials used for the various components of the prosthesis: bone cement, UHMWPE, metal alloys. Ceramics as a component of hip prosthesis femoral heads. Acetabular couplings. Surface modifications of biomaterials: Deposition of polymeric layers (non-stick, antimicrobial), Plasma functionalization: what is plasma, how it is generated and used to modify the surface properties of biomaterials, applications of plasma to modify the surface properties of biomaterials. SAM technology: self-assembled monolayers, techniques used to modify the surface properties of biomaterials with SAM technology. Surface modifications aimed at improving the osseointegration of the materials used in joint prostheses: hydroxyapatite, bioglasses, biomimetic titanium produced with the Kokubo method and Anodic Spark Deposition. Regulatory aspects of medical devices: European Directive 93/42/EC, Directive 2007/47. Borderline products and the European regulation 2017/475. Liposomes: definition and composition, phospholipids: structure and properties. The thermotropic behavior of the phospholipid bilayer and the importance of the main transition temperature. Influence of phospholipid type on the main transition temperature, effect of cholesterol on the fluidity of the phospholipid bilayer. Classification of liposomes according to the size and number of lamellae, MLV, LUV and SUV characteristics, liposome preparation methods: thin layer evaporation, solvent injection method for liposome preparation. Using high pressure extrusion and homogenization. Liposome loading methods: concentration gradient-mediated remote loading and freeze-thawing. Use of liposomes for drug delivery: concepts of passive and active targeting. Marketed liposomal formulations containing anticancer agents: comparison. Pharmaceutical applications: polymers used in microencapsulation, the case of polyesters and acrylates. Biodegradation and bioerosion of polymers. Methods of preparation of the microparticles: coacervation, evaporation of the solvent. Pharmaceutical applications: what is solubility and how many types of solubilities exist. The importance of solubility in drug discovery and development. How to determine equilibrium solubility: shake flask method, method of successive additions, parameters influencing solubility, dissolution media, influence of pH, impurities, polymorphic form. Cyclodextrins and cyclodextrin complexation to increase the apparent solubility of poorly soluble APIs. Properties of cyclodextrins and methods of preparation of inclusion complexes. Commercial products based on cyclodextrins.
The ionic gelation of sodium alginate.
Educational laboratories: Preparation of MLV liposomes with the Thin Layer Evaporation method using the DPPC.
Dimensional analysis of MLVs obtained with the SPOS technique - use of the Accusizer Particle Sizing System instrument, Preparation of albumin nanoparticles with the phase coacervation and thermal crosslinking method, dimensional analysis of albumin NPs prepared with the phase coacervation technique.
Preparation of liposomes containing alizarin red dye by the ethanol injection method. Dialysis of liposomes prepared for solvent injection and UV-vis analysis of the dialysate to determine the liposome encapsulation efficiency. Acyclovir-Hydroxypropyl-beta-cyclodextrin inclusioncomplex: kneading method, incorporation of the beta-CD/acyclovir complex into a mucoadhesive hydrogel for the production of a buccal patch and preparation of the backing layer, preparation of the buccal patch with acyclovir. Acyclovir loaded oil entrapped calcium alginate beads: ionotropic gelation method. Preparation of PLGA NPs with the nanoprecipitation technique. Preparation of Eudragit nanoparticles loaded with acyclovir, dimensional analysis and freezer-drying. In vitro release study of acyclovir from Eudragit nanoparticles and analysis by UV-Vis spectrophotometer to determine the concentration. Preparation of hydrogels with CMC and sodium hyaluronate. Nylon: interface polymerization.
Chitosan fibers for tissue engineering applications: fabrication and annealing. - Obiettivi Agenda 2030 per lo sviluppo sostenibile
- Health and wellness