This review shows the steps toward material selection focalized on the design and development of medical devices based on hyaluronan (HA). The selection is based on chemical and mechanical properties, biocompatibility, sterilization, safety, and scale-up costs. These facts play a vital role in the industrialization process. Approved medical devices containing-HA are illustrated to identify key parameters. The first part of this work involves the steps toward a complete characterization of chemical and mechanical aspects, reproducibility of the processes and scale up. In a second stage, we aimed to describe the preclinical in vitro and in vivo assays and selected examples of clinical trials. Furthermore, it is important to keep in mind the regulatory affairs during the research and development (R&D) using standardization (ISO standards) to achieve the main goal, which is the functionality and safety of the final device. To keep reproducible experimental data to prepare an efficient master file for the device, based on quality and recorded manufacturing data, and a rigorous R&D process may help toward clinical translation. A strong debate is still going on because the denominated basic research in HA field does not pay attention to the purity and quality of the raw materials used during the development. So that, to achieve the next generation of devices is needed to overcome the limitations of state of art in terms of efficacy, biodegradability, and non-toxicity.

• Klíčová slova
• FDA, chemical modification, clinical data, cross-linked, hyaluronan, hydrogel, preclinical data, risk management,
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

In this work, a hybrid copolymer consisting of poly(3-hydroxybutyrate) grafted to hyaluronic acid (HA) was synthesised and characterised. Once formed, the P(3HB)-g-HA copolymer was soluble in water allowing a green electrospinning process. The diameters of nanofibres can be tailored by simply varying the Mw of polymer. The optimization of the process allowed to produce fibres of average diameter in the range of 100-150 nm and low polydispersity. The hydrophobic modification has not only increased the fibre diameter, but also the obtained layers were homogenous. At the nanoscale, the hybrid copolymer exhibited an unusual hairy topography. Moreover, the hardness and tensile properties of the hybrid were found to be superior compared to fibres made of unmodified HA. Particularly, this reinforcement was achieved at the longitudinal direction. Additionally, this work reports the use in the composition of a water-soluble copolymer containing photo cross-linkable moieties to produce insoluble materials post-electrospinning. The derivatives as well as their nanofibrous mats retain the biocompatibility of the natural polymers used for the fabrication.

• MeSH
• biokompatibilní materiály * chemická syntéza   chemie   MeSH
• biomechanika MeSH
• hydrofobní a hydrofilní interakce MeSH
• hydroxybutyráty chemická syntéza   chemie   MeSH
• kyselina hyaluronová chemie   MeSH
• nanovlákna chemie   MeSH
• polyestery chemická syntéza   chemie   MeSH
• polymery chemická syntéza   chemie   MeSH
• poskytování zdravotní péče MeSH
• tkáňové podpůrné struktury chemie   MeSH
• vstřebatelné implantáty * MeSH
• zdravotnické prostředky MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• biokompatibilní materiály * MeSH
• hydroxybutyráty MeSH
• kyselina hyaluronová MeSH
• poly-beta-hydroxybutyrate MeSH Prohlížeč
• polyestery MeSH
• polymery MeSH