The aim of this study was to determine the influence of factors such as temperature and glutaraldehyde (GA) concentration on the mechanical properties of porcine pericardia, in order to propose the recommended optimal conditions of a cross-linking process. It was also to verify whether tannic acid (TA), a natural cross-linking agent that stabilizes collagenous tissues by a different mechanism than GA, may positively influence the strength of pericardium. Methods: The samples were incubated at various temperatures (4, 22, and 37 °C) and GA concentration solutions (0.6, 1.5 and 3%) for 7 days. Three series were selected and additionally cross-linked with 0.3% TA for another 7 days. Mechanical properties of cross-linked pericardium samples, i.e., ultimate tensile strength (UTS) and elastic modulus (E) were measured in uniaxial tensile testing. The hyperelastic model for incompressible materials – isotropic by Ogden [24] and anisotropic by Fung [7] were utilized to describe the mechanical behaviour of treated pericardium. Results: The temperature has an influence on cross-linking effects; the lowest values of UTS were reported for specimens cross-linked at 22 °C, while the mechanical properties of series treated at 4 °C or 37 °C were comparable. At a particular temperature of incubation, the GA concentrations have not affected the mechanical properties of tissues. The dependence between mechanical parameters and agent concentration was only observed for specimens treated with GA at 37 °C. Conclusions: The conditions of the cross-linking process affect the mechanical properties of the porcine pericardium. Room temperature (22 °C) and the concentration of 1.5% GA occurred to be ineffective. The mechanical properties of GA-treated pericardium were improved by an additional TA cross-linking.
Poly(L-lactide-co-glycolide-co-trimethylene carbonate) rods with risperidone and 17-β-estradiol were sterilized by electron beam irradiation. The aim of the study was to assess electron beam irradiation impact on terpolymer composition, chain microstructure, glass transition temperature, molecular weight and the morphological features of rods. Methods: Hot melt extrusion in the formulation of rods was applied. Sterilization of the rods was performed by electron beam in an electron beam accelerator (10 MeV, 360 mA, 25 kGy). The following methods in the development of rods were applied: nuclear magnetic resonance, differential scanning calorimetry, gel permeation chromatography and scanning electron microscopy. Results: Sterilization influenced only glass transition temperature in blind rods and rods with risperidone. As for the other parameters, no significant changes were observed as far as a sterilization effect is concerned. However, some changes were noted after introducing drug substances and after extrusion. Conclusions: Electron beam irradiation of rods with risperidone and rods with 17-β-estradiol is an adequate method for sterilizing implantable drug delivery systems.
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