Three generations of cyclosporine a formulations: an in vitro comparison

When the microemulsion formulation of the critical dose drug cyclosporine A (CsA) (Sandimmun Optoral) was introduced in the mid-1990s, it became clear that this new formulation improves the oral bioavailability of CsA and has a positive influence on its pharmacokinetic variability. Previous studies with the original CsA formulation (Sandimmun) showed that the size of the emulsion droplets and concomitant food intake has an effect on the absorption of CsA from the small intestine when orally administered. It was suggested that these effects might have an influence on the drugs' pharmacokinetic parameters.In this study, we focused on the two above-mentioned aspects and compared the first and second generations of CsA products (Sandimmun, Sandimmun Optoral) to generic CsA formulations by analyzing the contents of cyclosporine A gel capsules with respect to their emulsion droplet and micelle sizes using photon correlation spectroscopy (PCS). We tried to discern any differences in droplet size between different generations of CsA formulations, primarily the second and third generation, through simple physical tests. Because a high fat content food may influence the absorption of CsA, we also determined the distribution of CsA between hydrophilic and lipophilic phases using high-performance liquid chromatography analysis.It became clear that when compared under simple physical conditions, established cyclosporine formulations and new generic products show significant differences in droplet size and distribution between an aqueous phase and a high fat content food. Whether these differences are of clinical relevance remains to be investigated.     

Cost effective second generation AC-modules: Development and testing aspects

In the framework of the European research project PV2GO, a new AC-module inverter was developed, taking into account all relevant aspects from a European market's point of view (standards, market, application, and research and development goals). The project goal was to achieve the overall system costs of 3 Euro per Wp for a modular plug-and-play photovoltaic system. For the photovoltaic-module, a standard 130-Wp Eurosolare module was chosen. The research and development (R&D) goal was to develop an advanced DC-control system consisting of a state-of-the-art programmable digital device and an Application Specific Integrated Circuit (ASIC) for the AC-control of the inverter. According to the topology concept, thermal and magnetic designs were optimized with regard to production technology and packaging for large-scale production. The new AC-modules were tested in a number of field-test sites in various parts of Europe and their reliability was assessed through Highly Accelerated Stress Tests. Efficiency and power quality have been tested in the laboratory. Further in the PV2GO project an optimization study of the manufacturing process of the new generation of AC-modules for high volume output was done. Another task was the pre-certification procedure to assure compliance with the European guidelines and standards.     

NUMERICAL INVESTIGATION OF TRANSPORT PHENOMENA IN THE FUSION ZONE OF LASER BEAM WELDED JOINTS

The development of a steady-state process model for a numerical study of transport phenomena in the fusion zone of deep penetration laser beam welded joints is described. Based on the conservation equations of energy, momentum, and mass in dimensionless form, the three-dimensional modeling considers viscous, buoyancy, and friction forces as well as surface tension gradients. The developed simulation program enables the prediction of the local temperature and velocity distribution in the molten material. Consequently, the resultant weld pool dimensions dependent on the characteristic dimensionless groups can be derived.     

Bioactivity evaluation of collagen-based scaffolds containing a series of Sr-doped melt-quench derived phosphate-based glasses

Phosphate-based glasses have been attracting attention due to their possible medical applications arising from unique dissolution characteristics in the human body leading to the possibility of new tissue regeneration. In this study, the leaching kinetics of a series of melt-quenched Sr-doped phosphate glasses are presented. Regardless of the presence of Sr, all the glasses have an initial linear and sustained release of the ions followed by a plateau. To guarantee proper nutritional support to the growing tissue during regeneration and to mimic the 3-dimensional architecture of tissues, organic scaffold systems have been developed. However, their poor mechanical strength has limited their application. To overcome this problem, cross-linkers can be used although this then limits the solubility of the materials. To succeed in dealing with such a limitation, in this paper, by freeze-drying, the aforementioned soluble melt-quenched phosphate glasses were combined as powders with collagen fibres from bovine achilles tendon to make degradable scaffolds. The scaffolds were characterized by SEM, EDX and BET. Changes to the dissolution behaviour of the glasses arising from the presence of collagen interacting with the ions leached were reported. Furthermore, the ability of the scaffolds to induce hydroxyapatite (HA) formation was evaluated: one the elaborated scaffold could grow an HA-like layer after a week in SBF. Based on the results obtained, a possible application in restorative dentistry is proposed for one or more materials.

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Combinatorial corrosion study of the passivation of aluminium copper alloys

An Al_96.1–Cu_3.9 to Al_51.4–Cu_48.6 material library was obtained by thermal co-deposition and characterized by EDX and XRD. The crystallographic data reveals the presence of Al₂Cu and pure aluminium depending on the film composition and following the stoichiometry. Utilizing a scanning droplet cell setup, the zero current potential for anodization, the oxide formation factor and the dielectric constant of the oxide formed are presented with high resolution along the composition gradient.While the dielectric constant of the oxide formed remains nearly unaffected by the increasing copper content of the base material along the composition gradient, the zero current potential shows well defined steps between 6.9 and 8.5 at.% as well as between 20.9 and 26.7 at.% copper indicating an increased thickness of the native oxide present on the film. Additionally, starting around 25 at.% copper, oxygen evolution gradually superimposes the oxide growth and in turn significantly reduces the current efficiency for anodization. The formation of the intermetallic phase Al₂Cu was linked to both phenomena as it promotes the growth of native oxides and current leakage by oxygen evolution.