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Ausgewählte Originalarbeiten 2013/14Biomaterialien maachine Wirkstofffreisetzungssysteme - Grundlagenentwicklungen. Organspezifische in vivo Modelle - Vorbereitung der klinischen Erprobung. Querschnittsprojekte - Methodenentwicklungen an der Testosteron galenika kur von Medizin, Pharmazie und Technik. For developing injectable lenses the retention properties of the capsular bag are important. Therefore the apparent permeability coefficients of sodium fluorescein and fluorescent dextrans of different sizes were determined for the human anterior lens capsule to calculate a molecular weight cutoff from these data. In addition, permeability coefficients of drugs the best steroid stack for cutting machine for the suppression of secondary cataract were determined. The apparent permeability coefficients for actinomycin D and methotrexate were calculated to 0.
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Biomaterialien und Wirkstofffreisetzungssysteme - Grundlagenentwicklungen. Organspezifische in vivo Modelle - Vorbereitung der klinischen Erprobung. Querschnittsprojekte - Methodenentwicklungen an der Schnittstelle von Medizin, Pharmazie und Technik. For developing injectable lenses the retention properties of the capsular bag are important.
Therefore the apparent permeability coefficients of sodium fluorescein and fluorescent dextrans of different sizes were determined for the human anterior lens capsule to calculate a molecular weight cutoff from these data. In addition, permeability coefficients of drugs helpful for the suppression of secondary cataract were determined.
The apparent permeability coefficients for actinomycin D and methotrexate were calculated to 0. Hence, prepolymers are required to polymerize rapidly to be retained inside of the capsular bag. In addition, low-molecular substances intended as antiproliferative drugs for secondary cataract prevention should be applied within a time frame of five minutes in such a way that cells adjacent to the capsular bag will not be damaged. Polymer-based local drug delivery LDD systems have found applications in diverse medical fields.
Due to implant-induced, undesirable foreign body reactions especially implant-associated LDD systems, such as vascular drug-eluting stents, have achieved an increasing importance in the last decade.
Another interesting field of application is the use of polymers as carriers of injectable LDD systems. Therefore, the focus of our research presented in this article is the development of a novel biodegradable LDD system intended for the subconjunctival treatment of glaucoma.
Since hyaluronic acid sodium salt HA is commonly used in ophthalmology due to its viscoelastic and hydrophilic properties, HA was investigated as one polymeric component. As more hydrophobic second component a biodegradable oligomer based on a functionalized 1,2-ethylene glycol bis dilactic acid ELA-NCO was studied regarding its potential to act as drug carrier.
Drug-coated balloons DCB , which have emerged as therapeutic alternative to drug-eluting stents in percutaneous cardiovascular intervention, are well described with regard to clinical efficiency and safety within a number of clinical studies.
In vitro studies elucidating the correlation of coating method and composition with DCB performance are however rare but considered important for the understanding of DCB requirements and the improvement of established DCB. In this context, we evaluated the applicability of a pipetting, dip-coating, and spray-coating process for the establishment of DCB based on paclitaxel PTX and the ionic liquid cetylpyridinium salicylate Cetpyrsal as novel innovative additive in three different compositions.
Among tested methods and compositions, the pipetting process with 50wt. In comparison to literature values, these results support the high potential of Cetpyrsal as novel DCB matrix regarding low drug loss and efficient drug transfer.
New hydrogel materials were successfully synthesized by polymerization of imidazolium-based ionic liquids. These materials were fully characterized to compare chemical and mechanical properties with alginate based gels. The synthesized hydrogels are currently under investigation in vitro to determine drug release behaviour of drug-coated balloons within a vessel-simulating flow-through cell. The drug-coated balloon DCB is an emerging device in percutaneous coronary intervention, which has shown promising results by means of an efficient local release of paclitaxel PTX without the need of an implant remaining in the patient's body.
Safe and efficacy of DCB have been already proven in clinical trials for the treatment of in-stent restenosis and complex coronary de novo lesion subsets, such as small vessel diseases, diabetes, and fuse lesions, where stents obtain suboptimal results. However, there is only very few literature data about coating and drug delivery characteristics. In this context, we set up an in vitro evaluation system for DCB including determination of coating morphology, coating thickness, mechanical performance, drug loss and drug application as well as particle release during simulated use.
Exemplary data of drug delivery characteristics of an urea-based DCB are provided within the present paper. Despite the development of new coronary stent technologies, in-stent restenosis and stent thrombosis are still clinically relevant. Interactions of blood and tissue cells with the implanted material may represent an important cause of these side effects. We hypothesize material-dependent interaction of blood and tissue cells. The aim of this study is accordingly to investigate the impact of vascular endothelial cells, smooth muscle cells and platelets with various biodegradable polymers to identify a stent coating or platform material that demonstrates excellent endothelial-cell-supportive and non-thrombogenic properties.
Human umbilical venous endothelial cells, human coronary arterial endothelial cells and human coronary arterial smooth muscle cells were cultivated on the surfaces of two established biostable polymers used for drug-eluting stents, namely poly ethylene-co-vinylacetate PEVA and poly butyl methacrylate PBMA. Biocompatibility tests were performed under static and dynamic conditions.
Data show that PLLA and P 4HB tend to a more thrombotic response, whereas the polymer blend is characterized by a lower thrombotic potential. These data demonstrate material-dependent endothelialization, smooth muscle cell growth and thrombogenicity. Although polymers such as PEVA and PBMA are already commonly used for vascular implants, they did not sufficiently meet the criteria for biocompatibility.
Aiming at a speed up of the re-endothelialization process of biodegradable endovascular implants, novel approaches for the functionalization of poly l-lactide PLLA with anti-CD34 antibodies were established.
We propose a three-step process involving PLLA surface activation with functional amino groups, attachment of a protein repelling peptide spacer, and covalent random or site-selective immobilization of the antibodies. Obtainable antibody surface densities and antigen binding capacities were thoroughly evaluated by means of enzyme-linked immunosorbent assay. Results indicate that a lower amount of anchoring sites on the antibody favors high coupling efficiency, while localization of the anchoring sites, facing the antigen binding moiety, strongly enhances the antigen capture capacity of the support.
Besides minimization of physisorption and cell adhesion exemplarily shown with bovine serum albumin, avidin, and human umbilical vein endothelial cells, respectively, the inclusion of the protein-repelling spacer strengthened this effect, yielding antigen capture capacities exceeding values so far reported in literature.
In contrast, the number of amino groups on the PLLA surfaces, which is indeed highly dependent on the applied activation procedure, does not seem to influence antibody coupling efficiency and antigen capture capacity considerably.
This allows the choice of surface activation treatment, plasma or wet-chemical, regarding other processing parameters as for instance sterilizability or favored modification depth. Although the first generation of drug-eluting stents have revolutionized the treatment of coronary artery disease in terms of reduction of in-stent-restenosis, there is increasing evidence that the applied surface polymer coatings could be responsible for adverse effects like delayed healing, late stent-thrombosis, local hypersensitivity reaction and remaining in-stent restenosis.
Biodegradable polymers are hence investigated. However, tissue response to these materials in terms of vessel healing, inflammation and bio-compatibility is not described in detail yet.
In this context, the present study was designed to investigate endothelial cell function on biodegradable polymers using human endothelial cells applied to an in vitro flow chamber model with laminar shear stress exposure. Our data demonstrate a material dependent endothelial cell function. Controlling the post-implantation tissue response in the cardiovascular system remains a formidable challenge. Of utmost importance is the rapid endothelialisation of the implant surface.
To promote endothelial cell attachment to the model polymer PCL, we investigated multiple surface modifications in conjunction with VEGF stimulation. Plasma activation and pre-coating with extracellular matrix proteins proved to be especially useful in this context.
Silver containing diamond like carbon films were coated on the surface of polyethylene film PET using novel hybrid sputtering method. Polymeric substrates can create soft, flexible, highly absorbent and cost-effective materials by selecting or controlling their molecular structures. The material silver is known to be a potential antibacterial material. The silver containing coating has been potentially recommended for synthesis biomedical materials.
In the present work, we discussed the antibacterial activity of the silver containing DLC film coated PET film surfaces which was coated as a function of deposition power level. The hydrophilicity of the films was measured by contact angle analysis. The antibacterial activity of Ag-DLC films were evaluated by bacterial eradication tests with Escherichia coli at incubation time of one day.
In addition, blood compatibility of the Ag-DLC films were studied by in vitro blood compatibility tests. It was found that the surface of the obtained Ag-DLC decreases with increasing the deposition power level. The antibacterial and hemocompatibility of the silver containing DLC film increase gradually with increase of deposition power level.
Our results revealed that the Ag-incorporated DLC films are potentially useful as biomedical devices having good antibacterial and hemocompatibility. Using a pulse shaper femtosecond laser pulses with variable length are applied in machining biocompatible polymers.
It has been found that efficient material ablation can be achieved resulting in sharp cut edges. Systematic variation of the pulse length shows that the shortest pulses allow working with the lowest pulse energy. Alumina toughened zirconia ATZ ceramic composites have been machined and structured with ultrashort laser pulses.
With this approach the fabrication of various cavity patterns on the surface of the material with high precision becomes feasible. The scope of surface manipulation with femtosecond lasers gives opportunity to adopt the ceramic surface to tissue apposition for several different medical applications employing biocompatible ceramics.
Implants providing controlled, local release of active substances are of interest in different medical applications. Therefore, the focus of the present article is the development of implant-associated diffusion-or chemically controlled local drug delivery LDD systems based on biodegradable polymeric drug carriers. We demonstrate that polymers allow a wide range of control over the drug release characteristics.
In this regard, we show that the glass transition temperature of a polymer has an impact on its drug release. Additionally, the blending of hydrophobic, semicrystalline polymers with amorphous polymers leads to an increase in the rate of drug release compared with the pure semicrystalline polymer.
Moreover, the percentage loading of the embedded drug has a considerable effect on the rate and duration of drug release. Furthermore, we discuss chemically controlled LDD systems designed for the release of biomolecules, such as growth factors, as well as nanoparticle-mediated LDD systems. With our own published data on drug-eluting stents, microstents, and cochlear implants, we highlight exemplary implant-associated LDD systems designed to improve implant performance through the reduction of undesirable effects such as in-stent restenosis and fibrosis.
Within the context of novel stent designs we developed a dual drug-eluting stent DDES with an abluminally focussed release of the potent anti-proliferative drug sirolimus and a luminally focussed release of atorvastatin with stabilizing effect on atherosclerotic deposits and stimulating impact on endothelial function, both from biodegradable poly L-lactide -based stent coatings.
With this concept we aim at simultaneous inhibition of in-stent restenosis as a result of disproportionally increased smooth muscle cell proliferation and migration as well as thrombosis due to failed or incomplete endothelialisation. The impacts of tempering, sterilization, and layer composition on drug release are thoroughly discussed making use of a semi-empirical model. In vitro proliferation and viability assays with smooth muscle and endothelial cells underline the high potential of the developed DDES.
Polyelectrolyte multilayer PEM films, built using the layer-by-layer LbL technique, are attractive for controlled drug delivery in order to improve the tissue regeneration. The insertion of stimulus-responsive functions into hydrogels is a promising modification of local drug delivery LDD systems. In this context, we investigated systematically the drug permeation through different polyacrylamide PAAm gel types as model system. It could be shown that permeation behaviour is hardly dependent on structure semiinterpenetrating polymer network semiIPN versus conventional polymer network and crosslinking ratio but on gel content.
Biofunctionalization strategies can be adapted to allow short-term and long-term biomolecule immobilization. By using different protocols for the modification of poly L-lactide , we evidenced the possibility of drug release control as well as the provision of stable surface functionality at the example of vascular endothelial growth factors and anti-CD34 antibodies, respectively. To improve neuronal-electrode interfaces, we analyzed the influence of surface topographies combined with coating on the electrochemistry of platinum and neuronal differentiation of PC cells.
Surface structuring on nanoscale was realized by femtosecond laser ablation. We further demonstrated that impedance could be improved in all cases. The pre-requisites of differentiation - viability and attachment - were fulfilled on the topography. Cell attachment of non-differentiated and differentiated cells and their formation of focal adhesion complexes were even enhanced compared to unstructured platinum. However, without the nerve growth factor NGF no cellular outgrowth and differentiation were possible.
The topography enabled cell elongation and reduced the amount of rounded cells, but less effective than coating. Differentiation was either comparable or increased on the structures when compared with unstructured coatings. For instance, microtubule associated protein MAP2 was detected most on the topography alone. But a combination of surface structuring and coating had the strongest impact on differentiation: LA-coating had no noteworthy effect.
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