Modra, Slovakia
Modra, Slovakia

Time filter

Source Type

Grant
Agency: Cordis | Branch: FP7 | Program: CP-IP | Phase: NMP-2007-4.0-4 | Award Amount: 11.56M | Year: 2008

The breakthrough objective of NANOTHER is to develop & characterise a novel nanoparticle system that will be used as a therapeutic agent or diagnosis tool for breast cancer, colorectal cancer & bone metastasis. Theranostics, the development of nanoparticles with both functionalities, will also be carried out using the hyperthermic effect to kill tumour cells or to release the selected drug . The nanoparticles used in NANOTHER will be selected based on previous studies. Therefore, only polymeric micelles core-shell nanoparticles and magnetic nanoparticles will be included in the study. The nanoparticles will be functionalised by attaching targeting molecules, depending on the type of cancer to be treated or diagnosed. Labels for diagnosis will include fluorescent or contrast phase probes, which will later be imaged and analysed with the appropriate equipment optimised during the project. Therapeutic agents will be loaded on to the nanoparticle, including drugs like doxorubicin, and new marine pharmacological compounds already in clinical trials. One of the most innovative aspects of this proposal is the use of siRNA as the therapeutic agent. The use of magnetic nanoparticles as a theranostic mechanism is also an innovative aspect of the proposal, as these nanoparticles can be activated to kill tumour cells detected depending on a positive or negative diagnostic. The project has been structured in seven different sub-projects including aspects like toxicology, biocompatibility of the nanodevices, and also efficacy and biodistribution of the system. In vitro (cellular models) & in vivo assays (small animals; mice) will be used for the study of diagnosis & therapy. The latter will be kept to the minimum necessary to study the efficiency & biodistribution and always taking into account the three Rs & national / EU norms. The NANOTHER consortium includes 18 top-level partners from 8 EU countries as the critical mass required to achieve ambitious project objectives.


PubMed | ARGUS Chemicals srl, University of Pisa, Hameln rds a.s. and Leitat Centro Tecnologico C Of La Innovacio
Type: Journal Article | Journal: International journal of pharmaceutics | Year: 2014

Poly(ester-ether-urethane)s copolymers are a resourceful class of biopolymers for the preparation of nanocarriers for drug delivery applications. However, a simple clinical translation for this synthetic material with biological and quality features is still needed. In this view, poly(-caprolactone)-co-poly(ethylene glycol) copolymers were synthesized as semi-bulk pilot (Kg) scale under mild conditions in absence of catalyst, bearing functional termini such as fluorescein tag and anticancer targeting moieties. The obtained materials were processed into surface decorated paclitaxel (PTX) loaded nanoparticles (NPs). The NPs were fully characterized in vitro and in vivo biodistribution in healthy mice evidenced no sign of toxicity and lower levels of PTX in lung and spleen, compared to clinically applied PTX dosage form.


Rollerova E.,Slovak Medical University | Jurcovicova J.,Slovak Academy of Sciences | Mlynarcikova A.,Slovak Academy of Sciences | Sadlonova I.,Hameln rds a.s. | And 8 more authors.
Reproductive Toxicology | Year: 2015

We studied delayed effects of neonatal exposure to polymeric nanoparticle poly(ethylene glycol)-block-polylactide methyl ether (PEG-b-PLA) on the endpoints related to pubertal development and reproductive function in female Wistar rats from postnatal day 4 (PND4) to PND 176. Female pups were injected intraperitoneally, daily, from PND4 to PND7 with PEG-b-PLA (20 or 40 mg/kg b.w.). Both doses of PEG-b-PLA accelerated the onset of vaginal opening compared with the control group. In the low-dose PEG-b-PLA-treated group, a significantly reduced number of regular estrous cycles, increased pituitary weight due to hyperemia, vascular dilatation and congestion, altered course of hypothalamic gonadotropin-releasing hormone-stimulated luteinizing hormone secretion, and increased progesterone serum levels were observed. The obtained data indicate that neonatal exposure to PEG-b-PLA might affect the development and function of hypothalamic-pituitary-ovarian axis (HPO), and thereby alter functions of the reproductive system in adult female rats. Our study indicates a possible neuroendocrine disrupting effect of PEG-b-PLA nanoparticles. © 2015 Elsevier Inc.


Muranyi A.,Hameln rds a.s. | Muranyi A.,Comenius University | Bartos P.,Hameln rds a.s. | Tichy E.,Hameln rds a.s. | And 3 more authors.
Drug Development and Industrial Pharmacy | Year: 2015

The objective of this work was development and evaluation of gel-forming lyophilized formulation with recombinant human thrombin for topical administration. The influence of pH, ionic strength and buffer type on protein stability was evaluated as part of the pre-formulation screening studies. Results indicated an optimal pH from 6.0 to 7.0 and increased stability with increasing content of sodium chloride. The tested buffer types had no significant effect on thrombin stability. For further development, thermosensitive Pluronic® F-127 was employed as a bulking and gelling agent. Physical and mechanical characterization and viscosity measurement confirmed the gel-forming properties of the formulation at the application temperature of 32 °C. Several techniques (addition of well-soluble polyols, different freezing protocols and reconstitution under vacuum) were tested to decrease the reconstitution time. The obtained results revealed that a vacuum in the vial headspace is crucial for acceptable reconstitution. The freeze drying process has no negative impact on recombinant thrombin stability, and this was confirmed by reverse-phase-HPLC, activity assay and optical density measurements. © 2015 Taylor & Francis.


Muranyi A.,Hameln Rds A.S. | Vitkova M.,Comenius University
Ceska a Slovenska Farmacie | Year: 2014

Lyophilisation is a well-established method for drying of various substances with a wide range of applications in the pharmaceutical area. During the last decade its relevance increases with a number of therapeutically used proteins. A sensitive protein drug may undergo several changes, like unfolding and loss of activity due to various stresses during the lyophilisation process. Understanding of these processes (freezing, primary drying, secondary drying) is fundamental for manufacturing of a drug product with desired properties, namely its safety and efficacy. In order to reduce costs and increase the quality, new technologies are being rapidly developed and established in industrial lyophilisation (e.g. process analytical technologies, control nucleation techniques).


Bartos P.,Hameln Rds A.s. | Muranyi A.,Hameln Rds A.s. | Muranyi A.,Comenius University | Snauko M.,Hameln Rds A.s.
Acta Facultatis Pharmaceuticae Universitatis Comenianae | Year: 2015

Two reversed-phase high performance liquid chromatography analytical methods (Method I and Method II) for determination of assay of recombinant human thrombin in pharmaceutical formulations were developed and validated. Analysis was performed on chromatographic system Agilent 1200 series SL with diode array detection and mass selective detection. Method I was intended for faster determination of thrombin assay. Gradient programme was optimised to achieve sufficient separation and acceptable runtime. Chromatographic analysis was performed on analytical column Grace Vydac, C4 250 × 4.6 mm, 5 μm. Method II is Method I adapted to use the mass selective detector. Chromatographic separation was performed on analytical column Zorbax 300SB-C8 SolvSaver Plus, 150 × 3 mm, 3.5 μm. Both analytical methods were validated with respect to specificity, linearity, precision and accuracy. The response of thrombin was a linear function of concentration over the range 0.1-1.0 mg/ml. Precision and accuracy of thrombin was evaluated at three concentration levels low (0.2 mg/ml), medium (0.4 mg/ml) and high (0.8 mg/ml). Both validated methods have been successfully applied for determination of assay and thrombin degradation products in pharmaceutical formulations. © 2015 by A. Murányi.


Veverka M.,Eurofins | Muranyi A.,Hameln rds a.s. | Muranyi A.,Comenius University | Bakos D.,Slovak University of Technology in Bratislava | And 3 more authors.
Journal of Biomaterials Science, Polymer Edition | Year: 2016

The aim of this work was to evaluate the effects of incorporating thrombin in arabinogalactan (AG)/β-glucan (BG)-based carriers. The products were characterized by Fourier transform infrared spectroscopy, scanning electron microscopy, X-ray powder diffraction (XRPD) and X-ray photoelectron spectroscopy techniques. Results, especially deconvoluted XRPD patterns indicated creation of new phases and potential complex formation. Results also highlighted that the AG carrier leads to higher residual thrombin-specific activity, while the in vivo haemostatic effect was enhanced when insoluble BG was present in the matrix. Our results confirm that thrombin can be successfully added to the carriers and that these materials are promising alternatives to standard vehicles. © 2015 Taylor & Francis.


PubMed | Slovak Academy of Sciences, Eurofins, Slovak University of Technology in Bratislava and hameln rds a.s.
Type: Journal Article | Journal: Journal of biomaterials science. Polymer edition | Year: 2016

The aim of this work was to evaluate the effects of incorporating thrombin in arabinogalactan (AG)/-glucan (BG)-based carriers. The products were characterized by Fourier transform infrared spectroscopy, scanning electron microscopy, X-ray powder diffraction (XRPD) and X-ray photoelectron spectroscopy techniques. Results, especially deconvoluted XRPD patterns indicated creation of new phases and potential complex formation. Results also highlighted that the AG carrier leads to higher residual thrombin-specific activity, while the in vivo haemostatic effect was enhanced when insoluble BG was present in the matrix. Our results confirm that thrombin can be successfully added to the carriers and that these materials are promising alternatives to standard vehicles.


Zavisova V.,Slovak Academy of Sciences | Koneracka M.,Slovak Academy of Sciences | Muckova M.,Hameln Rds A.s. | Lazova J.,Hameln Rds A.s. | And 11 more authors.
Journal of Magnetism and Magnetic Materials | Year: 2011

Poly(ethylene glycol) (PEG)-containing magnetic fluids magnetite (Fe 3O4) stabilized by sodium oleate were prepared. Magnetic measurements confirmed superparamagnetic behaviour at room temperature. The structure of that kind of magnetic fluid was characterized using different techniques, including electron microscopy, photon cross correlation spectroscopy and small-angle neutron scattering, while the adsorption of PEG on magnetic particles was analyzed by differential scanning calorimetry and Fourier transform infrared spectroscopy. From the in vitro toxicity tests it was found that a magnetic fluid containing PEG (MFPEG) partially inhibited the growth of cancerous B16 cells at the highest tested dose (2.1 mg/ml of Fe 3O4 in MFPEG). © 2010 Elsevier B.V. All rights reserved.


Jurikova A.,Slovak Academy of Sciences | Csach K.,Slovak Academy of Sciences | Koneracka M.,Slovak Academy of Sciences | Zavisova V.,Slovak Academy of Sciences | And 6 more authors.
Journal of Physics: Conference Series | Year: 2010

Poly(D,L-lactide-co-glycolide) polymer (PLGA) nanospheres loaded with biocom-patible magnetic fluid as a magnetic carrier and anticancer drug Taxol were prepared by the modified nanoprecipitation method with size of 200-250 nm in diameter. The PLGA polymer was utilized as a capsulation material due to its biodegradability and biocompatibility. Taxol as an important anticancer drug was chosen for its significant role against a wide range of tumours. Thermal properties of the drug-polymer system were characterized using thermal analysis methods. It was determined the solubility of Taxol in PLGA nanospheres. Magnetic properties investigated using SQUID magnetometry showed superparamagnetism of the prepared magnetic polymer nanospheres. © 2010 IOP Publishing Ltd.

Loading Hameln rds a.s. collaborators
Loading Hameln rds a.s. collaborators