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Norbert Radacsi
School of Engineering, Institute for Materials and Processes, The University of Edinburgh, Sanderson Building, King’s Buildings, Edinburgh EH9 3FB, United Kingdom

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Journal article
Published: 31 July 2021 in European Journal of Pharmaceutical Sciences
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Our study aimed to formulate a novel dexamethasone (DXM)-loaded, mixed polymeric micelle-based drug delivery system, focusing on the auspicious nose-to-brain pathway, as a key delivery route to treat central nervous system (CNS) associated diseases. Polymeric micelles might be a solution to deliver drugs to the place of action compared to conventional formulations. Due to low Z-average (89.92 ± 2.7 nm), a polydispersity index of 0.216 ± 0.014 and high surface polarity (52.23%), a significant increase in water solubility (14-fold) was experienced. This increase resulted in favourable dissolution profile at nasal and axonal conditions with high in vitro permeability value (14.6×10−6 cm/s) on polar brain (porcine) lipid extract. Modified Side-bi-side® type diffusion study confirmed rapid and efficient passive diffusion through the nasal mucosa contributed by strong mucoadhesive properties. The final formulation met all the requirements of a nasal drug delivery system with rapid onset of action, meaning DXM can reach the CNS and there it can exert its beneficial effects in pathological conditions.

ACS Style

Bence Sipos; Ildikó Csóka; Mária Budai-Szűcs; Gábor Kozma; Dániel Berkesi; Zoltán Kónya; György Tibor Balogh; Gábor Katona. Development of Dexamethasone-loaded mixed polymeric micelles for nasal delivery. European Journal of Pharmaceutical Sciences 2021, 105960 .

AMA Style

Bence Sipos, Ildikó Csóka, Mária Budai-Szűcs, Gábor Kozma, Dániel Berkesi, Zoltán Kónya, György Tibor Balogh, Gábor Katona. Development of Dexamethasone-loaded mixed polymeric micelles for nasal delivery. European Journal of Pharmaceutical Sciences. 2021; ():105960.

Chicago/Turabian Style

Bence Sipos; Ildikó Csóka; Mária Budai-Szűcs; Gábor Kozma; Dániel Berkesi; Zoltán Kónya; György Tibor Balogh; Gábor Katona. 2021. "Development of Dexamethasone-loaded mixed polymeric micelles for nasal delivery." European Journal of Pharmaceutical Sciences , no. : 105960.

Journal article
Published: 19 July 2021 in Pharmaceuticals
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The objective of the present study was to develop n-propyl gallate-loaded solid lipid nanoparticles (PG-SLNs) in a hydrogel (HG) formulation using Transcutol-P (TC-P) as a permeation enhancer. Modified solvent injection technique was applied to produce optimized PG-SLNs via the Quality by Design approach and central composite design. The in vitro mucoadhesion, scavenging activity, drug release, permeation studies of PG from PG-SLNs-loaded HG were evaluated under simulated nasal conditions. Compared with in vitro release behavior of PG from SLNs, the drug release from the PG-SLNs-loaded HG showed a lower burst effect and sustained release profile. The cumulative permeation of PG from PG-SLNs-loaded HG with TC-P was 600 μg/cm2 within 60 min, which is 3–60-fold higher than PG-SLNs and native PG, respectively. Raman mapping showed that the distribution of PG-SLNs was more concentrated in HG having lower concentrations of hyaluronic acid. The scavenging assay demonstrated increased antioxidant activity at higher concentrations of HG. Due to enhanced stability and mucoadhesive properties, the developed HG-based SLNs can improve nasal absorption by increasing residence time on nasal mucosa. This study provides in vitro proof of the potential of combining the advantages of SLNs and HG for the intranasal delivery of antioxidants.

ACS Style

Fakhara Sabir; Gábor Katona; Ruba Ismail; Bence Sipos; Rita Ambrus; Ildikó Csóka. Development and Characterization of n-Propyl Gallate Encapsulated Solid Lipid Nanoparticles-Loaded Hydrogel for Intranasal Delivery. Pharmaceuticals 2021, 14, 696 .

AMA Style

Fakhara Sabir, Gábor Katona, Ruba Ismail, Bence Sipos, Rita Ambrus, Ildikó Csóka. Development and Characterization of n-Propyl Gallate Encapsulated Solid Lipid Nanoparticles-Loaded Hydrogel for Intranasal Delivery. Pharmaceuticals. 2021; 14 (7):696.

Chicago/Turabian Style

Fakhara Sabir; Gábor Katona; Ruba Ismail; Bence Sipos; Rita Ambrus; Ildikó Csóka. 2021. "Development and Characterization of n-Propyl Gallate Encapsulated Solid Lipid Nanoparticles-Loaded Hydrogel for Intranasal Delivery." Pharmaceuticals 14, no. 7: 696.

Journal article
Published: 13 July 2021 in Pharmaceutics
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Liposomal formulation development is a challenging process. Certain factors have a critical influence on the characteristics of the liposomes, and even the relevant properties can vary based on the predefined interests of the research. In this paper, a Quality by Design-guided and Risk Assessment (RA)-based study was performed to determine the Critical Material Attributes and the Critical Process Parameters of an “intermediate” active pharmaceutical ingredient-free liposome formulation prepared via the thin-film hydration method, collect the Critical Quality Attributes of the future carrier system and show the process of narrowing a general initial RA for a specific case. The theoretical liposome design was proved through experimental models. The investigated critical factors covered the working temperature, the ratio between the wall-forming agents (phosphatidylcholine and cholesterol), the PEGylated phospholipid content (DPPE-PEG2000), the type of the hydration media (saline or phosphate-buffered saline solutions) and the cryoprotectants (glucose, sorbitol or trehalose). The characterisation results (size, surface charge, thermodynamic behaviours, formed structure and bonds) of the prepared liposomes supported the outcomes of the updated RA. The findings can be used as a basis for a particular study with specified circumstances.

ACS Style

Zsófia Németh; Edina Pallagi; Dorina Dobó; Gábor Kozma; Zoltán Kónya; Ildikó Csóka. An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development. Pharmaceutics 2021, 13, 1071 .

AMA Style

Zsófia Németh, Edina Pallagi, Dorina Dobó, Gábor Kozma, Zoltán Kónya, Ildikó Csóka. An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development. Pharmaceutics. 2021; 13 (7):1071.

Chicago/Turabian Style

Zsófia Németh; Edina Pallagi; Dorina Dobó; Gábor Kozma; Zoltán Kónya; Ildikó Csóka. 2021. "An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development." Pharmaceutics 13, no. 7: 1071.

Review
Published: 28 June 2021 in Biofabrication
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Recent advancements in the bioinks and three-dimensional (3D) bioprinting methods used to fabricate vascular constructs are summarized herein. Critical biomechanical properties required to fabricate an ideal vascular graft are highlighted, as well as various testing methods have been outlined to evaluate the bio-fabricated grafts as per the Food and Drug Administration (FDA) and International Organization for Standardization (ISO) guidelines. Occlusive artery disease and cardiovascular disease are the major causes of death globally. These diseases are caused by the blockage in the arteries, which results in a decreased blood flow to the tissues of major organs in the body, such as the heart. Bypass surgery is often performed using a vascular graft to re-route the blood flow. Autologous grafts represent a gold standard for such bypass surgeries; however, these grafts may be unavailable due to the previous harvesting or possess a poor quality. Synthetic grafts serve well for medium to large-sized vessels, but they fail when used to replace small-diameter vessels, generally smaller than 6 mm. Various tissue engineering approaches have been used to address the urgent need for vascular graft that can withstand hemodynamic blood pressure and has the ability to grow and remodel. Among these approaches, 3D bioprinting offers an attractive solution to construct patient-specific vessel grafts with layered biomimetic structures.

ACS Style

Faraz Fazal; Sakshika Raghav; Anthony Callanan; Vasileios Koutsos; Norbert Radacsi. Recent advancements in the bioprinting of vascular grafts. Biofabrication 2021, 13, 032003 .

AMA Style

Faraz Fazal, Sakshika Raghav, Anthony Callanan, Vasileios Koutsos, Norbert Radacsi. Recent advancements in the bioprinting of vascular grafts. Biofabrication. 2021; 13 (3):032003.

Chicago/Turabian Style

Faraz Fazal; Sakshika Raghav; Anthony Callanan; Vasileios Koutsos; Norbert Radacsi. 2021. "Recent advancements in the bioprinting of vascular grafts." Biofabrication 13, no. 3: 032003.

Journal article
Published: 21 June 2021 in Materials & Design
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Fabrication of macroscopic three-dimensional (3D) structures made of nanofibers of widely used polymers is reported. 3D structures have several benefits over conventional flat two-dimensional (2D) structures by the added dimension. The structures have been fabricated by the 3D electrospinning technology that can build 3D structures rapidly due to certain additives in the solution and appropriate process conditions. The process parameters of 3D electrospinning have been identified and investigated to better understand the formation mechanism of the 3D build-up for polystyrene (PS), polyacrylonitrile (PAN), and polyvinylpyrrolidone (PVP). Different types of electrodes were inserted in the electrospinning chamber to alter the electric field and have better control over the shape of the 3D structure. The upscalability of this technology was investigated by using a standard electrospinner and a nozzle-free electrospinning setup. It was possible to manufacture 3D structures with these devices, highlighting the versatility of this technology. 3D electrospinning opens the pathway for the facile fabrication of macroscopic 3D structure with microfibrous features on a commercial scale.

ACS Style

Michel Vong; Francisco Javiez Diaz Sanchez; Antonios Keirouz; Wiwat Nuansing; Norbert Radacsi. Ultrafast Fabrication of Nanofiber-based 3D Macrostructures by 3D Electrospinning. Materials & Design 2021, 208, 109916 .

AMA Style

Michel Vong, Francisco Javiez Diaz Sanchez, Antonios Keirouz, Wiwat Nuansing, Norbert Radacsi. Ultrafast Fabrication of Nanofiber-based 3D Macrostructures by 3D Electrospinning. Materials & Design. 2021; 208 ():109916.

Chicago/Turabian Style

Michel Vong; Francisco Javiez Diaz Sanchez; Antonios Keirouz; Wiwat Nuansing; Norbert Radacsi. 2021. "Ultrafast Fabrication of Nanofiber-based 3D Macrostructures by 3D Electrospinning." Materials & Design 208, no. : 109916.

Short communication
Published: 16 June 2021 in Medical Engineering & Physics
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There is a high demand for small diameter vascular grafts having mechanical and biological properties similar to that of living tissues. Tissue-engineered vascular grafts using current methods have often failed due to the mismatch of mechanical properties between the implanted graft and living tissues. To address this limitation, a hybrid bioprinting-electrospinning system is developed for vascular tissue engineering applications. The setup is capable of producing layered structure from electrospun fibres and cell-laden hydrogel. A Creality3D Ender 3D printer has been modified into a hybrid setup having one bioprinting head and two electrospinning heads. Fortus 250mc and Flashforge Creator Pro 3D printers were used to print parts using acrylonitrile butadiene styrene (ABS) and polylactic acid (PLA) polymers. An Arduino mega 2560 and a Ramps 1.4 controller board were selected to control the functions of the hybrid bioprinting setup. The setup was tested successfully to print a tubular construct around a rotating needle.

ACS Style

Faraz Fazal; Francisco Javier Diaz Sanchez; Muhammad Waqas; Vasileios Koutsos; Anthony Callanan; Norbert Radacsi. A modified 3D printer as a hybrid bioprinting-electrospinning system for use in vascular tissue engineering applications. Medical Engineering & Physics 2021, 94, 52 -60.

AMA Style

Faraz Fazal, Francisco Javier Diaz Sanchez, Muhammad Waqas, Vasileios Koutsos, Anthony Callanan, Norbert Radacsi. A modified 3D printer as a hybrid bioprinting-electrospinning system for use in vascular tissue engineering applications. Medical Engineering & Physics. 2021; 94 ():52-60.

Chicago/Turabian Style

Faraz Fazal; Francisco Javier Diaz Sanchez; Muhammad Waqas; Vasileios Koutsos; Anthony Callanan; Norbert Radacsi. 2021. "A modified 3D printer as a hybrid bioprinting-electrospinning system for use in vascular tissue engineering applications." Medical Engineering & Physics 94, no. : 52-60.

Journal article
Published: 21 May 2021 in International Journal of Pharmaceutics
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With the increasingly widespread of central nervous system (CNS) disorders and the lack of sufficiently effective medication, meloxicam (MEL) has been reported as a possible medication for Alzheimer’s disease (AD) management. Unfortunately, following the conventional application routes, the low brain bioavailability of MEL forms a significant limitation. The intranasal (IN) administration route is considered revolutionary for CNS medications delivery. The objective of the present study was to develop two types of nanocarriers, poly (lactic-co-glycolic acid) nanoparticles (PLGA NPs) and solid lipid nanoparticles (SLNs), for the IN delivery of MEL adapting the Quality by Design approach (QbD). Turning then to further enhance the optimized nanoformulation behavior by chitosan-coating. SLNs showed higher encapsulation efficacy (EE) and drug loading (DL) than PLGA NPs (87.26% (EE) and 2.67% (DL); 72.23% (EE) and 2.55% (DL), respectively. MEL encapsulated into the nanoformulations improved in-vitro release, mucoadhesion, and permeation behavior compared to the native drug with greater superiority of chitosan-coated SLNs (C-SLNs). In vitro-in vivo correlation (IVIVC) results estimated a significant in vivo brain distribution of the nanoformulations compared to native MEL with estimated greater potential in the C-SLNs. Hence, MEL encapsulation into C-SLNs towards IN route can be promising in enhancing its brain bioavailability.

ACS Style

Hussein Akel; Ruba Ismail; Gábor Katona; Fakhara Sabir; Rita Ambrus; Ildikó Csóka. A comparison study of Lipid and Polymeric Nanoparticles in the Nasal Delivery of Meloxicam: Formulation, Characterization, and In-Vitro Evaluation. International Journal of Pharmaceutics 2021, 120724 .

AMA Style

Hussein Akel, Ruba Ismail, Gábor Katona, Fakhara Sabir, Rita Ambrus, Ildikó Csóka. A comparison study of Lipid and Polymeric Nanoparticles in the Nasal Delivery of Meloxicam: Formulation, Characterization, and In-Vitro Evaluation. International Journal of Pharmaceutics. 2021; ():120724.

Chicago/Turabian Style

Hussein Akel; Ruba Ismail; Gábor Katona; Fakhara Sabir; Rita Ambrus; Ildikó Csóka. 2021. "A comparison study of Lipid and Polymeric Nanoparticles in the Nasal Delivery of Meloxicam: Formulation, Characterization, and In-Vitro Evaluation." International Journal of Pharmaceutics , no. : 120724.

Journal article
Published: 14 May 2021 in Nano Materials Science
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Recent developments in the biochemical and medicinal industries have been heavily focused on producing affordable glucose biosensors due to the continuous annual increase of diabetic patients worldwide. The development of a fast, accurate, and reliable glucose sensor will increase confidence in controlling diabetes mellitus and its associated health complications among the diabetic community. Electrospinning is a versatile method that can produce complex nanofibrous assemblies with attractive and functional characteristics from various polymers. Electrospun nanofibers demonstrated high efficiency in the immobilization of biological molecules, which can improve the sensing performance further. Integration of polymer electrospun nanofibers with metal nanoparticles, metal oxide or transition metal in producing nanobiocomposites is also a highly popular approach in the past few years. This report presents the current progress and research trends of the technique, focusing on various materials and fabrication strategies used to produce biosensing interfaces. This helps readers decide the suitable approach in designing highly sensitive, selective, fast, and inexpensive glucose sensors.

ACS Style

Mohamed Hasaan Hussain; Lim Ping Fook; Maria Kana Sanira Putri; Huey Ling Tan; Noor Fitrah Abu Bakar; Norbert Radacsi. Advances on ultra-sensitive electrospun nanostructured electrochemical and colorimetric sensors for diabetes mellitus detection. Nano Materials Science 2021, 1 .

AMA Style

Mohamed Hasaan Hussain, Lim Ping Fook, Maria Kana Sanira Putri, Huey Ling Tan, Noor Fitrah Abu Bakar, Norbert Radacsi. Advances on ultra-sensitive electrospun nanostructured electrochemical and colorimetric sensors for diabetes mellitus detection. Nano Materials Science. 2021; ():1.

Chicago/Turabian Style

Mohamed Hasaan Hussain; Lim Ping Fook; Maria Kana Sanira Putri; Huey Ling Tan; Noor Fitrah Abu Bakar; Norbert Radacsi. 2021. "Advances on ultra-sensitive electrospun nanostructured electrochemical and colorimetric sensors for diabetes mellitus detection." Nano Materials Science , no. : 1.

Journal article
Published: 12 May 2021 in Pharmaceutics
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Nanoparticle research and development for pharmaceuticals is a challenging task in the era of personalized medicine. Specialized and increased patient expectations and requirements for proper therapy adherence, as well as sustainable environment safety and toxicology topics raise the necessity of well designed, advanced and smart drug delivery systems on the market. These stakeholder expectations and social responsibility of pharma sector open the space and call new methods on the floor for new strategic development tools, like Quality by Design (QbD) thinking. The extended model, namely the R&D QbD proved to be useful in case of complex and/or high risk/expectations containing or aiming developments. This is the case when we formulate polymeric micelles as promising nanotherapeutics; the risk assessment and knowledge-based quality targeted QbD approach provides a promising tool to support the development process. Based on risk assessment, many factors pose great risk in the manufacturing process and affect the quality, efficacy and safety profile. The quality-driven strategic development pathway, based on deep prior knowledge and an involving iterative risk estimation and management phases has proven to be an adequate tool, being able to handle their sensitive stability issues and make them efficient therapeutic aids in case of several diseases.

ACS Style

Bence Sipos; Gábor Katona; Ildikó Csóka. A Systematic, Knowledge Space-Based Proposal on Quality by Design-Driven Polymeric Micelle Development. Pharmaceutics 2021, 13, 702 .

AMA Style

Bence Sipos, Gábor Katona, Ildikó Csóka. A Systematic, Knowledge Space-Based Proposal on Quality by Design-Driven Polymeric Micelle Development. Pharmaceutics. 2021; 13 (5):702.

Chicago/Turabian Style

Bence Sipos; Gábor Katona; Ildikó Csóka. 2021. "A Systematic, Knowledge Space-Based Proposal on Quality by Design-Driven Polymeric Micelle Development." Pharmaceutics 13, no. 5: 702.

Short communication
Published: 06 May 2021 in Medical Engineering & Physics
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This technical note provides a step-by-step guide for the design and construction of a temperature-controlled nozzle-free electrospinning device. The equipment uses a rotating mandrel partially immersed within a polymer solution to produce fibers in an upward motion by inducing the formation of multiple Taylor cones and subsequently multi-jetting out of an electrified open surface. Free-surface electrospinning can overcome limitations and drawbacks associated with single and multi-nozzle spinneret configurations, such as low yield, limited production capacity, nonuniform electric field distribution, and clogging. Most importantly, this lab-scaled high-throughput device can provide an alternative economical route for needleless electrospinning research, in contrast to the high costs associated with industrially available upscaling equipment. Among the device's technical specifications, a key feature is a cryo-collector mandrel, capable of collecting fibers in sub-zero temperatures, which can induce ultra-porous nanostructures, wider pores, and subsequent in-depth penetration of cells. A multi-channel gas chamber allows the conditioning of the atmosphere, temperature, and airflow, while the chamber's design averts user exposure to the high-voltage components. All the CAD files and point-by-point assembly instructions, along with a list of the materials used, are provided.

ACS Style

Muhammad Waqas; Antonios Keirouz; Maria Kana Sanira Putri; Faraz Fazal; Francisco Javier Diaz Sanchez; Dipa Ray; Vasileios Koutsos; Norbert Radacsi. Design and development of a nozzle-free electrospinning device for the high-throughput production of biomaterial nanofibers. Medical Engineering & Physics 2021, 92, 80 -87.

AMA Style

Muhammad Waqas, Antonios Keirouz, Maria Kana Sanira Putri, Faraz Fazal, Francisco Javier Diaz Sanchez, Dipa Ray, Vasileios Koutsos, Norbert Radacsi. Design and development of a nozzle-free electrospinning device for the high-throughput production of biomaterial nanofibers. Medical Engineering & Physics. 2021; 92 ():80-87.

Chicago/Turabian Style

Muhammad Waqas; Antonios Keirouz; Maria Kana Sanira Putri; Faraz Fazal; Francisco Javier Diaz Sanchez; Dipa Ray; Vasileios Koutsos; Norbert Radacsi. 2021. "Design and development of a nozzle-free electrospinning device for the high-throughput production of biomaterial nanofibers." Medical Engineering & Physics 92, no. : 80-87.

Journal article
Published: 01 May 2021 in Pharmaceutics
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The aim of this study was to develop an intranasal in situ thermo-gelling meloxicam-human serum albumin (MEL-HSA) nanoparticulate formulation applying poloxamer 407 (P407), which can be administered in liquid state into the nostril, and to increase the resistance of the formulation against mucociliary clearance by sol-gel transition on the nasal mucosa, as well as to improve drug absorption. Nanoparticle characterization showed that formulations containing 12–15% w/w P407 met the requirements of intranasal administration. The Z-average (in the range of 180–304 nm), the narrow polydispersity index (PdI, from 0.193 to 0.328), the zeta potential (between −9.4 and −7.0 mV) and the hypotonic osmolality (200–278 mOsmol/L) of MEL-HSA nanoparticles predict enhanced drug absorption through the nasal mucosa. Based on the rheological, muco-adhesion, drug release and permeability studies, the 14% w/w P407 containing formulation (MEL-HSA-P14%) was considered as the optimized formulation, which allows enhanced permeability of MEL through blood–brain barrier-specific lipid fraction. Cell line studies showed no cell damage after 1-h treatment with MEL-HSA-P14% on RPMI 2650 human endothelial cells’ moreover, enhanced permeation (four-fold) of MEL from MEL-HSA-P14% was observed in comparison to pure MEL. Overall, MEL-HSA-P14% can be promising for overcoming the challenges of nasal drug delivery.

ACS Style

Gábor Katona; Bence Sipos; Mária Budai-Szűcs; György Balogh; Szilvia Veszelka; Ilona Gróf; Mária Deli; Balázs Volk; Piroska Szabó-Révész; Ildikó Csóka. Development of In Situ Gelling Meloxicam-Human Serum Albumin Nanoparticle Formulation for Nose-to-Brain Application. Pharmaceutics 2021, 13, 646 .

AMA Style

Gábor Katona, Bence Sipos, Mária Budai-Szűcs, György Balogh, Szilvia Veszelka, Ilona Gróf, Mária Deli, Balázs Volk, Piroska Szabó-Révész, Ildikó Csóka. Development of In Situ Gelling Meloxicam-Human Serum Albumin Nanoparticle Formulation for Nose-to-Brain Application. Pharmaceutics. 2021; 13 (5):646.

Chicago/Turabian Style

Gábor Katona; Bence Sipos; Mária Budai-Szűcs; György Balogh; Szilvia Veszelka; Ilona Gróf; Mária Deli; Balázs Volk; Piroska Szabó-Révész; Ildikó Csóka. 2021. "Development of In Situ Gelling Meloxicam-Human Serum Albumin Nanoparticle Formulation for Nose-to-Brain Application." Pharmaceutics 13, no. 5: 646.

Journal article
Published: 15 April 2021 in Pharmaceutics
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Nanofibers of the poorly water-soluble antibiotic ciprofloxacin (CIP) were fabricated in the form of an amorphous solid dispersion by using poly(vinyl pyrrolidone) as a polymer matrix, by the low-cost electrospinning method. The solubility of the nanofibers as well as their in vitro diffusion were remarkably higher than those of the CIP powder or the physical mixture of the two components. The fiber size and morphology were optimized, and it was found that the addition of the CIP to the electrospinning solution decreased the nanofiber diameter, leading to an increased specific surface area. Structural characterization confirmed the interactions between the drug and the polymer and the amorphous state of CIP inside the nanofibers. Since the solubility of CIP is pH-dependent, the in vitro solubility and dissolution studies were executed at different pH levels. The nanofiber sample with the finest morphology demonstrated a significant increase in solubility both in water and pH 7.4 buffer. Single medium and two-stage biorelevant dissolution studies were performed, and the release mechanism was described by mathematical models. Besides, in vitro diffusion from pH 6.8 to pH 7.4 notably increased when compared with the pure drug and physical mixture. Ciprofloxacin-loaded poly(vinyl pyrrolidone) (PVP) nanofibers can be considered as fast-dissolving formulations with improved physicochemical properties.

ACS Style

Luca Uhljar; Sheng Kan; Norbert Radacsi; Vasileios Koutsos; Piroska Szabó-Révész; Rita Ambrus. In Vitro Drug Release, Permeability, and Structural Test of Ciprofloxacin-Loaded Nanofibers. Pharmaceutics 2021, 13, 556 .

AMA Style

Luca Uhljar, Sheng Kan, Norbert Radacsi, Vasileios Koutsos, Piroska Szabó-Révész, Rita Ambrus. In Vitro Drug Release, Permeability, and Structural Test of Ciprofloxacin-Loaded Nanofibers. Pharmaceutics. 2021; 13 (4):556.

Chicago/Turabian Style

Luca Uhljar; Sheng Kan; Norbert Radacsi; Vasileios Koutsos; Piroska Szabó-Révész; Rita Ambrus. 2021. "In Vitro Drug Release, Permeability, and Structural Test of Ciprofloxacin-Loaded Nanofibers." Pharmaceutics 13, no. 4: 556.

Research article
Published: 13 April 2021 in ACS Omega
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This paper presents a scalable method of developing ultrasensitive electrochemical biosensors. This is achieved by maximizing sensor conductivity through graphene wrapping of carbonized electrospun nanofibers. The effectiveness of the graphene wrap was determined visually by scanning electron microscopy and chemically by Fourier transform infrared spectroscopy, Raman spectroscopy, and X-ray diffraction. The sensing performance of different electrode samples was electrochemically characterized using cyclic voltammetry and electrochemical impedance spectroscopy, with the graphene-wrapped carbonized nanofiber electrode showing significantly improved performance. The graphene-wrapped carbonized nanofibers exhibited a relative conductivity of ∼14 times and an electroactive surface area of ∼2 times greater compared to the bare screen-printed carbon electrode despite experiencing inhibitive effects from the carbon glue used to bind the samples to the electrode. The results indicate potential for a highly conductive, inert sensing platform.

ACS Style

Andreas Tsiamis; Francisco Diaz Sanchez; Niklas Hartikainen; Michael Chung; Srinjoy Mitra; Ying Chin Lim; Huey Ling Tan; Norbert Radacsi. Graphene Wrapping of Electrospun Nanofibers for Enhanced Electrochemical Sensing. ACS Omega 2021, 6, 10568 -10577.

AMA Style

Andreas Tsiamis, Francisco Diaz Sanchez, Niklas Hartikainen, Michael Chung, Srinjoy Mitra, Ying Chin Lim, Huey Ling Tan, Norbert Radacsi. Graphene Wrapping of Electrospun Nanofibers for Enhanced Electrochemical Sensing. ACS Omega. 2021; 6 (16):10568-10577.

Chicago/Turabian Style

Andreas Tsiamis; Francisco Diaz Sanchez; Niklas Hartikainen; Michael Chung; Srinjoy Mitra; Ying Chin Lim; Huey Ling Tan; Norbert Radacsi. 2021. "Graphene Wrapping of Electrospun Nanofibers for Enhanced Electrochemical Sensing." ACS Omega 6, no. 16: 10568-10577.

Journal article
Published: 06 April 2021 in Current Medicinal Chemistry
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: The translation of nanomedicines from the lab level into marketed product face several challenges including characterization of physicochemical properties, pharmacodynamics, pharmacokinetics, process control, biocompatibility and nanotoxicity, scale-up as well as reproducibility. The challenges of nanomedicine development are in connection with the different requirements from the patient (clinical and therapeutic use), industry (production) and regulatory bodies (authorization process). This paper aims at reviewing the status and regulatory aspects of nano-based drug delivery systems with a focus on the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) regulations. In addition to discussing the risks accompanied by the development of nanomedicine, the potential of following a risk-based methodology from the early stage of the R&D phase is emphasized here to ensure safety and efficacy when developing novel nano-based dosage forms. Nanomedicines R&D is a complex and multidisciplinary approach and there are still many challenges in their regulation and legislation. In general, the most critical considerations for nanomedicines are the product quality assessment (physicochemical characteristics, quality control, manufacturing process) and product safety assessment (pharmacokinetics, biodegradation, accumulation and nanotoxicity). The paper presents a promising paradigm in the development and marketing authorization of nanomedicines, namely the Quality by Design (QbD) approach. Sufficient knowledge on the quality, safety, and efficacy of nanomedicines is necessary to obtain with a significant focus on establishing robust, standardized methods to evaluate the critical quality attributes of nanomedicines. The QbD-based submission is highly recommended and required by the regulatory authorities and will enable a smooth clinical translation of the novel nanomedicines.

ACS Style

Ildikó Csóka; Ruba Ismail; Orsolya Jójárt-Laczkovich; Edina Pallagi. Regulatory considerations, challenges and risk-based approach in nanomedicine development. Current Medicinal Chemistry 2021, 28, 1 -1.

AMA Style

Ildikó Csóka, Ruba Ismail, Orsolya Jójárt-Laczkovich, Edina Pallagi. Regulatory considerations, challenges and risk-based approach in nanomedicine development. Current Medicinal Chemistry. 2021; 28 ():1-1.

Chicago/Turabian Style

Ildikó Csóka; Ruba Ismail; Orsolya Jójárt-Laczkovich; Edina Pallagi. 2021. "Regulatory considerations, challenges and risk-based approach in nanomedicine development." Current Medicinal Chemistry 28, no. : 1-1.

Journal article
Published: 06 March 2021 in Molecules
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The present study aimed to develop n-propyl gallate (PG)-encapsulated liposomes through a novel direct pouring method using the quality-by-design (QbD) approach. A further aim was to coat liposomes with hyaluronic acid (HA) to improve the stability of the formulation in nasal mucosa. The QbD method was used for the determination of critical quality attributes in the formulation of PG-loaded liposomes coated with HA. The optimized formulation was determined by applying the Box–Behnken design to investigate the effect of composition and process variables on particle size, polydispersity index (PDI), and zeta potential. Physiochemical characterization, in vitro release, and permeability tests, as well as accelerated stability studies, were performed with the optimized liposomal formulation. The optimized formulation resulted in 90 ± 3.6% encapsulation efficiency, 167.9 ± 3.5 nm average hydrodynamic diameter, 0.129 ± 0.002 PDI, and −33.9 ± 4.5 zeta potential. Coated liposomes showed significantly improved properties in 24 h in an in vitro release test (>60%), in vitro permeability measurement (420 μg/cm2) within 60 min, and also in accelerated stability studies compared to uncoated liposomes. A hydrogen-peroxide-scavenging assay showed improved stability of PG-containing liposomes. It can be concluded that the optimization of PG-encapsulated liposomes coated with HA has great potential for targeting several brain diseases.

ACS Style

Fakhara Sabir; Gábor Katona; Edina Pallagi; Dorina Dobó; Hussein Akel; Dániel Berkesi; Zoltán Kónya; Ildikó Csóka. Quality-by-Design-Based Development of n-Propyl-Gallate-Loaded Hyaluronic-Acid-Coated Liposomes for Intranasal Administration. Molecules 2021, 26, 1429 .

AMA Style

Fakhara Sabir, Gábor Katona, Edina Pallagi, Dorina Dobó, Hussein Akel, Dániel Berkesi, Zoltán Kónya, Ildikó Csóka. Quality-by-Design-Based Development of n-Propyl-Gallate-Loaded Hyaluronic-Acid-Coated Liposomes for Intranasal Administration. Molecules. 2021; 26 (5):1429.

Chicago/Turabian Style

Fakhara Sabir; Gábor Katona; Edina Pallagi; Dorina Dobó; Hussein Akel; Dániel Berkesi; Zoltán Kónya; Ildikó Csóka. 2021. "Quality-by-Design-Based Development of n-Propyl-Gallate-Loaded Hyaluronic-Acid-Coated Liposomes for Intranasal Administration." Molecules 26, no. 5: 1429.

Original research
Published: 01 February 2021 in Drug Design, Development and Therapy
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Background: Optimal transcorneal penetration is necessary for ocular therapy; meanwhile, it is limited by the complex structure and defensive mechanisms of the eye. Antimicrobial stability of topical ophthalmic formulations is especially important. According to previous studies, the mostly used preservative, benzalkonium-chloride is irritative and toxic on corneal epithelial cells; therefore, novel non-toxic, antimicrobial agents are required. In this study, prednisolone-containing ophthalmic formulations were developed with expected optimal permeation without toxic or irritative effects. Methods: The toxicity and permeability of prednisolone-containing eye drops were studied on a human corneal epithelial cell line (HCE-T) and ex vivo cornea model. The lipophilic drug is dissolved by the formation of cyclodextrin inclusion complex. Zinc-containing mucoadhesive biopolymer was applied as an alternative preservative agent, whose toxicity was compared with benzalkonium-chloride. Results: As the results show, benzalkonium-chloride-containing samples were toxic on HCE-T cells. The biopolymer caused no cell damage after the treatment. This was confirmed by immunohistochemistry assay. The in vitro permeability was significantly higher in formulations with prednisolone-cyclodextrin complex compared with suspension formulation. According to the ex vivo permeability study, the biopolymer-containing samples had significantly lower permeability. Conclusion: Considering the mucoadhesive attribute of target formulations, prolonged absorption is expected after application with less frequent administration. It can be stated that the compositions are innovative approaches as novel non-toxic ophthalmic formulations with optimal drug permeability.

ACS Style

Tivadar Bíró; Alexandra Bocsik; Bisera Jurišić Dukovski; Ilona Gróf; Jasmina Lovrić; Ildikó Csóka; Mária A Deli; Zoltán Aigner. New Approach in Ocular Drug Delivery: In vitro and ex vivo Investigation of Cyclodextrin-Containing, Mucoadhesive Eye Drop Formulations. Drug Design, Development and Therapy 2021, ume 15, 351 -360.

AMA Style

Tivadar Bíró, Alexandra Bocsik, Bisera Jurišić Dukovski, Ilona Gróf, Jasmina Lovrić, Ildikó Csóka, Mária A Deli, Zoltán Aigner. New Approach in Ocular Drug Delivery: In vitro and ex vivo Investigation of Cyclodextrin-Containing, Mucoadhesive Eye Drop Formulations. Drug Design, Development and Therapy. 2021; ume 15 ():351-360.

Chicago/Turabian Style

Tivadar Bíró; Alexandra Bocsik; Bisera Jurišić Dukovski; Ilona Gróf; Jasmina Lovrić; Ildikó Csóka; Mária A Deli; Zoltán Aigner. 2021. "New Approach in Ocular Drug Delivery: In vitro and ex vivo Investigation of Cyclodextrin-Containing, Mucoadhesive Eye Drop Formulations." Drug Design, Development and Therapy ume 15, no. : 351-360.

Conference paper
Published: 01 January 2021 in III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science
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ACS Style

Fakhara Sabir; Ruba Ismail; Gábor Katona; Ildikó Csóka. Nose to brain delivery of n-propylgallte loaded lipid nanoparticles for targeting glioblastoma multiforme via QbD approach. III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science 2021, 1 .

AMA Style

Fakhara Sabir, Ruba Ismail, Gábor Katona, Ildikó Csóka. Nose to brain delivery of n-propylgallte loaded lipid nanoparticles for targeting glioblastoma multiforme via QbD approach. III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science. 2021; ():1.

Chicago/Turabian Style

Fakhara Sabir; Ruba Ismail; Gábor Katona; Ildikó Csóka. 2021. "Nose to brain delivery of n-propylgallte loaded lipid nanoparticles for targeting glioblastoma multiforme via QbD approach." III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science , no. : 1.

Conference paper
Published: 01 January 2021 in III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science
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ACS Style

Zsófia Németh; Dorina Gabriella Dobó; Edina Pallagi; Ildikó Csóka. Quality-focused formulation - QbD-based liposome design and development. III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science 2021, 1 .

AMA Style

Zsófia Németh, Dorina Gabriella Dobó, Edina Pallagi, Ildikó Csóka. Quality-focused formulation - QbD-based liposome design and development. III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science. 2021; ():1.

Chicago/Turabian Style

Zsófia Németh; Dorina Gabriella Dobó; Edina Pallagi; Ildikó Csóka. 2021. "Quality-focused formulation - QbD-based liposome design and development." III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science , no. : 1.

Conference paper
Published: 01 January 2021 in III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science
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ACS Style

Hussein Akel; Ruba Ismail; Gábor Katona; Ildikó Csóka. Lipid-based nanosystems for the nose-to-brain delivery of biological drug, Insulin. III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science 2021, 1 .

AMA Style

Hussein Akel, Ruba Ismail, Gábor Katona, Ildikó Csóka. Lipid-based nanosystems for the nose-to-brain delivery of biological drug, Insulin. III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science. 2021; ():1.

Chicago/Turabian Style

Hussein Akel; Ruba Ismail; Gábor Katona; Ildikó Csóka. 2021. "Lipid-based nanosystems for the nose-to-brain delivery of biological drug, Insulin." III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science , no. : 1.

Conference paper
Published: 01 January 2021 in III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science
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ACS Style

S. P. Yamini Kanti; Ildikó Csóka; Orsolya Jójárt-Laczkovich; Livia Adalbert. Analysis of the regulations for medical devices in Europe & future perspectives. III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science 2021, 1 .

AMA Style

S. P. Yamini Kanti, Ildikó Csóka, Orsolya Jójárt-Laczkovich, Livia Adalbert. Analysis of the regulations for medical devices in Europe & future perspectives. III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science. 2021; ():1.

Chicago/Turabian Style

S. P. Yamini Kanti; Ildikó Csóka; Orsolya Jójárt-Laczkovich; Livia Adalbert. 2021. "Analysis of the regulations for medical devices in Europe & future perspectives." III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science , no. : 1.