Browsing by Keyword "Pharmaceutical Science"
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Item Application of 3D printing on the design and development of pharmaceutical oral dosage forms(2024-09) Paccione, Nicola; Guarnizo-Herrero, Víctor; Ramalingam, Murugan; Larrarte, Eider; Pedraz, José Luis; Generales3D printing technologies confer an unparalleled degree of control over the material distribution on the structures they produce, which has led them to become an extremely attractive research topic in pharmaceutical dosage form development, especially for the design of personalized treatments. With fine tuning in material selection and careful design, these technologies allow to tailor not only the amount of drug administered but the biopharmaceutical behaviour of the dosage forms as well. While fused deposition modelling (FDM) is still the most studied 3D printing technology in this area, others are gaining more relevance, which has led to many new and exciting dosage forms developed during 2022 and 2023. Considering that these technologies, in time, will join the current manufacturing methods and with the ever-increasing knowledge on this topic, our review aims to explore the advantages and limitations of 3D printing technologies employed in the design and development of pharmaceutical oral dosage forms, giving special focus to the most important aspects governing the resulting drug release profiles.Item Computational and experimental model of transdermal iontophorethic drug delivery system(2017-11-30) Filipovic, Nenad; Saveljic, Igor; Rac, Vladislav; Graells, Beatriz Olalde; Bijelic, Goran; Biomateriales; MercadoThe concept of iontophoresis is often applied to increase the transdermal transport of drugs and other bioactive agents into the skin or other tissues. It is a non-invasive drug delivery method which involves electromigration and electroosmosis in addition to diffusion and is shown to be a viable alternative to conventional administration routs such as oral, hypodermic and intravenous injection. In this study we investigated, experimentally and numerically, in vitro drug delivery of dexamethasone sodium phosphate to porcine skin. Different current densities, delivery durations and drug loads were investigated experimentally and introduced as boundary conditions for numerical simulations. Nernst–Planck equation was used for calculation of active substance flux through equivalent model of homogeneous hydrogel and skin layers. The obtained numerical results were in good agreement with experimental observations. A comprehensive in-silico platform, which includes appropriate numerical tools for fitting, could contribute to iontophoretic drug-delivery devices design and correct dosage and drug clearance profiles as well as to perform much faster in-silico experiments to better determine parameters and performance criteria of iontophoretic drug delivery.Item Development and validation of a bioanalytical method for the simultaneous determination of heroin, its main metabolites, naloxone and naltrexone by LC-MS/MS in human plasma samples: Application to a clinical trial of oral administration of a heroin/naloxone formulation(2015-10-01) Moreno-Vicente, Raquel; Fernández-Nieva, Zuriñe; Navarro, Arantza; Gascón-Crespí, Irene; Farré-Albaladejo, Magí; Igartua, Manuela; Hernández, Rosa María; Pedraz, José Luis; Desarrollo FarmaceuticoA bioanalytical method using high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) was developed and validated for simultaneous quantification of heroin, its main metabolites and naloxone. In addition, naltrexone was detected qualitatively. This method was used to analyse human plasma samples from a clinical trial after oral administration of a heroin/naloxone formulation in healthy volunteers. O-methylcodeine was used as an internal standard. Samples were kept in an ice-bath during their processing to minimize the degradation of heroin. A short methodology based on protein precipitation with methanol was used for sample preparation. After protein precipitation, only the addition of a formic acid solution was needed to elute heroin, 6-monoacetylmorphine, morphine, naloxone and naltrexone. Morphine metabolites were evaporated to dryness and reconstituted in a formic acid solution. Chromatographic separation was achieved at 35. °C on an X-Bridge Phenyl column (150. ×. 4.6. mm, 5. μm) using a gradient elution with a mobile phase of ammonium formate buffer at pH 3.0 and formic acid in acetonitrile. The run time was 8. min. The analytes were monitored using a triple quadrupole mass spectrometer with positive electrospray ionization (ESI+) in multiple reaction monitoring (MRM) mode. The method was found to be linear in a concentration range of 10-2000. ng/mL for M3G and 10-1000. ng/mL for the rest of compounds. Quality controls showed accurate values between -3.6% and 4.0% and intra- and inter-day precisions were below 11.5% for all analytes. The overall recoveries were approximately 100% for all analytes including the internal standard. A rapid, specific, precise and simple method was developed for the determination of heroin, its metabolites, naloxone and naltrexone in human plasma. This method was successfully applied to a clinical trial in 12 healthy volunteers.Item Efficient Ullmann and Suzuki-Miyaura cross-coupling reactions catalyzed by heterogeneous Pd-porous carbon beads catalysts in aqueous media(2022-12) Khosravi, Faezeh; Centeno-Pedrazo, Ander; Rajabi, Fatemeh; Len, Thomas; Voskressensky, Leonid G.; Luque, Rafael; Garcia-Suarez, Eduardo J.; Tecnalia Research & InnovationCarbon-carbon coupling reactions are of great interest for a wide range of applications including pharmaceutical compounds and biologically active molecules. Usually, coupling reactions were performed using a homogeneous catalyst and organic solvent. Thus, the use of greener solvents as well as the heterogenization of the classical metal-based catalyst are desirable and still under development. This contribution describes the synthesis of biaryl compounds in water by Ullmann and Suzuki reactions with carbon-supported Pd nanoparticles. As expected, the microwave activation method drastically decrease the reaction time. The utilization of trioctylphosphine (TOP) or triphenylphosphine (TPP) ligands slow down the Pd leaching without cancelling it compared to the unliganded Pd catalyst. Moreover, a treatment with H2O2 appears beneficial with respect to a thermal-oxidative treatment at 1500 °C due to higher hydrophilicity of the resultant carbon support. These results and methodology contribute to a greener future for C–C coupling reactions.Item Fluidized Bed Membrane Reactors for Ultra Pure H2 Production - A Step forward towards Commercialization(2016-03-19) Helmi, Arash; Fernandez, Ekain; Melendez, Jon; Pacheco Tanaka, David A.; Gallucci, Fausto; van Sint Annaland, Martin; TECNOLOGÍAS DE HIDRÓGENO; Tecnalia Research & Innovation; TECNOLOGÍA DE MEMBRANAS E INTENSIFICACIÓN DE PROCESOSIn this research the performance of a fluidized bed membrane reactor for high temperature water gas shift and its long term stability was investigated to provide a proof-of-concept of the new system at lab scale. A demonstration unit with a capacity of 1 Nm3/h of ultra-pure H2 was designed, built and operated over 900 h of continuous work. Firstly, the performance of the membranes were investigated at different inlet gas compositions and at different temperatures and H2 partial pressure differences. The membranes showed very high H2 fluxes (3.89E 6 mol m 2 Pa 1 s 1 at 400 C and 1 atm pressure difference) with a H2/N2 ideal perm-selectivity (up to 21,000 when integrating five membranes in the module) beyond the DOE 2015 targets. Monitoring the performance of the membranes and the reactor confirmed a very stable performance of the unit for continuous high temperature water gas shift under bubbling fluidization conditions. Several experiments were carried out at different temperatures, pressures and various inlet compositions to determine the optimum operating window for the reactor. The obtained results showed high hydrogen recovery factors, and very low CO concentrations at the permeate side (in average <10 ppm), so that the produced hydrogen can be directly fed to a low temperature PEM fuel cell.Item MiR-219a-5p Enriched Extracellular Vesicles Induce OPC Differentiation and EAE Improvement More Efficiently Than Liposomes and Polymeric Nanoparticles(2020-02) Osorio-Querejeta, Iñaki; Carregal-Romero, Susana; Ayerdi-Izquierdo, Ana; Mäger, Imre; Nash, Leslie A.; Wood, Matthew; Egimendia, Ander; Betanzos, M.; Alberro, Ainhoa; Iparraguirre, Leire; Moles, Laura; Llarena, Irantzu; Möller, Marco; Goñi-de-Cerio, Felipe; Bijelic, Goran; Ramos-Cabrer, Pedro; Muñoz-Culla, Maider; Otaegui, David; Tecnalia Research & Innovation; Biomateriales; MercadoRemyelination is a key aspect in multiple sclerosis pathology and a special effort is being made to promote it. However, there is still no available treatment to regenerate myelin and several strategies are being scrutinized. Myelination is naturally performed by oligodendrocytes and microRNAs have been postulated as a promising tool to induce oligodendrocyte precursor cell differentiation and therefore remyelination. Herein, DSPC liposomes and PLGA nanoparticles were studied for miR-219a-5p encapsulation, release and remyelination promotion. In parallel, they were compared with biologically engineered extracellular vesicles overexpressing miR-219a-5p. Interestingly, extracellular vesicles showed the highest oligodendrocyte precursor cell differentiation levels and were more effective than liposomes and polymeric nanoparticles crossing the blood–brain barrier. Finally, extracellular vesicles were able to improve EAE animal model clinical evolution. Our results indicate that the use of extracellular vesicles as miR-219a-5p delivery system can be a feasible and promising strategy to induce remyelination in multiple sclerosis patients.Item Morphology and N2 Permeance of Sputtered Pd-Ag Ultra-Thin Film Membranes(2016-02-10) Fernandez, Ekain; Sanchez-Garcia, Jose Angel; Viviente, J.L.; van Sint Annaland, Martin; Gallucci, Fausto; Pacheco Tanaka, David A.; Tecnalia Research & Innovation; TECNOLOGÍAS DE HIDRÓGENO; TECNOLOGÍA DE MEMBRANAS E INTENSIFICACIÓN DE PROCESOSThe influence of the temperature during the growth of Pd-Ag films by PVD magnetron sputtering onto polished silicon wafers was studied in order to avoid the effect of the support roughness on the layer growth. The surfaces of the Pd-Ag membrane films were analyzed by atomic force microscopy (AFM), and the results indicate an increase of the grain size from 120 to 250–270 nm and film surface roughness from 4–5 to 10–12 nm when increasing the temperature from around 360–510 K. After selecting the conditions for obtaining the smallest grain size onto silicon wafer, thin Pd-Ag (0.5–2-µm thick) films were deposited onto different types of porous supports to study the influence of the porous support, layer thickness and target power on the selective layer microstructure and membrane properties. The Pd-Ag layers deposited onto ZrO2 3-nm top layer supports (smallest pore size among all tested) present high N2 permeance in the order of 10−6 mol•m−2•s−1•Pa−1 at room temperature.Item Randomized, crossover and single-dose bioquivalence study of two oral desogestrel formulations (film-coated tablets of 75 μg) in healthy female volunteers(2012) Pena, María Ángeles; Sanz, Emilio; Francisco, Silvia; Alonso, Ainhara; Abajo, Zurine; Felipe, Izaskun; Pascual, Jaume; Tost, Digna; Bailac, Sandra; Tecnalia Research & InnovationDespite the increase in the substitution of branded medicinal product with generic drugs, this is a controversial issue for some pharmacological groups (such as contraceptives). The aim of the present clinical trial was to assess the bioequivalence and tolerability of two oral formulations of desogestrel. Thirty-three healthy female volunteers participated in this randomized and two-way crossover study. During two separate experimental periods, with at least four weeks of washout period, women received a single oral dose of 75 μg of desogestrel from each of the formulations (test formulation and reference formulation). Desogestrel bioavailability was determined by the measurement of 3-Ketodesogestrel plasma concentration. Pharmacokinetic parameters were comparable and the 90% CI for the ratio of C max (96.14-114.53%) and AUC 0-t (105.73-123.83%) values for the test and reference formulations fell within the established regulatory interval (80-125%). Both formulations were also comparable in terms of tolerability. From the results of this study it can be concluded that test formulation (desogestrel 75 μg, Cyndea PHARMA S.L.) is bioequivalent to the reference formulation (Cerazet® 75 μg, Organon Española S.A.).Item Recent Advances in Pd-Based Membranes for Membrane Reactors(2017-01-01) Arratibel Plazaola, Alba; Pacheco Tanaka, David A.; Van Sint Annaland, Martin; Gallucci, Fausto; Tecnalia Research & Innovation; TECNOLOGÍA DE MEMBRANAS E INTENSIFICACIÓN DE PROCESOSPalladium-based membranes for hydrogen separation have been studied by several research groups during the last 40 years. Much effort has been dedicated to improving the hydrogen flux of these membranes employing different alloys, supports, deposition/production techniques, etc. High flux and cheap membranes, yet stable at different operating conditions are required for their exploitation at industrial scale. The integration of membranes in multifunctional reactors (membrane reactors) poses additional demands on the membranes as interactions at different levels between the catalyst and the membrane surface can occur. Particularly, when employing the membranes in fluidized bed reactors, the selective layer should be resistant to or protected against erosion. In this review we will also describe a novel kind of membranes, the pore-filled type membranes prepared by Pacheco Tanaka and coworkers that represent a possible solution to integrate thin selective membranes into membrane reactors while protecting the selective layer. This work is focused on recent advances on metallic supports, materials used as an intermetallic diffusion layer when metallic supports are used and the most recent advances on Pd-based composite membranes. Particular attention is paid to improvements on sulfur resistance of Pd based membranes, resistance to hydrogen embrittlement and stability at high temperature.