Search results for: Helio C. Salgado

Authors: Adriana B. Ribeiro, Camila B. Araujo, Frank L. Bueno, Luiz Eduardo V. Silva, Caroline V. Fortes, Helio C. Salgado, Rubens Fazan Jr., Claudia H. L. da Silva

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Denture-related stomatitis (DRS) has recently been associated with deleterious cardiovascular effects, including hypertension. This study evaluated salivary parameters, blood pressure (BP) and heart rate variability (HRV), before and after DRS treatment in edentulous patients (n=14). Collection of unstimulated and stimulated saliva, as well as blood pressure (BP) measurements and electrocardiogram recordings were performed before and after 10 days of DRS treatment. The salivary flow (mL/min) was found similar at both times while pH was smaller (more neutral) after treatment (7.3 ± 2.2 vs. 7.1 ± 0.24). Systolic BP (mmHg) showed a trend, but not a significant reduction after DRS treatment (158 ± 25.68 vs. 148 ± 16,72, p=0,062) while diastolic BP was found similar in both times (86 ± 13.93 and 84 ± 9.38). Overall HRV, measured by standard deviation of RR intervals was not affected by DRS treatment (24 ± 4 vs 18 ± 2 ms), but differences of successive RR intervals (an index of parasympathetic cardiac modulation) increased after the treatment (26 ± 4 vs 19 ± 2 ms). Moreover, another index of vagal modulation of the heart, the power of RR interval spectra at high-frequency, was also markedly higher after DRS treatment (236 ± 63 vs 135 ± 32 ms²). Such findings strongly suggest that DRS is linked to an autonomic imbalance with sympathetic overactivity, which is markedly deleterious, increasing cardiovascular risk and the incidence of diseases such as hypertension. Acknowledgment: This study is supported by FAPESP, CNPq.

Keywords: biofilm, denture stomatitis, HRV, blood pressure

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Authors: Xavi Vilajosana Guillen, Emilio José Pérez Salgado

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This document presents experimental results obtained in a realistic environment using an underwater LoRa link. It aims to analyze the behavior of electromagnetic waves underwater and determine this communication capability. With this it has been tried to empirically evaluate the results obtained in the mathematical model using a commercial device with low cost and low consumption that works at frequency 433Mhz. The mathematical results obtained for wireless communication at 433Mhz underwater indicate that a communication of up to 7.5 m is possible, however experimentally 8 m has been achieved.

Keywords: 433Mhz link, internet of things, LoRa link, underwater communication

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Authors: Maria Da Glória Diniz De Almeida, Andreia M. P. Salgado

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This paper aims to present the creation of a mentoring program to be applied in developing future junior industrial engineers acting professionally. Its objective is to contribute to a better professional performance as engineers. It is a case-study for the RIP region (including the cities of Resende, Itatiaia and Porto Real), which is located in an industrial area in Rio de Janeiro State, in Brazil. As a result, 87% of mentors and mentees approved the program as efficient, based on the initial targets.

Keywords: mentoring program, mentors and mentees, student professional development, young engineers education

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Authors: Helio Arthur Reis Irigaray, Fabricio Stocker

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This study aims to discover the extent to which affinity groups effectively act to combat inequalities, promote diversity, and contribute to the inclusion of non-hegemonic groups in the work environment. To this end, we have built empirical research, in which we interviewed 36 leaders and members of the collectives of non-hegemonic groups, namely women, blacks, and LGBTQ. With the proper authorization of the participants, their interviews were transcribed and submitted for critical analysis of the discourse. The field revealed that collectives are the result of the articulation of non-hegemonic groups, which create and participate in legitimate and institutional spaces to promote diversity. We also identified that diversity actions have happened as a market trend and reproduced mimetically. As the largest companies implement these actions, they become benchmarking and thus create a flow that is reproduced by other companies. However, there is no effective change in the structures that could promote inclusion and belonging. We state that a diverse group of employees are not enough to claim that the organization is diverse and inclusive. There remains much more to discuss and delve into deeply, including gender, diversity, and intersectionality.

Keywords: diversity, inclusion, collectives, affinity groups, employee resource groups

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Authors: M. Fernanda Salgado, Alfonso Tierra, David S. Sandoval, Wilbert G. Aguilar

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Public transportation buses usually vary the speed depending on the places with the number of passengers. They require having efficient travel planning, a plan that will help them choose the fast route. Initially, an estimation tool is necessary to determine the travel time of each route, clearly establishing the possibilities. In this work, we give a practical solution that makes use of a concept that defines as areas of commercial incidence. These areas are based on the hypothesis that in the commercial places there is a greater flow of people and therefore the buses remain more time in the stops. The areas have one or more segments of routes, which have an incidence factor that allows to estimate the times. In addition, initial results are presented that verify the hypotheses and that promise adequately the travel times. In a future work, we take this approach to make an efficient travel planning system.

Keywords: commercial incidence, planning, public transport, speed travel, travel time

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Authors: Paulina Solórzano Salgado, Luis Rodrigo Valencia Pérez, Alberto de Jesús Pastrana Palma

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In this research, it is presented a digital maturity framework, which contributes to the development of small and medium-sized enterprises (SMEs) in the commercial sector. This proposal is based on three important concepts: Marketing activities in the enterprise, information and communication technologies ICT, as well as Innovation. Prior to the development of this framework, was formulated a quantitative assessment tool through a literature review, and was validated with a method used by experts, and which determines the relationship of digital marketing and innovation activities in companies. The instrument was applied to 64 Mexican companies from the Made in Mexico database, which allowed both descriptive results and correlation results. These contributed to the development of the methodology, and confirming that the management of digital marketing has a positive relation with innovation activities of companies. Also, that analytics in digital marketing is a source for its development. In this paper, the management stages and activities are presented to be developed by companies in order to generate knowledge, which will allow them to reach its digital maturity.

Keywords: digital marketing, digital maturity, innovation, SMEs

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Authors: Jadisha Cornejo, Helio Pedrini

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Recognition of emotions based on facial expressions has received increasing attention from the scientific community over the last years. Several fields of applications can benefit from facial emotion recognition, such as behavior prediction, interpersonal relations, human-computer interactions, recommendation systems. In this work, we develop and analyze an emotion recognition framework based on facial expressions robust to occlusions through the Weber Local Descriptor (WLD). Initially, the occluded facial expressions are reconstructed following an extension approach of Robust Principal Component Analysis (RPCA). Then, WLD features are extracted from the facial expression representation, as well as Local Binary Patterns (LBP) and Histogram of Oriented Gradients (HOG). The feature vector space is reduced using Principal Component Analysis (PCA) and Linear Discriminant Analysis (LDA). Finally, K-Nearest Neighbor (K-NN) and Support Vector Machine (SVM) classifiers are used to recognize the expressions. Experimental results on three public datasets demonstrated that the WLD representation achieved competitive accuracy rates for occluded and non-occluded facial expressions compared to other approaches available in the literature.

Keywords: emotion recognition, facial expression, occlusion, fiducial landmarks

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Authors: M. Fernanda Salgado, Alfonso Tierra, Wilbert Aguilar

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The present project consists in applying the informed search algorithm A star (A*) to solve traveler problems, applying it by urban public transportation routes. The digitization of the information allowed to identify 26% of the total of routes that are registered within the Metropolitan District of Quito. For the validation of this information, data were taken in field on the travel times and the difference with respect to the times estimated by the program, resulting in that the difference between them was not greater than 2:20 minutes. We validate A* algorithm with the Dijkstra algorithm, comparing nodes vectors based on the public transport stops, the validation was established through the student t-test hypothesis. Then we verified that the times estimated by the program using the A* algorithm are similar to those registered on field. Furthermore, we review the performance of the algorithm generating iterations in both algorithms. Finally, with these iterations, a hypothesis test was carried out again with student t-test where it was concluded that the iterations of the base algorithm Dijsktra are greater than those generated by the algorithm A*.

Keywords: algorithm A*, graph, mobility, public transport, travel planning, routes

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Authors: A. C. Galvis-Castro, R. D. Tovar, R. Salgado, M. Prezzi

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It is generally accepted that the shaft capacity of piles in the sand is lower for tensile loading that for compressive loading. So far, very little attention has been paid to the role of the influence of the installation method on the tensile to compressive shaft capacity ratio. The objective of this paper is to analyze the effect of installation method on the tensile to compressive shaft capacity of piles in dense sand as observed in tests on half-circular model pile tests in a half-circular calibration chamber with digital image correlation (DIC) capability. Model piles are either monotonically jacked, jacked with multiple strokes or pre-installed into the dense sand samples. Digital images of the model pile and sand are taken during both the installation and loading stages of each test and processed using the DIC technique to obtain the soil displacement and strain fields. The study provides key insights into the mobilization of shaft resistance in tensile and compressive loading for both displacement and non-displacement piles.

Keywords: digital image correlation, piles, sand, shaft resistance

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Authors: Ruben Dario Tovar-Valencia, Eshan Ganju, Fei Han, Monica Prezzi, Rodrigo Salgado

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Particle breakage occurs even in strong silica sand particles. There is compelling evidence that suggests that particle breakage causes changes in several properties such as permeability, peak strength, dilatancy and critical state friction angle. Current pile design methods that are based on soil properties do not account for particle breakage that occurs during driving or jacking of displacement piles. This may lead to significant overestimation of pile capacity in sands dominated by particles susceptible to breakage, such as carbonate sands. The objective of this paper is to study the influence of shear displacement on particle breakage and friction angle of carbonate sands, and to furthermore quantify the change in friction angle observed with different levels of particle breakage. To study the phenomenon of particle breakage, multiple ring shear tests have been performed at different levels of vertical confinement on a thoroughly characterized carbonate sand to find i) the shear displacement necessary to reach stable friction angles and ii) the effect of particle breakage on the mobilized friction angle of the tested sand. The findings of this study can potentially be used to update the current pile design methods by developing a friction angle which is a function of shear displacement and breakage characteristics of the sand instead of being a constant value.

Keywords: breakage, carbonate sand, friction angle, pile design, ring shear test

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Authors: Carolina Nunes, Sónia Ribeiro, Hélio Faustinho, Hélia Sales, Rita Pontes, João Nunes

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Pine resin activity in Portugal was one of the most important and major non-wood forestry, representing a strategic natural resource for Portuguese Bioeconomy and an important social activity for rural regions. Pine forests representing a stock of atmospheric carbon, contributing to greenhouse effect mitigation and social and environmental important services returns. They are important sources of numerous useful products, including not only wood and cellulose but also nonwood products used by the chemical, food, and pharmaceutical industries, as well as for biorefineries. Portuguese pine forest area decreases from 1 million hectares to 400 mil hectares in the last 20 years. Portugal, in 80´s decade, was one of the world´s TOP 3 producers, with a middle annual production of 140 mil tones.year-1. With the pressure of the social desertification, forest fires, phytosanitary problems (e.g. nematode of the pine wood) and the decrease of economic value and competitivity of the Portuguese forest, the actual middle annual production is less than 10 mil tones.year-1 (lesser 92%). This significant decrease representing an annual economic loss of approximately 130-140 million Euros. year⁻¹ for forest primary sector in Portugal. The Biopinus project design new forestry approach and strategic biotechnologies knowledge to increase the economic value of Pine resin in Portugal, with an impact on the growth of the economic value of Pine resin from 1,1 to 1,5 Euros/kg.

Keywords: pine resin, bioeconomy, economic value, biotecnology

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Authors: Debora C. Mendes, Matthias Eckert, Claudia S. Moço, Helio Martins, Jean-Pierre Gonçalves, Miguel Oliveira, Jose P. Da Silva

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Disposal of construction and demolition waste (C&DW) in embankments in the periphery of cities causes both environmental and social problems. To achieve the management of C&DW, a detailed analysis of the properties of these materials should be done. In this work we report a comparative study of the physical, chemical and environmental properties of natural and C&DW aggregates from 25 different origins. Assays were performed according to European Standards. Analysis of heavy metals and organic compounds, namely polycyclic aromatic hydrocarbons (PAHs) and polychlorinated biphenyls (PCBs), were performed. Finally, properties of concrete prepared with C&DW aggregates are reported. Physical analyses of C&DW aggregates indicated lower quality properties than natural aggregates, particularly for concrete preparation and unbound layers of road pavements. Chemical properties showed that most samples (80%) meet the values required by European regulations for concrete and unbound layers of road pavements. Analyses of heavy metals Cd, Cr, Cu, Pb, Ni, Mo and Zn in the C&DW leachates showed levels below the limits established by the Council Decision of 19 December 2002. Identification and quantification of PCBs and PAHs indicated that few samples shows the presence of these compounds. The measured levels of PCBs and PAHs are also below the limits. Other compounds identified in the C&DW leachates include phthalates and diphenylmethanol. The characterized C&DW aggregates show lower quality properties than natural aggregates but most samples showed to be environmentally safe. A continuous monitoring of the presence of heavy metals and organic compounds should be made to trial safe C&DW aggregates. C&DW aggregates provide a good economic and environmental alternative to natural aggregates.

Keywords: concrete preparation, construction and demolition waste, heavy metals, organic pollutants

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Authors: Iahtasham Khan, Vania Lucia De Assis Santana, Marcilia Maria Alves De Souza, Mabel Hanna Vance Harrop, Fernando Leandro Dos Santos, Cecília Maria Souza Leão E. Silva, Pedro Paulo Silveira, Marcelo Brasil, Marcus Vinícius, Hélio Cordeiro Manso Filho, Muhammad Younus, Aman Ullah Khan

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Glanders ranks high on clinical lists in some regions of Brazil as a cause of respiratory and lymphatic disease in equids. Glanders is caused by Burkolderia mallei (B. mallei) Gram-negative bacterium. B. mallei was first biological agent used in World War I in 20th century. The complement fixation test (CFT) is a serodiagnostic tool prescribed by the World Organization for Animal Health (OIE)for the diagnosis of glanders in the international trade of equids. The aim of the present study was to monitor the serological responses in equines naturally infected with B. mallei using the CFT. A total of 574 equids were tested with CFT, 30 days apart in a total of 12 samplings. One hundred thirty-four sera tested negative in all samplings; 192 sera tested positive in one sampling and 125 sera tested positive in two or more samplings. Remaining 123 samples showed uncertain results. Thus, CFT results can vary over a period of time. These variations could be the consequence of the effects of the natural immune response in each animal. The findings of the present study demonstrate difficulties regarding the simultaneous implementation of CFT and test and slaughter policies to eradicate glanders. Another constraint to control this disease is the presence of carrier/transitory CFT-negative animals, which are a potential source of disease in glanders-free areas. Serodiagnostic tests of higher sensitivity and specificity like immunobloat should be implemented to achieve success in the eradication of glanders.

Keywords: glanders, equids, horses, immunological, mules

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Authors: Juan Alfredo Guevara Carrio, Swamy Toolahalli Thipperudra, Riddhi Naik Dharmeshbhai, Sergio Graniero Echeverrigaray, Jose Vitorio Emiliano, Antonio Helio Castro

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In order to advance the hydrogen economy, several industrial sectors can potentially benefit from the trillions of stimulus spending for post-coronavirus. Blending hydrogen into natural gas pipeline networks has been proposed as a means of delivering it during the early market development phase, using separation and purification technologies downstream to extract the pure H₂ close to the point of end-use. This first step has been mentioned around the world as an opportunity to use existing infrastructures for immediate decarbonisation pathways. Among current technologies used to extract hydrogen from mixtures in pipelines or liquid carriers, membrane separation can achieve the highest selectivity. The most efficient approach for the separation of H₂ from other substances by membranes is offered from the research of 2D layered materials due to their exceptional physical and chemical properties. Graphene-based membranes, with their distribution of pore sizes in nanometers and angstrom range, have shown fundamental and economic advantages over other materials. Their combination with the structure of ceramic and geopolymeric materials enabled the synthesis of nanocomposites and the fabrication of membranes with long-term stability and robustness in a relevant range of physical and chemical conditions. Versatile separation modules have been developed for hydrogen separation, which adaptability allows their integration in industrial prototypes for applications in heavy transport, steel, and cement production, as well as small installations at end-user stations of pipeline networks. The developed membranes and prototypes are a practical contribution to the technological challenge of supply pure H₂ for the mentioned industries as well as hydrogen energy-based fuel cells.

Keywords: graphene nano-composite membranes, hydrogen separation and purification, separation modules, indsutrial prototype

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Authors: Débora C. Mendes, Matthias Eckert, Cláudia S. Moço, Hélio Martins, Jean-Pierre P. Gonçalves, Miguel Oliveira, José P. Da Silva

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Uncontrolled disposal of construction and demolition waste (C & DW) in embankments in the periphery of cities causes both environmental and social problems, namely erosion, deforestation, water contamination and human conflicts. One of the milestones of EU Horizon 2020 Programme is the management of waste as a resource. To achieve this purpose for C & DW, a detailed analysis of the properties of these materials should be done. In this work we report the physical, chemical and environmental properties of C & DW aggregates from 25 different origins. The results are compared with those of common natural aggregates used in construction. Assays were performed according to European Standards. Additional analysis of heavy metals and organic compounds such as polycyclic aromatic hydrocarbons (PAHs) and polychlorinated biphenyls (PCBs), were performed to evaluate their environmental impact. Finally, properties of concrete prepared with C & DW aggregates are also reported. Physical analyses of C & DW aggregates indicated lower quality properties than natural aggregates, particularly for concrete preparation and unbound layers of road pavements. Chemical properties showed that most samples (80%) meet the values required by European regulations for concrete and unbound layers of road pavements. Analyses of heavy metals Cd, Cr, Cu, Pb, Ni, Mo and Zn in the C&DW leachates showed levels below the limits established by the Council Decision of 19 December 2002. Identification and quantification of PCBs and PAHs indicated that few samples shows the presence of these compounds. The measured levels of PCBs and PAHs are also below the limits. Other compounds identified in the C&DW leachates include phthalates and diphenylmethanol. In conclusion, the characterized C&DW aggregates show lower quality properties than natural aggregates but most samples showed to be environmentally safe. A continuous monitoring of the presence of heavy metals and organic compounds should be made to trial safe C&DW aggregates. C&DW aggregates provide a good economic and environmental alternative to natural aggregates.

Keywords: concrete preparation, construction and demolition waste, heavy metals, organic pollutants

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Authors: Caroline M. Spagnol, Vera L. B. Isaac, Marcos A. Corrêa, Hérida R. N. Salgado

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Phenolic compounds are abundant in the Brazilian plant kingdom and they are part of a large and complex group of organic substances. Cinnamic acids are part of this group of organic compounds, and caffeic acid (CA) is one of its representatives. Antioxidants are compounds which act as free radical scavengers and, in other cases, such as metal chelators, both in the initiation stage and the propagation of oxidative process. The tyrosinase, polyphenol oxidase, is an enzyme that acts at various stages of melanin biosynthesis within the melanocytes and is considered a key molecule in this process. Some phenolic compounds exhibit inhibitory effects on melanogenesis by inhibiting the tyrosinase enzymatic activity and therefore has been the subject of studies. However, few studies have reported the effectiveness of these products and their safety. Objectives: To assess the inhibitory activity of tyrosinase, the antioxidant activity of CA and its cytotoxic potential. The method to evaluate the inhibitory activity of tyrosinase aims to assess the reduction transformation of L-dopa into dopaquinone reactions catalyzed by the enzyme. For evaluating the antioxidant activity was used the analytical methodology of DPPH radical inhibition. The cytotoxicity evaluation was carried out using the MTT method (3-(4,5-dimethyl-2-thiazolyl)-2,5-diphenyl-2H-tetrazolium bromide), a colorimetric assay which determines the amount of insoluble violet crystals formed by the reduction of MTT in the mitochondria of living cells. Based on the results obtained during the study, CA has low activity as a depigmenting agent. However, it is a more potent antioxidant than ascorbic acid (AA), since a lower amount of CA is sufficient to inhibit 50% of DPPH radical. The results are promising since CA concentration that promoted 50% toxicity in HepG2 cells (IC50=781.8 μg/mL) is approximately 330 to 400 times greater than the concentration required to inhibit 50% of DPPH (IC50 DPPH= 2.39 μg/mL) and ABTS (IC50 ABTS= 1.96 μg/mL) radicals scavenging activity, respectively. The maximum concentration of caffeic acid tested (1140 mg /mL) did not reach 50% of cell death in HaCat cells. Thus, it was concluded that the caffeic acid does not cause toxicity in HepG2 and HaCat cells in the concentrations required to promote antioxidant activity in vitro, and it can be applied in topical products.

Keywords: caffeic acid, antioxidant, cytotoxicity, cosmetic

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Authors: Ana Carolina Kogawa, Selma Gutierrez Antonio, Hérida Regina Nunes Salgado

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Rifaximin is an oral antimicrobial, gut - selective and not systemic with adverse effects compared to placebo. It is used for the treatment of hepatic encephalopathy, travelers diarrhea, irritable bowel syndrome, Clostridium difficile, ulcerative colitis and acute diarrhea. The crystalline form present in the rifaximin with minimal systemic absorption is α, being the amorphous form significantly different. Regulators are increasingly attention to polymorphisms. Polymorphs can change the form by altering the drug characteristics compromising the effectiveness and safety of the finished product. International Conference on Harmonization issued the ICH Guidance Q6A, which aim to improve the control of polymorphism in new and existing pharmaceuticals. The objective of this study was to obtain polymorphic forms of rifaximin employing recrystallization processes and characterize them by thermal analysis (thermogravimetry - TG and differential scanning calorimetry - DSC), X-ray diffraction, scanning electron microscopy and solubility test. Six polymorphic forms of rifaximin, designated I to VI were obtained by the crystallization process by evaporation of the solvent. The profiles of the TG curves obtained from polymorphic forms of rifaximin are similar to rifaximin and each other, however, the DTG are different, indicating different thermal behaviors. Melting temperature values of all the polymorphic forms were greater to that shown by the rifaximin, indicating the higher thermal stability of the obtained forms. The comparison of the diffractograms of the polymorphic forms of rifaximin with rifaximin α, β and γ constant in patent indicate that forms III, V and VI are formed by mixing polymorph β and α and form III is formed by polymorph β. The polymorphic form I is formed by polymorph β, but with a significant amount of amorphous material. Already, the polymorphic form II consists of polymorph γ, amorphous. In scanning electron microscope is possible to observe the heterogeneity of morphological characteristics of crystals of polymorphic forms among themselves and with rifaximin. The solubility of forms I and II was greater than the solubility of rifaximin, already, forms III, IV and V presented lower solubility than of rifaximin. Similarly, the bioavailability of the amorphous form of rifaximin is considered significantly higher than the form α, the polymorphic forms obtained in this work can not guarantee the excellent tolerability of the reference medicine. Therefore, studies like these are extremely important and they point to the need for greater requirements by the regulatory agencies competent about polymorphs analysis of the raw materials used in the manufacture of medicines marketed globally. These analyzes are not required in the majority of official compendia. Partnerships between industries, research centers and universities would be a viable way to consolidate researches in this area and contribute to improving the quality of solid drugs.

Keywords: electronic microscopy, polymorphism, rifaximin, solubility, X-ray diffraction

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Authors: Eliane G. Tótoli, Hérida Regina N. Salgado

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Daptomycin is an important antimicrobial agent used in clinical practice nowadays, since it is very active against some Gram-positive bacteria that are particularly challenges for the medicine, such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococci (VRE). The importance of environmental preservation has receiving special attention since last years. Considering the evident need to protect the natural environment and the introduction of strict quality requirements regarding analytical procedures used in pharmaceutical analysis, the industries must seek environmentally friendly alternatives in relation to the analytical methods and other processes that they follow in their routine. In view of these factors, green analytical chemistry is prevalent and encouraged nowadays. In this context, infrared spectroscopy stands out. This is a method that does not use organic solvents and, although it is formally accepted for the identification of individual compounds, also allows the quantitation of substances. Considering that there are few green analytical methods described in literature for the analysis of daptomycin, the aim of this work was the development and validation of a green analytical method for the quantification of this drug in lyophilized powder for injectable solution, by Fourier-transform infrared spectroscopy (FT-IR). Method: Translucent potassium bromide pellets containing predetermined amounts of the drug were prepared and subjected to spectrophotometric analysis in the mid-infrared region. After obtaining the infrared spectrum and with the assistance of the IR Solution software, quantitative analysis was carried out in the spectral region between 1575 and 1700 cm-1, related to a carbonyl band of the daptomycin molecule, and this band had its height analyzed in terms of absorbance. The method was validated according to ICH guidelines regarding linearity, precision (repeatability and intermediate precision), accuracy and robustness. Results and discussion: The method showed to be linear (r = 0.9999), precise (RSD% < 2.0), accurate and robust, over a concentration range from 0.2 to 0.6 mg/pellet. In addition, this technique does not use organic solvents, which is one great advantage over the most common analytical methods. This fact contributes to minimize the generation of organic solvent waste by the industry and thereby reduces the impact of its activities on the environment. Conclusion: The validated method proved to be adequate to quantify daptomycin in lyophilized powder for injectable solution and can be used for its routine analysis in quality control. In addition, the proposed method is environmentally friendly, which is in line with the global trend.

Keywords: daptomycin, Fourier-transform infrared spectroscopy, green analytical chemistry, quality control, spectrometry in IR region

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Authors: Osman Turkoglu, Alvin Estilo, Ritu Gupta, Liliam Pineda-Salgado, Rajesh Pandey

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Background: Hepatotoxicity can be linked to a variety of clinical symptoms and histopathological signs, posing a great challenge in the surveillance of suspected drug-induced liver injury (DILI) cases in the safety database. Additionally, the majority of such cases are rare, idiosyncratic, highly unpredictable, and tend to demonstrate unique individual susceptibility; these qualities, in turn, lend to a pharmacovigilance monitoring process that is often tedious and time-consuming. Objective: Develop a multifactorial algorithm to assist pharmacovigilance physicians in identifying high-risk hepatotoxicity cases associated with DILI from the sponsor’s safety database (Argus). Methods: Multifactorial selection criteria were established using Structured Query Language (SQL) and the TIBCO Spotfire® visualization tool, via a combination of word fragments, wildcard strings, and mathematical constructs, based on Hy’s law criteria and pattern of injury (R-value). These criteria excluded non-eligible cases from monthly line listings mined from the Argus safety database. The capabilities and limitations of these criteria were verified by comparing a manual review of all monthly cases with system-generated monthly listings over six months. Results: On an average, over a period of six months, the algorithm accurately identified 92% of DILI cases meeting established criteria. The automated process easily compared liver enzyme elevations with baseline values, reducing the screening time to under 15 minutes as opposed to multiple hours exhausted using a cognitively laborious, manual process. Limitations of the algorithm include its inability to identify cases associated with non-standard laboratory tests, naming conventions, and/or incomplete/incorrectly entered laboratory values. Conclusions: The newly developed multifactorial algorithm proved to be extremely useful in detecting potential DILI cases, while heightening the vigilance of the drug safety department. Additionally, the application of this algorithm may be useful in identifying a potential signal for DILI in drugs not yet known to cause liver injury (e.g., drugs in the initial phases of development). This algorithm also carries the potential for universal application, due to its product-agnostic data and keyword mining features. Plans for the tool include improving it into a fully automated application, thereby completely eliminating a manual screening process.

Keywords: automation, drug-induced liver injury, pharmacovigilance, post-marketing

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Authors: Tahisa M. Pedroso, Hérida R. N. Salgado

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The microbiological turbidimetric assay allows the determination of potency of the drug, by measuring the turbidity (absorbance), caused by inhibition of microorganisms by ertapenem sodium. Ertapenem sodium (ERTM), a synthetic antimicrobial agent of the class of carbapenems, shows action against Gram-negative, Gram-positive, aerobic and anaerobic microorganisms. Turbidimetric assays are described in the literature for some antibiotics, but this method is not described for ertapenem. The objective of the present study was to develop and validate a simple, sensitive, precise and accurate microbiological assay by turbidimetry to quantify ertapenem sodium injectable as an alternative to the physicochemical methods described in the literature. Several preliminary tests were performed to choose the following parameters: Staphylococcus aureus ATCC 25923, IAL 1851, 8 % of inoculum, BHI culture medium, and aqueous solution of ertapenem sodium. 10.0 mL of sterile BHI culture medium were distributed in 20 tubes. 0.2 mL of solutions (standard and test), were added in tube, respectively S1, S2 and S3, and T1, T2 and T3, 0.8 mL of culture medium inoculated were transferred to each tube, according parallel lines 3 x 3 test. The tubes were incubated in shaker Marconi MA 420 at a temperature of 35.0 °C ± 2.0 °C for 4 hours. After this period, the growth of microorganisms was inhibited by addition of 0.5 mL of 12% formaldehyde solution in each tube. The absorbance was determined in Quimis Q-798DRM spectrophotometer at a wavelength of 530 nm. An analytical curve was constructed to obtain the equation of the line by the least-squares method and the linearity and parallelism was detected by ANOVA. The specificity of the method was proven by comparing the response obtained for the standard and the finished product. The precision was checked by testing the determination of ertapenem sodium in three days. The accuracy was determined by recovery test. The robustness was determined by comparing the results obtained by varying wavelength, brand of culture medium and volume of culture medium in the tubes. Statistical analysis showed that there is no deviation from linearity in the analytical curves of standard and test samples. The correlation coefficients were 0.9996 and 0.9998 for the standard and test samples, respectively. The specificity was confirmed by comparing the absorbance of the reference substance and test samples. The values obtained for intraday, interday and between analyst precision were 1.25%; 0.26%, 0.15% respectively. The amount of ertapenem sodium present in the samples analyzed, 99.87%, is consistent. The accuracy was proven by the recovery test, with value of 98.20%. The parameters varied did not affect the analysis of ertapenem sodium, confirming the robustness of this method. The turbidimetric assay is more versatile, faster and easier to apply than agar diffusion assay. The method is simple, rapid and accurate and can be used in routine analysis of quality control of formulations containing ertapenem sodium.

Keywords: ertapenem sodium, turbidimetric assay, quality control, validation

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Authors: Danilo F. Rodrigues, Hérida Regina N. Salgado

Abstract:

Introduction: The emergence of resistant microorganisms to a large number of clinically approved antimicrobials has been increasing, which restrict the options for the treatment of bacterial infections. As a strategy, drugs with high antimicrobial activities are in evidence. Stands out a class of antimicrobial, the cephalosporins, having as fourth generation cefepime (CEF) a semi-synthetic product which has activity against various Gram-positive bacteria (e.g. oxacillin resistant Staphylococcus aureus) and Gram-negative (e.g. Pseudomonas aeruginosa) aerobic. There are few studies in the literature regarding the development of microbiological methodologies for the analysis of this antimicrobial, so researches in this area are highly relevant to optimize the analysis of this drug in the industry and ensure the quality of the marketed product. The development of microbiological methods for the analysis of antimicrobials has gained strength in recent years and has been highlighted in relation to physicochemical methods, especially because they make possible to determine the bioactivity of the drug against a microorganism. In this context, the aim of this work was the development and validation of a microbiological method for quantitative analysis of CEF in powder lyophilized for injectable solution by turbidimetric assay. Method: For performing the method, Staphylococcus aureus ATCC 6538 IAL 2082 was used as the test microorganism and the culture medium chosen was the Casoy broth. The test was performed using temperature control (35.0 °C ± 2.0 °C) and incubated for 4 hours in shaker. The readings of the results were made at a wavelength of 530 nm through a spectrophotometer. The turbidimetric microbiological method was validated by determining the following parameters: linearity, precision (repeatability and intermediate precision), accuracy and robustness, according to ICH guidelines. Results and discussion: Among the parameters evaluated for method validation, the linearity showed results suitable for both statistical analyses as the correlation coefficients (r) that went 0.9990 for CEF reference standard and 0.9997 for CEF sample. The precision presented the following values 1.86% (intraday), 0.84% (interday) and 0.71% (between analyst). The accuracy of the method has been proven through the recovery test where the mean value obtained was 99.92%. The robustness was verified by the parameters changing volume of culture medium, brand of culture medium, incubation time in shaker and wavelength. The potency of CEF present in the samples of lyophilized powder for injectable solution was 102.46%. Conclusion: The turbidimetric microbiological method proposed for quantification of CEF in lyophilized powder for solution for injectable showed being fast, linear, precise, accurate and robust, being in accordance with all the requirements, which can be used in routine analysis of quality control in the pharmaceutical industry as an option for microbiological analysis.

Keywords: cefepime hydrochloride, quality control, turbidimetric assay, validation

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Authors: Adriana Salgado, Sandra Castaneda, Ivan Perez

Abstract:

Learning to read and write is a complex process involving several cognitive skills, contextual, and cultural environments. The basis of this development is linguistic skills, such as the ability to name and understand vocabulary, retell a story, phonological awareness, letter knowledge, among others. In children with autism spectrum disorder (ASD), one of the main concerns is related to language disorders. Nevertheless, most of the children with ASD are able to decode written information but have difficulties in reading comprehension. The research of these processes in the Spanish-speaking population is limited. However, the increasing prevalence of this diagnosis (1 in 115 children) in Mexico has implications at different levels. Educational research is an important area of interest in ASD children, such as emergent literacy. Reading and writing expand the possibilities of academic, cultural, and social information access. Taking this information into account, the objective of this research was to identify the relationship between language skills, alphabet knowledge, phonological awareness, and early reading and writing in ASD Spanish-speaking children. The method used for this research was based on tasks that were selected, adapted and in some cases designed to measure initial reading and writing, as well as language skills (naming, receptive vocabulary, and narrative skills), phonological awareness (similar phonological word pairs, beginning sound awareness and spelling) and letter knowledge, in a sample of 45 children (38 boys and 7 girls) with prior diagnosis of ASD. Descriptive analyses, as well as bivariate correlations, cluster analysis, and canonical correspondence, were obtained for the data results. Results showed that variability was large; however, it was possible to characterize the sample in low, medium, and high score groups regarding children performance. The low score group (46.7% of the sample), had a null or deficient performance in language skills and phonological awareness, some could identify up to five letters of the alphabet, showed no early reading skills but they could scribble. The middle score group was characterized by a highly variable performance in different tasks, with better language skills in receptive and naming vocabulary, some narrative, letter knowledge, and phonological awareness (beginning sound awareness) skills. The high score group, (24.4% of the sample) had the best performance in language skills in relation to the sample data, as well as in the rest of the measured skills. Finally, scores were canonically correlated between naming, receptive vocabulary, narrative, phonological awareness, letter knowledge and initial learning of reading and writing skills for the high score group and letter knowledge, naming and receptive vocabulary for the lower score group, which is consistent with previous research in typical and ASD children. In conclusion, the obtained data is consistent with previous studies. Despite large variability, it was possible to identify performance profiles and relations based on linguistic, phonological awareness, and letter knowledge skills. These skills were predictor variables of the initial development of reading and writing. The above has implications for a future program and strategies development that may benefit the acquisition of reading and writing in ASD children.

Keywords: autism, autism spectrum disorders, early literacy, emergent literacy

Procedia PDF Downloads 110