Robustness evaluation of the chromatographic method for the quantitation of lumefantrine using Youden's test

O teste de Youden constitui um método confiável para avaliação da robustez de métodos analíticos, por meio de um delineamento que envolve sete parâmetros analíticos combinados em oito experimentos. No presente estudo, a robustez de um método cromatográfico para quantificação de lumefantrina em matéria-prima farmacêutica foi avaliada utilizando-se o teste de Youden. Assim, foi possível determinar o efeito de cada parâmetro analítico nos resultados finais das análises. O teste de Youden se mostrou um procedimento simples e confiável para a avaliação da robustez de métodos cromatográficos.Youden's test is a reliable method to evaluate the robustness of analytical methods, by means of an experiment design which involves seven analytical parameters combined in eight tests. In the present study, we assessed the robustness of a chromatographic method to quantify lumefantrine in raw material samples, using Youden's test. Hence, it was possible to determine the effect of each analytical parameter in the final analysis results. Youden's test showed to be a simple and feasible procedure to evaluate the robustness of chromatographic methods

Avaliação da bioequivalência entre duas formulações de Trazodona – comprimidos revestidos de 100 mg

Introdução: A trazodona é um antidepressivo atípico derivado da triazolopiridina, indicado para o tratamento da depressão com ou sem episódios de ansiedade, dor associada à neuropatia diabética e outros tipos de dor crônica. Objetivo: Este estudo teve como objetivo avaliar a bioequivalência entre a formulação teste de Trazodona 100 mg (Sanofi Medley Farmacêutica Ltda) e o produto de referência, Donaren (Apsen Farmacêutica S/A) de acordo com a legislação vigente. Método: Foi realizado um estudo cruzado, aberto, randomizado, de dose única com indivíduos saudáveis ​​de ambos os sexos. A fase clínica foi realizada com 48 indivíduos que receberam os medicamentos em condições de alimentação. A fármaco foi quantificado no plasma por cromatografia líquida acoplada a espectrometria de massas (LC-MS/MS). A avaliação da bioequivalência foi baseada em critérios de aceitação pré-definidos de 80,00 – 125,00% para o intervalo de confiança de 90% para a razão dos produtos teste e referência para os dados log-transformados da área sob a curva (ASC) e da concentração plasmática máxima (Cmax), conforme recomendação da Anvisa. Resultados: As razões geométricas médias (intervalos de confiança de 90%) para Cmax e ASC0-t foram 103,22% (96,13 – 110,84) e 99,06% (94,80 – 103,150), respectivamente. Não houve eventos adversos durante o estudo. Conclusão: As formulações teste e de referência foram consideradas estatisticamente bioequivalentes de acordo com os requisitos regulatórios. A formulação do teste tem sido disponibilizada no mercado local, contribuindo para o acesso da população a medicamentos genéricos de qualidade para o tratamento de transtornos depressivos

Development and validation of an HPLC method for the simultaneous determination of artesunate and mefloquine hydrochloride in fixed-dose combination tablets

The present study developed and validated an HPLC method for the simultaneous determination of artesunate (AS) and mefloquine hydrochloride (MQ) in fixed-dose combination tablets, according to ICH guidelines. The chromatographic separation was carried out on an XBridge C18 (250 x 4.6 mm i.d., 5 µm particle size, Waters) analytical column. The mobile phase included a 0.05 M monobasic potassium phosphate buffer (pH adjusted to 3.0 with phosphoric acid) and acetonitrile (50 + 50, v/v). The flow rate was 1.0 mL/min, and the run time was 13 minutes. A dual-wavelength approach was employed: AS detection was performed at 210 nm and MQ was detected at 283 nm, using a diode array detector. Stability of sample solutions was evaluated for 8 hours after preparation, during which time the solutions remained stable. Youden's test was employed to evaluate robustness. The method proved to be linear (r²>;0.99), precise (RSDUm método por cromatografia a líquido de alta eficiência para a determinação simultânea de artesunato (AS) e cloridrato de mefloquina (MQ) em comprimidos em dose fixa combinada foi desenvolvido e validado, de acordo com as normas do ICH. A separação cromatográfica foi realizada com uma coluna analítica XBridge C18 (250 x 4,6 mm d.i., partículas de 5 µm, Waters). A fase móvel foi constituída de tampão fosfato monobásico de potássio 0,05 M (pH ajustado para 3,0 com ácido fosfórico) e acetonitrila (50 + 50, v/v). O fluxo da fase móvel foi de 1,0 mL/min e o tempo de corrida foi de 13 minutos. Utilizaram-se dois comprimentos de onda: a detecção do AS foi realizada em 210 nm e a de MQ foi realizada em 283 nm, utilizando-se um detector de arranjo de diodos. A estabilidade das soluções padrão e amostra foi avaliada por 8 horas após sua preparação e as soluções permaneceram estáveis nesse período. O teste de Youden foi empregado para a avaliação da robustez do método. O método se mostrou linear (r²>;0,99), preciso (DP

Photocatalytic degradation of salicylic acid employing TIO2 and ZNO in aqueous suspension / Degradação fotocatalítica do ácido salicílico empregando TIO2 e ZNO em suspensão aquosa

The photocatalytic degradation of salicylic acid (SA) in reduced concentration (14.5 µmol L-1) was investigated using TiO2 and ZnO as photocatalysts under irradiation with UV light using UV-Vis spectrophotometry and HPLC analysis. The effect of different catalysts and catalyst loading, kinetic analysis, and dissolution of ZnO using the experimental conditions adopted were evaluated in acidic medium (pH = 3.0). Chronic ecotoxicity tests of the effluent from the reactions were conducted employing a concentration of 1 g L-1 of photocatalysts. The results showed that TiO2 and ZnO presented very similar performance for the SA degradation, whose profile followed first-order kinetics. The dissolution of ZnO observed was low using the experimental conditions adopted. Chronic ecotoxicity tests carried out showed that the use of ZnO/UV system for degradation of SA leads to a product with significant harmful effects on Ceriodaphnia dubia, even at reduced concentrations of the effluent from the reaction

Recombinant Plasmodium vivax circumsporozoite surface protein allelic variants: antibody recognition by individuals from three communities in the Brazilian Amazon

Circumsporozoite protein (CSP) variants of P. vivax, besides having variations in the protein repetitive portion, can differ from each other in aspects such as geographical distribution, intensity of transmission, vectorial competence and immune response. Such aspects must be considered to P. vivax vaccine development. Therefore, we evaluated the immunogenicity of novel recombinant proteins corresponding to each of the three P. vivax allelic variants (VK210, VK247 and P. vivax-like) and of the C-terminal region (shared by all PvCSP variants) in naturally malaria-exposed populations of Brazilian Amazon. Our results demonstrated that PvCSP-VK210 was the major target of humoral immune response in studied population, presenting higher frequency and magnitude of IgG response. The IgG subclass profile showed a prevalence of cytophilic antibodies (IgG1 and IgG3), that seem to have an essential role in protective immune response. Differently of PvCSP allelic variants, antibodies elicited against C-terminal region of protein did not correlate with epidemiological parameters, bringing additional evidence that humoral response against this protein region is not essential to protective immunity. Taken together, these findings increase the knowledge on serological response to distinct PvCSP allelic variants and may contribute to the development of a global and effective P. vivax vaccine

O parto prematuro induzido pela covid-19: uma revisão da literatura / Premature birth induced by covid-19: a literature review

INTRODUÇÃO: A Coronavírus Disease-2019 é uma infecção respiratória aguda potencialmente grave e de distribuição global. Devido à sua propagação global e ao estado de calamidade provocado foi declarado pela OMS, a pandemia por COVID-19. O seu acometimento em gestantes está associado a diversas repercussões, como o parto prematuro. METODOLOGIA: Trata-se de uma revisão narrativa de literatura, através de pesquisa na base de dados Pubmed utilizando os descritores: ''preterm birth''; ''coronavirus infection'', ''premature birth labor'' e ''pregnancy''.  RESULTADOS: Foram encontrados 121 artigos, entre os quais 17 foram selecionados, sendo todos publicados em 2020 e consistem em estudos de coorte prospectivos e retrospectivos, revisões sistemáticas e metanálises. DISCUSSÃO: Pesquisas que avaliaram mulheres grávidas infectadas apontam um índice superior de prematuridade entre os recém-nascidos de mães com COVID-19, em comparação com a população geral. A invasão viral poderia desencadear trabalho de parto prematuro via receptor toll-like TLR-3 ativando a via comum. Os partos prematuros ocorrem com frequência em mulheres com doença grave, sendo predominantemente cesáreas. CONCLUSÃO: A infecção pelo SARS-CoV-2 em gestantes foi associada a maiores índices de parto prematuro e de partos cesáreos quando comparados à população não infectada.

Análise Epidemiológica da Neoplasia Maligna de Pâncreas no Brasil: Internações, Óbitos e Taxa de Mortalidade

INTRODUCTION: Pancreatic malignancy is a highly lethal cancer, characterized by the formation of aggressive tumors in the pancreatic tissue. Due to often late diagnosis and resistance to treatment, the disease has high mortality rates. This article will analyze the hospitalizations, deaths and mortality rates associated with this condition, highlighting the importance of early diagnosis and advanced therapeutic interventions. OBJECTIVE: This study aims to quantify and analyze the rates of hospitalizations, deaths and mortality rates due to malignant neoplasia of the pancreas in Brazil. METHODOLOGY: This is a retrospective study with a quantitative approach, carried out from data collection by the SUS Hospital Information System (SIH/SUS), made available by the secondary database of the Department of Informatics of the Unified Health System (TABNET /DATASUS). The data studied referred to hospitalizations, deaths and the mortality rate due to malignant neoplasia of the pancreas in Brazil in the period between April 2023 and April 2024. The analysis was carried out using descriptive statistics, tabulation in an electronic spreadsheet using the Microsoft Excel program 2016 arranged in tables using Microsoft Word 10. RESULTS: Data on malignant neoplasia of the pancreas in Brazil between April 2023 and April 2024 reveal a total of 19,291 hospitalizations and 3,834 deaths. The Southeast region had the highest number of both hospitalizations (8,599, 44.60%) and deaths (1,882, 49.13%), while the North region had the highest mortality rate (25.97 per 100,000 inhabitants). These numbers highlight the significant burden of this disease and the need for specific policies to reduce its impactful statistics. CONCLUSION: The data highlights the severity of pancreatic cancer in Brazil between April 2023 and April 2024, with a high incidence of hospitalizations and deaths, especially in the Southeast region. The North region faces the highest mortality rate, indicating an urgent need for improvements in access and treatment.INTRODUÇÃO: A neoplasia maligna de pâncreas é um câncer altamente letal, caracterizado pela formação de tumores agressivos no tecido pancreático. Devido ao diagnóstico frequentemente tardio e à resistência ao tratamento, a doença apresenta altas taxas de mortalidade. Este artigo analisará as internações, óbitos e taxa de mortalidade associados a essa condição, destacando a importância do diagnóstico precoce e das intervenções terapêuticas avançadas. OBJETIVO: Este estudo visa quantificar e analisar as taxas de internações, óbitos e taxa de mortalidade por neoplasia maligna de pâncreas no Brasil. METODOLOGIA: Trata-se de um estudo retrospectivo com abordagem quantitativa, realizado a partir de coleta de dados pelo Sistema de Informações Hospitalares do SUS (SIH/SUS), disponibilizados pela base de dados secundária do Departamento de Informática do Sistema Único de Saúde (TABNET/DATASUS). Os dados estudados referiam-se às internações, aos óbitos e à taxa de mortalidade por neoplasia maligna de pâncreas no Brasil no período entre abril de 2023 e abril de 2024. A análise foi realizada por estatística descritiva, tabulação em planilha eletrônica do programa Microsoft Excel 2016 disposta em tabelas pelo Microsoft Word 10. RESULTADOS: Os dados sobre neoplasia maligna de pâncreas no Brasil entre abril de 2023 e abril de 2024 revelam um total de 19.291 internações e 3.834 óbitos. A região Sudeste teve o maior número tanto de internações (8.599, 44,60%) quanto de óbitos (1.882, 49,13%), enquanto a região Norte apresentou a maior taxa de mortalidade (25,97 por 100.000 habitantes). Esses números destacam a significativa carga dessa doença e a necessidade de políticas específicas para reduzir suas impactantes estatísticas. CONCLUSÃO: Os dados destacam a gravidade do câncer de pâncreas no Brasil entre abril de 2023 e abril de 2024, com alta incidência de internações e óbitos, especialmente na região Sudeste. A região Norte enfrenta a maior taxa de mortalidade, indicando necessidade urgente de melhorias no acesso e tratamento

ATLANTIC EPIPHYTES: a data set of vascular and non-vascular epiphyte plants and lichens from the Atlantic Forest

Epiphytes are hyper-diverse and one of the frequently undervalued life forms in plant surveys and biodiversity inventories. Epiphytes of the Atlantic Forest, one of the most endangered ecosystems in the world, have high endemism and radiated recently in the Pliocene. We aimed to (1) compile an extensive Atlantic Forest data set on vascular, non-vascular plants (including hemiepiphytes), and lichen epiphyte species occurrence and abundance; (2) describe the epiphyte distribution in the Atlantic Forest, in order to indicate future sampling efforts. Our work presents the first epiphyte data set with information on abundance and occurrence of epiphyte phorophyte species. All data compiled here come from three main sources provided by the authors: published sources (comprising peer-reviewed articles, books, and theses), unpublished data, and herbarium data. We compiled a data set composed of 2,095 species, from 89,270 holo/hemiepiphyte records, in the Atlantic Forest of Brazil, Argentina, Paraguay, and Uruguay, recorded from 1824 to early 2018. Most of the records were from qualitative data (occurrence only, 88%), well distributed throughout the Atlantic Forest. For quantitative records, the most common sampling method was individual trees (71%), followed by plot sampling (19%), and transect sampling (10%). Angiosperms (81%) were the most frequently registered group, and Bromeliaceae and Orchidaceae were the families with the greatest number of records (27,272 and 21,945, respectively). Ferns and Lycophytes presented fewer records than Angiosperms, and Polypodiaceae were the most recorded family, and more concentrated in the Southern and Southeastern regions. Data on non-vascular plants and lichens were scarce, with a few disjunct records concentrated in the Northeastern region of the Atlantic Forest. For all non-vascular plant records, Lejeuneaceae, a family of liverworts, was the most recorded family. We hope that our effort to organize scattered epiphyte data help advance the knowledge of epiphyte ecology, as well as our understanding of macroecological and biogeographical patterns in the Atlantic Forest. No copyright restrictions are associated with the data set. Please cite this Ecology Data Paper if the data are used in publication and teaching events. © 2019 The Authors. Ecology © 2019 The Ecological Society of Americ

Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Summary Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung’s disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung’s disease) from 264 hospitals (89 in high-income countries, 166 in middleincome countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030