Abstract The objective of this paper was to develop and evaluate two semi-solid pharmaceutical forms containing 0.1% tacrolimus: cream (CRT01) and gel (GLT01). For the evaluation of physicochemical stability, at times 0, 30, 60 and 90 days, at 23°C and at 40°C, High Performance Liquid Chromatography coupled with a Diode Array Detector (HPLC-DAD) was employed. This method was developed and validated for tacrolimus quantification. The occlusivity test and skin permeation assay were also performed, using an animal model (Wistar rats), and the CRT01 and GLT01 were compared to the 0.1% tacrolimus ointment (PFU01) obtained from the University Pharmacy, Federal University of Rio de Janeiro, Brazil. CRT01 and GLT01 presented a homogeneous aspect and consistency adequate for topical products, along with sensory characteristics above PFU01. They also presented adequate physicochemical stability for 90 days and a lower occlusive effect than PFU01 (p<0.05). CRT01 showed greater affinity for the skin when compared to PFU01 and GLT01, with low systemic absorption. The CRT01 semi-solid formulation was considered the most adequate one to treat patients with atopic dermatitis or other dermatologic inflammatory diseases, promoting rational use of tacrolimus.

Dados de soroprevalência oferecem informações relevantes relacionadas ao desenvolvimento e progressão de pandemia da COVID-19. Estimar a prevalência de anticorpos anti-SARS-CoV-2 em Mato Grosso, Brasil e sua distribuição segundo características sociodemográficas e econômicas. Inquérito soroepidemiológico de base populacional conduzido entre setembro e outubro de 2020, com indivíduos de 18 anos ou mais de idade, em dez municípios do Estado de Mato Grosso. As entrevistas e coleta de material biológico foram realizadas em domicílio, e a determinação de anticorpos IgG contra o SARS-CoV-2 foi feita por meio da quimioluminescência. Foram 4.306 indivíduos avaliados, e a prevalência de COVID-19 foi estimada em 12,5% (IC95%: 10,5; 14,7), variando de 7,4% a 24,3% entre os municípios. Não foram verificadas diferenças na prevalência da infecção segundo raça/cor da pele, escolaridade ou renda familiar, entretanto verificou-se menor prevalência entre indivíduos que residiam com algum morador que recebia aposentadoria, que não receberam auxílio financeiro emergencial e que a renda familiar não diminuiu após as medidas de distanciamento social para enfrentamento da epidemia. A prevalência de anticorpos contra SARS-CoV-2 estimada nesta pesquisa de base populacional é essencial para conhecer a magnitude da doença no estado e subsidiará ações de combate e controle da pandemia.

Seroprevalence data provide relevant information on the development and progression of the COVID-19 pandemic. The study aimed to estimate the prevalence of SARS-CoV-2 antibodies in Mato Grosso State, Brazil, and its distribution according to sociodemographic and economic characteristics. This population-based serological survey was conducted in September-October 2020 in individuals 18 years or older in ten municipalities (counties) in the state of Mato Grosso. Interviews and collection of biological samples were conducted in the households, and determination of IgG antibodies to SARS-CoV-2 was performed with chemiluminescence. A total of 4,306 individuals were evaluated, and COVID-19 prevalence was estimated at 12.5% (95%CI: 10.5; 14.7), ranging from 7.4% to 24.3% between municipalities. No significant differences were found in prevalence of infection according to race/color, schooling, or family income, but lower prevalence was seen in individuals with a pensioner living in the same household, who did not receive emergency financial aid, and whose family income had not decreased after social distancing measures during the epidemic. Estimated prevalence of SARS-CoV-2 antibodies in this population-based survey is essential to measure the magnitude of the disease and will back measures to confront and control the pandemic.

Los datos de seroprevalencia proporcionan información relevante relacionada con el desarrollo y la progresión de la pandemia del COVID-19. El objetivo fue estimar la prevalencia de anticuerpos anti-SARS-CoV-2 en Mato Grosso, Brasil, y su distribución según las características sociodemográficas y económicas. Encuesta seroepidemiológica de base poblacional, realizada entre septiembre y octubre de 2020 con individuos de los 18 años o más en diez municipios del estado de Mato Grosso. Las entrevistas y la recolección de material biológico se realizaron en el domicilio de los participantes, y para la determinación de anticuerpos IgG contra el SARS-CoV-2 se utilizó la quimioluminiscencia. Se evaluaron a 4.306 individuos, y la prevalencia del COVID-19 se estimó en un 12,5% (IC95%: 10,5; 14,7), que van del 7,4% al 24,3% entre los municipios. No se encontraron diferencias en la prevalencia de infección según la raza/color de la piel, la educación o los ingresos familiares; sin embargo, se encontró una menor prevalencia entre los individuos que vivían con un residente que recibía una pensión, que no recibía ayuda económica de emergencia y que los ingresos familiares no disminuyeron tras las medidas de distanciamiento social para hacer frente a la pandemia. La prevalencia de anticuerpos contra el SARS-CoV-2 estimada en esta investigación de base poblacional es imprescindible para conocer la magnitud de la enfermedad en el estado y subvencionar las acciones de enfrentamiento y control de la pandemia.

Seroprevalence data provide relevant information on the development and progression of the COVID-19 pandemic. The study aimed to estimate the prevalence of SARS-CoV-2 antibodies in Mato Grosso State, Brazil, and its distribution according to sociodemographic and economic characteristics. This population-based serological survey was conducted in September-October 2020 in individuals 18 years or older in ten municipalities (counties) in the state of Mato Grosso. Interviews and collection of biological samples were conducted in the households, and determination of IgG antibodies to SARS-CoV-2 was performed with chemiluminescence. A total of 4,306 individuals were evaluated, and COVID-19 prevalence was estimated at 12.5% (95%CI: 10.5; 14.7), ranging from 7.4% to 24.3% between municipalities. No significant differences were found in prevalence of infection according to race/color, schooling, or family income, but lower prevalence was seen in individuals with a pensioner living in the same household, who did not receive emergency financial aid, and whose family income had not decreased after social distancing measures during the epidemic. Estimated prevalence of SARS-CoV-2 antibodies in this population-based survey is essential to measure the magnitude of the disease and will back measures to confront and control the pandemic.

Los datos de seroprevalencia proporcionan información relevante relacionada con el desarrollo y la progresión de la pandemia del COVID-19. El objetivo fue estimar la prevalencia de anticuerpos anti-SARS-CoV-2 en Mato Grosso, Brasil, y su distribución según las características sociodemográficas y económicas. Encuesta seroepidemiológica de base poblacional, realizada entre septiembre y octubre de 2020 con individuos de los 18 años o más en diez municipios del estado de Mato Grosso. Las entrevistas y la recolección de material biológico se realizaron en el domicilio de los participantes, y para la determinación de anticuerpos IgG contra el SARS-CoV-2 se utilizó la quimioluminiscencia. Se evaluaron a 4.306 individuos, y la prevalencia del COVID-19 se estimó en un 12,5% (IC95%: 10,5; 14,7), que van del 7,4% al 24,3% entre los municipios. No se encontraron diferencias en la prevalencia de infección según la raza/color de la piel, la educación o los ingresos familiares; sin embargo, se encontró una menor prevalencia entre los individuos que vivían con un residente que recibía una pensión, que no recibía ayuda económica de emergencia y que los ingresos familiares no disminuyeron tras las medidas de distanciamiento social para hacer frente a la pandemia. La prevalencia de anticuerpos contra el SARS-CoV-2 estimada en esta investigación de base poblacional es imprescindible para conocer la magnitud de la enfermedad en el estado y subvencionar las acciones de enfrentamiento y control de la pandemia.

Dados de soroprevalência oferecem informações relevantes relacionadas ao desenvolvimento e progressão de pandemia da COVID-19. Estimar a prevalência de anticorpos anti-SARS-CoV-2 em Mato Grosso, Brasil e sua distribuição segundo características sociodemográficas e econômicas. Inquérito soroepidemiológico de base populacional conduzido entre setembro e outubro de 2020, com indivíduos de 18 anos ou mais de idade, em dez municípios do Estado de Mato Grosso. As entrevistas e coleta de material biológico foram realizadas em domicílio, e a determinação de anticorpos IgG contra o SARS-CoV-2 foi feita por meio da quimioluminescência. Foram 4.306 indivíduos avaliados, e a prevalência de COVID-19 foi estimada em 12,5% (IC95%: 10,5; 14,7), variando de 7,4% a 24,3% entre os municípios. Não foram verificadas diferenças na prevalência da infecção segundo raça/cor da pele, escolaridade ou renda familiar, entretanto verificou-se menor prevalência entre indivíduos que residiam com algum morador que recebia aposentadoria, que não receberam auxílio financeiro emergencial e que a renda familiar não diminuiu após as medidas de distanciamento social para enfrentamento da epidemia. A prevalência de anticorpos contra SARS-CoV-2 estimada nesta pesquisa de base populacional é essencial para conhecer a magnitude da doença no estado e subsidiará ações de combate e controle da pandemia.

ABSTRACT Determination of potential contaminants elements in food packing films arising from contact with acidic aqueous foods was undertaken by inductively coupled plasma optical emission spectrometry (ICP OES) in accordance with DIN EN 1186-1. Test sections from plastic films were totally immersed in 3% w/v CH3COOH used as the food simulant. Testing was conducted under three conditions: (1) 10 days at 40 ºC; (2) 30 min at 70 ºC and 10 days at 40 ºC; and (3) 30 min at 100 ºC and 10 days at 40 ºC. These time and temperature conditions were considered to be the most severe situations likely to be encountered in practice. Several different containers were investigated, including a borosilicate glass beaker, a glass bottle used for food canning, as well as one of polystyrene. The glass bottle was selected for testing treatments according to procedure (3) and a polystyrene one was chosen for use with procedures (1) and (2). Limits of quantitation were adequate for the determination of Ag, B, Ba, Cd, Cr, Cu, Pb, Sb, Sn and Zn by solution nebulization ICP OES and As by chemical vapor generation (CVG-ICP OES). Results for the analysis of AccuStandard certified reference materials as well as spike recoveries show good agreement with expected concentrations, demonstrating the accuracy and precision of the determinations. Eleven samples of food packing material were analyzed. The lead was present in the range 4.8 - 85.3 µg L-1 in 10 of 11 evaluated packing material, showing the importance of quality control measures.

ABSTRACT Twenty-seven bottled mineral waters from local markets in Curitiba, State of Paraná, Brazil were analyzed for a number of constituents, including: pH, conductivity, total dissolved solids, hardness, HCO3 - and CO 3 2-, as well as Ca2+, Mg2+, Na+, K+, NH4 + , F-, Cl-, NO3 -, NO2 - and SO4 2- by ion chromatography (IC); Al, Ba, Cd, Cr, Cu, Fe, Li, Mn, Ni, Sr, V and Zn by inductively coupled plasma optical emission spectrometry (ICP OES); Hg by cold vapor generation-ICP OES and As, Pb, Sb and Se by ICP-mass spectrometry (ICP-MS). The obtained limits of quantitation (LOQ) were adequate for the determination of all analytes using the various analytical techniques. Results for the analysis of AccuStandard certified reference materials QCS-01-5, QCS-02-R1-5 and TCLP-02-1 as well as spike recoveries to samples show acceptable values, within 90-111 % of expected concentrations with relative standard deviations below 10 %, demonstrating the accuracy of the determinations. Both NO2 - and NO 3 - were above the maximum limits set by Brazilian legislation in two samples, indicating a microbiological contamination. One imported sample presented As (6.1 ± 0.2 µg L-1) near the maximum limit (10 µg L-1) while all other elements of interest were below the values specified by Brazilian legislation. Principal component analysis revealed that four imported samples and one from the Minas Gerais State have the highest mineral concentrations.

Radiofármacos são compostos que possuem um radionucleotídeo, podendo ser emissor de radiação gama (γ) ou emissor de pósitrons (β+), ligado a uma molécula específica com finalidade diagnóstica e terapêutica. O avanço no uso dos radiofármacos tem culminado a um setor em comum com outros tipos de medicamentos: a regulamentação e fiscalização. Após 2006, a produção, a comercialização e a utilização destes medicamentos foram abertas ao mercado interno brasileiro com maior liberdade, pois a Emenda Constitucional 49, vinda da Emenda Constitucional 199/03, que retira da União o monopólio deste tipo de manipulação, ofereceu a outros centros de medicina nuclear a oportunidade desta produção. A partir desta data, a quantidade comercializada deste tipo de medicamento aumentou absurdamente e os núcleos de vigilância e regulamentação do Brasil avançaram também nos processos legislativos, criando os documentos mais voltados a Radiofármacos existentes no território nacional, as Resoluções n° 63 e n° 64. Em visão internacional, há muito ainda a ser feito em termos regulatórios no Brasil somando principalmente os assuntos vigilantes dos medicamentos como a prática de Farmacovigilância em Radiofármacos.

Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs.

O FDG-18 é o radiofármaco mais utilizado nos exames de PET e PET CT. O FDA recentemente aprovou o uso do PTS TM (Portable Test System) como método alternativo ao teste padrão de endotoxina, proposto pela Farmacopéia Americana, considerando que no primeiro há um tempo de espera de 1 hora frente a somente 15 minutos do segundo. Estudo recentes demonstram que a radiação poderia interferir no teste do PTS TM. De modo a avaliar os efeitos da radiação no teste PTS TM foram analisados 27 lotes de F-18 FDG produzidos no Instituto de Engenharia Nuclear. Os resultados demonstraram que em todos os casos nenhuma correlação direta com a radiação foi observada.

F-18 FDG (2-[18-F] fluoro-2-deoxy-D-glucose) is the most frequently used radiopharmaceutical for PET and PET CT imaging exams. The FDA recently approved the use of the PTS TM (Portable Test System) as an alternative to the standard test proposed by the United States Pharmacopeia using the LAL (Limulus Amebocyte Lysates), that takes longer to perform (about 1h) than the PTS TM (15 min). Recent studies have demonstrated that radiation could interfere with the PTS TM test. In order to study the effects of radiation on the PTS TM test and/or equipment, 27 batches of F-18 FDG produced in the Nuclear Engineering Institute were analyzed. The results showed that no direct correlation with radiation was found in any of the cases.

Diversos casos de interações medicamentosas com radiofármacos ocorrem diariamente na rotina hospitalar, contudo muitos deles não são notificados ou mesmo percebidos. Informações a respeito desse tipo de reação não é abundante e os profissionais da medicina nuclear muitas vezes estão assoberbados por essas informações. De modo a entender esse tipo de reação e auxiliar a medicina nuclear a lidar com essa situação uma revisão da literatura foi realizada. Os resultados mostraram que a totalidade dos radiofármacos comercializados no mundo apresentam interação medicamentosa com uma enorme variedade de outros medicamentos. Dessa forma sugere-se que revisões sobre radiofármacos inclua um capítulo sobre efeitos adversos. Além disso, um esforço mundial para notificar efeitos adversos deve ser realizado, pois somente dessa forma se terá um quadro real da situação referente interações medicamentosas com radiofármacos.

Numerous drug interactions related to radiopharmaceuticals take place every day in hospitals many of which are not reported or detected. Information concerning this kind of reaction is not abundant, and nuclear medicine staff are usually overwhelmed by this information. To better understand this type of reaction, and to help nuclear medicine staff deal with it, a review of the literature was conducted. The results show that almost all of radiopharmaceuticals marketed around the world present drug interactions with a large variety of compounds. This suggests that a logical framework to make decisions based on reviews incorporating adverse reactions must be created. The review also showed that researchers undertaking a review of literature, or even a systematic review that incorporates drug interactions, must understand the rationale for the suggested methods and be able to implement them in their review. Additionally, a global effort should be made to report as many cases of drug interaction with radiopharmaceuticals as possible. With this, a complete picture of drug interactions with radiopharmaceuticals can be drawn.

A Maytenus ilicifolia Mart. ex Reissek, Celastraceae, vem sendo utilizada à muitos anos na terapêutica clínica, contudo suas propriedades farmacológicas continuam sob estudo. O objetivo desse trabalho é fornecer subsídios teóricos para o aprimoramento dos estudos, em especial os estudos clínicos, e assim estabelecer definitivamente as propriedades reais da Maytenus ilicifolia.

The Maytenus ilicifolia Mart. ex Reissek, Celastraceae has been used for many years as a medicine in the therapeutic in Brazil. However, the pharmacological action still under evaluation by many research centres. The aim of this study is stablish, based in clinical trials, the real properties of Maytenus ilicifolia.

Os radiofármacos desempenham função crítica na medicina moderna, primariamente para fins diagnósticos, mas também no monitoramento da progressão de doenças assim como na avaliação de respostas ao tratamento. O uso da tecnologia por imagem tem crescido e conseqüentemente as prescrições de medicamentos (radiofármacos em especial) com esse propósito. Este fato, aumenta o risco de interações entre medicamentos e radiofármacos. Interações que podem ter um impacto na imagem, podem resultar em falso negativo e assim ter sérias conseqüências para o paciente. Já drogas que aceleram o metabolismo podem ter resultado positivo pois podem aumentar a taxa de eliminação do radiofármaco (clearance acelerado). Contudo, podem ainda ter resultados negativos, se a interação resultar em necessidade de repetição do exame. Em alguns casos, por exemplo em imagem cardíaca, entre pacientes sob o uso de doxarubicina, essas interações podem ter efeito terapêutico. A incidência de efeitos adversos envolvendo radiofármacos é desconhecida, além de não ser oficialmente reconhecida, nem notificada, principalmente no Brasil. Nesse estudo foram compilados da literatura médica, usando a metodologia da revisão sistemática, estabelecida pela Cochrane Collaboration, estudos e relatos de interações medicamentosas com radiofármacos. O objetivo é prover uma referência (sumário) de interações medicametosas com radiofármacos que possa auxiliar a medicina nuclear na sua rotina diária. Contudo, esforços devem ser feitos na tentativa de instituir a notificação de efeitos adversos com radiofármacos, e assim prevenir esse tipo de interação.

Radiopharmaceuticals play a critical role in modern medicine primarily for diagnostic purposes, but also for monitoring disease progression and response to treatment. As the use of image has been increased, so has the use of prescription medications. These trends increase the risk of interactions between medications and radiopharmaceuticals. These interactions which have an impact on image by competing with the radiopharmaceutical for binding sites for example can lead to false negative results. Drugs that accelerate the metabolism of the radiopharmaceutical can have a positive impact (i.e. speeding its clearance) or, if repeating image is needed, a negative impact. In some cases, for example in cardiac image among patients taking doxirubacin, these interactions may have a therapeutic benefit. The incidence of drug-radiopharmaceuticals adverse reactions is unknown, since they may not be reported or even recognized. Here,we compiled the medical literature, using the criteria of a systematic review established by the Cochrane Collaboration, on pharmaceutical-drug interactions to provide a summary of documented interactions by organ system and radiopharmaceuticals. The purpose is to provide a reference on drug interactions that could inform the nuclear medicine staff in their daily routine. Efforts to increase adverse event reporting, and ideally consolidate reports worldwide, can provide a critically needed resource for prevention of drug-radiopharmaceuticals interactions.

O objetivo deste artigo é descrever a história dos radiofármacos e as implicações da Emenda Constitucional N. 49 sobre a produção de radiofármacos no Brasil.

The purpose of this paper is to describe the history of radiopharmaceutical and the implications of amendment 49 upon the radiopharmaceuticals production in Brazil.

Se ha identificado que la información sobre la interacción entre medicamentos y radiofármacos es considerablemente insuficiente. El incremento en la utilización de radiofármacos ha llamado la atención de los grupos de medicina nuclear y los organismos reguladores. El objetivo es proporcionar información que podrían ayudar a los grupos de medicina nuclear en su rutina diaria, sobre las reacciones adversas. Presentación de informes de eventos adversos, incluidas las situaciones en que un acontecimiento adverso podría haber ocurrido, pero se evitó, es esencial para evaluar la magnitud de los problemas, alertar a los profesionales de la salud sobre estos problemas y, en definitiva, para mejorar la precisión diagnóstica.

There has been considerable under-reporting of drug and radiopharmaceutical interactions, security and adverse reactions. The increasing use of radiopharmaceuticals has come to the attention of nuclear medicine staff and regulatory bodies. The aim is to provide reference for adverse reactions which could help all nuclear medicine staff in their daily routine. Reporting adverse events, including situations where an adverse event may have occurred but was actually avoided, is essential when assessing the magnitude of problems, alerting health professionals to these problems and ultimately for improving diagnostic accuracy.

There has been considerable under-reporting of drug and radiopharmaceutical interactions, security and adverse reactions. The increasing use of radiopharmaceuticals has come to the attention of nuclear medicine staff and regulatory bodies. The aim is to provide reference for adverse reactions which could help all nuclear medicine staff in their daily routine. Reporting adverse events, including situations where an adverse event may have occurred but was actually avoided, is essential when assessing the magnitude of problems, alerting health professionals to these problems and ultimately for improving diagnostic accuracy.

Se ha identificado que la información sobre la interacción entre medicamentos y radiofármacos es considerablemente insuficiente. El incremento en la utilización de radiofármacos ha llamado la atención de los grupos de medicina nuclear y los organismos reguladores. El objetivo es proporcionar información que podrían ayudar a los grupos de medicina nuclear en su rutina diaria, sobre las reacciones adversas. Presentación de informes de eventos adversos, incluidas las situaciones en que un acontecimiento adverso podría haber ocurrido, pero se evitó, es esencial para evaluar la magnitud de los problemas, alertar a los profesionales de la salud sobre estos problemas y, en definitiva, para mejorar la precisión diagnóstica.

O aumento do uso de radiofármacos PET (Pósitron Emission Tomography) vem chamando a atenção dos profissionais da área de Medicina Nuclear e Farmácia, assim como das agências reguladoras. O objetivo é prover parâmetros estruturais e legais mínimos como uma referência nacional em radiofarmácia, que possam auxiliar as agências regulatórias, focando principalmente no projeto fabril.

The increasing use of radiopharmaceuticals for PET (Positron Emission Tomography) has come to the attention of nuclear medicine staff and regulatory bodies. The aim of this study is to provide a national reference in radiopharmacy that could help all nuclear medicine staff and specially the Brazilian's regulatory bodies focused on the industrial project.

O presente trabalho discute a contribuição da adoção de critérios mais objetivos e de maior credibilidade na seleção e análise de fontes de informação, levando à utilização de maior rigor científico neste processo. Neste sentido, se propõe a adoção de uma metodologia previamente testada e reconhecidamente eficaz, a Revisão Sistemática (RS), como metodologia básica para a análise sistemática de fitoterápicos. A discussão acerca dos resultados, aponta para uma contribuição positiva da incorporação da metodologia de RS na análise de fitoterápicos.

This work discusses the contribution of adopting more objective criteria and greater credibility in the selection and analysis of information sources, which would result in greater scientific rigour in this process. In this sense, the adoption of a previously tested methodology that is known to be efficient, such as Systematic Review (SR), is proposed as a basic methodology for systematic analysis of phytoterapeutics. The discussion on results shows the positive contribution of incorporating the RS methodology in the analysis of herbal medicines.