Relative Bioavailability of Two Oral Formulations of Risperidone 2 mg: A Single-Dose, Randomized-Sequence, Open-Label, Two-Period Crossover Comparison in Healthy Brazilian Volunteers

Background: Risperidone (RSP) is a benzisoxazole antipsychotic agent used to treat schizophrenia and other psychiatric illnesses in adults and children (including those with autism). After oral administration, RSP is completely absorbed from the gastrointestinal tract and undergoes hydroxylation to yield 9-hydroxyrisperidone (9-OH-RSP), an active metabolite that has a pharmacologic profile and potency similar to RSP. Objectives: The aims of this study were to compare the relative bioavailability of a pharmaceutical-equivalent (test) formulation with a reference formulation of oral RSP 2 mg, both available commercially on the Brazilian pharmaceutical market, and to generate data regarding the oral bioavailability of the tested drug in healthy Brazilian volunteers. Methods: This single-dose, randomized-sequence, open-label, 2-period crossover study was conducted in healthy Brazilian volunteers from August to December 2008. Subjects were randomly assigned to receive the test formulation followed by the reference formulation or vice versa, with a 30-day washout period between doses. Study drugs were administered after a 12-hour overnight fast. For pharmacokinetic analysis, blood samples were drawn at 0 (baseline), 0.25, 0.5, 1, 1.5, 3, 5, 8, 12, 24, 48, 72, 96, and 120 hours after administration. Plasma concentrations of RSP and 9-OH-RSP were determined using LC-MS/MS. The test and reference formulations were to be considered bioequivalent if the 90% CIs for the geometric mean test/reference ratios were within a predetermined range of 80% to 125%, in accordance with the policies of the Brazilian Sanitary Surveillance Agency and the US Food and Drug Administration. Tolerability was determined using clinical assessments, monitoring of vital signs, analysis of laboratory test results, and subject interviews regarding adverse events. Results: A total of 22 subjects were enrolled (11 men, 11 women; mean [SD] age, 32 [12] years [range, 18-58 years]; weight, 70.4 [11.9] kg [range, 50-103 kg]; height, 1.67 [0.08] m [range, 1.56-1.80 m]; and body mass index, 25 [4] kg/m(2) [range, 18-29 kg/m(2)]). For RSP, mean (SD) C(max) values were 12.6 (2.7) and 16.0 (2.3) ng/mL for the test and reference formulations, respectively. For 9-OH-RSP, mean C(max) values were 17.8 (1.3) and 21.0 (1.7) ng/mL for the test and reference formulations. The 90% CIs for the mean test/reference ratios for RSP C(max), AUC(0-120), and AUC(0-infinity) were 74% to 82%, 75% to 85%, and 76% to 85%, respectively, and 83% to 87%, 75% to 79%, and 75% to 78% for 9-OH-RSP. The related adverse events (headache, low back pain, drowsiness, standing hypotension, local postvenipuncture ecchymoses, insomnia, nausea, and vomiting) were transient and mild. Conclusions: This single-dose study found that the test and reference formulations of oral RSP 2 mg did not meet the Brazilian and US regulatory criteria for bioequivalence in these fasting, healthy volunteers. The study formulations appeared to be well tolerated. (Clin Ther 2010;32:2106-2115) (C) 2010 Elsevier HS Journals, Inc.

Determinação de hormônios estrógenos em água potável usando CLAE-DAD

An analytical procedure for determination of estriol, 17β-estradiol, estrone and 17α-ethinylestradiol in drinking water is presented. The method employs solid phase extraction (SPE) and sample dechlorination as cleanup procedures, followed by HPLC-DAD analysis. Validation was carried out using RE No. 899/2003 guidelines established by the Agência Nacional de Vigilância Sanitária (National Agency of Sanitary Surveillance, Brazil), with some adaptations. The statistically evaluated results have shown that the method is selective, precise (0,06% to 19,40% CV) and accurate (91,52% to 109,41% average recoveries). The developed method was applied to the analysis of these contaminants in drinking water from São Luís, MA.

Vigilância em saúde no Brasil: os desafios dos riscos sanitários do século XXI e a necessidade de criação de um sistema nacional de vigilância em saúde

The technological development experienced in the contemporary world are transforming society and relations between State and people. The mobility of human being has reached levels never before imagined and a person can move from one side of the world to the other side in less than 24 hours. This mobility also includes goods and services, giving the keynote of the globalized world of the XXI Century. In this context, the risks of diseases and others health problems are intensely amplified. Nowadays, an epidemic that begins in China can arrive in Brazil the following day. Brazil recognizes health as a universal right and also consider it a State's obligation. Therefore, the State of Brazil is obligated to organize itself to eliminate or control health risks. Today, the organization of the Brazilian State regarding the surveillance of risks of diseases and other health problems is fragmented and includes sanitary surveillance (focused on goods, products and services), epidemiological surveillance (diseases and investigations of other risks) and environmental surveillance in health (the environment in general, including the workplace). This fragmentation causes problems for the management and consolidation of strategic information for health protection. Brazil has the need to think about an other model of organization that put together all "kinds" of surveillances within a single coordinated system, called the National System of Health Surveillance, which would be able to coordinate the various specialties of health surveillance that exists in the country in order to provide a effective system of information and health surveillance, able to face emergency situations of public health

A survey on the sanitary condition of commercial foods of plant origin sold in Brazil

The objective of the study was to evaluate the hygienic conditions and practices of commercial foods of plant origin in establishments and street marketed by street vendors in cities in the State of Rio de Janeiro, Brazil. Forty different sales points were evaluated (establishments that prepared and sold fruit juices and street vendors that commercialized fresh coconut water, sugarcane juice and orange juice) using a questionnaire with 12 items, divided into three blocks (salesmen/handlers, operations, installations). The results indicated that the activities related to the commerce of fruit beverages in the cities of Sao Goncalo and Rio de Janeiro required the elaboration of a set of actions by the Sanitary Vigilance Agency in order to improve the hygienic and sanitary level and minimize health risk to consumers. Important requirements in the legislation relevant to this type of food are still not followed; adequate packaging and storage of the raw material, obtaining the raw material from registered suppliers, hygiene of the handlers and adequate management of wastes produced during the activities in question are amongst the main items deserving attention. (C) 2009 Elsevier Ltd. All rights reserved.

Vigilância sanitária, participação social e cidadania

O objetivo deste estudo é descrever e analisar as representações sociais dos conselheiros de saúde sobre a temática da vigilância sanitária. A pesquisa qualitativa de representação social foi adotada como metodologia, sendo utilizada a técnica de entrevista baseada em roteiro semiestruturado. Os dados obtidos com a realização das entrevistas foram analisados pela técnica do Discurso do Sujeito Coletivo. Através dos discursos, os conselheiros de saúde demonstraram conhecer a vigilância sanitária e reconhecerem sua importância para as práticas de Saúde Pública. Demonstraram também, estarem aptos a participar do processo de formulação da Política Municipal de Vigilância Sanitária. O estudo conclui que a vigilância sanitária, principalmente na esfera local, precisa se apropriar dos conselhos de saúde como espaços públicos capazes de legitimar e dar transparência às suas ações, discutindo as necessidades da coletividade democraticamente com a sociedade, sendo possível, dessa forma, construir a cidadania ao mesmo tempo em que se assegura o direito à proteção da saúde.

Aplicação experimental de um modelo de conduta de inspeção sanitária no comércio varejista de alimentos

Este trabalho teve por objetivo aplicar um procedimento para diagnóstico e modelo de inspeção higiênico-sanitária em estabelecimentos varejistas de alimentos, no Município de Ibiúna, Estado de São Paulo, Brasil, e analisar os resultados com vistas a atingir os objetivos da vigilância sanitária. O trabalho foi desenvolvido durante seis meses em 19 estabelecimentos varejistas de alimentos classificados como padarias, restaurantes e açougues, sendo que na primeira inspeção realizou-se o diagnóstico da situação, com a identificação das não conformidades e avaliação das condições higiênico-sanitárias dos estabelecimentos e foi obtida a pontuação média de 64. Após esta etapa iniciaram-se retornos programados aos estabelecimentos pela equipe da vigilância sanitária a fim de verificar a evolução das adequações sanitárias. No diagnóstico e em todos os retornos programados foi aplicado roteiro de inspeção e produção de relatórios detalhados destinados aos proprietários. Todos os manipuladores de alimentos dos estabelecimentos inspecionados foram capacitados em relação a conceitos básicos de higiene em alimentos. Os resultados mostraram que, após três retornos de inspeções em cada estabelecimento, 100% apresentaram-se como satisfatórios, com pontuação média de 90. O modelo de inspeção sanitária aplicado mostrou-se viável para a promoção da segurança alimentar.

Inspeção sanitária em creches: uma proposta de roteiro de inspeção

O trabalho apresenta um projeto de intervenção na realidade concreta das ações de Vigilância Sanitária, através da proposição de um roteiro para inspeção destinado a creches. Os objetivos específicos foram identificar os fundamentos jurídicos, técnico-científicos e sanitários que possam nortear a prática de inspeções sanitárias em creches; elaborar uma proposta de roteiro que permita um processo de análise mais explícito, objetivo e homogêneo e discutir a contribuição do instrumento proposto para a atividade de Vigilância Sanitária, com base na literatura científica pesquisada. Para a realização do trabalho foi feita uma revisão fundamentada em textos didáticos e normativos das áreas de educação e saúde, legislação sobre Vigilância Sanitária e Educação Infantil, outros roteiros já existentes e artigos da literatura científica sobre agravos à saúde em crianças que frequentam creches. O trabalho focaliza o conteúdo da legislação específica vigente e sua aplicabilidade na prática da inspeção sanitária em creches e baseia-se na Portaria - MS n. 321 de 26.05.1988. Este estudo apresenta um instrumento para avaliar a qualidade do atendimento nas creches sob o aspecto da promoção da saúde e sugere estudos posteriores de validação para o contexto, com a possível inclusão de um sistema de classificação para os padrões de conformidade, por meio de uma metodologia estatística

Four new species of Paratrizygia Tonnoir from the Brazilian Atlantic Forest (Diptera, Mycetophilidae, Sciophilinae)

Paratrizygia Tonnoir was originally described for P. conformis, from Australia, and since then only four species have been added to the genus, from Chile and Southern Argentina. We add four new species to the genus Paratrizygia-P. balbii sp. nov., P. alvesi sp. nov., P. camargoi sp. nov., and P. albidens sp.nov.-from the southern part of the Brazilian Atlantic Forest. Comments are made about the possible relationships of the Brazilian and other Neotropical species of the genus. An identification key to the Neotropical species of the genus is provided.

A second known species of Eratomyia Amorim & Rindal (Diptera, Rangomaramidae, Chiletrichinae) from Colombia

A second species of the genus Eratomyia Amorim & Rindal-E. risaralda, sp. n.-is described from Risaralda, Colombia, based on one male and three females. The female of Eratomyia is described for the first time. A number of striking modifications in the female terminalia shared with Chiletricha Chandler support the hypothesis that they are sister genera within the Rangomaramidae. The position of Chiletricha and Eratomyia within the Chiletrichinae is discussed.

The genus Phthinia Winnertz (Diptera, Mycetophilidae) in the Neotropical region, with the first records from Brazil

Three Neotropical species of Phthinia Winnertz have been described to date. The genus is known from Chile and southern Argentina. Four new species are herein described for the genus in the region, two from Brazil-Phthinia theresae, sp. n., from the State of Espirito Santo, and Phithinia urubici, sp. n., from the State of Santa Catarina-and two from Chile-Phthinia freemani, sp. n., and Phthinia parafurcata, sp. n. Comments are made about the relationships between the Neotropical species. Some notes are added about P. furcata Freeman, P. flagellata Freeman, and P. fasciata Freeman, from Chile and southern Argentina. Attention is called for the fact that Phthinia has two species in Brazil disjunct from the other temperate species of the genus in South America, differently from most similar cases, that have a single known representative in Brazil.

The identity of Paratrizygia conformis Tonnoir (Diptera, Mycetophilidae), with comments on its systematic position

Paratrizygia conformis, the type-species of the genus Paratrizygia, from Tasmania, is redescribed from the holotype. The wing venation and male terminalia are illustrated in detail. The question of the monophyly of the genus-which has four additional species in Chile and southern Argentina, and four species in the Atlantic Forest, in Brazil-is addressed. Comments are made on the relationships of the genus in the Azana-group of Sciophilinae. The hypothesis of monophyly of Paratrizygia is retained, as indicated by the presence of modified, elongated spines on a distal fold of tergite 9.

Eleven new species of the genus Cluzobra Edwards (Diptera, Mycetophilidae, Sciophilinae) from the Atlantic Forest of Brazil

Eleven new species of the sciophiline genus Cluzobra Edwards are described and illustrated - Cluzobra triocellata, sp.n., Cluzobra accola, sp.n., Cluzobra claripennis, sp.n., Cluzobra papaveroi, sp.n., Cluzobra coptolithus, sp.n., Cluzobra vockerothi, sp.n., Cluzobra sapiranga, sp.n., Cluzobra fluminense, sp.n., Cluzobra fritzmuelleri, sp.n., Cluzobra spinata, sp.n., Cluzobra elpidia, sp.n. Additional specimens of C. fuscipennis Edwards, C. plaumanni Edwards, and C. binocellaris (Edwards) have been identified, extending the distribution range of these species. The species were identified and described based on 173 specimens at different latitudes along the Atlantic Forest in eastern Brazil and northern Argentina. The position of the new species in the groups of species proposed for the genus in the literature is considered. Three areas of endemism are identified for the group, one from southern Brazil, northern Argentina and Paraguay northwards to areas at higher altitudes in the States of Minas Gerais and Rio de Janeiro, one from southern Bahia to the extreme north of the Atlantic Forest, in the State of Rio Grande do Norte, and one in west State of Sao Paulo, extending west and northwards into the states of Mato Grosso do Sul and Goias. This paper raises the number of known Cluzobra to 41 species.

Two new species of Simothraulopsis Traver, 1947 (Ephemeroptera: Leptophlebiidae: Atalophlebiinae) from northeastern Brazil

The genus Simothraulopsis contains three described species, one of which occurs in Brazil. The new species Simothraulopsis diamantinensis sp. n. and Simothraulopsis janae sp. n. are figured and described from male imagines. The main discriminating character of these two new species from their congeners is the fused forceps socket. The material was collected in Bahia State in northeastern Brazil.

Dynamics of Aeromonas species isolated from wastewater treatment system

Aeromonas are widely distributed in the aquatic environment, and are considered to be emerging organisms that can produce a series of virulence factors. The present study was carried out in a sanitary sewage stabilization pond treatment system, located in Lins, State of Sao Paulo, Brazil. Most probable number was applied for estimation of the genus Aeromonas. Colony isolation was carried out on blood agar ampicillin and confirmed by biochemical characterization. Aeromonas species were isolated in 72.4% of influent samples, and in 55.2 and 48.3% of effluent from anaerobic and facultative lagoons, respectively. Thirteen Aeromonas species were isolated, representing most of the recognized species of these organisms. Even though it was possible to observe a tendency of decrease, total elimination of these organisms from the studied system was not achieved. Understanding of the pathogenic organism`s dynamics in wastewater treatment systems with a reuse potential is especially important because of the risk it represents.