RESUMO
O cloridrato de clonidina é um α2-adrenérgico que reduz a pressão sanguínea e retarda a estimulação cardíaca simpaticomimética. Esse fármaco é uma substância de baixo índice terapêutico que possui alta potência, sendo utilizado em baixas concentrações. Pode ser preparado em farmácias magistrais, seguindo-se rigorosos critérios de Boas Práticas de Manipulação estipulados pela Anvisa. Esse controle surgiu em razão de diversos acidentes possivelmente associados ao uso de cloridrato de clonidina manipulado. Diante disso, o objetivo deste trabalho foi avaliar o processo de mistura de pós na manipulação magistral da clonidina, buscando segurança e reprodutibilidade no referido processo. Para tanto, foram produzidas 60 cápsulas de cada lote, seguindo o planejamento fatorial 2³, em que foram estabelecidas as seguintes variáveis de entrada: processo de mistura (diluição geométrica e misturador Mixer Plus®), tamanho do invólucro gelatinoso (n°03 e 02) e concentração do fármaco (0,1 e 0,2 mg). A variável resposta para o planejamento foi o teor do fármaco nas cápsulas. Além disso, foram verificados outros parâmetros de qualidade, como o peso médio e uniformidade de conteúdo. As cápsulas obtidas encontraram-se dentro dos limites especificados pelos compêndios oficiais. Por isso, os resultados sinalizam que apesar do processo de obtenção das cápsulas ser crítico é possível obter produtos com qualidade e segurança comprovada...
Clonidine hydrochloride is an α2-adrenergic agonist that reduces the blood pressure and delays cardiac sympathomimetic stimulation. This drug has a low therapeutic index, high potency and is commonly used at low concentrations. It can be prepared at compounding pharmacies, as long as the rigorous criteria of Good Handling Practices stipulated by Anvisa are followed. This control had its origins in several accidents possibly associated with the use of compounded clonidine hydrochloride. In this context, the present study was designed to assess the powder-mixing process during the compounding of clonidine, so as to optimize its safety and repeatability. To this end, 60 capsules were produced in each batch, following 23 factorial planning, using the following input variables: mixing process (geometric dilution or Mixer Plus®), size of gelatin shell(number 03 or 02) and drug concentration (0.1 and 0.2mg). The response variable for the planning was the amount of drug inside the capsules. In addition, other quality parameters were determined, such as the average weight and content uniformity. The capsules produced were within the limits specified by official compendia. Therefore, the results indicate that, although the process of compounding capsules is critical, it is possible to have products with assured quality and safety...
Assuntos
Anti-Hipertensivos , ClonidinaRESUMO
Mercury (Hg) pollution is one of the most serious environmental problems. Due to public concern prompted by the symptoms displayed by people who consumed contaminated fish in Minamata, Japan in 1956, Hg pollution has since been kept under constant surveillance. However, despite considerable accumulation of knowledge on the noxious effects of ingested or inhaled Hg, especially for humans, there is virtually nothing known about the genotoxic effects of Hg. Because increased mitotic crossing over is assumed to be the first step leading to carcinogenesis, we used a sensitive short-term test (homozygotization index) to look for DNA alterations induced by Hg fumes. In one Aspergillus nidulans diploid strain (UT448//UT184), the effects of the Hg fumes appeared scattered all over the DNA, causing 3.05 times more recombination frequencies than the mean for other strains. Another diploid (Dp II-I//UT184) was little affected by Hg. This led us to hypothesize that a genetic factor present in the UT184 master strain genome, close to the nicB8 genetic marker, is responsible for this behavior. These findings corroborate our previous findings that the homozygotization index can be used as a bioassay for rapid and efficient assessment of ecotoxicological hazards.
