Regulación y competencia en el mercado de medicamentos: experiencias relevantes para América Latina

Incluye Bibliografía

Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula

With recent advances in technology and research into drug delivery, the modernization of tests and greater emphasis on the predictability of therapeutic effect by means of in vitro tests, the dissolution test and the study of dissolution profiles are gaining more and more importance. Though introduced initially as a way of characterizing the release profile of poorly soluble drugs, dissolution tests are currently part of pharmacopoeial monographs on almost all the oral solid pharmaceutical forms. The objective of this study was to determine the dissolution profile (percent drug dissolved versus time) of the pioneer brand, generic and similar pharmaceutical capsules containing 500mg cephalexin. Three pharmaceutical brands (reference, generic and similar) were subjected to the dissolution test and in vitro dissolution profiles were recorded. From the results of the dissolution test, it was concluded that the samples met the acceptance criterion, as no difference was observed in the percentage of the drug dissolved in a standard time. The dissolution profile indicated that this medicine, in this pharmaceutical form, dissolves readily (85% of the drug dissolved in 15 minutes) and the curves showed great similarity, suggesting that the 3 brands are pharmaceutically equivalent.

Polimorfismo na produção de medicamentos

Polymorphism can cause quality deviations during the production of medicines and can influence their effectiveness. Therefore, an understanding of this phenomenon and its implications opens a wide field of possibilities to be explored in the pharmaceutical field, including the emergence of new paradigms and tools for the quality assurance of medicines. This paper presents an introduction to basic aspects of the polymorphism phenomenon and its implications for the production and control of medicines, with emphasis on drug polymorphs.

Contaminação das águas por resíduos de medicamentos: Ênfase ao cloridrato de fluoxetina

The objective of this paper was to review data on residues of medical products in aquatic environments and at wastewater treatment plants. Secondarily the paper presents a discussion about the need for a good management of drugs residues and effluents generated by this sector. Bringing the evidences of environmental possible damages reported by ecotoxicity data on the effects of fluoxetine to Vibrio fischeri and H. azteca, aquatic organisms daily exposed to environmental contaminants. From the results we observed that 0.3 mg.l-1 of fluoxetine hidrochloride induced lethality to H. azteca and 30 mg.l-1 reduced the luminescence of Vibrio fischeri. This assay evidenced higher toxicity when we used the generic product.

Uso do solo e monitoramento dos recursos hídricos no córrego do Ipê, Ilha Solteira, SP

Brazil has great potential of water resources, however, with deficiency in terms of qualitative and quantitative monitoring and knowledge of the influences of land use. So, this study had the purpose of presenting the qualitative and quantitative monitoring of water for irrigation and the influences caused by the use and occupation of land in the watershed of Ipê stream, in the municipality of Ilha Solteira, São Paulo. The qualitative monitoring was conducted from 2006 to 2011 and the quantitative monitoring from 2009 to 2011. In order to evaluate the influences, the Pearson correlation analysis was used. It was found that the watershed is mostly made up by the crop of sugar cane and the use in conflict with areas of permanent preservation are the fallow areas and pasture. The watershed is characterized with high concentrations of iron and coliforms, originating from degraded pastures and irregular use of urban and rural occupation. The small permanent preservation areas, bad soil conservation and expansion of urban areas imply in the deterioration of the quality and availability of water, generating socio-economic and environmental impact in the area.

Monitoramento temporal da pluma de contaminação no aterro de resíduos urbanos de Rio Claro (SP) por meio do método geofísico da eletrorresistividade

Several factors have contributed to the increase the world production of urban solid waste, resulting in difficulties to the correct management and the final environmentally appropriate disposal, in addition to causing serious socio-economic, environmental, and public health troubles. The soil and groundwater contamination by leachate in waste disposal sites is almost always present, leveraging the emergence and/or adaptation of methodologies for environmental assessment of these areas. The geophysical methods, especially the electrical resistivity method, are fast, reliable and low-cost alternative for this purpose. This paper reports the methodology adopted for the temporal monitoring of the plume of contamination of controlled landfill in the municipality of Rio Claro (SP). Electrical resistivity data were obtained in 1999 and 2008, by the resistivity method, using the techniques of vertical electrical sounding and electrical profile. In both years, similar tests were carried out in the same locations within the disposal area. The results indicated that the plume of contamination has resistivity values less than or equal to 50 ohm.m and moves guided by 2 flows: the main, to the southeast, and the secondary, to the west. Relatively to the first series of tests in 1999, the plume of contamination was higher and deeper in 2008, contrary to what was expected for a landfill deactivated for at least 10 years.

Análise das propagandas dos medicamentos isentos de prescrição veiculadas em revistas para prescritores na área médica

This article presents an analysis of the quality of advertisements for over-the-counter (OTC) drugs addressed to the medical profession, based on the new Anvisa resolution RDC 96 (17/12/2008). For this analysis, 16 volumes of the Brazilian Journal of Medicine (RBM) were collected, from August 2009 to December 2010. To investigate the quality of the adverts, we prepared a questionnaire divided into three parts. In total, 160 advertisements were found, of which 27 were related to drugs exempt from prescription, from 9 laboratories. It was observed that none of the advertisements complied fully with the new rules, as required by legislation (RDC 96/08), with violations ranging from identification of the advert to prohibitions of human figures and subjective messages. Therefore, it was concluded that there is a need to implement more effective monitoring, so as to improve the quality of the adverts, so they can be used as a reliable source of information and update by prescribers.

Qualidade do leite: Utopia sem um programa sério de monitoramento da ocorrência de mastite bovina

Bovine mastitis is still a costly issue in dairy farms, besides public health aspects considering the pathogen transmission to humans. Its multiple etiology with a high number of pathogens involved, demands a rigorous control program for monitoring and milk quality control, based on diagnostic actions and epidemiological vigilance regarding parameters which indirectly are associated with the occurrence of mastitis in dairy herds, as the California Mastitis Test (CMT) and Somatic Cell Count (SCC/mL of milk), of individual milk samples obtained from each cow, and from bulk tank which also allows the Total Bacteria Count (TBC), usually related to the incidence of mastitis, especially in subclinical cases. It is important to reinforce the microbiological milk exam, also to stress the importance of the milking process as a critical point, and to determine risk factors for mastitis. Based on these aspects, this review is presented with the aim to obtain high quality milk products, compromising the personal enrolled in milk production to be conscious that milk quality depends on all, inclusive the consumers which are the final element in the milk production chain.

Intervenções educativas com usuários de medicamentos como estratégias terapêuticas

A review and analysis of the literature on educative interventions (EI) for medicine users was carried out. For this purpose, databases were searched by employing descriptors related to pharmaceutical care, education and health, covering the period from 1997 to early 2011. A set of 21 articles related to EI with medicine users were selected, 18 (85.7%) of which referred to studies on basic health care. The EI most commonly reported in the articles were: talks, group discussions and educative material. The positive outcomes reported were: improvement in quality of life (better acceptance of the disease), economic advantages (reduction in number of medical consultations) and clinical improvement (risk reduction, prevention of complications).

Monitoramento de características físico-químicas da água e taxas de sedimentação de tripton no Córrego da Arribada (Baixo Tietê-SP) relacionadas à piscicultura em tanques-rede

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Monitoramento de hosts em redes tcp/ip sobre base georreferenciada com métricas de qualidade

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

MATIUDE - monitoramento e acesso a transdutores inteligentes (Padrão IEEE 1451) utilizando dispositivos embarcados (celulares e PDA´s)

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Modelo estocástico de programação matemática de alocação de medidores de tensão em alimentadores radiais de distribuição de energia elétrica para localização de faltas e monitoramento do perfil de tensão

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Monitoramento de dados via internet baseado em telefonia celular

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

MATIW 1451 - monitoramento e acionamento de transdutores inteligentes através da Web (Padrão IEEE 1451)

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)