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.

Influência de diferentes sistemas adesivos na resistência de união de pinos de fibra à dentina intrarradicular

Objective: To evaluate the influence of three adhesive systems on the bond strength of fiber post luted to root dentine. The hypothesis was that the bond strength is influenced by the adhesive system. Method: The canals of thirty single-root bovine roots (16mm in length) were prepared using the preparation drill (FGM) until 12mm. 14 mm of each root was embedded with acrylic resin and the specimens were allocated into three groups (n=10), considering the factor adhesive (3 levels): Gr1- Scotchbond Multipurpose Plus (3M ESPE), Gr2- One Step (Bisco) and Gr3- Excite DSC (Ivoclar Vivadent). The adhesive systems were applied using a microbrush, according to the manufacture's recommendations. The fiber posts (White Post DC, FGM) were luted with dual resin cement (All-Cem,FGM). After, the cores with composite resin (Llis, FGM) were made and each set of root/post/core was submitted to the mechanical cycling (Erios, Brazil) (10 6 cycles, 84N, 4 Hz, inclination of 45 o, 37 oC, water). Each specimen was cut in 4 samples (1.8mm in thickness), which were submitted to the push-out test in a universal testing machine (ServoPulser - Shimadzu) (50Kgf, 1mm/min). The data (MPa) were analyzed using ANOVA (1-way) and Tukey test (5%). Results: The factor adhesive (P=0.00352) influenced the bond strength significantly (ANOVA). Gr1 (6.8±3.8 MPa) a presented higher bond strength values than Gr2 (3.1±1.5 MPa) b and similar to Gr3 (4.4±3.3) a,b. Moreover, Gr3 and Gr2 were similar between them (Tukey). The hypothesis was accepted. Conclusion: Based on the results it was concluded that chemical and dual polymerization adhesive system should be used for the adhesive luting fiber post procedures.

Associação do padrão de ingestão lípidica com a qualidade da dieta, resistência insulínica e homocisteinemia em adultos

Objectives: To evaluate the association between the consumption of different dietary fats with the quality of the diet, insulin resistance, and hyperhomocysteinemia in adults. Methods: Cross-sectional study conducted with 624 overweight subjects (73.7% females). Assessments of food intake (24h food recall and health eating index-HEI), anthropometry, and biochemical assays of fasting glucose, insulin (HOMA-IR and β calculus) and homocysteinemia were performed. Results: The low quality of diet was associated with the vegetable oil at 3rd quintile (≥1.5-2.0 servings) showed risk 2.9 times and cholesterol at quintiles 2nd, 3rd, and 4th was 2.0 times. HOMA-IR was higher at 5th quintile of saturated fat (≥10,7% - total caloric value) with risk of 60% and hyperhomocysteinemia the vegetable oil at 3rd quintile (>1.5-2.0 servings) with risk of 12.0 times and 5th (≥3.5 servings) 7.1 times. However, significance disappeared when adjusted for anthropometric variables. Conclusion: Dietary fats were associated with the harm diet quality, insulin resistance, and hyperhomocysteinemia. However, associations are dependant of demographic variables, dietetic, and nutritional state. © 2011 CELOM.

Contaminação microbiana das soluções de processamento radiográfico: Risco de infecção cruzada

Objective: To evaluate the microbial contamination in samples of radiographic developing and fixing solutions, radiographic processing water, dental unit waterlines and dental office's external water supply. Methods: Samples of 50 private dental offices and 20 dental offices of the School of Dentistry de Araçatuba-UNESP were collected. The samples were subjected to neutralization of the residual inhibitory agents followed by pre-enrichment in peptone water and EVA broth and were inoculated in selective and non-selective culture media. The DNA of the samples was extracted and the presence of superinfectant microorganisms was evaluated by PCR. The differences in the prevalence of the microorganisms in the samples of the solutions were analyzed by repeated-measures analysis of variance for category data, while the Chi-Square and Mann-Whitney tests were used to evaluate the existence of associations between the total number of heterotrophic microorganisms and infection control protocols. The significance level was set at 5%. Results: Samples of radiographic fixing solution presented a remarkably less frequent contamination than radiographic developing solution and radiographic processing water. The latter exhibited microorganisms typically originated from the oral microbiota and human skin as well as microorganisms frequently found in dental unit waterlines. There was less contamination of radiographic processing water in the dental offices where the x-ray film packets were disinfected before processing or were covered by a plastic film. Additionally, all samples of dental office's external water supply were drinkable. Conclusion: Covering the x-ray film packets with a plastic film protection barrier was proven the best manner to reduce the contamination of the evaluated solutions.

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.

Perfil de resistência a antimicrobianos de Staphylococcus aureus isolados de granjas e frigoríficos de suínos

Staphylococcus aureus are involved in a wide range of clinical problems to swine industry as son in humans. Epidemiological researchs prove his potential to acquire resistantence to antibiotics. Nowadays, methicillin-resistant S. aureus (MRSA) are responsabilized for nosocomial infections and many studies are done because MRSA are spread to extra hospitalar enrivonment and frequentely isolated from domestic animals including pigs. The aim of this study was to determine the presence o S. aureus at swine farms and identify the mecA, icaA and icaD genes and the resistant proflife to antibiotics. Overal, 458 swabs were taked from five pigeris and two slautherhouses. All the samples were placed on Braid - Parker and blood agar follow by biochemical analyses. The suspect colonies were submitted to PCR to confirm the S. aureus species, by the detection of the coa gene, mecA to avaible meticillin-resistant as son to the virulence gens icaA and icaD that can determine slime production. Antibiogram were done to evaluate the response to 11 antibiotics. All pigeris and slautherhouse were positive and 81 (79%) samples were S. aureus positive including four isolates from pigs employeers. The mecA gene was not detected. The icaD gene was most frequent and 41% were positive to both genes. The antibiogram show a lot of samples penicillin and tetraciclin resistant. Most of the samples were multirestant.

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.

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.

Resistência de genótipos de soja ao nematoide reniforme em ambiente controlado

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Resistência de genótipos de eucalipto a ceratocystis spp

Eucalyptus is the most important plantation forest species in Brazil. Wilt and canker caused by Ceratocystis fimbriata on eucalyptus were first reported in 1998 in plantations of an E. grandis × E. urophylla hybrid in southern Bahia, Brazil. This work aimed at studying the reaction of different eucalyptus genotypes after inoculation with C. fimbriata isolates, in order to find a possible source of resistance. The study included four isolates of Ceratocystis collected from eucalyptus in different regions. One disc of fungal mycelium with 1-cm-diameter (from colonies growing for 10 days on malt extract agar medium-MEA) was inoculated on the stem of thus injured eucalyptus plants (six months old). A cotton wool moistened with sterile distilled water was wrapped with plastic film. Control plants were inoculated with discs of MEA without fungal colonies. The inoculated plants were kept in a greenhouse. Wilt symptoms were observed 90 days after inoculation. The seedlings were cut in the longitudinal direction of the stem in order to observe the colonization of fungus in the plant xylem. We tested twenty eucalyptus genotypes, but only five showed resistance to all isolates of Ceratocystis, belonging to different species of Eucalyptus: E. urophylla (C2 and C9), E. grandis (C3), E. saligna (C6 and C13) Most E. gramdis genotypes were more susceptible to all four fungal isolates. These results support future studies related to eucalyptus resistance to Ceratocystis.

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).

Variabilidade espacial da resistência mecânica do solo à penetração e umidade do solo em área cultivada com cana-de-açúcar na região de Humaitá, Amazonas, Brasil

The mechanical resistance to penetration (RP) is an attribute indicator of compaction was influenced by soil moisture. The objective of this study was to evaluate the spatial variability of soil resistance to penetration and soil moisture on area under cultivation of sugar cane in the region of Humaitá, Amazonas, Brazil. We conducted a sampling grid of 70x70 m where points were scored at regular intervals of 10 m, a total of 64 points. Soil samples were collected at depths of 0.00 to 0.15 m, 0.15 to 0.30 I 0.30 to 0.45 m for determination of soil moisture and soil resistance to penetration in the field. After analysis of these data analyzes were descriptive statistics and geostatistics. We conclude that all the variables studied showed spatial dependence and range values were higher than stipulated by the sampling grid and the RP and soil moisture showed a spatial relationship where lower values of PR concentrated on smaller values of soil moisture.

Resistência da parede abdominal após a remoção cirúrgica dos músculos retos abdominais: estudos experimental em ratos

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Efeito da corrente elétrica contínua isolada e da iontoforese transdermal, associada ao zinco, sobre a resistência mecânica e o conteúdo de hidroxiprolina de cicatrizes realizadas na pele de ratos diabéticos aloxânicos

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)