978 resultados para accelerated stability test


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In spite of the stated Brazilian policy on medicines that their quality, effectiveness and safety should be ensured at reasonable cost, hospitals in the ANVISA Surveillance Network have been receiving notifications of technical complaints, adverse reactions and suspected therapeutic ineffectiveness (STI) of medicines. The purpose of this study was to identify the medicines notified for suspicion of therapeutic ineffectiveness, at a university hospital participating in the national Surveillance Network, and to investigate the existence of polymorphs of any of the drugs involved, by examining the literature. There were 31 notifications of STI in a period of 18 months, concerning 11 different drugs, all of which were 'similar' drugs (neither original nor licensed by originator); five of these could contain polymorphs, according to the literature. However, this does not mean that the other drugs could not contain some unknown polymorphs, more studies being needed on polymorphism, especially in the cases of reported therapeutic ineffectiveness. Therefore, tests of polymorphism should be made part of the routine quality control of the raw materials during the development of medicines and in the studies of pharmaceutical equivalence to 'reference' medicines (innovative brands). The stability test should also involve a study of polymorphism, in order to confirm the solid state stability of the drug. All these measures will assure the effectiveness of medicines, since the reproducibility in the quality of pharmaceutical products could be monitored, as well as the equivalence of each production batch with the batch selected to determine the bioequivalence with the reference brand.

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The objective of this work was to evaluate the efficiency of different vigor tests to assess S. commersoniana seeds physiological quality during storage. Therefore, seeds were stored in cloth bags, plastic bags and glass containers for 531 days, both at room temperature and in a cold chamber. Periodically samples were taken and the following tests were conducted: standard germination, germination speed index, first count after germination, seedlings fresh and dry matter, electrical conductivity (imbibitions for 2 and 24 hours) and accelerated aging, in order to monitoring the seeds physiologic quality. Data were submitted to polynomial regression analysis, for each of the combination of packaging/storage condition. The results obtained led to the following considerations: a) the speed germination index and the accelerated aging test permitted a good evaluation of the seed-lots quality; b) the first count of germination did not allow any prediction about seed lots vigor; c) seedling fresh and dry matter did not discriminate among seed lots; d) electrical conductivity test after 2 h imbibitions was not adequate to evaluate the seed lots vigor and e) the electric conductivity test with 24 h imbibitions was more adequate to differentiate among seed lots, but with little efficiency to discriminate among seed lots with intermediate vigor or with low quality differences.

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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

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Purpose: The objective of this study was to evaluate the antioxidant effect of oregano and thyme extracts isolatedly and combinedly applied in soybean oil. Design/methodology/approach: Soybean oil containing 3,000 mg/kg of oregano and thyme oleoresins and the mixture of both, as well as soybean oil containing TBHQ (50 mg/kg) and soybean oil free of antioxidants, were subjected to accelerated oven test (60°C/10 days). Samples were collected every two days and analyzed as to their peroxide and conjugated diene values. Findings: The mixture of oleoresins and consequent increase of concentration were as effective as the antioxidant TBHQ. Practical implications: These studies may prove to be beneficial to the exploitation of natural antioxidant sources for the preservation and/or extension of raw and processed food shelf life. Therefore, they could also be applied in the area of pharmaceuticals for the protection of human life. Originality/value: This study offers information on the use of natural antioxidants as an alternative to the use of synthetic antioxidants, which might be considered toxic. © Emerald Group Publishing Limited.

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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

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Pós-graduação em Engenharia e Ciência de Alimentos - IBILCE

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

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Pós-graduação em Zootecnia - FCAV

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)