Made available in DSpace on 2016-08-10T10:29:46Z (GMT). No. of bitstreams: 1 VALQUIRIA LUZIA DE CASTRO.pdf: 16657284 bytes, checksum: 1a01a269f0ffa3172c86e8ea2baba363 (MD5) Previous issue date: 2010-06-30 / The bupropion hydrochloride is an antidepressant pharmacological used in treatment of smoking cessation; the drug increases the interstitial concentrations of dopamine, reducing the smoking habit. The objective was the achievement of physical and chemical tests of the tablets of bupropion hydrochloride, of a laboratory acquired in similar ethical and commercial pharmacies in Imperatriz city, the drug being used in the Smoking Cessation Program of the Ministry of Health, Brazil. Were evaluated twelve lots of tablets of bupropion hydrochloride and observed the conditions of air conditioning in commercial pharmacies using a digital thermometer of Sper Scient brand. The raw materials of bupropion hydrochloride was used as a reference standard, purchased at a masterful pharmacy and subjected to laboratory tests in Quality Control of Faculdade de Imperatriz. The temperature verification at pharmacies where the tablets were purchased ranged from 37 ° C to 40 ° C, which is above the specification of boxes of medicine, whose guidelines: keep the temperature between 15°C to 30°C, which can cause instability pharmaceuticals. When weighing values were observed within the variation limits allowed. The friability showed no variations. The disintegration occurred at the scheduled time of 45 minutes. The twelve lots subject to durometer to resistance verification were higher than 3 Kgf, it is possible to change the nature of the excipients. There was no significant dissolution of the samples showing a concentration of 0.95 μg / ml, less than 80% of predicted value. The content of the active principle, analyzed by non aqueous titration, samples were taken by present concentration of between 90% and 110% as stated in the American Pharmacopoeia. Pharmaceutical equivalence between the similar medicine and the ethical medicine becomes related that both possess the same fármaco, and similar results evaluated in vitro. One concludes that the process of dissolution and hardness can have been affected significantly for the peculiar characteristics to the proper fármaco, as well as for the presence of excipientes that had made it difficult the same dissolution or for the employed techniques of manufacture. Also suggesting an analysis in the process of production inside of the quality control in the Pharmaceutical Industry verifying the processes of validation for attainment of planned results. / O Cloridrato de bupropiona é um fármaco antidepressivo utilizado no tratamento na cessação do tabagismo, o fármaco aumenta as concentrações intersticiais de dopamina, diminuindo a saciedade do fumo. O objetivo deste trabalho foi a realização dos ensaios físicos e químicos dos comprimidos do Cloridrato de Bupropiona, de um laboratório ético e similar adquiridos nas farmácias comerciais na cidade de Imperatriz, sendo o fármaco empregado no Programa da Cessação do Tabagismo pelo Ministério da Saúde, Brasil. Foram avaliados doze lotes dos comprimidos do Cloridrato de Bupropiona e observadas as condições de climatização nas farmácias comerciais utilizando um termômetro digital da marca Sper Scient. Utilizou-se como padrão de referência a matéria prima, adquirida em uma farmácia magistral e submetida aos testes realizados no laboratório de Controle de Qualidade da Faculdade de Imperatriz. A verificação da temperatura nas farmácias onde os comprimidos foram adquiridos variava de 37°C a 40°C, estando acima das especificações das caixas do medicamento, cujas orientações: manter a temperatura entre 15°C a 30°C, o que pode causar instabilidade nos fármacos. Na pesagem foram observados valores dentro dos limites de variações permitidos. A friabilidade não apresentou variações. A desintegração ocorreu no tempo previsto de 45 minutos. Os doze lotes submetidos ao durômetro para verificação da resistência foram superiores a 3 Kgf, sendo possível a variação pela natureza dos excipientes. Não houve dissolução significativa das amostras analisadas apresentando uma concentração de 0,95 μg/ml, inferior a 80% do valor previsto. O teor do princípio ativo, analisado por titulação em meio não aquoso, as amostras foram aprovadas por apresentarem concentração situada entre 90% e 110% como consta a Farmacopéia Americana. A equivalência farmacêutica entre o medicamento similar e o medicamento ético relaciona-se que ambos possuem o mesmo fármaco, e resultados semelhantes avaliados in vitro. Conclui-se que o processo de dissolução e dureza pode ter sido afetado significativamente pelas características peculiares ao próprio fármaco, bem como pela presença de excipientes que dificultaram a dissolução ou mesmo pelas técnicas de fabricação empregadas. Sugerindo também uma análise no processo de produção dentro do controle de qualidade na Indústria Farmacêutica verificando os processos de validação para obtenção de resultados planejados.

Afin de répondre aux questions des propriétaires de structures atteintes de réaction alcali-silice (RAS), ce travail se concentre sur une partie d'une méthodologie globale, proposée initialement par le LMDC et EDF, et dont le but est l'étude du comportement mécanique des constructions endommagées par la RAS. Pour atteindre cet objectif, l'avancement chimique de la RAS des granulats récupérés dans les structures affectées doit être évalué. Ainsi, ce travail est consacré à la quantification de la silice potentiellement réactive des granulats, par l'utilisation de deux approches : une approche indirecte par un test d'expansion et une approche directe par des méthodes chimiques. La présentation du manuscrit s'articule autour des points suivants :• Un test d'expansion pertinent et rapide sur mortiers pour relier la quantité de silice réactive à l'expansion mesurée. Les conditions expérimentales suivantes ont été choisies pour tester différentes tailles et natures de granulats, ainsi que différentes tailles d'éprouvettes : solution de NaOH à 1 mol/l et température de conservation de 60°C.• Une méthode chimique rapide de dissolution sélective pour mesurer directement la quantité de silice réactive disponible pour la RAS. La méthode HF / HF+HCl a été trouvé comme étant la plus efficace.• Un modèle chemo-mécanique pour analyser les effets de la taille des granulats et des éprouvettes, et évaluer l'avancement chimique de la réaction.Finalement, une méthodologie est proposée pour calculer la constante cinétique de la réaction dans le cadre de la requalification des structures atteintes de RAS. / In order to answer the questions of the ASR-affected structures owners, this work focused on a part of a global methodology, which is proposed originally by the LMDC and EDF, aiming to reassess the mechanical behavior of ASR-damaged constructions. To achieve this purpose, the chemical advancement of ASR in the aggregates recovered from the structure should be evaluated. Thus, this work focuses on the assessment of the potentially reactive silica content with two main methods: indirectly by expansion test and directly by chemical methods. The presentation of this manuscript is around the following points: • A relevant and rapid expansion test on mortars to link the reactive silica content to measured expansion. The experimental condition: 1 mol/l NaOH solution conserved at 60°C is chosen to test different aggregate sizes, specimen sizes and natures of aggregate. • A fast chemical method of selective dissolution to measure directly the silica available for ASR. Acid/basic methods are tested and compared; HF / HF+HCl method is found to be the most effective. • A chemo-mechanical model to analyze the effect of aggregate size and specimen size, and evaluate the chemical advancement of ASR. Finally, a methodology is proposed to calculate the kinetics constant in the framework of structural requalification. Key words: alkali-silica reaction (ASR), chemical advancement, reactive silica, expansion test, chemical test, chemo-mechanical model, kinetic constant, selective dissolution