DEFAR - Departamento de Farmácia

URI permanente desta comunidadehttp://www.hml.repositorio.ufop.br/handle/123456789/530

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Resultados da Pesquisa

Agora exibindo 1 - 3 de 3
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    Gliclazide : biopharmaceutics characteristics to discuss the biowaiver of immediate and extended release tablets.
    (2020) Mapa, Bruna de Carvalho; Araújo, Lorena Ulhôa; Barcellos, Neila Marcia Silva; Caldeira, Tamires Guedes; Souza, Jacqueline de
    The lists of essential medicines of the World Health Organization (WHO) and Brazil include gliclazide as an alternative to the oral antidiabetic drug of first choice, metformin, in the treatment of type 2 diabetes mellitus because of its pharmacokinetic profile and few side effects. Thus, it is also considered by WHO and the International Pharmaceutical Federation (FIP) as a drug candidate to biowaiver, which is the evaluation of how favorable the biopharmaceutics characteristics are in order to obtain waiver from the relative bioavailability/bioequivalence (RB/BE) studies to register new medicines. This paper presents a review about the solubility, permeability and dissolution of gliclazide. A critical analysis of the information allowed to identify gliclazide as a Biopharmaceutics Classification System (BCS) Class II drug. Therefore, new drugs in immediate release dosage forms will not be eligible for biowaiver. Regarding the extended release dosage forms, besides the limited solubility, no information on the comparative dissolution profile was found, which would be necessary to analyze a possible biowaiver for a smaller dosage. It can be concluded that the registration of new medicines containing gliclazide must undergo RB/BE studies, since there is not enough evidence to recommend the replacement and waiver of such studies for immediate and extended release formulations.
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    The evaluation of valsartan biopharmaceutics properties.
    (2020) Castro, Lara Maria Lopes de; Souza, Jacqueline de; Caldeira, Tamires Guedes; Mapa, Bruna de Carvalho; Soares, Anna Flávia Matos; Gomes, Bruna Pegorelli; Croce, Carolina Carvalho Della; Barcellos, Neila Marcia Silva
    Background: Solubility, intestinal permeability and dissolution are the main factors that govern the rate and extent of drugs absorption and are directly related to bioavailability. Biopharmaceutics Classification System (BCS) is an important tool that uses in vitro results for comparison with bioavailability in vivo (biowaiver). Valsartan is widely used in the treatment of hypertension and shows different BCS classification in the literature (BCS class II or III). Objective: This work proposes the study of valsartan biopharmaceutics properties and its BCS classification. Method: High performance liquid chromatography (HPLC) method was developed and validated to quantify the drug in buffers pH 1.2, 4.5 and 6.8. Valsartan solubility was determined in these three different media using shake flask method and intrinsic dissolution rate. Evaluation of dissolution profile from coated tablets was conducted. Results: The low solubility (pH 1.2 and 4.5) and high solubility (pH 6.8) was observed for both solubility methods. Permeability data reported from literature showed that valsartan is a low permeability drug. Valsartan presented rapid release profile only in pH 6.8. Conclusion: We defined that valsartan is a class IV drug, in disagreement with what has been published so far. It is important to emphasize that the conditions considered here are the indicated to define the biopharmaceutics classification by regulatory agencies.
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    Pseudomonas aeruginosa em hospital da microrregião de Ouro Preto, Minas Gerais, Brasil.
    (2016) Souza, Gustavo Henrique Bianco de; Miranda, Renata Rezende; Inácio, Luciana de Jesus; Amparo, Tatiane Roquete; Vaz, Luana Beatriz Araújo; Fernandes, Maísa Angélica Silva; Mapa, Bruna de Carvalho; Teixeira, Luiz Fernando de Medeiros; Assenço, Regina Aparecida Gomes; Lanna, Maria Célia da Silva; Silva, Alessandra Júlia Santos; Campos, Marcela Maria de Castro; Rios, Elisa Maria Pedrosa da Fonseca
    A água representa o principal meio de transmissão de micro-organismos em centros de saúde, os quais podem causar infecções que são um grave problema de saúde pública. O objetivo desse estudo foi avaliar a qualidade microbiológica da água utilizada em um hospital da microrregião de Ouro Preto, Minas Gerais, Brasil. Foram coletadas doze amostras de água em pontos distintos para testes de detecção de coliformes totais e termotolerantes, assim como de outros microrganismos; além disso, testes de sensibilidade a antimicrobianos também foram realizados. A espécie bacteriana Pseudomonas aeruginosa foi detectada na amostra correspondente à água de enxágue de roupas limpas coletada na área limpa da lavanderia e foi identificada por coloração de Gram e análise automatizada utilizando o equipamento VITEK®. O isolado de P. aeruginosa mostrou-se sensível aos antibióticos usualmente utilizados no tratamento de infecções induzidas por esta bactéria, tais como cefalosporinas, fluorquinolonas, polimixinas e carbapenêmicos. Contudo, os resultados indicam a necessidade de maior atenção ao processo de higienização de roupas hospitalares, fato ainda negligenciado no Brasil.