Mestrado em Ciências Farmacêuticas

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    Avaliação da qualidade e da compatibilidade fármaco-excipientes das formulações farmacêuticas sólidas do mercado contendo meloxicam
    (Universidade Federal do Espírito Santo, 2017-03-15) Silveira, Lucas Melo da; Oliveira, Marcelo Antônio de; Jamal, Claudia Masrouah; França, Hildegardo Seibert
    Meloxicam (MLX) is a non-steroidal anti-inflammatory, cyclooxygenase (COX) inhibitor, used to relieve inflammation and pain. MLX have a preferential affinity for COX-2, which is associated with a lower incidence of gastrointestinal side effects. The drug belongs to Class II of the Biopharmaceutical Classification System (BCS) where dissolution is the bioavailability limiting step. In view of this classification, it is a fundamental to carry out further studies regarding the compatibility between drug and excipients, mechanisms and kinetics of degradation reactions, since any changes directly influence the quality of the product. The aim of the present work is to evaluate the solid pharmaceutical formulations containing MLX found on the market defining more suitable excipients to improve the stability of pharmaceutical formulations. Thermal analysis techniques were used to characterize and evaluate the compatibility between the drug and the excipients present in the market formulations. Method by high performance liquid chromatography was developed and validated for quantification of MLX and possible degradation products. Alternative method by UV spectrophotometry was validated for quantification of MLX in the formulations. In the study of compatibility between drug-excipient was found incompatibility with magnesium stearate, red iron oxide, povidone, sodium starch glycolate and mannitol. In the study of intrinsic stability, the drug was subjected to conditions of forced degradation where it was unstable in alkaline medium. In the evaluation of the solid state kinetics, the MLX degraded according to AvramiErofeyev A4 model, presenting a shelf life of about 6 years for the raw material under inert condition. In the evaluation of the quality control of the products of the market, it was observed that the Lab10 and Lab11 were disapproved in the dissolution test. As for the evaluation of the dissolution profile only two products have been shown to be pharmaceutical equivalents
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    Investigação de parâmetros de inflamação e estresse oxidativo em pacientes com diabetes mellitus tipo 2 usuários e não usuários de insulinoterapia
    (Universidade Federal do Espírito Santo, 2017-02-22) Paiva, Kainá Kiffer; Gonçalves, Rita de Cássia Ribeiro; Guimarães do Bem, Daniela Amorim Melgaço; Rodrigues, Lívia Carla de Melo; Borges, Karina Braga Gomes
    Type 2 diabetes mellitus (DM2) is a metabolic disorder resulting from hyperglycemia and insulin resistance which is characterized by increased production of reactive species leading to oxidative stress and inflammatory changes. The goal of this study was to investigate whether the use of insulin therapy in patients with Type 2 Diabetes Mellitus influences levels of inflammatory markers and oxidative stress. It is a clinical study in which 80 patients diagnosed with T2DM (40 in insulin therapy and 40 without insulin therapy) and 40 in the control group (without DM2) were selected. Adherence to treatment was assessed by the Morisky-Green test. Metabolic control was evaluated through tests of fasting glycemia, glycated hemoglobin and lipid profile. Oxidative stress was investigated through levels of nitric oxide (NO), lipid peroxidation (Malondialdehyde - MDA) and superoxide dismutase (SOD). The inflammation evaluation was performed through the markers: tumor necrosis factor alpha (TNFα), ultra sensitive C reactive protein (CRP) and fibrinogen. In addition, the -308 G / A polymorphism was investigated in the promoter region of the TNFα gene and its correlation with its plasma levels. In this study, an inadequate glycemic control was found in patients with DM2 who were on insulin therapy and a low adherence to treatment in both DM2 groups (approximately 50% of the patients). The DM2 group with insulin therapy had lower levels of NO and SOD, higher levels of fibrinogen and TNF-α, and lower levels of CRP than the DM2 group without insulin therapy. In lipid peroxidation both groups of patients with DM2 had higher levels of MDA than controls. There was no correlation of the -308 G / A polymorphism in the promoter region of the TNF-α gene with its plasma levels in patients with T2DM. In conclusion, patients with DM2, who are users or not of insulin therapy, have increased oxidative stress and inflammation, which may contribute to the various complications of the disease.