Navegando por Palavras-chave "Pharmacology, Clinical"

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    Avaliação farmacodinâmica e análise físico-química de duas formulações de propofol usadas em infusão alvo-controlada
    (Sociedade Brasileira de Anestesiologia, 2013-02-01) Simoni, Ricardo Francisco; Miziara, Luiz Eduardo De Paula Gomes; Esteves, Luis Otávio; D'castro, João Gilberto Ribeiro; Morales Jr, Carlos Alberto; Sandrin, Carlos Eduardo Esqueapatti; Contente, Thaís Costa; Oliveira-Silva, Diogo [UNIFESP]; Instituto Penido Burnier Sociedade Brasileira de Anestesiologia Centro de Ensino e Treinamento; Centro Médico de Campinas; Hospital Santa Sofia; Universidade de São Paulo (USP); Universidade Federal de São Paulo (UNIFESP)
    BACKGROUND AND OBJECTIVES: There are several formulations of propofol available to the anesthesiologist for clinical use. The aim of this study was to analyze the physicochemical properties, pharmacodynamic effect, and pharmaceutical and clinical equivalence of the reference drug propofol as well as a similar formulation. METHOD: Sixteen volunteers were enrolled in this randomized, double-blind, and paired study of Diprivan® and Propovan® formulations. Formulations were given as target-controlled infusion with target concentration of 3.0 μg.mL-1 for 15 minutes. Variables studied were the area under the curve (AUC) of the bispectral index (BIS) graph regarding time, minimum BIS reached and time to reach it, and recovery time. The two formulations were sent to analysis of particle size of lipid emulsion, surface potential, and active principle quantification. RESULTS: There was no difference between the formulations when comparing AUC, minimum BIS reached and time to reach it. The similar formulation recovery time was lower compared to the reference formulation (eight and 10 min, respectively, p = 0.014). Mean particle size of lipid emulsion, surface potential, and active ingredient quantification were similar for both formulations. CONCLUSION: There was no clinically significant difference between the use of propofol, reference Diprivan®, and the similar Propovan® during infusion. However, the recovery time was longer with the reference drug. Although analysis of both formulations studied show similar results regarding its physicochemical characterization, further studies should be conducted to justify this difference.