title: Pharmacodynamic evaluation and physical/chemical analysis of two formulations of propofol used in target-controlled infusion.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors: Centro de Ensino e Treinamento from Sociedade Brasileira de Anestesiologia, Instituto Penido Burnier and Centro Médico de Campinas, Campinas, Sao Paulo, Brazil. ricaboss@gmail.com
authors: Ricardo Francisco
authors: RF
authors: Simoni
authors: Luiz Eduardo
authors: LE
authors: de Paula Gomes Miziara
authors: Luis Otávio
authors: LO
authors: Esteves
authors: João Gilberto
authors: JG
authors: Ribeiro D'Castro
authors: Carlos Alberto
authors: CA
authors: Morales
authors: Carlos Eduardo
authors: CE
authors: Esqueapatti Sandrin
authors: Thaís Costa
authors: TC
authors: Contente
authors: Diogo
authors: D
authors: Oliveira-Silva
mesh_terms: D000328:Adult; D018686:Anesthetics, Intravenous / Q000008:administration & dosage / Q000493:pharmacokinetics*; D055598:Chemical Phenomena; D002626:Chemistry, Pharmaceutical; D004311:Double-Blind Method; D006801:Humans; D007262:Infusions, Intravenous / Q000379:methods; D008297:Male; D015742:Propofol / Q000008:administration & dosage / Q000493:pharmacokinetics*
chemical_list: D018686:Anesthetics, Intravenous; D015742:Propofol