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.affiliation: TSA; MD; Co-responsible for Centro de Ensino e Treinamento (CET) from Sociedade Brasileira de Anestesiologia (SBA), Instituto Penido Burnier and Centro Médico de Campinas. Electronic address: ricaboss@gmail.com.
authors.forename: Ricardo Francisco
authors.initials: RF
authors.lastname: Simoni
authors.affiliation: Anesthesiologist, Hospital Santa Soﬁa and Centro Médico de Campinas.
authors.forename: Luiz Eduardo de Paula Gomes
authors.initials: LE
authors.lastname: Miziara
authors.affiliation: TSA; Co-responsible for CET-SBA, Instituto Penido Burnier and Centro Médico de Campinas.
authors.forename: Luis Otávio
authors.initials: LO
authors.lastname: Esteves
authors.affiliation: ME3; CET-SBA Instituto Penido Burnier and Centro Médico de Campinas.
authors.forename: João Gilberto Ribeiro
authors.initials: JG
authors.lastname: D'Castro
authors.affiliation: ME3; CET-SBA Instituto Penido Burnier and Centro Médico de Campinas.
authors.forename: Carlos Alberto
authors.initials: CA
authors.lastname: Morales
authors.affiliation: ME3; CET-SBA Instituto Penido Burnier and Centro Médico de Campinas.
authors.forename: Carlos Eduardo Esqueapatti
authors.initials: CE
authors.lastname: Sandrin
authors.affiliation: PhD; Researcher at Faculdade de Ciências Farmacêuticas, Universidade de São Paulo.
authors.forename: Thaís Costa
authors.initials: TC
authors.lastname: Contente
authors.affiliation: PhD; Associate Professor at Universidade Federal de São Paulo (Unifesp), Campus Diadema.
authors.forename: Diogo
authors.initials: D
authors.lastname: Oliveira-Silva
mesh_terms: D000328:Adult; D018686:Anesthetics, Intravenous / Q000737:chemistry* / Q000494:pharmacology*; D002626:Chemistry, Pharmaceutical; D056805:Consciousness Monitors; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D015742:Propofol / Q000737:chemistry* / Q000494:pharmacology*
chemical_list: D018686:Anesthetics, Intravenous; D015742:Propofol
keywords: Anesthesia; Clinical; Consciousness Monitors; Intravenous; Pharmacology; Propofol