title: Analysis of the immunogenicity and stability of a porcine pulmonary surfactant preparation administered in rabbits.
abstract: OBJECTIVE
  To study the immunogenicity and the stability of the porcine pulmonary surfactant preparation produced by the Instituto Butantan.
  
  
  METHODS
  Immunogenicity assay: Sixteen New-Zealand-White rabbits (1000 g body weight) were divided into 4 study groups. Each group was assigned to receive either a) Butantan surfactant, b) Survanta (Abbott Laboratories), c) Curosurf (Farmalab Chiesi), or d) no surfactant. The surfactants were administered intratracheally, and the animals were collected immediately before and 60 and 180 days after surfactant administration. Sera were assayed for the presence of antisurfactant antibodies by enzyme-linked immunosorbent assay (ELISA). Stability assay: The Butantan surfactant used in this assay had been stored for one year in the refrigerator (4 to 8 degrees C) and its stability was evaluated in distinct assay conditions using a premature rabbit model.
  
  
  RESULTS
  Immunogenicity assay: None of the surfactants analyzed triggered antibody immune responses against their components in any of the animals. Stability assay: The results of this study demonstrate that Butantan surfactant was as effective as Curosurf when both were submitted to the adverse circumstance of short- and long-term storage at room temperature. A similar level of efficacy for the Butantan surfactant, as compared to Curosurf was demonstrated by the pulmonary dynamic compliance, ventilatory pressure, and pressure-volume curve results.
  
  
  CONCLUSIONS
  The results of our study demonstrate that Butantan surfactant may be a suitable alternative for surfactant replacement therapy.
authors: Pediatrics Department, São Paulo University Medical School, São Paulo, SP, Brazil. aprecioso@uol.com.br
authors: Alexander R
authors: AR
authors: Precioso
authors: Paula P O
authors: PP
authors: Sakae
authors: Renata S
authors: RS
authors: Mascaretti
authors: Flávia S
authors: FS
authors: Kubrusly
authors: Vera C B Cainelli
authors: VC
authors: Gebara
authors: Dmitri
authors: D
authors: Iourtov
authors: Celso M
authors: CM
authors: Rebello
authors: Flávio A C
authors: FA
authors: Vaz
authors: Isaías
authors: I
authors: Raw