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Tuesday 01 October 2002

Metal versus plastic spacers: an in vitro and in vivo comparison.

By: Janssen R, Weda M, Ekkelenkamp MB, Lammers JW, Zanen P.

Int J Pharm 2002 Oct 1;245(1-2):93-8

This study compared the metal Nebuchamber with the polycarbonate Volumatic spacer in vivo as well as in vitro. Seventeen asthmatic patients were evaluated in a crossover placebo-controlled double-blind study. Bronchodilation, heart rate and serum potassium levels were measured at baseline and 15 min after administration of salbutamol. Cumulative dose-response curves (200, 400, 800 and 1600 microg) were constructed. The Andersen Cascade Impactor was used to compare the aerodynamic particle size distribution. The FEV(1) measurements showed highly significant differences between placebo and the two active preparations (P<0.001), but not between the two active preparations (P=0.433). The serum potassium levels also showed highly significant differences between placebo and the two active preparations (P=0.009), but not between the two active preparations (P=0.532). Only 1600 microg salbutamol dose raised the heart rate significantly, but the difference between the two active preparations was not significant. The in vitro deposition study revealed no significant differences in the delivered dose or in the fine particle dose (P>0.05). In conclusion, there are no significant differences between the Volumatic and Nebuchamber either in vivo or in vitro.

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