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

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 m...

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Published in:International journal of pharmaceutics 2002-10, Vol.245 (1), p.93-98
Main Authors: Janssen, R, Weda, M, Ekkelenkamp, M.B, Lammers, J-W.J, Zanen, P
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Language:English
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cited_by cdi_FETCH-LOGICAL-c391t-25ca46597d6b244d1f6fa416c0ce172d149642eaefe1ddb651d890e47f881fe13
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container_issue 1
container_start_page 93
container_title International journal of pharmaceutics
container_volume 245
creator Janssen, R
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Ekkelenkamp, M.B
Lammers, J-W.J
Zanen, P
description 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 μg) 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 ( P0.05). In conclusion, there are no significant differences between the Volumatic® and Nebuchamber® either in vivo or in vitro.
doi_str_mv 10.1016/S0378-5173(02)00330-7
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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 μg) 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&lt;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 μg 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&gt;0.05). 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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 μg) 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&lt;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 μg 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&gt;0.05). 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Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Plastics</topic><topic>Respiratory system</topic><topic>Salbutamol</topic><topic>Volumatic</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Janssen, R</creatorcontrib><creatorcontrib>Weda, M</creatorcontrib><creatorcontrib>Ekkelenkamp, M.B</creatorcontrib><creatorcontrib>Lammers, J-W.J</creatorcontrib><creatorcontrib>Zanen, P</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of pharmaceutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Janssen, R</au><au>Weda, M</au><au>Ekkelenkamp, M.B</au><au>Lammers, J-W.J</au><au>Zanen, P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Metal versus plastic spacers: an in vitro and in vivo comparison</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2002-10-01</date><risdate>2002</risdate><volume>245</volume><issue>1</issue><spage>93</spage><epage>98</epage><pages>93-98</pages><issn>0378-5173</issn><eissn>1873-3476</eissn><coden>IJPHDE</coden><abstract>This study compared the metal Nebuchamber® with the polycarbonate Volumatic® spacer in vivo as well as in vitro. 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subjects Administration, Inhalation
Adult
Albuterol - administration & dosage
Albuterol - therapeutic use
Asthma - drug therapy
Biological and medical sciences
Bronchodilation
Bronchodilator Agents - administration & dosage
Bronchodilator Agents - therapeutic use
Cross-Over Studies
Dose-Response Relationship, Drug
Double-Blind Method
Female
General pharmacology
Humans
In vitro
Inhalation Spacers
Male
Medical sciences
Metals
Middle Aged
Nebuchamber
Particle Size
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Plastics
Respiratory system
Salbutamol
Volumatic
title Metal versus plastic spacers: an in vitro and in vivo comparison
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