Bioavailability of inhaled fluticasone propionate via chambers/masks in young children.

Abstract

We determined lung bioavailability of a fluticasone propionate (FP) pressurised metred-dose inhaler (Flovent HFA; GlaxoSmithKline, Research Triangle Park, NC, USA) administered via AeroChamber Plus (Monaghan Medical, Plattsburgh, NY, USA) with Facemask and Babyhaler (GlaxoSmithKline) valved holding chambers (VHCs) using a population pharmacokinetic approach. Children from 1 to <4 yrs of age with stable asthma but a clinical need for inhaled corticosteroid therapy were administered 88 μg FP hydrofluoroalkane (2 × 44 μg) twice daily delivered through the two devices in an open-label, randomised crossover manner for 8 days each. Patients were randomised to one of three sparse sampling schedules for blood collection throughout the 12-h dosing interval on the 8th day of each treatment for pharmacokinetic analysis. The area under the FP plasma concentration-time curve (AUC) was determined for each regimen. 17 children completed the study. The population mean AUC following FP with AeroChamber Plus with Facemask was 97.45 pg·h·mL(-1) (95% CI 85.49-113.32 pg·h·mL(-1)) and with Babyhaler was 51.55 pg·h·mL(-1) (95% CI 34.45-64.46 pg·h·mL(-1)). The relative bioavailability (Babyhaler/AeroChamber Plus) was 0.53 (95% CI 0.30-0.75). Clinically significant differences in lung bioavailability were observed between the devices. VHCs are not interchangeable, as differences in drug delivery to the lung may occur. A population pharmacokinetic approach can be used to determine lung bioavailability of FP.

• Authors: K Blake, R Mehta, T Spencer, R L Kunka, L Hendeles
• Journal: The European respiratory journal (Eur Respir J) Vol. 39 Issue 1 Pg. 97-103 (Jan 2012) ISSN: 1399-3003 [Electronic] England
• PMID: 21933835 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenal Cortex Hormones
• Androstadienes
• Bronchodilator Agents
• Fluticasone

Topics

• Administration, Inhalation
• Adrenal Cortex Hormones (administration & dosage)
• Androstadienes (administration & dosage, pharmacokinetics)
• Area Under Curve
• Asthma (drug therapy)
• Biological Availability
• Bronchodilator Agents (administration & dosage, pharmacokinetics)
• Child, Preschool
• Cross-Over Studies
• Drug Administration Schedule
• Equipment Design
• Female
• Fluticasone
• Hospitals, Pediatric
• Humans
• Infant
• Lung (drug effects)
• Male
• Nebulizers and Vaporizers