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

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.

Systemic exposure and urinary cortisol effects of fluticasone propionate formulated with hydrofluoroalkane in 4- to 11-year-olds with asthma.

The systemic exposure of fluticasone propionate with hydrofluoroalkane propellant compared with chlorofluoro-carbon propellant and the effect of fluticasone propionate hydrofluoroalkane on 24-hour urinary cortisol in children aged 4 to 11 years with asthma were evaluated. Study 1 was an open-label, 2-way crossover study in which 16 subjects were randomized to 7.5 days each of fluticasone propionate hydrofluoroalkane 88 mug twice a day or fluticasone propionate chlorofluorocarbon 88 mug twice a day.

An automated method for the determination of montelukast in human plasma using dual-column HPLC analysis and peak height summation of the parent compound and its photodegradation product.

Purpose: To develop an assay to evaluate the bioequivalence of overcoated and marketed montelukast formulations, the former to be used for future blinded clinical studies.

Methods: The method used automated 96-well sample preparation and dual-column HPLC analysis for increased throughput. Regression analysis was performed using the total peak height of montelukast and its photodegradent, a cis-ethenyl geometric isomer.

Bioavailability of fluticasone propionate and mometasone furoate aqueous nasal sprays.

Objectives: To compare the systemic exposure for intranasal mometasone furoate (MF) and fluticasone propionate (FP) aqueous nasal sprays (ANS) in terms of serum and urinary cortisol parameters and plasma pharmacokinetics.

Methods: Twelve healthy subjects completed this three-way, cross-over study. They received FPANS (50 microg/spray), MFANS (50 microg/spray) or placebo ANS, eight sprays per nostril every 8 h for 4 days.

Comparison of the systemic availability of fluticasone propionate in healthy volunteers and patients with asthma.

Objectives: The aim of this analysis was to compare the systemic exposure to inhaled fluticasone propionate (FP) after administration of either single or repeated dose regimens via dry powder and metered-dose inhalers in patients with asthma and healthy volunteers.

Background: The pharmacokinetics of FP, a topically active glucocorticoid administered by inhalation for the treatment of asthma and rhinitis, are well characterised in healthy volunteers. As asthma is characterised by pathophysiological changes in the lung, it may be inappropriate to use data from studies in healthy volunteers to predict the deposition and absorption of FP in patients with asthma.