Pharmacokinetic Comparison of a Unit Dose Dry Powder Inhaler with a Multidose Dry Powder Inhaler for Delivery of Fluticasone Furoate

• DOI: 10.1089/jamp.2016.1322
• Publication Date: 2017-05-02T16:06:29Z
• Authors: Rashmi Mehta; Alison Moore; Kylie Riddell; Shashidhar Joshi; Robert Chan
• Keywords: Dry-powder inhaler; Fluticasone propionate; Fluticasone; Metered-dose inhaler

The unit dose dry powder inhaler (UD-DPI) is being considered as an alternative platform that, if developed, has the potential to improve access inhaled respiratory medicines in developing countries.This study compared systemic exposure of fluticasone furoate after delivery from UD-DPI with that ELLIPTA® inhaler.This open-label, five-way cross-over, randomized, single-dose healthy subjects evaluated three strengths (using four inhalations), 4 × 80 μg [320 μg], 100 [400 and 140 [560 μg]), two percentages drug lactose blends (0.6% 0.8% by weight) exposures ELLIPTA (4 μg] dose, blend). primary treatment comparisons were area under concentration-time curve time 0 6 hours [AUC0-6] maximum plasma concentration [Cmax].After administration furoate, was lower all formulations versus terms both AUC0-6 [AUC0-6 geometric least squares mean (GLM) ratios confidence interval (90% CI) for: (400 blend)/ELLIPTA: 0.61 (0.55-0.67) Cmax GLM 0.56 (0.49-0.64)]. Systemic ∼10% for blend 0.6% [GLM ratio CI); 0.90 (0.81-1.00) 0.89 (0.77-1.01) Cmax], increasing doses showed approximately proportional. All treatments well tolerated.Fluticasone than inhaler, but did demonstrate detectable levels approximate proportionality. Together good tolerability shown, these data support further evaluation a device delivering drugs.