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  • Title: The Pharmacokinetics of Fluticasone Furoate Given Intranasally in Healthy Subjects Using an Ultra-Sensitive Analytical Assay.
    Author: Bouhajib M, Tayab Z.
    Journal: Drug Res (Stuttg); 2020 Jul; 70(7):310-316. PubMed ID: 32485781.
    Abstract:
    PURPOSE: It has been previously shown that the complete pharmacokinetic profile, in particular the elimination phase, of intranasal fluticasone furoate has not been fully characterized due to the inability to quantify concentrations at low enough levels. This study was designed to evaluate the pharmacokinetic profile of intranasal FF using a validated, ultra-sensitive analytical method in healthy subjects. METHODS: This was an open-label, single-dose, two-period, one-treatment, crossover study. A dose of 880 µg fluticasone furoate was administered intra nasally. Blood samples for pharmacokinetic analysis were collected at 23 time points up to 36 h and analyzed for FF plasma levels using a lower limit of quantitation (LLOQ) of 0.1 pg/mL. Medical and adverse events (AE) were monitored throughout the study. RESULTS: Eighteen subjects were enrolled in and 17 completed the study. The results showed that all 17 subjects had measurable fluticasone furoate plasma concentrations at all time points with a clearly defined elimination phase, thus allowing estimation of AUCinf and t1/2. Median Tmax was 1.33 h (range=0.75-6.00), mean Cmax was 13.05±7.59 pg/mL, mean AUCt was 148.48±77.76 pg/mL*h, mean AUCinf was 279.07±187.81 pg/mL*h, and mean t1/2 was 31.67±29.23 h. In total 4 subjects (22.2%) experienced 4 AEs. CONCLUSION: Using a lower LLOQ than what has been previously reported, a complete characterization of intranasal fluticasone furoate pharmacokinetics, including a clearly defined terminal elimination phase, was achieved. This method will allow for further investigations into the pharmacokinetics of fluticasone furoate.
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